We all are aware of the importance of medicines in our lives. Be it a mild headache to a disastrous cancer or any life-threatening ailment, the world of pharmaceuticals just proves that no ailment can be beyond its reach. But as every coin has two sides, do we ever question the safety of the drugs being taken by us in our routine?
Yes, we have also worked on that aspect and have thus emerged with a field called Pharmacovigilance.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions and other medicine-related problems.1
Abbreviated as (PV or PhV), also known as Drug Safety, its etymological roots for the word “pharmacovigilance” are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch).2
In order to better understand this definition, we need to know what could be considered as the “adverse reactions and other medicine-related problems”. Simply, adverse reactions are any unwanted or unintended or unexpected or dangerous reaction to a drug.
It could be sudden or may have developed over time.3 Other medicine-related problems could be medication errors like overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, even without any unintended reaction, because they may result in an adverse drug reaction.13
Key historical events that stimulated regulations were the:
- First UK law to seek to regulation of drugs was the 1868 Pharmacy Act.(4) It was the major 19th-century legislation in the United Kingdom limiting the sale of poisons and dangerous drugs to qualified pharmacists and druggists.5
- USA: 1902 Biologics Control Act.4 An Act to regulate the sale of viruses, serums, toxins, and analogous products in the District of Columbia; to regulate interstate traffic in said articles, and for other purposes, the Biologics Control Act was passed in the United States on July 1, 1902 after two incidents involving the deaths of children caused by contaminated vaccines.6
- USA: the 1938 Federal Food, Drug and Cosmetic Act was passed, which required proof of safety before the release of a new drug. The category of ‘Prescription Only’ drugs was codified into law by 1951.4 The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form.7
- The thalidomide tragedy in the early 1960 heralded the modern regulatory system in most western countries.4
- Insufficient evidence of safety from clinical trials. This could be because of the narrow population being age and gender specific, narrow indications considering the specific disease being studied and the shorter duration of not more than a few weeks.
- Medicines are supposed to save lives as “dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable.” Lepakhin V. Geneva 2005. It has been suggested that adverse drug reactions may cause 5700 deaths per year in UK – Pirmohamed et al, 2004. Adverse Drug Reactions were 4th-6th commonest cause of death in the US in 1994 – Lazarou et al, 1998.
- To retain the products on the market. A classic example is the recall of Thalidomide in 1960’s for causing Phocomelia.
- To protect patients from unnecessary harm as many adverse drug reactions are preventable.
- To reduce healthcare expenses as adverse drug reactions are a huge burden economically. Data from EU as a whole states that cost due to adverse drug reactions in EU is € 79 billions/year (Ref: Press Release from Brussels, 10 Dec 2008.)
- Because any medicine can be implicated. This means that a medicine can interact with another and play a significant role in the efficacy of either one of the medicines. In 1980 and 1982 two case reports documented reactivation of pulmonary tuberculosis in patients who had used nonsteroidal anti-inflammatory drugs (NSAIDs). A statistically significant relation was then found between the reactivation of tuberculosis and the use of NSAIDs.9
- Promoting rational use of medicines and adherence since irrational use of medicines is a major problem worldwide. WHO estimates that more than half of all medicines are prescribed, dispensed or sold inappropriately, and that half of all patients fail to take them correctly. The overuse, underuse or misuse of medicines results in wastage of scarce resources and widespread health hazards.10
- Ensuring public confidence by making them aware of the side-effects of their medicine clearly.
- It is an ethical thing to do as ‘To know of something that is harmful to another person who does not know, and not telling, is unethical.
- It can unveil lapses in best practices like unexpected lack of effect due to product counterfeiting, drug resistance and drug interactions, quality problems, dependence and abuse, poisoning and medication errors.
- Collecting and managing data on the safety of medicines.
- Looking at the data to detect ‘signals’ (any new or changing safety issue).
- Evaluating the data and making decisions with regard to safety issues.
- Pro-active risk management to minimise any potential risk associated with the use of the medicine.
- Acting to protect public health (including regulatory action).
- Communicating with and informing stakeholders and the public.
- Audit, both of the outcomes of action taken and of the key processes involved.
- Patients who are the users of medicines
- Doctors, pharmacists, nurses and all other health care professionals working with medicines
- Regulatory authorities responsible for monitoring the safety of medicines
- Pharmaceutical companies and companies importing or distributing medicines
- 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.11
Pharmacovigilance is relevant for everyone whose life is touched in any way by medical interventions. Taking medicines, and prescribing them, are among the commonest of activities of people who are unwell and of those who care for them. It makes sense that those medicines should be monitored so as to maintain their safety standards. It will not only ensure a good quality of the human life but also ensure their trust in the pharma world.
- Pharmacovigilance. European Medicines Agency, 2015. Updated May 2015.
http://www.ema.europa.eu/docs/en_GB/document_library/Brochure/2011/03/WC500104236.pdf Accessed 18 Aug 2015.
- “Importance of Pharmacovigilance in Indian Pharmaceutical Industry”, Asian Journal of Research in Pharmaceutical Science, 2, 2012, 04-08.
- “Biologics: A Short History of the National Institutes of Health”. Office of National Institutes of Health History. May 16, 2010.
- Effective communications in Pharmacovigilance. The Erice Report. International Conference on Developing Effective Communications in Pharmacovigilance, Erice, Sicily, 24-27 September 1997, at which a policy statement was drawn up known as The Erice Declaration.
- “International Drug Monitoring: The Role of National Centers”. Who-umc.org. Retrieved 2015-02-27.