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Motion graphics and animation software. Pivot Animator. Adobe Director Avid Elastic Reality. Adobe Flash. Adobe Flash Media Server. Coplan and colleagues examined the harms associated with reformulated OxyContin compared with other comparator prescription opioids, reporting a noticeable relative decrease for OxyContin, although this study did not specifically examine collateral outcomes such as potential transition to heroin and related harms.
A recent state-by-state analysis suggests that the introduction of ADF OxyContin in resulted in reduced OxyContin misuse, but with a trade-off of increased heroin-related deaths and evidence of an overall trend of increased opioid overdose deaths Alpert et al.
Black market exchange could play an additional role for individuals misusing prescription opioids whose access to non-abuse-deterrent formulations was replaced with ADFs. Even if such a person did not know how to defeat the abuse-deterrent technology, he or she could still sell the ADF drugs for cash and use the cash to buy heroin or other black market opioids.
ADFs such as the new formulations of OxyContin sell for a moderate discount compared with the non-abuse-deterrent formulations, 4 but markets for them nonetheless still exist. Also, some attempts to defeat abuse-deterrent properties could create uncertainty as to the actual dose ingested, which might in certain circumstances increase the risk of overdose. Such perverse effects do not necessarily have the potential to outweigh the beneficial effects of ADFs, but that they are readily imagined does underscore the point that no clinical trial finding an ADF to be safe and effective when the unit of analysis is the individual patient necessarily indicates that the ADF will have a net positive effect on public health.
In summary, although ADFs of opioids would be expected to reduce some opioid-related harms, it is necessary to consider whether these benefits are offset by their potential effect on movement to illicit markets either for diverted non-ADF prescription opioids or for illegal drugs such as heroin among people who misuse opioids or have OUD. Given the complexity discussed above and also in Chapter 4 , the committee views the evidence surrounding ADFs as not compelling enough to warrant a recommendation at this time.
The potential for benefit remains counterbalanced by recent examples of unexpected harm, and ongoing studies will help to clarify the optimal role for ADFs as a strategy for reducing misuse of prescription opioids.
The FDA's current cautious approach appears to be well advised. Once the FDA has approved an opioid formulation or other controlled substance for therapeutic use, federal and state agencies have the authority to control the amount, storage, and distribution of the drug at every stage in the course of commerce.
One key purpose of these restrictions is to limit access to and use of the drug to the amounts and indications for which it was lawfully prescribed and to curtail its distribution outside of lawful channels of commerce. This section reviews evidence regarding the effects of the federal and state controlled substances acts and their enforcement on access to approved drugs i. The discussion here also encompasses so-called take-back programs that facilitate the return or destruction of lawfully obtained but unneeded medication, as well as additional state and local restrictions on amounts that can be dispensed or prescribed within specific periods.
Related tools include licensing and limiting the class of persons or entities authorized to manufacture, ship, distribute, dispense, and prescribe the approved drugs.
The DEA license confers a considerable benefit and provides a source of leverage for regulation and enforcement. See Chapter 6 for a more specific discussion of the CSA as it relates to opioid regulation. This section also refers to studies regarding analogous actions by regulatory authorities in other countries, but the names and particular definitions of the categories differ. Scheduling of hydrocodone Perhaps the single most relevant example of opioid rescheduling is the DEA's moving hydrocodone products from Schedule III to Schedule II on October 6, , 7 but evidence concerning this event is still emerging.
Early studies document clear reductions in prescribing of hydrocodone and increases in prescribing of other opioids, but none examined effects on health outcomes such as death or OUD on the one hand or deficits in pain control on the other. Oehler and colleagues , for example, document that among emergency department patients in one academic tertiary hospital who received a pain-related prescription, the proportion receiving a prescription for hydrocodone-containing products fell from Seago and colleagues examined the effects on dispensing by 14 pharmacies in central Texas.
However, the ultimate goal of scheduling drugs under the CSA is to reduce misuse and diversion and the addiction, deaths, and other adverse effects associated with misuse. Seago and colleagues do not assess effects on any of those outcomes.
Similarly, Haynes and colleagues report reductions in hydrocodone exposures reported to Texas poison control centers, but increases in mentions of codeine, oxycodone, and tramadol that may reflect substitution.
However, this study used no control group, and opioid poisonings may have been increasing for other reasons as well.
Scheduling of other substances in the United States There are other reports of sharp declines in single drug—related indicators after a drug's classification as a controlled substance. Likewise, Stogner and colleagues report that self-reported current and past-year use of salvia fell after Florida classified it as a Schedule I drug on July 1, Spiller and colleagues' study of the effects of the scheduling of tramadol by Kentucky and Arkansas is particularly relevant, since it involves an opioid and takes advantage of comparison with two control states Ohio and West Virginia that did not schedule the drug.
Poison control center cases mentioning tramadol increased in all four states before the scheduling policy intervention, and thereafter continued to increase in the control states but fell in Kentucky and Arkansas. An older example concerns paregoric. Lerner documents a geometric rise in the number of paregoric-related arrests in Detroit from 0 in to in Michigan ended nonprescription sales of the drug in April , whereupon arrests collapsed, falling to 10 by Restrictions on precursor and essential chemicals A related literature explores the effect of adding legal restrictions on precursor and essential chemicals used in the production of controlled substances.
McKetin and colleagues review 10 studies of 13 regulations plus two enforcement operations directed at precursors for methamphetamine production in the North American market. Most of these studies found reductions in methamphetamine-related outcomes of 12 to 77 percent , with no evidence of shifts to other types of drug use; the exceptions were instances in which substitutes for the restricted chemicals were readily available.
However, the authors of one of the studies Dobkin and Nicosia, , while acknowledging short-term effects of that size, stress the impermanence of the reductions as other methods of production were developed over the longer term. Cunningham and Liu, the lead authors of the majority of the papers reviewed by McKetin and colleagues , also studied regulation of chemicals essential to the production of cocaine.
They again report evidence of reductions in various indicators of production and consumption Cunningham et al. In particular, they attribute the dramatic reduction in U. That decline is significant because it is among the largest in an illegal drug market in recorded history Caulkins et al. Thus, key regulatory tools of controlled substance legislation—especially tightening controls in particular through Schedule II of the CSA and banning precursor substances to prevent illicit manufacture—can be effective in accomplishing their purposes.
A key element of a regulatory system for controlling dangerous drugs is preventing and penalizing diversion of the drugs from the channels of distribution that have been authorized for medical use. Prescription drugs are diverted to nonmedical use in myriad ways, but it is useful to distinguish three categories: 1 diversion before a prescription has been filled e.
While the first category undoubtedly occurs, it appears to be of quite modest scale. As noted in Chapter 4 , the DEA b , p. By contrast, the DEA b , p. By contrast, the third category, diversion after a prescription has been filled, is much more common. One recent survey found that about one in five adults with an opioid prescription self-reported having shared those opioids with another person, most frequently for the purpose of helping to manage pain Kennedy-Hendricks et al.
However, such individual-level actions generally are not the concern of federal law enforcement, which focuses on misbehavior by DEA registrants and large-scale diversion by industry Sapienza, Some diversion within the second category, diversion via the filling of a prescription, also falls outside the priorities of federal law enforcement—notably diversion that is driven by the patient e. The portion of this diversion category that is more likely to attract the attention of federal law enforcement is that which involves the knowing misbehavior of DEA registrants, such as with so-called pill mills.
Some of these actions are civil, not criminal. For example, the DEA has pursued action against CVS in multiple states for filling forged prescriptions or knowingly dispensing to individuals without a legitimate medical need DOJ, ; Wang, The sanction in many DEA cases against practitioners is simply revocation of prescribing privileges, although some of those revocations stem from personal circumstances and errors, such as a practitioner who develops an OUD and is prescribing to him- or herself, not the more egregious cases.
The largest criminal case involving prescription drug diversion, Operation Piluted, led to arrests, including 22 doctors and pharmacists, for illegally prescribing and distributing controlled substances, including oxycodone and hydrocodone DEA, a. In a series of investigative journalism stories, The New York Times reporter Katie Thomas a , b , , a , b documented the criminal activity of InSys Therapeutics.
Employees were indicted for offering bribes and kickbacks to doctors and nurses in exchange for their prescribing more of the company's fentanyl product, Subsys, and several of the company's former executives have been charged under the Racketeer Influenced and Corrupt Organizations RICO Act. The DEA, among other agencies and organizations, also tries to reduce the supply of prescription opioids by facilitating the return of unused medications through drug take-back programs.
Typically, these are ad hoc or occasional events that allow individuals with unused medications to bring them in to be disposed of properly. Perhaps the best-known is an annual program sponsored by the DEA since Stewart et al. These programs are popular, and the literature on them is generally favorable, although all but devoid of high-quality evidence concerning effects on final outcomes, such as overdose Haegerich et al. Rather, the literature finds that the programs raise awareness e.
However, while the quantities may be substantial in absolute terms, they represent a very small proportion of the total dispensed. Egan and colleagues , for instance, found that over 4 weeks in one community, 21 million units of controlled medication were dispensed, but only 21 thousand were collected. Furthermore, evaluations of such programs generally cannot assess directly effects on such outcomes as OUD and mortality. Moreover, the reduction in harm may be even smaller than the reduction in volume of medications in circulation if the doses that are voluntarily surrendered are not the ones that would have caused OUD and death had they not been collected.
One might speculate that people struggling with OUD or selling pills on the black market would be among those least likely to surrender pills voluntarily. On the other hand, it is important to note that asking whether take-back programs are an effective way to ameliorate problems with prescription opioids is a very narrow framing.
Opioids are one of many categories of medications, and the literature is concerned as much with environmental harms from improper disposal as with harms from nonmedical use.
Despite the effort invested in occasional take-back programs, proper disposal of unused medications is relatively rare in the United States Glassmeyer et al. Maughan and colleagues found that this was the case for a majority of opioid pills dispensed to patients who had undergone surgical tooth extraction. Likewise, Harris and colleagues found that one-third of patients prescribed opioids after dermatology surgery did not fill their prescriptions, and 86 percent of those who did had leftover pills.
And Welham and colleagues found that among opioid prescriptions returned for disposal, the majority of the dispensed amount was unused. A large proportion of respondents report keeping medications around, even when they are not needed, and then disposing of them improperly, whether in the trash or down the drain. Reducing misuse may not be sufficient motivation for members of the public at large to go much out of their way to return drugs; in one study, far fewer participants were motivated by concern about accidental poisoning 14 percent than by environmental considerations 45 percent or a simple desire to clean house 68 percent Gray and Hagemeier, The literatures on other environmental problems conclude that getting the public to do what is right e.
The United States has largely failed in this regard with respect to disposing of unused medications. Once-per-year take-back programs do not meet that test, and the patchwork of state, local, and pharmacy-specific programs may confuse and deter the public.
By contrast, many peer nations have simple systems whereby most people can return any drug to any pharmacy on any day of the year. Australia's Return Unwanted Medicines program gets high marks in this regard, as do the programs in several of Canada's provinces, including British Columbia's Medications Return Program Daughton, Glassmeyer and colleagues report that many countries in Europe offer a similar service.
Sometimes these programs are funded by taxpayers, sometimes by the pharmaceutical industry, and sometimes by a mix of the two. Regardless of who pays, the basic idea of disposing of unwanted materials by operating the standard distribution system backward has many advantages and is a cornerstone of reverse logistics.
Box provides further detail on one example of a national-level take-back program. It is also important to note that many unused medications are in institutions, such as nursing homes, so ensuring that take-back programs are available to them, not just individual consumers, is important.
Ironically, both environmental and drug control laws make implementing convenient drug take-back programs challenging in the United States Glassmeyer, The Resource Conservation and Recovery Act exempts household hazardous wastes from many regulations, but when they are collected, they are regulated. So it is perfectly legal for 1, individual consumers to dispose of their unused drugs in the worst possible manner, but if an organization collects those unused drugs and disposes of them in a much better but not ideal way, the organization performing that service may run afoul of the law.
Historically, an even greater problem was a requirement of the CSA that scheduled drugs be under the control of law enforcement. Thus, a pharmacy could run afoul of the CSA if it allowed consumers to bring back opioids at any time unless law enforcement personnel were present Glassmeyer et al. On September 9, , the DEA published new guidelines allowing certain DEA registrants to become authorized collectors of returned controlled medications DEA, , although it is unclear whether full advantage is being taken of that new flexibility.
Certainly some organizations find ways to overcome the obstacles and create permanent drop-box options e. However, the advantages of allowing consumers to return medications on any day of the year to any of many locations they visit regularly e. As one example of early success, a U. Education for patients as to why safe disposal is important also is needed. Kennedy-Hendricks and colleagues report that almost half of survey respondents who were prescribed opioids said they did not recall receiving any instructions regarding safe storage or disposal.
The available evidence suggests that drug take-back programs in the United States can increase awareness about the safe disposal or return of many unused drugs, but effects of these programs on such downstream outcomes as diversion and overdose are unknown. As noted, moreover, many drug take-back programs in the United States are once-per-year events, and the patchwork of state, local, and pharmacy-specific programs may confuse the public.
Nevertheless, international examples and the recent success of a year-round disposal program at one pharmacy chain support policies expanding such programs to reduce the amount of unused opioids in the community. The committee recommends that states convene a public—private partnership to implement drug take-back programs allowing individuals to return drugs to any pharmacy on any day of the year, rather than relying on occasional take-back events Recommendation States vary widely in rates of prescribing opioids e.
There is, after all, a long history of published concern that misinformed and exaggerated fears about liability related to misuse of and addiction to opioids lead regulators to stifle the prescribing of these medications for patients who need them for pain relief e. What is less clear is whether one can infer from the variation among states or other evidence whether particular state policies are effective at reducing diversion and misuse of opioids without adversely impacting their availability for pain control.
Meara and colleagues , for example, find no association over a 7-year period between opioid-related outcomes in Medicare administrative data and states' adoption of controlled substance laws of the sort described further below. Unfortunately, they conclude that the available empirical studies are generally of low quality, and that the outcomes studied are often intermediate, such as prescribing practices, and not final, such as overdose.
The largest number of studies uncovered pertained to prescription drug monitoring programs PDMPs , naloxone, and clinical guidelines, all of which are addressed separately in this chapter; the others are briefly discussed here.
The pain clinic laws coincide with reductions in the number of clinics and the supply of drugs, but the nature of the evidence is weak. Florida is a special case, discussed further below. Studies of doctor shopping interventions are no better in terms of enabling causal inference concerning health outcomes. One might say the literature documents that these policies exist and have been implemented, and in a dog-not-barking sense, infer that they can be implemented without resulting in obvious catastrophic failures.
Furthermore, there are clear logic models for why one might expect these policies to have some beneficial effect. However, these studies are unconvincing if one adheres to the standards of scientific skepticism and disbelieves that interventions have any bottom-line effect unless clear evidence from high-quality empirical studies demonstrates this to be the case.
A Maine law that went into effect January 1, , for example, limits prescriptions for opioids or opioid-containing medications to morphine milligram equivalents MME per day. In addition, the law limits the number of opioid pills that can be prescribed to patients except in cases of inpatient, cancer-related, palliative, and end-of-life care, as well as treatment for substance use disorder to no more than a 7- and day supply for acute and chronic pain, respectively Traynor, In Massachusetts, a new law places a 7-day supply limit on first-time opioid prescriptions for adults and a 7-day limit at any time for minors.
One particular case study merits discussion: Florida's experience circa — Multiple policy interventions were being implemented simultaneously at that time, so it is impossible to use this case study as evidence concerning any one of them. Nonetheless, the changes in adverse outcomes were so abrupt both in absolute terms and relative to other states that it appears highly plausible that some combination of those interventions was responsible for the changes, and hence for averting thousands of premature deaths Chang et al.
Meinhofer shows that these supply reduction measures more than tripled street prices for oxycodone and sharply reduced oxycodone-related mortality and hospitalization with apparently minimal spillover effects on other states, suppliers, or drugs—the only exception being some substitution of heroin, which was small relative to the reductions in oxycodone use.
She observes that in the years preceding the operation, —, Florida's oxycodone supply per capita had risen from close to the national average to quadruple the national average. After the intervention, it fell back to the national average. Consumption of various substitutes never departed appreciably from national averages, and no other state experienced a spike in oxycodone supply even close to the same magnitude as that experienced in Florida.
The effects were dramatic, with the time trajectory of oxycodone deaths mirroring that of oxycodone supply. On the one hand, this circumstantial evidence suggests that supply-side interventions against prescription opioids can have dramatic effects.
On the other hand, Florida may have been experiencing a uniquely bad baseline situation in that may never again be replicated.
Examining Texas's pill mill law, for example, Lyapustina and colleagues found reductions in the number of opioid prescriptions, number of pills dispensed, opioid volume, and average morphine-equivalent dose per transaction, but the reductions were 8—24 percent, not the enormous reductions seen in Florida.
Overall, although further research is warranted, limited evidence suggests that state and local interventions aimed at reducing the supply of prescription opioids in the community may be effective. It should be emphasized, however, that none of these studies investigated the impact of reduced access on the well-being of individuals suffering from pain whose access to opioids was curtailed.
Reducing prescribing of opioids is at once a tool both for reducing lawful supply by limiting the indications for prescribing them or otherwise reducing the number of patients holding prescriptions and for reducing demand, or aggregate desire for using or misusing the drugs.
Reduced prescribing can affect demand in two ways: first, by reducing patients' reliance on opioids to manage pain by satisfying their needs through other forms of pain management; and second, by reducing the number of patients or others who develop OUD and increasing the incentive for treatment among patients with OUD. This section describes a range of formal and informal policies, interventions, and tools designed to shape, guide, and regulate the prescribing practices of physicians and other health care professionals the gatekeepers authorized to prescribe these drugs.
The relief of pain represents one of the primary responsibilities of the practice of medicine Federation of State Medical Boards, Compared with the progressive advancement of medical education surrounding such fields as cardiology and oncology, advances in pain management education are entirely absent or minimally developed—often limited to a few hours of didactic lectures over multiple years of training.
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