Counterfeit drugs and the threat to Mississippi patients
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The document discusses the risks associated with counterfeit medications and highlights the security of the regulated U.S. drug supply chain. It outlines unique challenges for Mississippi's disability community regarding prescription drug access under Medicaid. The text also emphasizes the importance of patient safety, educating individuals on the dangers of purchasing medications online, and provides resources for safe prescription savings.
Counterfeit drugs and the threat to Mississippi patients
- 1. COUNTERFEIT MEDICATION AND THE THREAT TO MISSISSIPPI PATIENTS
- 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. 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
- 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. 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.
- 7. 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.
- 8. UNIQUE THREATS TO THE MISSISSIPPI DISABILITY COMMUNITY AND THEIR FAMILIES
- 9. Unique challenges to our community • Medicaid & Medicaid Disable Child at Home Program provide access to Medicaid coverage for children with disabilities, but limit prescription drug coverage to 2 name brand and 3 generic drugs per month. • Individuals with disabilities and Seniors who are Medicaid beneficiaries and transitioning to the community out of care facilities have a limit of 5 prescription drugs where they had unlimited in the facility.
- 10. Children with seizure disorders • In most cases a generic is an easy swap with no therapeutic difference, but we see problems in this area. • Parents have reported generic antiseizure medications do not always work for the child and, in fact can make the condition and side affects worse. • This can also be true of Psychotropic Medications.
- 11. 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.
- 12. Our community needs information • Patients and their caregivers don’t know the risks or that even safe options exist. • Many seniors aren’t computer-savvy, and require assistance to take advantage of some of these programs.
- 13. THE PROBLEM BEYOND MISSISSIPPI
- 14. 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.
- 15. 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.2daydietsh opping.com." • 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
- 16. 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.
- 17. YouTube videos and cartoons teach IUD and implant insertion and removal, despite the risk of infection and death.
- 18. 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.
- 19. 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.
- 20. 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.
- 21. Map graphic courtesy of the Wall Street Journal.
- 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. 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.
- 24. 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.
Editor's Notes
- #15: 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.
- #18: 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.
- #22: 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?