Forty-four people across the United States die each day from overdosing on prescription painkillers, or opioids, according to the Centers for Disease Control and Prevention. An estimated 20 percent of patients with non-cancer pain symptoms or pain-related diagnoses are prescribed opioids for pain management. However, abuse and misuse of these products have created a serious public health problem.
Look at the stats:
- Deaths from prescription opioid pain medication overdose in the United States more than quadrupled from 1999 to 2011.
- From 1999 to 2014, more than 165,000 people died from an opioid-related overdose in the United States.
- Of the 43,982 drug overdose deaths in 2013, 37 percent were associated with prescription opioid analgesics such as oxycodone, hydrocodone and methadone.
- The 2013 National Survey on Drug Use and Health reported that 67.6percent of people who used prescription painkiller for non-medical use got them from a friend or relative by stealing them, buying them or getting them for free.
Because opioid products must be able to deliver pain relief to the patient, there may always be some potential for abuse. However, the severity of the opioid problem has made the development of opioid abuse-deterrent formulations a public health priority.
The Food and Drug Administration believes it is critical to address the problem of opioid abuse while ensuring that patients in pain have appropriate access to opioid products. Moreover, it is important that opioids without abuse-deterrent properties remain available for use in some clinical settings. For example, patients in hospice care who have difficulty swallowing may need opioid products that are in solution or that can be crushed.
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There are numerous ways that opioid products can be abused. They can be swallowed whole, crushed and swallowed, crushed and snorted, crushed and smoked or crushed, dissolved and injected.
Abuse-deterrent technologies are designed to target known or expected routes of abuse. Examples include:
- Physical/chemical barriers: Physical barriers prevent chewing, crushing, cutting, grating or grinding of the dosage form. Chemical barriers resist extraction of the opioid using common solvents like water, simulated biological media, alcohol or other organic solvents. Physical and chemical barriers work by limiting drug release following mechanical manipulation of the product or change the physical form of a drug, making it harder to abuse.
- Agonist/antagonist combinations: An opioid antagonist can be added to the formulation to reverse the pharmacologic effects of the drug, including euphoria. The antagonist is not clinically active when swallowed but becomes active when crushed, injected or snorted.
- Aversion: Substances can be added to the product to produce an unpleasant effect if the dosage form is manipulated or exceeds the directed dosage. For example, the formulation can include a substance irritating to the nasal mucosa if ground and snorted.
Xerox’s prescription clinical authorization tool gives physicians and pharmacists real-time insight into recent prescriptions received and filled by a patient
Pre-marketing and post- marketing assessments
The FDA requires that pharmaceutical manufacturers conduct pre- and post-marketing assessments for claims of abuse deterrence to be included in the labeling of an opioid formulation. Premarketing studies are primarily expected to characterize the abuse-resistance properties of a product under controlled conditions.
Post-marketing epidemiological studies determine whether the formulation results in meaningful decreases in adverse clinical outcomes related to abuse in real world settings. One study evaluating changes in drug abuse patterns found that when OxyContin was reformulated:
- A 32percent reduction in the rate of ER oxycodone-related poison control abuse cases.
- A 15percent reduction in the rate of poisonings related to therapeutic ER oxycodone use.
- The rate of ER oxycodone diversion declined by 50percent.
- The street price of ER oxycodone declined by 22percent.
Generic abuse-deterrent formulations
Although no generic formulations are commercially available, it is important that generic versions of opioids are developed to ensure widespread access to safe and effective painkillers for patients who need them. The availability of such generics must not exacerbate the public health problems associated with prescription opioid abuse. If the generic formulation is less abuse-deterrent, it could lead opioid abusers to preferentially seek out and use this easier-to-abuse version.
Post-marketing epidemiologic studies of opioid abuse-deterrent formulations show declines in abuse patterns, therapeutic errors, accidental exposures and diversion of prescription opioids. The evidence indicates that reformulating abused prescription opioids to include abuse-resistant properties may be an effective approach to reducing opioid abuse. However, a major observation from these studies shows that these formulations were associated with increased abuse of other opioids and illicit drugs.
Current methodologies alone will not likely be adequate to curb nonmedical opioid use. However, they may be effective as part of a comprehensive effort that includes other interventional strategies such as state prescription monitoring and overdose prevention programs. Xerox’s prescription clinical authorization tool gives physicians and pharmacists real-time insight into recent prescriptions received and filled by a patient. As a pharmacist fills a prescription, the tool investigates whether the patient has recently received another opioid. If so, the pharmacist receives a notification that prior authorization is required to verify the medication is correctly prescribed and necessary for the treatment plan. Xerox software then streamlines the prior authorization process by managing coordination between the patient’s physician, a state’s health network and the pharmacist. The increased communication between these groups helps manage a patient’s opioid dosage over a set period of time, which helps prevent abuse.