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.
Add to this the direct-to-consumer marketing that can be done easily, and often for free, on social media sites like Facebook and Twitter, as well as through basic spambots, and we have an international syndicate of medicine counterfeiters out to gyp every American looking to save a dollar out of their health as well as their wallet.
The FDA warned patients that both counterfeit Adderall and counterfeit Vicodin had been found on the internet. But medications contained active ingredients, of other medicines, that could have seriously harmed patients. The Adderall contained Tramadol and acetaminophen instead, both pain relievers, instead of the psychostimulant medication expected. The fake Vicodin contained NSAIDs instead.These two FDA warnings are just a sample of the variety of fake medications sold online . This year alone, in the US there were 5 separate prosecutions of fake medications sold via fake online pharmacies, one alone which conspired “to commit $95 million worth of mail fraud” by selling unapproved medication to Americans
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?
Patient advocate townhall: keeping patients safe from counterfeit drugs
BUYING MEDICATIONS ONLINE: HOWTO DO IT SAFELY AND AFFORDABLYShabbir Imber Safdar, Director, National OutreachPartnership 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 andprotocolAny break in the hand to hand regulatory chainendangers patients. America is one of the fewcountries with a closed, secure, drug supply chain.
How patients are endangered fromsupply chain breaks• Common: patients break it– Buying online from a non-VIPPS pharmacy– Buying from an offline non-pharmacy (in the US oroutside)• Less common:– Physicians, pharmacists, and distributors buyingfrom unlicensed distributors• Uncommon:– Manufacturing supply chain producer
97% of morethan 10,000websitessampled wereout ofcompliancewith laws andpharmacypracticestandards.1 in 6Americans buydrugs on theInternetwithout aprescription.
Patient story: Buying meds online isn’tlike buying socks(where’s the cheapest price?)• Even if it’s an over-the-counter medicine, it’s stillmedicine.• Victims purchased over-the-counter weight lossmedication from a website,"www.2daydietshopping.com."• Purchasers reported manylife-threatening side effectsincluding stroke.• 2 people were convicted in2011.Containing sibutramine, aprescription-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
So, where do the fake pharmacies gettheir medications?These products are not made in a sterile environment. And then these fakes are soldto American patients from “Canadian pharmacies” who ingest them.
5 separateprosecutions of fakemedications sold viafake online pharmaciesin 2012Fake Adderall containedTramadol and acetominophenFake Vicodin contained NSAIDsOne case aloneestimated $95 millionin fraud sellingunapproveddrugs to AmericansWhat ELSE are we getting?
YouTube videos andcartoons teach IUDand implantinsertion andremoval,despite the risk ofinfection and death.
Patient story: Lorna LambdenEven getting real medication can be deadlyShe bought medication online without aprescription and without a pharmacist toinform her.Said her family: “Lorna died after taking asmall amount of medication which she hadpurchased on the internet to help withtiredness and sleeping. This medicationturned out to be exceptionally dangerous.The Coroner thought Lorna’s death was atragic accident. Please can this be a warningto anyone purchasing prescription drugs onthe internet!”Lorna Lambden, 27, ordered froman online pharmacy ended upreceiving a very powerful sleepingaid without any safety instructions.
Doctors have been found withmisbranded drugsIn the past year alone…• Cancer drugs – 134 doctors in28 states• Osteoporosis – 20 doctors in 10states• Botox – 350 doctors in 38 statesFragile biologics that requirein-clinic use and careful storage arebecoming new targets forcounterfeiters.The clear liquid could bemedication, or it could be saline.
Map graphic courtesy of the Wall Street Journal.
Patient story: Ontario, CanadaA pharmacist in Hamilton, Ontario wasarrested in 2005 after 11 people died afterbeing prescribed Norvasc, a heartmedication. The pharmacist filled theirprescription with pills made only of talcumpowder.The coroner cited “unauthorized medicationsubstitution” in four of the deaths.At trial it was discovered that he boughtmedications from a distributor who walkedin off the street and drove a white van.Several customers pointed out differencesbetween the medication from thiswholesaler and previous doses acquiredfrom reputable wholesalers.The pharmacist was acquitted by a courtin 2007 because prosecutors failed toprove criminal intent. He sued to get hispharmacy license back.According to LinkedIn, he is theowner/operator of a pharmacy today inToronto.
UK pharmacy with fakes• In Wales, four people were sentenced fordistributing counterfeit drugs, manufactured inPakistan, all over Europe. (April 2013)• 70,000 packs of counterfeit life-saving drugs in UKpharmacies – cancer, stroke, schizophrenia(June 2007)• The fifth most likely country in which you will findcounterfeit drugs is the UK. (April 2013 UnitedNations Office on Drugs and Crime report)
Myths: Canadian online pharmacies arepharmacies in Canada with a websiteUnless you drive over the border into Canada toa bricks and mortar pharmacy, when you orderfrom an online pharmacy youre getting acompany that pretends to sell non-Canadiansprice-controlled medications for citizens.These companies are not regulated by HealthCanada or the Provincial Pharmacy Boards.
Myths: Canadian online pharmacies sellprice-controlled medication from CanadaCanadian citizen Andrew Strempler,38, sentenced January 9th, 2013 to4 years after pleading guilty toconspiracy to commit mail fraud.Strempler’s company, Mediplan,fulfilled online medicine orders forten different online pharmacies.FDA discovered that 90% of the drugs they seized from a Mediplan shipment werecounterfeit: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in theUS), 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.
Myths: Canadian medicines are cheaper• Generics are often cheaper in the US• Not all Canadian medication is price-controlled
Myth: Canadian pharmacists canlegally fill American prescriptions• Pharmacists in Canada are not allowed tolegally fill a prescription written by anAmerican physician.• Therefore if a “Canadian pharmacy” tells anAmerican to fax their prescription in, they’reeither breaking laws in their own country, orthere’s no pharmacist involved at all.
Myth: You or your doctor can billinsurance back for imported drugsThe government prosecutes people and physicians who commit fraudby billing government health programs for misbranded drugs. Onedoctor paid $1 million in fines.As Gerald T. Roy, of the Kansas City Regional Office of Investigations forthe Department of Health and Human Services stated last year, “Theseinvestigations and their outcomes not only protect the taxpayer fromwaste, fraud and abuse but, more importantly, insure our Beneficiariesare not provided misbranded or adulterated drugs that may adverselyimpact their health.We will continue to aggressively pursue those who seek to defraudthe Medicare and Medicaid programs by administering non- FDAapproved products and services.”
Ok, I’m scared.• How do I stay safe if I’m not in control wherethe medication comes from?• How do I stay safe but still save money?
Patient Safety: How to stay safe in thedoctor’s office• Signs of suspicious medication inthe doctor’s office.– Look for foreign writing– Ask to see bottle/bag/unit with lotnumber and write it down or take aphoto• Pay attention to new or unusualside effects or lack of therapeuticbenefit and notify yourphysician/pharmacist.
Patient Safety: How to find discountsThe NeedyMeds Drug Discount Cardsaves you up to 80% or more offthe cost of:Prescription MedicinesOver-the-Counter DrugsPet Prescription DrugsThe Partnership for Prescription Assistancewill help you find the program that’s right foryou, free of charge.
Patient Safety: Comparison shop theVIPPS pharmacies onlineVIPPS = Internetpharmacy thatcomplies withstate licensing.Look for theseal, and findthe list athttp://vipps.info
Save Money by Using FDA ApprovedGenericsNot only can a generic be cheaper than a name brand, but a generic in the USis usually cheaper than a name brand from a fake “Canadian pharmacy”. Andsafer too.
Handout resources at PSM• Save Money Safely on Your Prescriptions from OnlinePharmacies (brochure)• Learn 5 Kinds of Poisons Found in Counterfeit Medicines(interactive)• The 5 Secrets Canadian Web Pharmacies Don’t Want You toKnow (webpage)• SAFEDDRUG: An 8 Step Checklist for Medicine Safety(brochure)• Safe Savings: Tips for Saving Money on Medicine Safely(brochure)• A Risky Proposition: Opening The US To Foreign MedicinesWill Put American Children At Heightened Risk (brochure)
What can my patient organization doto educate our community?• Have us conduct a webinar dedicated to yourcommunity’s therapeutic or demographicsegment.• Distribute our handouts to your patientcommunity.• Adopt and echo our “patient safety tips”series. Take 1 or more of our 26 tips and usethem in Facebook, Twitter, Email, or your printnewsletters.
How can my healthcare professionalassociation educate our community?• Have us conduct a webinar dedicated to yourprofessionals role in medication handling.• Distribute the LEADERS guide for physicians,nurses, or pharmacists to your community.• Adopt and echo our “patient safety tips”series. Take 1 or more of our 26 tips and usethem in Facebook, Twitter, Email, or your printnewsletters.
Questions and AnswersOur members conduct joint education projects with us toimprove patient safety in their communities. Ourmembers include groups that representpatients, pharmacists, physicians, nurses, distributors andmanufacturers.To start educating your community, contact:Shabbir Imber SafdarDirector, National Outreachshabbir@safemedicines.org415-683-7526