Executive Summary
The Controlled Substances Act (CSA) requires that all prescriptions for medications on Schedules II-V (mostly pain medications) be written and signed by the prescriber. The DEA, which enforces the CSA, allows the prescriptions to be faxed but prohibits verbal orders except in emergency situations. The emergency exception is very narrowly construed so as to apply only when immediate administration of the medication is required (i.e., within minutes, not the next day). Despite the provisions of the CSA, the standard practice in nursing homes, hospices and other facilities has been to use “chart orders” to fill prescriptions. This involves the physician placing a standing order for medication in a nursing home resident’s chart, and a nurse at the nursing home calling in the prescription to the long-term care pharmacy when the resident needs the medication. Basically, the nurse is acting as the agent of the physician. The long-term care pharmacy would then fill the prescription and the nurse would note it in the resident’s chart. Chart orders routinely are used in hospitals. Chart orders are especially important in the nursing home and hospice fields for several reasons. First, nursing homes and hospices receive patients at all hours of the night and day, and on weekends. These patients are often coming directly from hospitals and are in dire need of pain medication. Second, approximately 40% of physicians that see nursing home patients work out of their vehicles and do not have an established office or staff. As a result, requiring an original or faxed prescription necessarily will result in delays getting the medications to the nursing home resident. In addition to causing significant distress to the patient, any such delay can form the basis of a citation against the facility under the nursing home regulatory enforcement rules.
In the past, the DEA did not enforce this aspect of the CSA; however, recently it has begun to do so. A coalition has been formed among pharmacists, long-term care providers, medical directors and others to work with the DEA on the issue, but to date, the DEA has been unresponsive. The DEA said that it would issue guidance in the form of a “Dear Practitioner” letter. While the DEA did issue a “Dear Practitioner” letter, it failed to provide any new information about the chart order issue. Rather, it merely restated the law and discussed the application of the emergency situation exception. In the past few weeks, members of the coalition have met with staff for Senators Whitehouse (D-RI) and Brown (D-OH), who seemed interested in seeking a legislative remedy to the issue. Most recently, staff in Senator John Cornyn’s (R-TX) office has expressed a willingness to explore a legislative solution to the problem.
Detailed Analysis
In long-term care, hospice and other care environments in which a resident’s/patient’s physician is not always physically on site, nurses play a vital role in communicating information to physicians and other practitioners, recording the practitioner’s verbal orders and ensuring that those orders are carried out, and monitoring the patient’s condition. For example, in a nursing facility (NF), if a nurse’s assessment indicates a change in the resident’s condition possibly requiring a change in medication or other treatment, the nurse contacts the physician, usually by telephone, to describe the resident’s symptoms, relay data such as vital signs and provide whatever additional information the physician needs to make a treatment decision. The nurse then records the physician’s verbal order in the resident’s clinical record creating what is know as a “chart order,” and makes sure that the physician’s orders are acted upon (similar to the process that occurs in the hospital setting). Thus, if a physician orders a new drug or makes any change in a patient’s drug regimen, it is the nurse’s responsibility to create, then fax, the chart order to the pharmacy so that the pharmacy can dispense the medication. Through this process, nurses ensure that medications are acquired timely to meet patients’ changing and emergent medical needs.
Direct communication between the physician and the nurse in the facility is critical both to quality care, and ensuring that licensed NFs and hospice providers comply with state and federal regulatory requirements governing quality and timeliness of medical and pharmaceutical care. Failure to comply with regulatory requirements, including delays in notifying a physician or in responding to the residents’ needs can affect the facility’s state licensure and federal certification status. If the failure to comply with a regulatory requirement causes actual harm to a resident, the facility could be fined or even decertified resulting in the loss of federal funding and ultimately, closure.
The federal Drug Enforcement Agency (DEA), an agency of the Department of Justice, has jurisdiction over all Schedule II, III, IV and V medications. These medications include all opiate pain medications. Federal regulations implementing the Controlled Substances Act (CSA) at 21 C.F.R. 1306.11(f) make clear that a prescription written for a Schedule II substance for a resident in a NF or under hospice care may be transmitted by the practitioner or the practitioner’s agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription and it must be maintained in accordance with the DEA’s record keeping requirements.
Since 2001, however, DEA has taken the position that under no circumstance does a legal agency relationship exists between a facility nurse and the physician. DEA’s refusal to recognize the nurse/agent relationship in NFs or for hospice patients even extends to situations where the nurse and physician are employed by the same entity.
Although DEA is well aware that practice standards in long-term care and hospice do not comport with its interpretation, for years, DEA did little or nothing to enforce its position. However, recently DEA agents have been inspecting long-term care pharmacies in Ohio, Michigan, Wisconsin and Virginia. Many of the practices that DEA agents have identified as non-compliant are “standard practice” in the long- term care setting and have been for years in this environment. Pharmacies are now suddenly facing huge fines and legal fees that threaten to shut them down. For example, one independent pharmacy was cited with over 3,000 violations and faces fines of over $32 million.
DEA’s recent enforcement actions have affected every provider who works with long-term care and hospice patients. Medications that previously were dispensed by the pharmacist based upon a “faxed” chart order from the nurse in the nursing facility now must be held until the physician is able to fax the prescription order directly to the pharmacy. Since many physicians who work in long term care do not have offices or are rarely in them, the delay involved in waiting for a fax can be substantial.
This past year, the Centers for Medicare and Medicaid Services (CMS) issued new surveyor guidelines that specifically address the importance of pain management. In the long-term care and hospice environments, any delay in providing a patient with needed pain medication places the patient at risk and violates quality of care standards. The pharmacist thus faces the ethical and legal dilemma of not filling a prescription for a patient in pain and violating practice standards and CMS regulations governing patient care or violating DEA’s interpretation of its regulations. In sum, the clinician’s commitment to patient care often conflicts with the DEA’s interpretation of the CSA.
While the failure of DEA to recognize the nurse as the agent of the practitioner imposes increased burdens and costs on all practitioners and providers, the most critical impact is on resident care. The primary interest of long-term care practitioners is to provide the best possible care for the resident, and it is becoming increasingly difficult to maintain an acceptable quality of care with the way that local DEA offices are interpreting and enforcing CSA provisions. The DEA has promised to issue a “Dear Registrant” letter clarifying its position with respect to the issue, particularly as it applies to Schedule III-V medications. To date, however, the agency has yet to release the letter.
A coalition of associations representing pharmacists, long-term care providers, hospice providers and physicians is working on a legislative remedy to the issue with the assistance of Senators Brown (D-OH), Cornyn (R-TX) and Whitehouse (D-RI); however with health reform being considered on the Hill, it is unlikely that Congress will be able to enact anything in the short term.