Counterfeit Medicine In America 2019 January 2019 New Mexico 2 - - PowerPoint PPT Presentation

Counterfeit Medicine In America 2019

January 2019 New Mexico

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The Partnership for Safe Medicines

Americans are largely unaware of this threat. PSM awareness tools:

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Comprehensive reporting on counterfeit incidents online

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Explaining the risks in a variety

• f mediums

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Telling the stories of people who have been hurt by fake medicine

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The United States has the safest drug supply in the world… …but as many as 19 million Americans buy medicines outside that supply chain, from foreign

• nline pharmacies or other

unlicensed sources.

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The first wave of counterfeit medicines

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The first wave of counterfeit medicines: late 1990s-present

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"Basically, all my competition started selling drugs they were sourcing

• verseas from, in my opinion, unsafe

countries and marketing them as

• Canadian. I couldn't compete with

that," he said. (CBC 6/20/2017)

Daren Jorgensen opened one

• f the first Canadian Internet

fake pharmacies in 2001, and exited in 2008.

Canada’s drug supply would be drained in 201 days, should just 20% of U.S. prescriptions shift to dispensing out of Canada. (Shepherd, Health Econ Outcome Res Open Access 2018, 4:1)

Illinois’ Experience With ISaveRX, 2003–2009

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A “white listed” online pharmacy program of 28 online drug sellers dispensing from Canada, the United Kingdom, Australia, and New Zealand to IL, WI, KS, MO, and VT.

Select IG findings

• Operating in violation of federal law with unapproved federal funds.
• Dispensing entities in the program in violation of IL pharmacy

practice law.

• 40% of the inspections records (32 of 80) were not completed.
• State did not monitor that only approved pharmacies participated.
• Significant labor costs of $488,000 for 26 employees (19 months).
• High expenses, incl. $111,000 for international travel and over

$350,000 for contract management, marketing, and legal services.

• Uptake of the program was small and it was eventually cancelled.

Minnesota RXConnect 2004-2010

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An online pharmacy regulation program started by Gov. Tim

• Pawlenty. After launch, the FDA cited a number of patient

safety issues, including several found during a pre-announced visit by Minnesota’s own inspectors:

• Pharmacy techs, not pharmacists, entering prescriptions.
• Having pharmacists check 100 prescriptions / hour or

refill 300 prescriptions / hour.

• Cold-chain drugs shipped not refrigerated / no historic thermometers in refrigerators.
• Allowing pharmacy techs instead of pharmacists contact U.S. medical providers
• Allowing faxed prescriptions.
• Failed to meet minimum lighting standards as set by MN pharmacy law.
• Uptake of the program was small and it was eventually cancelled.

Maine’s passage of LD 171 in 2013

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In 2013 Maine passed a law facilitating foreign mail order pharmacies from Canada, the UK, Northern Ireland, Australia, and New Zealand.

• Dr. McCall ordered three medications from Canada Drug Center,
• perated by Quantum Solutions. They all arrived from other

countries not on the approved list, and lab testing showed them to have insufficient API. The Maine Board of Pharmacy asked the AG to shut them down. The AG was powerless. The law was overturned in Federal Court in 2015. In 2018, the FDA’s Office of Criminal Investigation arrested the

• perators of Quantum Solutions and sentenced them to three

years probation and fines and forfeiture of over $4,000,000.

Kenneth L McCall BSPharm, Pharm.D., BCGP, RPh, FAPhA Associate Professor and Director

• f Residency Programs &

Professional Affairs University of New England

Since 2012, smugglers caught selling fake drugs sold up to 63 medications to over 3,000 doctors, clinics and hospitals across the U.S.

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Select medical clinics that received FDA warnings letters

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New Mexico: Medical clinics that received FDA warnings letters and counterfeit victims

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These are two of the ten clinics in New Mexico warned by the US FDA to stop buying from wholesalers in Canada such as TC Medical.

In 2012, the FDA discovered 2 lots of an imported counterfeit cancer drug (Avastin) with no active ingredient. The agency launched a massive recall and a lengthy investigation.

The second wave of counterfeit medicines

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The second wave of counterfeit medicines

Late stage lung cancer Betty Hunter was treated with counterfeit Avastin in 2011. Ms. Hunter died three months later.

15 Source: Medicin der Dræber Source: FDA

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Difficult prosecutions

Prosecuting foreign nationals for selling counterfeit drugs is hard, which makes a poor deterrent.

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2014: DOJ indicted 5 CanadaDrugs.com executives for selling $78 million of fake cancer drugs 2017: Canada set extradition hearing for May 2018. 2018: Plea approved - no jail time ($34mm penalty) 2018: CanadaDrugs.com shut down, but license was transferred

The criminals - Where are they now?

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Terms of plea deal

• Six months house arrest and four and

a half years of probation;

• a $250,100 fine; and
• Turn over records and cooperation.

The plea agreement does not require him to:

• serve any jail time;
• surrender his pharmacy license;
• enter a guilty plea of selling counterfeit

drugs. He is not prohibited from holding any kind of pharmacy license or starting a new pharmacy business to export to America. CanadaDrugs.com sold off most of the rest of their inventory to Americans for many more months while “shutting down”

Complete overview of wholesale criminal operations in America 2007-2018

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Across all therapeutic areas, the FDA has traced criminal wholesaler drug importation businesses to at least 3,000 medical practices across the United States. Importation is not safe, even at a wholesale level. Only licensed U.S. wholesalers selling FDA-approved medicines are safe for American patients.

https://www.safemedicines.org/2018/08/imported-black-market-cancer-meds.html

Fentanyl-laced counterfeits

First reports of counterfeit Xanax and fake opioids laced with fentanyl and analogues in late 2015.

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Photo originally created by New Hampshire Public Radio photographer Paige Sutherland

Fatal dose comparison

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Fentanyl-laced counterfeits

Counterfeit Xanax

Source: Yakima Police Department

Counterfeit Oxycodone

Source: Public Health Seattle & King County

Counterfeit Percocet

Source: Georgia Bureau of Investigations

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Fentanyl-laced counterfeits

Source data current as of January 2019

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Tosh Ackerman of Aptos, CA

The evening of October 27, 2015, 29-year-old Aptos, California resident Tosh Ackerman took a benadryl and part

• f a Xanax pill to help him sleep. He

never woke up, and his girlfriend found him dead the next day. Investigation showed that Ackerman’s Xanax was counterfeit. It contained a fatal dose of fentanyl. Carrie is an active speaker to schools and the media. You can reach her at ToshsStory@gmail.com

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Fentanyl is driving overdose deaths

Data source 1999-2017: CDC searchable database CDC Wonder.

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How does fentanyl get here?

Source: Twitter

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Die molds are readily available for any kind of pill

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Fentanyl trade attracts organized crime

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Fentanyl implications - officer exposure

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How do we address this problem? There are steps we can take to make the drug supply safer including resources for law enforcement, consumer education, and regulatory enhancement. AND There are steps we can avoid taking that would make the drug supply more dangerous.

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What can we do?

Friends and relatives, even ones you trust, are not as safe as a licensed pharmacist.

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We teach consumers that licensed pharmacies and pharmacists are the only safe sources of medication.

What can we do?

47 of the 50 most frequently prescribed medications in the U.S. are available in cheaper generic form. Americans pay less for most commonly prescribed generic medications than Canadians do.

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Teach consumers how to save money safely so they don’t buy off the black market.

36 We always tell consumers to consolidate their prescriptions at a single pharmacy when recommending they shop around. Patients should have a single dispensing pharmacist, preferably a community pharmacist who knows the patient well.

What can we do?

Even a very established generic, atorvastatin, has wild price differences around Albuquerque.

Support the FDA’s desired generic staffing levels through advocacy

37 FDA staffing is funded through a combination of user fees on generic drug makers and Congressional

• appropriations. When the FDA approves generics, especially multiple ones, prices go down and the

market for counterfeits evaporates.

What can we do?

Make your voice heard - Successes

38 INTERDICT Act New resources for CBP to detect Fentanyl STOP Act Electronic data for mail packages

Passed

Prohibition of Gag clauses

Passed

Re-affirmation of Drug Importation Prohibition

Passed

Opposition by FDA commissioners

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Opposition by healthcare professionals

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State Boards of Pharmacy oppose importation

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Law enforcement opposition

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Law enforcement opposition

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Key Findings:

• Increase counterfeits and illegal activity
• Worsen the opioid crisis
• Overburden law enforcement

resources

• Endangers law enforcement

New Report from Freeh Group

2017 Freeh report on importation

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• Allows non-FDA approved medication into the U.S.
• No FDA authority and no increased CBP resources
• Removes local pharmacist from the care team.
• Does not require prescriptions for any medication
• No enforcement mechanism to punish foreign

sellers of counterfeit or controlled substances

• Creates enormous pathway loophole for illegal

counterfeit, opioids and fentanyl

Make your voice heard: Drug Importation

In 2017-2018: 269 different federal bills on drug pricing with dozens of approaches Only drug importation sacrifices drug safety and worsens the opioid crisis

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What can we do? What can we do?

The New Mexico Board of Pharmacy could sign onto this letter from seven other boards of pharmacy or send a letter of support of the APhA/NACDS letter.

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What can we do? What can we do?

Have your organization join dozens of

• thers on our joint letter to Congress and

the White House. Tell them your

• rganization supports efforts to lower

health care costs, but not at the expense

• f safety. This letter will be delivered in

early Q1 2019.

SIGN ON AT: https://www.safemedicines.org/action-speak-up-for-patient-safety

In 2017, our joint letter to Congress included over 170 healthcare organizations across the whole supply chain.

Materials to help educate consumers and healthcare professionals that interact with them.

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What can we do?

Distribute our materials to consumers and pharmacists (we print them at no cost for you!) Re-share our materials on social media Print materials: editors@safemedicines.org

What can we do?

Thank you

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Shabbir Imber Safdar Executive Director, Partnership for Safe Medicines Phone: 415-630-3736 Email: shabbir@safemedicines.org