Many of the residents at skilled nursing centers are medically fragile, and with their changing medical needs, their prescribed medication also often changes. What happens to the medicines that are no longer needed for the resident? Some medications can be returned to the pharmacy for credit if the skilled nursing center is using a unit dose or customized patient medication pharmacy system.
64B16-28.118 Unit Dose and Customized Patient Medication Package Returns by In-patients
No pharmacist shall place into the stock of any pharmacy permittee any part of any prescription, compounded or dispensed, which is returned by a patient except under the following conditions:
(1) In a closed drug delivery system in which unit dose or customized patient medication packages are dispensed to in-patients, the unused medication may be returned to the pharmacy for redispensing only if each unit dose or customized patient medication package is individually sealed and if each unit dose or the unit dose system, or the customized patient medication package container or the customized patient medication package unit of which it is clearly a part is labeled with the name of the drug, dosage strength, manufacturer’s control number, and expiration date, if any.
(2) In the case of controlled substances, as it is allowed by Federal Law.
(3) A “unit dose system” to which this rule applies means a system wherein all individually sealed unit doses are physically connected as a unit. For purpose of this section, a product in an unopened, sealed, manufacture’s container is deemed to be a unit dose package.
(4) A “customized patient medication package” to which this rule applies means a system wherein all USP approved multi-dose units are physically connected and are referred to as a container. The use of customized patient medication packages must comply with the provisions of subsection 64B16-28.108(5), F.A.C.
(5) A “closed drug delivery system” to which this rule applies is a system in which the actual control of the unit dose or customized patient medication package is maintained by the facility rather than by the individual patient.
(6) All pharmacies utilizing unit dose or customized patient medication packages shall address specific policies and procedures regarding their preparation and use in their Policy and Procedures Manual.
Controlled substances can’t be returned and must be destroyed.
64B16-28.301 Destruction of Controlled Substances – Institutional Pharmacies
(1) Controlled substances that have been dispensed and not used by the patient shall not be returned to the pharmacy and shall be securely stored by the nursing home until destroyed.
(2) A document must be completed showing the name and quantity of the drug, strength and dosage form, patient’s name, prescription number and name of the institution. This documentation, at the time of destruction, shall be witnessed and signed by the consultant pharmacist, director of nursing, and the administrator or his designee, which may include a licensed physician, pharmacists, mid-level practitioner, or nurse.
In the past, skilled nursing centers have used different methods of destroying the controlled substance, such as flushing it down the toilet or crushing medications in kitty litter. Now, skilled nursing centers will need to learn a new set of regulations because of a new rule promulgated by the Environmental Protection Agency (EPA). The new rule revises management standards for hazardous waste pharmaceuticals (HWPs) for health care facilities, including skilled nursing centers. Not included within the scope of the definition of long term care facilities are assisted living communities and independent living centers. These revised rules will take effect in August 2019.
The Resource Conservation Recovery Act (RCRA) governs the generation, management, storage, treatment, and disposal of hazardous wastes. Prior to this new rule, long term care facilities were excluded from the RCRA and treated the same as residential households. The EPA makes clear in this new rule that because skilled nursing centers are more akin to hospitals, their management of any hazardous waste, including HWPs, will be subject to RCRA requirements.
The final rule prohibits HWPs from being disposed of down a drain or in a toilet, thereby reducing the amount of pharmaceutical ingredients that contaminate drinking water and endanger the environment. What is included as an HWP?
- Dietary supplements
- Prescripton drug
- Over-the-counter drugs
- Homeopathic drugs
- Compounded drugs
- Investigational new drugs
- Pharmaceuticals remaining in non-empty containers
- Personal protective equipment contaiminated with pharmaceuticals
- Clean-up material from spills of pharmaceuticals
A non-creditable HWP is a prescription pharmaceutical that does not meet the above three criteria and therefore is not likely to receive credit back through reverse distribution. Non-prescription HWPs that do not have a reasonable expectation to be legitimately used, reused or reclaimed are also considered non-creditable HWPs.
The skilled nursing center that is subject to the requirements of this new regulation must notify the EPA Regional Administrator within 60 days of the effective. The facility must keep a copy of the notification, which should be filed electronically. All facility employees who manage HWPs must be thoroughly familiar with proper waste handling and emergency procedures relative to their responsibilities. Because the skilled nursing center will likely accumulate HWPs for some period of time before shipping them off-site, the final rule prescribes standards for containers that will be used to store HWPs. Any container used to accumulate HWPs must be structurally sound, compatible with its contents, and lack evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions. Such containers must be kept closed and secured so as to prevent unauthorized access to their contents. The container used must be labeled or clearly marked with the phrase “Hazardous Waste Pharmaceuticals.” The facility may accumulate non-creditable HWPs on-site for a period not to exceed one year.
The skilled nursing center may accumulate non-creditable HWPs on-site only for a limited time before it must ship them off-site to a pre-designated authorized facility for treatment, storage or disposal.
There can be no doubt that the EPA’s final rule will require skilled nursing centers to navigate the new regulatory framework in the rule, and facilities should start now preparing for the August 2019 effective date.