Counterfeit Medicine Causing Worldwide Health Disparities
Counterfeit medicine or fake medicine is a worldwide problem. These medicines are harmful to health and lives of those who use them are endangered. Several countries have high rates of these drugs however; these countries are working with their government to remove the networks which sell these drugs.
According to the World Health Organization 50% of all prescription medicines sold online by websites that hide their physical address are counterfeit. Counterfeit pharmaceuticals are a global public safety threat which is estimated to be worth $75 billion. A study conducted in the US had found 85% of websites that sold controlled substances did not require a prescription. Counterfeit drugs are also making their way into pharmacies, nursing homes, hospitals and doctors' offices. According to data collected by FDAble since 2010, almost 1,400 adverse event associated to counterfeit drugs have been reported. Counterfeit drugs can be found anywhere worldwide. Counterfeit drugs are hard to detect, investigate and quantify. The following countries have the biggest counterfeit drug problems.
China’s pharmaceutical industry is one of the largest in the world. China’s pharmaceutical industry estimates that there are 10-15% of drugs circulating are counterfeit. It is possible one of the main reasons for the market of counterfeit drugs is the high cost of essential drugs which leads people to seek out less costly alternatives. Medicine-monitoring -regulations keep medications in China unaffordable.
The AIDS epidemic is severe in some areas and certain groups in China. At the end of 2014, there were 501,000 reported cases of people living with AIDS/HIV. The summer of 2003, pharmaceutical companies found alarming numbers of AIDS counterfeiting medications. Serostim prescribed for wasting due to AIDs was sold as counterfeit by Serono Pharmaceutical Company. Johnson & Johnson was another company that reported counterfeit vials of Procrit used in the treatment for anemia associated to chemotherapy. These were just some that were reported in a period of four weeks. Viagra Is the most counterfeit drug in China. Just only in four weeks of 2002, over one million counterfeit tablets were seized. (http://blog.hawaii.edu/aplpj/files/2011/11/APLPJ_05.1_wong.pdf)
In August 2012, The Partnership For Safe Medications Executive Director Scott LaGanga met with the Chinese government and business authorities. At that time $180 million worth of counterfeit medications had been seized. In 2012, the government mobilized over 18,000 officers to break up drug counterfeiting rings and they had seized around $182 million in fake drugs that included drugs to treat cancer, diabetes and hypertension. In the same year 200 people were arrested for manufacturing fake drugs.
The pharmaceutical industry in India ranks 4th in the world related to production volumes and 55% exports. As of the end of March 2012, drug exports totaled $14.6 billion. A report by Rama Lakshmi s suggested an estimated 12 to 25 percent of all drugs sold in India are counterfeit. India’s health ministry estimates five percent of drugs are counterfeit. Fake drugs which were confined to exotic and costly pills like Viagra have now increased to cough syrups, vitamins, supplements and painkillers. When it comes to generic drugs India is now is the focal point for counterfeit drugs. Most of the fake drugs have been in Bihar, West Bengal, Uttar Pradesh and Gujara. Counterfeit drugs in India are due to various reasons such as growing pharmaceutical industry, poor pharmaceutical regulations, high drugs prices, added value tax, and prescriptions for drugs without registration. (https://www.ripublication.com/ijmibs-spl/ijmibsv4n2spl_04.pdf)
According to a report by International Policy Network had found some drugs contained no active ingredients with others containing chalk or talcum powder which mixed with a pain reliever. Commonly used drugs like Pantocid used for acidity and gastro problems, Dopamine and antidepressant, Enalapril to treat blood pressure and Oflomac 400 and antibiotic are some of the drugs that are counterfeited.
In 2009, the ministry also strengthened its drug law to speed up court trials. Suspects found guilty of manufacturing and selling fake drugs can be sentenced to life in prison. Technology is now being used to detect fake medications. The Ministry of Health approved 2D barcodes and scratch off labels on medicines. The person using the drug simply scratches off the label and text. They call the toll free number to find out if the medicine is legitimate. The India government launched a reward program offering $55,000 to those who provide information about syndicates dealing in fake drugs. In 2013, the Health Ministry strengthened its drugs laws and speeded up drug trials. If a person or persons are found guilty of selling or manufacturing fake drugs they face life in prison.
In 2004, WHO estimated that 30 to 40 percent of drugs consumed in Pakistan were counterfeit that included those to treat the flu to cancer. Pakistani public uses almost 77 per cent of their health budget on the purchase of medicines.
In 2009, Medsafe, a medications safety authority had reported 65 websites running out of Pakistan were selling fraudulent herbal products. In 2008, the Federal Investigation Agency had reported USD 191,000 worth of counterfeit copies of lifesaving drugs in Karachi. In 2008, the Director of the Federal Investigation Agency had reported that 15 raids had seized five truckloads of medicines that were worth USDA 745,800. In 2009, the agency seized more counterfeit and unregistered drugs in 13 separate raids.
The Supreme Court has cited the government to demand warranties to accompany drugs to the supply chain from the manufacturers to retailers with the retailers being held legally responsible for products without a warranty. In 2006, a Supreme Court ruling Under the Drug Act 1976 the maximum sentence for counterfeiting is 10 years imprisonment and fine. (https://www.aei.org/wpcontent/uploads/2012/02/-appendix-a-master-2_170026856632.pdf)
The United States is not an exception when it comes to counterfeit drugs. However, the counterfeit drugs seem to be related to lifestyle such as diet and ED drugs. According to WHO it was estimated that 200,000 people die due to ineffective, fake and substandard malaria drugs.
In 2012, counterfeit maker of Avastin a cancer drug to into the US supply chain. Teva Pharmaceutical’s Adderall 30 mg tablets had a counterfeit version entering the market in 2012. The same year saw counterfeit fentanyl contributed to a spike in overdose deaths. The counterfeit pills often closely resembled the authentic medication that had been designed to mimic fentanyl and could only be detected by laboratory analysis. (https://www.dea.gov/docs/Counterfeit%20Prescription%20Pills.pdf) In 2012, the FDA warned healthcare professionals and consumers about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. Adderall is approved for ADHD and narcolepsy. The FDA preliminary tests revealed the counterfeit version contained the wrong active ingredients. (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm305932.htm)
In 2010 a generic version of Tamiflu was being sold on the internet which was a fraudulent version that but did not contain the active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin. This product was dangerous for those allergic to penicillin.
The US government has laws against counterfeit drugs but enforcement of these laws are spread out among several agencies which include the FBI, DEA, FDA and ICE. Marya Lieberman, a chemist at the University of Notre Dame developed a simple card that tests to see if a drug contains the correct active ingredients. To test the user scrapes the pill across the card and dips the card into water. The water travels up the card mixing the chemicals with the drug and colored code bar and shows if the correct active ingredients are present.
Interpol and WHO both reported fake pharmaceuticals in Africa are between 30 and 60 percent. It is understood that many substandard and fake pharmaceuticals make their way to Africa from countries such as China and India. A 2009 reveled over 45 million antimalarial drugs valued at over $438 million were shipped from India and China to West Africa.
In 2009 in Nigeria it was reported that 84 children died as a result from toxic chemicals that were laced with teething medications for babies. Angolan custom agents in 2012 busted counterfeiters which became one of the largest medicine imports in history. Containers shipped from China and Luanda were filled with over 1.4 million packets of fake malaria drug Coartem. WHO estimates about 100,000 deaths per year in Africa is associated to fake pharmaceuticals. A study conducted by Health action international and WHO noted 30 to 80 percent markups of retail prices in licensed and reputable vendors. Patients who need medications unavoidably don’t buy medications from licensed and regulated vendors due to poverty.
The US Pharmacopeial Convention and the Center for Pharmaceutical Advancement and Training (CePAT) this month have opened a brand new lab to train pharmaceutical and regulatory professionals in microbiology testing. This will allow pharmaceutical professionals to learn how to detect medicines contaminated by microorganisms, and will be able to keep more people in their community safe from poor quality medicines arising from contaminated products. (http://www.scidev.net/sub-saharan-africa/medicine/opinion/fighting-counterfeit-drugs-africa-medicine.html) In 2015, 29 pharmaceutical companies globally provided funding to Interpol to fight drug counterfeiting. Technology is also being used in the fight. Companies such as mPedigree and Sproxil have a scratch off on a encrypted label on the drugs packages. Consumers scratch off the label and text the encrypted code to the manufacturer to verify the drug’s authenticity for free.
Alliance for Safe Online Pharmacies
AARP Eaton, J. (2016, May). Counterfeit drugs flooding pharmacies, hospitals
FDA Counterfeit Drugs
Daily Mail UK Pandey, M. (2014, June 11). India in the grip of fake drugs, RTI inquiry shows
The Pharm Letter, T. P. (2011, October ). India takes action on spurious and sub-standard drugs
Law Street, McLaughlin, J. (2015, May 8). The United States Isn’t immune to counterfeit drugs.