TYMPANOMETRY
1) Tympanometer
Definition:
A tympanometer is an instrument, which provides information on the functioning and status of the middle ear.
2) Tympanometry:
Definition:
Tympanometry is an objective test and as it requires little cooperation, it can be carried out at any age and with any degree of deafness. It always for the measurement of the elasticity or compliance of the introduced into the middle ear system.
Tympanometry is one of three principal subtests of immittance audiometry. Immittance audiometry is an objective procedure that assesses, in an individual ear, the relative impedance (resistance offered to the flow of energy in acoustics signals) and admittance or compliance (the reciprocal of impedance, and the case with which the ear accepts the flow of energy in an acoustic signal). The other two subtests of immittance audiometry are static admittance/ compliance and the acoustic reflex test. The general term ‘immittance’ is used to indicate the principle of evaluating energy flow. Particular test equipment may measure either impedance or admittance.
Explanation:
Tympanometry assesses the ability of the tympanic membrane to accept sound, and is therefore a test of the conductive mechanism of the ear. It is a dynamic measure, meaning that the tympanic membrane is in motion during the test. The basic approach in tympanometry is to introduce a pure-tone (usually 220 Hz or 660 Hz) into the external auditory meatus and to measure how much of that sound wave is accepted (admitted) or rejected (impeded) by the tympanic membrane. In a normal ear the tympanic membrane will accept most of the sound and will do this when the air in the external auditory meatus is at or very close to normal atmospheric pressure.
During tympanometry, air pressure, expressed in decapascals (daPa) or millimeters of water (mm water), is varied continuously in the external auditory meatus from values greater than normal atmospheric pressure (usually + 200daPa/mm water), through normal atmospheric pressure (0 daPa/mm water), to values less than atmospheric pressure (usually- 200 daPa/mm water). This causes the tympanic membrane to move in the response to the positive and negative pressure allied to it.
3) Tympanogram-
Tympanometry results are plotted, either automatically or manually, on a tympanogram, a graph of impedance/admittance values against air pressure values.
By using handtymp we can get the tympanogram. It is very important to hold the handtymp properly. We have to set the tip in right position. Other wise it would be difficult for anyone to get the tympanogram. Then we can press the button until the pick showing. Thus we can have the result of the tympanogram. From this we can know air pressure, canal position, eardrum mobility etc. If the pick is in the range of 0.35-1.4 the compliance is normal. If the pick is in the range of –100-+50 the middle ear pressure is normal. And for other range it is not normal.
4) Instructions for the tympanometry
We should follow these instructions for the tympanometry-
a) Tympanometry may be carried out in almost any reasonably quiet room.
b) As very low levels of ambient noise are not required, although the British society of Audiology recommends that the ambient room noise be less than 50 dB A SPL, if possible (BSA, 1992).
c) The range of equipment available is considerable.
d) Glove should be used during middle ear testing.
e) An auroscope or otoscope is required for inspection of the external auditory meatus.
f) The tympanometer should be hold in proper way
g) The button of the tympanometer should be pressed until the pick showing.
h) The tip of the tympanometer should be set correctly in the ear.
i) Tip size will be well fitted for the client
j) Different tip for different client
k) All of the equipment will be neat and clean
l) Before starting test we have to check all of the equipments.
m) Set up the room and equipment to ensure satisfactory hygiene and client co-operation.
n) Washing hands and follow other hygiene protocols as appropriate
5) Instructions for testing the client
We have to always follow the instruction for testing the client-
a) Explain the test and instruct the client.
b) Inspect the pinna visually and the external auditory canal with an otoscope to determine the size and angle of lateral portion and to check for any contraindications to tympanometry.
c) Contraindications include discharge from the ear, wax occlusion, tenderness of the ear, foreign bodies and obvious perforation or inflammation of the tympanic membrane (ASHA< 1990c; BSA, 1992)
d) Select an appropriate sized probe tip for the client.
e) For all the things we have to get permission from the client.
f) Asking the client to open their mouth, and pull the pinna upwards and backwards
g) These actions will straighten the lateral, cartilaginous portion of the external auditory canal and make insertion easier.
h) If using an automatic tympanometer, the instrument will indicate whether or not an airtight seal has been obtained.
i) Inform the client of the result, taking care not to interpret beyond the available data.
j) Keep appropriate records, ensuring that the date of tympanometry screening is recorded.
References
a) Doyle, J., (2002), Practical audiology for Speech-language therapy, Whurr Publishers, London.
b) Bess, F.H.; Humes, L.E.; (1990), Audiology the Fundamentals, Wiliams & Wilkins, Baltimore.
c) Tucker, I.; Powell, C. (1991), The Hearing Impaired Child and School, A condor book, London
Dr. Md. Sohel Ahmed
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সোমবার, ২৭ সেপ্টেম্বর, ২০১০
Hearing Aid
Hearing aid
Definition:
Hearing aids are electroacoustic instruments that improve the audibility of speech and other important signals for the person with hearing loss. (Doyle, 2002)
The aim is to amplify the volume of the signal to a level that is, on average, above the individual’s hearing threshold and below that individual’s level of discomfort, so that the signal is comfortably audible, and to do so in a way that maximizes the intelligibility of speech signals.
Parts of a hearing aid
Hearing aids come in many shapes and sizes but they all have the same basic components.
The main parts of any hearing aid are:
1) Microphone
2) Amplifier
3) Lead (or cord)
4) Receiver (earphone)
5) Earmould
6) Battery
7) Volume control
8) On-off switch
In addition to the above components many hearing aids also have:
9) Tone control (may be inside)
10) Telecoil (T switch)
11) Maximum output control (Inside)
12) Gain control (Inside)
13) Audio input connection
The inside controls are for the audiologist to set, not for the wearer to adjust himself.
How does it work?
1) The microphne picks up sound from the environment and converts it from an acoustic signal to an electronic signal.
2) The amplifier processes and amplifies the electronic signal.
3) The receiver works like a speaker and converts the amplified electronic signal back to acoustic signals.
4) The sound is delivered to the ear canal through a tube in the earmould or via the hearing aid shell
5) All hearing aids require a battery to supply power to the system
6) The amount of amplification (or gain) is varied by means of the volume control.
7) The on/off switch turns the hearing aid on or off (Some times there is no separate on/off switch but the aid is turned off by the volume control)
8) When telecoil is in use the aid can pick up electromagnetic signals from a telephone or inductive loop.
9) Low cut tone control gives more high frequency emphasis by cutting the low frequency signals. It is sometimes used to cut background noise.
10) High cut tone control gives more low frequency emphasis by cutting the high frequency signals. It is sometimes used to reduce background noise.
11) The maximum output control (or peak clipping) limits the maximum intensity of sound that the aid will deliver.
12) The gain control reduces the maximum amplification.
13) A means for conection the aid directly to an FM radio receiver or other external device.
Types of hearing aids:
Hearing aids are most commonly classified by style, which is closely related to the size of the instrument. There are five basic types of hearing aid available today. These are-
1) Body-worn or Pocket hearing aid
2) Behind-the-ear (BTE) or Post-aural hearing aid
3) In the ear (ITE) aid
4) In the canal aid
5) Eyeglass or Spectacle aid
The Bone conduction hearing aid, Radio frequency (RF) or Frequency modulated (FM) are additional hearing aids.
When electroacoustic hearing aids were first developed several decades ago, the body aid was only type available. In the ensuring years, the other types of instrument were developed, with BTE hearing aids being the most common in the 1970s. During the 19980s, the trend has been for ITEs to capture an increasingly larger portion of the hearing aid market. The increasing popularity of the ITE and ITE and ITC hearing aids is a result of both consumer pressures to improve the cosmetic appeal of the devices and rapid developments in the field electronics. High fidelity electronic components and the batteries to power them have been drastically reduced in size, making the in the ear devices possible.
Description of various types of hearing aids:
1) Body-worn or Pocket hearing aid:
The largest and least frequently fitted aid is the body level hearing aid, which is worn clipped on to clothing, generally at chest level. The signal that is picked up and amplified in the body worn aid is fed to a receiver attached to a standard earmould. Because the microphone (Input transducer) and the receiver (output transducer) are a considerable distance apart, very powerful amplification may be provided with little risk of acoustic feedback. Even though powerful amplification is now available in much smaller aids, body-level aids remain appropriate for some individuals, particularly those who require very large controls because of reduced manual dexterity and/or poor vision.
2) Behind the ear (BTE) or Post-aural hearing aid:
In behind the ear (BTE) hearing aids all components are worn at ear level. The microphone, generally level with the top of the ear, is thus in a more natural position than it is in body aids. Even individuals with profound hearing losses may be fitted with BTE aids. Earmould styles and materials in BTE aids can vary greatly and are an important part of the sound delivery system. The same hearing aid can produce very different results with different earmoulds.
3) In the ear (ITE) aid:
In the ear (ITE) aids house all components in a custom made shell, which fits into the concha and external auditory meatus. The size of ITE aids varies with the size of the individual’s ear and the desired features. In the canal (ITC)
4) In the canal aid:
In the canal (ITC) hearing aids provide all components in a custom made shell that occupies the ear canal and less of the concha. The smallest aids are completely in the canal (CIC) aids, which are effectively not visible. There are some exciting developments in amplification with CIC. Deep canal hearing aids sit partly down in the bony portion of the ear canal and this appears to provide relief from the occlusion effect experienced by aid users who complain about how they hear their own voice.
Many smaller hearing aids cannot provide features (such as telicoil) beyond the standard microphone, amplifier, battery and receiver because of space limitation.
5) Eyeglass or Spectacle aid
Eyeglass or spectacle aids provide amplification through hearing aids built into the frame of spectacles. The amplified signal is fed via a tube to the ear canal. Spectacle aids may or may not be worn with earmoulds, depending on amplification.
Others:
Radio frequency (RF) or frequently modulated (FM) hearing aids are instruments in which the microphone is positioned at the sound source rather than at the ear of the listener. A type of aid that is fitted very infrequently is the bone conduction hearing aid, in which an oscillator placed on the mastoid and held in place by a spring steel band over the head replaces the output transducer. An advance on present situation is the implantable bone conduction aid (IHA) or bone anchored hearing aid (BAHA).
Hearing aids also can be classified as:
1) Analogue
2) Digital
1) Analogue:
Most hearing aids currently use ‘analogue’ circuits. These have developed a lot from the old ‘class A’ amplifiers and ‘class B’ push-pull amplifiers found in more powerful hearing aids (eg powermaster). Many aids now have ‘class D’ amplifiers in compression circuits.
2) Digital:
In the last few years a new range of hearing aids has been developed which use digital programming of analogue circuits. The aids are adjusted with the help of a computer. This often makes it easier to modify the frequency response according to the user’s audiogram.
The latest hearing aids use digital signal processing (sometimes called DSP or 100% digital). The electrical signal is converted into digital information and then ‘processed’ before being converted back to an analogue electrical signal and then into sound by the receiver.
One advantage is the lack of internal electrical noise. It is also possible to devide up, manipulate or ‘process’ the signal much more easily than with an analogue circuit.
Advantages of hearing aids:
Body worn hearing aids:
• Does not break easily.
• Cheap in rate
• Battery is available
• Easy to carry
• Safe for the client
• Easy to identify the problems
Behind the ear hearing aids:
• Not very visible
• Nice to look
• Need not wear in the body
• Can receive sounds from around of the client
• Modern pattern
• Very lightening
• Comfortable
Disadvantages of hearing aids:
Body worn hearing aids:
• Very visible
• Old fashion
• Does not look nice
• Not modern pattern
• Need to wear like a dress
• Not very comfortable
• Cannot receive all the sounds
Behind the ear hearing aids:
• Not cheap
• Battery is not available
• May break easily
• Repairment is not very easy
• Difficult to clean
Care and Maintenance of hearing aids:
Microphone:
a) The microphone is most effective within a distance of about 3 feet. Small children should wear their pocket hearing aids in a specially made belt or harness. This keeps the aid securely in the correct position.
b) With small children it must be protected from dirt, spiled food, drink etc by a baby cover
c) The microphone works on M setting (not T)
d) Switch off when not in use to save batteries.
Amplifier:
a) This consists of electronic components inside the case. They must be kept clean and dry.
b) The volume control determines the amount of amplification (or gain)
Cords (or leads):
a) A break in the lead sometimes causes an intermittent signal. (Sometimes on, sometimes off)
b) There should be no knots in the lead.
c) When the aid is not being used, the cord should be coiled correctly and loosely.
d) Different length cords are usually available. Try to get short cords for little children.
Receiver:
a) The receiver may be either 2 or 3 pin. It is matched to the aid. Do not allow children to exchange receivers.
b) If possible use a small size receiver with little children
c) Receivers are not easily damaged unless they get wet. Do not allow children to put the mouth.
Earmould:
a) This must be tight fitting or feedback and whistling occurs
b) Earmoulds must be kept clean. They should be removed from the receiver or hearing aid elbow and washed carefully in warm soapy water. They must be dried very carefully before replacing.
c) The tubing will need to be replaced about every six months
Batteries:
a) Pencil batteries run down gradually and must be changed frequently before they are drained.
b) Dead batteries must not be left in the hearing aid.
c) Post aural button batteries cut out suddenly. Spare batteries should be carried always.
d) Note that small button batteries contain poison. They must not be swallowed. Keep them away from babies.
References
a) Doyle, J., (2002), Practical audiology for Speech-language therapy, Whurr Publishers, London.
b) Bess, F.H.; Humes, L.E.; (1990), Audiology the Fundamentals, Wiliams & Wilkins, Baltimore.
c) Tucker, I.; Powell, C. (1991), The Hearing Impaired Child and School, A condor book, London
Definition:
Hearing aids are electroacoustic instruments that improve the audibility of speech and other important signals for the person with hearing loss. (Doyle, 2002)
The aim is to amplify the volume of the signal to a level that is, on average, above the individual’s hearing threshold and below that individual’s level of discomfort, so that the signal is comfortably audible, and to do so in a way that maximizes the intelligibility of speech signals.
Parts of a hearing aid
Hearing aids come in many shapes and sizes but they all have the same basic components.
The main parts of any hearing aid are:
1) Microphone
2) Amplifier
3) Lead (or cord)
4) Receiver (earphone)
5) Earmould
6) Battery
7) Volume control
8) On-off switch
In addition to the above components many hearing aids also have:
9) Tone control (may be inside)
10) Telecoil (T switch)
11) Maximum output control (Inside)
12) Gain control (Inside)
13) Audio input connection
The inside controls are for the audiologist to set, not for the wearer to adjust himself.
How does it work?
1) The microphne picks up sound from the environment and converts it from an acoustic signal to an electronic signal.
2) The amplifier processes and amplifies the electronic signal.
3) The receiver works like a speaker and converts the amplified electronic signal back to acoustic signals.
4) The sound is delivered to the ear canal through a tube in the earmould or via the hearing aid shell
5) All hearing aids require a battery to supply power to the system
6) The amount of amplification (or gain) is varied by means of the volume control.
7) The on/off switch turns the hearing aid on or off (Some times there is no separate on/off switch but the aid is turned off by the volume control)
8) When telecoil is in use the aid can pick up electromagnetic signals from a telephone or inductive loop.
9) Low cut tone control gives more high frequency emphasis by cutting the low frequency signals. It is sometimes used to cut background noise.
10) High cut tone control gives more low frequency emphasis by cutting the high frequency signals. It is sometimes used to reduce background noise.
11) The maximum output control (or peak clipping) limits the maximum intensity of sound that the aid will deliver.
12) The gain control reduces the maximum amplification.
13) A means for conection the aid directly to an FM radio receiver or other external device.
Types of hearing aids:
Hearing aids are most commonly classified by style, which is closely related to the size of the instrument. There are five basic types of hearing aid available today. These are-
1) Body-worn or Pocket hearing aid
2) Behind-the-ear (BTE) or Post-aural hearing aid
3) In the ear (ITE) aid
4) In the canal aid
5) Eyeglass or Spectacle aid
The Bone conduction hearing aid, Radio frequency (RF) or Frequency modulated (FM) are additional hearing aids.
When electroacoustic hearing aids were first developed several decades ago, the body aid was only type available. In the ensuring years, the other types of instrument were developed, with BTE hearing aids being the most common in the 1970s. During the 19980s, the trend has been for ITEs to capture an increasingly larger portion of the hearing aid market. The increasing popularity of the ITE and ITE and ITC hearing aids is a result of both consumer pressures to improve the cosmetic appeal of the devices and rapid developments in the field electronics. High fidelity electronic components and the batteries to power them have been drastically reduced in size, making the in the ear devices possible.
Description of various types of hearing aids:
1) Body-worn or Pocket hearing aid:
The largest and least frequently fitted aid is the body level hearing aid, which is worn clipped on to clothing, generally at chest level. The signal that is picked up and amplified in the body worn aid is fed to a receiver attached to a standard earmould. Because the microphone (Input transducer) and the receiver (output transducer) are a considerable distance apart, very powerful amplification may be provided with little risk of acoustic feedback. Even though powerful amplification is now available in much smaller aids, body-level aids remain appropriate for some individuals, particularly those who require very large controls because of reduced manual dexterity and/or poor vision.
2) Behind the ear (BTE) or Post-aural hearing aid:
In behind the ear (BTE) hearing aids all components are worn at ear level. The microphone, generally level with the top of the ear, is thus in a more natural position than it is in body aids. Even individuals with profound hearing losses may be fitted with BTE aids. Earmould styles and materials in BTE aids can vary greatly and are an important part of the sound delivery system. The same hearing aid can produce very different results with different earmoulds.
3) In the ear (ITE) aid:
In the ear (ITE) aids house all components in a custom made shell, which fits into the concha and external auditory meatus. The size of ITE aids varies with the size of the individual’s ear and the desired features. In the canal (ITC)
4) In the canal aid:
In the canal (ITC) hearing aids provide all components in a custom made shell that occupies the ear canal and less of the concha. The smallest aids are completely in the canal (CIC) aids, which are effectively not visible. There are some exciting developments in amplification with CIC. Deep canal hearing aids sit partly down in the bony portion of the ear canal and this appears to provide relief from the occlusion effect experienced by aid users who complain about how they hear their own voice.
Many smaller hearing aids cannot provide features (such as telicoil) beyond the standard microphone, amplifier, battery and receiver because of space limitation.
5) Eyeglass or Spectacle aid
Eyeglass or spectacle aids provide amplification through hearing aids built into the frame of spectacles. The amplified signal is fed via a tube to the ear canal. Spectacle aids may or may not be worn with earmoulds, depending on amplification.
Others:
Radio frequency (RF) or frequently modulated (FM) hearing aids are instruments in which the microphone is positioned at the sound source rather than at the ear of the listener. A type of aid that is fitted very infrequently is the bone conduction hearing aid, in which an oscillator placed on the mastoid and held in place by a spring steel band over the head replaces the output transducer. An advance on present situation is the implantable bone conduction aid (IHA) or bone anchored hearing aid (BAHA).
Hearing aids also can be classified as:
1) Analogue
2) Digital
1) Analogue:
Most hearing aids currently use ‘analogue’ circuits. These have developed a lot from the old ‘class A’ amplifiers and ‘class B’ push-pull amplifiers found in more powerful hearing aids (eg powermaster). Many aids now have ‘class D’ amplifiers in compression circuits.
2) Digital:
In the last few years a new range of hearing aids has been developed which use digital programming of analogue circuits. The aids are adjusted with the help of a computer. This often makes it easier to modify the frequency response according to the user’s audiogram.
The latest hearing aids use digital signal processing (sometimes called DSP or 100% digital). The electrical signal is converted into digital information and then ‘processed’ before being converted back to an analogue electrical signal and then into sound by the receiver.
One advantage is the lack of internal electrical noise. It is also possible to devide up, manipulate or ‘process’ the signal much more easily than with an analogue circuit.
Advantages of hearing aids:
Body worn hearing aids:
• Does not break easily.
• Cheap in rate
• Battery is available
• Easy to carry
• Safe for the client
• Easy to identify the problems
Behind the ear hearing aids:
• Not very visible
• Nice to look
• Need not wear in the body
• Can receive sounds from around of the client
• Modern pattern
• Very lightening
• Comfortable
Disadvantages of hearing aids:
Body worn hearing aids:
• Very visible
• Old fashion
• Does not look nice
• Not modern pattern
• Need to wear like a dress
• Not very comfortable
• Cannot receive all the sounds
Behind the ear hearing aids:
• Not cheap
• Battery is not available
• May break easily
• Repairment is not very easy
• Difficult to clean
Care and Maintenance of hearing aids:
Microphone:
a) The microphone is most effective within a distance of about 3 feet. Small children should wear their pocket hearing aids in a specially made belt or harness. This keeps the aid securely in the correct position.
b) With small children it must be protected from dirt, spiled food, drink etc by a baby cover
c) The microphone works on M setting (not T)
d) Switch off when not in use to save batteries.
Amplifier:
a) This consists of electronic components inside the case. They must be kept clean and dry.
b) The volume control determines the amount of amplification (or gain)
Cords (or leads):
a) A break in the lead sometimes causes an intermittent signal. (Sometimes on, sometimes off)
b) There should be no knots in the lead.
c) When the aid is not being used, the cord should be coiled correctly and loosely.
d) Different length cords are usually available. Try to get short cords for little children.
Receiver:
a) The receiver may be either 2 or 3 pin. It is matched to the aid. Do not allow children to exchange receivers.
b) If possible use a small size receiver with little children
c) Receivers are not easily damaged unless they get wet. Do not allow children to put the mouth.
Earmould:
a) This must be tight fitting or feedback and whistling occurs
b) Earmoulds must be kept clean. They should be removed from the receiver or hearing aid elbow and washed carefully in warm soapy water. They must be dried very carefully before replacing.
c) The tubing will need to be replaced about every six months
Batteries:
a) Pencil batteries run down gradually and must be changed frequently before they are drained.
b) Dead batteries must not be left in the hearing aid.
c) Post aural button batteries cut out suddenly. Spare batteries should be carried always.
d) Note that small button batteries contain poison. They must not be swallowed. Keep them away from babies.
References
a) Doyle, J., (2002), Practical audiology for Speech-language therapy, Whurr Publishers, London.
b) Bess, F.H.; Humes, L.E.; (1990), Audiology the Fundamentals, Wiliams & Wilkins, Baltimore.
c) Tucker, I.; Powell, C. (1991), The Hearing Impaired Child and School, A condor book, London
Pharmacy
Pharmacovigilance
Pharmacovigilance: Pharmacovigilance (PV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.
Generally pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to:
Identifying new information about hazards associated with medicines
Preventing harm to patients.
The etymological roots are: pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert, to keep watch.”
Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: "A response to a drug which is noxious and unintended, and which occurs at doses normally used… for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.
Pharmacovigilance is gaining importance for doctors and scientists as the number of stories in the mass media of drug recalls increases.Because clinical trials involve several thousand patients at most; less common side effects and ADRs are often unknown at the time a drug enters the market. Even very severe ADRs such as liver damage are often undetected because study populations are small. Postmarketing pharmacovigilance uses tools such as data mining and investigation of case reports to identify the relationships between drugs and ADRs.
IMPORTANCE OF PHARMACOVIGILANCE
• improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions.• improve public health and safety in relation to the use of medicines.• contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.• promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
1. Drug monitoring2. Pharmaceutical preparations - adverse effects3. Adverse drug reaction reporting4. Product surveillance, Postmarketing5. Legislation, Drug I.Series
Pharmacoenvironmentology:
A branch of environmental pharmacology and a form of pharmacovigilance which deals entry of chemicals or drugs into the environment after elimination from humans and animals post-therapy. It deals specifically with those pharmacological agents that have impact on the environment via elimination through living organisms subsequent to pharmacotherapy
Risks of medical treatment:
While medicines have led to major improvement in the treatment and control of diseases, they also produce adverse effects on the human body from time to time.
While many drugs are precisely targeted to the causes and mechanisms of disease, they may also have minor or distressing effects on other parts of the body, or interact negatively with the systems of the particular individual or with other drugs or substances they are taking, or not work well or at all for some, many or all of those who take them for illness.
There are risks in any intrusion into the human body, whether chemical or surgical. Nothing in this field is entirely predictable as the interaction between chemicals and the human body may produce surprises.
Terms commonly used in drug safety:
Benefits are commonly expressed as the proven therapeutic good of a product, but should also include the patient’s subjective assessment of its effects.
Risk is the probability of harm being caused, usually expressed as a percent or ratio of the treated population; the probability of an occurrence.
Harm is the nature and extent of the actual damage that could be caused. It should not be confused with risk.
Effectiveness is used to express the extent to which a drug works under real world circumstances, i.e., clinical practice (not clinical trials).
Efficacy is used to express the extent to which a drug works under ideal circumstances (i.e., in clinical trials).
Finding the risks of drugs:
Pharmaceutical companies are required by law in all countries to perform clinical trials, testing new drugs on people before they are made generally available. The manufacturers or their agents usually select a representative sample of patients for whom the drug is designed — at most a few thousand — along with a comparable control group. The control group may receive a placebo and/or another drug that is already marketed for the disease.
The purpose of clinical trials is to discover:
If a drug works and how well
If it has any harmful effects, and
Its benefit-harm-risk profile - does it do more good than harm, and how much more? If it has a potential for harm, how probable and how serious is the harm?
Clinical trials do, in general, tell us a good deal about how well a drug works and what potential harm it may cause. They provide information which should be reliable for larger populations with the same characteristics as the Trial group - age, gender, state of health, ethnic origin, and so on.
The variables in a clinical trial are specified and controlled and the results relate only to the population of which the trial group is a representative sample. A clinical trial can never tell you the whole story of the effects of a drug in all situations. In fact, there is nothing that could tell you the whole story, but a clinical trial must tell you enough; "enough" being determined by legislation and by contemporary judgments about the acceptable balance of benefit and harm.
Spontaneous reporting:
Spontaneous reporting is the core data-generating system of international pharmacovigilance, relying on healthcare professionals (and in some places consumers) to identify and report any suspected adverse drug reaction to their national pharmacovigilance center or to the manufacturer. Spontaneous reports are almost always submitted voluntarily.
One of this system’s major weaknesses is under-reporting, though the figures vary greatly between countries and in relation to minor and serious ADRs (also referred to as ICSRs, individual case safety reports).
Another problem is that overworked medical personnel do not always see reporting as a priority. If the symptoms are not serious, they may not notice them at all. And even if the symptoms are serious, they may not be recognised as the effect of a particular drug.
Even so, spontaneous reports are a crucial element in the worldwide enterprise of pharmacovigilance and form the core of the World Health Organization Database, which includes around 4.6 million reports (January 2009, growing annually by about 250,000
Other reporting methods:
Some countries legally oblige spontaneous reporting by physicians. In most countries, manufacturers are required to submit, through its Qualified Person for Pharmacovigilance QPPV, all the reports they receive from healthcare providers to the national authority. Others have intensive, focused programmes concentrating on new drugs, or on controversial drugs, or on the prescribing habits of groups of doctors, or involving pharmacists in reporting. All of these generate potentially useful information. Such intensive schemes, however, tend to be the exception.
International collaboration:
The principle of international collaboration in the field of pharmacovigilance is the principal basis for the WHO International Drug Monitoring Programme, through which over 90 member nations have systems in place which encourage healthcare personnel to record and report adverse effects of drugs in their patients. These reports are assessed locally and may lead to action within the country. Through membership of the WHO Programme one country can know if similar reports are being made elsewhere. (The European Union also has its own scheme.)
Member countries send their reports to the Uppsala Monitoring Centre where they are processed, evaluated and entered into the WHO International Database. When there are several reports of adverse reactions to a particular drug this process may lead to the detection of a signal — an alert about a possible hazard communicated to members countries. This happens only after detailed evaluation and expert review.
Pharmacovigilance of Herbal Medicines:
The safety of herbal medicines has become a major concern to both national health authorities and the general public[9]. The use of herbs in Traditional medicines continues to expand rapidly across the world. Many people now take herbal medicines or herbal products for their health care in different national health-care settings. However, mass media reports of adverse events tend to be sensational and give a negative impression regarding the use of Herbal medicines in general rather than identifying the causes of these events, which may relate to a variety of issues
Pharmacovigilance by region:
Europe:
The pharmacovigilance effort in Europe is coordinated by the European Medicines Agency (EMA) and conducted by the national competent authorities (NCAs). The main responsibility of the EMA is to maintain and develop the pharmacovigilance database consisting of all suspected serious adverse reactions to medicines observed in the European Community. The system is called EudraVigilance and contains separate but similar databases of human and veterinary reactions.
Europe requires the individual marketing authorisation holders (drug companies), to submit all received adverse reactions in electronic form (save in exceptional circumstances). The reporting obligations of the various stakeholders are defined in the Community legislation, in particular:
For human medicines, European Union Directive 2001/83/EC as amended and Directive 2001/20/EC
For veterinary medicines, Directive 2001/82/EC as amended.
Reporting can be performed with software developed for the purpose or with a web utility called EVWEB accessible through the EudraVigilance homepage. Registration for use of EVWEB is necessary.
In 2002 Heads of Medicines Agencies[11] agreed on a mandate for an ad hoc Working Group on establishing a European risk management strategy. The Working Group considered the conduct of a high level survey of EU pharmacovigilance resources to promote the utilisation of expertise and encourage collaborative working.
Japan:
In Japan, pharmacovigilance is regulated by the PMDA and MHLW.
United States:
See also: Regulation of therapeutic goods in the United States
Three primary branches of pharmacovigilance in the U.S. include the FDA, the pharmaceutical manufacturers, and the academic/non-profit organizations (such as RADAR and Public Citizen).
Introduction:
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
Drug therapy aims to maximize therapeutic efficacy and minimize the risk of harm. Treatment is monitored by patient and physician after its initiation. For individuals with life-long conditions, it is important that the cumulative adverse risks of frequently repeated treatment do not exceed the benefits of long-term therapy. The short-term benefits of therapy may be self evident, whereas the potential accumulation of adverse events may take a long time to become manifest. The time to quantify adverse events may be reduced by surveying and monitoring large numbers of patients, often many thousands of individuals, simultaneously. To do this for a rare disorder such as haemophilia requires extensive, often international, collaboration between haemophilia centres serving patients often living in very different social and environmental conditions. To collect and interpret, these data pose considerable challenges.
For most successful surveillance, it is necessary to identify, in advance, potential adverse events which can be ‘logged’, e.g. inhibitor development in haemophilia, but this may overlook new unexpected events, e.g. new infectious agent. The latter has been especially challenging in haemophilia therapy because most of the blood-borne infections are clinically ‘silent’ for prolonged periods. It is therefore especially important to have effective monitoring of potentially infectious agents in the blood-donor community, so that infectious donations do not contribute to the plasma pool from which the clotting factor concentrate is manufactured.
In addition to surveillance for expected adverse events, it is also desirable to have some form of ‘open-ended’ monitoring for other events. This is sometimes complicated by it being unclear whether the event is part of the underlying disease process, an alternative medical disorder or a side effect of therapy. One way to collect open-ended data is by recording causes of death. To analyse these, it is often necessary to relate the causes to what is found in the local general population. This can be challenging when the surveyed patients live in different communities in different geographical areas.
The challenge, therefore, is to arrange the collection of data that can be interpreted in a way that can be useful in guiding future therapy and managing the underlying medical condition. Some of the current schemes for haemophilia are outlined below. Ideas for improving surveillance, especially using information that is already being collected possibly for other purposes, are also considered.Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
Why do we need pharmacovigillance and biovigilance?
The US Advisory Committee:
The US Advisory Committee on Blood Safety and Availability has defined ‘biovigilance’ as a comprehensive and integrated national patient safety programme to collect, analyse and report the outcomes of collection and transfusion and/or transplantation of blood components and derivatives, cells, tissues and organs [1]. Here, we are using the term pharmacovigilance to apply to plasma dirivatives and their recombinant analogues. To the haemophilia and rare bleeding disorders community, the need for blood product phamacovigilance, and biovigilance which includes haemovigilance is self evident, given the challenges to patient and donor safety we have experienced over the past 30 years. These include problems with donor screening and testing; blood product manufacture; adverse events associated with product administration and receipt and threats of counterfeiting and terrorism.
The major focus of haemovigilance programmes in the United States and other countries is to assure the safety and supply of transfusible blood components, including whole blood, platelets, red blood cells and plasma. These products are not pathogen inactivated in the United States, are widely used, have inherent biological variability and are susceptible to shortages based on donor availability. This is not to say that pharmacovigilance with regard to plasma derivatives and recombinant analogues is neglected in any way, but that the expanding scope of haemovigilance activities directed toward blood components is greater, given their wide use and potential to transmit injections diseases.
Pharmacovigilance and biovigilance are needed to identify whether an emerging infectious agent is transmissible by a blood product. Examples of biovigilance in this area include identifying and understanding the nature and epidemiology of HIV, West Nile Virus and variant CJD. Through epidemiological studies and before specific tests are developed, biovigilance can help establish donor eligibility and deferral criteria, based on identifying potential sources of pathogen exposure. Once tests are developed to detect the agent, biovigilance can identify how many donors, patients and products are actually exposed to the pathogen, and whether current manufacturing procedures mitigate infectious disease risk.
Pharmacovigilance is needed to identify blood derivative products that are contaminated with pathogens or foreign material through failures in product manufacturing or through deliberate acts of counterfeiting or terrorism. For example, biovigilance identified a failure in good manufacturing practices, where patients developed sepsis through receipt of albumin contaminated with bacteria because of cracks in the product vial Deliberate acts of sabotage include adulteration of immune globulin and heparin Biovigilance can reveal whether the manufacturing process for a given product is capable of clearing a known or emerging pathogen. As one example of phamacovigilance in this category, examination of adverse event data and reports from a patient organization showed that patients acquired hepatitis A from one brand of factor IX. This led to manufacturing changes in the product that reduced the potential of hepatitis A transmission [5].
Pharmacovigilance can be used to identify products that have an intrinsic defect or cause an unexpected number of adverse events that are unrelated to pathogen contamination or manufacturing deviations. For example, on rare occasions, patients receiving a lot of immune globulin have experienced more than the expected rate of allergic reactions to the product for unknown reasons.
A North American perspective:
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
To address these challenges, pharmacovigilance and biovigilance programmes should provide mechanisms for surveillance, sentinel identification, traceability, exchange of information among stakeholders and analysis and interpretation of data.
Biovigilance has many different aspects that involve a variety of data collection methods, analysis and resolution. In the United States, biovigilance programmes are only now becoming centralized. Coordinated safety and public health efforts are shared by various divisions of Health and Human Services agencies including the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH) and Centers for Medicare and Medicaid Services (CMS), with input from trade, academic, industrial and patient groups.
In the US, the CDC has the primary responsibility for conducting national disease surveillance and developing epidemiological and laboratory tools to enhance surveillance. CDC’s emerging infectious disease working group gathers information from multiple sources, including state health surveillance, literature reports and reports from regulatory authorities worldwide. CDC shares information about pathogens that might affect blood products with relevant offices within the FDA, and other governmental agencies as appropriate, such as the Department of Defense. FDA assesses the risk of potential pathogen transmission by blood products and develops a risk mitigation strategy depending on the nature of the pathogen.
The Centers for Disease Control and Prevention’s National Healthcare Safety Network (NHSN) has worked with the AABB (formerly the American Association of Blood Banks), a trade organization, to develop a web-based haemovigilance system that collects data from hospitals to detect adverse transfusion events such as reactions to blood products, process problems and medical errors. The information, collected using standardized data collection tools, can be used to create benchmarks for trending purposes, provide opportunities for data-driven intervention, including validation, quality control and impact measurement. The first module of this programme, that became operational in February, 2010, is designed to collect information about recipients of blood product transfusions; a second module on blood donors will be implemented shortly.
Other CDC surveillance programmes include the Universal Data Collection project to monitor the safety of the nation’s blood supply for persons with bleeding disorders being treated with blood products, as well as to monitor the occurrence of joint complications experienced by persons with haemophilia. CDC also has a programme to monitor for any emergence of Creutzfeldt–Jakob disease.
The Food and Drug Administration has a number of different surveillance programmes for blood products that vary according to the type of product under scrutiny, e.g. blood components such as whole blood, cells or plasma, or manufactured products such as plasma derivatives.
The Food and Drug Administration leads biovigilance related to blood fatality surveillance for transfusions and donations. A blood collecting or transfusing facility must notify the FDA’s Center for Biologics Evaluation and Research’s (CBER) Office of Compliance and Biologics Quality (OCBQ) when a blood donor or recipient dies, and the death is possibly related to the donation or transfusion. Besides fatality reports, OCBQ receives biological product deviation reports on distributed biological products about any event associated with the manufacturing of blood, blood components or plasma derivatives that deviates from current good manufacturing practices, regulations, standards or specifications that may affect the safety, purity or potency of the product. OCBQ also receives reports about unexpected or unforeseeable events that may affect the safety, purity or potency of these products. Summary results are available at http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations
The Food and Drug Administration’s postmarketing safety surveillance programme for all approved drug and biological drug products (except blood and blood components) is supported by the Adverse Event Reporting System (AERS), a computerized information database. The FDA receives adverse drug event reports from manufacturers as required by regulation. Additionally, health care professionals and consumers send reports voluntarily through the MedWatch programme. Although MedWatch and AERS are the formal information systems for submitting suspected side effect reports to FDA, such information occasionally comes to light through other channels. Examples include direct informal consumer or health care professional contact with FDA’s Office of Communication, Outreach and Development (OCOD) or clinical trial data received by the Office of Blood Research and Review.
The Food and Drug Administration also collects information from large data sources such as CMS claims data, the Department of Defense and the Veterans Administration among others. FDA’s Sentinel Initiative that is currently under development will strengthen FDA’s ability to monitor postmarket product performance by expanding our access to existing automated healthcare data. Information from large data sources is used for biological product safety hypothesis testing and surveillance within defined populations. One example of the use of survey information from large databases might be examining CMS claims data for the occurrence of Transfusion Related Acute Lung Injury (TRALI) among US elderly inpatients.
Non-governmental organizations such as AABB, the Plasma Protein Therapeutics Association and the American Thrombosis and Hemostasis Network also have a role in monitoring and reporting adverse events. Efforts are now underway to expand our surveillance capability and increase cooperation amongst stakeholders.
In Canada, the Transfusion Transmitted Injuries Surveillance System (TTISS) of the Public Health Agency of Canada (PHAC) collects haemovigilance data. Hospitals report adverse incidents to provincial/territorial blood offices on standard forms, using standard definitions. The local offices report a subset of data to the PHAC that excludes minor incidents and incorrect blood component transfusion information. The PHAC also receives voluntary and mandatory reporting information, including deaths and severe reactions from plasma and blood manufacturers. The PHAC validates the data, assuring completeness and accuracy and compliance with standard definitions. An analysis of the data is reported annually. It includes information about adverse transfusion events by type of product, number of blood components transfused, diagnosis of adverse transfusion events by type of blood component or plasma derivative and fatalities.
A European perspective:
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
The demonstration of safety of the treatments relies on pharmacovigilance, a term used to describe surveillance, monitoring and investigation of adverse drug reactions. The two main aspects of pharmacovigilance are:
1.Voluntary reporting by health professionals (and patients) to regulatory authorities. This ideal is not however often followed, and some of the reasons for this failure are outlined in Table 1. Without an established process, voluntary reporting of adverse events in haemophilia has so far not worked well. Currently available reporting schemes such as Serious Hazards of Transfusion (SHOT) and Serious Adverse Blood Reactions and Events (SABRE) record only events in relation to unfractionated plasma products and specifically exclude clotting factor concentrates.
2. Mandatory reporting from manufacturers.
Table 1. Reasons for failure to report adverse events.
1. Physicians are too busy
2. Lack of awareness of the schemes available for reporting
3. Belief that the adverse reaction is well known
4. Wish to publish own series first
5. Failure to report suspicions until physicians are certain
Formal studies evaluating new concentrates in terms of efficacy and safety required to obtain marketing authorisation involve small numbers of patients followed for a short period of time. The usage of these concentrates in real-life situations involves large numbers of patients of different ethnic and genetic backgrounds using the products over many years. Postmarketing surveillance studies are required to document frequent as well as rare adverse effects that may escape or fail to reach statistical significance in small cohort studies. Most postmarketing pharmacovigilance studies in haemophilia initiated by manufacturers have also been small, rarely recruiting more than a hundred patients.
In Europe, the Paediatric Network for Haemophilia Management (PEDNET) is a group of 23 European paediatricians who since 2000 are enrolling all their new patients with haemophilia and following them prospectively for the development of inhibitors. The number of patients enrolled, however (250) is relatively small [6]. The primary aim of this group is to identify the incidence of inhibitors in untreated patients and investigate the role of factors in their development. While this is the most intensively studied group of patients, the number involved is relatively small.
The only sizeable surveillance project in Europe currently is the UK Haemophilia Centre Doctors Organisation (UKHCDO) national database that only covers the UK. For the last 20 years, there has been a paper-based surveillance system for regular reporting of inhibitors, thromboses and infections. The only analysis performed and reported on from this surveillance system concerned the development of inhibitors [7]. The problem with this national system is that the introduction of national contracting has meant that all patients will be exposed to only a very limited number of concentrates and the value of the surveillance will thus be limited. The only other European country with a central AERS is the Netherlands, but no data from this system have been formally reported. No central haemophilia AERS is available in the other European Countries. Recently, a European AERS called European Haemophilia Surveillance System (EUHASS) has been initiated.
European haemophilia surveillance system:
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
European Haemophilia Surveillance System is a prospective adverse and serious event reporting system. A total of 56 haemophilia centres caring for 18 000 patients with inherited bleeding disorders in 27 European countries are taking part. The system is electronic, in English, and events are reported live as they occur or 3 monthly at the latest. The reported events are allergic/acute reactions, transfusion transmitted infections, inhibitors, thromboses, malignancies and deaths. As centres report data on the exposed population, incident rates can be calculated. In the first year of surveillance, 167 events have been reported. A total of 56 different clotting factor concentrates were used in the participating centres. EUHASS has the potential to provide pharmacovigilance information on large numbers of exposed persons with inherited bleeding disorders. As this is a dynamic cohort, a new method has been developed to calculate the inhibitor risk in patients with <50 title="Link to external resource: http://www.euhass.org" href="http://www.euhass.org/">http://www.euhass.org.
A global perspective:
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
The World Health Organization (WHO) is interested in developing a global haemovigilance network. In December 2007, the WHO Global Collaboration for Blood Safety (GCBS) met and agreed on the need to support such a network. A global consortium consisting of WHO, Canada, International Society of Blood Transfusion, European Haemovigilance Network and the USPHS agreed to form a multilateral steering committee to support collaborative efforts and develop a work plan. The Global Steering Committee for Haemovigilance (GloSCH) will: ‘provide an ongoing, international forum to develop and promote global haemovigilance; function as a forum for dialogue, advice and information gathering; promote standardized global haemovigilance reporting tools and determine whether these tools are useful and relevant; and share information concerning haemovigilance data among member organizations.’ The GloSCH is currently working on two documents: ‘Development of WHO Recommendations on Establishment of National Haemovigilance Systems’; and a technical and/or guidance document to support standardization of haemovigilance reporting.
Acknowledgement
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
The EUHASS project has received funding from the European Union, in the framework of the Public Health Programme. Dr. Peter Gancz, Director, Centre for Biologics Evaluation, Biologics and Genetic Therapies, Health Canada, has kindly provided information about the haemovigilance in Canada, and the work of GCBS.
Disclosures
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
For M. Weinstein, the findings and conclusions in this presentation have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy.
Direct Link:
The focus of pharmacovigilance
The focus of pharmacovigilance is rapidly evolving from the processing and submission of single case and periodic aggregate reports concerning marketed products towards integrated proactive programs for safety signal detection, signal evaluation, risk assessment, and risk management throughout all phases of development and clinical use of pharmaceutical products.
The challenges of a complex and constantly changing environment require pharmacovigilance personnel with a high degree of competence, training, knowledge, and experience to ensure company compliance with evolving regulatory standards and good clinical and business practices.
Pharmacovigilance & Risk Management, Inc. (PvRM) was established by Dr. Sidney Kahn to provide expert advice on all aspects of pharmacovigilance to pharmaceutical manufacturers, pharmaceutical industry support organizations, and health authorities worldwide.
Pharmacovigilance
Working with the WHO Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre), WHO promotes pharmacovigilance at the country level. The aims of pharmacovigilance are to enhance patient care and patient safety in relation to the use of medicines, especially with regard to the prevention of unintended harm from the use of drugs; to improve public health and safety in relation to the use of medicines by the provision of reliable, balanced information resulting in more rational use of drugs; and to contribute to the assessment of the risk-benefit profile of medicines, thus encouraging safer and more effective use of medicines and a resolution of the sometimes apparently conflicting interests of public health and individual patient welfare. The document Importance of Pharmacovigilance : safety monitoring of medicinal products advocates and outlines the aims and objectives of Pharmacovigilance while the publication Safety of Medicines – a guide to detecting and reporting adverse drug reactions aims to raise awareness of the magnitude of the drug safety problem. In its various Pharamcovigilance activities QSM is advised by a high-level committee, the Advisory Committee on Safety of medicinal products (ACSoMP)
References
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
11Public Health Serivice Biovigilance Task Group. Biovigilance In The United States: Efforts To Bridge A Critical Gap In Patient Safety And Donor Health. http://www.hhs.gov/ophs/bloodsafety/biovigilance/index.html Ash_acbsa_oct_2009.pdf.
2.Notice to Readers Bacterial Sepsis Associated with Receipt of Albumin. MMWR Weekly. Notice to Readers Bacterial Sepsis Associated with Receipt of Albumin. October 11, 1996; 45: 866–7.
3.Dilution, counterfeiting of biotechnology products discovered. Biotechnology Law Report. 2002, 21: 366–366.
CrossRef
4.Haniff H Heparin products the targets of deliberate adulteration, says Baxter CEO. Biopharminternational.com, May 8, 2008.
5.Hepatitis A Among persons with haemophilia who received clotting factor concentrate – United States. September–December 1996. MMWR Weekly 1996; 45: 29–32.
6.Kurnik K, Thomas AE. Meeting report: ninth and tenth workshops of the European Paediatric Network for Haemophilia Management (PedNet). Haemophilia 2007; 13: 658–62.
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Abstract
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References
7.Chalmers EA, Brown SA, Keeling D et al. Early factor VIII exposure and subsequent inhibitor development in children with severe haemophilia A. Haemophilia 2007; 13: 149–55.
Full Article (HTML)
PDF(440K).
-FINISH-
Pharmacovigilance: Pharmacovigilance (PV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.
Generally pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to:
Identifying new information about hazards associated with medicines
Preventing harm to patients.
The etymological roots are: pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert, to keep watch.”
Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: "A response to a drug which is noxious and unintended, and which occurs at doses normally used… for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.
Pharmacovigilance is gaining importance for doctors and scientists as the number of stories in the mass media of drug recalls increases.Because clinical trials involve several thousand patients at most; less common side effects and ADRs are often unknown at the time a drug enters the market. Even very severe ADRs such as liver damage are often undetected because study populations are small. Postmarketing pharmacovigilance uses tools such as data mining and investigation of case reports to identify the relationships between drugs and ADRs.
IMPORTANCE OF PHARMACOVIGILANCE
• improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions.• improve public health and safety in relation to the use of medicines.• contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.• promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
1. Drug monitoring2. Pharmaceutical preparations - adverse effects3. Adverse drug reaction reporting4. Product surveillance, Postmarketing5. Legislation, Drug I.Series
Pharmacoenvironmentology:
A branch of environmental pharmacology and a form of pharmacovigilance which deals entry of chemicals or drugs into the environment after elimination from humans and animals post-therapy. It deals specifically with those pharmacological agents that have impact on the environment via elimination through living organisms subsequent to pharmacotherapy
Risks of medical treatment:
While medicines have led to major improvement in the treatment and control of diseases, they also produce adverse effects on the human body from time to time.
While many drugs are precisely targeted to the causes and mechanisms of disease, they may also have minor or distressing effects on other parts of the body, or interact negatively with the systems of the particular individual or with other drugs or substances they are taking, or not work well or at all for some, many or all of those who take them for illness.
There are risks in any intrusion into the human body, whether chemical or surgical. Nothing in this field is entirely predictable as the interaction between chemicals and the human body may produce surprises.
Terms commonly used in drug safety:
Benefits are commonly expressed as the proven therapeutic good of a product, but should also include the patient’s subjective assessment of its effects.
Risk is the probability of harm being caused, usually expressed as a percent or ratio of the treated population; the probability of an occurrence.
Harm is the nature and extent of the actual damage that could be caused. It should not be confused with risk.
Effectiveness is used to express the extent to which a drug works under real world circumstances, i.e., clinical practice (not clinical trials).
Efficacy is used to express the extent to which a drug works under ideal circumstances (i.e., in clinical trials).
Finding the risks of drugs:
Pharmaceutical companies are required by law in all countries to perform clinical trials, testing new drugs on people before they are made generally available. The manufacturers or their agents usually select a representative sample of patients for whom the drug is designed — at most a few thousand — along with a comparable control group. The control group may receive a placebo and/or another drug that is already marketed for the disease.
The purpose of clinical trials is to discover:
If a drug works and how well
If it has any harmful effects, and
Its benefit-harm-risk profile - does it do more good than harm, and how much more? If it has a potential for harm, how probable and how serious is the harm?
Clinical trials do, in general, tell us a good deal about how well a drug works and what potential harm it may cause. They provide information which should be reliable for larger populations with the same characteristics as the Trial group - age, gender, state of health, ethnic origin, and so on.
The variables in a clinical trial are specified and controlled and the results relate only to the population of which the trial group is a representative sample. A clinical trial can never tell you the whole story of the effects of a drug in all situations. In fact, there is nothing that could tell you the whole story, but a clinical trial must tell you enough; "enough" being determined by legislation and by contemporary judgments about the acceptable balance of benefit and harm.
Spontaneous reporting:
Spontaneous reporting is the core data-generating system of international pharmacovigilance, relying on healthcare professionals (and in some places consumers) to identify and report any suspected adverse drug reaction to their national pharmacovigilance center or to the manufacturer. Spontaneous reports are almost always submitted voluntarily.
One of this system’s major weaknesses is under-reporting, though the figures vary greatly between countries and in relation to minor and serious ADRs (also referred to as ICSRs, individual case safety reports).
Another problem is that overworked medical personnel do not always see reporting as a priority. If the symptoms are not serious, they may not notice them at all. And even if the symptoms are serious, they may not be recognised as the effect of a particular drug.
Even so, spontaneous reports are a crucial element in the worldwide enterprise of pharmacovigilance and form the core of the World Health Organization Database, which includes around 4.6 million reports (January 2009, growing annually by about 250,000
Other reporting methods:
Some countries legally oblige spontaneous reporting by physicians. In most countries, manufacturers are required to submit, through its Qualified Person for Pharmacovigilance QPPV, all the reports they receive from healthcare providers to the national authority. Others have intensive, focused programmes concentrating on new drugs, or on controversial drugs, or on the prescribing habits of groups of doctors, or involving pharmacists in reporting. All of these generate potentially useful information. Such intensive schemes, however, tend to be the exception.
International collaboration:
The principle of international collaboration in the field of pharmacovigilance is the principal basis for the WHO International Drug Monitoring Programme, through which over 90 member nations have systems in place which encourage healthcare personnel to record and report adverse effects of drugs in their patients. These reports are assessed locally and may lead to action within the country. Through membership of the WHO Programme one country can know if similar reports are being made elsewhere. (The European Union also has its own scheme.)
Member countries send their reports to the Uppsala Monitoring Centre where they are processed, evaluated and entered into the WHO International Database. When there are several reports of adverse reactions to a particular drug this process may lead to the detection of a signal — an alert about a possible hazard communicated to members countries. This happens only after detailed evaluation and expert review.
Pharmacovigilance of Herbal Medicines:
The safety of herbal medicines has become a major concern to both national health authorities and the general public[9]. The use of herbs in Traditional medicines continues to expand rapidly across the world. Many people now take herbal medicines or herbal products for their health care in different national health-care settings. However, mass media reports of adverse events tend to be sensational and give a negative impression regarding the use of Herbal medicines in general rather than identifying the causes of these events, which may relate to a variety of issues
Pharmacovigilance by region:
Europe:
The pharmacovigilance effort in Europe is coordinated by the European Medicines Agency (EMA) and conducted by the national competent authorities (NCAs). The main responsibility of the EMA is to maintain and develop the pharmacovigilance database consisting of all suspected serious adverse reactions to medicines observed in the European Community. The system is called EudraVigilance and contains separate but similar databases of human and veterinary reactions.
Europe requires the individual marketing authorisation holders (drug companies), to submit all received adverse reactions in electronic form (save in exceptional circumstances). The reporting obligations of the various stakeholders are defined in the Community legislation, in particular:
For human medicines, European Union Directive 2001/83/EC as amended and Directive 2001/20/EC
For veterinary medicines, Directive 2001/82/EC as amended.
Reporting can be performed with software developed for the purpose or with a web utility called EVWEB accessible through the EudraVigilance homepage. Registration for use of EVWEB is necessary.
In 2002 Heads of Medicines Agencies[11] agreed on a mandate for an ad hoc Working Group on establishing a European risk management strategy. The Working Group considered the conduct of a high level survey of EU pharmacovigilance resources to promote the utilisation of expertise and encourage collaborative working.
Japan:
In Japan, pharmacovigilance is regulated by the PMDA and MHLW.
United States:
See also: Regulation of therapeutic goods in the United States
Three primary branches of pharmacovigilance in the U.S. include the FDA, the pharmaceutical manufacturers, and the academic/non-profit organizations (such as RADAR and Public Citizen).
Introduction:
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
Drug therapy aims to maximize therapeutic efficacy and minimize the risk of harm. Treatment is monitored by patient and physician after its initiation. For individuals with life-long conditions, it is important that the cumulative adverse risks of frequently repeated treatment do not exceed the benefits of long-term therapy. The short-term benefits of therapy may be self evident, whereas the potential accumulation of adverse events may take a long time to become manifest. The time to quantify adverse events may be reduced by surveying and monitoring large numbers of patients, often many thousands of individuals, simultaneously. To do this for a rare disorder such as haemophilia requires extensive, often international, collaboration between haemophilia centres serving patients often living in very different social and environmental conditions. To collect and interpret, these data pose considerable challenges.
For most successful surveillance, it is necessary to identify, in advance, potential adverse events which can be ‘logged’, e.g. inhibitor development in haemophilia, but this may overlook new unexpected events, e.g. new infectious agent. The latter has been especially challenging in haemophilia therapy because most of the blood-borne infections are clinically ‘silent’ for prolonged periods. It is therefore especially important to have effective monitoring of potentially infectious agents in the blood-donor community, so that infectious donations do not contribute to the plasma pool from which the clotting factor concentrate is manufactured.
In addition to surveillance for expected adverse events, it is also desirable to have some form of ‘open-ended’ monitoring for other events. This is sometimes complicated by it being unclear whether the event is part of the underlying disease process, an alternative medical disorder or a side effect of therapy. One way to collect open-ended data is by recording causes of death. To analyse these, it is often necessary to relate the causes to what is found in the local general population. This can be challenging when the surveyed patients live in different communities in different geographical areas.
The challenge, therefore, is to arrange the collection of data that can be interpreted in a way that can be useful in guiding future therapy and managing the underlying medical condition. Some of the current schemes for haemophilia are outlined below. Ideas for improving surveillance, especially using information that is already being collected possibly for other purposes, are also considered.Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
Why do we need pharmacovigillance and biovigilance?
The US Advisory Committee:
The US Advisory Committee on Blood Safety and Availability has defined ‘biovigilance’ as a comprehensive and integrated national patient safety programme to collect, analyse and report the outcomes of collection and transfusion and/or transplantation of blood components and derivatives, cells, tissues and organs [1]. Here, we are using the term pharmacovigilance to apply to plasma dirivatives and their recombinant analogues. To the haemophilia and rare bleeding disorders community, the need for blood product phamacovigilance, and biovigilance which includes haemovigilance is self evident, given the challenges to patient and donor safety we have experienced over the past 30 years. These include problems with donor screening and testing; blood product manufacture; adverse events associated with product administration and receipt and threats of counterfeiting and terrorism.
The major focus of haemovigilance programmes in the United States and other countries is to assure the safety and supply of transfusible blood components, including whole blood, platelets, red blood cells and plasma. These products are not pathogen inactivated in the United States, are widely used, have inherent biological variability and are susceptible to shortages based on donor availability. This is not to say that pharmacovigilance with regard to plasma derivatives and recombinant analogues is neglected in any way, but that the expanding scope of haemovigilance activities directed toward blood components is greater, given their wide use and potential to transmit injections diseases.
Pharmacovigilance and biovigilance are needed to identify whether an emerging infectious agent is transmissible by a blood product. Examples of biovigilance in this area include identifying and understanding the nature and epidemiology of HIV, West Nile Virus and variant CJD. Through epidemiological studies and before specific tests are developed, biovigilance can help establish donor eligibility and deferral criteria, based on identifying potential sources of pathogen exposure. Once tests are developed to detect the agent, biovigilance can identify how many donors, patients and products are actually exposed to the pathogen, and whether current manufacturing procedures mitigate infectious disease risk.
Pharmacovigilance is needed to identify blood derivative products that are contaminated with pathogens or foreign material through failures in product manufacturing or through deliberate acts of counterfeiting or terrorism. For example, biovigilance identified a failure in good manufacturing practices, where patients developed sepsis through receipt of albumin contaminated with bacteria because of cracks in the product vial Deliberate acts of sabotage include adulteration of immune globulin and heparin Biovigilance can reveal whether the manufacturing process for a given product is capable of clearing a known or emerging pathogen. As one example of phamacovigilance in this category, examination of adverse event data and reports from a patient organization showed that patients acquired hepatitis A from one brand of factor IX. This led to manufacturing changes in the product that reduced the potential of hepatitis A transmission [5].
Pharmacovigilance can be used to identify products that have an intrinsic defect or cause an unexpected number of adverse events that are unrelated to pathogen contamination or manufacturing deviations. For example, on rare occasions, patients receiving a lot of immune globulin have experienced more than the expected rate of allergic reactions to the product for unknown reasons.
A North American perspective:
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
To address these challenges, pharmacovigilance and biovigilance programmes should provide mechanisms for surveillance, sentinel identification, traceability, exchange of information among stakeholders and analysis and interpretation of data.
Biovigilance has many different aspects that involve a variety of data collection methods, analysis and resolution. In the United States, biovigilance programmes are only now becoming centralized. Coordinated safety and public health efforts are shared by various divisions of Health and Human Services agencies including the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH) and Centers for Medicare and Medicaid Services (CMS), with input from trade, academic, industrial and patient groups.
In the US, the CDC has the primary responsibility for conducting national disease surveillance and developing epidemiological and laboratory tools to enhance surveillance. CDC’s emerging infectious disease working group gathers information from multiple sources, including state health surveillance, literature reports and reports from regulatory authorities worldwide. CDC shares information about pathogens that might affect blood products with relevant offices within the FDA, and other governmental agencies as appropriate, such as the Department of Defense. FDA assesses the risk of potential pathogen transmission by blood products and develops a risk mitigation strategy depending on the nature of the pathogen.
The Centers for Disease Control and Prevention’s National Healthcare Safety Network (NHSN) has worked with the AABB (formerly the American Association of Blood Banks), a trade organization, to develop a web-based haemovigilance system that collects data from hospitals to detect adverse transfusion events such as reactions to blood products, process problems and medical errors. The information, collected using standardized data collection tools, can be used to create benchmarks for trending purposes, provide opportunities for data-driven intervention, including validation, quality control and impact measurement. The first module of this programme, that became operational in February, 2010, is designed to collect information about recipients of blood product transfusions; a second module on blood donors will be implemented shortly.
Other CDC surveillance programmes include the Universal Data Collection project to monitor the safety of the nation’s blood supply for persons with bleeding disorders being treated with blood products, as well as to monitor the occurrence of joint complications experienced by persons with haemophilia. CDC also has a programme to monitor for any emergence of Creutzfeldt–Jakob disease.
The Food and Drug Administration has a number of different surveillance programmes for blood products that vary according to the type of product under scrutiny, e.g. blood components such as whole blood, cells or plasma, or manufactured products such as plasma derivatives.
The Food and Drug Administration leads biovigilance related to blood fatality surveillance for transfusions and donations. A blood collecting or transfusing facility must notify the FDA’s Center for Biologics Evaluation and Research’s (CBER) Office of Compliance and Biologics Quality (OCBQ) when a blood donor or recipient dies, and the death is possibly related to the donation or transfusion. Besides fatality reports, OCBQ receives biological product deviation reports on distributed biological products about any event associated with the manufacturing of blood, blood components or plasma derivatives that deviates from current good manufacturing practices, regulations, standards or specifications that may affect the safety, purity or potency of the product. OCBQ also receives reports about unexpected or unforeseeable events that may affect the safety, purity or potency of these products. Summary results are available at http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations
The Food and Drug Administration’s postmarketing safety surveillance programme for all approved drug and biological drug products (except blood and blood components) is supported by the Adverse Event Reporting System (AERS), a computerized information database. The FDA receives adverse drug event reports from manufacturers as required by regulation. Additionally, health care professionals and consumers send reports voluntarily through the MedWatch programme. Although MedWatch and AERS are the formal information systems for submitting suspected side effect reports to FDA, such information occasionally comes to light through other channels. Examples include direct informal consumer or health care professional contact with FDA’s Office of Communication, Outreach and Development (OCOD) or clinical trial data received by the Office of Blood Research and Review.
The Food and Drug Administration also collects information from large data sources such as CMS claims data, the Department of Defense and the Veterans Administration among others. FDA’s Sentinel Initiative that is currently under development will strengthen FDA’s ability to monitor postmarket product performance by expanding our access to existing automated healthcare data. Information from large data sources is used for biological product safety hypothesis testing and surveillance within defined populations. One example of the use of survey information from large databases might be examining CMS claims data for the occurrence of Transfusion Related Acute Lung Injury (TRALI) among US elderly inpatients.
Non-governmental organizations such as AABB, the Plasma Protein Therapeutics Association and the American Thrombosis and Hemostasis Network also have a role in monitoring and reporting adverse events. Efforts are now underway to expand our surveillance capability and increase cooperation amongst stakeholders.
In Canada, the Transfusion Transmitted Injuries Surveillance System (TTISS) of the Public Health Agency of Canada (PHAC) collects haemovigilance data. Hospitals report adverse incidents to provincial/territorial blood offices on standard forms, using standard definitions. The local offices report a subset of data to the PHAC that excludes minor incidents and incorrect blood component transfusion information. The PHAC also receives voluntary and mandatory reporting information, including deaths and severe reactions from plasma and blood manufacturers. The PHAC validates the data, assuring completeness and accuracy and compliance with standard definitions. An analysis of the data is reported annually. It includes information about adverse transfusion events by type of product, number of blood components transfused, diagnosis of adverse transfusion events by type of blood component or plasma derivative and fatalities.
A European perspective:
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
The demonstration of safety of the treatments relies on pharmacovigilance, a term used to describe surveillance, monitoring and investigation of adverse drug reactions. The two main aspects of pharmacovigilance are:
1.Voluntary reporting by health professionals (and patients) to regulatory authorities. This ideal is not however often followed, and some of the reasons for this failure are outlined in Table 1. Without an established process, voluntary reporting of adverse events in haemophilia has so far not worked well. Currently available reporting schemes such as Serious Hazards of Transfusion (SHOT) and Serious Adverse Blood Reactions and Events (SABRE) record only events in relation to unfractionated plasma products and specifically exclude clotting factor concentrates.
2. Mandatory reporting from manufacturers.
Table 1. Reasons for failure to report adverse events.
1. Physicians are too busy
2. Lack of awareness of the schemes available for reporting
3. Belief that the adverse reaction is well known
4. Wish to publish own series first
5. Failure to report suspicions until physicians are certain
Formal studies evaluating new concentrates in terms of efficacy and safety required to obtain marketing authorisation involve small numbers of patients followed for a short period of time. The usage of these concentrates in real-life situations involves large numbers of patients of different ethnic and genetic backgrounds using the products over many years. Postmarketing surveillance studies are required to document frequent as well as rare adverse effects that may escape or fail to reach statistical significance in small cohort studies. Most postmarketing pharmacovigilance studies in haemophilia initiated by manufacturers have also been small, rarely recruiting more than a hundred patients.
In Europe, the Paediatric Network for Haemophilia Management (PEDNET) is a group of 23 European paediatricians who since 2000 are enrolling all their new patients with haemophilia and following them prospectively for the development of inhibitors. The number of patients enrolled, however (250) is relatively small [6]. The primary aim of this group is to identify the incidence of inhibitors in untreated patients and investigate the role of factors in their development. While this is the most intensively studied group of patients, the number involved is relatively small.
The only sizeable surveillance project in Europe currently is the UK Haemophilia Centre Doctors Organisation (UKHCDO) national database that only covers the UK. For the last 20 years, there has been a paper-based surveillance system for regular reporting of inhibitors, thromboses and infections. The only analysis performed and reported on from this surveillance system concerned the development of inhibitors [7]. The problem with this national system is that the introduction of national contracting has meant that all patients will be exposed to only a very limited number of concentrates and the value of the surveillance will thus be limited. The only other European country with a central AERS is the Netherlands, but no data from this system have been formally reported. No central haemophilia AERS is available in the other European Countries. Recently, a European AERS called European Haemophilia Surveillance System (EUHASS) has been initiated.
European haemophilia surveillance system:
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
European Haemophilia Surveillance System is a prospective adverse and serious event reporting system. A total of 56 haemophilia centres caring for 18 000 patients with inherited bleeding disorders in 27 European countries are taking part. The system is electronic, in English, and events are reported live as they occur or 3 monthly at the latest. The reported events are allergic/acute reactions, transfusion transmitted infections, inhibitors, thromboses, malignancies and deaths. As centres report data on the exposed population, incident rates can be calculated. In the first year of surveillance, 167 events have been reported. A total of 56 different clotting factor concentrates were used in the participating centres. EUHASS has the potential to provide pharmacovigilance information on large numbers of exposed persons with inherited bleeding disorders. As this is a dynamic cohort, a new method has been developed to calculate the inhibitor risk in patients with <50 title="Link to external resource: http://www.euhass.org" href="http://www.euhass.org/">http://www.euhass.org.
A global perspective:
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
The World Health Organization (WHO) is interested in developing a global haemovigilance network. In December 2007, the WHO Global Collaboration for Blood Safety (GCBS) met and agreed on the need to support such a network. A global consortium consisting of WHO, Canada, International Society of Blood Transfusion, European Haemovigilance Network and the USPHS agreed to form a multilateral steering committee to support collaborative efforts and develop a work plan. The Global Steering Committee for Haemovigilance (GloSCH) will: ‘provide an ongoing, international forum to develop and promote global haemovigilance; function as a forum for dialogue, advice and information gathering; promote standardized global haemovigilance reporting tools and determine whether these tools are useful and relevant; and share information concerning haemovigilance data among member organizations.’ The GloSCH is currently working on two documents: ‘Development of WHO Recommendations on Establishment of National Haemovigilance Systems’; and a technical and/or guidance document to support standardization of haemovigilance reporting.
Acknowledgement
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
The EUHASS project has received funding from the European Union, in the framework of the Public Health Programme. Dr. Peter Gancz, Director, Centre for Biologics Evaluation, Biologics and Genetic Therapies, Health Canada, has kindly provided information about the haemovigilance in Canada, and the work of GCBS.
Disclosures
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
For M. Weinstein, the findings and conclusions in this presentation have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy.
Direct Link:
The focus of pharmacovigilance
The focus of pharmacovigilance is rapidly evolving from the processing and submission of single case and periodic aggregate reports concerning marketed products towards integrated proactive programs for safety signal detection, signal evaluation, risk assessment, and risk management throughout all phases of development and clinical use of pharmaceutical products.
The challenges of a complex and constantly changing environment require pharmacovigilance personnel with a high degree of competence, training, knowledge, and experience to ensure company compliance with evolving regulatory standards and good clinical and business practices.
Pharmacovigilance & Risk Management, Inc. (PvRM) was established by Dr. Sidney Kahn to provide expert advice on all aspects of pharmacovigilance to pharmaceutical manufacturers, pharmaceutical industry support organizations, and health authorities worldwide.
Pharmacovigilance
Working with the WHO Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre), WHO promotes pharmacovigilance at the country level. The aims of pharmacovigilance are to enhance patient care and patient safety in relation to the use of medicines, especially with regard to the prevention of unintended harm from the use of drugs; to improve public health and safety in relation to the use of medicines by the provision of reliable, balanced information resulting in more rational use of drugs; and to contribute to the assessment of the risk-benefit profile of medicines, thus encouraging safer and more effective use of medicines and a resolution of the sometimes apparently conflicting interests of public health and individual patient welfare. The document Importance of Pharmacovigilance : safety monitoring of medicinal products advocates and outlines the aims and objectives of Pharmacovigilance while the publication Safety of Medicines – a guide to detecting and reporting adverse drug reactions aims to raise awareness of the magnitude of the drug safety problem. In its various Pharamcovigilance activities QSM is advised by a high-level committee, the Advisory Committee on Safety of medicinal products (ACSoMP)
References
Top of page
Introduction
Why do we need pharmacovigillance and biovigilance?
A North American perspective
A European perspective
European haemophilia surveillance system
A global perspective
Acknowledgement
Disclosures
References
11Public Health Serivice Biovigilance Task Group. Biovigilance In The United States: Efforts To Bridge A Critical Gap In Patient Safety And Donor Health. http://www.hhs.gov/ophs/bloodsafety/biovigilance/index.html Ash_acbsa_oct_2009.pdf.
2.Notice to Readers Bacterial Sepsis Associated with Receipt of Albumin. MMWR Weekly. Notice to Readers Bacterial Sepsis Associated with Receipt of Albumin. October 11, 1996; 45: 866–7.
3.Dilution, counterfeiting of biotechnology products discovered. Biotechnology Law Report. 2002, 21: 366–366.
CrossRef
4.Haniff H Heparin products the targets of deliberate adulteration, says Baxter CEO. Biopharminternational.com, May 8, 2008.
5.Hepatitis A Among persons with haemophilia who received clotting factor concentrate – United States. September–December 1996. MMWR Weekly 1996; 45: 29–32.
6.Kurnik K, Thomas AE. Meeting report: ninth and tenth workshops of the European Paediatric Network for Haemophilia Management (PedNet). Haemophilia 2007; 13: 658–62.
Direct Link:
Abstract
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PDF(440K)
References
7.Chalmers EA, Brown SA, Keeling D et al. Early factor VIII exposure and subsequent inhibitor development in children with severe haemophilia A. Haemophilia 2007; 13: 149–55.
Full Article (HTML)
PDF(440K).
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শনিবার, ২৫ সেপ্টেম্বর, ২০১০
Independent daily living : Dressing:
Dealing with children with SPD
Independent daily living
By
Md. Sohel Ahmed
Speech and Sensory Integration Therapist
Dressing:
§ Use dummy.
§ Modeling.
§ Ask to choose.
§ Talk to him about the process of dressing.
§ Choose some specific action of dressing.
§ Use easy to remove dressing.
§ Physical guide with verbal cues.
§ Add any sticker s/ he likes.
§ Try to teach about color.
§ Use Reinforcement.
Some common sensory issues that may affect dressing
§ Try various types of materials to see which one the child will tolerate.
§ Show the object to the child.
§ Put the child’s hand on top of your hand and touch the cloth.
§ Brush down the child’s body before dressing to help to decrease their hypersensitivity.
§ Need to ensure other sensory developments like- body awareness balance, movement and language.
Independent daily living
By
Md. Sohel Ahmed
Speech and Sensory Integration Therapist
Dressing:
§ Use dummy.
§ Modeling.
§ Ask to choose.
§ Talk to him about the process of dressing.
§ Choose some specific action of dressing.
§ Use easy to remove dressing.
§ Physical guide with verbal cues.
§ Add any sticker s/ he likes.
§ Try to teach about color.
§ Use Reinforcement.
Some common sensory issues that may affect dressing
§ Try various types of materials to see which one the child will tolerate.
§ Show the object to the child.
§ Put the child’s hand on top of your hand and touch the cloth.
§ Brush down the child’s body before dressing to help to decrease their hypersensitivity.
§ Need to ensure other sensory developments like- body awareness balance, movement and language.
Independent daily living
Dealing with children with Autism
Independent daily living
By
Md. Sohel Ahmed
Speech and Sensory Integration Therapist
Toileting:
Check first:
1. Bladder control.
2. Willing to cooperate.
3. Physical fitness.
Some strategies can be used:
• Regular time.
• Observe his/her time of willing to go.
• Leave the child on the toilet.
• When s/he goes, show that you are pleased.
• If don't go just ignore it.
• Positive reinforcement.
• When the child has an accident and wets or dirties himself don't punish him.
• Quietly clean up and change him/her.
• If s/he started, take him/her into the bathroom.
• Use simple language.
• Demonstrate.
• Teach them sign.
• Use simple indication to identify toilet.
• Use potty in the bathroom.
• Physically guide and train him by your hand.
• Make the bathroom friendly to the child .
Some common sensory issues that may affect toileting:
• Poor body awareness.
• Poor balance.
• Sensitive to various aspect of toileting.
To increase body awareness:
• Pillow or cushion games.
• Bare hugs.
• Catching a ball
• Caring the child in different way
• Caring heavy loads
• Pushing or pulling
• Obstacle course
• Animal walking
• Joint compression
To increase balance and to provide vestibular stimulation:
• Singing song in movement action.
• Two hand swing while walking.
• Spinning.
• Sliding
• Trampoline
• Tilting Board
• Balancing
• Riding bicycle or tricycle
• Walking up and down stairs
• Swing
Other sensitive issues:
• Factor such as a child's sensitivity to various aspect like-tactile- the coldness of the seat of the toilet.
• Low or high lighting system in the toilet.
• Wet floor of the toilet.
Independent daily living
By
Md. Sohel Ahmed
Speech and Sensory Integration Therapist
Toileting:
Check first:
1. Bladder control.
2. Willing to cooperate.
3. Physical fitness.
Some strategies can be used:
• Regular time.
• Observe his/her time of willing to go.
• Leave the child on the toilet.
• When s/he goes, show that you are pleased.
• If don't go just ignore it.
• Positive reinforcement.
• When the child has an accident and wets or dirties himself don't punish him.
• Quietly clean up and change him/her.
• If s/he started, take him/her into the bathroom.
• Use simple language.
• Demonstrate.
• Teach them sign.
• Use simple indication to identify toilet.
• Use potty in the bathroom.
• Physically guide and train him by your hand.
• Make the bathroom friendly to the child .
Some common sensory issues that may affect toileting:
• Poor body awareness.
• Poor balance.
• Sensitive to various aspect of toileting.
To increase body awareness:
• Pillow or cushion games.
• Bare hugs.
• Catching a ball
• Caring the child in different way
• Caring heavy loads
• Pushing or pulling
• Obstacle course
• Animal walking
• Joint compression
To increase balance and to provide vestibular stimulation:
• Singing song in movement action.
• Two hand swing while walking.
• Spinning.
• Sliding
• Trampoline
• Tilting Board
• Balancing
• Riding bicycle or tricycle
• Walking up and down stairs
• Swing
Other sensitive issues:
• Factor such as a child's sensitivity to various aspect like-tactile- the coldness of the seat of the toilet.
• Low or high lighting system in the toilet.
• Wet floor of the toilet.
Anger:
Anger:
Many parents worry that if they playact a feeling – such as aggression – with their child, the pretending will actually encourage more aggression. But nothing could be further from the truth, because if you don’t help the child use imagination or words to express the feeling, he is left only with acting it out. The feeling is there; anger is a part of life just as love, curiosity and other warm feelings are. When the child can translate these feelings into ideas, he doesn’t have to express them through behavior or to inhibit them, which would result in tension, anxiety and compulsiveness.
When the child is angry what does s/he do?
§ Hitting
§ Biting
§ Head banging on the wall
§ Tapping on the floor
§ Flapping hands
§ Become Restless
§ Spitting
§ Breaking things/object near the child
§ Slap/punch
§ Cutting body parts
§ Screw
§ Screaming loudly
§ Move here and there
§ Pinching him/others
§ Crying
§ Jerking body parts/whole body
§ Pushing/pulling
§ Jumping
§ Some aggressive attitude
§ Mouthing/biting tongue
Why the child is angry?
§ S/he may not be able to express something verbally
§ When the child doesn’t feel good
§ The child doesn’t want to do the task
§ The child is interested to go outside. But none is going outside with the child
§ Nobody is getting his/her massage
§ The child is trying to get something
§ There is nothing to do
§ The child is not getting his/her favorite food
§ For sensory problem
§ When s/he is bored/irritate
§ When he is fearful
And even the child may become angry without any reason for behavioral issues.
What should you do?
§ First you must be calm
§ Use Deep touch
§ Bare hug
§ Use positive word
§ Don’t penalized the child
§ Don’t use any negative word
§ Use reinforcement
§ Go outside with the child
§ Use motivating task (the child like most)
§ Don’t say that “I will punish you.”
§ Teach the child what to do
§ Use song/rhymes
§ Use any sound making toy if the child like this
§ Play child’s favorite music
§ Sometimes, the child does this for getting special attention. Avoidance or not giving importance may help then.
ABC analysis
Task: Make a list what to do and what not to do
Facing a real situation:
Say, there is a situation like this- the child is biting/hitting you. S/he is very angry. What will you do then?
Will you?-
Ø Slap the child
Ø Hug/stroke the child
Ø Hit the child
Ø Strike/beat the child
Ø Push away from you
Ø Close the child in the room/lock the room
Ø Bind the hands & legs of the child
Ø Shout/scream at your child
Ø Scold your child
Ø Revile/insult your baby
Please don’t do this. At this time the child may need something important to him/her. The child may try to express something but it is not possible for him to express. The child may feel bored/angry or fearful for something.
What should you do then?
1) Don’t be angry. It will harm both you and your child.
2) Try to be calm and make the child calm.
3) Use deep touch saying- calm down, calm down.
4) Hug the child firmly
5) Manipulate child’s hand to stroke you by telling- “ooh pain” “ooh pain”- touch endearingly/caress me by touching the space where the child bites. (Do this several times.)
6) Don’t say any negative word (like- Why you did this? /I will kill you/I will punish you) or don’t scold/shout at the child.
7) Find out the reason why your child is angry. If it is possible to provide the expected object. Allow the child to get the object.
8) Give the child highly preferred object/toy to play
9) Substitute the toy/task if necessary.
10) Try to give something pleasant to your child.
11) Sometimes, avoidance or not giving importance may help.
[It depends on your child’s preference to be calm. Sometimes the child may become calm after swinging/sliding/trampling/cycling/ feeding food item/rhyming/ singing/ or riding]
Important to remember: Your child doesn’t know- how to act when they are angry. Teach them how to behave when they are angry and what to do instead of doing harmful and unexpected things.
Several basic causes of tantrums are familiar to parents everywhere:
§ The child is seeking attention or is tired, hungry, or uncomfortable.
§ In addition, tantrums are often the result of kids' frustration with the world — they can't get something to do what they want.
Many parents worry that if they playact a feeling – such as aggression – with their child, the pretending will actually encourage more aggression. But nothing could be further from the truth, because if you don’t help the child use imagination or words to express the feeling, he is left only with acting it out. The feeling is there; anger is a part of life just as love, curiosity and other warm feelings are. When the child can translate these feelings into ideas, he doesn’t have to express them through behavior or to inhibit them, which would result in tension, anxiety and compulsiveness.
When the child is angry what does s/he do?
§ Hitting
§ Biting
§ Head banging on the wall
§ Tapping on the floor
§ Flapping hands
§ Become Restless
§ Spitting
§ Breaking things/object near the child
§ Slap/punch
§ Cutting body parts
§ Screw
§ Screaming loudly
§ Move here and there
§ Pinching him/others
§ Crying
§ Jerking body parts/whole body
§ Pushing/pulling
§ Jumping
§ Some aggressive attitude
§ Mouthing/biting tongue
Why the child is angry?
§ S/he may not be able to express something verbally
§ When the child doesn’t feel good
§ The child doesn’t want to do the task
§ The child is interested to go outside. But none is going outside with the child
§ Nobody is getting his/her massage
§ The child is trying to get something
§ There is nothing to do
§ The child is not getting his/her favorite food
§ For sensory problem
§ When s/he is bored/irritate
§ When he is fearful
And even the child may become angry without any reason for behavioral issues.
What should you do?
§ First you must be calm
§ Use Deep touch
§ Bare hug
§ Use positive word
§ Don’t penalized the child
§ Don’t use any negative word
§ Use reinforcement
§ Go outside with the child
§ Use motivating task (the child like most)
§ Don’t say that “I will punish you.”
§ Teach the child what to do
§ Use song/rhymes
§ Use any sound making toy if the child like this
§ Play child’s favorite music
§ Sometimes, the child does this for getting special attention. Avoidance or not giving importance may help then.
ABC analysis
Task: Make a list what to do and what not to do
Facing a real situation:
Say, there is a situation like this- the child is biting/hitting you. S/he is very angry. What will you do then?
Will you?-
Ø Slap the child
Ø Hug/stroke the child
Ø Hit the child
Ø Strike/beat the child
Ø Push away from you
Ø Close the child in the room/lock the room
Ø Bind the hands & legs of the child
Ø Shout/scream at your child
Ø Scold your child
Ø Revile/insult your baby
Please don’t do this. At this time the child may need something important to him/her. The child may try to express something but it is not possible for him to express. The child may feel bored/angry or fearful for something.
What should you do then?
1) Don’t be angry. It will harm both you and your child.
2) Try to be calm and make the child calm.
3) Use deep touch saying- calm down, calm down.
4) Hug the child firmly
5) Manipulate child’s hand to stroke you by telling- “ooh pain” “ooh pain”- touch endearingly/caress me by touching the space where the child bites. (Do this several times.)
6) Don’t say any negative word (like- Why you did this? /I will kill you/I will punish you) or don’t scold/shout at the child.
7) Find out the reason why your child is angry. If it is possible to provide the expected object. Allow the child to get the object.
8) Give the child highly preferred object/toy to play
9) Substitute the toy/task if necessary.
10) Try to give something pleasant to your child.
11) Sometimes, avoidance or not giving importance may help.
[It depends on your child’s preference to be calm. Sometimes the child may become calm after swinging/sliding/trampling/cycling/ feeding food item/rhyming/ singing/ or riding]
Important to remember: Your child doesn’t know- how to act when they are angry. Teach them how to behave when they are angry and what to do instead of doing harmful and unexpected things.
Several basic causes of tantrums are familiar to parents everywhere:
§ The child is seeking attention or is tired, hungry, or uncomfortable.
§ In addition, tantrums are often the result of kids' frustration with the world — they can't get something to do what they want.
Early interaction and Communication:
EARLY INTERACTION
AND
NONVERBAL COMMUNICATION
INTRODUCTION
Young infants and babies are not able to communicate by words in the way adults can. As a substitute, they use natural gestures, facial expression and vocalization, which are general. At the earliest stage, these are gross to start with - cries or wriggles – but their methods become more and more exact as they grown-up and their sounds amalgamate into words. Interaction with responsive adults is must to develop their communication.
Early interaction and Communication:
Early interaction:
Early interaction refers to the interaction between an infant and caregivers before development of verbal speech and language.
The word infant is derived from the Latin infans, which means, “ not speaking”. But a lot of communication occurs before verbal speech and language develop. Development of language depends on the development of earlier preverbal (before speech) interaction and communication. (Owens, 2001, pp.157)
Communication:
“Communication is a natural way in which people exchange ideas, ask for something or someone, comment on what is happening around them and express their feelings.” (Crishna, 1996, pp. 1)
In case of infants – communication is the way in which they can request, protest, greet, comment, and ask for objects, attention, action etc.
“ Communication does not suddenly start when the child begins to talk; it has been taking place from the moment he was born. Often the child and the adult may be quite unconscious that what they are doing is communicating.” (McConkey, 1986, pp. 41)
People/children usually communicate-
1) By using speech:
It refers to the verbal expression in a language that is realized by other surround the child and includes-
Words ----------- Hello
Phrases ----------- Hello, Mina
Sentences ----------- Mina is sitting on the table
2) By using non-verbal means:
Sound - which express happiness or sadness or a . response
Eye gaze - by looking at an object when infants want it
Facial expression - by smiling when infants are happy
Body language - by turning away from things they do not like
Pointing - by pointing with a finger or a hand to a person
Gesture - by waving their hand to say hello
Touching - by touching anybody to get attention
(Crishna, 1996, pp. 2-3)
We can say that though speech is most accepted and normal form of communication, it develops later after using a lot of non-verbal means in a child. These early non-verbal skills are very essential for a child in acquisition of language. Early interaction between infant and mother occurs with these non-verbal forms of communication. For example- non-specific crying which could indicate a need for food or comfort or relief from pain, But the mother or the caregiver, responds to this early, unclear message by trying to find out what the child wants. The mother may get that the child is hungry, wet, cold, pricked by a safety pin or plagued by a pain in his stomach.
Stages in Early Communication Development:
Between birth and age one
· Can differentiate mother’s voice from stranger’s voice.
· Cries to gain contact/cries for assistance, when happy/uncomfortable/in pain/ hungry (reinforced behavior)
· Increasingly, chronological rather than instantaneous speech begins to develop.
· Improved turn-taking outline (pauses for response)
· Rituals and game-playing develop
· Rituals (conventional routines of feeding bathing etc.)
· Games = anticipation-based (Peek-a-boo, round the garden)
· These sequences of mutual gaze, smiles, and vocalization are like “protoconversation” (similar to conversation)
· Recognizes and responds to own name
· Interactions become more about the infant, caregiver and an object (i.e. triangle reference)
· Recognizes name of familiar people (mum, dad)
· Says 2-3 words besides "mama" and "baba".
· Use simple social gesture, e.g. wave bye bye, clap
· Turns to search and localize used words such as all gone, no, bye bye (Bangla-shes, na, bye bye)
Between one and two
· Understands "no".
· Uses 20 to 40 words, including names.
Uses new words regularly.
Removes shoes, socks, pants, and sweater
Replaces familiar objects where they belong
Sleeps ten-twelve hours at night
Refers to self by name.
Combines two words such as "daddy bye-bye".
Waves good-bye
Plays by self; initiates own play
Builds tower of 6-7 blocks.
Makes the "sounds" of familiar animals.
Uses word such, as "more" to make wants known.
Brings object from another room when asked.
Between two and three
Identifies body parts.
Gives full name.
Holds up fingers to tell age.
Carries on 'conversation' with self and dolls.
Asks, "What's that?" And "where's my?"
Uses 2-word negative phrases such as "no want".
Has a 450-word vocabulary.
Combines nouns and verbs "mummy come".
Understands simple time concepts: "last night", "tomorrow".
Refers to self as "me" rather than by name.
Tries to get adult attention: "watch me".
Likes to hear same story repeated.
May say "no" when means "yes".
Talks to other children as well as adults.
Solves problems by talking instead of hitting or crying.
Answers "where" questions.
Matches 3-4 colors, knows big and little
Names common pictures and things.
Uses short sentences like "me want more" or "me want biscuit".
Between three and four
Uses verb forms.
Uses 'I', 'you'.
Uses 'this', 'that'.
Names at least one color.
Counts to five.
Verbalizes recent experiences.
Can tell a story.
Understands 'what', 'where'
Uses 'what', 'where' and occasionally 'when', 'who'.
Has a sentence length of 4-5 words.
Has a vocabulary of nearly 1000 words.
Understands "yesterday," "summer", "lunchtime", "tonight", "little-big".
Begins to obey requests like "put the block under the chair".
Knows his or her last name, name of street on which he/she lives and several nursery rhymes
Between four and five
Has sentence length of 4-5 words.
Uses past tense correctly.
Comprehends the concept of 'better than'.
Uses size and colour adjectives in sentence form.
Has a vocabulary of nearly 1500 words.
Points to colors red, blue, yellow and green.
Identifies triangles, circles and squares.
Understands "In the morning", "next", "noontime".
Can speak of imaginary conditions such as "I hope".
Asks many questions, asks "who?" and "why?"
Outline of stages of early communication:
Perlocutionary stage 0-8 months:
· Infant has no goal awareness
· Attends to and responds to stimuli
· Uses undifferentiated behaviors (e.g. crying)
· Deliberate communicative attempts increase gradually (gestures, reaching)
Illocutionary stage 8-9 months:
· Coordinated plan to achieve goals
· Infant uses eye contact and repetition
· Uses gestures
· Uses protoimperatives (requests-reaching, pointing)
· Uses protodeclaratives (maintaining joint attention-pointing, showing)
Locutionary 12 months:
· Begins with first meaningful words and gestures together
· Words accompany or replace gestures to express
· Symbolic interaction occurs
· Elicited speech sounds sometimes words
STAGES OF EARLY COMMUNICATION
Coupe and Goldbart (1988) discuss 6 stages of early communication. These are-
Stage 1. Pre-intentional-Reflexive stage:
The carer to the individual’s very early and reflexive behaviours assigns communicative intent and meaning. These are produced in response to internal and external stimuli (especially auditory and visual stimuli) eg. Startle reflex, sucking reflex. At the reflexive level, the person appears to sleep a lot. However, when awake the individual will gaze at people or objects, which come into his or her visual field (15-20 cm). When the caregiver makes eye contact with the individual it is known as “mutual gaze.
Stage 2. Pre-intentional-Reactive stage:
The carer to the individual’s reactive behaviours assigns communicative intent and meaning. The individual reacts to people objects or events within his or her environment. He or she reacts to stimuli from all senses. There is now an expanded range of body and lime movements and vocalizations e.g. trunk turning, hand to mouth behaviours and a greater variety of facial movements. He or she learns to repeat a pleasurable action. The carer will talk to the individual and the content of the conversation will relate to the activity that they are involved in e.g. “Here is your dinner’’- at dinner time. The individual responds to different tones of voice and to different facial expressions. He or she will search for sound sources, especially speech or music. Any sound or movement made by the individual will have a major effect on the carer’s behaviour. At this stage, the first smile appears. Mutual gaze is changing and leading into shared attention where the individual and the carer may appear to be “looking” at the same object or event and the carer will comment on it.
Stage3. Pre-intentional-Proactive stage:
The individual’s efforts to act on the environment become signals to the carer who then assigns communicative intent and meaning. At this stage, there is the beginning of acting purpose fully on objects. The individual begins to realise that objects exits even if they cannot see them. He or she can retrieve partially hidden objects and can recognise some objects by function e.g. cup/drink. The individual will look for reach for desired objects and people. A repertoire of different behaviours is developing, for instance, hitting, shaking and mouthing various objects. He or she will attempt to repeat actions, which brought about novel changes. The individual can shift his or her attention to more than one thing at a time. He or she is beginning to understand another person’s expressions and actions. The individual will also continue a movement during a pause in familiar interaction e.g. If being rocked, s/he will continue the rocking a break as a signal to reinstate the movement. He or she begins to imitate simple gestures e.g. waving, clapping. Towards the end of stage, the behaviours become more intentional the individual sees what he or she wants and goes for it, although the way he or she does it may not always be successful.
Stage 4. Intentional-Informal stage:
The individual acts on the environment to create a specific effect. By the time the individual reaches the early intentional stage of development he or she knows how to use an object to get the carer’s attention or how to use another person to get an object that he or she wants. Object permanency is established and the individual will actively try to look for objects that disappear. He or she will also use a repertoire of behaviours including alternating gaze to get his or her needs met le. Looking back and forth between the communication partner and the item or activity that is wanted as a way of requesting it. There begins to be a range of communicative functions e.g. protests, greeting, positive and negative attention seeking. Receptively, the individual recogninises and responds to common gestures e.g. come here, go away, wave. He or she also shows simple imitation skills.
Stage 5. Intentional-Formal stage:
At this stage the individual is beginning to integrate the information from his/her senses. He or she will drop or throw something deliberately, monitor the action and look to see where it falls. The individual is more able to solve problems through trial and error. Objectives are beginning to be used appropriately e.g. use of a straw, a comb, a purse. The individual learns that the same object will do different things depending on how it is used e.g. papers tears, paper crumples. Reaching for something turns into pointing to something. The individual is able to communicate a wide range of intentions or functions to others in a way that is more conventionally understood e.g. through gestures, single words and vocalizations. He or she will show or give objects as a way of initiating or maintaining an interaction with another person. He or she will understand the key words in a sentence particularly when used in context.
Stage 6. Intentional-Referential stage:
The individual starts to have an internalized mental representation of the word around them; He or she is able to solve simple problems by thinking about them rather then through trial and error. Deferred imitation skills are established e.g. can imitate unfamiliar actions after an event. The individual may also be able to mime or act out an event. Joint action routines are established where the individual learns that interactions follows a familiar sequence of events and can anticipate these and indicate when the sequence is varied e.g. dressing, grooming, mealtimes. For instance, with dressing- the caregiver uses the same order- singlet first, then t-shirt or jumper, underpants, socks, pants and shoes. The function of a range of objects is known and objects are used purposefully. Objects may also be used to established or maintain a social interaction or because he or she needs help with an activity e.g. bring a key to open cupboard where a favourite item is kept.
Hierarchy of learning language:
Speech
Expressive language
Receptive language
Play
Attention
Interactional Behaviors:
Some interactional behaviors are essential for communication development of a child. These are-
Joint reference:
Also known as “joint attention”. Joint reference means- two or more individuals share a common focus together on one point of interest (object/event/person). (Owens, 2001, pp.184)
The baby and mother insert in a system to ensure joint selective attention at earliest stage. For an example, the mother will shake an object before her infant to be a focus for the infant’s attention it. These routines are accustomed to achieve eye contact, the first step in Joint reference.
Joint action:
Infant and the caregiver build up dual behaviors in a familiar context through out the first year of life. The routinized actions (i.e.- game playing and daily routine) are called joint action.
Conversational skills and turn taking are learned. Rules of communication can be learned within a familiar and pleasurable social sequence.
Game playing:
Caregiver and the infant begin to play almost from birth. Depending on caregivers and child’s interest, the games become ritual exchanges that mention upon or sensitively mark common patterns of interaction.
Routines:
It means- the conventionalized and predictable scripts or scaffolds for interpretation and behaviors in which caregiver provide order. Conceptual foundations of later language development is achieved within familiar daily routines and events (bathing, toileting, dressing, feeding etc.)
Turn taking:
Turn taking is very essential aspect of interactional behavior for rurther development of conversational skills that is language development. It occurs in early breast-feeding. A ‘turn” may entail vocalization, movement of body parts, facial expression etc. It occurs in games with pauses for infant responses (tickling, lifting, bouncing etc.). It develops protoconversation (similar to conversation) with alternating vocalization, then gestures and words.
Babytalk/motherese/parentese:
Motherese is a special style of talking with children which contains short and simple form of sentences, special body movement and special facial expression.
Characteristic of motherese:
· Small core vocabulary
· Short length of utterance
· Infant vocal behavior is treated as meaningful
· Much use of verbal rituals and repetitions
· Talk refers to the here and now
· Much use of greetings
· Mother pauses even if the child doesn’t respond
· Much use of pitch and loudness
Activities to Encourage your Child's Language
Encourage the child to express opinion by using gesture
Talk simply, clearly, and slowly to your child
Give him/her opportunities to make choice
Play simple games with your child
Comment on what you did or how you think your child feels.
Talk to your child as you care for him or her throughout the day
Use a lot of pictures
Tell rhymes and sing songs.
Allow the child to use symbolic or invented word e.g.- mew sound to indicate cat
Talk to your baby about everything you're doing while you're with him/her
Reward and encourage early efforts to communicate
Give reinforcement for child’s response
Continue to say social stories.
Praise your child when she talks about her feelings, thoughts, hopes and fears.
Look at family photos and talk to him about your family history.
Listen to her when she talks to you or tries to express something.
GLOSSARY
Approximate- near, estimated
Blink- flash
Core- center, middle
Dissimilar- different
Exact- precise/accurate
Increasingly- gradually
Imitation- reproduction
Intentionality- goal directed behavior
Interaction- interface, contact, relation
Manipulation- handling, management
Non-intentional- not goal directed or purposeful
Overhang- protrusion
Preverbal- before speech
Protest- objection, complain
Prick- puncture, perforation
Plagued- beset
Predilection- preference, liking, fondness
Pause- silence
Pitch- terrain
Predictable- expected
Protoconversation- similar to conversation
Quiver- tremble, shake
Ritual- formal procedure
Repetition- echo, recurrence
Remoteness- distance
Retort- comeback with, rejoin
Responsive- approachable, reactive
Reflexive- automatic, impulsive
Stimulate- arouse, inspire
Settle- clear up
Startle- surprise, shock, alarm
Substitute- alternate
Significance- importance
Stiffen- harden
Tickle- irritate, prickle
Unconscious- unaware
Wriggle- writhe
REFERENCES
1) Owens, R.E. (2001), Language Development: An Introduction, 5th Ed, Boston: Pearson Education, pp. 157-194
2) McConkey, R. & Price, P. (1986), Let’s Talk, London: Souvenir Press (E & A) Ltd., pp. 41-80
3) Crishna, B. (1996), Communication for the child with Cerebral Palsy, Calcutta: Indian Institute of cerebral palsy, pp. 1-6
4) Bloom, L. & Lahey, M. (1978), Language Development and Language Disorders, New York: John Wiley & Sons, pp. 69-97.
5) Coupe, J. Golart, J. (1988), Communication before Speech, London: Chpham and Hall, pp. 19-30
6) Sheridan, M., (1997), From Birth to Five years, London: Routledge.
AND
NONVERBAL COMMUNICATION
INTRODUCTION
Young infants and babies are not able to communicate by words in the way adults can. As a substitute, they use natural gestures, facial expression and vocalization, which are general. At the earliest stage, these are gross to start with - cries or wriggles – but their methods become more and more exact as they grown-up and their sounds amalgamate into words. Interaction with responsive adults is must to develop their communication.
Early interaction and Communication:
Early interaction:
Early interaction refers to the interaction between an infant and caregivers before development of verbal speech and language.
The word infant is derived from the Latin infans, which means, “ not speaking”. But a lot of communication occurs before verbal speech and language develop. Development of language depends on the development of earlier preverbal (before speech) interaction and communication. (Owens, 2001, pp.157)
Communication:
“Communication is a natural way in which people exchange ideas, ask for something or someone, comment on what is happening around them and express their feelings.” (Crishna, 1996, pp. 1)
In case of infants – communication is the way in which they can request, protest, greet, comment, and ask for objects, attention, action etc.
“ Communication does not suddenly start when the child begins to talk; it has been taking place from the moment he was born. Often the child and the adult may be quite unconscious that what they are doing is communicating.” (McConkey, 1986, pp. 41)
People/children usually communicate-
1) By using speech:
It refers to the verbal expression in a language that is realized by other surround the child and includes-
Words ----------- Hello
Phrases ----------- Hello, Mina
Sentences ----------- Mina is sitting on the table
2) By using non-verbal means:
Sound - which express happiness or sadness or a . response
Eye gaze - by looking at an object when infants want it
Facial expression - by smiling when infants are happy
Body language - by turning away from things they do not like
Pointing - by pointing with a finger or a hand to a person
Gesture - by waving their hand to say hello
Touching - by touching anybody to get attention
(Crishna, 1996, pp. 2-3)
We can say that though speech is most accepted and normal form of communication, it develops later after using a lot of non-verbal means in a child. These early non-verbal skills are very essential for a child in acquisition of language. Early interaction between infant and mother occurs with these non-verbal forms of communication. For example- non-specific crying which could indicate a need for food or comfort or relief from pain, But the mother or the caregiver, responds to this early, unclear message by trying to find out what the child wants. The mother may get that the child is hungry, wet, cold, pricked by a safety pin or plagued by a pain in his stomach.
Stages in Early Communication Development:
Between birth and age one
· Can differentiate mother’s voice from stranger’s voice.
· Cries to gain contact/cries for assistance, when happy/uncomfortable/in pain/ hungry (reinforced behavior)
· Increasingly, chronological rather than instantaneous speech begins to develop.
· Improved turn-taking outline (pauses for response)
· Rituals and game-playing develop
· Rituals (conventional routines of feeding bathing etc.)
· Games = anticipation-based (Peek-a-boo, round the garden)
· These sequences of mutual gaze, smiles, and vocalization are like “protoconversation” (similar to conversation)
· Recognizes and responds to own name
· Interactions become more about the infant, caregiver and an object (i.e. triangle reference)
· Recognizes name of familiar people (mum, dad)
· Says 2-3 words besides "mama" and "baba".
· Use simple social gesture, e.g. wave bye bye, clap
· Turns to search and localize used words such as all gone, no, bye bye (Bangla-shes, na, bye bye)
Between one and two
· Understands "no".
· Uses 20 to 40 words, including names.
Uses new words regularly.
Removes shoes, socks, pants, and sweater
Replaces familiar objects where they belong
Sleeps ten-twelve hours at night
Refers to self by name.
Combines two words such as "daddy bye-bye".
Waves good-bye
Plays by self; initiates own play
Builds tower of 6-7 blocks.
Makes the "sounds" of familiar animals.
Uses word such, as "more" to make wants known.
Brings object from another room when asked.
Between two and three
Identifies body parts.
Gives full name.
Holds up fingers to tell age.
Carries on 'conversation' with self and dolls.
Asks, "What's that?" And "where's my?"
Uses 2-word negative phrases such as "no want".
Has a 450-word vocabulary.
Combines nouns and verbs "mummy come".
Understands simple time concepts: "last night", "tomorrow".
Refers to self as "me" rather than by name.
Tries to get adult attention: "watch me".
Likes to hear same story repeated.
May say "no" when means "yes".
Talks to other children as well as adults.
Solves problems by talking instead of hitting or crying.
Answers "where" questions.
Matches 3-4 colors, knows big and little
Names common pictures and things.
Uses short sentences like "me want more" or "me want biscuit".
Between three and four
Uses verb forms.
Uses 'I', 'you'.
Uses 'this', 'that'.
Names at least one color.
Counts to five.
Verbalizes recent experiences.
Can tell a story.
Understands 'what', 'where'
Uses 'what', 'where' and occasionally 'when', 'who'.
Has a sentence length of 4-5 words.
Has a vocabulary of nearly 1000 words.
Understands "yesterday," "summer", "lunchtime", "tonight", "little-big".
Begins to obey requests like "put the block under the chair".
Knows his or her last name, name of street on which he/she lives and several nursery rhymes
Between four and five
Has sentence length of 4-5 words.
Uses past tense correctly.
Comprehends the concept of 'better than'.
Uses size and colour adjectives in sentence form.
Has a vocabulary of nearly 1500 words.
Points to colors red, blue, yellow and green.
Identifies triangles, circles and squares.
Understands "In the morning", "next", "noontime".
Can speak of imaginary conditions such as "I hope".
Asks many questions, asks "who?" and "why?"
Outline of stages of early communication:
Perlocutionary stage 0-8 months:
· Infant has no goal awareness
· Attends to and responds to stimuli
· Uses undifferentiated behaviors (e.g. crying)
· Deliberate communicative attempts increase gradually (gestures, reaching)
Illocutionary stage 8-9 months:
· Coordinated plan to achieve goals
· Infant uses eye contact and repetition
· Uses gestures
· Uses protoimperatives (requests-reaching, pointing)
· Uses protodeclaratives (maintaining joint attention-pointing, showing)
Locutionary 12 months:
· Begins with first meaningful words and gestures together
· Words accompany or replace gestures to express
· Symbolic interaction occurs
· Elicited speech sounds sometimes words
STAGES OF EARLY COMMUNICATION
Coupe and Goldbart (1988) discuss 6 stages of early communication. These are-
Stage 1. Pre-intentional-Reflexive stage:
The carer to the individual’s very early and reflexive behaviours assigns communicative intent and meaning. These are produced in response to internal and external stimuli (especially auditory and visual stimuli) eg. Startle reflex, sucking reflex. At the reflexive level, the person appears to sleep a lot. However, when awake the individual will gaze at people or objects, which come into his or her visual field (15-20 cm). When the caregiver makes eye contact with the individual it is known as “mutual gaze.
Stage 2. Pre-intentional-Reactive stage:
The carer to the individual’s reactive behaviours assigns communicative intent and meaning. The individual reacts to people objects or events within his or her environment. He or she reacts to stimuli from all senses. There is now an expanded range of body and lime movements and vocalizations e.g. trunk turning, hand to mouth behaviours and a greater variety of facial movements. He or she learns to repeat a pleasurable action. The carer will talk to the individual and the content of the conversation will relate to the activity that they are involved in e.g. “Here is your dinner’’- at dinner time. The individual responds to different tones of voice and to different facial expressions. He or she will search for sound sources, especially speech or music. Any sound or movement made by the individual will have a major effect on the carer’s behaviour. At this stage, the first smile appears. Mutual gaze is changing and leading into shared attention where the individual and the carer may appear to be “looking” at the same object or event and the carer will comment on it.
Stage3. Pre-intentional-Proactive stage:
The individual’s efforts to act on the environment become signals to the carer who then assigns communicative intent and meaning. At this stage, there is the beginning of acting purpose fully on objects. The individual begins to realise that objects exits even if they cannot see them. He or she can retrieve partially hidden objects and can recognise some objects by function e.g. cup/drink. The individual will look for reach for desired objects and people. A repertoire of different behaviours is developing, for instance, hitting, shaking and mouthing various objects. He or she will attempt to repeat actions, which brought about novel changes. The individual can shift his or her attention to more than one thing at a time. He or she is beginning to understand another person’s expressions and actions. The individual will also continue a movement during a pause in familiar interaction e.g. If being rocked, s/he will continue the rocking a break as a signal to reinstate the movement. He or she begins to imitate simple gestures e.g. waving, clapping. Towards the end of stage, the behaviours become more intentional the individual sees what he or she wants and goes for it, although the way he or she does it may not always be successful.
Stage 4. Intentional-Informal stage:
The individual acts on the environment to create a specific effect. By the time the individual reaches the early intentional stage of development he or she knows how to use an object to get the carer’s attention or how to use another person to get an object that he or she wants. Object permanency is established and the individual will actively try to look for objects that disappear. He or she will also use a repertoire of behaviours including alternating gaze to get his or her needs met le. Looking back and forth between the communication partner and the item or activity that is wanted as a way of requesting it. There begins to be a range of communicative functions e.g. protests, greeting, positive and negative attention seeking. Receptively, the individual recogninises and responds to common gestures e.g. come here, go away, wave. He or she also shows simple imitation skills.
Stage 5. Intentional-Formal stage:
At this stage the individual is beginning to integrate the information from his/her senses. He or she will drop or throw something deliberately, monitor the action and look to see where it falls. The individual is more able to solve problems through trial and error. Objectives are beginning to be used appropriately e.g. use of a straw, a comb, a purse. The individual learns that the same object will do different things depending on how it is used e.g. papers tears, paper crumples. Reaching for something turns into pointing to something. The individual is able to communicate a wide range of intentions or functions to others in a way that is more conventionally understood e.g. through gestures, single words and vocalizations. He or she will show or give objects as a way of initiating or maintaining an interaction with another person. He or she will understand the key words in a sentence particularly when used in context.
Stage 6. Intentional-Referential stage:
The individual starts to have an internalized mental representation of the word around them; He or she is able to solve simple problems by thinking about them rather then through trial and error. Deferred imitation skills are established e.g. can imitate unfamiliar actions after an event. The individual may also be able to mime or act out an event. Joint action routines are established where the individual learns that interactions follows a familiar sequence of events and can anticipate these and indicate when the sequence is varied e.g. dressing, grooming, mealtimes. For instance, with dressing- the caregiver uses the same order- singlet first, then t-shirt or jumper, underpants, socks, pants and shoes. The function of a range of objects is known and objects are used purposefully. Objects may also be used to established or maintain a social interaction or because he or she needs help with an activity e.g. bring a key to open cupboard where a favourite item is kept.
Hierarchy of learning language:
Speech
Expressive language
Receptive language
Play
Attention
Interactional Behaviors:
Some interactional behaviors are essential for communication development of a child. These are-
Joint reference:
Also known as “joint attention”. Joint reference means- two or more individuals share a common focus together on one point of interest (object/event/person). (Owens, 2001, pp.184)
The baby and mother insert in a system to ensure joint selective attention at earliest stage. For an example, the mother will shake an object before her infant to be a focus for the infant’s attention it. These routines are accustomed to achieve eye contact, the first step in Joint reference.
Joint action:
Infant and the caregiver build up dual behaviors in a familiar context through out the first year of life. The routinized actions (i.e.- game playing and daily routine) are called joint action.
Conversational skills and turn taking are learned. Rules of communication can be learned within a familiar and pleasurable social sequence.
Game playing:
Caregiver and the infant begin to play almost from birth. Depending on caregivers and child’s interest, the games become ritual exchanges that mention upon or sensitively mark common patterns of interaction.
Routines:
It means- the conventionalized and predictable scripts or scaffolds for interpretation and behaviors in which caregiver provide order. Conceptual foundations of later language development is achieved within familiar daily routines and events (bathing, toileting, dressing, feeding etc.)
Turn taking:
Turn taking is very essential aspect of interactional behavior for rurther development of conversational skills that is language development. It occurs in early breast-feeding. A ‘turn” may entail vocalization, movement of body parts, facial expression etc. It occurs in games with pauses for infant responses (tickling, lifting, bouncing etc.). It develops protoconversation (similar to conversation) with alternating vocalization, then gestures and words.
Babytalk/motherese/parentese:
Motherese is a special style of talking with children which contains short and simple form of sentences, special body movement and special facial expression.
Characteristic of motherese:
· Small core vocabulary
· Short length of utterance
· Infant vocal behavior is treated as meaningful
· Much use of verbal rituals and repetitions
· Talk refers to the here and now
· Much use of greetings
· Mother pauses even if the child doesn’t respond
· Much use of pitch and loudness
Activities to Encourage your Child's Language
Encourage the child to express opinion by using gesture
Talk simply, clearly, and slowly to your child
Give him/her opportunities to make choice
Play simple games with your child
Comment on what you did or how you think your child feels.
Talk to your child as you care for him or her throughout the day
Use a lot of pictures
Tell rhymes and sing songs.
Allow the child to use symbolic or invented word e.g.- mew sound to indicate cat
Talk to your baby about everything you're doing while you're with him/her
Reward and encourage early efforts to communicate
Give reinforcement for child’s response
Continue to say social stories.
Praise your child when she talks about her feelings, thoughts, hopes and fears.
Look at family photos and talk to him about your family history.
Listen to her when she talks to you or tries to express something.
GLOSSARY
Approximate- near, estimated
Blink- flash
Core- center, middle
Dissimilar- different
Exact- precise/accurate
Increasingly- gradually
Imitation- reproduction
Intentionality- goal directed behavior
Interaction- interface, contact, relation
Manipulation- handling, management
Non-intentional- not goal directed or purposeful
Overhang- protrusion
Preverbal- before speech
Protest- objection, complain
Prick- puncture, perforation
Plagued- beset
Predilection- preference, liking, fondness
Pause- silence
Pitch- terrain
Predictable- expected
Protoconversation- similar to conversation
Quiver- tremble, shake
Ritual- formal procedure
Repetition- echo, recurrence
Remoteness- distance
Retort- comeback with, rejoin
Responsive- approachable, reactive
Reflexive- automatic, impulsive
Stimulate- arouse, inspire
Settle- clear up
Startle- surprise, shock, alarm
Substitute- alternate
Significance- importance
Stiffen- harden
Tickle- irritate, prickle
Unconscious- unaware
Wriggle- writhe
REFERENCES
1) Owens, R.E. (2001), Language Development: An Introduction, 5th Ed, Boston: Pearson Education, pp. 157-194
2) McConkey, R. & Price, P. (1986), Let’s Talk, London: Souvenir Press (E & A) Ltd., pp. 41-80
3) Crishna, B. (1996), Communication for the child with Cerebral Palsy, Calcutta: Indian Institute of cerebral palsy, pp. 1-6
4) Bloom, L. & Lahey, M. (1978), Language Development and Language Disorders, New York: John Wiley & Sons, pp. 69-97.
5) Coupe, J. Golart, J. (1988), Communication before Speech, London: Chpham and Hall, pp. 19-30
6) Sheridan, M., (1997), From Birth to Five years, London: Routledge.
Autism
Autism
Definition
Autism is a severe disorder of brain function marked by problems with social contact, intelligence and language, together with ritualistic or compulsive behavior and bizarre responses to the environment.
Autism is a brain disorder that affects the way the brain uses or transmits information. Studies have found abnormalities in several parts of the brain that almost certainly occurred during fetal development. The problem may be centered in the parts of the brain responsible for processing language and information from the senses.
Autism is a developmental disorder and the specific cause for autism is not known. It is believed that some biochemical imbalance would have caused autism and some believe that it is a psychological disorder. Children with autism cannot communicate their feelings and emotions properly. Such children find it difficult to socialize. They communicate only to get their needs and not to socialize.
Autism behaviors include lack of proper response to social and environmental stimulations. Communication in a child with autism would be minimal and there would be no eye contact and the child would be in its own world and the response would be very slow. These are some of the autism behaviors that can be noted. There are many therapies available for treating such children.
About autism
· Autism is characterized by impaired development in social interaction, communication, and behavior.
· The degree of autism varies from mild to severe.
· Severely afflicted patients can appear to have a profound intellectual disability.
· The cause of autism is unknown.
· The optimal treatment of autism involves an educational or vocational program that is suited to the developmental level of the child or adult, respectively
· Lack of pointing to direct others’ attention to objects (occurs in the first 14 months of life)
· Does not adjust gaze to look at objects that others are looking at
· Cannot start or sustain a social conversation
· Develops language slowly or not at all
· Repeats words or memorized passages, such as commercials
· Does not refer to self correctly (for example, says "you want water” when the child means "I want water")
· Uses nonsense rhyming
· Communicates with gestures instead of words
Causes:
Autism is a physical condition linked to abnormal biology and chemistry in the brain. The exact causes of these abnormalities remain unknown, but this is a very active area of research. There are probably combinations of factors that lead to autism.
Genetic factors seem to be important. For example, identical twins are much more likely than fraternal twins or siblings to both have autism. Similarly, language abnormalities are more common in relatives of autistic children. Chromosomal abnormalities and other neurological problems are more common in families with autism.
What Are the Symptoms?
Symptoms of autism include:
Extreme difficulty in learning language.
Inappropriate response to people. A child with autism may avoid eye contact, resist being picked up or cuddled, and seem to tune out the world.
Inability or reduced ability to play cooperatively with other children or to make friends.
Inability to understand other people's feelings.
Need for a rigid, highly structured routine -- and being very distressed by changes in routines.
Extreme hyperactivity or unusual passivity, and extreme resistance to change.
Repetitive body movements including pacing, hand flicking, twisting, spinning, rocking or hitting oneself.
Insensitivity to pain or lack of response to cold or heat.
Impulsive behavior and no real fear of dangers.
An unusual attachment to inanimate objects such as toys, strings or spinning objects.
Frequent crying and tantrums for no apparent reason.
Peculiar speech patterns. An autistic child may use words without understanding their meanings.
Abnormal responses to sensations such as light sound and touch. At times an autistic child may appear deaf. At other times the child may be extremely distressed by everyday noises.
Some of these symptoms occur in children with other disabilities. Symptoms can change, as the child grows older.
Treatments:
There is no cure for autism. Treatments are aimed at reducing specific symptoms. Because the symptoms vary so widely from one person to the next, there is not a single approach that works for every person. A spectrum of interventions includes training in music, listening, vision, speech and language, and senses. Special diets and medications may also be prescribed. Speech and language therapists and Occupational therapists can help to improve their skills.
Definition
Autism is a severe disorder of brain function marked by problems with social contact, intelligence and language, together with ritualistic or compulsive behavior and bizarre responses to the environment.
Autism is a brain disorder that affects the way the brain uses or transmits information. Studies have found abnormalities in several parts of the brain that almost certainly occurred during fetal development. The problem may be centered in the parts of the brain responsible for processing language and information from the senses.
Autism is a developmental disorder and the specific cause for autism is not known. It is believed that some biochemical imbalance would have caused autism and some believe that it is a psychological disorder. Children with autism cannot communicate their feelings and emotions properly. Such children find it difficult to socialize. They communicate only to get their needs and not to socialize.
Autism behaviors include lack of proper response to social and environmental stimulations. Communication in a child with autism would be minimal and there would be no eye contact and the child would be in its own world and the response would be very slow. These are some of the autism behaviors that can be noted. There are many therapies available for treating such children.
About autism
· Autism is characterized by impaired development in social interaction, communication, and behavior.
· The degree of autism varies from mild to severe.
· Severely afflicted patients can appear to have a profound intellectual disability.
· The cause of autism is unknown.
· The optimal treatment of autism involves an educational or vocational program that is suited to the developmental level of the child or adult, respectively
· Lack of pointing to direct others’ attention to objects (occurs in the first 14 months of life)
· Does not adjust gaze to look at objects that others are looking at
· Cannot start or sustain a social conversation
· Develops language slowly or not at all
· Repeats words or memorized passages, such as commercials
· Does not refer to self correctly (for example, says "you want water” when the child means "I want water")
· Uses nonsense rhyming
· Communicates with gestures instead of words
Causes:
Autism is a physical condition linked to abnormal biology and chemistry in the brain. The exact causes of these abnormalities remain unknown, but this is a very active area of research. There are probably combinations of factors that lead to autism.
Genetic factors seem to be important. For example, identical twins are much more likely than fraternal twins or siblings to both have autism. Similarly, language abnormalities are more common in relatives of autistic children. Chromosomal abnormalities and other neurological problems are more common in families with autism.
What Are the Symptoms?
Symptoms of autism include:
Extreme difficulty in learning language.
Inappropriate response to people. A child with autism may avoid eye contact, resist being picked up or cuddled, and seem to tune out the world.
Inability or reduced ability to play cooperatively with other children or to make friends.
Inability to understand other people's feelings.
Need for a rigid, highly structured routine -- and being very distressed by changes in routines.
Extreme hyperactivity or unusual passivity, and extreme resistance to change.
Repetitive body movements including pacing, hand flicking, twisting, spinning, rocking or hitting oneself.
Insensitivity to pain or lack of response to cold or heat.
Impulsive behavior and no real fear of dangers.
An unusual attachment to inanimate objects such as toys, strings or spinning objects.
Frequent crying and tantrums for no apparent reason.
Peculiar speech patterns. An autistic child may use words without understanding their meanings.
Abnormal responses to sensations such as light sound and touch. At times an autistic child may appear deaf. At other times the child may be extremely distressed by everyday noises.
Some of these symptoms occur in children with other disabilities. Symptoms can change, as the child grows older.
Treatments:
There is no cure for autism. Treatments are aimed at reducing specific symptoms. Because the symptoms vary so widely from one person to the next, there is not a single approach that works for every person. A spectrum of interventions includes training in music, listening, vision, speech and language, and senses. Special diets and medications may also be prescribed. Speech and language therapists and Occupational therapists can help to improve their skills.
Prevention of ఆటిసం:
Until the cause of autism is discovered, prevention is not possible.
Until the cause of autism is discovered, prevention is not possible.
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