What is Pharmacovigilance?

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What is Pharmacovigilance?

By Joan Mwanaka, BSc

Did you know that every drug has a side effect?

It has been reported that a drug without a side effect will not work!

So, if drugs are supposedly causing side effects, why are they on the market, and how are these drugs monitored?

Pharmacovigilance is the answer to this!

Pharmacovigilance is defined at the activities relating to the detection (in a process called signal detection) and assessment (for the purpose of monitoring the benefit risk profile of the medicine) of a medicinal product.


What is the aim of Pharmacovigilance?

The aim of Pharmacovigilance is to protect public health by enhancing patient care and patient safety.

This is achieved in an array of ways; one of which is encouraging health care professionals, patients and carers to report any seemingly related or unrelated side effects of the medicine.

Once events are reported, the drug can then be closely monitored.


If we know all drugs have side effects, why are they being monitored?

Side effects, also known as adverse drug reactions vary from non-serious to serious.

For example, a non- serious side effect can be a skin rash, after a patient has taken Paracetamol to manage a headache. The risk of skin rash is outweighed by the benefits of Paracetamol managing the pain of a headache!

On the other hand, examples of a serious side effect could be, a life threatening event, patient hospitalization, patient death, significant disability or incapacity as well as congenital deformities.

The real question is, does the risk of the listed serious adverse event outweigh the benefits of the medicine?

If a drug is prescribed for managing morning sickness, and if its risk is neonatal birth defects in pregnant women, do these benefits really outweigh the risks?

Should the drug really be kept on the market?


So What is the History of Pharmacovigilance?

Do you remember the case with Thalidomide?

In the 1950s and 1960s, Thalidomide, a medical drug, caused serious adverse events to unborn babies.

It was prescribed to help manage the symptoms of morning sickness in pregnant women. Unfortunately, it had not been tested for use in this way and in turn caused more than 10,000 babies around the world to be experience neonatal birth defects.

As a result of this disaster, thalidomide was banned and drug safety became more rigorous than ever.

In turn, Thalidomide was then monitored and carefully assessed. When it returned on the market, it was prescribed for its proper use; the treatment of leprosy and bone cancer. Due to this tragedy, Thalidomide is heavily regulated.


Who is Responsible for Regulating Drug Safety?

It is the responsibility of the drug company to ensure the drugs that they manufacture are safe.

It is the responsibility of the regulatory bodies to monitor the safety profile of the medicinal product, whilst it is on the market.

For instance, if there are high cases of bladder cancer associated with a Rosiglitazone, regulatory bodies are expected to get involved. They regulate the drugs by ensuring the benefits of the medicine outweigh the risks. They communicate with drug companies enquiring about the risks associated with the medicine.

By doing so, they are protecting the public’s health.

It is in the interest of drug companies to do all they can to maintain a positive risk balance ratio for the drugs they have on the market. Drug companies are answerable to regulatory bodies.

This is what Pharmacovigilance entails.


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