Americans patients exposed to counterfeit and black market medication

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This was a presentation to the NADDI annual conference: St. Louis MO (Nov 20, 2013)

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  • It may seem obvious that certain medications are available illicitly on the internet, pain medications and lifestyle drugs, for example. And finding medications for recreational use can’t be so difficult because, as the NABP has determined from sampling for three years running, 97% of more than 10,000 websites analyzed were out of compliance with state and federal laws and or/NABP patient safety and pharmacy practice standards. Yet a December 2010 study by the Partnership at Drugfree.org found that 1 in 6 American obtain prescription drugs via the Internet without a valid prescription. This suggests that other medications are being purchased without doctor’s prescriptions to safeguard patient safety.
  • 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 problemsThe 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?
  • Americans patients exposed to counterfeit and black market medication

    1. 1. Fighting black market and counterfeit drugs in America Shabbir Imber Safdar Director of National Outreach Partnership for Safe Medicines www.safemedicines.org 415-683-7526 shabbir@safemedicines.org
    2. 2. PSM Members Academy of Managed Care Pharmacy AIDS Drug Assistance Program Alaska Pharmacists Association The ALS Association American Association for Homecare American College Health Association American Pharmacists Association American Society of Health System Pharmacists Arizona Pharmacy Alliance (AzPA) Association of Nurses in AIDS Care BioForward Biotechnology Industry Organization California Healthcare Institute California Pharmacists Association California Society of Health-System Pharmacists (CSHP) Colorado Biotechnology Association Community Access National Network The Council for Affordable Health Insurance European Federation of Pharmaceutical Industries and Associations (EFPIA) Generic Pharmaceutical Association Global Medicines Program Healthcare Distribution Management Association HealthCare Institute of New Jersey Healthcare Leadership Council The Hispanic Institute Illinois Pharmacists Association Institute of Health Law Studies Institute for Safe Medication Practices Interamerican College of Physicians and Surgeons North Carolina Association of Pharmacists International Anti-Counterfeiting Coalition Oklahoma Pharmacists Association International Federation of Pharmaceutical Parenteral Drug Association Manufacturers and Associations PDMA Alliance Kidney Cancer Association Pennsylvania Pharmacists Association The Latino Coalition Pennsylvania Society of Health-system The Life Raft Group Pharmacists Maryland Pharmacists Association Pharmaceutical Industry Labor Management Maine Pharmacists Association Association (PILMA) Maine Society of Health-System Pharmacists Pharmaceutical Security Institute (MSHP) Pharmacists Planning Services, Inc. Men’s Health Network PhRMA Missouri Pharmacy Association RetireSafe National Alliance for Hispanic Health Spina Bifida Association of America National Alliance On Mental Illness Texas Pharmacists Association National Association of Chain Drug Stores Texas Society of Health-System Pharmacists National Association for Uniformed Services United States Chamber of Commerce National Association of Boards of Pharmacy University of New England College of Pharmacy National Association of Drug Diversion University of Texas Pharmacy School Investigators Vietnam Veterans of America National Association of Manufacturers Virginia Pharmacists Association National Alliance of State Pharmacy Associations Vermont Pharmacists Association National Biopharmaceutical Security Council West Virginia Rx National Community Pharmacists Association WomenHeart National Grange of the Patrons of Husbandry International and Governmental Organizations National Latina Health Network World Health Organization NeedyMeds Nevada Board of Pharmacy Orange County Healthcare Agency New York State Council of Health-system Pharmacists (NYSCHP) 2
    3. 3. How Patients Are Protected • Regulated, closed, licensed, secure supply chain, covering: – Pharmacists and pharmacies – Nurses, Physicians – Wholesalers & Manufacturers • FDA testing of medications • FDA and company pharmacovigilance programs • Pharmacist and physician supervision of medication choices and interactions 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.
    4. 4. How patients are endangered from supply chain breaks • Common: patients break it – Buying online from unlicensed pharmacies • Less common: – Physicians, pharmacists, and distributors buying from unlicensed distributors • Uncommon: – Manufacturing supply chain producer
    5. 5. Patients Buy Counterfeits in Pursuit of Savings or Magical Solutions • Patients, too, break the supply chain by buying from fake online pharmacies (often claiming to be Canadian) or other unapproved avenues. • Recent examples: ● Weight loss pills ● Flu Treatments #fakedrugs #PSM2013
    6. 6. Patients Buy Counterfeits in Pursuit of Savings or Magical Solutions • These consumers don't realize that: ● Drugs they buy from Canadian online pharmacies are not from Canada's legitimate drug supply. ● Despite the assurances of drug exporters about "Tier One" countries the FDA has never designated any country from which it is universally safe to import medicine. ● If it’s not FDA-approved, you can’t be assured that the contents are safe, or what they’re supposed to be. #fakedrugs #PSM2013
    7. 7. 97% of more than 10,000 websites sampled were out of compliance with laws and pharmacy practice standards. 1 in 6 Americans buy drugs on the Internet without a prescription.
    8. 8. Patient story: Buying meds online isn’t like buying socks (where’s the cheapest price?) • Even if it’s an over-thecounter medicine, it’s still medicine. • Victims purchased overthe-counter weight loss medication from a website, "www.2daydietshopping.co m." • Purchasers reported many life-threatening side effects including stroke. • 2 people were convicted in 2011. Containing sibutramine, a prescription-only ingredient, the pills could lead to • elevated blood pressure • stroke • heart attack • anxiety • nausea • heart palpitations • a racing heart • insomnia • increases in blood pressure
    9. 9. YouTube videos and cartoons teach IUD and implant insertion and removal, despite the risk of infection and death.
    10. 10. The Problem of Misbranded Treatments ● The United States has seen a rash of cases in which medical professionals have purchased non-FDA approved medicines and other medical devices. ● Illegal distributors make a profit selling drugs from sources that aren’t trustworthy -- illegally imported, expired, stolen, damaged by bad handling. ● Doctors and pharmacist generate profit by billing insurance, Medicare and patients the full price for legitimate treatments. #fakedrugs #PSM2013
    11. 11. The Problem of Misbranded Treatments ● This problem threatens a broad range of patients who must rely on their healthcare providers for safe treatments. ● Infused, injected and inhaled drugs are particularly easy to counterfeit; the main challenge is packaging.
    12. 12. Misbranded Treatments Botox • Botox (onabotulinumtoxinA) -injected anti-wrinkle treatment, also for repetitive neck spasms and chronic migraines ● Multiple cases. One false distributor sold almost 6,000 doses of unapproved, imported Botox and Juviderm. ● FDA warnings to over 350 medical offices, including a Dallas area hospital, since 2012. #fakedrugs #PSM2013
    13. 13. Misbranded Treatments Botox • What’s the Impact? • 2.95 million Americans use Botox for a variety of reasons, both cosmetic and medical. • Since 2005, fake Botox has been found in investigations in Los Angeles, Miami, and Kentucky. • Patients have been disfigured and suffered respiratory paralysis from counterfeit Botox.
    14. 14. Counterfeit Medicines and Chronic Illness #fakedrugs #PSM2013 ● Patients are easily exploited while they are seeking better or less expensive treatments. ● Patients taking ongoing medications are at high risk because they have longer exposure to more medicines. ● Poor response to counterfeit or substandard medicines may be misdiagnosed as treatment failure.
    15. 15. Misbranded Treatments Osteoporosis Drugs • Aclasta (zoledronate) and Prolia (denosumab) -injected medicines to treat osteoporosis. ● Since September 2012, the FDA has warned 23 US medical practices that they may have purchased unapproved versions of these treatments. • What’s the Impact? ● 40 million Americans suffer from osteoporosis or are at high risk. #fakedrugs #PSM2013
    16. 16. Diverted Treatments HIV Drugs • MOMS Pharmacy, New York, 2012 ● 4 individuals allegedly resold black market HIV and AIDS medications that included drugs previously dispensed to individuals, as well as stolen and expired medications. ● MOMS Pharmacy and its parent company, Allion Healthcare sought reimbursement from Medicaid. ● The alleged scheme was a multi-state operation that netted millions of dollars. #fakedrugs #PSM2013
    17. 17. Diverted Treatments HIV Drugs • What’s the Impact? ● 1.1 million people are living with AIDS in the United States. ‣ (130,000 in New York State) ● Expired or poorly handled treatments are less effective (or ineffective). HIV/AIDS patients rely on these medicines to control their illness. Ineffective treatments lead to decline and death. #fakedrugs #PSM2013
    18. 18. Misbranded Drugs - Dialysis • American Inhalation Medication Specialists, Inc., Tennessee, May 2013 ● Tennessee pharmacist Robert Harshbarger, Jr. substituted a cheap Chinese import for the iron sucrose used to treat anemia kidney dialysis patients. ● Benefit programs paid more than $848,000 for the misbranded iron sucrose between 2004 and 2008. ● Several patients of Kansas Dialysis Services, L.C were treated with the misbranded dialysis drugs. #fakedrugs #PSM2013
    19. 19. Misbranded Drugs - Dialysis • What’s the Impact? ● At the end of 2009, more than 871,000 Americans were being treated for End Stage Renal Disease. ● Untreated (or ineffectively treated) iron deficiency anemia causes fatigue, shortness of breath, chest pain. Severe cases can cause heart problems, infections and other complications. ● Adulterated iron sucrose could cause severe illness and death. #fakedrugs #PSM2013
    20. 20. Fake Drugs - Diabetes ● 2013: FDA warned diabetics to beware of illegal “natural” remedies for the treatment of diabetes. ● Other cases around the world: ○ 2011 - Fake test strips in India ○ 2009 - Counterfeit insulin needles in the UK ○ 2006 - Counterfeit test strips in the US #fakedrugs #PSM2013
    21. 21. Fake Drugs - Diabetes • What’s the Impact? ● As of 2011, 18.8 million Americans had been diagnosed with diabetes. ● Diabetes contributes to 231,404 deaths each year. ● Ineffective treatment and poor blood sugar control cause heart disease, stroke, blindness, kidney disease, amputations, and poor immunity to other diseases. #fakedrugs #PSM2013
    22. 22. Emerging trend: black market IUDs Two physicians in Kentucky were recently indicted for purchasing IUDs bought from an unlicensed Chinese manufacturer and implanting them in patients.
    23. 23. Map graphic courtesy of the Wall Street Journal.
    24. 24. Misbranded Treatments Avastin ● McCleod Blood and Cancer Center ○ Kincaid, and his business manager purchased misbranded drugs, and administered them to patients. ○ Kincaid made at least $500,000 by seeking reimbursement through the Medicare and Medicaid/ TennCare programs as well as other health benefits programs. #fakedrugs #PSM2013
    25. 25. Misbranded Treatments Avastin • What’s the Impact? • It’s difficult to know because the drugs were administered to gravely ill patients who might have died anyway. • "People who receive a fake medication instead of Avastin could have lost several months of their lives.” – Dr. Nimesh Nagarsheth, oncologist #fakedrugs #PSM2013
    26. 26. Battleground: Maine • Prescription drug broker in Canada facilitates orders but not fulfillment. • New state law passed in 2013 allows importation of medication and prohibits board of pharmacy from any oversight. • Program has been going for over 8 eight years by the Portland Employees Union and several private Maine corporations.
    27. 27. Myths: Canadian online pharmacies are pharmacies in Canada with a website Unless you drive over the border into Canada to a bricks and mortar pharmacy, when you order from an online pharmacy you're getting a company that pretends to sell non-Canadians price-controlled medications for citizens. These companies are not regulated by Health Canada or the Provincial Pharmacy Boards.
    28. 28. Myth: Canadian pharmacists can legally fill prescriptions from US physicians • Pharmacists in Canada are not allowed to legally fill a prescription written by an American physician. • Therefore if a “Canadian pharmacy” tells an American to fax their prescription in, they’re either breaking laws in their own country, or there’s no pharmacist involved at all.
    29. 29. Myths: Canadian online pharmacies sell price-controlled medication from Canada Canadian citizen Andrew Strempler, 38, sentenced January 9th, 2013 to 4 years after pleading guilty to conspiracy to commit mail fraud. Strempler’s company, Mediplan, fulfilled online medicine orders for ten different online pharmacies. FDA discovered that 90% of the drugs they seized from a Mediplan shipment were counterfeit: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the US), Crestor, Celebrex, Arimidex, and Propecia. 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.
    30. 30. Save Money by Using FDA Approved Generics Not only can a generic be cheaper than a name brand, but a generic in the US is usually cheaper than a name brand from a fake “Canadian pharmacy”. And safer too.
    31. 31. Patient Safety: How to find discounts The NeedyMeds Drug Discount Card saves you up to 80% or more off the cost of: Prescription Medicines, Overthe-Counter Drugs, Pet Prescription Drugs The Partnership for Prescription Assistance will help you find the program that’s right for you, free of charge. Buy from a VIPPS-certified online pharmacy. Find a list at http://www.vipps.info
    32. 32. Patient Safety: How to stay safe in the doctor’s office • Signs of suspicious medication in the doctor’s office. – Look for foreign writing – Ask to see bottle/bag/unit with lot number and write it down or take a photo • Pay attention to new or unusual side effects or lack of therapeutic benefit and notify your physician/pharmacist.
    33. 33. Solving the problem • Distribute these materials to educate the public • Get informed by joining our email list for counterfeit warnings at www.safemedicines.org • Get our packet of handouts • Join the Partnership for Safe Medicines
    34. 34. Efforts of the Partnership This Year This year we have worked with partners to reach over 300,000 vulnerable American patients, nurses, doctors, and pharmacists, and nearly 1,000 at-risk clinics and doctor’s offices in six key states. Facebook ads Fact pack Patient handout 8
    35. 35. Save the Date for the 2014 Interchange September 18, 2014 Newseum Freedom Forum Knight Conference Center Washington, DC 17
    36. 36. Thank you! Please leave me your business card if you want to receive a complete packet of our printed materials after our next printing run in January 2014. We can provide large print runs of any printed product for distribution for free to any organization that joins PSM. 55
    37. 37. Customized for Tennessee Nurses Association
    38. 38. ‹#›
    39. 39. So, where do the fake pharmacies get their medications? These products are not made in a sterile environment. And then these fakes are sold to American patients from “Canadian pharmacies” who ingest them.
    40. 40. Misbranded Treatments Avastin • Kincaid and the manager conspired to hide the illegal purchases from nursing staff who recognized that the treatments were counterfeit. #fakedrugs #PSM2013

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