HIV/AIDs Medication: The - PowerPoint Presentation

Slide1

HIV/AIDs Medication: The Black Market and Safety

Jim Dahl, Board Member, PSMAugust 4, 2014Slide2

Today’s presentation

Meet the Partnership for Safe Medicines Black market

medicine in the USWhy is the black market a problem?

How the US regulates medicine

How black market drugs enter the US

How are HIV/AIDS patients being harmed?How can we protect patients?Where to learn more

Register for Interchange 2014: http://safedr.ug/NADDI14

Slide3

2

PSM Members

Academy of Managed Care Pharmacy

AIDS Drug Assistance Program

Alaska Pharmacists Association

The ALS AssociationAmerican Association for Homecare

American College Health AssociationAmerican Pharmacists AssociationAmerican Society of Health System Pharmacists

Arizona Pharmacy Alliance (AzPA)Association of Nurses in AIDS CareBioForwardBiotechnology Industry OrganizationCalifornia Healthcare InstituteCalifornia Pharmacists AssociationCalifornia Society of Health-System Pharmacists (CSHP)Colorado Biotechnology Association

Community Access National Network

The Council for Affordable Health Insurance

European Federation of Pharmaceutical Industries and Associations (EFPIA)

Generic Pharmaceutical AssociationGlobal Medicines ProgramHealthcare Distribution Management AssociationHealthCare Institute of New JerseyHealthcare Leadership CouncilThe Hispanic InstituteIllinois Pharmacists AssociationInstitute of Health Law StudiesInstitute for Safe Medication PracticesInteramerican College of Physicians and SurgeonsInternational Anti-Counterfeiting CoalitionInternational Federation of Pharmaceutical Manufacturers and AssociationsKidney Cancer AssociationThe Latino CoalitionThe Life Raft GroupMaryland Pharmacists AssociationMaine Pharmacists AssociationMaine Society of Health-System Pharmacists (MSHP)Men’s Health NetworkMissouri Pharmacy AssociationNational Alliance for Hispanic HealthNational Alliance On Mental Illness National Association of Chain Drug StoresNational Association for Uniformed ServicesNational Association of Boards of PharmacyNational Association of Drug Diversion InvestigatorsNational Association of ManufacturersNational Alliance of State Pharmacy AssociationsNational Biopharmaceutical Security CouncilNational Community Pharmacists Association National Grange of the Patrons of HusbandryNational Latina Health NetworkNeedyMedsNevada Board of PharmacyNew York State Council of Health-system Pharmacists (NYSCHP)North Carolina Association of PharmacistsOklahoma Pharmacists AssociationParenteral Drug AssociationPDMA AlliancePennsylvania Pharmacists AssociationPennsylvania Society of Health-system PharmacistsPharmaceutical Industry Labor Management Association (PILMA)Pharmaceutical Security InstitutePharmacists Planning Services, Inc.PhRMARetireSafeSpina Bifida Association of AmericaTexas Pharmacists AssociationTexas Society of Health-System PharmacistsUnited States Chamber of CommerceUniversity of New England College of PharmacyUniversity of Texas Pharmacy SchoolVietnam Veterans of AmericaVirginia Pharmacists AssociationVermont Pharmacists AssociationWest Virginia RxWomenHeartInternational and Governmental OrganizationsWorld Health OrganizationOrange County Healthcare Agency

Register for Interchange 2014: http://safedr.ug/NADDI14

Slide4

Black market drugs and HIV/AIDSAlmost since there were HIV/AIDS treatments, unlicensed distributors have been selling black market medications to American pharmacies and patients

.Since 2006 at least 86 individuals have been charged with distributing of black market meds prescribed to patients with HIV or AIDS in the US.Slide5

Advertising promoting the sale of cheap prescription medicines is ubiquitous in email and on the internet97% of websites selling prescription drugs do not follow safe practices1 in 6 Americans buys

drugs on the internet without a prescription

How common is black market medicine?Slide6

How common is black market medicine?Slide7

Why is this a problem?Medication from unlicensed sellers is of unknown quality.

Patients taking substandard medicines risk higher viral loads, poor health, and drug resistance, even if they are carefully following their drug regimen.The CDC reports that HIV surveillance sites in 2007 found that 1 in 6 newly diagnosed infections were

drug-resistant. Black market medicines are a serious threat to the health of current and future HIV/AIDS patients. Slide8

Why is this a problem?

Testing kits imported from countries with little or no regulation of the pharmaceutical market may not work. False negatives delay treatment for people who are HIV positive and could lead to higher transmission rates.Slide9

Why is this a problem?

Drugs on the black market are not being manufactured by companies accountable to the FDA, to state licensing boards or anyone. Counterfeiters claim to be selling Truvada

, Sustiva, Ziagen, and Serostim online, even without a prescription. But it’s impossible to know whether you’re receiving safe FDA-approved medicines or drugs that are expired, contaminated or diluted.Slide10

Why is this a problem?Counterfeiters substitute cheap ingredients, offer medicines in unfamiliar doses, omit instructions and safety warnings. Sometimes the medicine a patient receives contains harmful chemicals or contaminants. Sometimes “medicine” contains

no active ingredients at all.Slide11

Why is this a problem?

Diverters often adulterate medicine in the process of reselling it. In 2010, three men in New Jersey were caught relabeling expired medication with forged labels. They removed the old labels with lighter fluid, potentially contaminating the expired contents. Slide12

Why is this a problem?

Addicts who resell their medication often take a dose of an IV drug and replace the missing contents with water using the same syringe. As result, diverted medicines may be diluted and contaminated.

Patients have contracted hepatitis C as a result of diverted IV drugs. Since 2004, as many as 30,000 have been exposed to the virus as a result of diversion in hospital settings.Slide13

Why is this a problem?

Many drugs become ineffective without temperature control and careful handling.Norvir capsules should be refrigerated.Procrit, prescribed to HIV patients with anemia, may be damaged if the vials it comes in are shaken.

Who knows how black market medication has been stored or handled?Slide14

Why is this a problem?

UndocumentedUnregulatedUnsafe

IllegalSlide15

This is not victimless crime

Patients risk their own health buying medication from unknown sourcesBuying non-FDA approved medicine supports criminals who take advantage of people with chronic illnesses to line their own pocketsCut-rate diverted drugs usually come from patients who are selling their medicines at the cost of their own healthBuying discounted prescriptions from illicit sellers creates drug resistant strains of HIV, which makes treatment more difficult for othersSlide16

How does the US regulate medicine distribution to keep patients safe?

The FDA regulates manufacturers of medicines where ever the production facilities are, in the US and beyond.

Wholesalers are regulated by the US states, each with different rules. A voluntary cross-state licensing program (VAWD) helps ease license verification.

Doctors, pharmacists and pharmacies purchase from wholesalers, and are themselves regulated by each state.

Patients are protected by the closed, secure supply chain. Every entity in the chain is answerable to a regulator.

Register for Interchange 2014: http://safedr.ug/NADDI14

Slide17

How a closed supply chain gets broken

Patients purchase directly from unlicensed sources, i.e. flea markets, swap meets, non-pharmacy stores, individuals or the Internet.

Wholesalers forge documentation of legitimacy for counterfeit drugs and pass off as authentic.Doctors and pharmacists purchase from counterfeit drug distributors.

Stolen and partially used medications are re-sold as unused, untampered drugs through clearinghouses back to into the legitimate supply chain.

Counterfeiters send mass quantities through customs packed in disguised packages, i.e. speakers full of fake aspirin, that are then packaged and distributed to pharmacies and stores looking for discounted products.Slide18

An example: Ozay Pharmaceuticals Co

In May 2011, 2 cancer patients in Arizona had immediate bad reactions to chemotherapy medication administered to them in their oncologist’s office.They’d been treated with Altuzan, the Turkish version of a cancer drug sold as Avastin

in the U.S.The “Altuzan” they received contained water and mold, but none of the active ingredient that makes Avastin effective. Slide19

An example: Ozay Pharmaceuticals Co

Those drugs were falsely labeled as giftsSome of them had counterfeit packaging and vial labelingThey were shipped at temperatures too high to maintain their quality

One source of that counterfeit medicine was

Ozkan

Semizoglu, the foreign trade

director of a Turkish company called Ozay Pharmaceuticals. He sold the medicine to a British wholesaler, who sold it to American doctors. In 2013,

Semizoglu also smuggled drugs into the U.S. directly. Slide20

The Path of Fake AvastinSlide21

How are these products marketed?Slide22

How are these products marketed?Slide23

Rick Roberts’ health was threatened by counterfeit medicine

In 2000, university professor Rick Roberts began taking

Serostim, a human growth hormone, to treat weight loss and fatigue related to HIV wasting syndrome.Over time, he noticed stinging at the injection site and inconsistencies in the quantities in the vials.

He learned from his pharmacist that he had been taking fake drugs.

A distributer in Nevada had purchased unapproved

Serostim

that included doses of a women’s fertility drug and contaminated, diluted Serostim. Counterfeits caused Rick 6 months of anxiety and denied him several months of treatment. Unchecked, they could have caused permanent damage.Slide24

Black market Serostim, Nutropin AQ

Between 2000 and 2003, at least 3 different counterfeit operations sold hundreds of boxes of diverted human growth hormone to pharmacies who dispensed them to HIV/AIDS patients and children. Patients who unknowingly purchased these secondhand drugs could not rely on their medicine to help with wasting syndrome, and

they may have been harmed by contaminants,too.One child—a brain cancer survivor—suffered developmental and growth delays after he was treatedwith counterfeit Nutropin

AQ, another growth hormone. Slide25

Black market Serostim, Nutropin

AQThe black market drugs ultimately came from illegal sources—often from patients re-selling their medicine or doctors selling supplies meant for patients.Licensed wholesalers bought questionable medicine from networks of unlicensed distributors who covered their tracks with forged paperwork.

One group laundered more than $2.1 million in funds from the transactions over just 2 years.In the meantime, patients who were very ill paidfull price—more than $1,700 a week—for drugs

that were expired, diluted, damaged, contaminated,

or outright counterfeit. Slide26

Black market HIV & Hep-C testing kits

HIV and Hepatitis-C test kits help people stay healthy and protect their partners. False positives cause tremendous stress. False negatives mean delays in treatment and accidental transmission.Between 2006 and 2008, residents of Louisiana, New Jersey, Ohio and Florida unwittingly bought unapproved HIV and Hepatitis C testing kits.

Florida resident Jonathan Barash had illegally imported the kits from China, repackaged them and sold them as FDA approved devices.(This is still a problem. In 2011,

Canadian and British authorities warned citizens

that

“illegal HIV test kits imported from China for sale online could give an incorrect diagnosis.”) Slide27

Drug diversion of antiretrovirals

Since 2012, investigations have shown that diversion of HIV/AIDS medicines is happening on a massive scale.Patients have been sold secondhand, stolen and expired medicines that have been stored in uncontrolled conditions. There is no guarantee that these medicines are safe or effective.Slide28

Drug diversion of antiretroviralsBetween 2008 and 2012, customers of New York

branches of MOMS Pharmacy were prescribed $274 million in second hand, stolen or expired HIV treatments.In 2012 in New York, the FBI seized more than 33,000 bottles of second-hand AIDS, asthma and schizophrenia drugs and 250,000 loose pills from drug diverters. They were bound for local pharmacies.

Between 2006 and 2009 a Tennessee based company called Cumberland Distribution sold $58 million in HIV/AIDS, antipsychotics and diabetes treatments to pharmacies. Their sources had acquired the drugs from “street level drug diverters.”

Slide29

Selling American patients unsafe medicine is big business

Pharmacists in the MOMS case were paid more than $27 million to sell patients unsafe drugs. Cumberland Distribution made over $14 million in profit.

Defendants in the New York diversion case sold more that $62 million worth of second-hand prescription drugs over a 12-month period. Slide30

“The ringleaders of this complex scheme not only cheated the state Medicaid program out of millions of dollars, but preyed on some of New York’s most vulnerable patients just to make a quick buck.”~ New York Attorney General Eric

SchneidermanSlide31

Strategies for saving money safely

Adopt FDA approved generics if possible.Generic versions of Ziagen, Combivir, Viramune, Retrovir

, Videx and Zerit currently existMore key patents are expiring between now and 2017Slide32

Strategies for saving money safely

Use discount cards. The NeedyMeds DrugDiscount Card can save you as much as 80% on your prescriptionsComparison shop using online tools

Pharmahelper.com compares prices at VIPPS-accredited online pharmacies to find you the best price.WeRx.com, LowestMeds.com and GoodRX.com canfind you the lowest prices in your own neighborhood.Slide33

Strategies for saving money safely

The Partnership for Prescription Assistance (PPA) matches patients who cannot afford medication to prescription assistance programs. Find the program that’s right for you for free at www.pparx.org

. Slide34

How patient advocates can helpEducate people—patients and medical professionals— about the risks of buying medication from unlicensed distributorsBlack market

medicines are being sold outside the regulated drug supply. They are often counterfeit, contaminated, diluted, improperly stored and transported or expired. Substandard medicines may not stop the progress of a patient’s disease and may foster drug resistant HIV.Since 2005, doctors and pharmacists

have paid more than $13.4 million in fines in connection with buying black market drugs. Some have also been sentenced to prison. Slide35

How patient advocates can helpTeach patients to identify illegitimate

medication at the doctor’s office:Ask to see the packaging the drugs came in.Look for accurate labeling, packaging that is in good condition, and product descriptions in English.Keep a record of the lot number of the medicineSlide36

How patient advocates can help

Teach patients to identify illegitimate medication at homeCheck that the packaging is clean and correctly sealed, with instructions in English. Compare it to past packaging. Look for differences in paper, printing, color, and fonts. If you notice changes, do not take the drugs, and show the packaging to your doctor

.Examine the appearance of the medicine. If it looks chipped or cracked, or different from earlier prescriptions, it may be fake. If unsure whether the prescription is genuine, visit

WebMD online to look up the drug's

description

and appearance. Slide37

How patient advocates can helpTeach them to recognize symptoms of ineffective medicinePay attention to changes in the way medicine tastes.

Do not ignore side effects from a new dose of a prescription. New reactions like a stomach ache or a head ache could signal changes to the drug.Note adverse effects or failure of treatment.

If you work with medical professionals, make sure that they are alert to the possibility that patients may be using compromised medication.Slide38

How patient advocates can helpTeach patients and medical professionals what to do if they suspect that there is something wrong with a drug

Patients should contact the pharmacy where you purchased the medicinePatients and medical professionals should contact the FDA and the manufacturer of the medication to report your concerns. The FDA can be contacted by calling toll-free 1-800-FDA-1088 (800-332-1088), or on the Web at www.fda.gov

/medwatch.Slide39

Where can you learn more?Pick up your copy of our report at the conference

today.www.safemedicines.orgThank you for the opportunity to speak to you today.

Jim DahlThe Partnership for Safe Medicines

Register for Interchange 2014

: http://

safedr.ug/CANN2014 Slide40

Register and Attend our Annual Conference - September 18 in DCBuy tickets and use discount code “CANN2014”

to save $100 on registration. http://safedr.ug/CANN2014

Sessions include:New research about counterfeit drugs by Dr. Marv Shepherd, University of Texas, Austin and Dr. Tim Mackey, University of San DiegoNew international developments in the fight against counterfeit medicinesRecent prosecutions of counterfeit drug criminals in the United StatesImpacts on patient safety from counterfeit, unapproved and diverted drugsThe real dangers and fake drugs found at fake online pharmacies

Hear representatives of:

The Department of Justice

The Institute of Medicine

The Pharmaceutical Security Institute

The Office of Criminal Investigations, FDANational Association of Drug Diversion InvestigatorsThe Alliance for Safe Online PharmaciesThe Federal Bureau of InvestigationThe Maine Pharmacy AssociationRegister for Interchange 2014: http://safedr.ug/CANN2014 Slide41

Register and Attend our Annual Conference - September 18 in DCSeptember 18, 2014Knight Conference Center

The Newseum555 Pennsylvania Av., NWWashington, DCBuy tickets and use discount code

“CANN2014” to save $100 on registration.Use this link: http://safedr.ug/CANN2014Keynote speakers:Mississippi Attorney General Jim Hood and

FDA Deputy Commissioner Howard

Sklamberg

Register for Interchange 2014:

http://

safedr.ug/CANN2014