5 Pharmacy Laws and Regulations Affecting Facilities
There are hundreds of laws and regulations in place, at both the state and federal levels, to protect the residents of skilled nursing and other residential care facilities. Every aspect of a facility’s operation is subject to strict oversight and tight controls to ensure that the residents are safe and that their conditions are being appropriately managed.
One of the most regulated aspects of care facility management is administering medication to residents. Every state has laws and guidelines that regulate how prescription and over-the-counter drugs are managed for residents. Federal laws also impact how medication is dispensed in facilities. Among these are several Medicare requirements that facilities must adhere to.
This month, we’ll look at five of the most commonly cited pharmacy laws and regulations, particularly Medicare regulations, that impact patients in residential care facilities.
Care Facilities Must Provide Pharmacy Services
This regulation is fundamental to care facility management: skilled nursing and other facilities are required to arrange pharmacy services for all residents. Those services may be provided by an in-house pharmacy or by an outside, independent retail or consulting pharmacy.
In-house pharmacies are expensive to staff and maintain, usually meaning that only the largest care facilities or those attached to a hospital operate their own pharmacies. Most facilities choose to partner with a retail or consulting pharmacy to provide their residents with pharmacy services.
Regardless of whether the medications are dispensed in-house or externally, the regulation also requires that facilities have a system in place to minimize medication errors. Each facility can develop its own prescription safety program, and these safety systems can take many different forms, including:
- Only allowing licensed medical staff to administer medication
- Using a computerized tracking system and scanners to verify medication accuracy at multiple steps of the administration process
- Relying on a consulting pharmacy and compliance packaging to automate medication dosing
Regular medication audits, performed by a licensed pharmacist, are commonly used to assess a facility’s medication safety protocols and identify areas for improvement.
Residential Care Patients Have Part D Options
Federal regulations require that patients in skilled nursing facilities have the right to choose a Medicare Prescription Drug Benefit Plan, commonly known as Part D.
Part D plans add prescription drug coverage to a patient’s existing Part A (hospital coverage) and Part B (medical coverage) Medicare plans and help reduce the cost of prescription medications. Private companies offer Part D plans through a contract with the federal government. As of 2023, more than 75% of all Medicare patients receive drug coverage through a Part D plan.
In addition to the right to use a Part D plan, Medicare patients in care facilities also have the right to change Part D plans at any time.
Residential Care Patients May Have Pharmacy Choice Options
In many states—including Georgia—residents in skilled nursing and other care facilities have the right to choose their own pharmacy, regardless of the facility’s internal medication/pharmacy policies. The only caveat to this freedom is that if the care facility has certain “unit dose system” requirements, the patient’s chosen pharmacy must use that system to dispense medications.
In other words, if a facility requires that patient medication be dispensed using a particular form of compliance packaging (pill packs or bubble packs), residents can be required to choose a pharmacy that offers that type of packaging.
Care Facilities Must Provide Pharmacy Consultations and Reviews
In order to ensure that every resident of a care facility (or their guardian) understands the medications they’ve been prescribed and that the prescriptions make sense for their conditions, care facilities are required to provide access to consultations from a licensed pharmacist. During these consultations, patients can ask any questions they have about their medications, discuss any interactions or adverse effects, and get reassurance as to the benefits of their various medications.
In addition to providing consultations on request, facilities are also required to have patient prescriptions reviewed by a licensed pharmacist once a month.
Unnecessary Medications Must Be Avoided
The Center for Medicare & Medicaid Services (CMS) prohibits the overuse of unnecessary medications. While any drug not strictly required for the treatment or management of a chronic or acute condition is unnecessary, this regulation primarily targets three classes of drugs that are frequently overused in residential care facilities:
- Antibiotics: These drugs only fight certain types of infections, but they are commonly prescribed even for infections they can’t affect. Overusing antibiotics increases the likelihood of infectious diseases becoming antibiotic-resistant, causing significant health problems for facility residents.
- Anticoagulants: Anticoagulants are frequently administered to residential care patients to control thrombosis, embolisms, and other clotting conditions, as well as atrial fibrillation. In many cases, the adverse side effects, such as gastrointestinal bleeding, increased healing time for wounds, and other potential problems, end up being as dangerous or more so than the condition they were prescribed to treat.
- Antipsychotics: Proven to have limited efficacy for patients in skilled nursing facilities, antipsychotics are still dispensed to these patients with some regularity. As with anticoagulants, many antipsychotics come with numerous potential adverse effects that make their use less desirable in older patients.
Angus Lake Healthcare provides full-service pharmaceutical services for residential care facilities throughout Middle Georgia.
One easy way to ensure that your facility is compliant with all applicable pharmacy laws and regulations is to partner with a dedicated consulting pharmacy that can provide support for every part of your facility’s medication program. Schedule a consultation with Angus Lake Healthcare today to learn more: 478-233-1828.
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