Hospitals are under increased scrutiny from regulatory agencies over prescription drug abuse and the potential for drug diversion from medical institutions. For hospital leadership, it is a patient safety issue. It is an employee health issue. It is a clinical quality and readmissions issue. And it is a legal and compliance issue.
The traditional approach to alleviating patient pain by using prescription opioids as the primary solution has created an environment where opioids are plentiful. And because hospitals hold a high inventory of regulated pharmaceuticals, they risk becoming a prime source of prescription drugs hitting the streets, where their value becomes highly inflated.
By taking a hard look at policies and oversight, hospital administrators can help reduce their institution’s risk of prescription drug inventory diversion and greatly reduce the risk of fines by federal drug agencies. By working with their hospital staff, hospital administrators also can help inform their employees about the opioid abuse epidemic and protect them from falling prey to it by working to solve potential “leakage” problems as well as possible staff addiction issues.
Medical professionals who divert controlled substances pose significant threats to patient safety and become a liability to their hospital, creating the opportunity for potential criminal and civil consequences. The Federal Drug Administration, the Centers for Disease Control and Prevention and the U.S. Drug Enforcement Agency are scrutinizing such cases, and fines are severe for not having adequate controls in place.
In a recent California case, a hospital was fined $1.55 million for failing to properly record hundreds of transactions involving controlled substances in violation of the Controlled Substances Act. The hospital was found to have insufficient procedures and controls in place on the distribution of controlled substances and to prevent diversion in its prescription drug dispensing operations.
In the largest settlement of its kind to date related to drug diversion at a hospital, a Massachusetts institution had to pay $2.3 million to the government to resolve allegations of allowing employees to divert controlled substances for personal use. The hospital also agreed to incorporate a corrective action plan to prevent and address future diversions.
Hospital administrators are on the front line of protecting hospital workers from falling prey to addiction. Education and training programs need to be in place that inform staff of the dangers of pharmaceutical addiction and the risks pharmaceutical dependency can pose. Additionally, a diversion prevention program needs to be reviewed by hospital leadership and updated if necessary.
An effective hospital or health system controlled substance diversion prevention program should contain several actions:
- Review policies and procedures that are in place to minimize diversion. Review and audit controlled substance data in the hospital organization. There are tools available to assist in identifying gaps in the system and develop a long-term solution. Beyond following the law, having these monitoring tools in place ensures that there are no gaps between dispensing controlled substances and administering those medications to patients.
- Create standards for ordering and prescribing controlled substances. This should include maintaining a chain of custody and utilizing witnesses when disposing of controlled substances. Be aware if a practitioner is always taking a larger dose in syringes for patients or not getting a second witness when disposing of controlled substances.
- Establish education and training across multiple disciplines to educate staff on controlled substance diversion. Staff need to understand the issue, risks to patients and the hospital and hospital procedures to reduce diversion. Train staff on what to do if they suspect a co-worker is diverting controlled substances. Health care professionals have an ethical duty to protect patients. Part of this responsibility is to report impaired staff members so they get help and patients are protected.
- Place camera surveillance in high-risk areas. This is a useful tool to monitor access to controlled substances in the hospital.
- When something does go wrong, have procedures ready to launch to investigate potential cases of diversion and discrepancies in controlled substance inventory. The DEA recommends that the hospital notify local law enforcement immediately because missing controlled substances could be hitting the streets in the community. In addition, the DEA requires that its office be notified immediately of the theft or significant loss of a controlled substance.
- Review staff practices that can help avoid the problem on the front end by reducing the vast number of opioid prescriptions that are being written. Clearly, it is important to treat a patient’s pain, but the more traditional methods of escalating narcotic use are not always in the best interest of the patient. Clinical protocols regarding pain management processes can be expanded to a multimodal approach that includes opioid pain killers when appropriate but may also include anti-inflammatories and muscle relaxants, as well as alternative therapies that help patients relax and relieve their pain.
The problem of diversion by hospital staff across the country puts hospitals and their patients at risk. Inventory management of controlled substances needs to be addressed by every hospital, with proper controls put in place to reduce and ultimately eliminate diversion. Doing so can dramatically reduce a hospital’s risk of putting patients in harm’s way and incurring financial penalties.
Sherry A. Umhoefer, MBA, R.Ph., is division president, compliance and regulatory services, for Comprehensive Pharmacy Services in Brooklyn Park, Minn. Marvin Finnefrock, Pharm.D., is division president of clinical and purchasing services for Comprehensive Pharmacy Services in Costa Mesa, Calif.