Counterfeit Pharmaceuticals

How To Detect Counterfeit Pharmaceuticals

•  Establish the integrity of the source prior to need . Where possible, establish a list of approved suppliers.

• The chosen alternative source of supply should provides the following as a minimum:
• A pedigree back to the previous source 
• Certification that it is not a diverted product 
• Certification that any actions by the alternative source will not alter any original manufacture warranties or guarantees 
• Certification that the product has been stored and handled consistent with product labelling requirements 

•  If a product is being offered at an unusually cheap price, treat with extra caution. 
• Consider developing a list of key pharmaceutical products that will not be purchased from sources other than the manufacturer, or authorised distribution channel.  
• Look for signs of a removed or switched product label 

One common practice by counterfeiters is to remove the original label and replace it with a  counterfeit label. To do this, they use lighter fluid, acetone or some other solvent which may leave a tacky residue on the container. Also, the label may be faded or discoloured along the edges due to the solvent.  

• Look for an altered expiry date.Counterfeiters commonly purchase ‘short-dated’ products and then alter the labels  
•  Look for subtle changes in the product’s package (compare with previously purchased products), not withstanding legitimate parallel imported products
•  Examine the package for differences in paper texture, size and thickness of the labels, also the gloss or finish on the paper. Look for differences in fonts and font sizes, print colour or raised print. Examine all printing on flaps and surfaces of the box in comparison with previously purchased products where possible. Look for overt security features such asholograms or colour shifting inks. Finally, look for breaks or tears in the sealing tape and seals. 
•  Look for variations in the size of the container (compare with previously purchased products), not withstanding legitimate parallel imported products 
• Look for differences in container length, diameters and shapes. Examine for variations in diameters of bottle openings or lids. Examine for variations in the thickness of glass or plastic containers and for variations in container colour tints. 
• Listen to patients. The majority of counterfeit medicines are first detected by patients.
• Compare the physical characteristics of the product 
• Look at colour, tablet or capsule markings, shape and thickness of the medicine. You can also weigh the product to see if there are wide variations. 
• Report all suspicious approaches or known information on counterfeits to MHRA on 0207 084 2574 

Pharmacists should always purchase medicines from reliable, trusted 
wholesalers and suppliers – due diligence checks should be conducted regularly 
and systems reviewed.

Action to be taken for Potentially Conterfeit Medicines: 

Pharmacists worried about a counterfeit medicine need to do certain things to minimise / prevent harm to patients: 

• Submit a report to the MHRA who will conduct definitive tests for counterfeits as quickly as possible 

• Await MHRA instructions – conducting unilateral action may prove ill-advised, unnecessary, confusing and be counter-productive 

• If a drug alert and recall notice is received, be prepared to: 

• Check the current stock held in the pharmacy and return any potential counterfeit medicines in line with guidance issued 

• If possible, interrogate the PMR systems to reveal which individual patients are on that particular medicine and when it was dispensed 

1. Contact those patients who have been supplied with that particular medicine within the suggested timeframe to check on their medication.
2. If a patient is concerned that they have a counterfeit medicine then the pharmacist should make a record of this and inform the MHRA immediately. 
3. Dispensing doctor’s practices are covered in the same alert system as pharmacies.