All Posts Tagged With: "counterfeit medicines"
Growing concern over EU counterfeit medicines problem
United Kingdom, Dec 7 - Senior EU policy makers are becoming increasingly concerned as further evidence suggests the region is awash with counterfeit medicines .
The illegal drugs frequently contain too much, too little or no active ingredient at all, or they may contain toxic substances, posing a risk to the lives of EU patients.
Counterfeit medicines pose a serious threat to EU citizens says the commission (Photo: www.freeimages.co.uk) On Monday (7 December), EU industry commissioner Gunter Verheugen said the extent of the problem is highly alarming.
"The number of counterfeit medicines arriving in Europe …is constantly growing. The European Commission is extremely worried," he told the German newspaper Die Welt.
Read more here .
The Partnership for Safe Medicines Seeks Stronger Regulations for Online Pharmacies Selling Counterfeit Medicines
The Partnership for Safe Medicines seeks stronger regulations and penalties for online pharmacies
WASHINGTON—The Partnership for Safe Medicines (PSM) issued the following statement regarding the International Internet Week of Action, code named Operation Pangea II, intended to curb illegal actions involving medical products. PSM is a group of organizations and individuals dedicated to protecting consumers from counterfeit medicines.
As an advocate for drug safety, the Partnership for Safe Medicines applauds this international effort, which has the potential to positively impact patients around the world. PSM congratulates INTERPOL, the World Health Organization’s (WHO) International Medical Products Anti-Counterfeiting Taskforce (IMPACT) and the law enforcement agencies from the 24 participating countries who took part in the International Internet Week of Action (IIWA).
International cooperation is essential to shutting down rogue online pharmacies and curbing the widespread illicit sale of substandard, unapproved and counterfeit drugs. While investigations in a number of countries are still ongoing, Operation Pangea II has already resulted in a series of arrests, revealed 751 Web sites engaged in illegal activity, 72 of which have now been taken down, and the seizure of nearly 167,000 illicit and counterfeit medicines. The exemplary collaboration between drug regulators, the customs services and the police is evident in these cases.
Read the rest of this statement here.
Health Topic: Counterfeit medicines
Counterfeit medicines are part of the broader phenomenon of substandard pharmaceuticals - medicines manufactured below established standards of quality and therefore dangerous to patients’ health and ineffective for the treatment of diseases. The difference is that counterfeits are deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients.
A global public health crisis
Counterfeit medicines represent an enormous public health challenge. Anyone, anywhere in the world, can come across medicines seemingly packaged in the right way, in the form of tablets or capsules that look right, but which do not contain the correct ingredients and, in the worst case scenario, may be filled with highly toxic substances. In some countries, this is a rare occurrence, in others, it is an everyday reality.
Counterfeit medicines range from random mixtures of harmful toxic substances to inactive, useless preparations. Occasionally, there can be "high quality" fakes that do contain the declared active ingredient. In all cases, contents of counterfeits are unreliable because their source is unknown or vague and always illegal. Fake drugs can cause harm to patients and sometimes lead to death.
Any kind of product can be and has been counterfeited: expensive lifestyle and anti-cancer medicines, antibiotics, medicines for hypertension and cholesterol lowering drugs, hormones, steroids and inexpensive generic versions of simple pain killers and antihistamines. In developing countries the most disturbing issue is the common availability of counterfeited medicines for the treatment of life-threatening conditions such as malaria, tuberculosis and HIV/AIDS.
Counterfeit medicines can harm and kill
The regular use of substandard or counterfeit medicines can lead to therapeutic failure or drug resistance. In some cases, it can lead to death.
A case in Argentina: In 2004, fake medicine led to a trail of death in Argentina.
Veronica Diaz was a healthy 22 year old woman, living in Viedma, Argentina, who had mild anaemia caused by insufficient iron in her blood and required her to receive iron injections. In December of 2004, she became very sick and died of liver failure after receiving the 7th of a 10 injection treatment. The medicines authority of Argentina, ANMAT, determined that she had been given a highly toxic counterfeit. Authorities were unable to determine the source of the counterfeit product due to falsified paper work. While most of the counterfeit production throughout Argentina was recovered and four persons were prosecuted, the highly fragmented distribution system prevented the recall from being 100% successful. In May of 2005 another woman died and a 22 year old pregnant woman was injected with the same counterfeit. She survived but gave birth to a 26 week premature baby. To date, Argentinean law does not consider counterfeiting medicines a crime.
Some other examples are below.
- During a meningitis epidemic in Niger in 1995, more than 50 000 people were inoculated with fake vaccines resulting in 2 500 deaths. The vaccines were received as a gift from a country which thought they were safe.
- 89 children died in Haiti in 1995 and 30 infants died in India in 1998 due to the consumption of paracetamol cough syrup prepared with diethylene glycol (a toxic chemical used in antifreeze).
- In 2001, in South-East Asia, a Wellcome Trust study revealed that 38% of 104 anti-malarial drugs on sale in pharmacies did not contain any active ingredients.
- In Cambodia, in 1999, at least 30 people died after taking counterfeit anti-malarials prepared with sulphadoxine-pyrimethamine (an older, less effective anti-malarial) which were sold as artesunate.
Estimates
The US based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005.
Although precise and detailed data on counterfeit medicines is difficult to obtain, estimates range from around 1% of sales in developed countries to over 10% in developing countries, depending on the geographical area. That range takes into consideration both regional disparities in the presence of counterfeits, and specific global market value shares. Apart from the huge differences between regions, variations can also be dramatic within countries, i.e. city versus rural areas, city versus city.
Currently, the sources of information available include reports from non-governmental organizations, pharmaceutical companies, national drug regulatory and enforcement authorities, ad hoc studies conducted on specific geographical areas, and occasional surveys.
Counterfeiting is greatest in those regions where the regulatory and legal oversight is weakest.
Read the rest of this page on counterfeit medicines here .
Counterfeit Medicines: International Council of Nurses Position
The International Council of Nurses (ICN) is very concerned with the growing problem of counterfeit medicines and the negative consequences on the prevention and treatment of disease, which can include poor treatment outcomes, or failure of treatment, loss of confidence in health care, resistance to antibiotics and poisoning due to harmful ingredients.
ICN supports international initiatives to combat counterfeiting and urges nurses and NNAs to collaborate with pharmacy associations, pharmacists, physicians and others to disseminate accurate information on detection and elimination of counterfeit medicines. More specifically ICN supports actions that aim to:
- Strengthen quality assurance and medicines regulatory authorities.
- Detect and expose sources of counterfeit medicines.
- Improve supply of medicines to health facilities.
- Educate nurses in detection and prevention of counterfeit medicines.
- Monitor for any failure of treatment that could be a sign of counterfeit medicine.
- Educate and create awareness among the public of counterfeit medicines.
Background
According to the United States Food and Drug Administration (FDA), counterfeit medicines make up more than 10% of the global medicines available in the market and are available in both developed and developing countries. Though there is no accurate data, the World Health Organization has announced that up to 25% of medicines consumed in developing nations, often to treat life-threatening conditions, are believed to be counterfeit or substandard. All medicines and even vaccines can be counterfeited with serious consequences to patients and the health care system.
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. As frontline health care providers, nurses are key players in increased vigilance for counterfeit medicines and increased reporting of possible counterfeit drugs.
Counterfeit medicines, as deliberate and fraudulent products with questionable efficacy, represent a serious challenge to the treatment or prevention of disease. According to the World Health Organization’s definition a counterfeit medicine is one, 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.
Counterfeit products may contain too much, too little or no active ingredient, the wrong ingredients or high levels of impurities, contaminants and even toxic substances. They could be reject or out-of-date formulations withdrawn from the market which are obtained by counterfeiters, relabeled as bona fide product and introduced back into circulation. Counterfeit medicines have killed and injured thousands of people around the world.
Read more here .
Counterfeit medicine. Real danger.
One in 10 UK men interviewed recently admitted to purchasing prescription-only medicines from unregulated sources, without a prescription. What they probably don’t know is that it’s estimated that between 50 and 90 per cent of medicines sold in this way have proven to be counterfeit which means they are taking a real gamble with their health.
The World Health Organisation (WHO) estimates that 10% of all medicines available around the world are counterfeit.
And counterfeiters do not only target medicines for weight loss, smoking cessation and erectile dysfunction (ED) but also pain, heart and mental health conditions.
The cinema commercial on this site portrays a man pulling a dead rat from his mouth after taking a counterfeit pill. This site allows you to view the commercial, learn more about the dangers of counterfeit drugs and share this information with friends and colleagues.
Watch a video about the danger of counterfeit medicines .
Counterfeit Medicines Q&A from Pfizer
This product information is intended only for residents of the United States.
- How do you know when you’ve purchased a counterfeit product?
- What are the dangers of taking counterfeit products?
- How can you avoid buying or receiving counterfeit products?
- How serious a problem is the counterfeiting of prescription medicines?
- What are the causes of counterfeiting?
- What are the consequences of counterfeiting?
- What is Pfizer doing to combat the counterfeiting problem?
- What can be done to improve the situation?
- What can you do to help?
How do you know when you’ve purchased a counterfeit product?
Consumers may not know that the medicines they’ve purchased are counterfeits. That’s why it’s important to purchase prescription products from a pharmacy and pharmacist with whom you’re familiar.
In some cases, patients have noticed a different taste, consistency, or appearance of products that are later identified as being counterfeit, or they may have a different reaction to the counterfeit drug.
If you suspect the Pfizer product you have pruchase may be counterfeit, contact us at 1-800-438-1985.
What are the dangers of taking counterfeit products?
One of the biggest concerns is that you may not be getting the therapeutic benefit you expect from the product. For example, a drug you count on to lower your cholesterol level—or to shrink a cancerous tumor—may not be providing any benefit at all because it’s counterfeit. Or the product may contain too much active ingredient, which also could be harmful. A fake drug also could interact with other medications you’re taking and create potential health issues.
Counterfeit products may be manufactured in substandard environments without appropriate controls that ensure their safety and efficacy and they could contain dangerous contaminants.
Given the present environment in which we live, there also is a concern that counterfeit drugs could be used as a tool by terrorists.
Finally, counterfeit products undermine the basic tenet of our health care system: to enable people to live healthier, happier lives.
Read the rest of these Q&A’s on counterfeit medicines.
IFPMA Issues: Counterfeit Medicines
Counterfeit Medicines
Position
Trade in counterfeit drugs is widespread and affects both developing and developed countries. All medicines are subject to counterfeiting, both branded and generic.
Counterfeit drugs are found under different forms, including:
- Products with the correct ingredients (but often with incorrect quantities of active ingredients, or time-expired active ingredients, creating an increased risk of drug resistance. The product may also have been relabelled, which can lead to allergic reactions and harmful interactions with other drugs);
- Products with the wrong ingredients (possibly toxic and therefore directly harmful to patients);
- Products without active ingredient (leaving patients at risk as their disease is left without treatment)
It is virtually impossible to tell the difference between real and fake medicines. Taking for granted that the drugs can be trusted, patients, doctors and other medical staff often do not even suspect that there is anything wrong with their medicines. However, not only is it in most cases hard to detect suspicious products, but there is also a lack of public awareness about counterfeit drugs and their seemingly uncontrolled presence on the market. As a consequence, medicines that do not work or cause unusual side-effects are rarely even reported, since symptoms (including deaths) are usually attributed to the disease. From a judicial perspective, prosecution is complicated by the fact that the evidence of counterfeiting is consumed.
Because the public health risk of counterfeit medicines recognizes no national boundaries, companies have created the Pharmaceutical Security Institute (PSI) and developed global security strategies to ensure public safety and product integrity. The pharmaceutical industry works closely with law enforcement and regulatory agencies in both developed and developing countries to implement a multilayered security strategy focused on both prevention and enforcement. The IFPMA’s Director General serves as President of the PSI.
Counterfeit Medicines on IPHA.ie
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 the 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 (1). 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 (2). According to the World Health Organisation, around one percent of medicines in Europe are now counterfeit (3).
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.
IPHA encourages patients to purchase prescription medicines through authorised distribution channels only and continues to raise awareness of the dangers of purchasing medicines online. A report published in 2008 revealed that a frightening 62% of medicines purchased on the internet were fake or substandard (4). The pharmaceutical industry spends billions in developing reliable, safe, life-saving and life-enhancing medicines. The system that enables such medicines to reach patients, through the collaboration of regulators, pharmacists, healthcare professionals and the manufacturers of medicines, has protected Irish consumers very successfully.
The European pharmaceutical industry recently proposed a European track and trace system to enhance product security. A pilot project which will see the mass serialisation of pharmaceutical products was launched in Sweden in 2009. Industry has also called for a ban on repackaging of pharmaceutical products; clearly defined liabilities for all involved in the distribution chain (including brokers, traders and agents); stricter auditing rules and controls of the supply chain; application of penalties for trafficking in counterfeits and for patients to be encouraged to purchase prescription medicines through authorised distribution channels only.
The EU Pharmaceutical Package which has begun the co-decision procedure in the European Parliament includes draft counterfeit medicines legislation which has taken note of industry’s calls and includes proposals for increased Good Manufacturing Practice inspections on a risk basis in non EU countries; the use of tamper evident packaging; strengthening of product identification at individual pack level; a ban on repackaging of medicines and auditing of the entire medicines supply chain.
Only when these are implemented will European patients be guaranteed a genuine pharmaceutical product.
- Association of International Pharmaceutical Manufacturers (AIPM) and the Coalition for Intellectual Property Rights (CIPR) 2002
- 2006 Customs Seizures of Counterfeit Goods. European Commission. 31 May 2007. http://ec.europa.eu/taxation_customs/customs/customs_controls
/counterfeit_piracy/statistics/index_en.htm
- Counterfeit Medicines – a New Update on Estimates. Position statement by the International Medical Products Anti-Counterfeiting Taskforce (WHO). November 2006.
- Counterfeiting Superhighway (EAASM) 2007 http://www.eaasm.eu/Media_centre/News/
The_Counterfeiting_Superhighway
UNDOC report on counterfeit medicines in Africa
Angie Drakulich blogged yesterday about a new report from the UN Office on Drugs and Crime (UNODC), which highlights that West Africa has “increasingly become the target of a range of counterfeit medications, including antibiotics, antiretroviral drugs and medicines to fight malaria and tuberculosis.”
The high demand for these types of drugs in West Africa and some other developing nations is the primary reason behind the significant increase in drug counterfeiting. West Africa has the highest estimated rate of malaria incidence on the African continent (98 million cases per year), according to a UNODC release. Nearly 60% of anti-infective medicines tested in Asia and Africa have been found to contain “insufficient amounts of active ingredients,” which can potentially promote the development of drug-resistant strains that can spread beyond those regions, says the release.
Because consumers have virtually no purchasing power or political voice, and counterfeit detection methods are extremely low in these regions, says the UNODC release, the environment is a counterfeiter’s dream. Revenues gained from 45 million counterfeit antimalarial medicines totaled $438 million in 2005, according to the UNODC report, and in 2010, that number is expected to rise to $75 billion.
Read the rest of this article on counterfeit medicines .
Combating Counterfeit Medicines: Tougher Penalties for Counterfeiters Under Consideration
On June 4, Rep. Steve J. Israel (D-NY) introduced the Counterfeit Enforcement Act of 2009 (H.R. 2726). This proposed legislation, which would amend the Federal Food, Drug and Cosmetic Act, increases penalties for the sale of contraband or counterfeit medicines.
If passed, this legislation brings to life many of the ideas that the Partnership for Safe Medicines advocates in the Principles for Drug Safety. In addition to increasing penalties, the bill calls for several key steps to combating counterfeit medicines, including:
• Increasing authority for the U.S. Food and Drug Administration (FDA) to issue subpoenas addressing matters that have the potential to threaten public health - including drug counterfeiting operations;
• Authorizing the FDA to require pharmaceuticals to incorporate anti-counterfeiting technologies;
• Removing the stay placed on the paper pedigree requirement originally mandated by the Prescription Drug Marketing Act of 1987 for tracking drugs through the pharmaceutical supply chain;
• Increasing criminal penalties for drug counterfeiters;
• Increasing funding for FDA inspections, examinations, and investigations of manufacturers; and
• Requiring a pharmaceutical manufacturer to alert the FDA when one of its drugs may have been counterfeited.
Read the rest of this article on counterfeit drugs on safemedicines.org.