Chapter 03. Institutional Pharmacy

“Decentralized pharmacy” means an institutional pharmacy which provides services for the population of an institutional facility and is:

“Direct supervision” means that a licensed pharmacist is physically available to supervise the performance of delegated pharmacy acts.

“Director of pharmacy” means a pharmacist who is responsible for the pharmacy services provided by an institutional pharmacy in compliance with appropriate State and federal laws and regulations.

“Dispense” or “dispensing” means the procedure which results in the receipt of a prescription or nonprescription drug or device by a patient or the patient’s agent and which entails the:

Distribute.

“Drug” means a prescription or non-prescription medication or other material used in the diagnosis or treatment of injury, illness, or disease.

“Drug recall” means the recall of a drug by a manufacturer or the U.S. Food and Drug Administration (FDA) in the event that there is a reasonable possibility that the use of or exposure to an affected product may cause either:

“Emergency drug supply” means a process for supplying drugs which:

“Institutional facility” or “institution” means an entity other than a comprehensive care facility, assisted living facility, developmental disabilities facility, or correctional facility whose primary purpose is to provide a physical environment for patients to obtain inpatient, outpatient, or emergency care, except for urgent care facilities that are not part of an institution.

“Institutional medication protocol” means a course of therapy including drug treatment predetermined and documented by the institution and the generally accepted medical practice for proper completion of a particular therapeutic or diagnostic intervention ordered by an authorized prescriber and which allows the pharmacist to execute the protocol.

“Institutional pharmacy” means a pharmacy which:

“Licensed pharmacist” means an individual who is licensed by the Board to practice pharmacy.

“Medication order” means a patient-specific order entered on the chart or a medical record of a patient by an authorized prescriber or the authorized prescriber’s designee for a drug or device that is transmitted in writing, verbally or by electronic means and includes the:

“Order-sets” means predefined orders, including medication orders, that are based on an institutionally approved protocol.

“Pavilion” means a detached or semidetached part of a hospital devoted to a special use.

Pharmaceutical care.

“Prescription Drug.

“Second identifier” means a reliable method to:

“Verbal order” means a medication order from an authorized prescriber which is received by an authorized licensed practitioner using appropriate read back procedures that is subsequently recorded in the patient’s chart and countersigned by the prescriber within a time period required by the institution.

“Written order” means a medication order that is recorded as a written document by an authorized prescriber.

Staff a pharmacist at each decentralized pharmacy site within the building or pavilion in which it is located; and

List decentralized pharmacy sites within the building in which it is located, on the initial application, or on the renewal application;

Complies with this chapter;

Defines the scope and method of pharmacy services provided to the patients of the institutional facility;

Determines when personnel may have access to the pharmacy area;

Provides for the safe and efficient dispensing and delivery of pharmaceutical products as outlined in this subtitle;

Includes:

Is provided to:

Is in a form that is:

Be in full and actual charge of the pharmacy and its personnel;

Be responsible for the operations of the pharmacy and for compliance with the requirements of Health Occupations Article, Title 12, Annotated Code of Maryland, and the regulations promulgated under that title; and

Review the policies and procedures of the pharmacy annually and revise them as necessary.

The pharmacy permit holder shall employ licensed pharmacists, registered pharmacy technicians, and unlicensed personnel as required to competently and safely provide pharmacy services.

The director of pharmacy shall delegate responsibility for the operations of the pharmacy to a designated pharmacist when the director of pharmacy is not available.

A security system to detect entry after hours, if applicable;

A security system that provides additional protection against theft and diversion;

Appropriate software to facilitate the identification of evidence of tampering with computers or electronic records;

An inventory management and control system designed to protect against, detect, and document instances of theft, diversion, or counterfeiting;

A security system designed to protect the integrity and confidentiality of data and documents;

Video monitoring of entrances and exits, or alternate acceptable security; and

A means to make the data and documentation required under this chapter readily available to:

Establishing policies and procedures for preparation and handling of the admixtures; and

Providing incompatibility information with respect to the admixtures;

Current antidote information;

Telephone numbers of a regional poison information center;

Other emergency assistance organizations; and

Such other materials and information as may be considered necessary by the governing body of the institutional facility;

Administration of drugs at an institutional facility to ensure that only authorized individuals administer drugs; and

Self-administration of drugs not on the hospital formulary by patients to ensure that the:

Accuracy;

Completeness:

Appropriateness; and

Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia approved packaging.

Lot number assigned by the distributor or manufacturer;

Manufacturer’s expiration date;

Manufacturer;

Lot number assigned by the pharmacy;

Quantity packaged;

Expiration date as defined in §C of this regulations;

Generic name of the drug;

Strength;

Date of packaging;

Name of person packaging; and

Initials of verifying licensed pharmacist.

Twelve months from the date of packaging;

The manufacturer’s or distributor’s listed expiration date; or

The maximum time period allowed for the specific packaging used for the medication.

Generic name of the medication;

Brand name of the medication, if appropriate

Strength of the medication, if appropriate;

Lot number of the distributor or manufacturer;

Expiration date of the medication; and

Beyond use date of the medication, if appropriate.

The emergency drugs and supplies are stored in an environment which:

The institution follows a policy that drugs will be dispensed from the emergency drugs and supplies formulary only upon written or verbal order by an authorized prescriber;

The emergency drugs and supplies are stocked and maintained in a manner that complies with the standards of applicable State law;

The emergency drugs and supplies are:

The emergency drugs and supplies are labeled as follows:

When the emergency drugs and supplies are contained within an emergency cart, the pharmacist checking the emergency cart shall ensure that the exterior of the cart is labeled with the:

The director of pharmacy or designee shall ensure that repackaged drugs contained in emergency drugs and supplies are labeled:

Restock the emergency drugs and supplies; or

Provide a replacement supply.

That the expiration date of emergency drugs and supplies is the earliest date of expiration of any drug supplied; and

Before the expiration date, the pharmacist or designee shall replace the expired drug and relabel the emergency drugs and supplies as provided in §C(5) of this regulation.

Institutional Medication Protocols.

A pharmacist may provide medications based on orders which do not contain unapproved abbreviations as published by the appropriate committee of the institutional facility.

The director of pharmacy or designee shall ensure that authorized personnel have access to patient information necessary for drug monitoring including the patient's:

The director of pharmacy is responsible for establishing procedures and maintaining adequate written or electronic records regarding dispensing and accountability of controlled dangerous substances which specify at least the following:

The director of pharmacy shall be responsible for establishing and maintaining adequate procedures for documentation of:

The director of pharmacy or designee shall be responsible for establishing and maintaining adequate procedures for documenting partially administered controlled dangerous substances:

The director of pharmacy or designee shall establish procedures to ensure that controlled dangerous substance records include the handwritten or electronic signature of the individual authorized:

On at least a monthly basis, a pharmacist or registered pharmacy technician shall perform a physical count of each Schedule II controlled dangerous substance in the pharmacy and shall then compare that count with the perpetual inventory maintained by the pharmacy with reference to each drug;

On at least a monthly basis, the director of pharmacy or designee shall:

The director of pharmacy or designee shall establish a procedure by which previously dispensed controlled dangerous substances that are no longer necessary for medical reasons are returned to the pharmacy.

Access to controlled dangerous substances outside the pharmacy is restricted to authorized personnel approved by institutional policy;

Controlled dangerous substances stored outside the pharmacy are accounted for at least at the change of each shift by licensed personnel authorized by the institution, unless a controlled access automated dispensing system provides an on-demand report of a perpetual inventory; and

A pharmacist reviews the discrepancies in counts of controlled dangerous substances previously reported by other professional personnel.

Medication selection;

Dosages;

Routes and methods of administration;

Medication therapy monitoring; and

The provision of medication-related information and counseling to individual patients;

Curing the disease;

Eliminating or reducing a symptomatology;

Arresting or slowing a disease process;

Preventing a disease or symptomatology; and

Improving patient’s quality of life.

Untreated indications;

Improper drug selection;

Sub-therapeutic dosage;

Failure to received medication;

Over dosage;

Adverse drug reactions;

Drug interactions, including drug-drug, drug-food, drug-laboratory test interactions; and

Medication use without appropriate indication.

Health Occupations Article, Title 12, Annotated Code of Maryland;

This subtitle; and

Other applicable State and federal laws and regulations.

Supervise pharmacy operations; and

Provide the final check for preparing medication orders for administration in the institutional facility.

In addition to the security requirements outlined in COMAR 10.34.05, a decentralized pharmacy shall have adequate security and procedures to:

Access to the decentralized pharmacy shall be limited to pharmacists, pharmacy technicians, and pharmacy technician trainees employed by the institutional pharmacy, and other personnel authorized by the director of pharmacy.