Pharmacovigilance – Some Facts

Pharmacovigilance refers to collection of all details related to Adverse Drug Reactions & its reporting ,understanding and prevention of adverse effects or any other possible drug-related problems, Drug Monitoring and Reporitng, Product Survillance, Legislation, Drug -I – Series etc.

It also establishes the magnitude of the Drug Safety Problems.

Basically 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.

Recently, Pharmacovigilance concerns have been widened to include

• herbals
• traditional and complementary medicines
• blood products
• biologicals
• medical devices
• vaccines.

The programme particularly solicits reports of:

• All adverse events suspected to have been caused by new drugs and ‘drugs of current interest’
(List to be published by CDSCO from time to time)
• All suspected drug interactions
• Reactions to any other drugs which are suspected of significantly affecting a patient’s management, including reactions suspected of causing:
• Death
• Life-threatening (real risk of dying)
• Hospitalisation (initial or prolonged)
• Disability (significant, persistent or permanent)
• Congenital anomaly
• Required intervention to prevent permanent impairment or damage

The Specific Aims of Pharmacovigilance are to

• 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.

Pharmacovigilance and all drug safety issues are relevant for everyone whose life is touched in any way by medical interventions.

There are differences among countries (and even regions within countries) in the occurrence of ADRs and other drug-related problems. This may be due to differences in diseases and prescribing practices, genetics, diet, traditions of the people, drug manufacturing processes used which influence pharmaceutical quality and composition, drug distribution and use including indications, dose and availability.

The use of traditional and complementary drugs (e.g. herbal remedies) may also pose specific toxicological problems, when used alone or in combination with other drugs.Therefore, Pharmacovigilance is needed for detecting ADRs and specifically to combat counterfeit and substandard quality products. ADR monitoring ensures that patients obtain safe and efficacious products.

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).

Pharmacovigilance of Herbal Drugs

The safety of herbal medicines has become a major concern to both national health authorities and the general public. 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

In India, the ADR forms which can be filled by the Physicians only(and not by the patients) , but in some countries like USA, even patients can fill the ADR forms & submit these online.

Pharmacovogilanec System in India is Pyramid shaped with the National Pharmacovigilance Centre at AIIMS, New Delhi at the top; followed by Zonal and then state level Pharmacovigilance centres thoughout the country. The centres in the Medical Colleges help in collecting information from the peripheral dispenseries  civil hospitals.

More details about the Pharmacovigilance & its SCOPE in India as well as worldwide will be explored in our upcoming blog posts

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