New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter V - Medical Facilities › Subchapter A - Medical Facilities-minimum Standards › Article 2 - Hospitals › Part 405 - Hospitals-Minimum Standards › Section 405.17 - Pharmaceutical services

Current through Register Vol. 46, No. 28, July 10, 2024
The hospital shall provide pharmaceutical services that
						are available at all times on the premises to meet the needs of the patients.
						The hospital shall have a pharmacy that is registered and operated in
						accordance with article 137 of the New York State Education Law and is directed
						by a registered pharmacist trained in the specialized functions of hospital
						pharmacy.
(a)
Organization and
					 direction.
The pharmacy shall be responsible, in conjunction with
						the medical staff, for ensuring the health and safety of patients through the
						organization, management and operation of the service in accordance with
						generally accepted professional principles and the proper selection, storage,
						preparation, distribution, use, control, disposal and accountability of drugs
						and pharmaceuticals.
(1) The director
					 shall be employed on a full-time or part-time basis based on the needs of the
					 hospital.
(2) The director, in
					 conjunction with designated members of the medical staff, shall ensure that:
(i) for patients of all ages weight shall be
					 measured in metric units. Up-to-date drug information reference systems
					 relating to drug interactions, drug therapies, side effects, toxicology,
					 dosage, indications for use, and routes of administration are available to the
					 professional staff. Pediatric dosing resources shall include age and size
					 appropriate fluid and medication administration and dosing. Pediatric dosing
					 must be weight based, should include the calculated dose, the dosing
					 determination, such as the dose per weight (
e.g.
, milligrams
					 per kilogram) or body surface area, to facilitate an independent double-check
					 of the calculation, and should not exceed adult maximum dosage, or in
					 emergencies, length based;
(ii) a
					 formulary is established and reviewed at least annually and updated as
					 necessary to meet the needs of the patients for use in the hospital to assure
					 quality pharmaceuticals at reasonable costs;
(iii) standards are established concerning
					 the use and control of investigational drugs and research in the use of
					 recognized drugs;
(iv) clinical
					 data are evaluated concerning new drugs or preparations requested for use in
					 the hospital; and
(v) the list of
					 floor stock medication is reviewed and recommendations are made concerning
					 drugs to be stocked on the nursing unit floors and by other services.
(3) The director shall be
					 responsible for developing and implementing written policies and procedures for
					 the intrahospital distribution of drugs.
(4) Effective October 1, 1990, each hospital
					 shall have implemented a unit-dose distribution system.
(5) The pharmaceutical service shall have an
					 adequate number of registered pharmacists and other qualified personnel to
					 ensure the availability of quality services including emergency services, 24
					 hours per day, seven days per week.
(6) All drug storage, preparation and
					 dispensing shall be under the supervision of the director and shall be
					 monitored for adherence to hospital policies and procedures. Monitoring reports
					 shall be documented and available for inspection.
(7) The director shall ensure that current
					 and accurate records are kept of the transactions of the pharmacy, including
					 but not limited to:
(i) a system of records
					 and bookkeeping in accordance with the policies of the hospital for:
(a) maintaining adequate control over the
					 requisitioning and dispensing of all drugs and pharmaceutical supplies;
					 and
(b) charging patients for drugs
					 and pharmaceutical supplies;
(ii) a record of inventory and dispensing of
					 all controlled substances maintained in accordance with article 33 of the
					 Public Health Law and Part 80 of this Title; and
(iii) the labeling of all inpatient and
					 outpatient medications in accordance with article 137 of the State Education
					 Law and 8 NYCRR section 29.7.
(8) The director shall ensure that drug
					 monitoring services are provided appropriate to each inpatient's needs. This
					 shall include, but not be limited to, the maintenance of a medication record or
					 drug profile for each inpatient which is based on available drug history and
					 current therapy.
(9) The director
					 will ensure that there is a quality assurance program to monitor personnel
					 qualifications, training, performance, equipment and facilities.
(i) The director shall require and document
					 the participation of pharmacy personnel in relevant education programs,
					 including orientation of new employees as well as inservice and outside
					 continuing education programs.
(ii)
					 The quality assurance program shall include policies, procedures and monitoring
					 and improvement activities to identify, measure, prevent, minimize and/or
					 mitigate adverse drug events, adverse drug reactions and medication errors in
					 accordance with generally accepted standards and practices in the field of
					 medication safety and quality improvement.
(iii) The director in conjunction with the
					 medical staff shall ensure the monitoring and evaluation of the quality and
					 appropriateness of patient services provided by the pharmaceutical
					 service.
(10) The
					 director shall participate in those aspects of the hospital's overall quality
					 assurance program that relate to drug utilization and effectiveness.