1. Comments to the FDA on Conditions of Safe Use To Expand Which Drug Products Can Be Considered Nonprescription
Marissa Schlaifer, RPh
Director of Pharmacy Affairs
Academy of Managed Care Pharmacy

2. Academy Of Managed Care Pharmacy
AMCP is a national professional association
Pharmacists and other health care practitioners
> 6,000 members
Provide clinical, educational and business management services and strategies on behalf of the > 200 million Americans covered by managed care pharmacy benefits

3. Conditions of Safe Use Specific to drug product Could include
Assistance with self-selection
Follow up monitoring
Pharmacist intervention
Innovative technologies

4. Choice of Medications
Selection must be based on clinical effectiveness and safety, such as drug to treat illnesses that:
Require limited physical assessment
Can be identified by easily interpreted lab tests
Drug products should have
Low risk when used appropriately
Sufficient testing/experience to ensure safety and effectiveness
Uncomplicated instructions for use

5. Pharmacist Processes Ordering and dispensing should be standardized
Pharmacies should develop further documentation and reporting
Electronic health records (EHRs) are ideal to exchange this data with prescribers
Clinical evaluation and intervention before dispensing
Counseling on safe use

6. Pharmacist Training Two years pre-professional coursework
Four years professional education
Doctor of Pharmacy degree
Postgraduate training
Certificate training programs
Fellowships
Residencies
Board certification

7. Protect Patient Information
Standards for use and disclosure of Protected Health Information (PHI)
Restrict unauthorized use
Permit use when information is related to treatment

8. Public Benefit
Patients do not always schedule appointments with physicians
Especially for minor illnesses
Could provide access to treatment regimens
Foster a pharmacist-patient relationship
Pharmacists would refer patients to physicians when more in-depth treatment is needed

9. Public Benefit (cont’d)
Increased disease awareness by patients
Greater patient participation in his/her treatment
Reduction on burden on emergency departments
Greater access to treatments through pharmacies