COUNTERFEIT DRUGS 101 FOR HEALTHCARE PROFESSIONALS

Tom Kubic, President and CEO of the Pharmaceutical Security Institute and Treasurer of the Partnership for Safe MedicinesShabbir 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 and

protocol

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.

How patients are endangered from supply chain breaks?

• Common: patients break it– Buying online from a non-VIPPS pharmacy– Buying from an offline non-pharmacy (in the US or

outside)• Less common (but getting more common):– Physicians, pharmacists, and distributors buying

from unlicensed distributors• Uncommon:– Manufacturing supply chain producer

How often are medicines counterfeited?

Where do they come from?

What’s counterfeited?

2012 Situation Report

Industry’s assessment of worldwide pharmaceutical crime

How Often?

• 7,844 incidents – 2012

• 5,242 incidents – 2011

• 49.6% increase in reported incidents

• 2,504 reports, studies, summaries reviewed

Incident Trends

• 2,018 unique incidents* – 1.6% increase

• 1,664 counterfeiting incidents – 2.2% increase

• 327 illegal diversion incidents – virtually even

• 27 major theft incidents – v. 33 in 2011

*Unique incidents are less than reported incidents as PSI staff link related incidents as part of their analytical reviews.

Where do fake medicines come from?

123 Countries with identified incidents:218 Illegal manufacturing operations since 2009

These products are not made in a sterile environment. Sold to American patients from “Canadian pharmacies”

Incidents by Region

Incidents by Country

What’s being counterfeited?

523 different drugs

53 different drugs in one case

Genito-urinary, anti-infectives, CNS

Tablets/Cap. 86%; Injectables 10%

Increase TC - Hormones

YouTube videos and cartoons teach IUD and implant insertion and removal, despite the risk of infection and death.

Patient story: Fake IUDs in Kentucky

3/2013, a Kentucky OB-GYN was charged with buying counterfeit non-FDA-approved birth control devices from an unregulated foreign supplier over the Internet. • The indictment claims that for over a year he billed insurance for the cost of genuine devices. • If convicted, Canh Jeff Vo faces fines of as much as $3 million and a maximum sentence of 233 years in prison.

Physicians and their staff are the new weak link in the supply chain

In the past year alone…•Cancer drugs – 134 doctors in 28 states•Osteoporosis – 20 doctors in 10 states•Botox – 350 doctors in 38 statesFragile 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.

Myths: Canadian online pharmacies sell price-controlled medication from Canada

1/9/2013 Canadian Andrew Strempler, sentenced to 4 years after pleading guilty to conspiracy to commit mail fraud. •He used ten different online pharmacies to fill orders. •FDA discovered that 90% of the drugs they seized from a Mediplan shipment were counterfeit•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.

Map graphic courtesy of the Wall Street Journal.

Oncologists paying steep prices for their mistakes

• Dr. Wm Kincaid (TN): 2 years prison, $2.55M civil claims. His fellow oncologists fined $850k each. Office manager Mr. Combs plead guilty.

• Dr. Abid Nisar (MO): Forfeited $1m for false Medicare/Medicaid claims - two years probation. Seven year ban from gov’t programs for 7 years.

• FDA warned over 100 physicians that they may have done business with unlicensed suppliers and broken the law.

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, Kansas City Regional OI, DHHS 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.”

And even pharmacists…Michael Markiewicz, a Chicago pharmacist bought counterfeit medication from China and filled prescriptions with them.

2013 - he was charged with eight counts of violating the federal Food, Drug and Cosmetic Act, four counts of trafficking in counterfeit drugs, and three counts of smuggling.

Medications ordered online and declared as “gift pens”

Trafficking c/f drugs carries a maximum penalty of 20 years and a $2 M fine.

Nurses play a role in patient safety

• In Dr. Kincaid’s case, the first introduction of illegally acquired medication was spotted by the leader of the nursing team who ensured the practice was stopped.

• After she left the cancer center 18 months later for another job, the practice of illegally acquiring and administering non-FDA appoved medication resumed.

Dr. William Kincaid at the courthouse in December 2012

Doctors giving dangerous adviceAli Baney a Colorado resident in 2009 whose doctor told her to go online to buy medication to save money. She received a counterfeit and suffered life-threatening side effects.

Rachael Jablo, a San Francisco resident, provided PSM an affidavit that her doctor at the University of California – San Francisco suggested she go to an online “Canadian pharmacy” to save money on an antibiotic that costs $1,000 for a two week cycle.

The online pharmacy is a Canadian business, but not a pharmacy, and ships it medications from countries such as Turkey and Singapore. Of course, they could come from anywhere.

Libby Baney telling her sister’s story at the PSM annual conference in 2011.

Addressing the problem

• Educating all healthcare professionals (nurses, doctors, pharmacists, support staff) on two issues:– Legal and best practices for medication sourcing;– Legal and financial consequences for receiving,

administering, or claiming reimbursements for misbranded medication

• Additionally, providing some basic patient-level education to healthcare professionals on how to safely save money

How PSM can partner with you to educate healthcare professionals

With co-branded handouts, articles for your newsletter, infographics, and videos, PSM can help educate your audience and protect their patients.

Slides from a recent PSM patient safety training webinar

Infographics and postcards customized for your community

Men’s Health Network is a very active member of PSM. Our deep commitment to working with each other resulted in this infographic which is also being used as a large format postcard.

A safety tips campaign in a box

• PSM has created 26 safety tips for healthcare professionals that can be adapted for Twitter, Facebook, Email, Websites, or Print.

• All illustrations are in black and white.

• Entire collection of tips is licensed through Creative Commons

Tip #12: Tell your patients that while we think of Canada as a safe, modern country, an online pharmacy that has a Canadian flag on its home page does not mean it is located in Canada. Find out where that online pharmacy is really located before buying anything from them.

Custom educational materials

This is part of a custom handout for a non-profit in Virginia that works with volunteer pharmacists to connect patient with low-cost medication.

It was designed specifically with Virginia residents in mind, and discusses specific programs available to them.

Resources for 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)

Articles written for your newsletter

• We’ve helped to get the word out… – Malpractice insurance carrier The Doctor Company – Parenteral Drug Association

• We’d be happy to write one for you! – PSM has written articles about drug safety that

specifically speak to that audience and their needs.

Questions and AnswersOur 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 Outreachshabbir@safemedicines.org

415-683-7526