Every prescription pharmaceutical product poses inherent risks, yet a high-risk pharmaceutical product may nevertheless be considered relatively safe due to the benefit the product can bring through its therapeutic application in a clinical setting. So in this post, we take a closer look at Prescribing of Abuse-Deterrent Opioids (ADOs) – Oversight of Drug Safety. See also this Mayo Clinic Video:
The analysis of product safety requires a balancing of risks versus benefits. The risk that opioid analgesics will be abused is a safety factor that must be balanced against the benefits this class of drugs affords patients with pain.
Product sponsors, who have obtained FDA approval of their product and who manufacture or distribute the product for use in therapy, are required to limit their promotion of opioid analgesics to the information contained within approved product labeling. A safe opioid analgesic may become unsafe through over promotion, and if this occurs the sponsor may be exposed to liability for over promotion.
The challenge of preventing product overpromotion, and limiting inappropriate product use by patients, can be daunting for the sponsor of an opioid analgesic. Unlike most drugs, opioid analgesics produce a rapid and easily recognized response for patients, so they are aggressively sought for legitimate use, in ways that may easily be confused with addiction. Much has to do with pain management and the balance and adoption of ADOs. Patient advocacy groups have promoted increased access to these medications.
Pharmaceutical companies’ promotion of opioids for the relief of chronic pain, consistent with the goals of zealous patient advocates, may at times have contributed to overuse of the products. Misuse of opioids by patients, and by non-patients to whom opioids are inappropriately distributed, can produce an understandable regulatory reaction that creates an unintended chilling effect on the continued provision of opioids to patients who need them.
Regulatory agencies with the responsibility for assuring the safety of opioid medications have struggled to find the right balance between policies that allow access for those who need pain medications and at the same time deny access for those who have no legitimate need as was indicated in the Mayday Project that showed us that a different insight was required.
A systematic approach to drug safety is currently being developed under a program known as Risk Evaluation and Mitigation Strategies (REMS), pursuant to authority granted to the FDA by the Food and Drug Administration Amendments Act of 2007.
Currently, under consideration are REMS for opioid analgesic products. One component of the overall REMS program is that drug risks may be mitigated using what is referred to as Elements to Assure Safe Use, (ETASUs). Well, many hospitals have taken tentative steps, not only regarding, for example, EMRs but also to comply with ADOs and pain management regulations.
The purpose of an ETASU is to allow for continued distribution of a product that is associated with serious risk and would otherwise be removed from the market were it not for the REMS program. Although most ETASUs currently under consideration focus on the prescribing and dispensing process, and on enhanced education of those who can mitigate product risks, abuse-deterrent technology could be adopted as an ETASU.
The REMS program is intended to mitigate risks that arise during the appropriate medical use of a product. Well, prescription drug monitoring is a great tool for pharmacists but can be useful for other healthcare workers as well. The responsibility for reducing the risks of drug diversion and abuse remain with the DEA.
Drug Enforcement Administration Regulatory Framework
Regulation by the DEA focuses generally on product, personnel, and process. Pharmaceutical products that have a potential for abuse and a currently accepted medical use in treatment are placed into one of four schedules, with Schedule II being the most highly regulated and Schedule V being the least highly regulated. So just like cell infusion may be a miracle for diabetics, ADOs may be a perfect solution for pain management as long as we make sure only the appropriate individuals have access to the drugs.
The lower the schedule number the higher the abuse potential associated with the product. These scheduled pharmaceutical products, often referred to as controlled substances, may be distributed only under the supervision of a person or business that is registered with the DEA. Security requirements assure that the personnel who oversee controlled substance distribution are qualified to do so. See also: “Health Threats: Who’s in Charge?”
The distribution process requires strict record keeping to create a clear audit trail, and it ends with the requirement that prescribers and pharmacists assure controlled substances are made available only for a legitimate medical purpose and in the usual course of professional practice. Controlled substances that are available for use outside this closed distribution system are said to have been diverted.