Pharmacovigilance and ADRs

Pharmacovigilance, or in simple terms drug safety, is a medicinal science which involves the research and prevention of reactions which may take place following the administration of pharmaceutical medication or devices. As such, one of the main topics of importance in the science is Adverse Drug Reactions. ADR, as the name implies, is the unforeseen reaction in a body which may take place upon the consumption of pharmaceutical products. Pharmacovigilance is a serious health issue that can potentially affect entire populations, and is therefore overseen by the WHO in association with medical institutions throughout the world.
ADR Suspicion

As mentioned earlier, there can be various causes of ADR which are not so easily unearthed. Various methods have been formed to help assess the occurrence and causation of an ADR and whether it is to be reported to the local authorities. This includes the Venulet Algortihm and the Naranjo Algorithm. It is given, however, that no report of ADR is filed without the challenge-dechallenge-rechallenge , which basically means that the drug is stopped and restarted to check the relation between the reactions and the medicines.

ADR Reporting
WHO or local government sanctioned Medical institutions accept every case of ADR, no matter how unlikely. Reporting is vital to Pharmacovigilance, playing a major role in deducing whether or not a new drug or medical device is passed for testing or marketing. This, in turn, helps prevention of future cases, potentially saving millions spent in healthcare. Reports can be submitted by any certified medical professional and the form for such are available on national medical websites.

ADR Analysis
Compiled reports are forwarded to the national clinical authorities or their offshoots. After reviewing the reports, the reports are forwarded to WHO affiliated organisations to be compiled in the drug safety database, where it joins similar reports from different parts of the world to be studied and assessed by experts to identify patterns in ADRs and factors which may be the cause. ADRs are categorised by drug, extent of severity and other factors. Various research programs conducted have found, for example, that anti coagulation and anticonvulsant drugs had cases with more preventable ADRs compared to drugs such as anti inflammatory medication.

The effects of Pharmacovigilance are numerous and help better millions of lives globally. The process helps improve public safety with respect to regulation and use of drugs, encourages their proper and sensible use, and helps raise awareness for the benefit of future generations.

Major Cases

  • Medicine – Reaction
  • Chloramphenicol – Aplastic Anemia
  • Clioquinol – Myelooptic Neuropathy
  • Reserpine – Depression
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