Recently I worked with a pharmacist colleague and conducted a year long project in order to assess the ambulatory and hospital based outpatient programs for a healthcare system with 12 different healthcare organizations.  It was a huge project with so many learnings.  We recognize there are so many aspects as outlined below in controlled substance management in healthcare.  However, we focused on the management of the substances that are stored and administered in these settings.   We found many interesting challenges with that limited scope. 

  1. The lack of knowledge of physicians, all levels of leaders, and nursing staff of the regulatory guidelines from the FDA that organizations must comply with.
  2. The lack of education for everyone on the specific processes that need to be followed, risks, and what medications are classified as controlled substances.
  3. With a multi-organization system, each site has developed its own process leading to confusion and non-compliance. 

We worked to discover and document every organizational process, compare to the regulations, assess the knowledge base of the various roles and leaders, and then work to create a safe, standard policy and work standards that were adaptable to all the organizations. We then worked to create a central intranet website with every resource in one place.    We created education on this process and conducted our first annual audit to assess our starting point as far as compliance with the policy and identify areas for further education, storage changes, documentation enhancement, and process improvements. 

We also recommended the next steps for the healthcare system, additional education, and monitoring needed for the future to ensure compliance.  One of the challenges in healthcare currently is that most systems are stretched for resources so it’s a challenge for the leaders to determine where to devote resources. 

Controlled substance issues in healthcare encompass a range of other challenges related to the prescribing, dispensing, and misuse of controlled substances.  The comprehensive list of all the challenges including diversion are listed below.

1. **Overprescribing:** Healthcare providers may overprescribe controlled substances, leading to misuse, addiction, and overdose among patients. This can occur due to inadequate training, pressure to treat pain aggressively, or lack of awareness of the risks associated with certain medications.

2. **Misuse and diversion:** Controlled substances are sometimes diverted for illicit purposes, such as selling or trading them on the black market. This can occur within healthcare settings, where drugs may be stolen or misappropriated by staff members or patients.

3. **Addiction among healthcare professionals:** Healthcare professionals themselves may be at risk of developing substance use disorders, including addiction to controlled substances. Factors such as easy access to drugs, high levels of stress, and stigma around seeking help can contribute to this issue.

4. **Regulatory compliance:** Healthcare providers must adhere to strict regulations and guidelines when prescribing, dispensing, and documenting controlled substances. Failure to comply with these regulations can result in legal consequences, loss of licensure, or disciplinary action.

5. **Patient safety:** Misuse of controlled substances can compromise patient safety and quality of care. Patients may experience adverse effects, drug interactions, or complications from substance use disorders, leading to increased healthcare utilization and costs.

6. **Stigma and discrimination:** Individuals with substance use disorders may face stigma and discrimination within healthcare settings, which can deter them from seeking treatment and support. This can exacerbate their condition and contribute to negative health outcomes.

7. **Prescription drug monitoring programs (PDMPs):** PDMPs are databases that track the prescribing and dispensing of controlled substances, allowing healthcare providers to identify potential misuse or diversion patterns. However, challenges such as incomplete data, limited interoperability between systems, and varying state regulations can limit their effectiveness.

Addressing controlled substance issues in healthcare requires every organization to have a comprehensive approach that includes education, training, regulatory oversight, monitoring programs, access to treatment for substance use disorders, and multidisciplinary collaboration among healthcare providers, policymakers, law enforcement agencies, and community stakeholders.

We are happy to complete an assessment of your organization and outline a recommended plan of action that will bring you into compliance as it relates to the management of controlled substances, education, and monitoring.  Feel free to submit a request form to have a complimentary discovery conversation. Together we can make managing controlled substances a safer process for everyone.