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Managing a safe and legal formulary

This is an excerpt from Athletic Training and Therapy With HKPropel Access by Leamor Kahanov & Ellen K. Payne.

By Leamor Kahanov, EdD, ATC, LAT

Typically, athletic training settings are formularies in the management of drugs. A formulary is an entity that maintains a list of drugs that are available (provided or sold), while a pharmacy is an entity that sells, dispenses, and prepares medications (compounding).^{1,3-6,11,66,67} Management of drugs in an athletic training setting requires that each facility have a policy and procedure manual that is aligned with federal and state laws and guidelines and also creates explicit guidelines for employees. The policy and procedure manual should include guidelines for drug ordering, receiving, storage, securing, dispensing, administration, transportation, disposal, record keeping, inventory, and audits. It should be approved by the employment agency and reviewed annually by a minimum of a physician, pharmacist, and lead or head athletic trainer.^7-10,12

A component of managing a formulary is ensuring that nonprescription drugs administered or dispensed have the required appropriate labeling:^7-10,12

1. The name of the product
2. The name and address of the manufacturer, packer, or distributor
3. The net contents of the package
4. The established name of all active ingredients and the quantity of certain other ingredients, whether active or not
5. The name of any habit-forming drug contained in the preparation
6. Cautions and warnings needed to protect the consumer
7. Adequate directions for safe and effective use

Ordering

Ordering OTC medications may be accomplished through medical supply companies. You should confer with the team physician or clinical administrator to determine the medications identified as part of the health care center’s formulary. Any prescription drugs must be ordered by the designated physician or practitioner and locked in a storage location; only the designee should have a key.⁸

Receiving

The process for receiving and reconciling medication should be outlined in the facility’s established guidelines. Incoming medications should be verified for quantity, drug name, dosage, and lot number and rectified with the existing accurate list of all possible medications in the facility to ensure that all the medications are accounted for.

Storage

Storage of medications is regulated by federal and state laws in addition to best practices and guidelines. Medication storage is specific to the facility, but medication generally should be stored in a locked cabinet away from patient access. Ensuring medication potency and efficacy requires that the storage area remain temperate (i.e., it should not get too hot or cold), dry, and dark. Some medications may need refrigeration; the same safety guidelines for patient access apply to refrigerators where medication is stored.

Securing, Dispensing, and Administering Medication

When securing, dispensing, and administering medication, you must follow both federal and state guidelines in addition to facility protocols. The steps to ensuring secure dispensation and administration are as follows:

• Verify the prescription or directions from the medical provider.
• Check and double check that the medication is accurate per prescription or directions.
• Check to make sure that the correct dosage, directions, lot number, and federally required packet information appear on the medication.
• Check and double check that the accurate information is in the patient’s chart.
• Validate that medication removal process was followed for medication reconciliation processes.

Transportation

Transportation of medication is state regulated; thus, transferring medication across state lines may violate laws. Review federal and state laws on transporting medications for the purpose of athletic competition.

Disposal

Disposal of medication should be outlined in the facility’s established guidelines. Guidelines for disposal of OTC and prescription drugs should include recommendations from the dispensing pharmacist. You should maintain an authorized collection receptacle for drug disposal and return unused and expired medications to a designated pharmacy.^21-23 Avoid flushing medications down the toilet or throwing them away in common garbage bins, which can contaminate the water supply.^21-23

Record Keeping

Per federal law, the health care facility must keep records available for all prescription drugs for a minimum of three years. Drug records should include the administration and dispensation of all medications, inventory received and disposed of, and a current balance of medications. The policy and procedure manual should outline the timeline for audit and reconciliation of the drugs.

Patient records for administration and dispensation of drugs must list information both on a log sheet for drugs and in the patient’s file and should include the following:^7-10,12

• Patient’s name
• Date
• Injury or illness
• Drug administered or dispensed
• Dose
• Quantity
• Lot number

Inventory

A formulary managed by an athletic trainer must maintain accurate records of inventory separate from individual patient charts. Prescription medications should be maintained by the designated physician or practitioner. The quantity of drugs remaining available for administration must match the number on the tally sheet for each 

medication if audited by accreditation teams or state or federal authorities. Although a hard copy approach is acceptable, many computer programs are available that automatically calculate inventory. Inventory accountability should include the following:^7,8

• A running tally of the quantity available for each medication
• The date and quantity of each dispensation
• Name of drug and lot number
• Expiration dates for each medication (Expired medications must be removed from stock.)

Audit

An audit of a pharmacy is a formal review from an outside regulatory body or entity to ensure compliance with federal, state, and institutional regulations. Audits can include a review of processes, reconciliation of drug accounting, agreements, insurance claims, and overall document verification. Medications and drugs that are maintained in an athletic training setting may also be subject to external audits.

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