Beating the counterfeiters

Following the recent, high profile discoveries of counterfeit drugs on the UK market, Pfizer considers how patients could be protected in future.

In July 2005, counterfeit Lipitor was discovered in the legitimate UK supply chain.This latest incidence of counterfeiting further evidences the fact that counterfeiters and criminals appear to be targeting the ethical pharmaceutical market. Counterfeit activity can undermine the integrity of the medicines supply chain and damage patient trust and confidence in their prescribed medication a threat to patient safety that Pfizer believes must not be ignored.

Counterfeit medicines have also recently been found in other European countries. In 2004, significant amounts of a counterfeit medicine were found in the Netherlands after a patient complained of a crumbling tablet. The Dutch pharmacy journal, Pharmaceutisch Weekblad, stated that the medicine 'arrived with the pharmacist (in the Netherlands) via parallel import'. The distribution was investigated by the Dutch Institute of Public Health.¹

It is estimated that up to 15% of the global medicines supply chain is counterfeit, but could be as high as 25% in some countries.² The largest counterfeit market with close proximity to Europe is Russia, where it is generally accepted that 12% of medicines are counterfeit.³ The WHO's expert on counterfeit medicines, Dr Wondemagegnehu, has stated that the risks are 'obvious'.⁴

Pfizer believes that the rising incidence in the parallel trade of medicines within the European Union (EU) has the potential to undermine patient safety and put the integrity of the supply chain at risk.⁵

Some 140 million packs of medicines are parallel traded every year within the EU as part of the legal free trade of goods. Parallel trade of medicines is highly lucrative, with profits estimated to be in excess of €459m each year and the number of parallel traders is growing rapidly (see figure 1).

Graham Satchwell, a former UK police detective superintendent, has argued parallel trade provides counterfeiters with an easy route for selling counterfeit products into the legitimate supply chain. He warns that this high volume and high profit business activity, which poses a clear threat to patient safety, is not being sufficiently regulated and monitored.⁶

trade concerns

Long before counterfeits were found in the legitimate UK supply chain, the Social Market Foundation (SMF), an independent UK think-tank, warned of a risk of counterfeit medicines being introduced through parallel trade.

In a report published by the SMF in 2004, entitled 'Parallel Trade in Medicines', concerns were highlighted about purchasing medicines from parallel traders who source their pharmaceuticals from across the EU. The report argued that 'there are concerns that the practice of repackaging imported medicines has the potential to put patient safety at risk'.⁷ The SMF stated that the repackaging of medicines has the potential to undermine patient safety by acting as a potential vehicle for counterfeits to enter the legitimate supply chain.⁸

Parallel trade requires the medicine to be repackaged to conform to the requirements of the import member state. Medicine boxes are opened, the contents are removed and the product is then repackaged. This introduces the possibility of human error into the process.

Pfizer has found numerous examples of human error in the repackaging of samples of parallel traded medicine which have the potential to compromise patient safety. Examples of the errors found are: different doses of medicine inside the packs than those stated on the outside; the pack containing capsules when the box states tablets; and expiry dates and batch numbers on the box not matching those on the medicines inside. There have also been cases of the patient information leaflets being in the wrong language or out of date.

safety issues

In a UK audit of parallel trade samples, Pfizer found that more than half had patient safety issues and more than a quarter were serious enough to have to be referred to the Medicines and Healthcare products Regulatory Agency (MHRA) , the UK regulator (see figure 2).

Even Boots the Chemist, the UK's largest pharmacy, has been affected. It reported that it had identified five instances of problems with parallel traded medicines, such as labelling errors and incorrect pack size - one of which resulted in a batch recall.⁹

Patient advocacy organisations have also expressed concern about the practice of parallel trade. Jim Thompson, former chief executive of the UK's Depression Alliance, recently expressed concern that parallel trade generates profit without re-investment in research or proper responsibility for patient welfare.¹⁰

Parallel traded medicines may go through as many as 20 to 30 pairs of hands before finally reaching the patient.¹¹ Inevitably this hinders the ability to recall medicines efficiently and effectively. If a batch of medicines sold in Spain is recalled, tracing where the entire batch may have been distributed is substantially more challenging when it has left Spain and moved throughout the EU.

Yet there is no regulatory requirement to record the batch numbers of imports and exports of medicines with the regulatory authorities across the EU. This means that the efficient and effective track and trace of medicines across the EU supply chain is made very difficult.

Undoubtedly, patient safety can be enhanced with a secure and safe medicines supply chain. At present the European supply chain is fragmented, with no supra-national regulatory oversight. With the growing threat of counterfeit medicines entering the supply chain, the current system needs to be assessed; there is a need for even higher standards and greater responsibility on behalf of every stakeholder in the supply chain.

Pfizer is committed to working with key stakeholder groups, including regulators and the EU institutions, in order to help protect both the integrity of the medicines supply chain and patients from counterfeit products. counter measures

The company is currently introducing a series of security measures that will help to deter counterfeiting activity, including a unique Pfizer logo on packaging that uses colour-shift ink - a technology that is, similar to the ink used on bank notes, difficult to fake but easy to verify.

A verification card will be given to pharmacists and it will take only seconds to check the authenticity of a medicine box. In addition, tamper-evident packaging is being introduced that will make it obvious to pharmacists and patients if any attempt has been made to tamper with the product before it reaches them.

This will provide reassurance to pharmacists and patients over the integrity of the medicine.

Pfizer is also working with stakeholders to develop solutions to help protect patient safety, including a vision of a pharmaceutical 'safety chain' for Europe. The safety chain would harness new technologies to enable standardised product identification across the EU via a unique coding system. This will allow the necessary stakeholders to verify the authenticity of medicines as they travel through the supply chain and across national borders.

authenticity check

The safety chain will act as a three-way check to verify the legitimacy of the immediate supplier, the immediate purchaser and, via a central database will, the authenticity of the medicines. The database will assist with issues surrounding patient safety, such as track and traceability for product recall and supply chain security against counterfeits.

Pfizer believes the process of repackaging medicines is not in the interests of patient safety and that there is a need for regulation to prevent the opening of and interference with original manufacturers' medicine packaging by parallel traders.