Understanding About Drug Safety And Pharmacovigilance

Pharmacovigilance or Drug Safety is related to collection, detection, monitoring, assessment and prevention of adverse effects associated with pharmaceutical products. It is an important component which comes under effective drug regulation system. Highly qualified expertise is needed to identify the risks associated with drugs and also to defend the drugs against inappropriate branding.

In many countries, ADR (Adverse Drug Reaction) is one of the top 10 causes of illness, disability or death. Due to this, Pharmacovigilance is gaining its importance worldwide with advancement in clinical research. It aims at reducing the harm caused by adverse drug reactions, to improve public health and ensure patient safety. They have deployed numerous mechanisms for evaluating, regulating and monitoring the safety of pharmaceutical drugs.

Global Partners to Practice Drug Safety

A wide range of drug safety measures have been implemented through the global partners to practice drug safety. Some of the important organizations are mentioned below:

The Quality Assurance and Safety- A team which is a part of the Department of Essential Drugs and Medicines Policy. This comes under the umbrella of WHO and Pharmaceuticals cluster.

The Uppsala Monitoring Centre- This center manages the international database of ADR reports obtained from the National Centers.

The National Pharmacovigilance Centers- National Centers have a greater role in public health which works to increase the awareness in masses about drug safety.

Hospitals and Academia- Many reputed medical institutes globally are continuously monitoring and recording the adverse reactions and medication errors caused due to specific drugs. Even case-control studies have been deployed to gauge the public health.

Health Professionals- Health professionals from varying disciplines tend to observe various types of drug related problems which are recorded, monitored and regulated time and again.

Patients- Direct patient participation plays a vital role and increases the efficiency of drug safety.

Drug Regulation authorities

There are many drug regulation authorities who carry out Pharmacovigilance programs in order to ensure safety of medicines.

Few such regulations are Clinical trial regulation, Post-marketing safety drug monitoring, Pharmacovigilance in national drug Policy and Pharmacovigilance in Disease Control Public Health Programs.

Uppsala Monitoring Centre at Sweden plays a pivotal role in pharmacovigilance and heads the global network of drug safety regulators. These regulators work continuously on drug safety issues which might potentially affect the public health across international borders. The safety profile of medicines is a sensitive issue which directly relates to the social, political, economic and cultural factors of a country.

The Erice Declaration

This declaration plays a pivotal role in pharmacovigilance and all the health players come under its ambit; be it public health administration, health professionals, the pharma industry, drug regulators, government, media or even consumers. The declaration is meant to achieve highest ethical, professional and scientific standards in order to ensure safe use of medicines.

Future Challenges

Pharmacovigilance should concentrate more on extending the knowledge of drug safety instead of finding harm in products.

Below mentioned are some of the major challenges faced by pharmacovigilance:

•          Globalization

•          Web-based sales and information

•          Broader safety concerns

•          Public health versus pharmaceutical industry economic growth

•          Monitoring established products

•          Attitudes and perceptions to benefit and harm

•          Outcomes and impact

With the medical advancements and rapid inventions in the field of pharma worldwide, there is an increased risk of unpredictable potential harm. Hence, Pharmacovigilance play a pivotal role to meet the challenges, to regulate or to monitor the drug safety.

There is a need to continuously check for adverse effects or toxicity in the medicines globally. All such issues must be reported appropriately, analyzed and acted upon accordingly. With the high demand for improvised medicines, many unauthorized companies which do not follow the specified standards ae entering the market. Such medicines may cause adverse effects in public health. The quality of medicines must be constantly checked or regulated and monitored.

Pharmacovigilance must ensure risks are anticipated and managed, regulations are properly implemented and communication between the health professionals and the public are improved in order to achieve global health.