Individuals who reside in long-term care facilities, including nursing homes and assisted living settings, typically take a variety of medications. A national study by Tobias and Sey found that nursing home residents take an average of 6.7 routinely scheduled medications, plus up to 2.6 medications given on an “as needed” basis. Twenty-seven percent of nursing facility residents take nine or more routinely scheduled medications.(1) In assisted living, a survey by Armstrong and colleagues found an average of 6.2 routinely scheduled medications per resident.(2)
One subset of medications provided to these residents is controlled substances. Controlled substances are medications that have high potential for abuse, such as tranquilizers and narcotic pain medications. Physicians, pharmacies, and other health care providers are subject to regulations of the federal Drug Enforcement Administration (DEA) that pertain to the prescribing, dispensing, storage, and other aspects of these controlled substances. When these medications are stolen, or diverted from the intended patient, or other regulations are violated, the DEA or state narcotic abuse agency may become involved.
Long-term care (LTC) facilities often use large quantities of these controlled substances, especially when residents who are near the end of life need these medications for control of severe pain. To ensure that these medications are not stolen or diverted, LTC facilities generally require the nursing staff to inventory all of the controlled medications stored in the facility at every change of shift (usually three times per day). Without such a policy, investigating discrepancies can be extremely difficult.
Rationale for Special Packaging of Medications
One of the clear expectations of agencies that oversee long-term care facilities is that medications will be provided to residents accurately and on-time. Because of the importance of medications in the care of these residents, errors in medication administration are taken seriously. Medication administration is one of the key issues examined by government inspectors or surveyors when these organizations are reviewed for quality.
Long-term care facilities are regulated by government agencies, and are held accountable for the quality of care provided to their residents. When the quality of care provided is below expected standards, these facilities may be penalized with fines or other sanctions, or in extreme cases, may have their operating license revoked.
There are three key reasons why long-term care facilities use specialized packaging for medications for their residents:
Seniors who live in the community and obtain their medications from a retail or mail order pharmacy will usually get their medications provided in a prescription bottle or vial containing a monthly supply of their maintenance medications. In long-term care settings, this traditional style of packaging presents a number of problems for the staff of the LTC facility. During the 1960s, pharmacists who served nursing homes developed a specialized form of medication packaging, known as the blister package or "bingo card." Most nursing homes now use this type of packaging. Some nursing homes, particularly those that are physically connected to a hospital and served by the hospital’s pharmacy, may use a unit-dose drug distribution system that is used by the hospital, in lieu of the blister package.
One of the key principles of continuous quality improvement is that, to ensure a consistent quality in the outcome, process deviation should be minimized. For example, in the manufacture of a car, every step of the process should be described in detail and every person on every assemblyline should follow exactly the same process. The Institute of Medicine, in its report on improving the quality of health care, urged the adoption of this principle in health care organizations.(3)
With respect to medication administration, this principle says that the facility should have clearly established procedures on medication administration and every nurse should follow the same procedure in administering medication to every resident. Medication errors are minimized when the packaging and labeling of the medication is consistent for every resident, so that the nurse can follow the same process in each case. When medications are provided in different packaging styles, and with different labeling formats and styles from various pharmacies, the chances of error in medication administration are significantly increased.
With the traditional bottle and vial system, counting all the doses of every controlled substance three times per day becomes an unmanageable feat. The nurse must pour out a bottle containing up to 120 tablets of medication (a monthly supply of a medication taken four times daily) onto a pill counting tray, and count all the pills to verify that the quantity matches the amount recorded on the accountability form. In a typical nursing home with 120 beds, this could involve counting thousands of tablets several times daily.
Besides the enormous amount of time spent counting these pills, other problems arise. What happens if a nurse drops or spills some of the pills on the floor? If these pills are discarded, two nurses must sign on a form to document that the pills were wasted and discarded. If they are put back into the bottle, dirty pills could contaminate the entire bottle.
In addition, because of the time involved in counting pills, nurses may be tempted to skip the counting or eventually become less careful about the counting. In either case, the risk of controlled substances being stolen or diverted increases greatly. When a significant loss of controlled substances occurs, the facility may be investigated by a variety of agencies: the state licensing agency, the Board of Nursing, the DEA or other agencies may become involved.
Special packaging greatly enhances the efficiency of the nurse in handling and administering medication. Consistent use of the blister cards throughout the facility enables the nurse to become proficient in quickly preparing and administering medications to the resident. Accountability of controlled substances is easily accomplished because the nurse can tell how many doses of medication are present in a card with a single glance. There is no need to manipulate the dosage forms at all, and no risk of spilling or contaminating the medication.
Consequences of Eliminating Special Packaging
What would happen if nursing homes were required to implement the traditional bottle and vial system of medications? There would be an increase in medication errors for nursing home residents, and substantially increased time involvement of nursing staff in medication tracking and administration.
The impact on nursing staff time is especially significant. The United States already has a shortage of nurses, and this is particularly acute in long-term care. Forcing nurses to spend more time on “busywork” like counting controlled substances makes no economic sense. Either nursing facilities would have to hire more staff, increasing the cost of long-term care, or nurses would have to decrease the time they spend in patient care, reducing the quality of care provided to these vulnerable elders.
With the shortage of nursing staff, nurses have their pick of jobs and practice settings. If the working conditions in nursing homes become more undesirable because of the added administrative burden, nurses may choose to work in other sectors of health care. This could lead to a worsening of the nurse shortage in long-term care.
Resident's Right To Chose A Pharmacy
Although Medicare and Medicaid statutes include provisions that allow beneficiaries to exercise freedom of choice of providers that participate in the programs, these rights do have certain limitations. The issue of a nursing home resident’s right to choose a pharmacy provider was addressed by the Health Care Financing Administration (now known as the Centers for Medicare and Medicaid Services) in the issuance of a final rule on September 26, 1991 (42 CFR Part 431, p. 48834). Here is an excerpt from that Federal Register:
Comment: Two commenters asked that we expand the right to choose an attending physician to include the right to choose other providers such as pharmacists.
Response: We have not amended the regulation to include a right of a resident to select other providers because we believe that the resident has already exercised freedom of choice in selecting the facility. The facility has the responsibility of maintaining appropriate methods of dispensing and administering drugs in the facility. With that responsibility goes the right to define certain methods and procedures with which the pharmacist must comply. These methods and procedures are essential to assuring that the patient is protected from medication errors. Therefore, the facility has the right to restrict the variety of drug labeling and packaging practices that can result from using multiple pharmacies in an effort to reduce or eliminate medication errors.
Because the nursing facility is responsible for the quality of care provided to its residents, the facility has the right to establish guidelines and standards for pharmacy providers that serve its residents. This includes setting standards for medication labeling and packaging. The facility must have the right to set these standards because of the facility’s responsibility for accuracy of medication administration.
In cases where the resident is responsible for the cost of medications, and has a pharmacy benefit that provides coverage for part or all of the medication costs, the best solution at this time is to handle these situations on a case-by-case basis. The nursing facility social worker may be able to work out an arrangement with the insurance company or pharmacy benefit manager to reimburse the patient for the cost of medications obtained from the LTC pharmacy.
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