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Medtech

Controlled Medication Management: Transparency and Security through Connected Technology

Amr Ashmawy. B.Pharm. Clinical Solution Specialist, Dispensing, Medication Management Solutions. Becton Dickinson Middle East, North Africa, and Turkey.

Aya Idriss. BSc. Product Specialist, Medication Management Solutions. Becton Dickinson Middle East, North Africa, and Turkey.

Larry Neal. Regional Marketing Manager, Medication Management Solutions, Becton Dickinson. Europe, Middle East and Africa

James Waterson. M.Med.Ed, M.HEc, RN. Medical Affairs Manager. Medication Management Solutions. Becton Dickinson, Middle East & Africa.

The relief of suffering is central to the role of every clinician, freedom from pain is crucial to the quality of life of patients, and an optimized and safe pain control strategy is an essential part of the patient experience in every healthcare encounter. Pain is ‘an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.’1 There are well documented clinical benefits of effective analgesia for acute pain in avoiding the development of chronic pain2 and avoidance of impaired function, delayed recovery from surgery, reduced quality of life, prolonged opioid use, and increased medical costs.3 These increased medical costs are commonly directly attributable to complications of poor mobility including iatrogenic pneumonias and venous thrombosis.4

Opiates, opioids, and other potent and controlled medications are vital therapeutic agents for the control of both acute and chronic pain. Management of this group of medications, however, places a requirement for physical security, and precise recording of use and of disposal of any waste on healthcare facilities. 

Clinician abuse of, and addiction to, prescription narcotics has reached ‘epidemic proportions’5 in the United States and is a major driver of drug diversion. The issue is a complex one and harms both the clinicians suffering with addiction issues and patients, as diversion can lead to substandard care delivered by an impaired healthcare provider, denial of essential pain medication or therapy to the patient, and risks of infection (e.g., with hepatitis C virus or bacterial pathogens) if a provider tampers with injectable medications.6

The problem of diversion of controlled substances (and other high value medications) has also been recognized as an emerging issue in Europe with guidance for healthcare on the monitoring and control of prescriptions of opioids, in particular, being advocated by regulatory bodies and research centres. 

Opiate diversion has been ‘on the radar’ since at least 20017 and can take place at multiple points in the medication chain, from the original manufacturing site, through to the wholesale distributor, the facility, the retail pharmacy, or even via the patient.8

Ensuring physical security of controlled medications, whilst ensuring rapid access when needed for patient care and pain control is job number one for any facility. Biometric access and automation of witness processes can make these processes safer and more accessible across the facility.

This is an area that technology can have an impact in for the management of Controlled Substances. The BD Pyxis™ CIISafe™ system stores, tracks, and monitors the replenishment of controlled substance inventory across a facility. It can be integrated with BD Pyxis™ medication management technologies to provide a seamless, facility-wide management of controlled substances.

More effective and transparent supply of controlled medications to nursing units through automated refill requests can potentially reduce the risk of unsafe or insecure workarounds such as borrowing from other nursing units.

Another issue with diversion is that by its very nature it is a secretive activity. Without robust track and trace solutions it is practically impossible to gauge the size of the issue but ‘tangential’ evidence from the United States indicates that it is a growing problem. Abuse-related Emergency Department visits involving prescription opioids increased by 153% from 1995 through 2002,9 so an iceberg effect is certainly present here.

Probing into data supplied by integrated, secure systems like BD Pyxis™ CIISafe™ and BD Pyxis™ Automated Dispensing Cabinets (ADC) can indicate trends that can be investigated for evidence of possible diversion.

In one European study there was a 100% reduction in the number of narcotic registry errors after the introduction of automation to the dispensing, storage and administration process.10

At the most fundamental level we would look at anomalies. This can be a straightforward as controlled medications being repeatedly accessed by the same clinician with the same witness. This may of course be coincidental, but patterns of such behavior may indicate collusion to divert medications. Using patterns of data to identify possible problems is certainly less ‘invasive’ than surveillance programs such as cameras in medication storage areas and routine, random controlled substance audits. In one study there was a 100% reduction in the number of narcotic registry errors after the introduction of Automated Dispensing Cabinets’.10

The Alaris SystemTM PCA infusion pump has physical security for controlled substance analgesia including a locking IV-pole clamp and its medication library can be matched to standardized dose syringes delivered directly from the pharmacy to the nursing unit.

Of course, medication errors also occur with controlled medications, and errors involving Patient Controlled Analgesia (PCA) are far too common.11 Using standardized dose syringes dispensed from the pharmacy and held securely in the CIISafe™ and BD Pyxis™ ADCs can help reduce this risk. The dose/volume can be set as a standardized dose in the Dose Error Reduction Software of the PCA infusion pump to reduce the risk of programming error.12 Barcoding these syringes also allows the clinician to confirm the specific dosage against the prescription for individual patients11 as the syringe is removed from the Pyxis ADC or BD Pyxis™ ES Refrigerator. Controlling doses physically in this way and being able to track these controlled medications through to administration, may also assist in safer dose delivery in pediatric patients.

In the Operating Room, standardized doses of intravenous narcotics can be stored in single dose access drawers in the BD Pyxis™ Anesthesia Station ES to reduce the risk of their loss or diversion, and to aid in the delivery of correct dosing during manual-push administration.

Wastage of controlled medications is tightly controlled in many regions, with returns of empty ampoules to the pharmacy being required in many organizations, with documented and witnessed wastage of unused medication being a standard across most healthcare organizations. BD Pyxis™ Med Link Queue & Waste, supported by the BD Pyxis™ ES platform allows for documented and witnessed waste of narcotics to be recorded and for the facility inventory to be balanced as data flows across the enterprise system.

Tracking of medications and data pertaining to controlled medications can be made virtually seamless with the enterprise solution BD HealthSight™ which includes dashboards specifically for tracking medications through the facility and for reviewing possible diversion. Identifying suspected diversion without generating false positives, which wastes resources and can alienate clinicians, can be enhanced by reconciling reports from ADCs, waste disposal, the Electronic Medical Record and other sources as well as evaluating anomalous behaviors.

The BD PyxisTM Anesthesia Station ES features single access drawers to allow for automatic documentation of withdrawal of each controlled substance unit, and utilizes biometric access, wastage management, and patient ID scanning to track administration.

Essentially, BD HealthSight™ automates controlled substance reconciliation and flags discrepancies. The system identifies non-compliance with controlled substance policies, its analytics and machine learning capacities can compare peer behavior to individual patterns of behavior with controlled medications and rank users by risk score, and monitor, triage, and assign potential diversion cases to investigators and document investigation results. This includes an ability to drill-down on non-compliance with policies by specific user ID.HealthSight™ can also support more effective and transparent supply of all medications to nursing units. This can reduce the risk of unsafe or insecure workarounds such as borrowing from other nursing units and use of patient specific medications. HealthSight™ can achieve this through: 

Attention notices: Exclusive visibility of BD Pyxis™ ES system attention notices so pharmacy staff can address them before they become problems for nurses and patients.

Dose requests: Simple visibility of medication requests from nursing made through BD Pyxis™ Med Link Queue and Waste.

Delivery tracking: Near real-time visibility of medication status and location to help reduce wasted time and effort.

Controlled medication diversion is a sensitive subject which requires organizations to be open about the potential for it to occur, and to be frank and honest with staff in supportive training and team meetings. The transparency that connected medication management brings to a facility can make a substantial contribution to securing controlled medications, to inventory tracking, and to early interventions to reduce risk of diversion.

BD HealthSightTM includes dashboards specifically for tracking medications through the facility and for reviewing possible diversion through reconciling reports from ADCs, waste disposal, the Electronic Medical Record and other sources as well as evaluating anomalous behaviors. This includes using machine learning to create diversion risk scores.

References:

1. Raja et Al. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. 

2. Sinatra R. Causes and consequences of inadequate management of acute pain. Pain Med. 2010 Dec;11(12):1859-71. 

3. Gan T. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. 

4. Miskovic A, Lumb A. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002. PMID: 28186222.

5. https://www.cdc.gov/injectionsafety/drugdiversion/index.html

6. https://www.cdc.gov/injectionsafety/pdf/Drug-Diversion-Dangers-P.pdf

7. Thompson C. Prescription Drug Misuse Highlighted as National Problem. American Journal of Health-System Pharmacy. 2001;58(11):956, 960.

8. Inciardi J, Surratt H, Lugo Y, Cicero T. The Diversion of Prescription Opioid Analgesics. Law Enforc Exec Forum. 2007 Nov;7(7):127-141. 

9. Substance Abuse and Mental Health Services Administration, & Office of Applied Studies. Treatment Episode Data Set (TEDS) 1992-2002: National Admissions to Substance Abuse Treatment Services. Author; Rockville, MD: 2004d.

10. Portelli G, Canobbio M, Bitoni R, Della Costanza C, Langella R, Ladisa V. The Impact of an Automated Dispensing System for Supplying Narcotics in a Surgical Unit: The Experience of the National Cancer Institute Foundation of Milan. Hosp Pharm. 2018;54(5):335-342.

11. Schein JR, Hicks RW, Nelson WW, Sikirica V, Doyle DJ. Patient-controlled analgesia-related medication errors in the postoperative period: causes and prevention. Drug Saf. 2009;32(7):549-59. 

12. Aydinc E, Samuda N, Gangol L, Waterson J. https://hospitalsmagazine.com/pain-is-the-fifth-vital-sign-and-pain-management-is-vital-to-quality-patient-care/

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