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