Why any adverse drug reaction needs to be reported immediately

Imagine a situation where you have been invited for an interview. You are in the waiting area with about 15 minutes to compose yourself, and only then do you realise you have time to attend to your pounding headache. From your bag, you take and swallow painkillers, then wait for the headache to subside.

Shortly after, the pretty office administrator comes your way with a gracious smile to usher you in for the interview. Suddenly, your stomach starts rumbling and it appears your intestines are trying to avert some explosions. You manage only a weak 'hi' before running off to save yourself.

How about this; do you know someone who has a never-ending cough? Not productive. Just an irritating dry cough. Day in, day out. This cough is not contagious. The person does not have a cold or chest infection, and neither do they smoke.

But the cough persists, and it comes at the most notorious of times. Imagine this person walking to the podium to give a keynote speech and shortly after the opening remarks, serenading the audience with a bout of dry irritating coughing that appears to suck the life out of them.

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If you observe closely, you will realise this person has actually been on some long-term anti-hypertensive medication. Is there a connection between this medication and the cough?

Surprise destination

And lastly, your soon-to-be spouse informs you that they have planned a surprise destination for your honeymoon! All you know is you will be flying out of the country for the first time. That in itself is a dream come true. Your travel preparations entail, among other things, getting some vaccinations.

But a week after you get your jabs, you are so lethargic that you can't even leave your bed. You seem to have a fever and you are drenched in sweat. The injection site is still swollen and painful to touch.

These three are examples of what is called adverse events (AE) or adverse drug reaction (ADR).

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An AE is any untoward medical occurrence in a patient, or a clinical investigation subject following the administration of a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An ADR is an injury caused by taking a medication.

Every one of us has a right to healthcare. High quality, affordable and safe treatment options have become the goal for your healthcare provider, your in-country health authority and world health leaders.

Therefore, to achieve safe treatment options, everyone must play their part.

When you experience any of these reactions to medication, your goal as a patient is to inform your doctor, nurse or pharmacist immediately.

You should also disclose all the medication you are taking, whether long-term or short-term. Your healthcare provider will immediately work on alleviating the injurious event.

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The healthcare professional attending to your case must also submit this report to both the pharmaceutical company that manufactures or distributes that medication in the country, and the health authority. In Kenya, the body governing medicines is the Pharmacy & Poisons Board.

Integral role

While the pharmaceutical companies play an integral role in providing healthcare solutions, they do have a regulatory mandate to be responsible and accountable for the risks and the benefits associated with the medicines they manufacture.

The health authority on the other hand has a mandate to ensure that health technologies provided in the country are safe, efficacious and of high quality. 

“But why do I need to report this adverse event yet it’s a known side effect?” You might say; “as a matter of fact, the issue ‘died off’ after a while and I didn’t even need to see a doctor."

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It is vital for you to share any adverse events encountered. Before any medicinal product is approved and registered for either human or animal consumption, the drug substance must have gone through a clinical trial where between 1,000 and 3,000 subjects are exposed to this product to understand its benefit and risks.

When you consider these figures in relation to the human race - composed of about 7 billion people - 3,000 is too small a number to vividly represent every patient’s needs and outcomes.

Growing up, our parents cherished us by constantly reminding us how special and unique we were. Medically speaking, I can confirm that you are indeed special and unique. No one has the exact copy of your DNA and this explains why we get varying reactions to any given drug.

Please engage your doctor, nurse or pharmacist whenever you encounter any untoward event after treatment.

Dr Mathenge is the founder and managing director of PVCC Consulting; [email protected]

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