Pharmacovigilace: An Incredible Panacea for human beings

Pharmacovigilance: An overview

Pharmacovigilance (PV) or Drug Safety:

Pharmacovigilance (also known as Drug Safety) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Pharmacovigilance: pharmakon (Greek word for drug) and vigilare (Latin word for to keep watch). So, it simply states that pharmacovigilance is to keep watch on drug.

Drug:

A drug is a natural or synthetic substance which (when taken into a living body) affects its functioning or structure, and is used in the diagnosis, mitigation, treatment, or prevention of a disease or relief of discomfort.

Drug Development Process Overview:

An historical overview of pharmacovigilance:

Due to some serious adverse events associated with medical products and drugs that resulted in pressure on governments and businesses to produce legalization and guidance, as well as the evolution of pharmacovigilance activities to protect the safety of patients.

Below are the important timelines and milestones which results into evolution of Pharmacovigilance:

1902	Biologics Control Act passed in USA, following the death of children caused by vaccines
1906	Pure Food and Drug Act passed in the USA
1937	In USA the Elixir of Sulfanilamide (liquid form contained the poisonous diethylene glycol, DEG), killed over 100 people, many of whom are children, highlighting the need to establish drug safety before marketing
1938	Because of DEG deaths, Federal Food, Drug and cosmetic Act was established
1947	Nuremberg Code- A set of research ethical principles regarding human experimentations
1949	Council for International organizations of medical Sciences (CIOMS) established jointly WHO and UNESCO
1961	The Thalidomide disaster led to limb deformities in the new-borns of those mothers who took the drug while pregnant. Thalidomide withdrawn from market.
1962	Because of Thalidomide disaster, Kefauver-Harris amendments passed in USA
1964	The Yellow Card was structured in UK for collecting ADR’s of medicines. Declaration of Helsinki- A set of ethical principles and guidelines for the protection of human subjects of research
1968	WHO programme for International Drug monitoring was instituted
1973	French pharmacovigilance system executed
1978	Belmont- A set of ethical principles and guidelines for the protection of human subjects of research
1995	European Medicines Agency was set up
2001	EudraVigilance was funded
2012	Good Pharmacovigilance Practices was released to replace volume 9A
2017	New EudraVigilance format

Important Terms

Adverse drug reactions (ADRs):

ADRs, which are defined as any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function.

Medication errors:

Medication errors are mishaps that occur during prescribing, transcribing, dispensing, administering, adherence, or monitoring a drug. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest (even without adverse event itself), because they may result in an ADR.

Adverse events:

An adverse event is an undesired occurrence that results from taking a medication correctly. The event can either be a type A reaction or a type B reaction. Type A reactions are predictable adverse events which are commonly dose dependent and can be mild, moderate, or severe. Type B reactions are completely unpredictable and have nothing to do with doses.

Side effects:

A side effect is an undesired effect that occurs when the medication is administered regardless of the dose. Unlike adverse events, side effects are mostly foreseen by the physician and the patient is told to be aware of the effects that could happen while on the therapy.

Allergy:

An allergy is an adverse drug reaction mediated by an immune response (e.g., rash, hives).

Difference between Adverse events and side effects:

Adverse events are unintended pharmacologic effects that occur when a medication is administered correctly while a side effect is a secondary unwanted effect that occurs due to drug therapy.

The Importance of Pharmacovigilance:

• Patient’s safety: Drug safety ensures that a patient’s safety and wellbeing is safeguarded throughout the entire drug development lifecycle, as well as when the drug is readily available on the market.
• Drug monitoring: Drugs are continuously monitored for side effects on patients, and any new data is collected and reported to health authorities on a regular basis.
• Adverse drug reaction reporting: Monitoring and reporting of the adverse drug reactions to regulatory authorities. Action could include changing the dose or stopping the drug and trying an alternative.
• Pharmaceutical preparations efficacy: Research the efficacy of drug and by monitoring the adverse drug reaction of drugs right from the lab to the pharmacy and then on for many years.
• Public awareness: Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
• Benefit-Risk balance: Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.

Reporting of Adverse events:

Any individual or organization who coming across any adverse effect due to medicinal product can report it to qualified health care professional or regulatory agency as shown below.

Sources of AE reports:

Solicited reports- Solicited reports are those derived from organized data collection systems, which include clinical trials, registries, post-approval named patient use programs, other patient support and disease management programs, surveys of patients or healthcare providers, or information gathering on efficacy or patient compliance.

Unsolicited reports: An Unsolicited report (spontaneous report) is an unsolicited communication by healthcare professionals or consumers to a company, regulatory authority or other organization that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme. Eg. Spontaneous reports, literature, other sources (internet, social networks, lay press, etc.).

Elements of valid ICSR:

If one or more of these four elements is missing, the case is not a valid AE report. Although there are no exceptions to this rule there may be circumstances that may require a judgment call. For example, the term "identifiable" may not always be clear-cut.

Pharmacovigilance process:

In pharmacovigilance data of all drugs if they are under clinical trial or marketed is gathered by regulatory authorities or by pharma companies. This data is then analysed by qualified healthcare professionals of pharma company and regulatory authorities. It includes writing about drug and its side effects, risk, benefits etc and notifying this to regulatory authorities, patients and healthcare professionals. This safety data is gathered and monitored throughout the life of a product.

So, this is just an overview of pharmacovigilance. Pharmacovigilance is a vast concept which we will discuss in coming post in detail.