Last month during the health care debate, the Senate Special Committee on Aging held an informational session (hearings were banned for those days) titled “The War on Drugs Meets the War on Pain: Nursing Home Patients Caught in the Crossfire.” The main cause for the hearing was to address the U.S. Drug Enforcement Administration’s (DEA) recent crackdown of nursing homes, which “appeared to be exacerbating” the suffering of elderly in nursing homes.
The purpose of the hearing, according to Chairman Herb Kohl’s (D-WI) opening statement, was to examine the dispensing of pain medication in nursing homes across the country. Mr. Kohl noted that while the DEA claims they are working to keep prescription drugs out of the wrong hands, in reality they are causing widespread confusion, with the result of interruption and delays in timely access to pain medication for vulnerable seniors. Accordingly, the Committee heard testimony from the following witnesses:
– Michael Schanke, Administrator, Oakridge Gardens Nursing Center, Menasha, WI, on behalf of American Health Care Association & National Center for Assisted Living
– Robert Warnock, DPh, Vice President of Pharmacy Services, Golden Living, Fort Smith, AR
– Cheryl Phillips, MD, President, American Geriatrics Society, New York, NY
– Ross Brickley, RPh, President of Continuing Care Rx, Inc., Raleigh, NC on behalf of American Society of Consultant Pharmacists and the Quality Care Coalition for Patients in Pain
– Joesph Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, US Department of Justice, Washington, DC
– Carmen Catizone, DPh, Executive Director, National Association of Boards of Pharmacy, Mount Prospect, IL
Michael Schanke
As the owner of three long term care facilities in Wisconsin, one of which he is the Administrator of, Mr. Schanke used his testimony to discuss DEAs “rules and regulations that are the root cause of unimaginable, unacceptable delays in access to the pain medication patients in nursing homes and assisted living facilities across the country need.”
In fact, he noted that current DEA rules are contributing, albeit unintentionally, to the suffering that many patients in pain must endure. This kind of needless suffering is something Mr. Schanke experienced first-hand, as family members either watch helplessly, or berate care giving staff who is struggling with the new regulations. Such rules create frustration for many because they may only allow access to inadequate or inappropriate pain relief, even though the medication they need may sit in a locked pharmacy box only steps away.
Mr. Schanke and other witnesses pointed to the Quality Care Coalition for Patients in Pain’s (QCCPP’s) report entitled, Patients in Pain: How the US. Drug Enforcement Administration Rules Harm Patients in Nursing Facilities, for further evidence.
Part of the frustration comes from the fact that long term care facilities now must tell their staff that the nurse – who has been trained to treat patients, who has been thoroughly educated on the administration of medication, who is licensed by the state, who is with the patient around the clock, who is assessing the individual’s condition in real time – can no longer perform one aspect of the job that he or she has been trained and licensed to do – in short, the nurse can no longer fax physician’s telephone and chart orders to the pharmacy.
The fact that the DEA does not recognize long term care nurses as agents of the prescriber, nor does it consider facility chart orders as valid prescriptions, remains the core of this issue. Mr. Schanke portrayed these problems by telling the stories of two patients, one of which ran out of pain medication, suffered a delay, and ultimately was transferred back to the ER. The second patient experienced an unanticipated change in condition that caused a sudden, dramatic increase in pain.
From these examples, he recommended that the DEA clarify that the long term care facility nurse is acting as the agent of a prescriber and may communicate verbal orders to the pharmacy that have been issued by the prescribing practitioner for Schedule III – V drugs, and emergency orders for Schedule II medications. He noted that this change would help facilities through the delays that can occur most often for late-night and weekend admissions.
Robert Warnock
As a Vice President of Pharmacy Services, Mr. Warnock’s testimony came from the perspective of Skilled Nursing Facilities (SNFs). His experience as a Certified Geriatric Pharmacist (CGP) and licensed Doctor of Pharmacy, as well as a professor of pharmacy in Atlanta gave him a unique set of experiences to discuss.
Similar to Mr. Schanke’s testimony, Warnock discussed how DEA’s regulations are placing SNFs at the risk of being noncompliant with CMS regulations governing the patient care responsibilities of SNFs. Specifically, he addressed the same two problems as Mr. Schanke, as did all the witnesses. He also noted how DEA regulations inhibit SNFs ability to meet the expectations of SNF residents and their families in terms of appropriately addressing their medical and pain-relief needs through prescription drug therapy.
In addressing these problems, Warnock outlined how ordering narcotics is a burdensome process when all individuals are not present, which can result in delays of treatment. These kinds of delays he felt were unnecessary considering CMS regulations on SNFs require that all patients choose a primary care physician to coordinate their care. Additionally, it is only the patient’s primary care physician and the facility’s coverage physician or Medical Director who can order medications for residents. Also, CMS regulations cover all aspects of medication ordering, procurement, delivery, administration, storage and disposal.
Cheryl Phillips
As the Chief Medical Office of On Lok Lifeways, and President of the American Geriatrics Society, Dr. Phillips agreed with the other witnesses that the DEAs interpretation of the Controlled Substance Act was preventing patients in long-term care settings from receiving much needed pain relief and other medications in a timely manner.
Dr. Phillips emphasized how untreated pain has serious medical consequences that include poor oral intake and weight loss, inability to sleep, depression, loss of mobility and increased risk of falls, and increased risk of pressure ulcers. As the list keeps going, she noted that poor pain management in the nursing home setting has significant associated costs, including increased emergency room transfers and increased re-hospitalization rates.
Her testimony also noted that poor access to pain control creates a disincentive for physicians to practice in the nursing home setting. This result is significant because more 1.38 million older Americans reside in nursing homes and need physicians. As a result, identifying physicians who are willing to provide quality care in the nursing home setting is a significant challenge across the country, another reason for changing DEA enforcement.
Ross Brickley
Mr. Brickely, a Certified Geriatric Pharmacist, and President of a long-term care pharmacy serving nursing facilities and assisted living, testified from the pharmacist perspective. His concern focused on how nationwide, 65% of clinicians reported that DEA’s rules were causing delays, in which 40% reported delays of up to one day, while another 40% reported delays of up to two days. Delays of two or more days were reported by 12% of these respondents.
The survey also documented that the biggest challenges involve emergency situations, and situations that involve transitions in care, where patients are either being admitted or readmitted to the nursing facility from a hospital or other care setting. Other challenges found in the survey dealt with DEA rules that impede post-surgical rehabilitation, delay recovery, extend the need for skilled nursing care, and send other patients back to the hospital for treatment and readmission.
From these findings, Mr. Brickley recommended that the DEA update its rules and policies for prescribing and dispensing in nursing homes because under CMS regulations, nursing facilities must provide pharmaceutical services to meet the patient’s routine and emergency needs.
Joesph Rannazzisi
Giving the DEA’s perspective, Mr. Rannazzisi, Deputy Assistant Administrator for the Agency, outlined how Long-Term Care Facilities (LTCFs) were different from other health care facilities such as hospitals because patients generally reside in LTCFs. He added further that patients generally do not receive daily care from a physician, and how many facilities do not have 24 hour physicians on site. His testimony also largely focused on explaining the significance of the Controlled Substance Act (CSA), and how its impact has provided security and accountability for the nations controlled substance supply—ignoring the negative consequences it has left for patients in pain at LTCFs.
While he states that the requirements of CSA are designed to facilitate appropriate medical care and thereby ensure the safety of patients, causing a two hour delay and sometimes emergency admission to receive pain medication seems to contradict this. In fact, preventing access to pain medication at an LTCF, when the same is permissible at a hospital seems to be unbalanced.
Carmen Catizone
As the Executive Director of the National Association of Boards of Pharmacy, Ms. Catizone’s discussed inviting the DEA and all stakeholders in long term care and other practice settings, to their May Annual Meeting. At this meeting, she noted they will review and pose revisions to the Controlled Substances Act that address the two issues previously mentioned.
She also recommended that the DEA establish a new registration category for LTC facilities, as defined by the states, with similar privileges and responsibilities as now exist for hospitals. If this could be enacted the dilemma surrounding “chart orders” and the “agent of the prescriber” could move forward toward a resolution.
Conclusion
In 1970, the DEA never envisioned the evolution of the practice of pharmacy and medical care to what it has become today, and as a result, the Controlled Substances Act has led to numerous issues within LTCFs that the agency has been unable to resolve to this day. With one in five older Americans (18%) having persistent pain, and taking analgesic medications regularly (several times a week or more), our health care system cannot continue these delays. With 63% of the same population haven taken prescription pain medications for more than 6 months a solution is needed now. Older people are more likely to suffer from chronic conditions often associated with persistent pain, and if left untreated, the associated costs will surely outweigh the risks associated with DEAs enforcement.
While long term care professionals understand and support the DEA’s role in preventing the diversion of controlled pharmaceuticals, the reality is pharmaceutical care within the nursing home environment is already highly regulated. Pharmacists are licensed by states and must comply with both state and federal regulations governing the dispensing and storage of all medications. At the federal level, CMS regulations governing pharmaceutical care in nursing facilities are extensive.
Following the example of Arkansas State Board of Pharmacy, which has passed a resolution recognizing SNF nurses as agents for a prescribing physician, and the use of a chart order as a legal prescription, Congress and other states must follow.
Allowing such pain to continue, when we have the means to stop it, runs counter to the Hippocratic Oath’s admonition to ―first, do no harm.