Risk Management and Pharmacovigilance!

Medicinal products, when they are launched for the first time in the market, are assessed for their potential risks. A product is authorized only when it is found that its risk-benefit ratio is positive for the target population. Every product has some risks associated with its usage.

Risk Management is a systematic approach to identifying, assessing, understanding, communicating and mitigating risk. The risks associated with the use of any drug could be its adverse reaction, its reaction with other drugs and risk related to its ineffectiveness.

Pharmaceutical companies,regulatory authorities, health care officials and patients, all form part of Risk Management exercise.  A proactive approach to risk management in drug safety is always recommended to protect the interest of the patient population. Management of any single risk involves four major steps as follows-

• Risk Detection
• Risk Assessment
• Risk Mitigation (minimization)
• Risk Communication

However, any medicinal product carries multiple risks. Studying impact of various risks along with drug benefits is essential to ensure that the benefits exceed risks by substantial margin. This ensures success of any medicine in either treatment or for clinical trial or research.

Pharmacovigilance forms part of overall “Risk Management Plan”. The concept of pharmacovigilance is not new and its origins date back over 50 years. The thalidomidetragedy of 1961 drew attention to the importance of the assessment of the adverse effects of drugs. World Health Organization (WHO) defines pharmacovigilance as science and activities related to detection, assessment, understanding and prevention of adverse effects of use of any medicine. During clinical trials of any drug, it is tested on very few subjects (sample population). In most cases, the count rarely exceeds 5000. It is therefore important that, any new drug or evolving medical treatment is monitored for its effectiveness and safety post its release for use by general population. More information needs to be collected and analyzed about its use by certain population groups such as children, pregnant women and the elderly. It is also important to monitor the effects in chronic cases and in combination with other drugs.

The main objectives of pharmacovigilance are –

• To improve patient care and safety when any new drug is administered. This includes any medical or para-medical intervention
• To assess the risk – benefit ratio and effectiveness of any drug
• To create awareness among health professionals and public about good pharmacovigilance practices. Conduct training programs to spread awareness.

Several national and international organizations provide information & guidelines related to good pharmacovigilance practices. Notable among them are WHO and USFDA (United States Food & Drugs Administration).

Reporting of concerns over adverse effects of any drug, their investigation, acceptance by medical fraternity & regulatory bodies till issuing of warnings would take years or sometimes even decades in earlier days. Things have changed now with the availability of health records, claims history, medical literature and regulatory reports in electronic form. The time involved from initial detection of adverse effects to its monitoring and reporting has drastically reduced in recent times due to information technology.

Today pharmaceutical industry is moving towards a more data driven and analytics enabled approach towards drug safety and pharmacovigilance. However, it is a long journey and there is ongoing debate regarding use of secondary data (from social media) in the pharmacovigilance practices. The secondary data sources can supplement the data collected by primary research and clinical trials.