How to Identify Falsified Medicines: A Guide for Healthcare Professionals

Falsified medicines pose a significant threat to patient safety and public health worldwide. These are not just counterfeit or substandard products; falsified medicines are deliberately misleading in their contents, quality, or packaging, designed to deceive consumers. For healthcare professionals (HCPs) in the UK, recognising falsified medicines is critical to ensuring the integrity of patient care. This article provides essential guidance on identifying falsified medicines, drawing on regulatory frameworks and practical tips.

 

1. Understanding Falsified Medicines

The European Medicines Agency (EMA) defines falsified medicines as those that misrepresent:

• Identity: Incorrect labelling, packaging, or brand.
• Source: False information regarding the manufacturer, country of origin, or marketing authorisation holder.
• Ingredients: Incorrect, insufficient, or inactive ingredients.

Unlike legitimate generics or parallel imports, falsified medicines compromise safety, efficacy, and quality, making their identification imperative for HCPs.

 

2. Key Indicators of Falsified Medicines

To effectively spot falsified medicines, HCPs should focus on the following aspects:

a) Packaging and Labelling

Falsified medicines often have minor errors or irregularities in packaging. Key things to check include:

• Spelling mistakes: Incorrect spelling on labels or instructions.
• Colour and print quality: Substandard or uneven printing, faded labels, or unusual colour schemes can indicate falsification.
• Tampered or broken seals: Missing or damaged security seals, or packages that appear to have been opened, should be treated with caution.
• Differences in batch numbers or expiry dates: Batch numbers or expiration dates on the outer packaging not matching the inner product.

 

b) Product Appearance

The physical appearance of the medicine itself can provide critical clues:

• Changes in colour, shape, or texture: If a product looks different from the original medication.
• Unexpected smell or taste: If patients report differences in the smell or taste of their medicine.
• Tablet or capsule inconsistencies: Variations in the size or weight of tablets and capsules within the same pack.

 

c) Medicine Efficacy and Patient Response

• Therapeutic failure: Patients experiencing diminished therapeutic effects or adverse reactions, despite following proper dosage, should prompt an investigation into the medicine’s authenticity.
• Unexplained side effects: If patients report unexpected side effects, this could be due to incorrect ingredients or unsafe impurities.

 

d) Price Discrepancies

Significantly lower prices compared to the standard market price for a specific medicine could indicate it is falsified. While legitimate price reductions exist, HCPs should be cautious of unusually discounted products.

 

3. Regulatory Frameworks and Safety Features

a) Falsified Medicines Directive (FMD)

The Falsified Medicines Directive (FMD) introduced by the EU, establishes requirements to combat falsified medicines in the legal supply chain. A key feature of the FMD is the Unique Identifier (UI), a 2D barcode placed on all prescription medicines, enabling verification of authenticity before dispensing. The UI includes:

• Product code
• Serial number
• Batch number
• Expiry date

HCPs can scan these barcodes to confirm the medicine’s legitimacy. Additionally, an anti-tampering device (ATD) should be present on the outer packaging of the product. Any tampering or absence of an ATD could signal a falsified product.

The ‘safety features’ elements of the EU FMD (FMD, 2011/62/EU) and Delegated Regulation (2016/161) ceased to have effect in Great Britain from 31 December 2020 due to Brexit.

This means that pharmacies (and other end users such as wholesalers, hospitals and others handling or supplying medicines, including dispensing doctors) will no longer be required by law to verify and decommission unique identifiers on prescription medicine packs.

 

b) MHRA Yellow Card Scheme

Healthcare professionals should utilise the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme [link https://yellowcard.mhra.gov.uk/] to report any suspicions of falsified medicines. This system allows healthcare providers to share concerns about medicines that appear counterfeit or substandard, contributing to nationwide surveillance and mitigation efforts.

 

4. Sources of Falsified Medicines

Healthcare professionals must remain vigilant about where medicines are sourced. In the UK, the legitimate supply chain, which includes licensed pharmacies, wholesale dealers, and hospitals, is closely regulated. However, falsified medicines can still infiltrate the system through:

• Unregulated online pharmacies: Purchasing from websites without valid UK licences increases the risk of counterfeit products. Legitimate online pharmacies will have the voluntary internet pharmacy logo displayed on their website to give reassurance to patients that they’re buying medicines online from a registered pharmacy that are up to the General Pharmaceutical Council’s (GPhC’s) standards.

• Unregulated online or physical sellers: Human medicines purchased directly from individuals, through social media or any unreputable website are likely not authorised to sell them.
• Suspicious suppliers: Any third-party suppliers offering medications at vastly reduced prices or without proper documentation should be scrutinised.

 

5. Educating Patients and Staff

Healthcare professionals play a crucial role in educating both colleagues and patients about the risks of falsified medicines. Ensure that:

• Patients are advised to only buy medicines from trusted, licensed sources.
• HCPs are trained to recognise suspicious packaging and products upon receipt, during dispensing and before administration of the product, and how to handle potential falsified medicines.
• Robust stock management processes are in place in the healthcare facility, especially when ordering and receiving stock.
• Your healthcare facility only purchase medicines from reputable WDA(H) holders. You can ascertain a supplier’s licence details on the MHRA-GMDP website

 

6. What to Do if You Suspect a Falsified Medicine

If you suspect that a medicine might be falsified, take immediate action:

• Quarantine the product: Isolate the suspected medicine and prevent it from reaching patients.
• Report to the MHRA: Use the Yellow Card Scheme  or the Medicines Enforcement contact to notify the MHRA of your suspicions, providing details such as batch numbers and packaging discrepancies.
• Notify your pharmacy lead or procurement team: They may need to trace the source of the medicine and liaise with suppliers.
• Counsel patients: If a patient has been dispensed a falsified medicine, provide them with appropriate advice, including monitoring for adverse effects or lack of efficacy.

 

7. Conclusion

For healthcare professionals in the UK, identifying falsified medicines is an essential aspect of ensuring patient safety and maintaining the integrity of medical treatments. By staying informed of regulatory guidelines, carefully inspecting medicines and packaging, and leveraging reporting tools like the MHRA Yellow Card Scheme, HCPs can play a pivotal role in detecting and preventing the distribution of falsified medicines.

Remaining vigilant in this regard is key to protecting patients and upholding the standards of healthcare delivery in the UK.