FDA Risk Management Workshop:FDA Risk Management Workshop:Concept Paper: Risk Management Concept Paper: Risk Management

ProgramsPrograms

April 10, 2003April 10, 2003

Gary C. Stein, Ph.D.Gary C. Stein, Ph.D.

Director of Federal Regulatory AffairsDirector of Federal Regulatory Affairs

American Society of Health-System American Society of Health-System PharmacistsPharmacists

ASHP CommitmentASHP Commitment

Recent Risk Management PlansRecent Risk Management Plans

Fall short of what is needed.Fall short of what is needed. Lack collaborative patient care Lack collaborative patient care

efforts.efforts.

What we need is fundamental What we need is fundamental reformreform

Package inserts and “Dear Health Package inserts and “Dear Health Professional” letters are not Professional” letters are not adequate.adequate.

Current labeling does not present Current labeling does not present enough information oriented toward enough information oriented toward practice environments.practice environments.

What FDA needs to doWhat FDA needs to do

Collaborate with health care Collaborate with health care practitioners a “core protocol.”practitioners a “core protocol.” Progression from diagnostic workups to Progression from diagnostic workups to

prescribing decisions.prescribing decisions. Adherence would help influence Adherence would help influence

decisions to prescribe or not, based decisions to prescribe or not, based on selection criteria and interaction on selection criteria and interaction liabilities.liabilities.

Include patient counseling and written Include patient counseling and written information.information.

New paradigm is imperativeNew paradigm is imperative

Currently, physicians and Currently, physicians and pharmacists not systematically pharmacists not systematically caring for patients – no similar basis caring for patients – no similar basis of information.of information.

Standardized protocol a viable tool Standardized protocol a viable tool for risk management.for risk management. Basis for collaborative drug therapy Basis for collaborative drug therapy

management relationship between management relationship between prescribers and pharmacists.prescribers and pharmacists.

In the best interests of patients.In the best interests of patients.

FDA going in the right directionFDA going in the right direction

Section II(D) of the concept paper Section II(D) of the concept paper suggests as a goal for a risk suggests as a goal for a risk management program “judicious management program “judicious patient selection for therapy” and patient selection for therapy” and “appropriate prescribing and “appropriate prescribing and dispensing to the appropriate dispensing to the appropriate patient group.”patient group.”

Restricted Drug Distribution Restricted Drug Distribution SystemsSystems

A “tool” being relied upon more and A “tool” being relied upon more and more frequently.more frequently.

Increased reliance of these systems Increased reliance of these systems a growing concern.a growing concern.

Exclude individual hospitals and Exclude individual hospitals and community pharmacies.community pharmacies.

No information on how well these No information on how well these systems work.systems work.

Hope for FDA survey of Hope for FDA survey of pharmacists.pharmacists.

Pharmacists’ Responsibilities Pharmacists’ Responsibilities ThreatenedThreatened

Ensure that medications are readily Ensure that medications are readily available and used properly.available and used properly.

Non-standardized distribution Non-standardized distribution processes create confusion – and processes create confusion – and potential for errors.potential for errors.

Disruption of the central oversight Disruption of the central oversight role of pharmacists interrupts role of pharmacists interrupts standard medication-use policies standard medication-use policies and procedures in health systems.and procedures in health systems.

FDA and ManufacturersFDA and Manufacturers

When a manufacturer implements When a manufacturer implements a restricted distribution, must a restricted distribution, must ensure that patients’ relationship ensure that patients’ relationship with pharmacist not disrupted.with pharmacist not disrupted.

If FDA considers a restricted If FDA considers a restricted system as a condition for system as a condition for approval, must consult with approval, must consult with pharmacists.pharmacists.

ExceptionsExceptions

Despite general principle and goal Despite general principle and goal of standardization, some of standardization, some exceptions will occur.exceptions will occur.

Should be EXTRAORDINARY Should be EXTRAORDINARY exceptions!exceptions!

Prospect of multiple, unique Prospect of multiple, unique restrictive drug distribution restrictive drug distribution systems is frightening.systems is frightening.

Restricted Systems Limit Restricted Systems Limit Pharmacists AbilityPharmacists Ability

Limit ability to develop patient Limit ability to develop patient relationship.relationship.

Prevent pharmacists from providing Prevent pharmacists from providing appropriate checks, counsel, appropriate checks, counsel, monitoring, and follow0up.monitoring, and follow0up.

Hospitalized Patients Rarely Hospitalized Patients Rarely ConsideredConsidered

Medications initiated or continued.Medications initiated or continued. Acquisition of medications in timely Acquisition of medications in timely

mannermanner Adverse effect on care and cost.Adverse effect on care and cost.

Need for models for managing Need for models for managing patientspatients

Patients for whom ANY high-risk Patients for whom ANY high-risk drug product might be indicated.drug product might be indicated.

Incorporate core protocols.Incorporate core protocols. Focus on requirements for Focus on requirements for

ensuring appropriate use and ensuring appropriate use and monitoring.monitoring.

This system could answer a This system could answer a number of concerns.number of concerns.