Bangor health dept presentation on dangers of counterfeit drugs to Maine patients
COUNTERFEIT MEDICATION: THEIMMEDIATE DANGER TO MAINE PATIENTSAND HOW TO PROTECT THEMFelicity Homsted, PharmD, BCPSDirectory of Pharmacy at Penobscot Community Health CareShabbir Imber SafdarDirector, National Outreach at 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 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.
How good are the fakes?Authentic and Fake Lipitor
YouTube videos andcartoons teach IUDand implantinsertion andremoval,despite the risk ofinfection and death.
Patient story: Fake IUDs in KentuckyIn March 2013, a Kentucky OB-GYNwas charged with buyingcounterfeit non-FDA-approvedbirth control devices from anunregulated foreign supplier overthe Internet for a discount. Theindictment claims that for over ayear he then implanted them intowomen and billed back insurancefor a normal (higher) cost.If convicted, Canh Jeff Vofaces fines of as much as$3 million and amaximum sentence of233 years in prison.
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: Chicago, IllinoisMichael Markiewicz, apharmacist/pharmacy owner in Chicago,Illinois was buying counterfeit medicationfrom China and filling prescriptions with itfor his customers.He was charged in 2013 indictment he wascharged with eight counts of violating thefederal Food, Drug and Cosmetic Act, fourcounts of trafficking in counterfeit drugs,and three counts of smuggling.His store remains open as a nutrition andherb retailer.The medications were ordered over theInternet and then delivered in a packageidentified on the customs declaration asa “gift pen”.Trafficking counterfeit drugs carries a maximum penalty of 20 years in prison and a $2million fine.
UK pharmacies selling fakes toAmericans• In June 2013 two men from the UK wereextradited to the US to face charges of sellingAmericans drugs from their online pharmacy thatpromised US citizens drugs from the UK.• The real source of the medication was Pakistan(steroids, Xanax, Valium, Ativan, and Klonapin).• 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 theworld, 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 can legallyfill prescriptions from US physicians• 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.”
How do we protect patients?• Teach patients– how to address issues of cost without endangeringtheir safety.– how to access affordable medications locally– how to spot safe online options (proactive notprohibitive message).– the warning signs of non-FDA-approved medication sothey might spot them in a clinic setting.• Teach healthcare professionals about the dangerand legal liability of breaking the secure supplychain.
Affordable Care Programs• Federal funding- ensures access to services• Program Enrollment – at the health center• Qualifying patients Receive– Discounted health care services– Discounted medication– Access to other programs, including pharmacy runprescription assistance programs
Patients Assistance Programs• For qualifying patients, many drugmanufacturers offer discounted or freemedication through Bangor pharmacies.• Types of Programs– Pharmacy– Health Center– Other
PCHC Rx.AP Navigator Program• Rx.AP Navigators for each site• Coordinate prescription assistance application– Meet with patient, gather needed applicationcomponents, submit applications,• Coordinate medication delivery• Troubleshoot issues• Guide patients to other available services
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.
How to save money at higher incomelevels?If you make too much money to qualify for anyof the programs mentioned previously, but youstill face income challenges affording yourmedication, what options do you have?• Comparison shopping (generics and brandedproducts)• Discussing generics with yourdoctor/pharmacist
GoodRX, WeRX, and LowestMedMobile apps and website comparison tools show local and mail-order US-licensedpharmacies and their price differences. Also provide discount cards and coupons thatyou can use to reduce your cost.
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.
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.
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.
Distribute our resources to yourcommunity• Save Money Safely on Your Prescriptions from OnlinePharmacies (brochure)• Learn 5 Kinds of Poisons Found in CounterfeitMedicines (interactive)• The 5 Secrets Canadian Web Pharmacies Don’t WantYou 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 handoutfor your community.
Co-branded patient webinar• We can hold a shorter,customized joint co-brandedwebinar for your patientcommunity.• We can highlight the specificdangers in your therapeutic ordemographic segment.• The webinar can be recorded soyou can continue to promote itto your community after it’sconducted.
Infographics and postcards customizedfor your communityMen’s Health Network is a very active member of PSM. Our deep commitment to working with each other resulted in this infographicwhich is also being used as a large format postcard.
Live patient safety eventWith active PSM memberswe have also done liveevents, where we bringtogether patientadvocates and safetyexperts to talk aboutensuring safety.PSM Board member Bryan Liang led abriefing on patient safety andcounterfeit drugs with the FDA andPSM member the National Associationof Boards of Pharmacy in 2011 inWashington DC.
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 AnswersShabbir Imber SafdarDirector, National OutreachPartnership for SafeMedicinesshabbir@safemedicines.org415-683-7526Felicity HomsteadDirector of PharmacyPenobscot Community HealthCarefhomsted@pchcbangor.org(207) 992-9200 x539