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Regulations Update

Federal Regulation - F431 Pharmacy Services

Marci Pederson, RN, BSN, Nurse Educator/Consultant

F431 Pharmacy Services was the 8th most cited regulation as a deficiency during 2009 in long term care facilities in South Dakota. There were 19 deficiencies written for F431.

This regulation says,

483.60(b) Service Consultation. The facility must employ or obtain the services of a licensed pharmacist who—

(2) Establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and

(3) Determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.

483.60(d) 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.

483.60(e) Storage of Drugs and Biologicals.

(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.

(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.”

This regulation covers three main areas of interest:

  • Safe and secure storage of medications
  • Accurate labeling of medications to assure they are stored safely and are provided accurately in accordance with the prescriber’s instructions
  • Security and safeguarding controlled medications

I will address safe and secure storage of medications this month, but first the rationale for this regulation contained in the Guidance to Surveyors needs to be shared. Due to the number and types of medications that may be used and the vulnerable populations being served in long term care facilities, the regulations require all facilities to have formal mechanisms to safely handle and control medications, and to maintain accurate and timely medication records.  In order to do this facilities are required by regulation to use a pharmacist to help establish and evaluate these mechanisms or systems.

Storage of Drugs and Biologicals

How medications are stored is of critical importance to the safety of the residents in our facilities. Each facility is required to secure all medications in a locked storage area. The facility is also required to limit access to medications to authorized personnel only. Storage areas may include, but are not limited to drawers, cabinets, medication rooms, refrigerators, and carts. Sometimes when medications are stored in locked drawers or cabinets, access to the medication room will not provide access to medications. When medications are not stored in separately locked compartments within a medication room, only authorized personnel may have access to the medication room. Most facilities are able to control access to medications by limiting keys, security codes, cards, or fingerprints.

Key points regarding controlling access to the medication room

If the facility uses a key to access the medication room, there should be no more than one key for the facility (director of nursing, charge nurse, or medication nurse) and one key for the pharmacist and/or pharmacy technician.

The risk for drug diversion is high when several people have access to the medication room such as director of nursing, medication nurse, charge nurses, and even housekeeping/maintenance staff. In one facility the maintenance director actually did have a key for the medication room. The controlled drugs which had been discontinued were stored in the medication room until the pharmacist could come to participate in destroying them. Fortunately there was no evidence of drug diversion, and the key number was reduced to one for the facility.

The key or security code which opens the Scheduled II medications and other medications subject to abuse cannot be the same key or security code used to obtain non-scheduled medications. It is also a priority to limit access to schedule II medications and medications potentially abused. Exception: Controlled medications and those 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.

Safe Storage in Medication Carts

Medication carts are commonly used for storing and administering the majority of medications prescribed in nursing homes. Medication carts continue to be improved for safety reasons. Some carts are still locked with a key which takes more time to make sure medications are not accessible. There are more medication carts with security codes, and some nursing homes actually have the finger print system which saves time and helps ensure consistency with keeping medications secure in locked storage.

Secure Medication Carts

When the medication nurse or aide needs to go into a resident’s room to administer a medication, the medication cart should be locked if left in the hallway. The door to the room, privacy curtain, or just the fact the nurse or aide’s back is to the cart causes the cart not to be in full view of the person administering medications.

When the medication nurse or aide administers medications in the dining room, they need to lock the cart whenever they do not have full view of the medication cart. The medication nurse or medication aide cannot depend on other staff in the dining room to help watch the cart. The medication nurse and/or medication aide are ultimately responsible for making sure the medications in the medication cart are not accessible.

Medications left on top of the medication cart while the medication nurse and/or medication aide do not have the cart in full view is not acceptable. One facility’s medication nurse walked away from the cart which had several topical medications sitting on top of it while she administered medication to residents in the dining room. Confused residents could potentially ingest such medications.

Key Points on Storage Temperature and Medications

  • Medications must be stored in an environment that matches the manufacturers’ recommendations.
  • Medications that require refrigeration usually need to be maintained between 36 and 46 degrees Fahrenheit (2 and 8 degrees centigrade).

One time when surveying a dialysis unit I was assigned to check the dialysis unit’s refrigerator temperature log. One of the medications stored in the refrigerator was Epogen which is frequently used to treat anemia in persons with kidney failure. Epogen is expensive, and the manufacturer recommends storage in temperatures between 36 to 46 degrees Fahrenheit. It must not be frozen or its effectiveness will be impaired. The refrigerator temperature log showed numerous days when the temperature was below 32 degrees with some days showing the temperature of 28 degrees Fahrenheit. Interview with the staff revealed they had not done anything to correct the situation when the temperature was outside of the 36 to 46 degree Fahrenheit range. Review of the patients’ hemoglobin and hematocrit levels indicated they continued to be below normal even with the medication. Monitoring refrigerator temperatures is good. Action must be taken when the temperature is not within the range needed by contacting maintenance staff.

An example of a medication that should not be refrigerated but is frequently found in medication refrigerators is acetaminophen suppositories. The manufacturer’s recommendations on the box indicate they are supposed to be stored at room temperature between 59 and 86 degrees Fahrenheit (15 and 30 degrees centigrade).

F431 is a regulation that requires good systems in place in order for compliance to occur, but compliance with this regulation means so much more than avoiding a deficiency. Compliance with this regulation helps us honor our elders by keeping them safe and providing the best quality of care possible.

How is your facility going to ensure safe practices are consistently followed?  One wise co-worker of mine reviews research frequently for evidence-based practices. She recently shared information from a research report which stated a desired new behavior needs to be repeated at least 21 times before a change in behavior begins to occur. When we seek compliance and improved quality, the process takes time, team work, and consistency.

Look no further for survey success! Last week one of my clients called me with the following report after yet another survey with no deficiencies:

“I just wanted to pass on that we had our survey this week. They came Monday afternoon and left yesterday afternoon. I’m happy to report that we had no deficiencies. Thanks for all you do, Marci. I think your services are a big reason we’ve had so much success.”

Don’t wait another day! Contact me at or call me at 605-668-8475 for all of your survey needs.

Contact Avera Education and Staffing Solutions at 605-668-8475 to schedule a consultation.



Marci Pederson, RN, BSN

Marci Pederson, RN, BSN

As a former health facilities senior surveyor, Marci served a variety of health care facilities. Her experience includes nursing education, medical/surgical nursing, psychiatric nursing, infection control, utilization review and quality assurance.

Have a question for Marci? A topic idea for her next column? Need more information on having a mock survey at your facility? Send her an email at