Drug security and chain of custody
Secure controlled substances at all times
- Before leaving the medication preparation area, secure vials containing leftover controlled substances yet to be discarded. Walking away to administer a dose or attend to a pharmacy task without securing the vial can invite diversion.
- Prohibit drawing more than a single dose of a controlled substance into a syringe; saving partial doses in syringes exposes the drug to possible diversion.
- Remove controlled substances from an ADC close to the time they are needed for a procedure or for administration. Avoid removing a drug “just in case” it is needed.
- Secure all controlled substance infusions in locked infusion pumps and require a witness to observe the waste once the infusion is removed from the pump.
- Secure the patient’s home medications immediately after collection.
- Secure controlled substances in the operating room, procedural areas, and anesthesia work areas during and between surgical cases.
Manage inventory. Require staff to verify dispensing and receipt of controlled substances. In areas without ADC storage, the person delivering and the person receiving controlled substances should each cosign on the appropriate record, and the drugs should be immediately secured. When using an ADC for dispensing and storage of controlled substances, activities should be tracked and reconciled using data available in the vault software.
Use the correct containers. Know the federal, state, tribal, and local laws regarding pharmaceutical wastage of controlled substances, hazardous waste, and sharps, and choose the most appropriate and secure containers for safe disposal.
Secure and track sharps/pharmaceutical waste containers
- In patient care areas, use sharps/pharmaceutical waste containers with small openings that do not easily allow medication devices or waste to be shaken out. (Some pharmaceutical waste containers [e.g., Cactus Smart Sink] render narcotics unrecoverable, non-retrievable, and unusable.)
- When a larger sharps/pharmaceutical waste container must be used (e.g., operating rooms, procedural areas), utilize video cameras nearby and regularly observe the monitors.
- Lock sharps/pharmaceutical waste containers to the wall or secure to other stationary equipment that cannot be easily removed from a clinical unit. Secure all keys to replace a container, and limit access to just a few designated staff (or an external company that may collect and replace the containers). Establish a process to track and reconcile all containers to ensure detection of unauthorized removal (some containers have barcodes). Restrict access to stock of empty back-up containers.
- Place containers in areas where they can be consistently observed or monitored by a video surveillance system. If a container must be removed from a secure wall unit or its usual location because it is full, establish a secure holding area while awaiting proper pick-up for disposal.
Restrict access to controlled substances
- Establish strict guidelines regarding who can have access to controlled substances, including those stocked in ADCs, pharmacy vaults, treatment kits, and areas where expired drugs are stored.
- Adjust par levels of controlled substances in the pharmacy (including satellites) and on patient care units based on use rates so excess supplies are not available.
- Place each type of controlled substance (including opioid infusions) in ADCs in a separate lidded compartment or area so only access to the intended drug is granted.
- Allow access to medications in clinical areas for current patients on that unit only.
- Limit who can add new patient profiles to the ADC software.
Reduce waste. Provide controlled substances in dose sizes that eliminate or minimize waste (e.g., provide a 2 or 5 mg syringe of morphine instead of a 10 or 15 mg syringe).
Monitor prescription pads. Establish a process to secure, track, and reconcile all prescription pads used for controlled substances in patient care units.
Allow no bags. Do not allow purses, backpacks, briefcases, or other personal storage cases in areas where controlled substances are stored or discarded.
Safe drug disposal
While following all applicable federal, state, tribal, and local laws and regulations regarding the disposal of controlled substances, consider the following recommendations:
Remaining controlled substance left in a single-use vial: With a witness present, draw the remaining medication into a syringe, require the witness to verify the volume in the syringe, and then squirt the medication into a pharmaceutical waste box* while the witness watches. Do not discard the vial in the sharps box before removing and wasting any leftover medication from the vial.* Document the volume and dose of the pharmaceutical wastage, which should be verified and cosigned by the witness.
Extra or remaining controlled substance in a prefilled syringe: Require a witness to verify the volume in a prefilled syringe, then squirt the medication into the pharmaceutical waste box* while the witness watches. Do not discard the syringe in the sharps box before removing and wasting any leftover medication. Document the volume and dose of the pharmaceutical wastage, which should be verified and cosigned by the witness.
Unused or expired controlled substance: Return the container of unused inventory to the pharmacy for disposal using a process that verifies delivery and receipt.
FentaNYL transdermal patches: Current manufacturer and U.S. Food and Drug Administration guidelines direct users to fold the patch in half with the sticky sides together, and then flush the patch down the toilet. If flushing the patch is not an option, a device that deactivates any remaining drug in the patch should be used prior to disposal. Deactivation and disposal should be documented with a witness.
Selected high-alert medications: For selected high-alert medications (e.g., neuromuscular blocking agents, concentrated electrolytes), follow the same disposal procedures used for controlled substances, although witnessing waste may not be necessary.
Inventory disposal: Establish a witnessed process for disposal of controlled substance inventory in the pharmacy by a pharmacist or an authorized third party.
Implement monitoring systems
- Allocate sufficient human resources for an interprofessional team to develop and oversee a controlled substance management and prevention program. Activities should include ensuring proper documentation, conducting periodic documentation reviews and routine inventory counts, investigating all reports of potential diversion or an impaired worker and unreconciled counts or discrepancies, viewing footage of monitoring, and conducting observations of practices with controlled substances.
- Use recording surveillance cameras in high-risk areas where diversion might take place (e.g., narcotic vault, IV room, ADCs) and review the monitors or footage regularly.
- Use software to monitor controlled substance movement in ADCs (e.g., Pandora) and pharmacy narcotic vaults (e.g., NarcStation, CIISafe).
Periodic documentation review. Establish a system for reviewing the documentation and use of controlled substances, paying particular attention to:
- Comparing removal of a controlled substance from an ADC or other storage location to the medication administration record
- Comparing the time of removing a controlled substance to the time of dispensing or administering the drug (delays could signal diversion)
- Comparing pain medication administration time to patient-reported pain scales
- Documented pain medication administered to an unconscious patient
- Pain scores much higher when a particular staff member is on duty
- Frequent ADC overrides by a practitioner to gain access to controlled substances
- Irregular usage reports from ADCs and narcotic vaults
Observe staff. Regularly observe how staff manage controlled substances, including wasting drugs and other security processes. Also observe staff for at-risk behaviors such as badge sharing or unsecured drugs, and coach them to exhibit the desired behaviors.
Investigate immediately. Start an investigation as soon as it is learned that the count of controlled substances does not reconcile with documentation. The investigation should be completed before any staff member on the unit or in the pharmacy leaves the hospital.
This column was prepared by the Institute for Safe Medication Practices (ISMP), an independent, nonprofit organization dedicated entirely to medication error prevention and safe medication use. Any reports described charitable in this column were received through the ISMP Medication Errors Reporting Program. Errors, close calls, or hazardous conditions may be reported online at www.ismp.org or by calling 800-FAIL-SAFE (800-324-5723). ISMP is a federally certified patient safety organization (PSO), providing legal protection and confidentiality for patient safety data and error reports it receives. Visit www.ismp.org for more information on ISMP’s medication safety newsletters and other risk reduction tools. This article appeared originally in the March 10, 2016, issue of the ISMP Medication Safety Alert!
Center for Behavioral Health Statistics and Quality. (2015). Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health (HHS Publication No. SMA 15-4927, NSDUH Series H-50). Rockville, MD: Substance Abuse and Mental Health Services Administration. Retrieved from www.ismp.org/sc?id=1675
Copp, M. A. B. (2009, April 1). Drug addiction among nurses: Confronting a quiet epidemic. Modern Medicine Network. Retrieved from www.ismp.org/sc?id=1677
Dunn, D. (2005). Substance abuse among nurses—Defining the issue. AORN Journal, 82(4), 573–582,585–588,592–596.
Dwyer, D. (2015, September 28). Mass. General will pay $2.3 million to resolve allegations of drug diversion. Boston.com. Retrieved from https://www.boston.com/news/untagged/2015/09/28/mass-general-will-pay-2-3-million-to-resolve-allegations-of-drug-diversion
Eisler, P. (2014, April 17). Doctors, medical staff on drugs put patients at risk. USA Today. Retrieved from http://www.usatoday.com/story/news/nation/2014/04/15/doctors-addicted-drugs-health-care-diversion/7588401/
Fayerman, P. (2016a, February 4). Dedicated health worker felled by temptation of drug access. The Vancouver Sun. Retrieved from www.ismp.org/sc?id=1674
Fayerman, P. (2016b, February 7). VGH plans tighter controls over drugs after care aide’s overdose death. The Vancouver Sun. Retrieved from http://www.vancouversun.com/health/plans+tighter+controls+over+drugs+after+care+aide+overdose+death/11706330/story.html
Fayerman, P. (2016c, February 9). Health minister to tell B.C. hospitals to tighten control on drugs. The Vancouver Sun. Retrieved from www.ismp.org/sc?id=1672
National Center for Health Statistics, National Vital Statistics System, Mortality File. (2015). Number and age-adjusted rates of drug-poisoning deaths involving opioid analgesics and heroin: United States, 2000–2014. Atlanta, GA: Centers for Disease Control and Prevention. Retrieved from www.ismp.org/sc?id=1678
TheFoundingCrew. (2009, November). What substances are commonly abused? [Blog post]. Retrieved from www.ismp.org/sc?id=1680
Thomas, C. M., & Siela, D. (2011). The impaired nurse: Would you know what to do if you suspected substance abuse? American Nurse Today, 6(8), 1–9.
Trinkoff, A. M., Storr, C. L., & Wall, M. P. (1999). Prescription-type drug misuse and workplace access among nurses. Journal of Addictive Diseases, 18(1), 9–17.
U.S. Department of Health and Human Services. Substance Abuse and Mental Health Services Administration. Office of Applied Studies. (2015, November 23). National Survey on Drug Use and Health, 2007. ICPSR23782-v5. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor]. Retrieved from www.ismp.org/sc?id=1676