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Counterfeit drugs 101 for Healthcare Providers

Counterfeit drugs 101 for Healthcare Providers



Healthcare providers are increasingly breaking the secure supply chain and endangering patients. Learn about counterfeit drugs and most recent incidents involving providers. ...

Healthcare providers are increasingly breaking the secure supply chain and endangering patients. Learn about counterfeit drugs and most recent incidents involving providers.

Also learn about how you can be a part of the solution by working with the Partnership for Safe Medicines.



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  • Annual incident total moved in a narrow range… The largest annual increase involved +169 incidents and the largest (and only decrease) was -68 incidents. This likely reflects the fact that the number of PSI members who report incident data has remained relatively stable over the same period of time. And, while the Institute recognizes that there has been a greater law enforcement effort and improved public awareness, public sector reporting of incidents continues to be inconsistent. There is no international body which has established reporting requirements or standards to date.
  • illegal diversions 2011 was 325
  • Asia 1073 (2010) fell to 954 LatA 348 (2010) rose to 381 Europe 327 (2010) rose to 351 Eurasia 255 (2010) rose to 257 NAmer 201 (2010) rose to 237
  • Asia 1073 (2010) fell to 954 LatA 348 (2010) rose to 381 Europe 327 (2010) rose to 351 Eurasia 255 (2010) rose to 257 NAmer 201 (2010) rose to 237
  • And it’s not just websites selling medications without prescriptions that promote harm. Social media sites such as Facebook, and instructional websites like YouTube are being used effectively to subvert the safety protocols of medicine. Every type of contraception is available online, including implants and IUDS complete with YouTube videos that demonstration self-implantation and insertion, despite the risk of infection and death.   The health impact from a teenager purchasing and self-inserting a fake IUD is not just detrimental to the child’s health. It is symptomatic of a world-wide problem that causes the development of medicine-immune diseases and the death of many children. Fake medication given anywhere impacts health of everyone worldwide – It’s an issue that hurts everyone, especially women and children.
  • Cross-border jurisdiction problems The US case of the counterfeit cancer medications found in doctor’s clinics is a great example of how medication can move from country to country, with no authentication between sources. While the medication that ended up doctors’ offices from California to Illinois came from unauthorized distributors in the US, those people in turn purchased the medication from other unauthorized distributors from overseas where the medication wasn’t required to be inspected because it was “for export only.” Back from the UK, to Denmark, to Switzerland, to Egypt, the original signatory for the medication came froman illiterate supplier who signed his name with an “X” before traveling across three countries and through six countries. What jurisdiction did this crime occur in? Are the countries that passed the medication “for export only” through responsible? How do we protect patient safety when it’s so easy to pass the hot potato on to another party in another country?

Counterfeit drugs 101 for Healthcare Providers Counterfeit drugs 101 for Healthcare Providers Presentation Transcript

  • COUNTERFEIT DRUGS 101 FOR HEALTHCARE PROFESSIONALS Tom Kubic, President and CEO of the Pharmaceutical Security Institute and Treasurer of the Partnership for Safe Medicines Shabbir Imber Safdar, Director, National Outreach Partnership for Safe Medicines
  • How American Patients Are Protected • Regulated, closed, secure supply chain, covering: – Pharmacists and pharmacies – Nurses, Physicians – Wholesalers & Manufacturers • FDA testing of medications • FDA and company pharmacovigilance programs • Physician/Pharmacist supervision of medication choices and protocol Any break in the hand to hand regulatory chain endangers patients. America is one of the few countries with a closed, secure, drug supply chain.
  • How patients are endangered from supply chain breaks? • Common: patients break it – Buying online from a non-VIPPS pharmacy – Buying from an offline non-pharmacy (in the US or outside) • Less common (but getting more common): – Physicians, pharmacists, and distributors buying from unlicensed distributors • Uncommon: – Manufacturing supply chain producer
  • How often are medicines counterfeited? Where do they come from? What’s counterfeited?
  • 2012 Situation Report Industry’s assessment of worldwide pharmaceutical crime
  • How Often? • 7,844 incidents – 2012 • 5,242 incidents – 2011 • 49.6% increase in reported incidents • 2,504 reports, studies, summaries reviewed
  • Incident Trends • 2,018 unique incidents* – 1.6% increase • 1,664 counterfeiting incidents – 2.2% increase • 327 illegal diversion incidents – virtually even • 27 major theft incidents – v. 33 in 2011 *Unique incidents are less than reported incidents as PSI staff link related incidents as part of their analytical reviews.
  • Where do fake medicines come from? 123 Countries with identified incidents: 218 Illegal manufacturing operations since 2009 These products are not made in a sterile environment. Sold to American patients from “Canadian pharmacies”
  • Incidents by Region
  • Incidents by Country
  • What’s being counterfeited? 523 different drugs 53 different drugs in one case Genito-urinary, anti-infectives, CNS Tablets/Cap. 86%; Injectables 10% Increase TC - Hormones
  • YouTube videos and cartoons teach IUD and implant insertion and removal, despite the risk of infection and death.
  • Patient story: Fake IUDs in Kentucky 3/2013, a Kentucky OB-GYN was charged with buying counterfeit non-FDA-approved birth control devices from an unregulated foreign supplier over the Internet. • The indictment claims that for over a year he billed insurance for the cost of genuine devices. • If convicted, Canh Jeff Vo faces fines of as much as $3 million and a maximum sentence of 233 years in prison.
  • Physicians and their staff are the new weak link in the supply chain In the past year alone… •Cancer drugs – 134 doctors in 28 states •Osteoporosis – 20 doctors in 10 states •Botox – 350 doctors in 38 states Fragile biologics that require in-clinic use and careful storage are becoming new targets for counterfeiters. The clear liquid could be medication, or it could be saline.
  • Myths: Canadian online pharmacies sell price-controlled medication from Canada 1/9/2013 Canadian Andrew Strempler, sentenced to 4 years after pleading guilty to conspiracy to commit mail fraud. •He used ten different online pharmacies to fill orders. •FDA discovered that 90% of the drugs they seized from a Mediplan shipment were counterfeit •These were not Canadian medicines, they were fakes from all over the world, mailed from the Bahamas, with labels saying they were filled from Canada.
  • Map graphic courtesy of the Wall Street Journal.
  • Oncologists paying steep prices for their mistakes • Dr. Wm Kincaid (TN): 2 years prison, $2.55M civil claims. His fellow oncologists fined $850k each. Office manager Mr. Combs plead guilty. • Dr. Abid Nisar (MO): Forfeited $1m for false Medicare/Medicaid claims - two years probation. Seven year ban from gov’t programs for 7 years. • FDA warned over 100 physicians that they may have done business with unlicensed suppliers and broken the law.
  • Myth: You or your doctor can bill insurance back for imported drugs The government prosecutes people and physicians who commit fraud by billing government health programs for misbranded drugs. One doctor paid $1 million in fines. As Gerald T. Roy, Kansas City Regional OI, DHHS stated last year, “These investigations and their outcomes not only protect the taxpayer from waste, fraud and abuse but, more importantly, insure our Beneficiaries are not provided misbranded or adulterated drugs that may adversely impact their health. We will continue to aggressively pursue those who seek to defraud the Medicare and Medicaid programs by administering non- FDA approved products and services.”
  • And even pharmacists… Michael Markiewicz, a Chicago pharmacist bought counterfeit medication from China and filled prescriptions with them. 2013 - he was charged with eight counts of violating the federal Food, Drug and Cosmetic Act, four counts of trafficking in counterfeit drugs, and three counts of smuggling. Medications ordered online and declared as “gift pens” Trafficking c/f drugs carries a maximum penalty of 20 years and a $2 M fine.
  • Nurses play a role in patient safety • In Dr. Kincaid’s case, the first introduction of illegally acquired medication was spotted by the leader of the nursing team who ensured the practice was stopped. • After she left the cancer center 18 months later for another job, the practice of illegally acquiring and administering non-FDA appoved medication resumed. Dr. William Kincaid at the courthouse in December 2012
  • Doctors giving dangerous advice Ali Baney a Colorado resident in 2009 whose doctor told her to go online to buy medication to save money. She received a counterfeit and suffered life-threatening side effects. Rachael Jablo, a San Francisco resident, provided PSM an affidavit that her doctor at the University of California – San Francisco suggested she go to an online “Canadian pharmacy” to save money on an antibiotic that costs $1,000 for a two week cycle. The online pharmacy is a Canadian business, but not a pharmacy, and ships it medications from countries such as Turkey and Singapore. Of course, they could come from anywhere. Libby Baney telling her sister’s story at the PSM annual conference in 2011.
  • Addressing the problem • Educating all healthcare professionals (nurses, doctors, pharmacists, support staff) on two issues: – Legal and best practices for medication sourcing; – Legal and financial consequences for receiving, administering, or claiming reimbursements for misbranded medication • Additionally, providing some basic patient-level education to healthcare professionals on how to safely save money
  • How PSM can partner with you to educate healthcare professionals With co-branded handouts, articles for your newsletter, infographics, and videos, PSM can help educate your audience and protect their patients. Slides from a recent PSM patient safety training webinar
  • Infographics and postcards customized for your community Men’s Health Network is a very active member of PSM. Our deep commitment to working with each other resulted in this infographic which is also being used as a large format postcard.
  • A safety tips campaign in a box • PSM has created 26 safety tips for healthcare professionals that can be adapted for Twitter, Facebook, Email, Websites, or Print. • All illustrations are in black and white. • Entire collection of tips is licensed through Creative Commons Tip #12: Tell your patients that while we think of Canada as a safe, modern country, an online pharmacy that has a Canadian flag on its home page does not mean it is located in Canada. Find out where that online pharmacy is really located before buying anything from them.
  • Custom educational materials This is part of a custom handout for a non-profit in Virginia that works with volunteer pharmacists to connect patient with low-cost medication. It was designed specifically with Virginia residents in mind, and discusses specific programs available to them.
  • Resources for your community • Save Money Safely on Your Prescriptions from Online Pharmacies (brochure) • Learn 5 Kinds of Poisons Found in Counterfeit Medicines (interactive) • The 5 Secrets Canadian Web Pharmacies Don’t Want You to Know (webpage) • SAFEDDRUG: An 8 Step Checklist for Medicine Safety (brochure) • Safe Savings: Tips for Saving Money on Medicine Safely (brochure)
  • Articles written for your newsletter • We’ve helped to get the word out… – Malpractice insurance carrier The Doctor Company – Parenteral Drug Association • We’d be happy to write one for you! – PSM has written articles about drug safety that specifically speak to that audience and their needs.
  • Questions and Answers Our members conduct joint education projects with us to improve patient safety in their communities. Our members include groups that represent patients, pharmacists, physicians, nurses, distributors and manufacturers. To start educating your community, contact: Shabbir Imber Safdar Director, National Outreach shabbir@safemedicines.org 415-683-7526