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Can Drug Manufacturers Do More to Deter Prescription Opioid Misuse?

New guidelines issued by the U.S. Food and Drug Administration urge pharmaceutical manufacturers to adapt new methods of preventing or deterring the product tampering that helps facilitate prescription opioid misuse, abuse and addiction.

Misusers of opioid medications can considerably increase the potency and danger of these powerful substances by tampering with them and consuming them in unintended ways. While some pharmaceutical manufacturers have taken steps to deter or prevent tampering, such efforts still frequently occur. In a report issued in April 2015, the U.S. Food and Drug Administration (FDA) set forth new recommendations designed to encourage further steps to reduce the odds that opioid medications will be manipulated by end users and consumed inappropriately.

Dangers of Opioid Medication Misuse

All opioid medications are natural, semi-synthetic or fully synthetic derivatives of mind-altering chemicals naturally found in the plant papaver somniferum (i.e., the opium poppy). Inside the human body, all of these medications travel through the bloodstream to the brain, where they gain access through portals known as opioid receptors. Inside the brain, opioid medications (and illicit/illegal opioid drugs) reduce activity in the central nervous system, and thereby achieve their usefulness as painkillers and cough suppressants. In a brain area called the pleasure center, prescription opioids also trigger heightened levels of a sensation called euphoria.

Euphoria production is the typical underlying mechanism of non-addicted opioid medication abuse, as well as opioid medication addiction. This is true, in part, because repeated attempts to experience opioid-induced euphoria will eventually alter the pleasure center’s long-term chemical balance and set the stage for a dependence on continuing consumption. Doctors use a diagnosis called opioid use disorder to identify individuals who progress from dependence to full-blown opioid addiction, as well as non-dependent, non-addicted individuals whose opioid use still seriously compromises their ability to function. Prescription opioid misusers who consume too much of a given medication can also excessively reduce their central nervous system activity and enter a potentially fatal episode of opioid overdose. In the U.S., medication-related opioid overdoses happen much more often than heroin-related opioid overdoses.

Opioid Medication Tampering

The most commonly misused opioid medications come in tablet form and are intended for oral use. Compared to injection or nasal inhalation, oral consumption of an opioid medication results in a relatively slow onset of drug effects inside the brain. However, many prescription opioid misusers crush the medications and attempt to inhale them, smoke them or inject into a vein, into muscle tissue or under the skin. This tampering effectively increases the potency of opioid medications; unfortunately, it also increases the odds that an individual will develop opioid use disorder or experience an opioid overdose. Some pharmaceutical companies (including the makers of a commonly abused opioid medication called OxyContin) have sought to limit the risks for tampering by creating versions of their products that are relatively hard to alter.

Increasing Anti-Tampering Efforts

In its newly issued report, the FDA seeks to encourage American pharmaceutical companies to bring more tamper-resistant prescription opioids to market. It begins by outlining the possible methods of deterring tampering efforts. These methods include developing new chemical or physical mechanisms that reduce opioid medications’ susceptibility to crushing, grinding and other forms of manipulation; adding secondary ingredients that reduce the drug effects of prescription opioids if tampering occurs; adding secondary ingredients that produce unpleasant sensations in people who tamper with prescription opioids; developing non-tablet-based opioid medications that can’t be manipulated by the end user; and combining multiple deterrent approaches.

The FDA also recommends that pharmaceutical manufacturers increase their knowledge of the ways in which manipulated opioid medications interact with the body. In turn, such a knowledge increase may improve subsequent efforts to develop products that are resistant to specific avenues of misuse, such as injection or nasal inhalation. For the same reason, the FDA recommends that pharmaceutical companies increase their understanding of the ways in which the body processes altered opioid medications that make it into the bloodstream.

Other steps recommended by the FDA include determining how marketing affects awareness of the tamper-resistant nature of opioid medications, as well as improving understanding of the social, behavioral and medical forces that increase the likelihood that a person who misuses a prescription opioid will resort to tampering. It’s important to note that the FDA’s recommendations are not binding; pharmaceutical manufacturers can adopt or ignore specific recommendations as they see fit.

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