F761

(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.45(g) Labeling of Drugs and Biologicals

Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable.

§483.45(h) Storage of Drugs and Biologicals

§483.45(h)(1) In accordance with State and Federal laws, the facility must store all drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys.

§483.45(h)(2) 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.

INTENT §483.45(g) Labeling of Drugs and Biologicals and §483.45(h) Storage of Drugs and Biologicals

The intent of this requirement is that the facility, in coordination with the licensed pharmacist, provides for:

• • Accurate labeling to facilitate consideration of precautions and safe administration, of medications; and
  • Safe and secure storage (including proper temperature controls, appropriate humidity and light controls, limited access, and mechanisms to minimize loss or diversion) of all medication.

NOTE:     For purposes of this guidance, references to “the pharmacist” mean the licensed pharmacist, whether employed directly by the facility or through arrangement.

DEFINITIONS §483.45(g) Labeling of Drugs and Biologicals and §483.45(h)

Storage of Drugs and Biologicals

“Biologicals” are made from a variety of natural sources––human, animal, or microorganisms. Biologics are used to treat, prevent, or diagnose diseases and medical conditions. They may include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

“Controlled Medications” are substances that have an accepted medical use (medications which fall under US Drug Enforcement Agency (DEA) Schedules II—V), have a potential for abuse, ranging from low to high, and may also lead to physical or psychological dependence.

GUIDANCE §483.45(g) Labeling of Drugs and Biologicals and §483.45(h) Storage of Drugs and Biologicals

LABELING OF MEDICATIONS AND BIOLOGICALS

This section requires facility compliance with currently accepted labeling requirements, even though the pharmacies are responsible for the actual labeling. Labeling of medications and biologicals dispensed by the pharmacy must be consistent with applicable federal and State requirements and currently accepted pharmaceutical principles and practices. Although medication delivery and labeling systems may vary, the medication label at a minimum includes the medication name (generic and/or brand), prescribed dose, strength, the expiration date when applicable, the resident’s name, and route of administration. The medication should also be labelled with or accompanied by appropriate instructions and precautions (such as shake well, take with meals, do not crush, special storage instructions).

For medications designed for multiple administrations (e.g., inhalers, eye drops), the label identifies the specific resident for whom it was prescribed.

When medications are prepared or compounded for intravenous infusion, the label contains the name and volume of the solution, resident’s name, infusion rate, name and quantity of each additive, date of preparation, initials of compounder, date and time of administration, initials of person administering medication if different than compounder, ancillary precautions as applicable, and date after which the mixture must not be used.

The FDA and the Institute for Safe Medication Practices provide labelling guidance and recommendations aimed at preventing errors, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid ances/UCM349009.pdf and https://www.ismp.org/tools/guidelines/labelFormats/comments/default.asp.

For over-the-counter (OTC) medications in bulk containers (e.g., in states that permit bulk OTC medications to be stocked in the facility), the label contains the original manufacturer’s or pharmacy-applied label indicating the medication name, strength, quantity, accessory instructions, lot number, and expiration date when applicable. The facility ensures that medication labeling in response to order changes is accurate and consistent with applicable state requirements.

Additionally, to minimize contamination, facility staff should date the label of any multi- use vial when the vial is first accessed and access the vial in a dedicated medication preparation area:

• • If a multi-dose vial has been opened or accessed (e.g., needle-punctured), the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.
  • If a multi-dose vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer’s expiration date.

The Centers for Disease Control and Prevention website provides additional information regarding multi-use vials, http://www.cdc.gov/injectionsafety/providers/provider_faqs_multivials.html.

MEDICATION ACCESS AND STORAGE

A facility is required to secure all medications in a locked storage area and to limit access to authorized personnel (for example, pharmacy technicians or assistants who have been delegated access to medications by the facility’s pharmacist as a function of their jobs) consistent with state or federal requirements and professional standards of practice.

Storage areas may include, but are not limited to, drawers, cabinets, medication rooms, refrigerators, and carts. Depending on how the facility locks and stores medications, access to a medication room may not necessarily provide access to the medications (for example, medications stored in a locked cart, locked cabinets, a locked refrigerator, or locked drawers within the medication room). When medications are not stored in separately locked compartments within a storage area, only appropriately authorized staff may have access to the storage area.

Access to medications can be controlled by keys, security codes or cards, or other technology such as fingerprints. Schedule II-V medications must be maintained in separately locked, permanently affixed compartments. The access system (e.g. key, security codes) used to lock Schedule II-V medications and other medications subject to abuse, cannot be the same access system used to obtain the non-scheduled medications. The facility must have a system to limit who has security access and when access is used.

Exception: Controlled medications and those medications subject to abuse may be stored with non-controlled medications as part of a single unit package medication distribution system, if the supply of the medication(s) is minimal and a shortage is readily detectable. During a medication pass, medications must be under the direct observation of the person administering the medications or locked in the medication storage area/cart. In addition, the facility should have procedures for the control and safe storage of medications for those residents who can self-administer medications. (See F554, §483.10(c)(7) for guidance related to the right to self-administer medications).

Safe medication storage includes the provision of appropriate environmental controls. Because many medications can be altered by exposure to improper temperature, light, or humidity, it is important that the facility implement procedures that address and monitor the safe storage and handling of medications in accordance with manufacturers’ specifications, State requirements and standards of practice (e.g., United States Pharmacopeia (USP) standards).

PROCEDURES

Use the Medication Administration Observation Facility Task and the Medication Storage and Labeling Critical Element pathway, as appropriate, along with the above interpretive guidelines when determining if the facility meets the requirements for, or investigating concerns related to, Medication Labeling and Storage.

KEY ELEMENTS OF NONCOMPLIANCE §483.45(g) Labeling of Drugs and Biologicals and §483.45(h) Storage of Drugs and Biologicals

To cite deficient practice at F761, the surveyor’s investigation will generally show that the facility failed to:

• • Ensure that all drugs and biologicals used in the facility are labeled in accordance with professional standards, including expiration dates and with appropriate accessory and cautionary instructions; or
  • Store all drugs and biologicals in locked compartments, including the storage of schedule II-V medications in separately locked, permanently affixed compartments, permitting only authorized personnel to have access except when the facility uses single unit medication distribution systems in which the quantity stored is minimal and a missing dose can be readily detected, or
  • Store medications at proper temperatures and other appropriate environmental controls to preserve their integrity.

DEFICIENCY CATEGORIZATION

In addition to actual or potential physical harm, always consider whether psychosocial harm has occurred when determining severity level (See Appendix P, Section IV, E, Psychosocial Outcome Severity Guide).

Examples of noncompliance that demonstrate severity at Level 4 include, but are not limited to:

• • The facility failed to assure that medications were secure and inaccessible to unauthorized staff and residents. As a result, a resident accessed and ingested medications that caused clinically significant adverse consequences necessitating hospitalization to stabilize the resident; or
  • As a result of an incorrect label on the package, staff administered the wrong medication or wrong dose(s) of a medication (e.g., anticonvulsant, antihyperglycemic, benzodiazepine) with a potential for clinically significant adverse consequences, which resulted in, or had the potential for, serious harm or death (e.g., toxic levels of the medication, unresponsiveness, uncontrolled seizures).