Techniques used by health care professionals to minimize the illegal acquisition of opioid analgesics by those with no medical need have included urine drug tests, pill counts, survey instruments, medication use agreements, and the review of electronic prescription monitoring program reports. So now, let’s take a look at prescription drug abuse – clinical strategies to minimize risk.
While these activities have undoubtedly achieved some level of success, they have failed to stem the tide of increased prescription drug abuse. A shift in focus of diversion prevention from health care provider behaviors toward pharmaceutical product characteristics presents an opportunity to address the problem of prescription drug abuse from a more foundational perspective.
No matter how conscientious health care providers may be in their efforts to prevent diversion, some illicit drug acquisition will necessarily occur due to the need to assure that the legitimate patients are not denied necessary medication through overly aggressive diversion prevention.
The data indicating that prescription drug abusers often acquire drugs from a patient who has obtained the drugs legally further challenge the idea that focusing only on restrictive practices by health care professionals can effectively prevent prescription drug abuse.
The recent development of ADOs has the potential to augment the strategies used in combating prescription drug diversion and abuse, by decreasing the abuse potential of the drugs themselves. It’s about Drug Safety and how to prevent ADO abuse. Even though safer products are being made available, practices geared toward decreasing the illegal acquisition of prescription drugs will continue to be necessary.
Despite the apparent public health benefits of ADO products, it is important to consider the extent to which the interests and needs of patients with legitimate and significant pain problems can be compromised, either by the clinical practices of individual health care professionals or by regulatory constraints that are intended to balance the individual patients need for relief with the goal of reducing prescription drug abuse and diversion.
The Promise of Abuse-Deterrent Formulations
Drug regulators have traditionally concluded that opioid analgesics are inherently abusable and that the best means to reduce their abuse is by controlling the distribution of them. See also this post about prescribing abuse-deterrent opioids (ADOs and the Mayday Project but be aware that some past efforts to create less abusable opioid products have been disappointing.
The development of ADOs challenges the regulatory tradition that accepts the inevitability of controlled substance abuse if drugs are diverted. It now seems possible to reduce the abuse potential of a drug product, even though the drug contained within the product is inherently subject to abuse.
While a drug may be attractive to drug abusers, the form in which the drug is distributed may discourage efforts to abuse it. A solid, oral pharmaceutical product for pain management regarding the balance and adoption of ADO formulations is comprised of both the active drug ingredient, sometimes referred to as the molecular entity, as well as numerous diluents, excipients, binders, and other components that are either encapsulated with the drug or are pressed into a tablet with the drug to create a product that can be easily ingested.
The drug is the pharmacologically active ingredient, while the drug product is the incorporation of that drug into a dosage form that can be used as a medication. The formulation of a raw drug into a dosage form suitable for medical use can make the resulting product either more or less attractive to abusers.
A drug product may release the active ingredient immediately after it has been ingested and absorbed into the body. We know that prescription drug monitoring is a powerful tool for pharmacists and these professionals know that many of these immediate release dosage forms are considered short-acting because the body metabolizes them quickly.
Alternatively, a drug product may be designed elegantly to deliver the active ingredient over time, producing a sustained release into the body, and thus be long-acting. The long-acting formulations contain more of the active ingredient because they must release that ingredient from the formulation over time.
Some drug abusers have taken advantage of this higher potency by tampering with the dosage form, destroying the long-acting feature of the product, and either injecting or snorting what results from their product tampering.
Redesigning the formulation with abuse-deterrent properties so that it retains effectiveness for legitimate pain patients, but loses attractiveness for drug-abusers, is the goal of those who are developing ADOs. The drug is the same, but the formulation is different. New formulations may be developed to prevent product tampering so that an oral product cannot be abused through inhalation or intravenous injection.
Formulations may also be designed to deter abuse through oral ingestion of a product that has not been subjected to tampering. Formulations that reduce the inherent abusability of opioid analgesics cannot replace vigilance by health care professionals, but they can enhance diversion prevention practices. We know as well that, at the same time, antioxidants are possibly the solution for improved health and that they may also play a role in pain management.
The availability of abuse-deterrent opioid formulations will be welcomed by clinicians who care for patients in pain and who conscientiously restrict access to opioids for those who have no legitimate need. Yet it is a development that presents a new set of challenges for those who treat chronic pain patients. Healthcare professionals may also want to take a look at this post about unusual nursing jobs.
Not all opioid molecular entities will initially be available in both short-acting and long-acting abuse-deterrent formulations. The variability in patient response to opioids, based on individual physiologic reactions to a drug, makes it impossible to select a product for a patient based solely on abuse-deterrent characteristics. Assessment of a patient’s use of opioid analgesics may lead to the conclusion that a product without abuse-deterrent properties is clinically superior and should be prescribed for a patient.
For example, a clinician may know from experience in treating a particular patient that one molecular entity is more effective than the others for this patient and that the short-acting version of this drug provides the flexibility to adjust dosing to enhance efficacy and reduce side effects in this patient.
If the clinically optimal short-acting drug is not available as an ADO formulation, public health and regulatory concerns may lead the clinician to choose an ADO product with a different drug and/or different release mechanism that is clinically considered to be less safe and less effective for this patient. Patients’ benefits could be sacrificed in favor of public benefit.