Consumer feedback on medicines vs Spontaneous ADR reporting
In my previous blog post, I had touched upon the basics of pharmacovigilance (PV), the different stakeholders and the various mechanisms available for reporting adverse events (AE) which could possibly be an adverse drug reaction (ADR). In this post, I want to focus on the reasons for under-reporting AEs, the importance of self-reporting, the different reporting mechanisms available and finally end with a short note urging relevant bodies to simplify their PV approach for maximum benefit of all stakeholders.
What do we mean by Spontaneous Reporting?
Spontaneous Reporting is the regulatory term for self-reporting of AEs by both consumers and healthcare professionals (HCPs) such as Nurses, Physicians, Pharmacists etc. Can you take a brief moment and recollect when was the last time you (or a family member/friend) took a medicine and experienced an event that was not desired or expected? While I hope it never happened, I am fairly certain that many of us can recollect at least one such incident in our lifetime. So what did you do when you experienced this event?
From my personal experience, and that of people I have spoken to, you would have either
1. Ignored the event and continued with the medicine dosage
2. Reviewed the medicine’s paper handout or researched online to learn that it was an expected minor side-effect and hence continued the medication
3. Found it to be more severe than expected and discontinued the medicine, at the risk of your primary health condition (not recommended)
4. Reached out to your pharmacist or physician and conveyed your situation. In all likelihood, they would have prescribed an alternate medicine or reduced the dosage of the medicine
But, did any of you actually ask the physician/pharmacist why it happened and what they or you can do to prevent this from happening again to you or any other individual? Very unlikely! I certainly did not myself, in the past, but going forward I would definitely. As you read on, hopefully you will be able to relate to my thought.
Why do we not report or question such side-effects?
Research suggests that there are broadly 7 different reasons for under-reporting of ADRs[i]
1) Ignorance: belief that it is only necessary to report serious ADRs
2) Lack of financial incentives: what do I get in return?
3) Legal aspects: fear of litigation
4) Complacency: belief that ADRs are well documented by the time they are released in the market
5) Diffidence: belief that reporting should only be done if there is certainty that the adverse event was related to the use of a particular drug
6) Indifference: belief that a single case cannot contribute significantly to drug safety
7) Lethargy: procrastination and disinterestedness in reporting
While the above points are accurate, there are a few other important systemic reasons for this under-reporting
a) Lack of awareness about reporting methods
b) Lack of a feedback loop for both consumers and HCPs
c) Lack of intuitive and easy to access reporting solutions
Why should we self-report drug reactions? How does it benefit us?
As consumers, we are best placed to describe side-effects without any medical bias. We can provide a detailed account of not just the suspected drug and reaction, but also other drugs and food products that were taken along with the suspected drug. This information is important to identify potential drug-drug and drug-food interactions that can cause harm to all of us. The below table mentions some important drug-food interactions
Additionally, Alcohol interacts with most medications and can be particularly dangerous with prescription stimulants (methylphenidate, amphetamines etc.) and anti-depressants. Similarly, below is a list of common drug-drug interactions
This begs us to think if there are more such food-drug and drug-drug interactions that are yet to be discovered. It is practically impossible to identify all or even most of them during clinical trials.
So, how can we self-report drug reactions?
Self-reporting can be done formally through the following channels
i. Reporting to Physicians or Pharmacists
Healthcare professionals have a moral and ethical obligation to pass on AE information to either regulatory bodies or pharmaceutical companies or both. They should use either of the below two methods to report this information.
ii. Reporting directly to Pharmaceutical companies
Through the customer care email-id or the phone number mentioned on their website or medicine packet.
iii. Reporting to regulatory bodies
Most national pharmacovigilance programs provide the flexibility to report AEs via online/physical forms which can submitted via email/fax or via mobile phone applications.
But, is it time to reconsider our approach to PV?
I would urge all PV stakeholders to take a cue from the CLEVER project[ix] undertaken by Australian drug regulatory body (TGA) to increase consumer participation in improving drug safety, after observing a decline in consumer reporting in 2014.
The biggest and most intuitive finding of the project was that consumers could better relate to terms such as “side-effect”, “problem” etc. than medical jargon such as “adverse event” and “adverse reaction”. This finding prompted them to change their website and consumer outreach content to use simpler terms. Subsequently, as a result of such progressive steps, the TGA observed a significant increase in consumer reports in subsequent years.
Perhaps, we need to think of ADR reporting not as a complaints system rather as a feedback system to make drugs safer. Through timely feedback, adverse reactions can be identified and analyzed sooner than conventional means and suitable corrective action can be taken by pharmaceutical companies/regulatory bodies before it affects more patients. As a community, my feedback on a drug/vaccine can help you and your feedback can help me during critical times.
In my next blog post, I shall cover how technology can play an important role in dramatically increasing the volume of captured AE reports, improving the efficiency of PV teams through automated analysis and triaging of AE reports and capturing new ADR signals through the analysis of drug concerns mentioned by patients on social media and online forums.
Credits: I would like to express my gratitude to our advisor- Dr. Ghanashyam Rao, Co-Founder-Adveesan Pharma Consulting, for his clinical guidance to our team.
References:
[i] https://www.medscape.com/viewarticle/713733
[ii] https://www.mayoclinic.org/diseases-conditions/thrombophlebitis/expert-answers/warfarin/faq-20058443
[iii] https://www.mayoclinicproceedings.org/article/S0025-6196(11)64645-4/fulltext
[iv] https://www.fda.gov/downloads/Drugs/.../.../UCM229033.pdf
[v] https://www.rxlist.com/isoniazid-drug.htm
[vi] https://www.drugs.com/drug-interactions/isosorbide-mononitrate-with-sildenafil-1401-0-2061-0.html
[vii] https://www.drugs.com/drug-interactions/diclofenac-with-warfarin-869-0-2311-0.html
[viii] https://www.medicines.org.uk/emc/files/pil.3768.pdf
[ix] https://www.tga.gov.au/presentation-role-patient-pharmacovigilance
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