WHAT TO DO IF YOU HAVE A CONCERN AstraZeneca urges patients and healthcare professionals to be alert to the possibility of counterfeiting. Patients can protect themselves from the risks associated with counterfeit drugs by obtaining all prescription and over-the-counter medications from regulated licensed pharmacies. They should be vigilant when examining their medications, paying attention to altered or unsealed packaging or changes in the product packaging. Patients should be especially vigilant with products obtained on the internet because their origin and quality cannot be guaranteed. If you have a concern, you should contact your physician, pharmacist or other healthcare professional. |
The World Health Organization (WHO) defines a counterfeit medicine as one that is deliberately and fraudulently mislabelled with respect to identity and/or source. Whilst the full extent of counterfeiting is difficult to quantify, the problem is worldwide and particularly prevalent in developing countries. WHO’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT) estimates that approximately 10 to 30% of medicines in emerging economies are counterfeit, with parts of Latin America, Asia and Africa even greater than that. By contrast, in countries with effective regulatory systems, counterfeits represent less than 1% of the market.
Counterfeiting, which can apply to both branded and generic medicines, means that a product is deliberately and fraudulently labelled in a way that suggests that it is the authentic, approved medicine made by the genuine manufacturer. Counterfeits may include products made: - Without the active ingredient
- With an insufficient or excess quantity of the active ingredient
- With the wrong active ingredient
- With fake packaging
- With incorrect labelling or administration instructions
Counterfeit drugs therefore pose many hazards to patients because they may: - Contain the wrong ingredients or improper doses of the correct ingredients
- Contain inert substances instead of active ingredients
- Contain harmful ingredients
- Convey incorrect patient information, which could result in incorrect use
- Be genuine but out-of-date or expired products
Counterfeit drugs are unlikely to be as effective as genuine products. A patient who takes a counterfeit medication may be at risk from a number of dangerous health consequences. Patients may experience allergic reactions, unexpected side effects, or a worsening of their medical conditions. In the worst cases, these drugs could cause serious harm or even death.
Whilst the counterfeiting of medicines is a complex problem with no single or absolute solution, we have a range of activities focused on protecting patients. These include: - Using technologies that make our products easier to identify and more difficult for counterfeiters to copy
- Monitoring market and supply chain activities to identify potential counterfeiting operations
- Working with supply chain partners to address product security issues
- Supporting increased awareness and education for patients and healthcare professionals
Alongside this, we continue to work with governments, regulatory authorities, law enforcement agencies and trade associations in efforts to ensure a secure drug supply chain.
We take immediate action when counterfeit AstraZeneca products are suspected. Suspected counterfeit samples are sent for analysis and authentication, and internally a global issues management team is convened. This team can comprise representatives from the local Marketing Company, Security, Legal, Quality Control, Medical, Regulatory, Supply, and Communications.
We are committed to the vigorous pursuit of anyone who makes, distributes or sells counterfeit versions of our products and we will seek prosecution of offenders to the fullest extent of the law.
We continue to explore other measures for combating counterfeit medicines and
participate in a range of anti-counterfeiting public/private sector forums, including IMPACT and the Pharmaceutical Security Institute. In 2007, AstraZeneca in the UK was alerted to an incident of counterfeiting of one of our anti-cancer medicines, Casodex. We worked with the UK Medicines and Healthcare Products Regulatory Agency to identify the counterfeit product and protect patient safety. Pharmacists, hospitals and dispensing doctors were given a dedicated AstraZeneca Customer Service number that they could call to discuss any concerns. We also ensured that our communications included a message to patients about what they should do. We continue to collaborate with law enforcement and regulatory authorities on their investigation of the incident and those responsible. |
In 2007, AstraZeneca joined the Transported Asset Protection Association (TAPA). TAPA brings together global manufacturers from a range of industries, freight carriers, law enforcement agencies and other stakeholders with a common aim of combating supply chain crime.
Membership of TAPA complements our existing transport security arrangements and provides globally acknowledged standards for the protection of goods in transit by third parties. It also offers opportunities to share information and best practice with other manufacturers, the freight industry and key law enforcement partners in the countries in which we operate.
The content of this page was externally assured by Bureau Veritas, February 2008 |