# Presentation: 841528

## Slide 2

## Patient Information as a Means to Decrease Adverse Events with Medications

- Thomas J. McGinnis, R.Ph.
- US Food and Drug Administration

## Trends in Medication-Related Patient Information

- The number of retail prescriptions was expected to rise 6.0% to 2.8 billion in 1999 and to 4 billion in 2004.
- Most consumers, 70% according to a 1998 FDA survey, say they receive written information when they pick up their prescriptions.
- The quality and understandability of prescription information is uneven.

## Cost of Medication Misuse

- The FDA estimates that the cost of hospitalizations caused by the inappropriate use of prescription medicines is about $20 billion annually.
- A study published in the Archives of Internal Medicine estimates that drug-related morbidity and mortality in the ambulatory care setting in the US costs almost $77 billion annually in 1995.

## Compliance Issues

- A review of the literature shows that lack of information about prescription drugs is one of the main reasons 30 to 50 percent of patients do not follow their prescribed treatment regimens.
- The public needs comprehensive information on prescription medications and health care products.

## Background: Patient Information

- FDA began requiring warnings on isoproterenol inhalation products in 1968.
- FDA began requiring written information with oral contraceptives and other hormone based products in 1970.
- FDA proposed patient package insert (PPI) rule for 10 drugs or drug classes (375 medications) in 1979.

## Background: MedGuide Proposal

**1993**
**1995**
**1996**

- Section 4401(g) of OBRA ‘90, required pharmacists counsel Medicaid recipients, more than 40 states applied requirement to all consumers
- FDA published “Prescription Drug Product Labeling: Medication Guide Requirements”
- FDA convened a workshop on the MedGuide proposal

## Background: MedGuide Debate

**1996**

- Public Law 104-180 “Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act”
- Prescription Drug Information for Patients: Notice of Request for Collaboration to Develop an Action Plan
- Action Plan for the Provision of Useful Prescription Medicine Information: Submitted 12/13/96 and Approved 1/13/97

## Background: MedGuide Debate

**1998**
- 1999

- Prescription Drug Product Labeling, Medication Guide Requirements: Final Rule Issued 12/1/98
- MedGuide Final Rule Effective 6/1/99

## Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act 1997

- Patient information for new prescriptions:
- 75% distribution by 2000
- 95% distribution by 2006
- Action plan to allow voluntary distribution of information by the private sector
- Review action plan accomplishments by 1/1/01
- Assess “Quantity” and “Quality” of distributed information

## What is Useful Information?

- Name
- Warnings “Black Box”
- Indication for use
- Contraindications
- Precautions
- Possible adverse reactions

- Tolerance or dependence
- Proper use
- Storage instructions
- General information
- Disclaimer

## MedGuide: Final Rule

- Published 12/1/98, effective 6/1/99
- 5-10 products yearly (60-70 products leaflets now)
- Accompany prescriptions (new and refills)
- Indications:
- Help prevent serious adverse effects
- Serious risk versus benefit ratio
- Adherence to directions impacts effectiveness
- Manufacturer responsible for MedGuide

## MedGuide: Final Rule

- Broader use of MedGuides will be considered in 2000
- “Quality” survey completed in the fall of 1999
- Feedback to information producers expected in early 2000
- Outreach campaigns by FDA and others to consumers on the importance of understanding and avoiding risks

## Summary 

- Pharmacists are accessible, respected members of your community   -   CONTACT THEM, USE THEM!
- Collaboration is Key!
- Pharmacists are involved in population based healthcare.
- The time to collaborate is now         (pharmacists and students).

## Contact Information

- American Pharmaceutical Association (APhA)
- www.aphanet.org
- Mitch Rothholtz
- 1-800-237-2742 x 7549
- _[Mcr@mail.aphanet.org](mailto:Mcr@mail.aphanet.org)_

## Contact Information (cont)

- Schools of Pharmacy
- 	- Jean Schreck
- 	-_[Schreck](mailto:Schreck_99@yahoo.com)__[_99@yahoo.com](mailto:Schreck_99@yahoo.com)_
- National Association of Boards of Pharmacy (NABP)
- http://www.nabp.org

## Contact Information 

- Thomas McGinnis, RPh
- Deputy Associate Commissioner for Health Affairs, Food and Drug Administration
- 5600 Fishers Lane, Room 15-36
- Rockville, Maryland 20857
- Phone: 301-827-6597
- Fax: 301-443-1309
- Email: tmcginni@oc.fda.gov