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Non-FDA approved foreign drugs are being provided to vulnerable patients in Massachusetts Todd Brown Massachusetts Independent Pharmacists Association
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PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

Jun 21, 2015

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Page 1: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

Non-FDA approved foreign drugs are being provided to vulnerable patients in

MassachusettsTodd BrownMassachusetts Independent Pharmacists Association

Page 2: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• Lack of active ingredient.• Expired medication

repackaged with fake expiration dates.

• Toxic fillers such as roach poison, road paint, etc.

• Lack of safety information that endangers the patient.

What is the Danger?

Page 3: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

Why is this occurring?

• Ignorance

• Unaware of the dangers

• Sold a tale of lies

+

Mostly greed

Page 4: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• Patients are told they are receiving medication from countries that have FDA-approved facilities.

• Marketing materials claim “The FDA and Health Canada (FDA equivalent) have had a Memorandum Of Understanding for decades regarding safety standards for Rx medications.”

• Medications come from “Tier 1 Countries.”

Vague statements mislead patients to think the medications are from “safe” countries

Page 5: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• Pharmacist/Pharmacy License cannot be reviewed. No recourse if a problem occurs.

Even if these were “safe” countries

Page 6: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• Pharmacist/Pharmacy License cannot be reviewed. No recourse if a problem occurs.

• No or limited access to patient records to prevent drug interactions (“Does this medication interact with another condition I have or another medication I’m taking?”).

Even if these were “safe” countries

Page 7: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• Pharmacist/Pharmacy License cannot be reviewed. No recourse if a problem occurs.

• No or limited access to patient records to prevent drug interactions (“Does this medication interact with another condition I have or another medication I’m taking?”).

• No ability to talk with a pharmacist (“should alcohol or OTC medications be avoided?”) and no safety packaging (childproof caps).

Even if these were “safe” countries

Page 8: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• Self-funded insurers (cities, towns, school districts, etc) organize into larger groups to purchase a variety of services.

• Those that purchase various healthcare services for employees and retirees are known as health groups or trusts.

• Health care services include insurance, dental, vision and prescription drug coverage.

How it works - Overview

Page 9: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• The health groups contract with Group Benefit Strategies (GBS) a health care consulting firm located in MA. GBS uses Prescription Benefit Services, Inc. (PBS) a for profit insurance advisor located MA (same ownership) to provide pharmacy benefit management services.

• PBS directs customers to use a web-based tool (myMedication Advisor) developed by a for-profit company, Abucus Group located in Rhode Island.

How it works in MA – Rx Medications

Page 10: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• Patients provide prescription information through the web tool myMedication Advisor.

• This information is reviewed by a pharmacist to determine if it can be purchased for less outside the US. If so the patient is directed to the Canadian Mail Order Pharmacy “CanaRx.”

• CanaRx obtains the medications from wholesalers and retailers in Canada, United Kingdom, Australia, and New Zealand.

How it works in MA – Rx Medications

Page 11: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• The medication from the wholesaler or retailer is shipped to the patient at no charge.

• CanaRx bills the health care group or trust for the cost of the medication. Each self-funded insurer is then billed for the medications used by their employees/retirees.

How it works – Financial Incentives

Page 12: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

How it worksGBS PBS

myMedication Advisor

Page 13: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

How it worksmyMedication Advisor CanaRx - meds from

wholesaler or retailer

Financial incentives for the patient and self-funded insurer

Page 14: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• Cape Cod Municipal Health Group - fifty-three (53) participating governmental units on the Cape & Martha’s Vineyard with 10,662 health plan contracts and 20,818 members.

• West Suburban Health Group - seventeen (17) participating governmental employers with 12,092 health plan contracts and over 22,632 covered members.

Participating Health Groups & Trusts

Page 15: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• Minuteman Nashoba Health Group - seventeen (17) participating governmental employers plus one affiliated member with 3,966 health plan contracts and over 7,678 covered members.

• Scantic Valley Regional Health Trust – four (4) towns and two (2) school districts.

• Amherst Pelham Regional Health Insurance Trust - two (2) towns and one school district.

Health Groups & Trusts (continued)

Page 16: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

How big is the problem?

Page 17: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

Does the problem exist elsewhere?

Page 18: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• Over the last nine months, the Massachusetts Independent Pharmacists Association (MIPA) has used Freedom of Information Act (FOIA) requests to obtain documents and contracts about these programs.

Documents available

4 towns have materials that are forthcoming. We also have an additional 38 pages of documentation from our independent research.-Eva Reffell
Page 19: PSM Interchange 2014 Panel 3: Todd Brown: Non-FDA Approved Foreign Drugs Are Being Provided to Vulnerable Patients in Massachusetts

• Food and Drug Administration• Department of Labor• Massachusetts Attorney General• Massachusetts Board of Registration in

Pharmacy• Individual Health groups/trusts

Next Steps – Avenues for Intervention

4 towns have materials that are forthcoming. We also have an additional 38 pages of documentation from our independent research.-Eva Reffell