Impact of the Controlled Substances Act on Assisted Living Facilities
Impact of the Controlled Substances Act on Assisted Living Facilities
In 2009, the United States Drug Enforcement Administration (DEA) started auditing some long-term care facilities to establish the extent of compliance with the Controlled Substance Act regulations for prescribing and dispensing controlled drugs to residents (Elon et al., 2011). Ohio was first in this program, followed by Virginia, Wisconsin and Michigan. It has been found that the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services, oversees more than 3,000 assisted living facilities that offer skilled nursing care to about 250,000 disabled Americans per year. According to these federal guidelines, assisted living facilities are required to give patients specified scheduled and emergency medical attention, in line with the prescriber’s order, and promptly. Moreover, the medical care of every resident is supposed to be overseen by a physician. These physicians visit with their clients who reside in these facilities but are barely physically present. Thus, many treatment orders are often relayed to facility staff over the phone. Additionally, many assisted living facilities have on-site pharmacies; many of them contract with exterior pharmacies that specialize in working with long-term facilities. Consequently, the audits conducted by the DEA have revealed variations between the standards for practice in these facilities, which are aimed at ensuring that patients get prompt and appropriate access to required medications, and DEA regulations, which are designed to reduce the risk of drug diversion (Stefanacci, 2014). This paper discusses the impact of the Controlled Substances Act on assisted living facilities and develops several recommendations for this matter.
When the physician communicates a medication order over the phone to the nurse, the latter assumes the role of the prescriber’s agent by entering the order in the resident’s medical record and then relays it to the assistant living home pharmacy. It only takes a few hours, depending on the distance between the pharmacy and the facility, before the pharmacy dispenses the drugs and deliver them (Stefanacci, 2014). The duty of the nurse at this point is to administer the medication according to the prescriber’s orders.
Normally, most pharmacies that are contracted with assisted living homes have provisions for small emergency supplies of drugs including controlled substances and antibiotics that are accessible only during emergencies. Such medications are usually locked up in boxes or cabinets known as emergency boxes or contingency boxes. In cases where the resident has an urgent requirement for medication, the nurse concerned consults a physician to acquire the prescriber’s orders, then secures the medication from the emergency box and administers it to the resident in line with the orders (Stefanacci, 2014). In such a scenario, the nurse again plays the role of the prescriber’s agent by performing the prescriber’s orders and making sure the resident gets the ordered medication. These guidelines are aimed at meeting residents’ needs and satisfying CMS quality of care regulations.
The current DEA regulations classify residents in assisted living facilities as outpatients despite nursing facilities being arguably similar to hospitals than physicians’ offices regarding operations and supervision. Accordingly, the DEA necessitates that pharmacies, nurses, and physicians should provide extra documentation before a pharmacist is allowed to dispense a controlled substance for administration to a resident. The main reason for such a situation is that the DEA does not appreciate the vital role of nurses in long-term care when they act as the prescriber’s agents (Elon et al., 2011; Stefanacci, 2014). In other words, whenever there is an emergency, and the physician gives the nurse a verbal order for a controlled medication, the nurse is not allowed by law to retrieve this medication from the emergency box unless the doctor personally calls or faxes a prescription order to the pharmacy. Further, the nurse has to call the pharmacy and confirm whether the pharmacy has gotten the order. Such procedures tend to delay treatment considerably, leaving residents with inadequate symptom relief to deal with pain, psychiatric conditions, and seizures. Some authors hold that residents in assisted living facilities have been left in pain for hours, sometimes days, as the care providers in these institutions struggle to obey such and other regulations from the DEA (Good et al., 2014).
Survey by the Quality Care Coalition for Patients in Pain
Of the participants in the survey, 59% conceded to experiencing delays in obtaining medication for the residents. 28% of them indicated that there was a significant change in prescribing patterns for new residents in assisted living facilities, while 21% gave the same report for existing residents (Good et al., 2014). In Ohio, the state where the DEA has been most active, 78% of the participants revealed that treatment was being delayed. 39% of respondents in this state said that there “has been a considerable change in prescribing patterns for new residents in assisted living facilities.” 32% of them indicated that prescribing patterns for existing residents had also changed. These changes include the application of less efficient, non-narcotic medications. Such medications are often inadequate to treat pain; rather, they increase the potential for severe side effects in older residents.
The findings also implied that the delays in treatment vary in duration. For instance, only one-tenth of the respondents reported delays of up to an hour, while a similar fraction reported delays of more than two days. 40% stated delays of one day, while the remaining 40% recounted delays of up to two days (Good et al., 2014).
The delays in treatment resulting from the implementation of DEA regulations compel assistant living homes to send some residents to hospital and readmission. For instance, in the event that the resident undergoes surgery, delays pose several challenges to their ability to take part in post-surgical rehabilitation, thereby lengthening their need for skilled care (Good et al., 2014). Such practices tend to be expensive and challenging, both for the facility’s management and the resident, yet they are entirely preventable.
Discussion
More than half of the respondents in the survey indicated delays in obtaining controlled substances for residents. Key areas for consideration are new admissions and cases whereby existing residents experience a change in condition, particularly over the weekends and aside from regular working hours (Good et al., 2014).
New admissions pose several challenges for assisted living facilities since hospitals do not send prescription drug orders in hard copy, especially for physically challenged people being discharged to long-term facilities (Elon et al., 2011). Typically, hospitals send a formalized transfer form that comprises a listing of orders for the resident’s care, including drugs. Before the implementation of the current DEA regulations, facility nurses would authenticate the hospital orders with the resident’s doctor, transcribe the doctor’s orders, enter them in the resident’s chart, and then send a copy of the chart to the pharmacy. The pharmacy would then dispense the medications to the facility according to the chart. However, after implementation of the current DEA regulations, assisted living facilities have to either request the hospital to send a printed document for prescriptions or try to get the resident’s doctor to give emergency verbal orders.
New orders for existing patients, particularly on holidays and weekends are also significantly delayed because of the DEA rules. The doctors tend to respond promptly during regular working hour; however, during weekends and after hours, they are usually difficult to come by. The process of getting formalized prescription orders is lengthy given that many residents may have more than one doctor, particularly if they are transitioning between facilities (Stefanacci, 2014). Furthermore, in cases where a resident’s doctor cannot be reached, on-call physicians are less willing to give prescriptions for controlled substances for patients they have not interacted with personally before the incident.
Residents requiring Controlled substances for Non-Pain-Related Treatment
It is necessary to appreciate that controlled substances may be used for other treatments that are not pain-related. The respondents in the survey identified residents with psychiatric issues, who need to access the medications, including controlled drugs, to control seizures (Stefanacci, 2014). According to some facility nurses, the DEA, and other government agencies do not understand the level of care some of the residents in assisted living homes require.
Negative Impact on Care Providers
Health care professionals in the assisted living facilities have expressed great concern over the effects of the DEA regulations on their ability to offer sufficient care to residents. The need to work in line DEA regulations on prescriptions and dispensing of controlled substances and the consequent delays put assisted living facilities and health care providers at cross-roads with their professional duties and personal morals (Stefanacci, 2014). As a result, many of them perceive that they are being targeted for attempting to offer proper care for residents. Some of them even consider abandoning their jobs in assisted living homes or any other long-term care facility because they are frustrated in their responsibility to provide adequate care for residents (Elon et al., 2011). Given the fact not many physicians and other health care professionals are currently willing to venture into long-term care, assisted living homes can afford to lose any more staff.
The need to comply with DEA rules on the prescription and dispensing of controlled substances and the consequent delays also places assisted living facilities and health care providers at risk of violating quality of care standards based on federal and state law (Twillman et al., 2014).
Disposal of Controlled Substances
The latest regulations from the United States DEA on disposal of controlled substances have significant implication for assisted living homes. Therefore, the care providers in these facilities need to make several changes concerning policies and procedures. In response to statements by assisted living providers, the DEA confirmed that, according to Controlled Substances Act and related regulations, the staff in assisted living facilities are not allowed to dispose of unused substances on behalf of their patients, except for special circumstances (Stefanacci, 2014). For instance, skilled nursing homes and other facilities that offer extra care to resident patients may dispose of controlled substances in place of ultimate users who live or have lived in such homes.
The DEA holds that, while it is aware of the hardship facing assisted living homes’ staff concerning the disposal of controlled substances, the Controlled Substances Act does not authorize providers to dispose of these substances (Stefanacci, 2014). Rather, it grants the DEA ability to approve only three sets of people to be in charge of delivering controlled substances for drug disposal. The first set comprises ultimate users who acquire the controlled substances through legal means. Ultimate users may refer to the individual who legally acquired, and possesses, a controlled substance for personal use or the use of a family member. The second set includes people who are entitled by the law to dispose of the property in the event of the resident’s death. The last set of people includes other long-term care facilities in the place of ultimate users who live or have lived in such homes (Elon et al., 2011). Therefore, it is only in the case of a patient’s death, and with the permission of state law, that assisted living home staff may deliver the unused controlled substances for disposal. Otherwise, the personnel in these homes are not allowed to obtain pharmaceutical controlled substances from ultimate users with the aim of disposal.
Conclusions and Recommendations
The discussion demonstrates that the current DEA regulations pose considerable challenges to the adequate and timely administration to residents in assisted living facilities. These rules contradict treatment guidelines and standards of practice. For instance, the DEA does not consider the facility nurse to be an agent of the prescriber; neither does it appreciate the validity of a doctor’s order reduced to writing in the resident’s chart. Consequently, residents who are vulnerable and experience pain struggle through such circumstances for hours, even days, while care providers try to obtain the required DEA documents.
Given the current state of residents, staff, and management in assisted living facilities, there is a need for immediate action. Notably, the DEA should consider changing some of its policies to appreciate the crucial role of nurses as agents of the prescriber in a long-term care setting. As is the case with hospitals, the DEA should consider removing the limitations on the validity of “chart orders” that are representative of the prescribers’ genuine prescription medication orders. There is a prerequisite for a more balanced regulatory structure that addresses the valid requirements of law enforcement without bringing pain and danger to residents. Until a desirable regulatory structure is put in place, the DEA should strive to employ its implementation discretion to make sure residents in need of medications that are regulated by the DEA do not lack sufficient, proper and prompt access such medical care.
References
Elon, R. D., Schlosberg, C., Levenson, S., & Brandt, N. (2011). DEA enforcement in long-term care: Is a collaborative correction feasible? Journal of the American Medical Directors Association, 12(4), 263-269.
Good, H., Riley-Doucet, C. K., & Dunn, K. S. (2014). The prevalence of uncontrolled pain in long-term care: a pilot study examining outcomes of pain management processes. Journal of gerontological nursing, 41(2), 33-41.
Stefanacci, R. G. (2014). Long-term care regulatory and practice changes: impact on care, quality, and access. Ann LTC, 22, 11.
Twillman, R. K., Kirch, R., & Gilson, A. (2014). Efforts to control prescription drug abuse: Why Clinicians should be concerned and take action as essential advocates for rational policy. CA: a cancer journal for clinicians,64(6), 369-376.
