42 CFR §483.45
Pharmacy services.
Extracted obligations
- The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in § 483.70(f). · pharmacy services · 99%
- If the facility permits unlicensed personnel to administer drugs (where State law allows), it must ensure they do so only under the general supervision of a licensed nurse. · medication administration · 99%
- The facility must provide pharmaceutical services, including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals, to meet the needs of each resident. · pharmacy services · 99%
- The facility must employ or obtain the services of a licensed pharmacist who provides consultation on all aspects of the provision of pharmacy services in the facility. · pharmacy services · 99%
- The facility must employ or obtain the services of a licensed pharmacist who establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation. · controlled drug records · 99%
- The facility must employ or obtain the services of a licensed pharmacist who determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled. · controlled drug records · 99%
- The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist, and this review must include a review of the resident's medical chart. · drug regimen review · 99%
- The pharmacist must report any irregularities (including any unnecessary drug as defined in paragraph (d)) to the attending physician and the facility's medical director and director of nursing, and these reports must be acted upon. · drug regimen review · 99%
- Any irregularities noted by the pharmacist during the monthly review must be documented on a separate, written report sent to the attending physician and the facility's medical director and director of nursing, listing at minimum the resident's name, the relevant drug, and the irregularity identified. · drug regimen review · 99%
- The attending physician must document in the resident's medical record that the identified irregularity has been reviewed and what, if any, action has been taken to address it; if there is to be no change in the medication, the attending physician should document his or her rationale in the resident's medical record. · drug regimen review · 98%
- The facility must develop and maintain policies and procedures for the monthly drug regimen review that include, at minimum, time frames for the different steps in the process and steps the pharmacist must take when an irregularity requiring urgent action to protect the resident is identified. · drug regimen review · 99%
- Each resident's drug regimen must be free from unnecessary drugs, including drugs used in excessive dose, for excessive duration, without adequate monitoring, without adequate indications, in the presence of adverse consequences indicating the dose should be reduced or discontinued, or any combination of these. · unnecessary drugs · 99%
- Based on a comprehensive assessment, the facility must ensure that residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record. · psychotropic drugs · 99%
- The facility must ensure that residents who use psychotropic drugs receive gradual dose reductions and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs. · psychotropic drugs · 99%
- The facility must ensure that residents do not receive psychotropic drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record. · psychotropic drugs · 99%
- PRN orders for psychotropic drugs must be limited to 14 days; if the attending physician or prescribing practitioner believes extension beyond 14 days is appropriate, they should document their rationale in the resident's medical record and indicate the duration for the PRN order. · psychotropic drugs · 99%
- PRN orders for anti-psychotic drugs must be limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication. · psychotropic drugs · 99%
- The facility must ensure that its medication error rates are not 5 percent or greater. · medication errors · 99%
- The facility must ensure that residents are free of any significant medication errors. · medication errors · 99%
- Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, including appropriate accessory and cautionary instructions and the expiration date when applicable. · drug labeling · 99%
- The facility must store all drugs and biologicals in locked compartments under proper temperature controls, in accordance with State and Federal laws, and permit only authorized personnel to have access to the keys. · drug storage · 99%
- The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected. · drug storage · 99%
Source: eCFR 2024-12-31 · hash sha256:59b0613f71c13625bad3079dd63048731b6027f6e5fb95531792a05b423a943c