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(Editor’s note: This is the second article by Dr. Nisha Nair in a series launched by India-West specifically designed to provide an insight into clinical trials and the process of ensuring that the medicines people consume are safe. Also, they will not only provide information about and explore various areas of the medical research industry, but will serve to highlight the clinical research industry as a good career prospect for the Indian American community.) 

In the last article, we saw how all medications undergo a rigorous process called clinical trials to obtain regulatory approval and reach the market. However, we find that many drugs are withdrawn by the Food and Drugs Administration from the market. This gives rise to a big question: does this mean clinical trials cannot ensure safety of drugs? The answer is yes and no.

Clinical trials have many limitations like:

  1. They include a limited number of people,
  2. They do not usually include pregnant women, the elderly and children unless the drug is meant to be used by them
  3. Problems caused due to taking the drug in an unintended way, for example, crushing a tablet and dissolving it in water before taking it.
  4.  Long-term use of drugs, effect of other co-existing conditions etc. are not studied, to name a few.

The solution lies in continued monitoring after the drug comes into the market. Derived from the Greek work pharmakon meaning drug and the Latin word vigilare meaning stay alert, pharmacovigilance believes in collecting data of adverse events that happen after taking a marketed drug, analyzing it periodically and drawing appropriate conclusions.

These data are collected from patients and healthcare professionals including physicians, nurses and pharmacists reporting by themselves, or from further studies being conducted by pharmaceutical companies to obtain more information regarding a marketed drug, legal reports or from published research papers, which describe adverse events after taking a drug.

All collected data are entered into a safety database and analyzed by medically qualified professionals on whether this was caused by the drug. If the event is classified as serious, unexpected and related to the drug in question, this needs to be reported to global regulatory authorities within specified timelines. Also, periodic aggregate reports are submitted to regulatory authorities with analysis of data that are reported over a specified period of time.

Along with these, all safety data entered in the database is analyzed periodically to identify unexpected trends of adverse events to understand if they pose any risk to the known safety profile of the drug. This is usually carried out by data mining and statistical methods. If previously unknown or incompletely documented, this is called a safety signal and may result in identifying potential risks. Upon identifying a potential safety risk, the company/ regulator may decide to do the following:

  1. Withdraw the drug from the market
  2. Impose marketing restrictions, for example, adding warnings/precautions on package inserts to ensure safer use
  3. Additional studies may be undertaken to further explore the obtained safety data to determine its significance

While it is known that all drugs carry certain risks, it is expected that the benefits from a drug outweigh the risks by a significant amount.

Along with the FDA, pharmaceutical manufacturers and academic/non-profit organizations such as RADAR and Public Citizen also play a role in pharmacovigilance in the US.

Pharmacovigilance is a lucrative career option for physicians, nurses and pharmacists as this a field that requires extensive medical knowledge. To know more about career options in the field of pharmacovigilance and also if you need help in getting to this field, please contact the author at: dr.nishaputhiyedath@gmail.com

(Dr. Nisha Nair is director of the Pacific Biosafety Group. She is an industry consultant in the field of clinical research, medical writing and pharmacovigilance, a trainer and career counselor for those in the biopharmaceutical industry and academia that want to get into these fields.)

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