WHO updates fact sheet on Substandard, Spurious, Falsely labelled, Falsified and Counterfeit (SSFFC) medical products

The World Health Organization (WHO) recently updated its fact sheet on SSFFC medical products.

Background information:

There is no universally accepted definition of ‘counterfeit’ medical products. Therefore, till such time when such a definition is agreed upon, the WHO will use the term Substandard, Spurious, Falsely labelled, Falsified and Counterfeit (SSFFC) Medical product until a new definition is agreed.

Substandard medicines: Genuine medicines produced by manufacturers authorized by the National Medicines Regulatory Authority (NMRA) which do not meet quality specifications set for them by National standards.

Counterfeit medicines: A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source.

Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of ingredient(s) or with fake packaging.

Caution: Whilst spurious, falsely labelled, falsified or counterfeit medicines are by their very nature substandard, it is not necessarily true that all substandard medicines are spurious, falsely labelled, falsified or counterfeit. The latter may include accidental manufacturing errors or where a medical product has degraded due to poor storage.

Key Messages:

Falsified medical products are manufactured in many different countries and in all regions.

SSFFC medical products may cause harm to patients and fail to treat the diseases for which they were intended.

They lead to loss of confidence in medicines, healthcare providers and health systems.

They affect every region of the world.

SSFFC medical products from all main therapeutic categories have been reported to WHO including medicines, vaccines and in vitro diagnostics.

Anti-malarials and antibiotics are amongst the most commonly reported SSFFC medical products.

Both Generic and Innovator medicines are falsified including very expensive products for cancer to very inexpensive products for treatment of pain.

They can be found in illegal street markets, via unregulated websites through to pharmacies, clinics and hospitals.

Contents of falsified products:

These medical products may contain no active ingredient, the wrong active ingredient or the wrong amount of the correct active ingredient.

They are found to commonly contain corn starch, potato starch or chalk.

Some SSFFC medical products have been toxic in nature with either fatal levels of the wrong active ingredient or other toxic chemicals.

Identifying an SSFFC product:

Check packaging

for condition,
for spelling mistakes or grammatical errors
for manufacturing and expiry dates
if details on outer packaging match those on the inner packaging

Check medicines to see if they

look correct
are not discoloured/ degraded
have an unusual smell

Discuss with your pharmacist/ doctor if

you suspect it is not working properly
you have suffered an adverse reaction

SSFFC products and the Internet:

Beware of the following:

spam email advertising medicines
lack of authenticity; no verification logo or certificate
spelling mistakes and poor grammar on the packaging
websites that do not display a physical address or landline
websites offering prescription only medicines without a prescription
suspiciously low priced products.

Checklist for medicines bought online:

Is it exactly the medicine ordered?
Is it the correct dosage?
Is the packaging in good condition, clean, with a patient information leaflet and in the language in which it was advertised?
Does the medicine look, feel and smell as it should?
Are security seals intact with no signs of tampering?
Does any customs declaration or postal label declare the contents as medicines?
Does the batch number and expiry date on the primary internal packaging match the batch number and expiry date on the secondary (external) packaging?
Have you noticed any unusual activity on your credit card since the purchase?