A manual patient medication record system consists of the hard copy of the original prescription and a card or filing procedure that contains all data on new and refill prescriptions for a patient. This data must be organized in such a fashion that information relating to all prescription drugs used by a patient will be reviewed each time a prescription is filled.

(1) All manual patient medication record systems must maintain the following information with regard to ambulatory patients:

(a) Patient's full name and address.

(b) A serial number assigned to each new prescription.

(c) The date of all instances of dispensing a drug.

(d) The identification of the dispenser who filled the prescription.

(e) The name, strength, dosage form and quantity of the drug dispensed.

(f) The prescriber's name, address and DEA number where appropriate.

(g) Any patient allergies, idiosyncrasies or chronic conditions which may relate to drug utilization. If there is no patient allergy data the pharmacist should indicate none or "NKA" (no known allergy) on the patient medication record.

(2) All manual patient medication record systems must maintain the following information with regard to institutional patients:

(a) Patient's full name.

(b) Unique patient identifier.

(c) Any patient allergies, idiosyncrasies, or chronic conditions which may relate to drug utilization. If there is no patient allergy data the pharmacist should indicate none or "NKA" (no known allergy) on the patient medication record.

(d) Patient location.

(e) Patient status, for example, active, discharge, or on-pass.

(f) Prescriber's name, address and DEA number where required.

(g) Minimum prescription data elements:

(i) Drug name, dose, route, form, directions for use, prescriber.

(ii) Start date and time when appropriate.

(iii) Stop date and time when appropriate.

(iv) Amount dispensed when appropriate.

(h) The system shall indicate any special medication status for an individual prescription, for example, on hold, discontinued, self-administration medication, investigational drugs, patient's own medications, special administration times, restrictions, controlled substances.

(i) The system shall indicate on the labeling, and in the system, (for the pharmacist, nursing and/or physician alert) any special cautionary alerts or notations deemed necessary by the dispenser for the patient safety.