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Pharmacovigilance - Essay Example

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The recent drug safety scares with Vioxx and Seroxat have highlighted the problems associated with the long term effects of taking medication. Such incidences have resulted in the current focus being placed on pharmacovigilance, which is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits from medicines (EU Commission 2006)…
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Introduction The recent drug safety scares with Vioxx and Seroxat have highlighted the problems associated with the long term effects of taking medication. Such incidences have resulted in the current focus being placed on pharmacovigilance, which is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits from medicines (EU Commission 2006). Pharmacovigilance involves: collecting and managing data on the safety of medicines; looking at the data to detect signals; evaluating the data and making decisions with regard to safety issues; and acting to protect public health (EU Commission 2006). All this is achieved by including communication from patients, who are the users of the medicine, doctors, pharmacists, nurses, regulatory authorities and drug companies (EU Commission 2006).
Pharmacovigilance is important if the medical establishment is to avoid incidences like the thalidomide disaster in the 1960s when thousands of babies were born with limb deformities as a result of their mothers taking the drug as a sedative during pregnancy (EU Commission 2006). Pharmacovigilance is important for a number of reasons; clinical trials have their own limitations when it comes to marketing a drug for the first time. Clinical trials are also: tested on relatively health patients, the sample size reduces the chances of finding an adverse effect, they have a limited duration which precludes the discovery of long term consequences and drug interactions can be substantial in a population of patients taking various drugs; a situation which is difficult to replicate in a trial environment (Stricker & Psaty 2004). Pharmacovigilance is important as 5% and over 10 000 of all admissions to hospitals are due to adverse drug reactions (Pirmohamed & Darbyshire 2004) caused by a reaction to the drug or combination of drugs, which is harmful and unintended which occurs at a dose normally used for prophylaxis, diagnosis or treatment (Metters 2004). Pharmacovigilancne also involves monitoring new drugs for signs of adverse drug reactions, particularly those not detected in clinical trials (Rawlins 1995). It is also important because a limited amount of information can only be gained from clinical trials, approval times are becoming shorter for medicines, there is an increase in the use of over-the-counter drugs and more importantly, the economic costs of sudden drug withdrawals associated adverse drug reactions can no longer be ignored (ISDB 2005).
Pharmacovigilance is a legal requirement and in Europe this is enshrined in Directive 2001/83/EC and Regulation (EC) 726/2004 (EU Commission 2006). The EU Clinical Trials Directive of 2004 was also enforced for all clinical trials of medicinal products, and Regulation 2309/93 and Directive 75/319/EEC place requirements on Member States to establish national pharmacovigilance systems to collect and evaluate information on adverse reactions to medicinal products or their side effects and to take appropriate action where necessary (EU Commission 2006). Regulation 540/95 lays down specific requirements for reporting non-serious unexpected, adverse reaction (EU Commission 2006). All these regulations and directives are necessary so that if a medicinal product's overall risk/benefit profile changes significantly for any reason, then the authorities will be able to vary, withdraw or suspend its use.
To summarise, pharmacovigilance is important as it advances future research, increases our medical understanding, helps drug development and contributes to epidemiological data. By understanding drug safety, patients will also benefit for improved care and better medicine.
1. ISBD EU. 2005. Berlin declaration on pharmacovigilance. Berlin: ISBD.
2. Metters, J. 2004. Report of an independent review of access to the Yellow Card scheme. London: The Stationery Office.
3. Pirmohamed, M and Darbyshire, J. 2004. Collecting and sharing information about harms. British Medical Journal. 329: 6-7.
4. Rawlins, MD. 1995. Pharmacovigilance: paradise lost, regained or postponed Journal of the Royal College of Physicians of London. 29(1): 41-9.
5. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down the Community procedures for the authorisation and supervision of medical products for human and veterinary use and establishing a European Medicines Agency: Official Journal of the European Union 30 April 2004: L 136/l - L136/33. Read More
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