Aegate.com

Commentary
Using Information Technology to Combat
Counterfeiting in the EU
Gary Noon explains how using information technology to enhance
communications can help industry better deliver quality assured medicines The advent of information technology has had a profound course of action for the industry to follow are unlikely impact on industry and the pharmaceutical community is no to materialise this year – time that industry and patients exception. With a complex supply chain and a growing need to can ill afford as drug counterfeiting becomes ever more guarantee the safety and well-being of consumers, information technology is a powerful enabler. Increasingly, technology is critical to ensure all industry stakeholders are kept up-to-date What are the challenges?
with the latest regulatory and legislative changes.
The primary challenge for industry has been the inherent As the last point of professional contact between the complexity of the pharmaceutical supply chain. As many as patient and the industry, pharmacists are on the front line 20 different parties can become involved in the distribution when it comes to ensuring patient safety. The quality and of medicines before they reach the pharmacist, and this timeliness of information flowing to pharmacists about gives counterfeiters numerous opportunities to penetrate the chain. As ownership and title of goods passes to the Providing the pharmacist with information in real-time purchaser as soon as the medicine is sold, the original – as the medication is dispensed – creates the opportunity manufacturer cannot completely control the quality to provide new levels of patient safety previously not available. Implementing a communications network in which the product finally reaches the patient. Each between pharmacies, manufacturers and regulatory stakeholder must take liability for the part they play in the authorities that operates in real time on a pan-European basis will revolutionise the pharmaceutical industry.
When quality issues occur, it is also extremely important to be able to efficiently and effectively withdraw What is the issue?
affected products. However, such products are often difficult to locate, which raises another patient safety issue. As an The threat of patients receiving substandard or example, the UK’s Medicines and Healthcare products counterfeit medicines is a clear and present danger. Regulatory Agency in June 2007 issued three emergency This multibillion dollar global industry is accountable for an estimated half a million deaths a year, and drug recall notices4 relating to the medicines Casodex (bicalutamide), Plavix (clopidogrel bisulfate) and Zyprexa single doses of fake medicines were discovered across (olanzapine). Out of the 70,000 packs that were distributed Europe. The following year that number escalated to to pharmacies and wholesalers, only 40,000 were effectively 2.5 million. The World Health Organization estimates recalled, meaning up to 30,000 of these drugs may have still the trade in fake drugs to represent as much as 10% of all pharmaceutical sales worldwide. The WHO also In May 2009, Glaxo SmithKline and the MHRA believes that up to 30% of medicines in Russia and issued a recall for a batch of Seretide (salmeterol xinafoate in some countries in Africa, Asia and Latin America and fluticasone propionate) 250 Evohalers, which are are counterfeit. However, quantification of a true used to treat asthma, because of possible interference figure is almost impossible as often the evidence has by counterfeiters in the plastic inhalers themselves5. It was reported this product had reached patients through Indeed, even in Europe, as Jean-Francois Dehecq, the legitimate supply chain, resulting in a nationwide chairman of pharmaceutical firm sanofi-aventis acknowledges, counterfeits are now starting to appear The costs and time involved in a full global product in the legitimate supply chain – in pharmacies as well as recall are vast. The risk associated with the loss of public distributors and wholesalers. Dr Dehecq estimates that confidence in a manufacturer’s products is probably counterfeit medicine affects around 2-3% of sanofi-aventis’s In addition, in some countries – such as Turkey – In December 2008, the European Commission pharmacists are liable for the quality of the medicines they announced its health package, which contains legislative sell and can be imprisoned for dispensing a counterfeit proposals relating to several pressing industry issues, one drug, even if this is done so unknowingly.
of which is counterfeit medicines3; true recognition that This example highlights that speed of communication drug counterfeiting is a serious and growing problem. is vital; if information reaches the pharmacy quickly However, this is a complex area and will be the subject enough it can act as an effective barrier between patients of much debate before legislation can be agreed.
and medicine that is unsafe for public use.
With re-elections to the European Parliament due to Technological intervention would be helpful as, until take place in the summer of 2009, the dates of a unified now, the method of communicating regulatory and product Gary Noon is the chief executive officer of Aegate, a patient safety communications company that offers a direct, IT enabled channel between pharmacies, pharmaceutical
companies, professional associations and regulators.
www.rajpharma.com
RAJ Pharma July 2009 419
Commentary
changes (including recalls and suspect counterfeits) to the Beyond the operational benefits that technology offers pharmacist has been fax or email, or even post. Given the pharmacists, there is a strong case for technology within time constraints pharmacists are often operating under, the pharmacy to assure patients of the quality of medicines these notifications might not get picked as quickly as they they receive. Perhaps this will also discourage patients need to and inadvertently compromise the well-being from accessing medicines from more dubious and risky sources via the internet, where as much as 60% of medicines purchased may be counterfeit6. An available solution
The pharmaceutical industry can gain a significant Both the product licence holder and pharmacists, when amount of goodwill by being able to demonstrate that it has faced with ever-changing status relating to the quality taken every reasonable care to protect consumers. There of medicines supply – such as notification of a product is widespread acknowledgement that efforts to promote withdrawal, product expiry or changes in a dosing schedule public safety generate a positive return on investment7.
– want to be in a position to assure the patient of the quality of the product they are about to receive. To achieve Staying one step ahead
this pharmacists require the very latest on the product In a world where counterfeits have no borders, solutions to as it is being dispensed. This requires input from the combat the trade in counterfeits must be applied across all pharmaceutical manufacturer and regulatory agency and participation from the pharmacists themselves. Implementing a communications network that One method that uses technology to improve operates in real time on a pan-European basis could communication in the pharmacy is authentication. This revolutionise the European pharmaceutical industry. With method has proved to be effective in improving the speed a concrete effort from all stakeholders to embrace the of recalls and protecting against counterfeiting trade. technology available, pharmacists can assure the level of Authentication involves setting up an open, quality and regulatory compliance sought by industry as direct communications link between the pharmacy, the manufacturer and the regulatory body by simply The challenge that industry and governmental installing broadband connectivity and upgrading the organisations face is to convert collective responsibility existing pharmacy software with an authentication system. Pharmaceutical manufacturers need to add to every pack In the economics of the counterfeiting industry, using of medicine before distribution a mass serialisation code technology that collectively addresses the issue and erects (a “passport” number), which is effectively a unique an even greater barrier for the entry of counterfeits to the machine readable number. With authentication installed, market will lead even the most persistent counterfeiters pharmacists are alerted rapidly to any issues relating to to acknowledge that their money spinning days might be Every time the passport number of the medicinal item is scanned by the pharmacist, he or she receives relevant messages from the pharmaceutical manufacturer or regulatory body directly into his or her computer screen before passing 1. The Daily Telegraph, 5 April 2008, Counterfeit medicines – the item to the patient. If there are issues, the system will the pills that kill, www.telegraph.co.uk/health/3354135/Counterfeit-medicines-the-pills-that-kill.html “freeze” and the manufacturer can immediately relay any 2. Outsourcing Pharma, 23 June 2008, EFPIA says traceability important instructions, such as “hold the product” directly to www.outsourcing-pharma.com/On-your-radar/Patient-safety/EFPIA-says-traceability-pilot-will-start-next-year 3. The Regulatory Affairs Journal – Pharma, 2009, 20(1), 47-49
Effective authentication systems limit the negative publicity 4. BBC News online, 3 February 2009, Thousands “have taken associated with drug scares and minimise the threat of fake drugs”, http://news.bbc.co.uk/1/hi/health/7865246.
litigation if patients suffer as a result of taking fake or 5. Chemist & Druggist, 13 May 2009, Counterfeit fears prompt An authentication system that uses mass serialisation www.chemistanddruggist.co.uk/c/portal/layout?p_l_ technology allows manufacturers and regulators to recall id=259751&CMPI_SHARED_articleId=2462900&CMPI_ batches or sub-batches of fake or substandard drugs SHARED_ImageArticleId=2462900&CMPI_SHARED_ quickly and efficiently before they reach the patient. articleIdRelated=2462900&CMPI_SHARED_ Using a dedicated communications channel, ToolsArticleId=2462900&CMPI_SHARED_CommentArticleI pharmacists can play a key role on behalf of the manufacturer d=2462900&articleTitle=Counterfeit%20fears%20prompt%20 in the intervention of the prescribed drug before it reaches the patient. Pharmacists who have already installed this 6. European Alliance for Access to Safe Medicines, The infrastructure have seen a change in how their role relates Counterfeiting Superhighway, 2008, http://v35.
pixelcms.com/ams/assets/312296678531/455_EAASM_ to the patient. Historically, the pharmacist was seen as a “shopkeeper”, an individual whose function it was to sell 7. Frost and Sullivan, Working together on mass serialisation; medicines, but this is evolving. The pharmacist is now Whose responsibility is ensuring patient safety?, 28 April reminded to be a “consultant”, offering patients relevant, 2008, www.aegate.co.uk/assets/_files/documents/aug_08/ timely advice relating to the treatment they are receiving. aeg__1219846309_FrosSullivanexesummarywhitepap.pdf 420 July 2009 RAJ Pharma
www.rajpharma.com

Source: http://www.aegate.com/assets/_files/documents/jul_09/aeg__1248351969_RAJ_Pharma_July_2009_GNoon_Com.pdf