NMBOP: 16.19.07 HOSPITAL PHARMACIES

Question 1

Q: Who is responsible for overseeing the hospital pharmacy?

Answer 1

A: There shall be a pharmacist-in-charge of the hospital pharmacy. The pharmacist-in-charge may be employed part-time or full-time as the activity of service requires.

Question 2

Q: How frequently must the pharmacist-in-charge visit the facility if they are employed part-time?

Answer 2

A: When services are provided on a part-time basis, the pharmacist-in-charge or designated pharmacist shall visit the facility at least every 72 hours. Visitation schedules exceeding 72 hours must request Board approval.

Question 3

Q: What support should the pharmacist-in-charge have?

Answer 3

A: The pharmacist-in-charge shall be assisted by an adequate number of competent and qualified personnel.

Question 4

Q: What must be included in the pharmacy policy and procedure manual?

Answer 4

A: A pharmacy policy and procedure manual shall be prepared by the pharmacist-in-charge and readily available. The manual shall be reviewed annually for the purpose of establishing its consistency with current hospital practices and the process documented.

Question 5

Q: What is the process for submitting the pharmacy policy and procedure manual?

Answer 5

A: A copy of the manual shall be submitted to the Board or its agent for review and approval at the time of the hospital license application. Any subsequent changes shall be reviewed by the Board or its agent.

Question 6

Q: What security measures must be in place for the hospital pharmacy when a pharmacist is not present?

Answer 6

A: The hospital pharmacy shall be enclosed and locked if a pharmacist is not present in the facility. Adequate security systems shall be maintained and be consistent with the security plan of the facility.

Question 7

Q: How should access to the pharmacy be controlled and what is required for emergency access?

Answer 7

A: The pharmacist-in-charge shall control access to the pharmacy and develop an emergency access procedure that may include the following:
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1. The hospital administrator or designee may possess a key to the pharmacy for emergency access.
2. For the purposes of withdrawing limited doses of a drug for administration in emergencies when the pharmacy is closed, if the drugs are not available in floor or emergency drug supplies, the following is applicable:
- Only one designated licensed nurse per shift may remove drugs from the pharmacy. The quantity of drugs shall not exceed the quantity needed to last until the pharmacist is in the facility.
- A record shall be made at the time of withdrawal by the authorized person removing the drugs. The record shall contain the following:
- Name of patient;
- Name of drug, strength, and dosage form;
- Dose prescribed;
- Quantity taken;
- Time and date; and
- Signature (first initial and last name or full signature) or electronic signature of person making the withdrawal.
- The original or direct copy of the medication order may substitute for such record, providing the medication order meets all of the requirements of the record.
- The nurse withdrawing the drug shall place upon the record of withdrawal an example of the medication removed.
- An electronic record of the withdrawal is required when the nurse is withdrawing more than a 72-hour supply.
- The pharmacist shall verify the withdrawal after a reasonable interval, but in no event may such interval exceed 72 hours from time of withdrawal. Verification may be accomplished electronically from a remote site, if approved by the board.
- A drug regimen review, pursuant to a new medication order, will be conducted by a pharmacist either on-site or by electronic transmission within 24 hours of the new order.
- Another duly registered pharmacy may supply medications pursuant to a patient-specific medication order provided:
- Supplying pharmacy is licensed in this state;
- Supplying pharmacist is licensed in this state;
- All pharmacy preparations of sterile products (including total parenteral nutrition and chemotherapy) shall be performed in accordance with board of pharmacy 16.19.36 NMAC.

Question 8

Q: Can drugs be prepackaged for emergency withdrawal?

Answer 8

A: Yes, the pharmacist-in-charge or designated pharmacist, intern, or technician may prepackage drugs for emergency withdrawal.

Question 9

Q: What is required regarding pharmacist availability when not physically present in the facility?

Answer 9

A: A pharmacist shall be “on call” during all absences from the facility.

Question 10

A hospital pharmacy shall have within the institutional facility it services sufficient floor space allocated to ensure that pharmaceutical services are provided in an environment which allows for the proper compounding, dispensing and storage of medications. The minimum required pharmacy floor space excluding office area is:

Answer 10

Question 11

Q: How is the adequate square footage for a hospital pharmacy determined?

Answer 11

A: Adequate square footage will be decided by the board at the time of licensure. The yearly license application will be accompanied by photos and a drawing of the pharmacy area. The board may ask for more detailed information to make a determination.

Question 12

Q: How can a hospital obtain a specialty designation from the board?

Answer 12

A: A hospital must petition the board for a specialty designation. The board may consider, but is not limited to, the following:

Size of facility;
Type of patient population; or
Number and types of drugs stored and dispensed from the pharmacy.

Question 13

Q: What equipment is required for a hospital pharmacy?

Answer 13

A: The hospital pharmacy shall have the necessary equipment for the safe and appropriate storage, compounding, packaging, labeling, dispensing, and preparation of drugs and parenteral products depending on the scope of pharmaceutical services provided. This includes:

Refrigerator.
Sink with hot and cold water.

Question 14

Q: How many pharmacy technicians can be present in the pharmacy when the pharmacist is not in the facility?

Answer 14

A: Only one registered or certified pharmacy technician may be present in the pharmacy when the pharmacist is not in the facility, and only to perform clerical tasks. A written log shall be maintained of technician activities while alone in the pharmacy.

Question 15

Q: What is a pharmacy service unit?

Answer 15

A: A pharmacy service unit:
- Is a separate entity from the central hospital pharmacy, within the same physical building;
- Provides limited and/or specialized inpatient pharmacy services with a minimum of 100 square feet;
- Has the necessary space, references, and equipment to perform the pharmacy service to be provided.

Question 16

Q: What are the requirements for storing controlled substances in a Pharmacy Service Unit?

Answer 16

A: If controlled substances are stored in and/or dispensed from the Pharmacy Service Unit, a locked storage space must be provided and used to store all controlled substances.

Question 17

Q: What license covers the Pharmacy Service Unit?

Answer 17

A: The Pharmacy Service Unit shall be covered by the hospital pharmacy license.

Question 18

Q: What is required regarding pharmacist availability in the Pharmacy Service Unit?

Answer 18

A: A pharmacist shall be available to the Pharmacy Service Unit during operational hours.

Question 19

Q: Who may be present in the Pharmacy Service Unit during operational hours and under what conditions?

Answer 19

A: A pharmacist shall control access to the Pharmacy Service Unit. Pharmacy technician(s) or intern(s) may be present in the Pharmacy Service Unit during operational hours when the pharmacist is present in the facility.

Question 20

Q: What is required for drug storage and distribution in hospitals without a pharmacy?

Answer 20

A: In hospitals where there is not a pharmacy, prelabeled, prepackaged medications shall be stored in and distributed from a drug storage area or automated medication management system, which is under the supervision of a pharmacist.

Question 21

Q: Who is responsible for the procurement and storage of all drugs in a hospital?

Answer 21

A: The pharmacist-in-charge shall have the responsibility for the procurement and storage of all drugs.

Question 22

Q: How must medications be issued for inpatient use?

Answer 22

A: All medications, with the exception of those for emergency use, shall be issued for inpatient use pursuant to the review of the physician’s order or direct copy thereof, prior to dispensing. If the pharmacy is closed when the order is written, the pharmacist shall review the order within 24 hours.

Question 23

Q: What information must be included in the medication profile for inpatients and outpatients?

Answer 23

A: A medication profile for all inpatients and outpatients shall be maintained and used. The medication profile shall serve as the distribution record for inpatient medications. Dangerous drug distribution records, for inpatient use, must include the following information:
- The patient’s name and room (or bed) number;
- The name, strength, quantity, and dosage form of the drug distributed;
- The name of the technician filling the drug order and pharmacist responsible for checking the technician’s work;
- The name of the pharmacist or pharmacist intern filling the drug order;
- The date filled;
- The date and amount of unwanted/unused drug returned to the pharmacy stock;
- Records for schedule II controlled substances must be kept separate;
- Schedule III-V must be kept separate or if stored with non-controlled records, readily retrievable.

Question 24

Q: What are the requirements for floor stock dangerous drug distribution records?

Answer 24

A: Floor stock dangerous drug distribution records must include the following:
- Name, strength, dosage form, and quantity of the drug distributed;
- Date of filling;
- Name of the technician filling the drug order and the supervising pharmacist;
- The name of the pharmacist or pharmacist intern filling the drug order;
- The destination location of the drug in the hospital;
- The date and quantity of unwanted/unused drug returned to the pharmacy’s stock;
- Schedule II controlled substance records must be kept separate from all other records;
- Schedule IV controlled substance records must either be kept separate from other non-controlled substances records or are readily retrievable.

Question 25

Q: How should dangerous drug distribution records, inpatient and floor stock, and medication profiles be stored?

Answer 25

A: Dangerous drug distribution records, inpatient and floor stock, and medication profiles may be stored electronically if such a system is capable of producing a printout of all the required information and the information is retrievable within 72 hours upon demand. The pharmacist stating that it is a true and accurate record must certify the printout. Hospitals utilizing automated drug distribution must comply with Subsection M of 16.19.7.11 NMAC in lieu of the above. Hospital pharmacies are subject to all applicable state and federal record-keeping requirements when a prescription from a licensed practitioner is filled.

Question 26

Q: What must be maintained for controlled substances in a hospital pharmacy?

Answer 26

A: A distribution system for controlled substances shall be maintained including a perpetual inventory of all schedule II controlled substances. All schedule II controlled substances that are stored in the pharmacy will be kept in a locked storage area in the pharmacy.

Question 27

Q: Who is responsible for drug storage and preparation areas within a facility?

Answer 27

A: Drug storage and preparation areas within the facility shall be the responsibility of the pharmacist-in-charge. All areas shall be inspected on a monthly basis and documented by a pharmacist, intern, or technician.

Question 28

Q: What are the regulations for floor stock drugs?

Answer 28

A: Floor stock drugs, including those issued from automated medication management systems, shall be limited to drugs for emergency use and routinely used items as listed in the pharmacy policy and procedure manual and approved by the pharmacy and therapeutics committee. Floor stock drugs shall be supplied in individual doses unless the bulk container cannot be individualized. Dangerous drug floor stock must be reviewed by the pharmacist or pharmacist intern on a routine basis to ensure appropriate use.

Question 29

Q: What is the role of the pharmacist-in-charge or designated pharmacist in pharmacy and therapeutics committees?

Answer 29

A: Where such committees exist, the pharmacist-in-charge or designated pharmacist shall be a voting member of the pharmacy and therapeutics committee or its equivalent.

Question 30

Q: How must medications be dispensed in the emergency room of a hospital?

Answer 30

A: Medications dispensed in the emergency room will be dispensed only by a licensed pharmacist, a licensed pharmacist intern, or a licensed practitioner and shall comply with the following:
- A record shall be kept of all medications dispensed from the emergency room of a hospital; the record shall include:
- The date the drug was dispensed;
- Name and address of the patient;
- Name of the prescribing physician;
- The name of the drug;
- The strength of the drug;
- The quantity of drug dispensed;
- Initials of the person recording the information if not a physician.
- A separate record shall be kept for schedule II controlled substances;
- The following will be recorded in the patient’s medical chart:
- The name of the drug(s) prescribed;
- The strength of the drug;
- The quantity of the drug dispensed;
- When medications are prescribed by the physician and dispensed to the patient in the emergency room of the hospital, the dispensing label shall contain the following information:
- The name of the patient;
- The name of the prescribing physician;
- Name of the drug;
- Strength of the drug;
- Quantity of the drug;
- Name and address of the hospital;
- Date the drug is dispensed;
- Directions for use;
- Expiration date of medication.

Question 31

Q: What are the requirements for automated pharmacy systems?

Answer 31

A: Automated pharmacy systems must comply with the following provisions:
- General Statement: Automated devices for storage and distribution of floor stock or patient profile drugs or both, shall be limited to licensed health care facilities and shall comply with all the following provisions. Written policies and procedures, approved by the appropriate health care facility committee, shall be in place to ensure safety, accuracy, security, and patient confidentiality. Personnel allowed access to an automated dispensing device shall have a confidential access code that records the identity and electronic signature of the person accessing the device.
- Security/Access: The control of access to the automated device must be controlled by the pharmacist-in-charge. Proper identification and access control, including electronic passwords or other coded identification, must be limited and authorized by the pharmacist-in-charge. The pharmacist-in-charge must be able to stop or change access at any time. The pharmacist-in-charge must maintain a current and retrievable list of all persons who have access and the limits of that access. Review of user access reports shall be conducted at least quarterly as established by policy and procedures to ensure that persons who are no longer employed at the facility do not have access to the system.
- Records: The records kept by the automated drug delivery system must comply with all state, federal, and board requirements. Records must be maintained by the pharmacy and be readily retrievable. Records may be retained in hard copy or an alternative data retention system may be used where current technology allows.
- Automated Drug Distribution: An automated medication management system shall be under the control of the pharmacist-in-charge. If used for storage and dispensing of doses scheduled for administration, there shall be a procedure by which orders for a drug are reviewed and approved by the pharmacist before the drug may be withdrawn from the automated dispensing device. There shall be written procedures for downtime in the event of system malfunction or otherwise inoperable. A downtime log shall be maintained and include:
- Date of transaction;
- Patient;
- Drug/dose;
- Quantity of transaction;
- Nurse signature;
- Beginning count;
- Ending count;
- Wasted amount;
- Witness signature, if needed;
- Prescriber (for controlled substances only).
- Quality Assurance: The pharmacist-in-charge shall be responsible for developing and implementing a quality assurance program which monitors total system performance. Quality monitors shall include:
- The proper loading/refilling of the device, including proof of delivery;
- The proper removal, return or waste of drugs;
- Processes for recording, resolution, and reporting of discrepancies;
- Processes for conducting periodic audits to assure compliance with policies and procedures.
- Records: Transaction records: At the time of any event involving the contents of the automated device, the device shall automatically produce on demand, a written or electronic record showing:
- The date and time of transaction;
- The type of transaction;
- The name, strength, and quantity of medication;
- The name of the patient for whom the drug was ordered;
- The name or identification code (electronic signature) of the person making the transaction;
- The name of the attending, admitting or prescribing practitioner;
- The identity of the device accessed.
- Delivery Records: A delivery record shall be generated on demand for all drugs filled into an automated dispensing device which shall include:
- Date;
- Drug name;
- Dosage form;
- Strength;
- Quantity;
- Identity of device;
- Name or initials of the person filling the automated dispensing device.

Question 32

Q: What is the responsibility of the pharmacist-in-charge regarding drug information in a healthcare facility?

Answer 32

A: The pharmacist-in-charge is responsible for the provision of drug information to the staff and patients of the healthcare facility. The pharmacist-in-charge shall also be responsible for providing in-service education to the facility’s professional staff. In-service activities shall be documented.

Question 33

**Q: What reference materials must the pharmacist-in-charge maintain?*

Answer 33

A: The pharmacist-in-charge is responsible for maintaining up-to-date reference materials or electronic access to reference publications commensurate with the scope of practice. At a minimum, these references will include the current editions of:
- A drug interactions text;
- An injectable drug text;
- A general drug information text; and
- New Mexico Pharmacy Law and Rules and Regulations and all available revisions.

Question 34

Q: What must be posted in all areas where medications are stored?

Answer 34

A: The telephone number of a regional Poison and Drug Information Center shall be posted in all areas where medications are stored.

Question 35

Q: What should the pharmacist, in conjunction with other staff, develop regarding adverse drug reactions and medication errors?

Answer 35

A: The pharmacist, in conjunction with practitioners, nurses, and other professional staff, shall develop a procedure for the review and reporting of significant adverse drug reactions and medication errors. These events shall be reported to the prescribing practitioner and the appropriate hospital quality assurance committee, such as the Pharmacy and Therapeutics Committee or its equivalent.

Question 36

Q: What clinical information must be available to the pharmacist?

Answer 36

A: Clinical information about patients must be available and accessible to the pharmacist for use in daily practice activities.

Question 37

Q: What is the pharmacist’s responsibility in reviewing medication orders?

Answer 37

A: The pharmacist shall review each medication order for safety and appropriateness and communicate with the prescriber when adjustments may be necessary. Suggested changes made to the prescriber must be documented.

Question 38

Q: What type of program must be in place for medication use measurement?

Answer 38

A: A documented medication-use-measurement program, developed, shall be in place to evaluate the medication-use-process of prescribing, dispensing, administering, and monitoring.

Question 39

Q: What are the pharmacist’s responsibilities regarding medical and pharmaceutical research?

Answer 39

A: The pharmacist shall conduct, participate in, and support medical and pharmaceutical research appropriate to the goals, objectives, and resources of the facility.

Question 40

Q: What role must a pharmacist have in relation to the facility’s Institutional Review Board?

Answer 40

A: There shall be a pharmacist member on the facility’s Institutional Review Board, or its equivalent. The pharmacist shall ensure that policies and procedures for the appropriate use of investigational drugs are established and followed.

Question 41

Q: What must be provided to the pharmacist regarding research protocols?

Answer 41

A: A copy of the research protocol for a study involving investigational drugs and the facility’s patients shall be provided to the pharmacist. A copy of drug protocols shall be maintained in the pharmacy of all active investigational drug studies and similar research projects involving drugs in which the facility’s patients are participants.

Question 42

Q: Can an in-house clinic operate under the hospital pharmacy’s license?

Answer 42

A: Yes, the clinic may operate under the license of the hospital pharmacy and is not required to obtain a separate license or permit from the Board.

Question 43

Q: Why might dispensing by a hospital pharmacy occur upon a patient’s discharge?

Answer 43

A: Dispensing by a pharmacist in a hospital pharmacy not otherwise licensed as a retail pharmacy may occur to improve continuity of care by avoiding temporary disruption in a patient’s prescribed medication regimen upon discharge and to decrease medication waste, such as that from a partially used multidose container.

Question 44

Q: What conditions must be met for a prescription or order to be dispensed upon discharge?

Answer 44

A: A prescription or order issued by a licensed practitioner of the hospital must be dispensed to the patient upon discharge. If not specified, the pharmacist is responsible for obtaining and documenting any additional information needed for dispensing, including directions for use and quantity. The prescription or order may not be refilled or transferred.

Question 45

Q: Can naloxone be dispensed upon discharge?

Answer 45

A: Yes, naloxone for rescue use may be dispensed to the patient upon discharge pursuant to standing order, in accordance with Section 24-23-1 NMSA 1978.

Question 46

Q: What is the requirement regarding the medication being dispensed upon discharge?

Answer 46

A: The medication being dispensed upon discharge must not be a controlled substance.

Question 47

Q: How should patient counseling be conducted upon discharge?

Answer 47

A: Responsibilities of the pharmacist and pharmacist intern shall be fulfilled in accordance with 16.19.4.16 NMAC. Patient counseling shall be in person whenever practicable, or by telephone. If the pharmacist is absent at the time of patient discharge, written information on side effects, interactions, and precautions concerning the drug or device should be provided, either printed or electronic. The pharmacy phone number must be available for patient consultation.

Question 48

Q: What must be done if the drug or device is not dispensed directly to the patient or patient’s agent upon discharge?

Answer 48

A: If the drug or device is not dispensed directly, the pharmacist must require the patient or patient’s agent to sign a drug receipt record listing those prescriptions received from the pharmacy.

Question 49

Q: How long must records be retained and what are the requirements for electronic records?

Answer 49

A: Records must be readily retrievable and available for inspection for three years unless longer retention is otherwise required by board regulation. If records are maintained electronically, the computer must be capable of producing a printout of prescription or order information within a 72-hour period on demand, certified by the pharmacist as true and accurate. Requested printouts include: patient specific; practitioner specific; drug specific; or date specific reports. The printout must include:
- The prescription number, if applicable;
- The prescriber’s name and license classification;
- The full name and address of the patient;
- The date of issuance of the prescription or order and the date filled;
- The name, strength, dosage form, and quantity dispensed;
- Identification of the dispensing pharmacist; computer-generated pharmacist initials are considered to be the pharmacist of record unless manually overridden by a different pharmacist who will be the pharmacist of record.