When providers undertake efforts aimed at improving medication compliance, they not only help themselves and their organizations avoid potential legal and regulatory hot water, but can also enhance patient, staff, and community safety in the process. The good news is that for providers and organizations interested in improving medication compliance efforts, there are many real-life examples of where medication compliance has come up short. These instances help shine a light on what can go wrong and what organizations can do to avoid a similar fate.
How to Improve Medication Compliance
Here are four examples and summaries of the corrective actions taken by the organizations to help you understand how to improve medication compliance in your organization.
1. Drug Diversion
In August 2018, the University of Michigan Health System agreed to a settlement resolving allegations that the organization violated provisions of the Controlled Substances Act (CSA). As a report from the U.S. Drug Enforcement Administration (DEA) notes, its investigation into the UMHS began in December 2013 after two employees overdosed on opioids, including fentanyl, at a UMHS facility. One of the employees died. Following its investigation, DEA determined that several practices concerning controlled substances violated the CSA. These included the following:
- UMHS failed to secure DEA registrations for more than a dozen ambulatory care locations which, received narcotics from the main hospital's pharmacy and dispensed them to patients. All narcotics distributions from the main hospital to the unregistered locations were illegal.
- The unregistered locations' dispensing of these narcotics to their patients were illegal.
- UMHS committed significant recordkeeping violations. These included failing to maintain complete and accurate records of certain controlled substances that it received, sold, delivered, or otherwise disposed of.
- UMHS failed to notify DEA in a timely manner regarding instances of thefts or significant losses of controlled substances.
How UMHS Worked on Improving Medication Compliance
Coverage of the settlement by The Ann Arbor News identified conditions of the three-year Memorandum of Agreement entered into by UMHS with the DEA. Some of the conditions spoke to the specific ways the organization would be improving medication compliance going forward. These corrective actions included the following:
- Conduct unannounced quarterly audits of randomly chosen schedule II-V controlled substances.
- Use software to track the dispensing, usage, administration, and wasting of controlled substances at all sites that anesthesia provides services.
- Institute an educational program on prevention of drug diversion in the workplace.
2. Medication Management
In December 2016, California's Rideout Health agreed to a three-year compliance plan to settle alleged violations of CSA by three of Rideout Health's facilities: two hospitals and one surgery center. The payment and plan, the U.S. Department of Justice (DOJ) notes, resolved claims that the facilities failed to properly record and maintain thousands of transactions involving controlled substances, which violated the CSA.
The settlement also resolved the contention that the system used by the organization during the period in question to distribute controlled substances between the facilities failed to provide sufficient security controls. More specifically, pharmacy technicians at one of the facilities transported controlled substances between the facilities with little or no of such controls in place.
How Rideout Health Worked on Improving Medication Compliance
Coverage of the settlement by The Sacramento Bee noted that Rideout Health collaborated with DEA and DOJ officials to improve facility-wide drug management and protocols. "That includes the integration of a new electronic medication delivery system with built-in security features [and] the hiring of a director of pharmacy and a medication safety officer."
3. Medication Administration
In early 2019, an investigation revealed that a former physician at Ohio's Mount Carmel Health System ordered excessive and potentially fatal doses of pain medication for more than 30 patients near death between 2015 and 2018. As the health system notes, "These patients' families had requested that all life-saving measures be stopped, yet the amount of medicine the doctor ordered was more than what was needed to provide comfort."
The investigation eventually led to the physician being charged with killing 25 patients, multiple lawsuits, nearly two dozen employee terminations, two hospitals being placed in "immediate jeopardy" status for continued participation in Medicare and Medicaid, and the resignation of the organization's chief executive officer.
How Mount Carmel Worked on Improving Medication Compliance
The organization worked to develop a comprehensive action plan, which was eventually accepted by the Centers for Medicare & Medicaid Services. This allowed the two hospitals to be released from their immediate jeopardy status.
Actions undertaken by the hospital included the following:
- Add a new protocol to set maximum appropriate doses for pain medication in the electronic medical record system.
- Implement a new escalation policy for deviations in pain medication protocols.
- Restrict the ability to bypass pharmacy review of medication orders.
- Increase clinician education on standards and practices concerning end-of-life care.
A WOSU report shared new medication guidelines distributed to Mount Carmel staff in early 2019. As the report notes, the guidelines provided a checklist for sedation management in the intensive care unit, where the former physician worked at Mount Carmel.
4. Medication Administrator Errors
To conclude, we're going to look back at a significant story from about 15 years ago that resulted in major changes at a highly respected organization. In 2004 and 2005, four preventable deaths occurred at Kaiser Permanente hospitals, according to an ABC7 report. Three of the deaths were linked to medication administration errors.
As a Drug Topics report notes, one patient died after receiving a double dose of a stroke medication due to a nursing administration error. Another patient died after receiving a double dose of epinephrine. The third medication-related death occurred after the patient received a chemotherapy drug intended for another patient.
The deaths ultimately led to new state legislation concerning reporting of adverse events and the ability for the state to fine hospitals for deficiencies. More importantly, the state and hospitals began sharing best practices to reduce medication errors.
How Kaiser Permanente Worked on Improving Medication Compliance
The two reports detailed some of the corrective actions taken by the organization. They included the following:
- Staff training on the "five rights" of medication administration, use of patient identifiers, and policy of checking chemotherapeutic agents.
- Implementation of a "quiet zone" to avoid distractions during medication preparation.
- New procedures for handling cytotoxic and hazardous drugs to verify that the correct drug is being administered.
- Restrictions on who could retrieve and deliver chemotherapeutic agents.
- New labeling of high-risk medications.
- Investment in bar-coding technology for patients and medications.
As the ABC7 report, which was published a few years following the deaths, notes, "In responding to its own problems, Kaiser is now widely regarded as a leader in adopting both low- and high-tech solutions to improve patient safety."