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Counterfeit Medicine In America: 2018

Shabbir Imber Safdar The Partnership for Safe Medicines

Academy of Managed Care Pharmacy

Alaska Pharmacists Association

American Association for Homecare

American College Health Association

American Pharmacists Association

American Society of Health System Pharmacists

Arizona Pharmacy Alliance (AzPA)

Association for Accessible Medicines

Association of Nurses in AIDS Care

BioForward

Biotechnology Innovation Organization

California Life Sciences Association

California Pharmacists Association

California Society of Health‐System Pharmacists (CSHP)

Colorado BioScience Association

Community Access National Network

European Federation of Pharmaceutical Industries and Associations (EFPIA)

Healthcare Distribution Alliance

HealthCare Institute of New Jersey

Healthcare Leadership Council

The Hispanic Institute

Illinois Pharmacists Association

Institute for Safe Medication Practices

International AntiCounterfeitingCoalition

International Federation of Pharmaceutical Manufacturers and Associations

International Health Facility Diversion Association

Kidney Cancer Association

The Latino Coalition

The Life Raft Group

Maryland Pharmacists Association

Maine Pharmacy Association

Maine Society of Health‐System Pharmacists (MSHP)

Men’s Health Network

Minnesota Pharmacists Association

Missouri Pharmacy Association

National Alliance for Hispanic Health

National Alliance On Mental Illness

National Association of Chain Drug Stores

National Association of Boards of Pharmacy

National Association of Drug Diversion Investigators

National Association of Manufacturers

National Alliance of State Pharmacy Associations

National Biopharmaceutical Security Council

National Community Pharmacists Association

National Grange of the Order of Patrons of Husbandry

NeedyMeds

New York State Council of Health‐system Pharmacists (NYSCHP)

North Carolina Association of Pharmacists

Oklahoma Pharmacists Association

Parenteral Drug Association

PDMA Alliance

Pennsylvania Pharmacists Association

Pennsylvania Society of Health‐system Pharmacists

Pharmaceutical Industry Labor‐Management Association (PILMA)

Pharmaceutical Security Institute

Pharmacist Planning Services Institute

PhRMA

RetireSafe

Spina Bifida Association of America

Texas Pharmacy Association

Texas Society of Health‐System Pharmacists

United States Chamber of Commerce

University of New England College of Pharmacy

University of Texas at Austin College of Pharmacy

Vietnam Veterans of America

Virginia Pharmacists Association

Vermont Pharmacists Association

West Virginia Rx

WomenHeart

The Partnership for Safe Medicines

News and resources at safemedicines.org, on Facebook and Twitter

Print materials:editors@safemedicines.org

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 online pharmacies or other unlicensed sources.

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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Fake Botox incidents as of 2017

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Black market IUD incidents as of 2017

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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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Counterfeit Avastin

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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.

Public health threat is real

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

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Source: Medicin der Dræber

Source: FDA

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Case Study: Path of Fake AvastinLack of prosecution

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 bargain pending - no jail time

CanadaDrugs.com still has their Canadian wholesale license and continues to sell to Americans.

The criminals - Where are they now?

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Terms of pending plea deal with U.S. Department of Justice for Kris Thorkelson● Six months house arrest and four and a

half years of probation;● a $250,100 fine; and● Turn over records and cooperate in future

investigations.

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.

Thorkelson’s company, CanadaDrugs, continues to hold provincial wholesale pharmacy licenses and a Canadian Federal manufacturing pharmacy license.

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Photo originally created by New Hampshire Public Radio photographer Paige Sutherland

What does a fatal dose look like?Fentanyl exposure risks through inhalation / contact

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Fentanyl is not only dangerous for the drug’s users, but for law enforcement, public health workers and first responders who could unknowingly come into contact with it in its different forms. Fentanyl can be absorbed through the skin or accidental inhalation of airborne powder can also occur.

DEA (June 10 2016): Warning to Police and Public: Fentanyl Exposure Kills

Fentanyl is a powerful synthetic drug that is similar to morphine and heroin, but is 50 to 100 times more potent. … Exposure through the skin, inhalation, and ingestion are all possible routes of exposure. Inhalation exposures can quickly result in respiratory depression.

CDC (June 2017): Fentanyl Exposure Risks for Law Enforcement and

Emergency Response Workers

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Since 2015, counterfeit pills that are laced with deadly imported fentanyl have been killing Americans across the U.S.

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Fentanyl is cheap and readily available online

Investigators for the US Permanent Subcommittee of Investigations communicated with online vendors who sold fentanyl. They provided the following price list to the investigators.

A kilo of fentanyl costs roughly $11,000 when paid through Western Union. A fatal dose of fentanyl for an adult is 3mg.

That’s enough for 333,333 fatal doses.

Read the entire report: Combatting the Opioid Crisis: Exploiting Vulnerabilities In International Mail, Staff Report, Permanent Subcommittee on Investigations, US Senate.

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Law enforcement and journalists working on this issue report fentanyl for sale for $3.5k-$5k / kg.

Fentanyl is cheap and readily available online

During the committee’s investigation, they tracked five sellers in China for a short time period. During the time of that investigation, they tracked their sales and shipments to purchasers in 43 different states.

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Read the entire report: Combatting the Opioid Crisis: Exploiting Vulnerabilities In International Mail, Staff Report, Permanent Subcommittee on Investigations, US Senate.

How does it get here?

Source: Twitter

“..many Americans are purchasing fentanyl and other illicit opioids online and having them shipped here through the international mail system.” Jan. 23, 2018

Source: eBay

Equipment for deadly trade readily available

Pill presses readily available on the internet.

As are counterfeit medicine die molds

Source: eBay

But how does it become a counterfeit pil?

In 2011, Customs and Border Protection agency disclosed that they intercepted and seized 2 pill presses all yeyear at the Port of Los Angeles.

In 2017, they seized 396.

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Fentanyl-laced counterfeits

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

Fentanyl-laced counterfeits

Counterfeit Xanax Source: Yakima Police Department

Counterfeit Oxycodone Source: Public Health Seattle & King County

Counterfeit Percocet Source: Georgia Bureau of Investigations

Die molds are readily available for any kind of pill

Pills have been found in 43 states, with deaths reported in 22 – March 2019

Fentanyl-laced counterfeit

Full report: “Forty Three States and Counting” at www.safemedicines.org

Prince died of a fentanyl overdose

Counterfeit hydrocodone, containing a fatal quantity of fentanyl, were found at his residence.

Blood tests done in the weeks preceding his death showed no residual amounts of fentanyl in his system, suggesting that he may have been unaware that he had a counterfeit.

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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 of 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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Joe Patterson of Gainesville, GA

Before he died of a fentanyl overdose on February 16, 2015, 23-year-old Joe Patterson had a lot to look forward to.

The Georgia resident had been working for Sherwin Williams while he pursued a degree in exercise science. His girlfriend was expecting a baby in April 2015, and he was preparing to be a devoted father. He had even picked out his son’s name: Gabriel.

On Valentine’s Day weekend, Joe pulled a muscle during his customary gym workout and took an oxycodone he got from a close friend.

The counterfeit pill contained a fatal dose of fentanyl.

Betty Jean Collins of Macon, Georgia

A 60-year-old Macon resident recovering from open-heart surgery took one of her husband’s Percocets and ended up in the hospital with an overdose. The medication was counterfeit–made with fentanyl–and Collins was one of a series of poisoning cases across Georgia.

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Source: gbi.georgia.gov

95,000 pills seized in Cottonwood, Utah - 2016

They used pill presses, dies, and stamps and illegally imported fentanyl and alprazolam from China.

In the November 2016 raid, the DEA seized $1.2 million and 95,000 pills that could have been sold for as much as $2.2 million. His trial is set for August 2018.

Source: www.deseretnews.com

Aaron Shamo and 5 others allegedly manufactured and sold hundreds of thousands of fake prescription pills across the U.S. via the Darknet.

Just one criminal ring can have a huge impact on the country

Locations That Shamo Drug Ring Shipped PillsSource: U.S. Immigration and Customs Enforcement

The Shamo ring out of Utah had many of their shipments traced to cities all over the country. This map shows where they sent pills after investigators finished combing through their sales records.

Law Enforcement Risk: Officer Exposure

Orlando, FL: A homicide detective had trouble breathing while investigating a drug overdose death (July 2017).

New Hanover, PA: 2 officers became ill while assisting an overdose victim (October 2017).

Similar incidents in Ohio, Connecticut, New Jersey, Kentucky, Wisconsin

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Law Enforcement and First Responders at Risk

Police departments across the country have changed their procedures to lower the risk of fentanyl exposure to officers.

Officers are increasingly wearing masks, booties, 2 layers of gloves or full hazmat suits. In many jurisdictions they no longer perform drug tests in the field.

Even simple tasks such as bagging and tagging evidence have become dangerous because such a small amount of fentanyl can be fatal.

Source: KEPRTV.com

DEA issued a guide for first responders in June 2017.

Law Enforcement Risk: Pittsburgh

...and Pittsburgh:

18 SWAT team members exposed to a powder during a fentanyl bust.

Taken to hospitals after some of them became dizzy (August 2017).

Source: Police.com

All first responders are in danger

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K-9s, EMTs, Trauma staff, even hospital custodial staff are endangered by a toxic substance that can be absorbed through the skin.

Main source of Fentanyl - China

October 2017: DOJ indicts 2 Chinese nationals in fentanyl trafficking case

• More than 103 lbs. of heroin and fentanyl seized - worth $22 million

• 32 people arrested• Mexican Drug Cartel

leader arrested and charged

Law Enforcement Risk: Officer Exposure

Minuscule (2mg) exposure can cause injury and death

New procedures for law enforcement Suspension of field tests

Source: KEPRTV.com

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Law Enforcement Fentanyl Exposure Precautions

Feb. 21, 2018

Law Enforcement Engagement

□Resolutions in Opposition

Michigan Code: Pharmacist in Charge must...

● Supervise all employee activities, ● Enforce policies and procedures, ● Establish and supervise the storage, safekeeping, and

recordkeeping around...

...the purchasing, storage, compounding, repackaging, dispensing, and distribution of drugs

Courts found pharmacists & pharmacies liable when

● A pharmacy was not in compliance with federal or state law

● A compounding pharmacy makes substandard medication

● A pharmacy knowingly distributes ANY medicine from a unsafe source (foreign wholesaler, drug diversion) or

● A pharmacy purchased medication from a licensed wholesaler, but the pharmacist or pharmacy should have known the product was unsafe.

Redford, MI: Kuznar v. Raksha Corporation, 2008

A non-pharmacist Crown Pharmacy employee made an error refilling a prescription that injured a patient. In a suit, the Michigan Supreme Court concluded that

The person to whom a pharmacy license is issued and the pharmacists on duty are responsible for compliance with federal and state laws regulating the distribution of drugs and the practice of pharmacy.

Massachusetts: U.S. v Glenn Chin, 2018

New England Compounding Center supervisory pharmacist manufactured ~ 17,000 vials of contaminated MPA that infected 753 patients with a fungal infection, and killed 64.

● Convicted of 77 counts● 8 years in prison, 2 years of supervised release● $175,000 forfeiture

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Pontiac, MI: U.S. v Gupta, 2017

Dell’s Prescription Center supplied nursing homes and assisted living facilities who returned drugs that were not used. They repackaged and resold the drugs with false expiration dates.

● 2 defendants paid $41,300 each

● 3 years probation

● Pharmacist lost license

Grand Rapids: United States v. Mulder, 2015

Kentwood Pharmacy resold returned drugs they were supposed to dispose of, leading to cross-contamination, improper labeling, mislabeled doses and the wrong drugs.

● CEO sentenced to 10 years for health care fraud● 6 pharmacists received felony misbranding

convictions○ Suspended and/or revoked licenses○ Fines $15,000 - $30,000

Pennsylvania: USA v. Markowitz, 2017

Jeffrey A. Markovitz (Dierken’s Pharmacy) ordered drugs from a Canadian company that sold medications from other countries and used them to fill his orders.

● Pleaded guilty to conspiracy to smuggle foreign drugs and conspiracy to money launder

● 3 years probation with 6 months home confinement● More than $665,000 in forfeiture and fines● Surrendered license

New York: Fagan v. AMERISOURCEBERGEN, et al, 2004

16-year-old liver transplant patient was injured when the local CVS sold his parents counterfeit Epogen that was 1/20 the strength it should have been.

Fagan sued the whole supply chain, including CVS.

● A 2004 opinion says that CVS might be liable because the pharmacy should have detected labeling differences that showed the drug was counterfeit.

● Fagan settled for an undisclosed amount of money.

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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.

What can we do?

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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?

Regulatory enhancement

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What can we do?

Support efforts to remove gag clauses that prevent pharmacists from helping patients save money.

What can we do?

The Partnership for Safe Medicines

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

□ Comprehensive reporting on counterfeit incidents online

□ Explaining the risks in a variety of mediums

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

What we can do

Share PSM patient resources:www.safemedicines.org/patient-resourceswww.safemedicines.org/safe-savings-tip

Share PSMs Fentanyl resources:http://safedr.ug/fentanyl101http://safedr.ug/40statesandcounting

Contact Members of Congress on the dangers of importation

http://safedr.ug/NoPoisonInUSA

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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 cost for you!)

Re-share our materials on social media

Ask the person who maintains your social media and email newsletter to watch our site for new content. You are pre-authorized to link to and share it. No need to ask permission.

What can we do?

Support the FDA’s desired generic staffing levels through advocacy

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What can we do?

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?

Support enhancement to border security through advocacy

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What can we do?

More resources for package inspection at International Mail Facilities

Require electronic data on international mail to facilitate more efficient inspections

Sen. Rob Portman introduces the Synthetics Trafficking & Overdose Prevention (STOP) Act

What can we do?What we can do

Law Enforcement Engagement

• Public Opposition to importation

• OpEd’s and LTE’s

• Public Education

(Town Halls)

• Fentanyl Exposure

Training

• Naloxone / Narcane

Law Enforcement Engagement

□Law Enforcement OpEd’s:■California (Bob Marchesi IACC)■Kentucky (Sheriff Cain)■Arizona (Ret. Commander Phoenix PD)■Georgia (DEA Agent Salter)

□Social Media Engagement□Community Education

The dangers of importation

IMF’s are overburdened and FDA cannot inspect enough shipments.

USPS: handled ~ 621 million pieces of inbound international mail in 2016–54% more than 2012

Operation Pangea X(2017)

□ 123 countries

□ 400 arrests

□ Stopped 3,584 websites and >3,000 fake pharmacy ads

□ Seized >$51 million in medicinesPackages for inspection and

suspected counterfeit tramadol, Source: GAO

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New legislative threat: Drug Importation

Imported drugs–whether they are sold by wholesalers or retail pharmacies–are not monitored by any regulatory agency.

“Drug importation proposals would worsen the opioid crisis…” 2017 report from Louis Freeh, FBI Director 1993-2001

Health Canada “…does not assure that products being sold to U.S. citizens are safe…and does not intend to...”

U.S. regulators cannot ensure the safety of drugs produced outside FDA-approved sources.

Oppose importation proposals at the state and federal level● These proposals (both federal and state) have always been opposed by U.S.

FDA commissioners appointed by both Democrats and Republicans.● State proposals have never been supported or approved by the U.S. FDA,

and in fact have been opposed in many cases.● Don’t actually work when the U.S. has 10x the population of Canada.● Will be impossible to secure given the history of failures in bringing foreign

counterfeit criminals to justice in America.● Such proposals blow a hole in the safety of the new Track and Trace system

being implemented by the Federal government.● The Congressional Budget Office has studied drug importation proposals and

determined they would have “negligible reduction on drug spending”.● Would expose pharmacists and pharmacies to increased liability for

dispensing unsafe medication.

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How to avoid making it worseWhat can we do?

Thank you

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Program Claim Code:

S21ZDW

Overview of Counterfeit Drugs in America

0112-0000-18-244-L01