Tampering with Prescription Opioids: Nature and Extent of the Problem, Health Consequences, and Solutions

Katz, Nathaniel; Dart, Richard C.; Bailey, Elise; Trudeau, Jeremiah; Osgood, Eric; Paillard, Florence

doi:10.3109/00952990.2011.569623

Cited by 143 publications

(157 citation statements)

References 31 publications

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“…[15] The vast majority of published data concerning routes of abuse of prescription opioid analgesics have been obtained in the USA (Table 1). Available data suggest that ingestion (with or without manipulation of the prescribed formulation) is the most prevalent route of abuse of prescription opioid analgesics, followed by inhalation and injection.…”

Section: Frequency Of Different Routes Of Abusementioning

confidence: 99%

“…[16] Available data suggest that immediate-release formulations are more often abused intact (e.g., by over-ingestion), whereas extended-release formulations are more likely to be manipulated and then swallowed, inhaled or injected. [15,29] Eightythree percent of individuals with a history of prescription opioid abuse reported oral abuse for an immediate-release formulation of oxycodone/acetaminophen (swallowing intact tablets and chewing combined), with inhalation reported by 44% and injection by 0.5%. [36] Similarly, 89% of individuals abusing immediate-release hydrocodone/acetaminophen used the oral route, with inhalation reported by 40% and injection by 1%.…”

Section: Differences In Routes Of Abuse Between Formulationsmentioning

confidence: 99%

“…[15,16] This paper reviews published data on the different routes of abuse of currently available prescription opioid analgesics and assesses the similarities and differences in routes of abuse across different products and populations. The potential impact of emerging abuse-deterrent formulations on routes of abuse will also be assessed.…”

Section: Introductionmentioning

confidence: 99%

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Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Gąsior

Bond

Malamut

2015

Postgraduate Medicine

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Prescription opioid analgesics are an important treatment option for patients with chronic pain; however, misuse, abuse and diversion of these medications are a major global public health concern. Prescription opioid analgesics can be abused via intended and non-intended routes of administration, both intact or after manipulation of the original formulation to alter the drug-delivery characteristics. Available data indicate that ingestion (with or without manipulation of the prescribed formulation) is the most prevalent route of abuse, followed by inhalation (snorting, smoking and vaping) and injection. However, reported routes of abuse vary considerably between different formulations. A number of factors have been identified that appear to be associated with non-oral routes of abuse, including a longer duration of abuse, younger age, male sex and a rural or socially deprived location. The development of abuse-deterrent formulations of prescription opioid analgesics is an important step toward reducing abuse of these medications. Available abuse-deterrent formulations aim to hinder extraction of the active ingredient, prevent administration through alternative routes and/or make abuse of the manipulated product less attractive, less rewarding or even aversive. There are currently five opioid analgesics with a Food and Drug Administration abuse-deterrent label, and a number of other products are under review. A growing body of evidence suggests that introduction of abuse-deterrent opioid analgesics in the USA has been associated with decreased rates of abuse of these formulations. The availability of abuse-deterrent formulations therefore appears to represent an important step toward curbing the epidemic of abuse of prescription opioid analgesics, while ensuring the availability of effective pain medications for patients with legitimate medical need.

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Section: Frequency Of Different Routes Of Abusementioning

confidence: 99%

Section: Differences In Routes Of Abuse Between Formulationsmentioning

confidence: 99%

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Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Gąsior

Bond

Malamut

2015

Postgraduate Medicine

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“…Tampering is common with more than 80 % of a group of prescription drug abusers entering a treatment facility admitting that they had altered the drug delivery system by tampering in some way [15]. The major forms of tampering other than ingestion (which includes chew and swallow) are inhalation, parenteral use, and smoking [15,16].…”

Section: Abuse and Tampering Of Opioid Analgesicsmentioning

confidence: 99%

Abuse-Deterrent Formulations, an Evolving Technology Against the Abuse and Misuse of Opioid Analgesics

Schaeffer

2012

J. Med. Toxicol.

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The increased use of opioid pain medication has been mirrored by the increased misuse and abuse of these drugs. As part of a multidisciplinary approach to this epidemic, pharmaceutical companies, with the encouragement of the Food and Drug Administration, have increased the development of abuse-deterrent formulations. While all have the goal of treating pain while mitigating misuse and abuse, there are different technologies utilized to impart the abuse-deterrent properties. The goal of this paper is to review the basis of abuse-deterrent formulations, the different types and approaches of some of the abuse-deterrent products, and their current regulatory status in the USA.

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“…Some formulations of immediate-release (IR) and extended-release (ER) opioids can be manipulated to achieve more rapid drug release and to facilitate alternate routes of administration (i.e., injecting, snorting, and smoking) (6,7). Abuse-deterrent (AD) formulations have been developed to substantially reduce misuse and abuse of opioids by making manipulation more difficult or rendering the manipulated product less attractive and less amenable to alternate routes of administration (8).…”

Section: Introductionmentioning

confidence: 99%

The ALERRT^® instrument: a quantitative measure of the effort required to compromise prescription opioid abuse-deterrent tablets

Cone¹,

Buchhalter²,

Lindhardt³

et al. 2017

The American Journal of Drug and Alcohol Abuse

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Background: US FDA guidance recommends measuring the degree of effort needed to manipulate abuse-deterrent (AD) opioids. The ALERRT ® instrument (PinneyAssociates; Bethesda, MD) uses visual analog scales to assess the labor, effort, and resources necessary to physically compromise AD product candidates in standardized settings. Objective: Use the ALERRT ® instrument for testing morphine abuse-deterrent, extended-release, injection-molded tablets (ADER-IMT) 60 and 100 mg and the comparators immediate-release (IR) morphine sulfate 30 mg and extended-release (ER) morphine sulfate 60 mg. Methods: Four technicians tested the products using 10 household tools. The ALERRT instrument quantified effort (all tools) and time (3 preselected tools) required for manipulation. Results: Morphine-ADER-IMT 60 and 100 mg were difficult to manipulate, as demonstrated by high scores (mean range, 71.0−99.0 and 77.0−99.5, respectively). IR and ER morphine sulfate were easy to manipulate (low scores; mean range, 2.0−14.8 and 2.3−17.5, respectively). Statistically significant mean differences between morphine-ADER-IMT and comparators' ALERRT scores were observed. Manipulations of morphine-ADER-IMT 60 and 100 mg for 300 seconds failed to produce substantial powdering. Manipulations of IR morphine sulfate (mean range, 65.5−175.8 seconds) and ER morphine sulfate (49.3−163.0 seconds) produced substantial to complete powdering in 92% of tablets. Conclusions: Morphine-ADER-IMT was extremely difficult to manipulate versus non-AD formulations of morphine. The ALERRT system differentiated the degree of effort for manipulation of morphine-ADER-IMT and non-AD morphine formulations, indicating sensitivity of this instrument as part of Category 1 testing. By measuring the degree of effort required for manipulation, the ALERRT instrument provides an empirical assessment into the relative difficulty of manipulating opioid analgesics for abuse.

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Tampering with Prescription Opioids: Nature and Extent of the Problem, Health Consequences, and Solutions

Abstract: The seriousness of health outcomes associated with tampering with POs warrants the development of PO formulations that prevent or deter tampering.

Cited by 143 publications

References 31 publications

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Abuse-Deterrent Formulations, an Evolving Technology Against the Abuse and Misuse of Opioid Analgesics

The ALERRT^® instrument: a quantitative measure of the effort required to compromise prescription opioid abuse-deterrent tablets

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Tampering with Prescription Opioids: Nature and Extent of the Problem, Health Consequences, and Solutions

Abstract: The seriousness of health outcomes associated with tampering with POs warrants the development of PO formulations that prevent or deter tampering.

Cited by 143 publications

References 31 publications

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Abuse-Deterrent Formulations, an Evolving Technology Against the Abuse and Misuse of Opioid Analgesics

The ALERRT® instrument: a quantitative measure of the effort required to compromise prescription opioid abuse-deterrent tablets

Contact Info

Product

Resources

About

The ALERRT^® instrument: a quantitative measure of the effort required to compromise prescription opioid abuse-deterrent tablets