Counterfeit Medicine In America 2019 January 2019 New Mexico
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The Partnership for Safe Medicines Americans are largely unaware of this threat. PSM awareness tools: □ Comprehensive reporting on counterfeit incidents online □ Explaining the risks in a variety of mediums □ Telling the stories of people who have been hurt by fake medicine 3
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The United States has the safest drug supply in the world… …but as many as 19 million Americans buy medicines outside that supply chain, from foreign online pharmacies or other unlicensed sources. 5
The first wave of counterfeit medicines 6
The first wave of counterfeit medicines: late 1990s-present "Basically, all my competition started selling drugs they were sourcing overseas from, in my opinion, unsafe countries and marketing them as Canadian. I couldn't compete with that," he said. (CBC 6/20/2017) Canada’s drug supply would be drained in 201 days, should just 20% of U.S. prescriptions shift to dispensing out of Canada. (Shepherd, Health Econ Outcome Res Open Daren Jorgensen opened one Access 2018, 4:1) of the first Canadian Internet fake pharmacies in 2001, and exited in 2008. 7
Illinois’ Experience With ISaveRX, 2003–2009 A “white listed” online pharmacy program of 28 online drug sellers dispensing from Canada, the United Kingdom, Australia, and New Zealand to IL, WI, KS, MO, and VT. Select IG findings • Operating in violation of federal law with unapproved federal funds. • Dispensing entities in the program in violation of IL pharmacy practice law. • 40% of the inspections records (32 of 80) were not completed. • State did not monitor that only approved pharmacies participated. • Significant labor costs of $488,000 for 26 employees (19 months). • High expenses, incl. $111,000 for international travel and over $350,000 for contract management, marketing, and legal services. • Uptake of the program was small and it was eventually cancelled. 8
Minnesota RXConnect 2004-2010 An online pharmacy regulation program started by Gov. Tim Pawlenty. After launch, the FDA cited a number of patient safety issues, including several found during a pre-announced visit by Minnesota’s own inspectors: • Pharmacy techs, not pharmacists, entering prescriptions. • Having pharmacists check 100 prescriptions / hour or refill 300 prescriptions / hour. • Cold-chain drugs shipped not refrigerated / no historic thermometers in refrigerators. • Allowing pharmacy techs instead of pharmacists contact U.S. medical providers • Allowing faxed prescriptions. • Failed to meet minimum lighting standards as set by MN pharmacy law. • Uptake of the program was small and it was eventually cancelled. 9
Maine’s passage of LD 171 in 2013 In 2013 Maine passed a law facilitating foreign mail order pharmacies from Canada, the UK, Northern Ireland, Australia, and New Zealand. Dr. McCall ordered three medications from Canada Drug Center, operated by Quantum Solutions. They all arrived from other countries not on the approved list, and lab testing showed them to have insufficient API. The Maine Board of Pharmacy asked the Kenneth L McCall AG to shut them down. The AG was powerless. BSPharm, Pharm.D., BCGP, RPh, FAPhA Associate Professor and Director The law was overturned in Federal Court in 2015. of Residency Programs & Professional Affairs In 2018, the FDA’s Office of Criminal Investigation arrested the University of New England operators of Quantum Solutions and sentenced them to three years probation and fines and forfeiture of over $4,000,000. 10
Since 2012, smugglers caught selling fake drugs sold up to 63 medications to over 3,000 doctors, clinics and hospitals across the U.S. 11
Select medical clinics that received FDA warnings letters 12
New Mexico: Medical clinics that received FDA warnings letters and counterfeit victims These are two of the ten clinics in New Mexico warned by the US FDA to stop buying from wholesalers in Canada such as TC Medical. 13
The second wave of counterfeit medicines In 2012, the FDA discovered 2 lots of an imported counterfeit cancer drug (Avastin) with no active ingredient . The agency launched a massive recall and a lengthy investigation. 14
The second wave of counterfeit medicines Late stage lung cancer Betty Hunter was treated with counterfeit Avastin in 2011. Ms. Hunter died three months later. Source: Medicin der Dræber Source: FDA 15
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Difficult prosecutions Prosecuting foreign nationals for selling counterfeit drugs is hard, which makes a poor deterrent. 2014: DOJ indicted 5 CanadaDrugs.com executives for selling $78 million of fake cancer drugs 2017: Canada set extradition hearing for May 2018. 2018: Plea approved - no jail time ($34mm penalty) 2018: CanadaDrugs.com shut down, but license was transferred 18
The criminals - Where are they now? Terms of plea deal ● Six months house arrest and four and a half years of probation; ● a $250,100 fine; and ● Turn over records and cooperation. The plea agreement does not require him to: ● serve any jail time; ● surrender his pharmacy license; ● enter a guilty plea of selling counterfeit drugs. He is not prohibited from holding any kind of pharmacy license or starting a new CanadaDrugs.com sold off most of the rest of their pharmacy business to export to America. inventory to Americans for many more months while “shutting down” 19
Complete overview of wholesale criminal operations in America 2007-2018 Across all therapeutic areas, the FDA has traced criminal wholesaler drug importation businesses to at least 3,000 medical practices across the United States. Importation is not safe, even at a wholesale level. Only licensed U.S. wholesalers selling FDA-approved medicines are safe for American patients. https://www.safemedicines.org/2018/08/imported-black-market-cancer-meds.html 20
Fentanyl-laced counterfeits First reports of counterfeit Xanax and fake opioids laced with fentanyl and analogues in late 2015. 21
Fatal dose comparison Photo originally created by New Hampshire Public Radio photographer Paige Sutherland 22
Fentanyl-laced counterfeits Counterfeit Oxycodone Source: Public Health Seattle & King County Counterfeit Xanax Source: Yakima Police Department Counterfeit Percocet Source: Georgia Bureau of Investigations 23
Fentanyl-laced counterfeits Source data current as of January 2019 24
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Tosh Ackerman of Aptos, CA The evening of October 27, 2015, 29-year-old Aptos, California resident Tosh Ackerman took a benadryl and part of a Xanax pill to help him sleep. He never woke up, and his girlfriend found him dead the next day. Investigation showed that Ackerman’s Xanax was counterfeit. It contained a fatal dose of fentanyl. Carrie is an active speaker to schools and the media. You can reach her at ToshsStory@gmail.com 27
Fentanyl is driving overdose deaths Data source 1999-2017: CDC 28 searchable database CDC Wonder.
How does fentanyl get here? Source: Twitter 29
Die molds are readily available for any kind of pill 30
Fentanyl trade attracts organized crime 31
Fentanyl implications - officer exposure 32
How do we address this problem? There are steps we can take to make the drug supply safer including resources for law enforcement, consumer education, and regulatory enhancement. AND There are steps we can avoid taking that would make the drug supply more dangerous. 33
What can we do? We teach consumers that licensed pharmacies and pharmacists are the only safe sources of medication. Friends and relatives, even ones you trust, are not as safe as a licensed pharmacist. 34
What can we do? Teach consumers how to save money safely so they don’t buy off the black market. 47 of the 50 most frequently prescribed medications in the U.S. are available in cheaper generic form. Americans pay less for most commonly prescribed generic medications than Canadians do. 35
What can we do? Even a very established generic, atorvastatin, has wild price differences around Albuquerque. We always tell consumers to consolidate their prescriptions at a single pharmacy when recommending they shop around. Patients should have a single dispensing pharmacist, preferably a community pharmacist who knows the patient well. 36
What can we do? Support the FDA’s desired generic staffing levels through advocacy FDA staffing is funded through a combination of user fees on generic drug makers and Congressional appropriations. When the FDA approves generics, especially multiple ones, prices go down and the market for counterfeits evaporates. 37
Make your voice heard - Successes INTERDICT Act STOP Act Prohibition of New resources for CBP Electronic data Gag clauses to detect Fentanyl for mail packages Passed Passed Passed Re-affirmation of Drug Importation Prohibition 38
Opposition by FDA commissioners 39
Opposition by healthcare professionals 40
State Boards of Pharmacy oppose importation 41
Law enforcement opposition 42
Law enforcement opposition 43
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