Md. Code Regs. 10.07.12.19

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.07.12.19 - Pharmacy Services

A. Procedures for Administration of Pharmaceutical Services. Each facility shall comply with all federal, State, and local laws, ordinances, standards and codes regulating the purchasing, storage, dispensing, administration, and recording of drugs. Each health care facility shall:

(1) Ensure that pharmaceutical services are provided;

(2) Make provision for prompt and convenient acquisition of prescribed drugs;

(3) Record all supplies and drugs requisitioned and received from the pharmacy;

(4) Record all prescriptions dispensed;

(5) Obtain a permit to operate a pharmacy from the Board of Pharmacy in the State if the pharmacy is located within the correctional facility;

(6) If the facility has no pharmacy, there shall be a written agreement for qualified pharmacy services, including provision for emergency service and consultation.

B. Staff Requirements.

(1) Pharmaceutical service, when provided within the health care facility, shall be under the direction and supervision of a pharmacist licensed to practice pharmacy in the State.

(2) The staff or consultant pharmacist at each correctional facility shall participate in planned inservice education programs for the facility on topics related to pharmaceutical services.

(3) The consultant pharmacist shall be available to assist in formulating the procedures, rules, and regulations for the acceptable distribution of drugs throughout the correctional system and shall visit the facility on a regular basis to review all aspects of the services provided and to ensure that proper controls are maintained.

C. Formulary. There shall be a formulary system, approved by the institutional physician and pharmacist and by other appropriate facility staff. Copies of the formulary shall be located and available as appropriate to the institution.

D. Space and Equipment. If the pharmacy is located within the health care facility there shall be adequate space and equipment to house the drugs and supplies. The pharmacist and pharmacy personnel, under the direct supervision of the pharmacist, may not dispense medications, make label changes, or transfer medications on other than the original containers. Documentation of the qualifications of the pharmacy personnel shall be available.

E. Emergency Kit. There shall be an emergency drug kit immediately available at each nursing or service area for use by medical personnel. Written policies and procedures establishing the contents of the supply and procedures establishing the contents of the supply and procedures for use, restocking, and sealing of the emergency drug supply shall be available. A list of drugs shall be signed by the pharmacist and physician and attached to the kit.

F. Stop Order Policy. Automatic stop orders on all drugs shall be maintained by the medical and pharmacy staff. These orders may not apply when the physician indicates a specific period of time a drug is to be used, or a specific number of dosages.

G. Medication Release. All medications to be released to the patient shall be approved in writing by the physician. A notation concerning their disposition shall be made on the patient's clinical record.

H. Administration of Medications.

(1) All medications shall be administered by licensed medical or nursing personnel or by personnel who possess written documentation of training in theory and practice in the administration of medications. This written documentation shall be available for review by the Department.

(2) The person assigned the responsibility of administering medications to inpatients shall complete the procedure by:

(a) Personally preparing the dose;

(b) Observing the act of swallowing the oral medications;

(c) Recording the act of administration.

(3) In the case of unit dose medications the person administering medication shall:

(a) Open the unit dose package;

(b) Observe the taking and swallowing of the medication;

(c) Record the administration of the medication.

(4) Medication shall be given only to the individual patient for whom the prescription was issued and shall be given according to directions as prescribed.

(5) Medication cards and lists, or acceptable substitutes, shall be used and checked against the physician's orders when administering medications to inpatients.

(6) Self-administration of medications by patients shall be permitted only when specifically ordered by the attending physician.

(7) Medication errors and drug reactions shall be reported to the physician responsible for the resident. An entry of the medication error or the drug reaction or a combination of both, shall be recorded in the patient's record.

(8) Current pharmaceutical reference materials shall be provided in order to furnish the medical, pharmacy, and nursing staffs with current information concerning the drugs used in the hospital.

I. Investigational Drugs. Investigational drugs, properly labeled according to federal regulations, may be used only under the direct supervision of the principal investigator and after written consent is obtained from the patient. The drugs shall be approved by an appropriate medical staff committee acting according to established policies and procedures. Only physicians and nurses may administer investigative drugs after they have been made aware of the essential pharmacologic information necessary for them to discharge their professional responsibilities. A central location shall be established where information on investigational drugs being used is maintained.

J. Labeling and Storing of Medication.

(1) All medications shall be properly labeled and stored in a locked cabinet at the medical unit. The key to this cabinet shall be in the possession of authorized personnel. The labels shall bear the name and strength of the drug, expiration date of all time-dated drugs, name of the pharmacy issuing the drug, name of patient, and federal and State cautionary statements. Necessary labels shall be affixed to the labeled container.

(2) Medications requiring refrigeration shall be kept in a locked refrigerator. Poisons and medication for "external use only", including rubbing alcohol, shall be kept in a locked cabinet or compartment separate and apart from internal medications.

(3) Discontinued and outdated drugs, and containers with worn, illegible, or missing labels, shall be returned to the pharmacy for proper disposition.

(4) A drug recall procedure shall be established that can be readily implemented.

(5) Drug cabinets on the medical units shall be checked by the pharmacist at least every 2 months.

K. Control of Schedule II and Legend Drugs.

(1) All Schedule II drugs shall be kept in a separately locked, securely fastened compartment within the locked medicine cabinet.

(2) All Schedule II drugs retained on each nursing unit shall be counted at the termination of each tour of duty. This record shall be signed by both the outgoing and incoming professional nurse or authorized person. Schedule II drugs which are outdated and no longer in use shall be disposed of according to federal regulations. All other discontinued or outdated drugs shall be disposed of according to State regulations.

Md. Code Regs. 10.07.12.19