Counterfeit drugs presentation to Pharmacy-3 students in South Dakota

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This presentation covered the current threats of counterfeit drugs to Americans.

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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.
  • 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?
  • 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.
  • Counterfeit drugs presentation to Pharmacy-3 students in South Dakota

    1. 1. BROKEN PROMISES: COUNTERFEIT MEDICATION AND AMERICAN PATIENTS Shabbir J. Imber Safdar, Director of National Outreach
    2. 2. 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.
    3. 3. How patients are endangered from supply chain breaks • Common: patients break it – Buying online from unlicensed pharmacies • Uncommon: – Physicians, pharmacists, and distributors buying from unlicensed distributors – Manufacturing supply chain producer
    4. 4. 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.
    5. 5. 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.
    6. 6. 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.
    7. 7. 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.
    8. 8. Patient story: Buying meds online isn’t like buying socks (where’s the cheapest price?) • Even if it’s an over-the- counter medicine, it’s still medicine. • Victims purchased over- the-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. Patient story: Lorna Lambden Even getting real medication can be deadly She bought medication online without a prescription and without a pharmacist to inform her. Said her family: “Lorna died after taking a small amount of medication which she had purchased on the internet to help with tiredness and sleeping. This medication turned out to be exceptionally dangerous. The Coroner thought Lorna’s death was a tragic accident. Please can this be a warning to anyone purchasing prescription drugs on the internet!” Lorna Lambden, 27, ordered from an online pharmacy ended up receiving a very powerful sleeping aid without any safety instructions.
    10. 10. 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.
    11. 11. Map graphic courtesy of the Wall Street Journal.
    12. 12. Doctors have been found with misbranded drugs 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.
    13. 13. YouTube videos and cartoons teach IUD and implant insertion and removal, despite the risk of infection and death.
    14. 14. First occurrence: fake devices Two physicians in Kentucky were recently indicted for purchasing IUDs bought from an unlicensed Chinese manufacturer and implanting them in patients.
    15. 15. 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, of the Kansas City Regional Office of Investigations for the Department of Health and Human Services 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.”
    16. 16. Physician: Johnson City, TN An oncologist and his office manager conspired to buy oncology injectables from an unlicensed wholesaler and deliver them to patients. When caught by the head nurse spotting foreign writing on the vials, they ceased their activity for 18 months until she left the practice. When they restarted they rented a storage unit as a temporary holding facility and smuggled the fake medication into the office at night. A second physician in Tennessee is under indictment. Other physicians have plead guilty in Maryland and Missouri. The three main doctors with the McLeod Cancer and Blood Center have since worked out a restitution settlement with the U.S. government and State of Tennessee for a combined $4.4 million. Dr. Kincaid will also serve two years in prison.
    17. 17. Pharmacist: Ontario, Canada A pharmacist in Hamilton, Ontario was arrested in 2005 after 11 people died after being prescribed Norvasc, a heart medication. The pharmacist filled their prescription with pills made only of talcum powder. The coroner cited “unauthorized medication substitution” in four of the deaths. At trial it was discovered that he bought medications from a distributor who walked in off the street and drove a white van. Several customers pointed out differences between the medication from this wholesaler and previous doses acquired from reputable wholesalers. The pharmacist was acquitted by a court in 2007 because prosecutors failed to prove criminal intent. He sued to get his pharmacy license back. According to LinkedIn, he is the owner/operator of a pharmacy today in Toronto.
    18. 18. 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.
    19. 19. Patient Safety: Comparison shop the VIPPS pharmacies online VIPPS = Internet pharmacy that complies with state licensing. Look for the seal, and find the list at http://vipps.info
    20. 20. Myths: Canadian medicines are cheaper • Generics are often cheaper in the US • Not all Canadian medication is price- controlled
    21. 21. Patient Safety: How to find discounts The NeedyMeds Drug Discount Card saves you up to 80% or more off the cost of: Prescription Medicines Over-the-Counter Drugs Pet Prescription Drugs The Partnership for Prescription Assistance will help you find the program that’s right for you, free of charge.
    22. 22. 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.
    23. 23. Healthcare provider education
    24. 24. Clinic poster for patients
    25. 25. Partnering locally – co-branded handouts
    26. 26. Digital outreach to patients Over a 30 day period, this advertising ran and was exposed to 140,000 people in communities in Virginia where our partner has free health clinics.
    27. 27. Distribute our resources to 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) • We can also design a custom patient safety handout for your community.
    28. 28. 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

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