Current Controlled Substance Monitoring Programs Are Causing Patients Harm

The opioid epidemic has had devastating effects on the lives of millions of individuals in the United States and has negatively impacted the life expectancy of Americans.¹ For this reason, evidence-based and personcentered measures developed to reduce these effects are welcome and should be aggressively pursued in health systems across the nation.¹

So far, health systems have implemented opioid stewardship programs that have reduced opiate prescribing, expanded use of multimodal pain control strategies, introduced controlled substance contracts, and educated health care professionals and patients about safer use of opioids.² Further, payers (commercial and governmental) have created clinical monitoring programs to reduce inappropriate use of long-acting opiates, increased monitoring requirements for doses above safety thresholds, and increased restrictions on prescribing dangerous drug combinations (eg, benzodiazepines and opioids). Governmental agencies have established e-prescribing mandates, prescribing limits, and prescription drug monitoring programs to reduce risks of doctor shopping and overprescribing. Further, restrictions on the use of medication-assisted therapy with naltrexone have been properly relaxed, and naloxone has been approved for OTC availability. Although many of these programs may be imperfect and become occasional sources of frustration for stakeholders, they are evidence-based and patient-centered in their focus on improving the safety of the use of controlled substances, and specifically of opiates.

As part of the legal settlement by large wholesale drug distributors with federal and state governments over their alleged bad behaviors contributing to the opioid epidemic, they have each been required to implement controlled substance monitoring programs (CSMPs).^3-5 To date, these programs are the opposite of evidence-based and patient-centered, and they appear to have been developed and implemented by those in the legal and law enforcement professions and not within health care. The CSMPs, which are directed primarily at outpatient or community pharmacies, have established thresholds for controlled substance use (and use of some noncontrolled drugs) based on historical use. However, the methodology for these thresholds has not been clear or shared with health care professionals working in these health systems or, more specifically, with those working in the pharmacy. Instead, the pharmacy learns that a threshold has been reached when it attempts to place an order and the order is then refused due to that limit. However, communication forewarning of this limit is not present. This often results in a failure to provide these prescribed medications to patients, regardless of their need level or the potential impact to their health.

Recently, our main outpatient pharmacy hit a threshold limit for clobazam (Onfi; H. Lundbeck A/S), a benzodiazepine that is most commonly used for refractory seizure disorders, particularly among children. Upon reaching unforeseen thresholds in dispensing of this drug, our pharmacists had to reach out to multiple parents to provide the distressing news that their child may have trouble getting what is considered potentially a life-altering therapy. Following this series of difficult calls, we later learned that several pharmacies in the community had also hit their thresholds, so pediatric neurologists had been referring their patients to our pharmacy for their therapies, which of course drove up our use of this drug.

This unknown threshold limit being reached resulted in a situation that was potentially disastrous for our patients’ health, as well as disastrous for our ability to provide safe and effective patient care. Further, the recommendation made by drug distributors when meeting this threshold was to refer patients to another pharmacy—this is also misguided, as many of our patients have specific needs we know how to support. Many of our patients come from underserved communities, have transportation issues, and are often dependent on patient support programs offered by our institution when they cannot afford their medications. Therefore, being refused medications at our pharmacy due to a threshold limit may mean they will have no other method of obtaining their medications elsewhere.

Following this situation, we were instructed by drug distributors that we could request an increase in our threshold limit. This process required submitting detailed prescription data to the CSMP, and then several weeks of back-and-forth before the threshold was increased. It was clear that the CSMP data staff we were working with understood little to nothing about patient care. We have since gone through multiple cycles of this process, each time leading to refused access to ongoing drug therapy, referring distressed patients to other pharmacies, and submitting more data. All these requests for threshold increases then led to the CSMP requiring a detailed US Drug Enforcement Administration (DEA)–guided on-site audit by a third party before further threshold increases would be granted. This further delayed our ability to provide good patient care at our large academic medical center.

Along with creating all this busywork for our staff, we were also notified that each threshold being reached triggers a report of our site to the DEA for “suspicious behavior.” However, we also learned that there was no due process established in determining whether this threshold being reached was in fact suspicious or just the normal process of delivering patient care at our large academic medical center.

In early 2023, we opened a new ambulatory surgery center with an operating room (OR) pharmacy. Because this pharmacy dispenses discharge prescriptions, it was subject to CSMP management. Shortly after opening the pharmacy, the wholesaler refused to ship intravenous midazolam, fentanyl, and propofol because of reaching thresholds, and it was entirely unclear how thresholds were created for this new OR pharmacy’s operation.

Instead of communicating these details, the CSMP requested prescription data to justify our threshold increase requests. You can imagine the confusion that was created by trying to figure out how they wanted us to provide said data from anesthesia records to justify our request. If we had not been able to address the problem internally, this challenge would have threatened shutting down the surgical schedule at this site, which can be a state-reportable event in our jurisdiction.

Of course, any poor but well-intended system is going to lead to work-arounds that are not positive for patient safety. One aspect of the CSMP that reflects its nonclinical origins is that all dosage forms of a drug are counted in the same way, with the threshold based on the total “doses.” In this way, some community pharmacists have shifted to ordering only the higher strengths of controlled substances, then altering patient directions to use partial tablet doses; this is a really bad idea for patient safety. Other pharmacies in our community are refusing to provide care for patients who are not “regulars” or who have high needs (eg, chronic pain or end-of-life care). These artificial drug shortages created by CSMPs are only exacerbating the already significant drug shortages in our communities.

It is clearly time for the large drug distributors and their lawyers to come together with patient care professionals and patient advocates to design a better approach. We all have an interest in reducing harm and deaths from opiates and other controlled substances, but we should have evidence-based and patient-centered approaches that do not have unintended consequences on patient health and safety. In our experience, CSMPs imposed by the drug distributors have so far been an unmitigated disaster for patient care.

About the Author

Curtis E. Haas, PharmD, FCCP, is director of pharmacy for the University of Rochester Medical Center in New York.

References

1. Harper S, Riddell CA, King NB. Declining life expectancy in the United States: missing the trees for the forest. Ann Rev Public Health. 2021;42:381-403. doi:10.1146/annurev-publhealth-082619-104231
2. Shrestha S, Khatiwada AP, Sapkota B, et al. What is “opioid stewardship?” An overview of current definitions and proposal for a universally acceptable definition. J Pain Res. 2023;16:383-94. doi:10.2147/JPR.S389358
3. Controlled Substance Monitoring Program (CSMP). Cardinal Health. Accessed June 20, 2023. https://www.cardinalhealth.com/en/about-us/environmental-social-governance/controlled-substance-monitoring-program.html
4. McKesson’s controlled substance monitoring program. McKesson Corporation. Accessed June 20, 2023. https://www.mckesson.com/About-McKesson/Fighting-Opioid-Abuse/Controlled-Substance-Monitoring-Program/
5. Fighting the opioid epidemic. AmerisourceBergen Corporation. Accessed June 20, 2023. https://www.amerisourcebergen.com/pharmaceutical-distribution/fighting-the-opioid-epidemic