Solutions to combat counterfeit drugs

By Nordvalls

The number of counterfeit medicine packs seized by customs in Europe keeps on going up. This is a concern for both authorities and pharmaceutical companies who fear that counterfeit medications may end up in ordinary pharmacies.

In 2006, seizures by European customs rose by 384% and the following year by a further 51%.

Customs are discovering more and more counterfeit medicines every year and even if the record rise in Europe 2006 may have been a chance peak, the problem is growing all over the world. In the UK in recent years, counterfeit medications have been discovered in pharmacies in nine cases.

Though extremely rare, these discoveries were particularly alarming because they related to drugs for cancer, heart disease and schizophrenia.

They were discovered when a wholesaler noticed that the pack numbers were wrong, and reported the fact to the manufacturer.

So far no deaths have been reported as a result of the counterfeit medicines in the UK, but several cases are known from the USA and Canada, and in the developing countries, counterfeits have killed thousands.

One of the problems is that the chain from manufacture to sale of pharmaceuticals is very long. Often, a drug manufactured in China or India, for example, will pass through several wholesalers who can repack the tablets or change the whole packaging. The more links in the chain, the easier it is to introduce a counterfeit.

Trading in counterfeit medicines over the Internet is increasing dramatically.

According to a study by the Swedish Drugs Administration, two thirds of Internet pharmacies are involved in shady practices. Other studies show that more than 50% of the pharmaceuticals sold over the net are counterfeit.

In 2005, WHO estimated the market for counterfeit medications at USD 35 billion. They judge that this will have increased to USD 75 billion by 2010.

What are the authorities doing? California , one of the states which has done most about the problem, has decided to bring in a law of pharmaceutical pedigrees. The law was due to come into force in 2009, but the authorities foresaw that this was unrealistic and therefore deferred implementation to 2011. Even 2011 was seen as unrealistic by the pharmaceuticals sector, so it has once more been deferred until 2015.

In summary, the Californian pedigree law is in two parts. One describing the general principles of the law and one laying down the statutory information which must accompany the pharmaceutical.

General principles – “The pedigree must be created and maintained in an interoperable electronic system which ensures that it is available and compatible throughout the distribution flow.”

The pedigree must contain:

• An electronic tracing system for designated medications at the lowest packing level.
• Use of a unique identity number of every consumer pack created by the manufacturer
• Be stored in a non-proprietary data format and architecture
• Be treated identically by manufacturer, distributor and pharmacist
• Prohibition on all parties from receiving, selling, trading or passing on a designated medication in California without an accompanying pedigree

California Pedigree Legislation Required Information applies to:

• Information on prescription drugs
  • Contains the pharmaceutical name, quantity, dose, strength, size of container, expiry date and batch/manufacturing number
• Information on source and all transactions
  • Contains company name, manufacturer’s national registration number, address of source, date of transaction, invoice number
• Information on product owner
• Certificate/signature
  • A certificate from the responsible party that the information in a pedigree is accurate and correct

Within the EU, the Commission is also working on a proposal for legal measures to ensure the authentication and traceability of pharmaceuticals. The proposed measures up for discussion are:

• Supervision by GMP, GDP and inspection procedures
• The rules must cover all parts of distribution
• The authorities must be active in their supervision
• Amendments to 2001/83/EEC are under discussion
• Requirements on players in the distribution chain in addition to wholesale traders
  • Must include players involved in trading who do not handle the product
  • Export checks
  • Wholesaler must always check that the supplier has a permit
  • Approved wholesale traders must be registered in a database
• Facility for requiring security measures for packaging (sealing or serial number)
• Prohibition on manipulating safety packs
  • Must not be removed, replaced or covered over
  • But potential for certain deviations from the labelling rules
• Obligatory wholesaler inspections
• Clearer requirements for imports of active ingredients
  • Must fulfil GMP
• Inspections of manufacturers of active ingredients
  • Guidelines for inspections of manufacturers and wholesale traders must be strengthened

A decision on the Commission’s proposal for legal measures will be taken by the end of the year. The proposed date for implementation is 2010.

The big challenge facing the industry is to safeguard the whole supply chain and all involved parties. In other words from the substance manufacturer to the pharmaceutical manufacturer, to capsule packing, carton packing, pallet loading, distribution via several wholesaling links before finally ending at the pharmacist or hospital. Securing traceability and authentication through the whole chain is a difficult task. In addition, fulfilling all the other requirements and expectations from all the involved parties in respect of an efficient production and handling flow and the statutory regulations. This is the big challenge.

Will there be a global solution, fulfilling all demands and expectations? The answer is no, or at least not within the foreseeable future. The reason is partly that the levels of technology and knowledge vary wildly in different parts of the world – in many countries for example there are no pharmacies – and partly that certain countries have already set up their own rules and methods for better securing traceability and authentication in pharmaceuticals.

We shall therefore see a variety of different systems with different techniques and varying safety levels, depending on geographical destination and the economic value of the medication and its effect on the patient.

What techniques and solutions exist for securing traceability and authentication of medicine packs? There is no 100% technique or solution which can guarantee traceability and authentication. On the other hand there are a number of techniques and solutions which make it much harder and/or financially unremunerative for criminal gangs to counterfeit pharmaceuticals.

Techniques/methods for securing authentication at product level include:

• Materials with watermarking
• Void material – A tamper-evident material specially developed for security labelling.
• Hologram – A unique pattern can be obtained from the manufacturer, e.g. for a special pharmaceutical.
• Microtext
• UV fluorescent inks
• Infra Red Luminescent Nano Pigments

Often two or more variants are used, e.g. a visible and an invisible technique, to increase the safety level and make copying more difficult.

One interesting security system for ensuring authentication at parcel and pallet level is Tamper Seal™. Tamper Seal is a vacuum pack with a vacuum sensor which sounds an alarm if the pack is broken. The pack can also be fitted with other functions, e.g. a timer, RFID tag and mobile phone. In this way it is easy to detect where and when a pack has been broken.

A few examples of security systems for securing traceability are:

• 2D Barcodes, e.g. Datamatrix code
• RFID, Radio Frequency Identification
• Variable security printing

RFID and variable security printing are also excellent system solutions for securing authentication.

With the new chip in the RFID tag, with its expanded memory unit – Tag ID, a permanent unique ID number determined by the IC manufacturer – it is now also possible to safeguard authentication, as this unique ID number is almost impossible to copy. Traceability is achieved via the memory unit UII – Unique Item Identification. UII stores the company prefix, article number and unique serial number, which are locked by the pharmaceuticals manufacturer with a specific code.

Alongside RFID, variable security printing is the other interesting system solution which fulfils the authorities’ proposed directive for traceability and authentication. Briefly put, variable security printing means that each label is provided with a unique randomly selected code. This code is then stored in a database. All affected parties in the supply chain are able to read off and verify this code against the database.

No-one can guarantee a 100% security solution for securing traceability and authentication of medicine packs. But with the aid of the existing techniques and security systems and once the proposed EU directive is agreed on and implemented, it will become highly difficult and financially unremunerative for illegal gangs to counterfeit pharmaceuticals.

About Torbjörn Gunnarsson

Business Area Manager Pharma
He has been employed at Nordvalls for three years, the last two years as Manager for Nordvalls’ Business Area Pharma. His main work tasks are to manage and develop activities within Nordvalls Pharma, both strategically and operationally. It is a really exciting job, which he finds both interesting and stimulating.