Opioids and Public Health: The Prescription Opioid Ecosystem and Need for Improved Management

Evan D. Kharasch, M.D., Ph.D.; J. David Clark, M.D., Ph.D.; Jerome M. Adams, M.D., M.P.H.

Disclosures

Anesthesiology. 2022;136(1):10-30. 

In This Article

Prescription Opioid Ecosystem

A new paradigm and new messages are needed. Our proposal is the concept of the prescription opioid ecosystem (Figure 2). The ecosystem consists of providers/prescribers, pharmacies, patients, and disposal (and manufacturers, distributers, and pharmacy benefit managers, albeit not discussed here), all of which bear directly on the opioid pool.

The prescription opioid ecosystem is a superset of the recently introduced concept of opioid stewardship.[138] Opioid stewardship is modeled on now-standard institutional antibiotic stewardship programs. One definition of opioid stewardship is "coordinated interventions designed to improve, monitor, and evaluate the use of opioids in order to support and protect human health."[139] The opioid stewardship concept has also been echoed by the National Quality Forum (Washington, D.C.).[140] Nevertheless, this important yet still developing concept lacks consensus definition and implementation, and is sometimes conflated with institutional administrative superstructures or with clinical pain management approaches.[141–144] In addition, opioid stewardship programs are institution-based and institution-specific, often focused mainly on prescribing practices, prescribing monitoring, and addiction.[141–144] Programs are often linked to hospital pharmacy consult services or to clinical pharmacy specialists within hospitals and health systems. Last, they are not widely found, and are variably effective.[141–144] Programs focus on clinicians, administrators, quality assessment personnel, clinical disciplines, administrative structure, organizational policies, tasks, tracking, and reporting.[138,142,145] These are all extremely valuable institutional efforts, but they are not patient-centric, and do not directly address patients and communities at large or the problem of the opioid pool and its consequences. The prescription opioid ecosystem can include institution-based opioid stewardship, but extends well beyond, to the broader concept of opioid use, storage, return, and harm reduction, with a specific focus on patients and communities.

Prescription opioid ecosystem patient messaging and implementation should be patient-centric and stress safe handling and storage of opioids, opioid use only by the recipient and only for the prescribed indication, patient transition to nonopioid analgesics as recovery progresses, and then appropriate opioid return or disposal to minimize diversion, misuse, and harm. One suggestion is the novel messaging that opioids are not "given" to patients (denoting permanent possession) but rather "loaned" for appropriate and recipient use only, and that they should be returned when no longer needed. The healthcare system needs to make "the right to return" as easy or easier than "the right to receive." Inherent in this strategy, however, it is crucial that patients need to be confident and assured that their next episode of pain will be appropriately treated, lest they hoard unused opioids for fear that any such future pain and suffering will not be treated.

Opioid ecosystem education should target greater patient (and caregivers of children) engagement in pain management and safe opioid use.[146] Patient education by providers and other caregivers is unquestionably needed and an attractive opportunity for shrinking the opioid pool. However, surveys of U.S. adults found that 40 to 50% said they received no information on either safe storage or proper disposal.[58,147] Another survey of children's caregivers found that education on proper storage was reported by only 60%, and education on disposal by 50%.[66] Opioid disposal rates are typically less than half the rate of patient education.

Opioid education is laudatory and unassailable as an ideal. Preoperative education may reduce postoperative pain scores and opioid use,[148] or hasten opioid cessation.[149] Nevertheless, it must be recognized that patient education alone is insufficient and inconsistent, effective strategies are lacking, little progress has been made, and education will require substantial effort, take considerable time, and need greater evidence of effectiveness.[150] Passive education (informational pages and brochures) has unfortunately not been successful. A single-page document given to patients after dental surgery increased the proportion of patients who disposed or reported intent to dispose of unused opioids by only 22%.[68] Dissemination of an educational brochure about safe disposal of unused opioids doubled the disposal rate, but still only a small fraction (22%) of patients did so.[151] More recently, even with greater awareness of the opioid crisis, patient education handouts did not increase opioid disposal.[152,153] Although education of children's caregivers on proper storage and disposal was reported by 60% and 50%, respectively, locked storage and disposal were reported by only 18% and 25%.[66] Moreover, there is insufficient knowledge among those providers who would need to be the educators. In an opioid knowledge assessment examination taken by physicians, nurses, and pharmacists involved in opioid administration in Pennsylvania hospitals, only 9% of respondents correctly answered all of the 11 basic questions.[154]

Appropriate, rational, and safe opioid prescribing as well as safe return or disposal need to be part of undergraduate and graduate medical and pharmacy curricula and continuing medical and pharmacy education. Educating patients cannot occur until we educate the educators. From the perspective of postsurgical opioids, preoperative clinics, or possibly transitional pain services, typically run by anesthesiologists, could be the most opportune place for perioperative practitioner and surgical patient education about postoperative pain, opioids and other pain drugs, opioid stewardship, and opioid return/disposal. More broadly, primary care providers, who are the largest group of opioid prescribers,[67] constitute the greatest need and opportunity for provider, and in turn, patient education.

Other approaches to the prescription opioid ecosystem are also needed that target disposal and return more specifically. Home disposal is one option. Unfortunately, home disposal guidelines for patients vary widely, can be confusing, are infrequently communicated, and are not intuitively found by patients. Contrasting recommendations, even within and between U.S. federal and state agencies (Drug Enforcement Administration; Environmental Protection Agency, Washington., D.C.; state boards of pharmacy; individual state agencies) can be confusing to patients.[155] The U.S. Food and Drug Administration (Silver Spring, Maryland) recommends flushing some drugs down the sink or toilet, while recommending that others should be mixed with used coffee grounds, dirt, or cat litter, placed in a closed unmarked container, and thrown in the garbage.[156] In contrast, the U.S. Environmental Protection Agency advises against flushing unwanted drugs down the toilet. U.S. news media articles rarely cover flushing as an option, and often present it as environmentally harmful.[155] Some state guidelines contradict federal guidelines.[157,158] In contrast to the United States, Health Canada (Ottawa, Canada) recommends that unused drugs be returned to local pharmacies or municipal waste disposal centers and discourages other forms of disposal (flushing, pouring down the drain, or throwing in the trash).[159]

The current difficulty of returning prescription opioids contrasts markedly with the ease of obtaining them. This is illogical and unsafe. A less confusing, more effective, and more environmentally sound approach is needed, specifically the creation and facilitation of effortless and free pathways for disposal and return that are widely known, widely available, and widely used. Events such as National Prescription Drug Take Back Day are welcome, but occur only once per year, and in a limited 4-h window,[160] and are not widely publicized and well-known.[161] These do collect tons of unused medications, but only a tiny fraction are opioids,[162] and take-back events and drug disposal sites remove only a miniscule fraction (0.3%) of opioids dispensed.[163] This is inadequate. More promising are year-round drug disposal locations, yet the availability, awareness, and use of these sites, particularly for opioids, is insufficient.[164] Most patients (84%) surveyed would be more likely to use a take-back kiosk if it was in a frequently visited location.[135] Even though there is considerable variability in opioid prescribing, the variability in opioid consumption and thus the variability in amounts left over are even greater.[47] Hence intervention on the disposal side may have even better impact than just trying to throttle opioid dispensing.

There need to be common sense, convenient, widely available, accessible, appealing, and inexpensive (preferably free) methods for patients to return unused opioids. Even terminology may be influential. "Return," "take-back," and "give-back" may have subtle influence on behaviors, as the former two terms connote effort required on the part of patients and potential inconvenience, while the latter does not and may even sound more genial. One approach is mailable disposal bags. Providing patients with a bag containing an inactivating modality (e.g., activated charcoal, coffee grounds) for in-home opioid disposal was found in various studies to double the disposal rate compared with an educational pamphlet (57% vs. 29%),[152] increase it by 50% (33% vs. 19%),[75] increase it by 20%,[165] or have no effect at all.[153] An interactive Web-based educational program combined with a disposal kit was more effective than just a kit alone.[75] After pediatric surgery, provision of a mail-back envelope resulted in opioid return by 19% of patents, comprising 58% of the prescriptions written.[166] Opioid "buy-back" sounds even more appealing, and may also facilitate return.[91] This novel pilot program for buy-back of postsurgical opioids (nominal $5 reimbursement with a limit of $50) resulted in 30% participation of 934 patients, returning 3,165 unused pills (median 10 per patients, 22% of pills dispensed), at a cost of $31 per patient. In a patient survey, most (70%) reported that compensation would lead them to dispose of unused opioids.[135]

Regulations require that prescription drugs must be dispensed with patient instructions for use, and there are telephone numbers for refills on every medication container label for patient convenience, refills, and obvious business reasons. Perhaps regulations are also needed requiring that opioids be dispensed with explicit and plain instructions for proper return or disposal, and preferably with some message on the label rather than just a handout. Perhaps patient instructions, including addresses/telephone numbers of disposal stations, and a return mailing envelope for unused drugs, should be mandatory. Such an envelope should be preaddressed and postage-prepaid, to maximize return rates. More than half of patients surveyed would use such a prepaid envelope for opioid return.[135] Regulations must be federal, for uniformity, lest there be a patchwork of variable state regulations. Opioid take-back is currently subject to federal, state, and board of pharmacy regulations, which may be complex if not conflicting and certainly confusing to patients.

processing....