pharm law lecture 15

-required in Wi for all new and refill prescriptions
-OFFER to counsel DOES NOT meet this requirement
-exception: when the Rxc is delivered to the patient by an agent of the pharmacist - should be given info and phone number to call if consultation is desired, and written info provided
Counseling Standards:
-name and description of the medication
-dosage form, route of administration, and duration of drug therapy
-special directions and precautions for prepatration, administration, and use by the patient
-common severe SEs, adverse effects, or interactions and therapeutic contraindications that may be encountered, including ways tp prevent them and the action required if they so occur
-tecniques for self-monitoring drug therapy
-proper storage
-prescrption refill information
-action to be taken in the event of a missed dose

*there are no FDA rules and regs in place saying that written info must be given to patients
*Voluntary written information = 95% of patient receiving new Rxs must get useful written information
-FDA guidelines for content of written info do exist

a type of written information that is required for oral contraceptives and progestational drugs used as oral contraceptives
-federally required, otherwise misbranding
-manufacturers provide PPIs, and then pharmacist gives to patient
Community setting: PPI must be given with each new and refill container dispensed
Inpatient setting: PPI given with first does and every 30 days

-federally required for select products where:
-patient labeling could prevent serious adverse effects
-serious risks relative to the benefits that patient needs to know
-patient adherence to directions is crucial for effectiveness of drug

a record of all the meds that a patient has every had filled at a particular pharmacy
for each Rx, should include:
-patient name and address
-birth date of patient, if obtainable
-name, strength, and dosage form of drug dispensed
-quantity of drug dispensed
-directions for use
-retrieval designation assigned to Rx order (Rx number)
-date of all instances of dispensing, new and refill
practitioner ID
-tech can collect this info, but only if NON-JUDGMENTAL (if any confusion, pharmacist should clarify)