This blog post offers insight into the Adverse Event Category, focusing on:
- Clarification of “counterfeit”
- The nature of counterfeit events
- The special considerations surrounding counterfeit drugs in pharmacovigilance
Table of Contents:
- Definitions
- Counterfeit vs. Falsified: Distinctions
- Counterfeit Products: A Common Occurrence in the Market
- Counterfeit drugs and their effects
- Counterfeit Drugs: A Special Consideration in Pharmacovigilance
- Using MedDRA to Code Counterfeit Drugs/Products
- Conclusion
- References
Definitions
Counterfeit: Imitation of original, replica, forged, adulterated.
Counterfeit Medicines: Similar products resembling authentic medications, manufactured illegally and possibly lacking correct or any active ingredients.
Counterfeit Medicinal Events: Events or issues associated with counterfeit medicines.
Counterfeit vs. Falsified: Distinctions
While some may perceive counterfeit and falsified to be synonymous, they are not. Although there are similarities, they are distinct.
Counterfeit Product:
In the pharmaceutical industry, counterfeit products are essentially imitations of the original product. While their effectiveness may be similar or even higher than the original, their authenticity is uncertain as they are not authorized.
Falsified Product:
Falsified pharmaceutical products, on the other hand, are essentially fake products with low or no efficacy. They are exact replicas of the original products, including similar labels and packaging.
“Counterfeit products not only rob consumers of their hard-earned money but also jeopardize their health and safety. Stay vigilant with Drugvigil.”
Counterfeit Products: A Common Occurrence in the Market
Counterfeit medications are consistently substandard in terms of quality, safety, and effectiveness when compared to genuine pharmaceuticals.
Consequently, they present an unpredictable threat to public health and result in diminished trust in medications, healthcare professionals, and healthcare systems.
Origin:
Per the 2020 report by the Organization for Economic Co-operation and Development (OECD), China, Hong Kong, Singapore, and India identified as the main origins of adulterated pharmaceuticals. This global market valued between USD 65 and 200 billion annually, making it an extremely profitable criminal endeavor.
Target Market:
The target market for counterfeit medicines is continuously expanding and changing. In developed nations, high-value pharmaceuticals such as hormones, steroids, anorectics, erectile dysfunction drugs, and psychotropic drugs are prime targets.
Conversely, in developing countries, life-saving medications like antibiotics, anti-malarials, anti-tuberculosis drugs, and anti-retro-viral drugs are commonly counterfeited.
Counterfeit drugs and their effects
Counterfeit drugs and pharmaceuticals are a major issue affecting public health, and healthcare systems around the globe.
I highly recommend checking our blog discussing the differences between adverse reactions and adverse events.
Safety Precautions: Avoiding Risks
Table:1
Guidelines for potential consumers as were given by the INTERPOL.
| Never buy | Only buy |
|---|---|
| From unknown websites or in a marketplace | Medicines prescribed by doctors |
| From pharmacies making promises like “too good to be true”, “cures all types” of a major illness, “money-back guarantee”, or “no risk” | From websites that require prescription and have authenticity certificate |
| Substantially cheaper product, it is likely to be a fake | After checking the price against usually bought products from reputable providers |
| If the product contains different ingredients, claims to have different properties, has a different shape, is not correctly labeled, has an out-of-date or missing expiry date, or the packaging looks badly made | After comparing the medicine against the usually prescribed one |
Table: 2
Possible types of drug counterfeiting with examples.
| S. no. | Type of counterfeiting | Example |
|---|---|---|
| 1. | No active drug + no harmful substance | a. Vials of PROCRIT® (epoetin) were found to contain nothing but Miami city tap water b. Remdesivir ampoules filled with normal saline |
| 2. | Excessive (concentrated) active drug | Concentrated onabotulinumtoxin A (Botox®) not meant for human application |
| 3. | Wrong active drug | Sibutramine instead of orlistat in GSK’s Alli® |
| 4. | Drug contaminated with microbes, toxins and harmful chemicals | a. Fake inhalers for the treatment of paediatric cystic fibrosis were found to contain contaminated bacteria b. Counterfeit cough syrup that was mixed with ethylene glycol (i.e., antifreeze) |
Counterfeit Drugs: A Special Consideration in Pharmacovigilance
- They pose unique challenges and risks to public health.
- Quality control considerations.
- Monitoring availability of false products in the market.
- It leads to adverse health effects such as allergic reactions, worsening medical conditions and even very serious effects (sometimes death) in some cases.
- Raising awareness
Using MedDRA to Code
Examples of Verbatim Reporting:
The patient mentioned that the recent medicine bought from an online store was ineffective, but the pharmacy-bought one was effective, which experienced many times and comparatively good.
In the example above, it may appear that the reported verbatim is “lack of efficacy,” but it is not.
Until a proper investigation confirms the drug is ineffective, it should consider as counterfeit/falsified medicine.
📢 Recommend checking, to learn more into understanding how to manage cases of lack of efficacy.
Code with MedDRA
For both counterfeit and falsified medicines. We believe that both terms should align with these terms but are certain that they fall under the same SOC, but PT may vary.
| SOC | PT | |
|---|---|---|
| Counterfeit | Product issues | Product counterfeit |
| Falsified | Product issues | Quality issues |
It is customary for a more detailed inquiry to conduct using the gathered information. Ultimately, the reality will emerge. At first, the product presumed to be from the company, but the truth will uncover through thorough examination.
Final note
This write-up aims to provide you with better clarification under the “Adverse Events” category of our pharmacovigilance articles. Our goal is to address any doubts or mistakes that may arise.
We hope you’ve learned something valuable about pharmacovigilance today.
If you notice any errors or omissions, don’t hesitate to inform us in the comments section below. We welcome your feedback and encourage you to reach out to us at any time.
References:
- FDA.gov
- ncbi.nlm
- OECD/EUIPO . OECD Publishing; Paris: 2020. Trade in Counterfeit Pharmaceutical Products, Illicit Trade. Google Scholar
- Bottoni P., Caroli S. Fake pharmaceuticals: a review of current analytical approaches. Microb. J. 2019;149:1–7. doi: 10.1016/j.microc.2019.104053. CrossRefGoogle Scholar
- Interpol, Covid-19: the Global Threat of Fake Medicines, 2020.
- ncbi.nlm/discussing challenges in counterfeit medicines
Leave a Reply