All Posts Tagged With: "counterfeit medicines"
Counterfeit Medicines from the European Commission
Counterfeit medicines are a major threat to public health and safety. As counterfeiting methods become more sophisticated the risk that counterfeit medicines enter the EU through illegal distribution channels increases every year. Compared to 2005 seizures of counterfeit medicines at the boarder of the EU have increased in 2007 by 380%. Fake medicines represent a serious threat to global health and call for a comprehensive strategy both at European and at international level.
The European Commission works together with European and international partners to ensure that legal methods for the marketing of medicines are respected and enforced. The Commission is an active member the International Medical Products Anti Counterfeiting Taskforce (IMPACT) created by the World Health Organisation in 2006 and has specifically co-funded and supported WHO in the development of the recommendation “Principles and Elements for National legislation against Counterfeit Medical Products“. The Commission also works together with the European Medicines Agency (EMEA) and the Council of Europe, in particular with the European Directorate for Quality of Medicines and Healthcare (EDQM) on specific questions related to counterfeit medicines.
At EU-level, an amendment of the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use was announced in early 2008. The aim of this initiative is to address in particular the risk of counterfeit medicines entering the legal supply chain of medicines in the EU.
The genuine danger of counterfeit medicines
Counterfeits pose serious public health risks and negatively affect treatment outcomes of patients who are inadvertently administered counterfeit products. Counterfeits can kill. Even if a patient is only injured, the effects can be devastating and there is no regulatory or other recourse for the patient to obtain redress against the counterfeiter.
For more information, watch the video on the original blog post on counterfeit medicines .
Pharmaceutical Industry Announces Launch Of Anti-counterfeit Medicines Pilot Project In Sweden
EFPIA, the voice of the pharmaceutical industry in Europe, of which the Irish Pharmaceutical Healthcare Association (IPHA) is a member, has announced an important step in the industry’s efforts to protect Europe’s citizens against counterfeit medicines. EFPIA has agreed to run a pilot of its coding and identification solution (1) in Sweden later this year in partnership with Swedish retail pharmacy chain Apoteket AB and local wholesalers Tamro and KD.
Under the EFPIA solution, pharmacists will check a unique identification code on each individual pack when it is dispensed to the patient. These codes are generated and applied by manufacturers using a simple 2D data matrix barcode, which contains a unique serial number. The scan will reveal any duplication of data on packs and will trigger the system to immediately alert the pharmacist to the possibility of a counterfeit product, who can take the necessary steps.
“The threat posed by counterfeit medicines is real and growing,” said David Brennan, CEO of Astra Zeneca. “As an industry, we are focused on patient safety and ensuring the public can have confidence in their medicines. This coding system represents a major step forward towards that goal”.
“We are pleased to partner with EFPIA in this project” said Director General of Apoteket AB, Stefan Carlsson. “The 2D matrix coding solution contributes not only to the improvement of patient safety with regards to counterfeiting, but also to more effective ways of managing pharmaceutical products in pharmacies in the future.”
Director General of EFPIA, Brian Ager, added, “Obviously we share the European Commission’s concerns on counterfeit medicines. Therefore we are committed to making proactive contributions to reduce the risk; this initiative further underlines our commitment to patient safety.”
The coding solution is being developed in collaboration with GIRP (the European Federation of full line wholesalers). It has the potential to provide an efficient and cost-effective method to meet the new traceability requirements, being proposed by the European Commission, to combat the infiltration of counterfeit medicines into Europe.
The pilot is expected to last between three and four months and will be entirely financed by the pharmaceutical industry. It will be a scaled-down version of a full EFPIA solution: a key goal is to demonstrate that it is a practical and effective solution for manufacturers, pharmacists and patients alike, providing a standardised and interoperable system throughout Europe. The system is designed to ensure product identification from point of manufacture to point of dispensation, ensuring that the authenticity of each unit can be ascertained before it reaches the patient.
(1) For more information on the coding and identification solution visit here.
What are counterfeit medicines?
Counterfeit medicines are any brand (or generic) medicines and active pharmaceutical ingredients (APIs) that are deliberately and fraudulently mislabelled by unauthorised parties with respect to source, and / or composition and / or therapeutic quality. They include products without active ingredients, or with the wrong active ingredients, or with insufficient active ingredients, or with fake packaging. Sometimes they contain substitutes, or are diluted with foreign or toxic bodies, to increase the quantity of the original medicine.
The World Health Organisation (WHO) estimates that 8% to 10% of medicines in the global medicine supply chain are counterfeit, reaching as high as 25% in some countries. The largest counterfeit market with close proximity to the EU is Russia, where it is estimated that 12% of medicines are counterfeit. Counterfeit medicines are entering Europe’s legitimate supply chain in increasing numbers. More than 4.081 million counterfeit medicines packs were seized at Europe’s borders in 2007, a 51% increase on the previous year. According to the World Health Organisation, around one percent of medicines in Europe are now counterfeit.
To date Ireland has had few incidences of counterfeits attempting to enter the legitimate supply chain however continued vigilance is required. The reality is that as long as repackaging and breaking of seals in the distribution chain is allowed, patient safety will be at risk and the potential for more incidences will only increase.
Read the rest of this article here.
Counterfeit Medicines - The Global Hazard
A counterfeit medicine is a product, which is deliberately and fraudulently mislabeled with respect to identity and/or source, ingredients or the packaging while substandard medicines are genuine medicines produced by legitimate manufacturers that do not meet the quality specifications that the producer says they meet.
Even countries with advanced regulatory systems are seriously challenged by this deceptive practice. An analysis conducted by International Medical Product Anti-Counterfeiting Taskforce (IMPACT) shows that counterfeiting is greater in those areas where regulatory and legal oversight is weaker. This easy and lucrative business has attracted organized crime and in most of the countries, the punishment is not sufficiently strong to deter criminals. The fight against counterfeit medicines requires collaboration at national, regional and international levels. The absence of deterrent legislation, non implementation of Good Manufacturing Practices (GMPs), lapses in the product supply chain and unauthorized internet based sales of pharmaceuticals remain the major reasons of the proliferation of this crime. To deal with this problem strict measures are to be taken by the governments,complementing the legislation with effective law enforcement. RFID (Radio frequency identification technology) and OVDs (optically variable devices) can help track and authenticate the drugs.
Introduction
Counterfeiting is deceptive and immoral in any field. But in healthcare, it is criminal and simply unacceptable. According to World Health Organization the definition of counterfeit medicines is “A counterfeit medicine is a product which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging”. It is important to make a distinction between counterfeit medicines and other kinds of substandard medicines. All counterfeit medicines are substandard because they are manufactured and distributed outside of regulatory control and their composition is unpredictable. On the other hand, not all substandard medicines are counterfeit because not all of them have been ‘deliberately and fraudulently mislabeled’. According to WHO, Substandard medicines are genuine medicines produced by legitimate manufacturers that do not meet the quality specifications that the producer says they meet. For example, they may contain less (or more) active ingredient than written on the package. This may not be an intention to cheat, but may be due to problems with the manufacturing process Many cases of counterfeiting have been uncovered while investigating therapeutic failure or adverse events observed in patients. Such cases lead to a serious consequence i.e. the erosion of confidence in health-care systems. Counterfeit drugs particularly affect the most disadvantaged people in poor countries.
One of the most worrying implication of counterfeit medicines is the emergence of drug resistant pathogens, bacteria, viruses, parasites. Substandard or counterfeit drugs increase the risk of spreading the resistance. Such a situation will lead to therapeutic failure and a need for discovery and development of new drugs will arise. The counterfeit medicines could also cause adverse effects through excessive dose or due to the presence of potentially toxic active ingredients or pathogenic contaminants. Loss of confidence and faith in the medicines and in the health care system is also a very serious damaging consequence of the counterfeit medicines. Not only the patient but also the health professional, pharmaceutical manufacturers, distributors, suppliers, retailers etc. loose confidence in the medicine that they rely upon. The pharmaceutical companies may loose the interest to invest in research and development and future innovation because the counterfeit product deprives the pharmaceutical companies of significant amount of revenues.
Some facts highlighting the presence of counterfeit medicines globally
The problem is truly global. Counterfeit medicines are increasingly detected not only in developing countries but also in European and North-American countries. This suggests that even countries with advanced regulatory systems are seriously challenged by this menace. Rough estimates suggest that up to 10% of the medicines circulating in the world could be counterfeit. They are present in all regions but developing countries face the worst part of the problem. An estimated 25% of the medicines consumed in developing countries are believed to be counterfeit. In some countries, the figure is thought to be as high as 50%. According to a prediction made by the Center for Medicine in the Public Interest, in the United States of America, counterfeit drugs sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005.
- WHO conducted a survey of counterfeit medicines in 20 countries between Jan 1999 to Oct 2000 and found that 60% of counterfeit medicine cases occurred in poor countries and 40% in industrialized countries. In 2001, China had roughly 500 illegal medicine manufacturers and the Lao Peoples Democratic Republic had about 2100 illegal medicine sellers. In Thailand 8.5% are substandard medicines in the market, 8% in Vietnam and 16% in Myanmar WHO estimated in 2003 that there were 2800 illegal medicine sellers in Combodia, and 1000 unregistered medicines in the market.
Read the rest of this article on counterfeit medicines.
The genuine danger of Counterfeit Medicines
Learn how counterfeit medicines can affect patients’ health in Europe from the EFPIA.
Counterfeit medicines: the pills that kill
The multi-billion-pound global trade in bogus medicines is responsible for an estimated half a million deaths a year. As Europe becomes an ever-more lucrative target for counterfeiters, Eric Clark meets the government agents and pharmaceutical company investigators who are taking the fight to the fakers
Half an hour before dawn, the semi-detached house, like the rest of the silent East Midlands town, is in darkness. Two investigators, search warrant at the ready, approach the front door, while a man with a battering ram takes up position. There has already been a 6am briefing session at the local police station, and the raid has a code name - Operation Mexico.
But the investigators about to move into the house are not police officers. They belong to the Medicines and Healthcare Products Regulatory Agency (MHRA) intelligence and enforcement unit, a small specialist group that seeks to keep Britain free of illegal and counterfeit medicines - a multi-billion-pound worldwide trade that is estimated to lead directly to the deaths of more than a half million people a year across the globe.
Today’s target is the man behind a website, ostensibly based in Belize but in reality located in this nondescript house and an office in a small modern block a few minutes away. Malik (not his real name), the intelligence officer on the operation, has already made a purchase on the site, buying Kamagra, an Indian version of Viagra, illegal in the UK, using a bogus credit card and phoney mail address to hide his real identity.
‘You never know what you are going to find behind closed doors,’ Stan, the lead investigator, says. Other recent MHRA raids have uncovered everything from rudimentary machines for pressing baking powder and shoe polish into fake pills to so-called ‘miracle cancer cures’.
Fake pharmaceutical drugs - whether sold directly over the internet or infiltrated into the neighbourhood pharmacy or local hospitals - have become a huge and fast-increasing threat. In 2005, 500,000 single doses of fake medicines were discovered across Europe. The following year that number had shot up to 2.5 million.
Worldwide, according to figures collected by the pharmaceutical giant Eli Lilly, customs seized more than three million counterfeit or suspected counterfeit tablets in more than 1,000 separate actions in the two years up to January.
Counterfeit medicines are easy to produce, low risk and vastly profitable. A drug costing a fraction of a penny can be sold for 50 times as much and more. In one MHRA case, 100,000 fake tablets supplied by a Chinese manufacturer for about 25p each were being sold for up to £20 each in the UK, worth £1.6 million in total.
Read the rest of this article here.
Nurses Raise the Alarm: Counterfeit Medicines Kill
International Council of Nurses Launches a Global Anti-counterfeit Campaign
Geneva, 11 May 2005 - Nurses worldwide are using the occasion of International Nurses Day to draw attention to the dramatic increase of counterfeit medicines in today’s global market. The World Health Organization (WHO) estimates that one in ten medicines sold worldwide is fake, with no medical effect whatsoever. In developing countries, up to 25% of the medicines used are counterfeit or substandard. Some estimates place the annual earnings from counterfeit medicines at over US $32 billion globally. 1
Counterfeiting is not only costly to consumers, it is a particularly serious area of crime because it puts the lives and well-being of patients at risk, leads to loss of confidence in the healthcare professions and in the quality, safety and efficacy of the medicines they prescribe.
Counterfeit medicines can kill. In 1992, 233 Bangladeshi children died after taking a paracetamol-based syrup that was tainted with antifreeze. In 1995, 2,500 children in Niger died after taking a fake meningitis vaccination. Of the one million deaths that occur from malaria annually, as many as 200,000 would be avoidable if the medicines available were effective, of good quality and used correctly.
"Patients and consumers are the primary victims of counterfeit medicines. In order to protect them from the harmful effects of counterfeit medicines it is necessary to provide them with appropriate information and education on the consequences of counterfeit medicines," says Christine Hancock, President of the International Council of Nurses. "As frontline health care providers, nurses are key players in increased vigilance for counterfeit medicines and increased reporting of possible counterfeit drugs."
In their campaign to improve patient safety, nurses worldwide are hoping to raise awareness of the increasing availability of counterfeit and substandard drugs and to lobby for fair prices of medicines, as the high cost of medicines in developing countries makes them unaffordable to large sectors of the population and increases the risk of counterfeiting. Unaffordable essential medicines can lead people who cannot afford legal medicines to seek out alternative sources. ICN is working with governments, industry and regulatory authorities in this initiative and encourages national nurses associations to do the same at the national level.
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1 World Health Organization (WHO) (2003). Substandard and Counterfeit Medicines, Fact Sheet no. 275. Retrieved December 2004 from http://www.who.int/mediacentre/factsheets/fs275/en/
Editor’s Note:
The International Council of Nurses is a federation of 133 national nurses’ associations representing millions of nurses worldwide. Operated by nurses for nurses since 1899, ICN is the international voice of nursing and works to ensure quality care for all and sound health policies globally.