PFIZER ‘TAMPER EVIDENT’PACKAGING TO COMBAT COUNTERFEIT THREAT

Pfizer, manufacturer of some of the world’s leading medicines, such as LIPITOR™ (atorvastatin) and VIAGRA™ (sildenafil citrate), is to introduce new packaging security measures for its medicines sold in Europe . This is in response to evidence of increasing risks posed to the medicines supply chain across Europe from counterfeiting and the growing evidence of improper re-packaging, poor storage and transportation of medicines by parallel trade wholesalers.

Some 140 million medicines are parallel traded every year in the European Union[1] and can travel through as many as 20-30 pairs of hands before finally reaching the patient.[2]

Pfizer’s new security measures will become a key component of anti-counterfeiting and packaging integrity efforts to protect patient safety.

Among the new security measures to be introduced by Pfizer, tamper-evident packaging will make obvious any attempt to interfere with a medicine before it reaches the patient. By introducing tamper-evident packaging, Pfizer is leading the industry in providing reassurance to pharmacists and patients of the integrity of the Pfizer medicine.

These initial packaging security measures are the first phase of a long-term strategy to enhance medicines packaging. Later phases will introduce even more sophisticated security measures across the whole range of Pfizer medicines.

Announcing the move Julian Mount, European Director of Trade for Pfizer said:

“A recent audit of Pfizer medicines imported into the UK wholesale supply chain by parallel traders has uncovered numerous examples* of poorly re-packaged medicines. We are now convinced that the re-packing of medicines by these commercial ‘grey’ middlemen adds to the risk of error in the supply chain. We are also concerned that this fragmentation of the supply chain by parallel traders could be attractive to would-be counterfeiters. As was demonstrated in the MHRA’s recent counterfeit discovery, of a well-known medicine, in the legitimate supply chain.”

“There is a need for increased vigilance in the supply of medicines to patients. Patient safety must remain paramount but, unfortunately, there are now a number of factors that suggest that the integrity of medicines could be threatened, and we now need to take steps to protect the patient from potential harm.”

Pfizer believes that efforts to protect the integrity of medicines must include new and enhanced regulations and oversight by regulatory authorities together with greater enforcement effort, enhanced business practices by all participants in the supply chain and the use of new technologies. Heightened diligence and increased accountability by all in the distribution channel and with those with oversight responsibilities is essential to counter the growing threat of counterfeit medicines being found in the legitimate supply chain.

Notes

1.      Medicines originally intended for use in one country e.g. Greece that are diverted to another country e.g. the UK by a commercial middleman are referred to as parallel trade products.

2.      In the UK , the market share of parallel traded products has increased from 11% in 1999 to 17% in 2003, an increase of over 50%.[3]  Parallel traded medicines now account for approximately 20% of the prescriptions dispensed to patients.[4]

3. Examples found in Pfizer’s audit of UK imports included:

a.      a different dose of medicine inside the pack than that stated on the outside;

b.      a medicine pack containing capsules but the box stating tablets;

c.      the expiry date and batch number on the medicine box not matching the expiry date and batch number on the medicines inside;

d.      patient information leaflets in the wrong language.

4. Pfizer, with its global headquarters in New York , is a research-based global medicines company.  Pfizer discovers, develops, manufactures and market-leading prescription medicines for humans and animals, and many of the world's best-known consumer products.  Since 1998 Pfizer has made a capital investment of more than £1billion in the UK and, following its acquisition of Pharmacia in April 2003, is the largest supplier of medicines to the NHS.  It is estimated that on any given day, 40 million people around the world are treated with a Pfizer medicine.

5. These same counterfeiting concerns were raised in June 2004 in a Social Market Foundation report: Parallel Trade in Medicines.

(25/8/04)