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.
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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.
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