1. FDA Risk Management Workshop: Concept Paper: Risk Management Programs April 10, 2003 Gary C. Stein, Ph.D. Director of Federal Regulatory Affairs American Society of Health-System Pharmacists

2. ASHP Commitment

3. Recent Risk Management Plans Fall short of what is needed. Fall short of what is needed. Lack collaborative patient care efforts. Lack collaborative patient care efforts.

4. What we need is fundamental reform Package inserts and “Dear Health Professional” letters are not adequate. Package inserts and “Dear Health Professional” letters are not adequate. Current labeling does not present enough information oriented toward practice environments. Current labeling does not present enough information oriented toward practice environments.

5. What FDA needs to do Collaborate with health care practitioners a “core protocol.” Collaborate with health care practitioners a “core protocol.” Progression from diagnostic workups to prescribing decisions. Progression from diagnostic workups to prescribing decisions. Adherence would help influence decisions to prescribe or not, based on selection criteria and interaction liabilities. Adherence would help influence decisions to prescribe or not, based on selection criteria and interaction liabilities. Include patient counseling and written information. Include patient counseling and written information.

6. New paradigm is imperative Currently, physicians and pharmacists not systematically caring for patients – no similar basis of information. Currently, physicians and pharmacists not systematically caring for patients – no similar basis of information. Standardized protocol a viable tool for risk management. Standardized protocol a viable tool for risk management. Basis for collaborative drug therapy management relationship between prescribers and pharmacists. Basis for collaborative drug therapy management relationship between prescribers and pharmacists. In the best interests of patients. In the best interests of patients.

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

8. Restricted Drug Distribution Systems A “tool” being relied upon more and more frequently. A “tool” being relied upon more and more frequently. Increased reliance of these systems a growing concern. Increased reliance of these systems a growing concern. Exclude individual hospitals and community pharmacies. Exclude individual hospitals and community pharmacies. No information on how well these systems work. No information on how well these systems work. Hope for FDA survey of pharmacists. Hope for FDA survey of pharmacists.

9. Pharmacists’ Responsibilities Threatened Ensure that medications are readily available and used properly. Ensure that medications are readily available and used properly. Non-standardized distribution processes create confusion – and potential for errors. Non-standardized distribution processes create confusion – and potential for errors. Disruption of the central oversight role of pharmacists interrupts standard medication-use policies and procedures in health systems. Disruption of the central oversight role of pharmacists interrupts standard medication-use policies and procedures in health systems.

10. FDA and Manufacturers When a manufacturer implements a restricted distribution, must ensure that patients’ relationship with pharmacist not disrupted. When a manufacturer implements a restricted distribution, must ensure that patients’ relationship with pharmacist not disrupted. If FDA considers a restricted system as a condition for approval, must consult with pharmacists. If FDA considers a restricted system as a condition for approval, must consult with pharmacists.

11. Exceptions Despite general principle and goal of standardization, some exceptions will occur. Despite general principle and goal of standardization, some exceptions will occur. Should be EXTRAORDINARY exceptions! Should be EXTRAORDINARY exceptions! Prospect of multiple, unique restrictive drug distribution systems is frightening. Prospect of multiple, unique restrictive drug distribution systems is frightening.

12. Restricted Systems Limit Pharmacists Ability Limit ability to develop patient relationship. Limit ability to develop patient relationship. Prevent pharmacists from providing appropriate checks, counsel, monitoring, and follow0up. Prevent pharmacists from providing appropriate checks, counsel, monitoring, and follow0up.

13. Hospitalized Patients Rarely Considered Medications initiated or continued. Medications initiated or continued. Acquisition of medications in timely manner Acquisition of medications in timely manner Adverse effect on care and cost. Adverse effect on care and cost.

14. Need for models for managing patients Patients for whom ANY high-risk drug product might be indicated. Patients for whom ANY high-risk drug product might be indicated. Incorporate core protocols. Incorporate core protocols. Focus on requirements for ensuring appropriate use and monitoring. Focus on requirements for ensuring appropriate use and monitoring. This system could answer a number of concerns. This system could answer a number of concerns.