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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
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
Conditions of Safe Use
• Specific to drug product
• Could include
– Assistance with self-selection
– Follow up monitoring
– Pharmacist intervention
– Innovative technologies
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
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
Pharmacist Training
•
•
•
•
Two years pre-professional coursework
Four years professional education
Doctor of Pharmacy degree
Postgraduate training
– Certificate training programs
– Fellowships
– Residencies
– Board certification
Protect Patient Information
• Standards for use and disclosure of Protected
Health Information (PHI)
– Restrict unauthorized use
– Permit use when information is related to treatment
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
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