New law stops potential criminalization of EMS ‘standing orders’ for timely controlled-substance use

A new bipartisan law, the Protecting Patient Access to Emergency Medications Act of 2017, P.L. 115-83, signed by President Trump on November 17, 2017, amends the Controlled Substances Act (CSA) (P.L. 91-513) to clarify that emergency medical services (EMS) professionals (including nurses, paramedics, and emergency medical technicians) are able to continue administering controlled substances (contained in schedules II, II, IV, or V) to critical patients, such as pain narcotics and anti-seizure medications, pursuant to standing (written medical protocol) or verbal (oral directive) orders when authorized by state law (Protecting Patient Access to Emergency Medications Act of 2017, P.L. 115-83, enacted November 17, 2017).

It has been a long-standing practice for medical directors of EMS agencies to write standing orders for the administration of controlled substances by EMS professionals. As reported by Emergency Physicians Monthly, in a January 2015 meeting with the National Association of EMS Physicians (NAEMSP) Executive Committee to discuss possible EMS regulations, the Drug Enforcement Administration (DEA) stated its position that the CSA only allows for patient-specific orders for controlled substances and that it is illegal for EMS agencies to deliver any controlled substances under written medical protocols or standing orders. Therefore, absent this new legislation, it was the position of the DEA that any regulations concerning EMS agencies would be required to prohibit the continued use of standing orders for EMS professionals.

The law also allows EMS agencies the option of having a single DEA registration in each state where the EMS agency administers controlled substances, in lieu of requiring a separate registration for each location of the EMS agency within the state, as long as certain transportation, storage, re-stocking, and recordkeeping rules for controlled substances are followed by the EMS agency. The act further provides that a hospital-based EMS agency may use the DEA registration of the hospital to administer controlled substances without an additional registration of its EMS agency.

The law was introduced as H.R. 304 in the House of Representatives by Reps. Richard Hudson (R-NC) and G.K. Butterfield (D-NC). The Senate version, S. 916, was introduced by Sens. Bill Cassidy (R-La) and Michael Bennet (D-Colo). H.R. 304 initially passed the House by a vote of 404-0 on January 9, 2017. It passed the Senate, as amended, by unanimous consent, on October 24, 2017.

Four VA facilities weak on controlled substance diversion protections

In recent years, diversion of controlled substances has occurred at several Veterans Affairs (VA) medical facilities. In fact, in a 2009 and 2014 report, the VA Office of the Inspector General (OIG) identified a number of weaknesses in VA medical facilities’ implementation of controlled substance inspection programs. For example, the VA OIG found that some VA medical facilities had not conducted the required monthly inspections, and when facilities did conduct the monthly inspections, the inspections were sometimes incomplete because they did not follow all of the required Veterans Health Administration (VHA) procedures.

GAO review

As a result of these deficiencies, Congress requested that the Government Accountability Office (GAO) report on VHA’s processes to reduce the risk of diversion of controlled substances at its medical facilities and VHA’s oversight of these processes. The report examined: (1) the extent to which selected VA medical facilities have implemented controlled substance inspection programs as required by VHA policies, and (2) VHA’s oversight of these programs at selected VA medical facilities.

Implementation of inspections

The GAO found weaknesses in the way four VA medical facilities were implementing their controlled substance inspection programs. Two of the four facilities did not conduct monthly inspections of controlled substances as required by the VHA. Between January 2015 and February 2016, one facility missed 43 percent of monthly inspections in critical patient care areas and the pharmacy. Further, inspections that three of the four facilities performed did not include or follow three or more of the nine VHA requirements. At two of the three facilities, inspectors did not properly verify that controlled substances had been transferred from VA pharmacies to patient care areas; nor did inspectors ensure that all controlled substances on hold for destruction were properly documented.

Contributing factors

GAO discovered that several factors contributed to the failure to adhere to VHA policy. First, the two facilities that missed inspections lacked an additional control procedure (such as the use of an alternate controlled substance coordinator) to help prevent missed inspections when inspectors could not conduct them due to professional or other personal responsibilities. Second, three of the four facilities did not ensure their written procedures included the nine VHA program requirements. Third, while the VHA relies on coordinators at the facilities to ensure that the inspections are completed appropriately, the GAO found that VHA’s training course for the coordinators does not focus on its required inspection procedures.

Inconsistent oversight

The GAO also found inconsistent oversight at the selected facilities of their controlled substance inspection programs by facility directors and the Veterans Integrated Service Networks to which the facilities report. Directors at two of the four selected VA medical facilities had not implemented corrective actions to address missed inspections identified in the monthly inspection reports. In addition, two of the four selected networks did not review their facilities’ quarterly trend reports, as required by VHA. One network that had reviewed the trend reports failed to follow up with a facility to ensure it had submitted missed trend reports. The GAO concluded that without effective oversight of the inspection programs by directors and networks, VHA lacks reasonable assurance that its programs are being implemented as required to prevent and identify diversion of controlled substances.

Recommendations

The GAO recommended that the Secretary of the VA direct the Under Secretary for Health to:

  • ensure that VA medical facilities have established an additional control procedure, such as an alternate controlled substance coordinator or additional inspectors, to help coordinators meet their responsibilities and prevent missed inspections;
  • ensure that VA medical facilities have established a process where coordinators, in conjunction with pharmacy officials, periodically compare facility inspection procedures to VHA’s policy requirements and modify facility inspection procedures as appropriate;
  • improve the training of VA medical facility controlled substance coordinators by ensuring the training includes the inspection procedures that VHA requires;
  • ensure that medical facility directors have designed and implemented a process to address nonadherence with program requirements, including documenting the nonadherence and the corrective actions taken to remediate nonadherence or the actions that demonstrate why no remediation is necessary; and
  • ensure that networks review their facilities’ quarterly trend reports and ensure facilities take corrective actions when nonadherence is identified.

The VA concurred with the GAO’s recommendations.

Highlight on Arkansas: medical marijuana amendment approved

On November 8, 2016, Arkansas voters approved Issue 6, the Arkansas Medical Marijuana Amendment which amended the state’s constitution, by a margin of 53 percent in favor to 47 percent against, and became the first state in the South to legalize medical marijuana. The governor had voiced his opposition to the measure. With the approval, more than half of the states in the U.S. have now legalized medical marijuana.

A “yes” vote supported legalizing medical marijuana for 17 qualifying conditions, creating a Medical Marijuana Commission, and allocating tax revenue to technical institutes, vocational schools, workforce training, and the state’s general fund. A “no” vote opposed the amendment to legalize medical marijuana. The amendment will allow patients with a variety of medical conditions, including cancer, Tourette’s syndrome, Crohn’s disease, fibromyalgia, post-traumatic stress disorder, and HIV/AIDS, along with a doctor’s permission to buy marijuana from dispensaries. Patients, however, won’t be allowed to grow their own marijuana.

The Arkansas Department of Health was given up to 120 days to adopt rules for various provisions of the amendment, including, but not limited to:

  1. applications for and renewals of registry identification cards;
  2. labeling and testing standards for marijuana distributed to patients;
  3. care givers assisting patients who are physically disabled or under the age of 18;
  4. requirements for oversight, recordkeeping, security requirements for dispensaries and cultivation facilities;
  5. the manufacture, processing, packaging, and dispensing of marijuana to patients;
  6. procedures for suspending or terminating the licenses of dispensaries and cultivation facilities that violate the provisions of the amendment;
  7. procedures for inspections and investigations of dispensaries and cultivation facilities; and
  8. advertising restrictions for dispensaries and cultivation facilities;

A separate marijuana question had been approved, but Arkansas’ Supreme Court last month directed that votes not be counted. Justices said the petition lacked enough valid signatures. In 2012, Arkansas voted on the Arkansas Medical Marijuana Question, which failed to garner enough support. Following the approval of Issue 6, opponents vowed to fight the amendment in the Arkansas legislature.

 

Highlight on Maryland: Citing prison smuggling, opioid options handcuffed for all

In a change to the dismay of physicians and patients, Maryland’s Medicaid program recently removed Suboxone film, a drug used in the treatment of opioid addiction,  from the state’s list of preferred drugs and substituted it with the tablet form Zubsolv. Suboxone helps people control their opioid habit, but is an opioid as well. While Suboxone does not produce a high as intense as other opioids, it keeps cravings in check while creating some feelings of euphoria in users. The concern underlying Suboxone is that it comes as a tiny, dissolvable film, about the size of a breath mint strip, and thus, transparent and easy to hide. Suboxone will only be covered if prescribing physicians first go through a prior authorization process.

Maryland state officials stressed that the change was made to stop the flow of the drug into jails and prisons. According to the Department of Health and Mental Hygiene (DHMH), Suboxone strips were diverted or smuggled into prisons and resold or traded in criminal activity. The Department of Public Safety and Correctional Services (DPSCS) noted that seizures of the drug were up about 40 percent compared to 2015, with more than 2,300 doses of Suboxone confiscated. The strips are often divided up and sold individually in prisons. DPSCS had argued that the change was necessary because of 13 fatal overdoses in prisons since 2013. Opponents stressed that without Medicaid reimbursement, the well-tolerated Suboxone will be virtually unavailable for the most vulnerable patients, resulting in a serious restriction of access to treatment. The state health department did acknowledge that the overdoses were for opioids in general, not specifically related to Suboxone.

Physicians are against the change because the tablet form is not as effective at keeping opioid withdrawal symptoms in check. Suboxone film, as well as the Zubsolv pill that replaces it, actually protect against overdoses because they contain both the opioid buprenorphine and a drug called naloxone that reverses the effects of an overdose. Naloxone is used by emergency responders to revive people who overdose. Some physicians have reported that patients who were stable and doing well on Suboxone were reacting differently to Zubsolv, in many instances negatively.