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Supplements Combating the Opioid Epidemic
Introduction to the Opioid Epidemic: The Economic Burden on the Healthcare System and Impact on Quality of Life
Nicholas E. Hagemeier, PharmD, PhD
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Current and Emerging Options to Combat the Opioid Epidemic
Courtney Kominek, PharmD, BCPS, CPE
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Current and Emerging Options to Combat the Opioid Epidemic

Courtney Kominek, PharmD, BCPS, CPE

 
Managing chronic pain is a conundrum for many clinicians, particularly those in primary care. The abuse potential of opioids can make it challenging to offer them to patients who are at elevated risk for opioid misuse and abuse, yet clinicians increasingly have need to treat severe pain in such patients. Existing ADFs of opioid analgesics are intended to provide pain relief to patients while deterring misuse and abuse. According to FDA Commissioner Scott Gottlieb, MD, until new nonopioid forms of pain management are available, it is critical to promote the development of opioids that are harder to manipulate and abuse and to encourage their use over opioids that offer no form of abuse deterrence.22

In a recent report, the National Academies of Sciences, Engineering, and Medicine recommend caution and ongoing studies on the optimal role of ADFs in reducing misuse of prescription opioids.8 According to this report, ADFs have the potential for benefit, but reliance on them may undermine a successful public health response to the opioid epidemic.Although the direct and indirect cost savings of ADFs may be substantial, these benefits have been accompanied by an increase in abuse of other opioids, particularly heroin.17 Data collected with the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System Web Monitoring Program, an online surveillance system that collects and organizes posts about prescription drugs from social media websites, blogs, and forums, indicated that users will gravitate to non-ADFs in general, and specifically to immediate-release, non-ADFs as long as these options remain on the market.23 Nevertheless, the introduction of an immediate-release ADF that resists physical methods of abuse—such as crushing, grinding, or extraction—in commonly used solvents, is hoped to offer clinicians a new approach for treating patients in pain while simultaneously fighting against the potential for abuse.24

Opioid analgesics can be abused simply by being taken at or above the recommended dosage, and ADFs do not protect against swallowing several intact capsules or tablets to achieve a feeling of euphoria.25 However, many who abuse opioids tamper with the drug product to ingest more of the active drug. For this reason, extended release/long-acting formulations are often the preferred formulation over short-acting formulations, as these contain greater amounts of the active agent.26 Tampering could include crushing or grinding the drug for ingestion, smoking, or rectal administration. The drug could also be dissolved in a solvent such as water or ethanol for injection. Oral ingestion is the most common route of abuse, followed by inhalation and injection.17 Those who abuse may also take the opioid with alcohol or another drug such as a benzodiazepine. Differences in the routes of abuse vary between drug formulations, duration of abuse, age, sex, and geographic location.

Pharmacologic approaches to deter opioid abuse have included incorporating characteristics designed to make it more difficult to tamper with the oral tablets to obtain rapid absorption of the opioid.25 These include adding an opioid antagonist such as naloxone, adding an agent that induces unpleasant symptoms with excessive intake, and incorporating physicochemical barriers intended to confer resistance to tablet tampering.

To help transition to a market in which most opioids have abuse-deterrent properties, the FDA recently issued its Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling on the development of generic versions of approved ADF opioids.27 The guidance includes recommendations about the type of studies companies should conduct to demonstrate that the generic drug is no less abuse deterrent than its brand-name counterpart. In addition, the FDA is investigating ways to help generic ADF manufacturers bring their drugs to market as quickly and efficiently as possible, such as improved testing methodologies for evaluating abuse deterrence and advancing new review policies.22

Currently, 9 extended-release/long-acting opioids and 1 immediate-release opioid are FDA approved with labeling describing abuse-deterrent properties that are consistent with the FDA’s guidance.25,28 For more information on these agents, see Table 3.29-38

The uptake of ADFs has been slow among physicians because of lack of awareness of their availability, uncertainty about when to prescribe them, and limited postmarketing evidence demonstrating effectiveness.39 Price can also be a significant barrier as new formulations are available only as brand-name products and therefore are more expensive than non-ADFs and their generic counterparts.22 The higher costs of ADF therapy may necessitate prior authorization requirements that require clinicians’ time and could impact productivity and patient care.40

In addition, an economic modeling analysis of costs related to prescribing ADF opioids indicate that they have the potential to substantially reduce the incidence of abuse in patients who have been prescribed opioids for chronic pain relative to non-ADF opioids, but at significantly higher costs to the healthcare system. Unless ADF opioids are discounted by 41% from current prices, healthcare cost neutrality could not be achieved, even if the effectiveness of ADF opioids in preventing abuse were 100%.40

Prescription Drug Monitoring Programs

PDMPs are state-run, electronic databases used to track the prescribing and dispensing of controlled prescription drugs to patients. This information is monitored for suspected drug abuse or diversion. It can provide the prescriber or pharmacist with information on a patient’s controlled-substance prescription history, identify patients using more than 1 pharmacy or more than 1 prescriber, or identify those with inappropriate prescriptions. As of September 2017, 49 states had active PDMPs, as well as the District of Columbia and St. Louis county in Missouri, which is the only state without an active PDMP.41

Research has shown that the outcomes of using PDMPs have been mixed because of under-usage of the database and limited effectiveness in reducing overdose deaths and the consumption of controlled substances.42 Perrone and Nelson described limited use of PDMPs among some practitioners because of time constraints and access issues, along with the belief that using the system will not change their patients’ behaviors.43 Nevertheless, an analysis of PDMP data indicated that a state’s implementation of the program was associated with an average reduction of 1.12 opioid-related overdose deaths per 10,000 population, which could be increased if programs monitored a greater number of drugs with abuse potential and data were updated at least weekly.44

Urine Drug Monitoring

UDM is an important tool for managing patients’ opioid use. Testing helps determine whether patients are taking their prescribed medications appropriately and whether they are taking other substances not prescribed or illegal. Guidelines and consensus recommendations suggest UDM at baseline and at least yearly during chronic opioid therapy with increased frequency of UDM based on the patient’s level of risk.11,14,45

A new consensus document released in July 2017 by the American Society of Addiction Medicine provides practical guidance on the appropriate use of drug testing for the identification, diagnosis, treatment, and monitoring of patients with or at risk for SUDs.46 The value of drug testing depends on using it correctly—selecting the right test for the right patient at the right time.46 As part of the multidisciplinary team, pharmacists can be helpful in ensuring that healthcare providers understand the principles of drug tests and testing limitations. According to an interdisciplinary group of clinicians with expertise in pain, SUDs, and primary care, evidence on the efficacy of UDM in preventing OUD, overdose, and diversion is limited; however, UDM should be included as part of ongoing risk monitoring in patients who have been prescribed opioids for chronic pain.45

Naloxone

Although several screening instruments are available to assess the risk of misuse, abuse, or addiction in patients being treated with prescription opioids, an instrument to assess the likelihood of opioid-induced overdose or life-threatening respiratory or central nervous system depression has only recently been developed.47,48 The Risk Index for Overdose or Serious Opioid-Induced Respiratory Depression is a screening tool that can provide valuable decision support to clinicians so they are able to manage pain more effectively in their patients.47,48 Patients identified as having increased risk are most likely to benefit from preventive and potentially life-saving interventions, including education, increased attention to opioid selection and dose escalation, referral to a pain management specialist, and heightened vigilance for opioid-related AEs.

Naloxone, a highly effective opioid antagonist, is recommended for patients who are at increased risk for opioid overdose, including those on chronic opioid therapy. Until a few years ago, naloxone was available only as an injection, with the potential for accidental needlesticks and transmission of hepatitis or HIV infection. Some emergency workers had been using an adapter placed at the tip of the syringe to convert the injectable into a spray. In April 2014, the FDA approved a naloxone autoinjector product, the first naloxone product specifically approved for administration for suspected opioid overdose outside a medically supervised setting.49 In November 2015, a ready-to-use, needle-free nasal device was approved by the FDA and is now commercially available.50 Naloxone injections and nasal spray can be administered easily and safely by a first responder with no prior training and are recommended for use in the revised Substance Abuse and Mental Health Services Administration (SAMHSA) Opioid Overdose Toolkit.51

Although some states and cities embrace the life-saving potential of naloxone, a few law-enforcement individuals question whether its availability is helping to enable the opioid epidemic rather than to prevent it. The CDC credits naloxone for saving 26,000 lives between 1996 and 2014.52 But some officers report that naloxone allows the addiction cycle to continue because often they are saving the same individual multiple times, without long-term treatment options. Yet, others say that naloxone ultimately saves lives and helps people stay alive until, hopefully, they can be successfully treated.53 Nonetheless, on April 5, 2018, the Office of the Surgeon General released an advisory encouraging increased access in the community to naloxone for those and their friends and families who are at increased risk for overdose, including those on opioids for chronic pain.54

Identifying Patients at Risk for Prescription Opioid Abuse

 
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