“Nobody knows how you’re supposed to interpret it:” End-user perspectives on Prescription Drug Monitoring Program in Massachusetts

Abstract

Objectives:

America’s overdose crisis spurred rapid expansion in the number and scope of prescription drug monitoring programs (PDMPs). As their public health impact remains contested, little is known about PDMP user experiences and perspectives. We explore perspectives of PDMP end-users in Massachusetts.

Methods:

Between 2016–2017, we conducted semi-structured qualitative interviews on overdose crisis dynamics and PDMP experiences with a purposive sample of 18 stakeholders (prescribers, pharmacists, law enforcement, and public health regulators). Recordings were transcribed and double-coded using a grounded hermeneutic approach.

Results:

Perspectives on prescription monitoring as an element of overdose crisis response differed across sectors, but narratives often critiqued PDMPs as poorly conceived to serve end-user needs. Respondents indicated that PDMP: 1) lacked clear orientation towards health promotion; 2) was not optimally configured or designed as a decision support tool, resulting in confusion over interpreting data to guide health care or law enforcement actions; and, 3) problematized communication and relationships between prescribers, pharmacists, and patients.

Conclusion:

User insights must inform design, programmatic, and policy reform to maximize PDMP benefits while minimizing harm. Their collateral impact may be compounded by COVID-19.

Introduction

For over two decades, the United States has been experiencing an unprecedented overdose crisis, driven primarily by opioids.^{1,2 3,4} For a substantial (but declining) proportion of overdose decedents, prescription opioid medications continue to figure as their initial exposure to opioids. ^5,6,7 Spurred by concerns about over-utilization and diversion of prescription opioids, the principal policy response had focused on tighter regulations on opioid medication supply. ⁵ Almost universally, this has included in the state policymaking realm the development and expansion of prescription drug monitoring programs (PDMPs).

The original design and utilization of PDMPs squarely positioned them as an instrument of law enforcement.⁸ These state-level monitoring systems track controlled substance prescription and dispensing patterns, potentiating surveillance of prescriber, pharmacist, and patient behavior. By collecting information on who is prescribing, dispensing, and receiving scheduled drugs, PDMPs are intended to help identify patients, prescribers, and pharmacists who may have been diverting potentially addictive drugs.⁹ Although program scope varies by state, PDMPs typically cover patient demographics, list of drugs dispensed, location, prescriber characteristics, method of payment, and among others.¹⁰ Data collected are used by police, prosecutors, professional boards, and other regulatory and enforcement bodies to identify patterns of “aberrant” practitioner, pharmacist, and patient behavior. Increasingly, they use algorithmic or other big data analytics tools.^8,11,12

More recently, PDMPs have been advanced as a overdose prevention tool. It is theorized that PDMPs can assist health care providers in identifying patients who are at risk for substance use disorders or problematic behaviors that signal a need for more in-depth consultations.^{13 14} If providers find concerning information in the PDMP, they can use the opportunity to discuss matters with the patient and potentially connect the patient to treatment or other services. Prescribers can also calculate the total daily dose of opioids to prevent adverse events, communicate with other prescribers for the at-risk patient, or consider offering naloxone.¹⁵ Pharmacists can communicate their concerns to prescribers before dispensing prescriptions.¹⁶ Theoretically, these systems could also be used as a harm reduction decision support tool.

Although drug control and other state agencies have long operated PDMPs in some states, concerns about the overdose crisis have sparked an unprecedented expansion in their number and capacity. After this period of rapid growth, PDMPs are now operating in all 50 states, Washington, D.C., and US territories.^15,17 With proponents of the systems suggesting their most significant value lies in universal utilization, an increasing majority of states have also passed legislation mandating prescribers to consult the PDMP in some circumstances.¹⁷ In line with their roots, the policy structure of most PDMPs allows for broad access by law enforcement.^8,11

In line with many other states, Massachusetts has relied on its PDMP (MassPAT) as one of the central features in its overdose crisis response. After several legal reforms and an infusion of funding, an updated PDMP went live in Massachusetts in August 2017. This enhanced platform allowed faster access to data, also allowing users to see scheduled drug history from neighboring states. Until recently, police and other enforcement agencies did not require a warrant to access prescription data in the system.

Despite broad enthusiasm for PDMPs¹⁵, the clinical and public health benefit of these mounting mandates and the broader embrace of PDMPs remains controversial.^8,18 This is partly because the evidence on their impact is mixed. ^{8 18 19,20} Concerns have been raised that PDMP design and implementation has remained too firmly tethered to drug control and law enforcement, without sufficiently operationalizing care coordination and other health care improvement and public health goals.^8,11,12

Some have sought to understand how PDMPs shape healthcare provider attitudes and practices.^21,22,23 Health care decision support tools have been also shown to perpetuate racial and other biases.²⁴ To date, several studies have assessed PDMP end-user experiences of health care providers.^25,26,27 However, there is little research elucidating how the experiences and attitudes of the full spectrum of PDMP users—including law enforcement—may shape these systems’ public health impact.

To close this knowledge gap, we explored the perspectives and experiences of a diverse sample of PDMP end-users in Massachusetts. We focused on the PDMP’s hypothesized role in informing provider decision-making and increasing care coordination, while also contrasting perspectives of health care providers with those of law enforcement PDMP users.

Methods

Setting and recruitment:

Using a purposive sampling strategy to maximize the diversity of viewpoints, we recruited Massachusetts PDMP users among prescribers who work with patients with pain or substance use disorder, community pharmacists, law enforcement agents engaged in drug law enforcement activities, and public health government regulators engaged in overdose response. The sample size was pre-determined by resource and time constraints, but designed to enable sufficient saturation to generate formative data. Participants were identified through professional networks and recruited through a referral from other consented participants. If participants were perceived to use PDMP in their work, an email was sent detailing the study and asking for their anonymous participation for an interview. Our recruitment was limited to the Greater Boston Area. Inclusion criteria were: 1) Being 18 and over and, 2) utilizing the PDMP in a professional capacity for at least six months. No monetary incentive was provided. The study was deemed exempt by the institutional review boards of Northeastern and Tufts Universities.

Interview domains:

Our semi-structured interview guide covered perceptions of the overdose crisis, its leading causes and solutions, PDMP design, perceptions of the PDMP, and PDMP data utilization. Specifically, we sought a better understanding of how the utilization of PDMP data drives public health, public safety, and health care provider decisions and practices. We focused on exploring what opportunities exist to use the PDMP data in ways of improving patient care and public health outcomes. Ultimately, our goal was to understand the decisions that are made based on PDMP data and perceptions of the systems’ impact.

Data Collection.

Between October 2016 to March 2017, we interviewed participants using a semi-structured script by a mix of undergraduate and graduate students with initial and ongoing training in ethnographic methods. We obtained verbal consent from all respondents, and respondents agreed to have their interviews digitally recorded. Data collection was conducted in person or through telephone interviews. The mean time to complete interviews was forty minutes.

Data Analysis.

We used VoiceBase (machine-based transcription software) for initial transcriptions of recordings. Members of our research team redundantly quality-checked final transcriptions against the audio-recording. Individual identifying information was redacted from the interview transcripts to ensure the anonymity of the study participants. We developed a codebook using inductive and deductive techniques. Afterward, we analyzed and coded the transcripts using Atlas.ti, version 8 (Scientific Software Development, Berlin, Germany). Two research team members independently conducted thematic coding analysis, which included a coding reconciliation process to ensure inter-coder reliability. We assessed coded interview data using a grounded hermeneutic approach²⁸ to identify emerging themes, find similarities and differences across respondent categories, and generate grounded hypotheses for future research. To provide context, we annotate each narrative with the respondent’s sector of employment and time in the sector.

Results

Our analytic sample consisted of 18 individuals, covering prescribers, pharmacists, law enforcement agents, and public health regulators in Massachusetts. Overall, 72% of those contacted completed an interview. Study participants were actively working in positions in which they utilized the PDMP system regularly. This paper examines the attitudes of six prescribers (covering primary care, pain clinic, and addiction clinic settings), five community pharmacists (covering chain and independently-owned pharmacies), four law enforcement agents (covering city, state, and federal level agencies), and three public health regulators working at the Massachusetts state level. Respondents had a mix of short-term (0 to 5 years), medium (6 to 10 years), and long-term (11 years and longer) work experience. When we refer to “health care professionals” in this paper, we include prescribers and pharmacists (See Table 1).

Table 1.

Respondent Data

		Type of Employment	Years of Experience	Gender
Health Care Professionals	Physicians	Primary Care	11+	M
		Primary Care	0 to 5	F
		Pain Clinic	11+	M
		Addiction Clinic	11+	M
		Addiction Clinic	11+	F
		Addiction Clinic	11+	M
	Retail Pharmacists	Corporate	0 to 5	F
		Corporate	0 to 5	F
		Corporate	6 to 10	M
		Independently-owned	6 to 10	F
		Independently-owned	0 to 5	F
Law Enforcement Agents		City	11+	M
		State	6 to 10	M
		State	11+	M
		Federal	11+	M
Public Health Regulators		State	6 to 10	F
		State	6 to 10	M
		State	11+	M

Three salient themes emerged from our findings. First, health care professionals, law enforcement specialists, and public health regulators were similarly mixed on the perceived role of the PDMP, and how it could be best used in their practice. Second, health care professionals reported that they did not believe that the PDMP provided the necessary decision support tools to adequately inform their decision-making regarding opioid prescribing and other care decisions. Third, health care professionals—especially pharmacists—described frustration with an inability to adequately follow up on patient-care issues identified within the PDMP because of lack of system functionality, communication gaps with providers, and lack of time.

Of Law Enforcement or Health Care: Divergent Views on PDMP Purpose and Design

When participants were asked about the overall goal and focus of the PDMP, health care professionals and law enforcement personnel had divergent views. When respondents were asked of PDMP’s original purpose, a little more than half of the respondents (a mix of healthcare respondents, law enforcement, and public health regulators) believed the PDMP was created to be a health care tool. A few respondents were unsure while some knew the PDMP was originally designed as a law enforcement tool.

Almost all respondents (health care professionals, law enforcement, and public health regulators) considered the PDMP as a tool that could help identify patients who might be experiencing substance use and misuse challenges and ensure medications were prescribed appropriately. One pharmacist with substantial work experience explained,

…[the PDMP helps] make sure that [the] patients are being well cared for, and they’re not heading down the road of misuse or diversion because, number one: you want to care for your patient and make sure they’re not running into any problems, and number two: you want to care for your community because you don’t want those pills ending up in the hands of anyone else.

While some respondents viewed the PDMP as a health care tool, all law enforcement and public health regulators considered their involvement in using the system to be central to its functionality. One law enforcement agent with over 11 years of experience explained how the PDMP could act as a key piece of evidence for investigations: “If we have evidence of a crime, [PDMP is] a tool to gather information.”

Gaps in Decision Support and Data Interpretation

The ability to provide comprehensive, timely pharmacotherapy data to inform health care provider practice is one of the vital purported benefits of PDMPs.¹⁵ In our findings, while the PDMP was seen to offer more detailed information about patient medication prescription and dispensing patterns than the patients themselves or pharmacy records, the vast majority of health care professionals suggested they struggle with understanding how to utilize PDMP data to inform their clinical decision-making. One prescriber working in addiction services for more than fifteen years articulated this frustration:

There’s a huge question on what we’re supposed to do with the information, and there’s no guidance on that. We’re just told that we have to do it [consult the PDMP]. But nobody knows how you’re supposed to interpret the information that you get from the prescription monitoring program and what you’re supposed to do with that information.

The PDMP gives end-users all the information that is available on the prescription, including patient demographics, medication information, prescriber and pharmacy information, method of payment, and more depending on different variabilities. While some information is required, there is additional optional information that a pharmacy can provide such as pharmacy contact name and the type of patient identification.¹⁰ Almost all health care professionals perceived PDMP to be burdensome in their practice, and all the prescriber respondents believed that the premise that the PDMP was a helpful tool was flawed. An addiction medicine specialist with long-term work experience explained this concern as follows: “I think the problem is that we consider the P[D]MP system to be an answer, … when it should be a component of the answer. And it should be linked to other kinds of information.”

Health care professionals mostly reported they did not receive meaningful training or received minimal informal training (e.g., shown by a mentor, continuing education credit) on how to utilize PDMP in practice. Another addiction prescriber of thirty years explained: “I don’t think I’d like to spend an hour learning how to use it … [we] need to be educated in what the purpose is- helping the diagnosis and appropriate treatment.”

Similarly, law enforcement agents and regulators spoke about unmet training needs for law enforcement agents for PDMP. They all believed it is a useful tool for law enforcement agents, but many individuals do not know how to use it.

Poor Support for Communication and Care Coordination

Almost all health care professionals mentioned the lack of operational forethought in PDMP deployment. Most of the pharmacists spoke in detail about their frustrations communicating with prescribers. Corporate or store policy required them to check the PDMP, especially in cases when possible misuse or diversion are suspected. However, when pharmacists check the PDMP and spot signs of misuse or inappropriate prescribing, their response options were limited. Pharmacists reported having a narrow set of practice responses such as: withhold the medication and risk upsetting the patient, or attempt to contact the prescriber to reconcile or better understand the treatment rationale. One pharmacist working in an independently-owned pharmacy for over eleven years opined:

Trying to reach a prescriber is almost impossible [because] they’ve insulated themselves... When we try to make phone calls and alert prescribers that there is a problem or potential problem, it is almost impossible for us even to get through.

Even when pharmacists could get through, speaking with the prescriber regarding opioid medications led to friction-laden interactions with the prescriber or the waiting patient. Responding appropriately to possible misuse or diversion within the PDMP was perceived to be disruptive for the community pharmacists. The pharmacists we interviewed did not know the patients’ diagnoses; therefore, the decision to withhold or dispense a medication often reflected the pharmacists’ dependence on fragmented information gleaned from the patient or the prescriber.

Almost all of the pharmacists expressed concern that the PDMP had worsened communication and relationships between health care professionals. One pharmacist in a chain pharmacy with eleven years’ experience reflected on her interaction with a prescriber when she tried to follow up on an unusual prescription:

It’s usually the old-school thinkers where they say, “who are you to ask me what I’m prescribing?” That scares pharmacists off. That happens once, and now they don’t ever want to call a doctor ever again… being yelled at by a doctor is one of the things that pharmacists really don’t like.

All five pharmacists expressed exasperation over conversations with prescribers sparked by PDMP data—precisely the kind of conversations PDMPs are theorized to facilitate. The pharmacist working in an independently-owned pharmacy added, “I know pharmacists are frustrated because we see these problems, and we’re trying to alert prescribers and let people know that they need to do something about this, but there is not a satisfying conclusion.”

Some pharmacists even spoke about expanding pharmacists’ roles as opioid gatekeepers. Retail pharmacy’s PDMP use is high, and there should be incentives for their due diligence in checking and taking part in the patient’s health needs. The pharmacist with over ten years of experience said,

There hasn’t been much discussion on pharmacists’ role in this crisis... If pharmacists were playing a more active role, those [inappropriate or potentially harmful] prescriptions wouldn’t be getting out into the communities.

All pharmacists noted changes in policy and management in response to the overdose crisis in their work setting. Some were company-wide policies, but others were policies within independently-owned stores. These chain pharmacies and independently-owned pharmacies are adopting similar practices as doctors, such as mandating PDMP use, although it is not legally required for pharmacists. Retail pharmacies in our subgroup were required to check certain opioid medications on the PDMP before every fill.

Pharmacists recalled that they checked the updated PDMP online system in Massachusetts more frequently than the previous version. Still, practices varied: some pharmacists attempted to check every prescription, and others only consulted the system for prescriptions that had possible misuse. Pharmacists working in chain pharmacies noted the desire to check the PDMP more frequently, but reported they did not have sufficient time or appropriate staffing. All but one pharmacist spoke about the burden of checking the PDMP and the lack of time they had to abide by the rules. A pharmacist working in a chain pharmacy for about three years explained:

I probably fill thirty to forty narcotic prescriptions [a day], opioids and amphetamines included, so if I had an extra five minutes to add for each one of those prescriptions, we would be bogged down on people that are sick…

These problems make it very difficult for pharmacists to provide appropriate and timely care to patients. Pharmacists act as reluctant gatekeepers, deciphering if they are dispensing inappropriate opioid medications or withholding prescriptions and hindering patient care.

Pharmacists, law enforcement officials, and regulators spoke about the potential for the PDMP to facilitate communication between pharmacies and prescribers by improving the software. These improvements could facilitate better communication between multiple pharmacies that patients visit and eliminate the wait time that pharmacists endure when they are inspecting a questionable prescription.

Discussion

Although PDMP utilization can improve patient care and public health, its actual use in decision making and care coordination is not well-understood by health care professionals. ²⁹ In general, the Massachusetts PDMP system did not appear to have been designed or implemented with clinical end-users in mind. The PDMP data system provided very limited patients information and medication history. While these data can help inform care by ensuring patients are getting the right medication or the correct amount, health care professionals felt it was inadequate to guide clinical and prescribing decisions fully, and could lead to wrong conclusions on complex patients.

Pharmacists felt they were forced to make decisions based on PDMP information without a complete contextual understanding of the patient’s medical background, mainly if patients did not consistently visit the same pharmacies. The discretion to follow up with a prescriber is left solely to the pharmacist, and triggers for follow-up can vary. Policing patients requires pharmacists to take on a disciplinarian role that may compromise patient care and create ethical and dual loyalty issues.³⁰ This role also imposes opportunity costs, uncompensated through billing. Interestingly, overly suspicious pharmacists have also faced push-back from prescribers’ groups and sometimes dismissal from employment.³¹ Therefore, the balance between providing excellent patient care versus delicately managing relationships with patients and prescribers can create for pharmacists difficult professional and ethical dynamics.

There is an increasing body of research focused on the critical patient “touchpoints” for intervention to reduce opioid overdoses.³² Doctor-patient and pharmacy-patient interactions tied to opioid prescriptions represent vital opportunities. Participants in our study, however, indicated that it was not always clear how they should interpret findings within the PDMP, and how they should respond to potentially inappropriate opioid prescribing patterns.^33,34 Research also indicates that experiences with potentially inappropriate opioid prescribing patterns vary geospatially, which may indicate the need for nuanced PDMP education and support across distinct regions.³⁵

Participants in our study also alluded to the burden the PDMP places on their day-to-day work. As PDMP systems have been implemented and prescribers and pharmacists have been increasingly mandated to use them, this has led to additional responsibilities on the job that amounts to an unfunded mandate.

The implementation of a monitoring tool designed for—and accessible to—law enforcement merits closer examination as a driver of clinical decision-making.³⁶ Analytical tools can assist health care professionals in identifying at-risk patients, including those who are especially vulnerable to overdose risk. Automation and algorithms could also facilitate and streamline harm reduction interventions like naloxone co-prescribing to reduce fatal overdose risk. Unfortunately, our analysis did not document current deployment of PDMP to improve patient access to harm reduction tools and services. Nevertheless, including such services among system defaults and alerts would allow providers to make decisions more consistently and help reduce the deleterious impact of stigma, which is crucial for improving life-saving care for patients with substance use disorder.³⁷ Conversely, the use of such algorithmic tools also carries substantial risk, especially when considered in light of active law enforcement utilization to PDMPs and the real or perceived repercussions of surveillance among prescribers, pharmacists, and patients.⁸

Limitations

This study, across four different groups (prescribers, pharmacists, law enforcement agents, and regulators), provides a relatively small sample size. As with all qualitative research, our findings are not generalizable to the broader professional groups or the population at large. Although all PDMP systems are somewhat unique, the MassPAT system is fairly typical of databases in other U.S. states. The role of PDMPs in regulatory decisions serves as a focus of a separate analysis, which will highlight regulator narratives and perspectives not covered here. Nonetheless, the perspectives we describe, provide useful formative data for further qualitative and quantitative research.

Conclusion

In the context of the overdose crisis response, PDMPs should be reoriented to support clinical decision-making and coordination between health care professionals. More care should be taken to design and operationalize prescription monitoring programs and policies in ways that reduce, rather than aggravate the problems they are intended to solve.