Return of Rx Medication & Pharmacy Practice

Question 1

Prescription medication correctly dispensed to a patient may be accepted for return by the pharmacist but shall not…

Answer 1

be placed back in stock for reuse or resale

Question 2

Prescription medication incorrectly dispensed to a patient shall be accepted for return by the pharmacist and shall not…

Answer 2

be placed back in stock for reuse or resale

Question 3

For purposes of this subsection, a prescription medication shall be considered to be abandoned when a prescription is prepared and made available for dispensing by the pharmacy but is not dispensed to the patient for whom it was prepared within two weeks. Prescription medication that has been prepared for a patient and that is abandoned by a patient, or that has not been dispensed by a long-term care pharmacy to a patient in a long-term care facility, may be placed back in stock for reuse or resale provided that:

Answer 3

In the professional judgment of the pharmacist, the prescription medication is eligible for re-dispensing. Eligible medications are those medications that are able to be consumed by a patient within the original time frame established for the medication’s stability and expiration, were maintained under proper storage conditions to ensure their integrity, and have remained under the exclusive control and custody of the
pharmacy or the patient’s long-term care facility, as applicable, at all times. Products that have a limited shelf life and/or that have not been stored consistent with manufacturers’ storage requirements may not be re-dispensed;

Question 4

The prescription medication shall not be placed in manufacturers’ stock containers of different…

Answer 4

lot numbers and/or with different expiration dates

Question 5

Manufacturers’ stock containers shall not be…

Answer 5

overfilled

Question 6

In those circumstances in which prescription medications cannot be properly returned to the original manufacturers’ stock containers, the medication shall be…

Answer 6

held in the pharmacy in the labeled container in which it has been repackaged. Prior to redispensing, such medications shall be placed in a new container with a new label or the original label shall be removed and the container shall be relabeled;

Question 7

If the manufacturer or the FDA orders a recall of a drug product, the pharmacist shall assume…

Answer 7

products held in labeled containers without lot numbers are included in the recall and proceed accordingly;

Question 8

Medications held for re-dispensing shall be used as soon as possible. Such medications, lacking original lot numbers and expiration dates, shall not be dispensed to patients later than…

Answer 8

one year from the date the medications were originally prepared for dispensing. Re-dispensed medications shall be marked with the same use by date as the medication which was originally prepared for dispensing

Question 9

Unwanted drugs shall be disposed of…

Answer 9

in a manner that does not cause them to become a

health hazard, and in accordance with all local, State, and Federal codes.

Question 10

No outdated, misbranded, deteriorated, improperly stored or adulterated drugs, or any drugs marked “sample” or with any like designation or meaning shall be…

Answer 10

dispensed or placed or maintained in active stock for use or sale.

Question 11

An electronic patient profile system shall be maintained by all pharmacies for persons for whom prescriptions are dispensed. The Patient Profile Record System (PPRS) shall be devised, so as to…

Answer 11

enable the immediate retrieval of current clinical information necessary to enable the dispensing pharmacist to identify previously dispensed medication and patient-specific information at the time a prescription is presented for dispensing.

Question 12

The following information shall be recorded in the PPRS:

Answer 12

1) The family name and the first name of the person for whom the medication is intended (the patient);
2) The address and telephone number of the patient;
3) Indication of the patient’s age, birth date or age group (infant, child, adult) and gender;
4) The original or refill date the medication is dispensed;
5) The number or designation identifying the prescription;
6) The practitioner’s name;
7) The name, strength and quantity of the drug dispensed;
8) Pharmacist’s comments relevant to the patient’s drug therapy; and
9) Any allergies and idiosyncrasies of the patient and any medical conditions that may relate to drug utilization, as communicated by the patient or the patient’s representative.

Question 13

If there are no patient allergies, idiosyncrasies or medical conditions that may relate to drug utilization, such information shall be…

Answer 13

documented in the patient profile record system.

Question 14

The pharmacist shall use professional judgment to review and monitor the patient profile, determine if there should be any adjustment in the original patient information and so…

Answer 14

indicate the appropriate change in the patient profile record.

Question 15

All prescription patients who patronize a pharmacy shall have a profile record as specified by this section, and the pharmacist shall…

Answer 15

inquire as to whether other prescription drugs are being concomitantly utilized in order to establish a current drug history for the patient

Question 16

A patient profile record shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for a period of not less than…

Answer 16

5 years from the date of the last entry in the
profile record. In using an electronic data processing system, the system shall have the
capability of producing retrievable and readable documents of all original and refilled prescription data for a period of not less than five years, including the number of refills authorized by the practitioner. The oldest four years of record information shall be
maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of record information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but offsite facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.

Question 17

If an electronic data processing system is used, the system shall provide adequate…

Answer 17

safeguards against manipulation and alteration of records and to protect the confidentiality of the information contained in the data bank

Question 18

If the pharmacy uses an electronic data processing system, an auxiliary recordkeeping system shall be established when the electronic data processing system is inoperative for any reason. When the electronic data processing system is restored to operation, the…

Answer 18

patient profile information and number of refills authorized during the time the electronic system was inoperative shall be entered into the electronic data processing system within 72 hours.

Question 19

Upon receipt of a new or refill Rx, a pharmacist shall examine the patient’s profile record before dispensing the medication, to determine the possibility of…

Answer 19

a potentially significant drug interaction, reaction or misutilization of the prescription. Upon determining a potentially significant drug interaction, reaction or misutilization, the pharmacist shall take the appropriate action to avoid or minimize the problem, which shall, if necessary, include consultation with the patient and/or the practitioner.

Question 20

Upon receipt of a refill prescription, a pharmacist shall determine if a substantial time, as is appropriate for that drug in the pharmacist’s professional judgment, has elapsed from the last filling. When necessary, the pharmacist shall…

Answer 20

consult with the practitioner and/or the patient to ensure that continued use of the medication is appropriate.

Question 21

When patient profile records indicate sporadic, erratic or irrational use of medication by a patient, the pharmacist shall…

Answer 21

consult with the patient and/or the practitioner to determine if continued use of the medication is appropriate.

Question 22

Before dispensing a new medication, a pharmacist

shall make reasonable efforts to counsel the patient or the patient’s caregiver. Counseling may include the following:

Answer 22

1) The name and description of the medication;
2) The dosage form, dosage, route of administration, and duration of drug therapy;
3) Special directions and precautions for preparation, administration and use by the patient;
4) Common adverse or severe side effects or interactions and contraindications that may be encountered, including how to avoid such side effects, interactions and contraindications, and the action required if they occur;
5) Techniques for self-monitoring drug therapy;
6) Proper storage;
7) Prescription refill information; and
8) Action to be taken in the event of a missed dose.

Question 23

The offer to counsel may be made by pharmacy personnel. However, counseling shall be performed only by a…

Answer 23

a pharmacist, or by a pharmacy intern or pharmacy extern under the immediate personal supervision of a pharmacist

Question 24

A pharmacist shall not be required to counsel a patient or caregiver when…

Answer 24

the patient or caregiver refuses such counseling.

Question 25

If the patient or caregiver is not physically present, the offer to counsel shall be made by…

Answer 25

telephone or in writing on a separate document accompanying the prescription. A written
offer to counsel shall be in bold print, easily read, and shall include the hours a pharmacist is available and a telephone number where a pharmacist may be reached. The telephone service must be available at no cost to the pharmacy’s primary patient population

Question 26

At the time of dispensing, the pharmacist shall document by obtaining…

Answer 26

the signature of the patient or caregiver that counseling was provided or refused.

Question 27

The counseling requirements of this section shall not apply to a pharmacist who…

Answer 27

dispenses any drug to an inpatient at a hospital or a long-term care facility in which the resident is provided with 24-hour nursing care.

Question 28

A pharmacist shall be responsible for the…

Answer 28

processing, accuracy, appropriateness, and

dispensing of the filled prescription

Question 29

If a pharmacist dispenses a biological product, the pharmacist or the pharmacist’s designee shall…

Answer 29

within 5 business days following the dispensing of the biological product, communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer

Question 30

A pharmacist who substitutes a biological product in compliance with this section shall record, on the prescription label and record of dispensing, the…

Answer 30

product name and manufacturer of the biological product dispensed, followed by the words: “Substituted for” and the name of the biological product for which the Rx was written.