Prescription Drug Importation: Can it Help America's Seniors? Safety of Imported Medications: I-SaveRx Case Study

Transcription

1 Prescription Drug Importation: Can it Help America's Seniors? Safety of Imported Medications: I-SaveRx Case Study Presented By: Scott McKibbin Special Advocate For Prescription Drugs State Of Illinois

2 Presentation Topics State of Illinois International Drug Studies Canadian Prescription Drugs European Union Prescription Drugs Personal Importation Parallel Imports Safety and supply-chain integrity issues I-SaveRx 2

3 Background According to the World Health Organization, U.S. residents spend more money on health care than residents of all other countries in the world. In 2001, the average cost of a prescription drug was $71.18, an increase of 162% from Almost 70 million Americans lack prescription drug coverage. 3

4 Pharmaceutical Revenue Allocations, 2000* Company Merck % of Revenue Allocated to Marketing, Advertising, Administration 15% % Allocated to R&D 6% Pfizer 39% 15% Bristol- Myers Squibb Allergan 30% 42% 11% 13% *All figures from Families USA, Off the Charts: Pay, Profits and Spending in Drug Companies, July 2001, 4

5 State of Illinois International Drug Studies 5

6 Central Policy Issues Can Illinois Residents and Businesses Safely and Effectively Purchase Prescription Drugs from Europe? Can Illinois State Employees and Retirees Safely Purchase Prescription Drugs in Canada at a Lower Cost to the Taxpayers? 6

7 Study Team Interdisciplinary Medical Doctor Pharm.D. R.Ph. Ph.D. JD 7

8 Study Team (Continued) Multi-Agency Department of Public Health Department of Public Aid Department of Professional Regulations Central Management Services Department of Human Services Governor s Office 8

9 Primary Research Teams traveled to Canada and Selected EU Member States Versus Requiring Interested Parties Testify in Washington New York Mail Facility Reports Are Annotated Team Members Had No Financial Interest In Study Outcome 9

10 Regulation of Pharmacies Regulatory systems in Canada, Europe (Select EU Member States), and US provide substantially equivalent protection for the health and safety of the public Findings Methods of ensuring safety and efficacy of prescription drugs are comparable. Requirements for manufacturing, warehousing and storage of pharmaceuticals are comparable. Pricing and Distribution of pharmaceuticals is less likely to foster drug counterfeiting. 10

11 Regulation of Pharmacies Pharmaceutical dispensing requirements are substantially equivalent Educational requirements and professional regulation of pharmacists are equally rigorous Incident reporting of internal process errors was more rigorous in the Canadian provinces of Manitoba and Ontario than in the State of Illinois 11

12 Findings: Consumer Safety Safeguards: Patients would be required to submit medical history, current medications, and allergies Drugs that could be imported would be restricted to those deemed clinically appropriate and unlikely to spoil in transit. No habit-forming pain medications No antibiotics for acute illnesses No generics 12

13 Consumer Safety Patients can only import drugs prescribed by a doctor in US and first filled in a local pharmacy for a month. Vendors will supply drugs only in sealed packages obtained from wholesalers supplied directly from manufacturers Each patient would select a Primary Care Pharmacist who would coordinate pharmaceutical care incorporating prescriptions obtained through local retail pharmacies, domestic mail order pharmacy, and Canadian Mail Order Plan 13

14 Proposed Plan: Summary Contract with a non-domestic Pharmacy Benefits Manager (PBM) or similar entity Establish a Primary Care Pharmacist (PCPh) Model (State of Illinois Employees and Retirees) Require the employees and retirees to pay only the shipping cost for drugs obtained from Canadian sources 14

15 Proposed Plan: Drugs The program drugs include long term use, brand name drugs approved in the US by the FDA. The following types of drugs are not included: Antibiotics Controlled substances Drugs that are likely spoil during transit Generics Over The Counter (OTC) Drugs Medications otherwise deemed unsuitable for transportation 15

16 Domestic Medication Supply Chain Example Manufacturer ( 55 Gallon Drum ) 1 st Wholesaler/Repack (5,000 Units) 2 nd Wholesaler/Repack (1,000 Units) 3 rd Wholesaler/Repack (500 units) 4 th Wholesaler (or 5 th, 6 th, or 7 th ) Pharmacy Patient (Per Doctor s Script) 16

17 U.S Drug Distribution Models 17

18 Parallel Importation Wholesale Drug Distributors and Parallel Importers: Demonstrated and Maintained a Chain of Custody Qualified Person (QP as a technical qualification) met all of the requirements for experience in the field of pharmaceutical manufacturing. Standard operating procedures incorporating the Good Manufacturing Practices (GMP) were utilized for repackaging Entities had a valid license to participate in wholesale drug distribution Drugs were stored under conditions of proper temperature and humidity Secure sites with security systems in place were maintained Quarantine areas were maintained separately and distinctly from the general area 18

19 EU Guide to GMP Specifically Provides compliance and regulatory guidelines on who: May trade and/or take possession Repack Manipulate Distribute, or Store Pharmaceutical Products. 19

20 Parallel Import Traceability Documents Must Be Maintained By The Parallel Importer To Assure Traceability: The identity of the original manufacturer; Addresses of the original manufacturer; Purchase orders; bills of lading (tracking documents between the carrier and shipper); Receipt documents; Name or designation of the product; Manufacturer s batch number; Transportation and distribution records; All authentic Certificates of Analysis of the products received, including those of the original manufacturer; Any retest or expiry dates of the products obtained. 20

21 Canadian & European Distribution Models 21

22 I-SaveRx Offers more safety, accountability and regulation than the existing system of uncontrolled personal importation Stringent system of quality controls and multiple safety checks: Only refill prescriptions are filled Only licensed and state-inspected pharmacies participate in I-SaveRx I-SaveRx pharmacies required by contract to follow same standards used by Illinois pharmacies (and those of member States), including storage, warehousing, and dispensing standards State of Illinois regulatory agencies inspect all participating pharmacies on ongoing basis 22

23 I-SaveRx When order is placed, the Pharmacy Benefits Manager: Verifies that medication is eligible for dispensing Conducts a full US-based Drug Utilization Review (DUR) using First Databank software used by US pharmacies I-SaveRx program physician, licensed in selected country, will: Review the entire health history file and refill prescription If necessary, contact original physician to discuss questions/concerns I-SaveRx network pharmacy conducts final checks before shipping prescription: Pharmacist conducts another of safety checks in compliance with local law Prints information packets with same information (First Databank) provided by US pharmacies 23

24 I-SaveRx Current States State of Wisconsin State of Missouri State of Kansas Vermont Legislature Approves Bills, Requiring VT Join I-SaveRx Similar Bills Pending in Minnesota, Connecticut, West Virginia, and Tennessee 24

25 I-SaveRx Medication Supply Chain Manufacturers (sealed one month supply) Blister Packed typically in 28 or 30 units Wholesaler or Manufacturers Agent Pharmacy Patient (Via Traceable System) 25

26 State Sponsored Websites The Fight For Affordable Drugs I-SaveRx: Safe and Affordable Prescription Drugs 26