CMS SOM App. A, Tag A-0500

In order to provide patient safety, drugs and biologicals must be controlled and distributed

in accordance with applicable standards of practice, consistent with Federal and State law.

Interpretive Guidelines §482.25(b)

Drugs and biologicals must be controlled and distributed in accordance with applicable Federal

and State laws and regulations, and in accordance with applicable standards of practice.

Applicable standards of practice include compliance with all Federal and State laws, regulations,

and guidelines. The procedures established to prevent unauthorized usage and distribution must

provide for an accounting of the receipt and disposition of drugs subject to the Comprehensive

Drug Abuse Prevention and Control Act of 1970.

Other sources of additional guidelines could include, but are not limited to: American Society of

Health-System Pharmacists, American College of Clinical Pharmacy, American Pharmacists

Association, United States Pharmacopeia, etc.

The hospital must have a process in place for medication orders to be received in the pharmacy

and dispensed in a safe and timely manner. Safe dispensing of medications must be in

accordance with accepted standards of practice and includes, but is not limited to, the following:

• Implementing systems such as dose limits, pre-printed orders, special labeling, or double

checks to minimize adverse drug events, especially for high alert medications;

• Reviewing all medication orders (except in emergency situations) for appropriateness by

a pharmacist before the first dose is dispensed. A process is established for resolving

questions with the prescribing practitioner and the discussion and outcome are

documented in the patient’s medical record or pharmacy copy of the prescriber’s order;

This review should include:

• Therapeutic appropriateness of a patient’s medication regimen;

• Therapeutic duplication in the patient’s medication regimen;

• Appropriateness of the drug, dose, frequency, and route of administration;

• Real or potential medication-medication, medication-food, medication-laboratory

test and medication-disease interactions;

• Real or potential allergies or sensitivities; and

• Other contraindications.

• Medications dispensed by the hospital are retrieved when recalled or discontinued by the

manufacturer or the Food and Drug Administration (FDA) for safety reasons;

• Policies and procedures that address the use of medications brought into the hospital by

patients or their families when self-administration of medications is permitted by hospital

policy; and

• Having a system in place to reconcile medications that are not administered (e.g., left in

the patient’s medication drawer) when the pharmacy inventories patient medications or

restocks patient medications. For example, did the patient refuse the medication, was

there a clinical or treatment reason the medication was not used, or was the medication

not used due to an error?

Monitoring the Effects of Medications

The pharmaceutical service may be responsible for monitoring the effects of medication(s)

specified per hospital policy to assure medication therapy is appropriate and minimizes the

occurrence of adverse events. Typically this occurs with anticoagulant therapy and antibiotics

prescribed for the pharmacy to establish or adjust the dosage (i.e.; “pharmacy to dose” order). In

such cases, the pharmacy’s monitoring process includes:

• Clinical and laboratory data to evaluate the efficacy of medication therapy to anticipate or

evaluate toxicity and adverse effects;

• Physical signs and clinical symptoms relevant to the patient’s medication therapy;

• Assessing the patient’s own perceptions about side effects, and, when appropriate,

perceived efficacy.

(See also the Nursing CoP discussion regarding monitoring of patients at §482.23(c)(4)).

Survey Procedures §482.25(b)

• Are medication orders routinely reviewed by the pharmacy before the first dose? What

evidence can the hospital present that such reviews take place?

• Are questions regarding medication orders resolved with the prescriber and a written

notation of these discussions documented in the patient’s medical record or pharmacy

copy of the prescriber’s order?

• Does the hospital pharmacy have a system for monitoring the effects of medication

therapies for cases specified per hospital policy?

• Does the hospital retrieve and remove medications available or patient use when the

hospital has been informed of a drug recall?