ACCORDING to the Stanford-Lancet Commission on the North American Opioid Crisis, there has been 600,000 deaths associated with opioid overdose since 1999, and it is projected that 1.2 million more persons in the US and Canada will die in the next decade if this scourge is not intercepted now.

This man-made crisis has been 20 years in the making. It is described by the Center for Disease Control (CDC) as the worst drug overdose epidemic in the history of United States.
The American Medical Association Journal of Ethics 2020 highlighted how the failures of the Food and Drugs Authority (FDA) contributed to the opioid crisis. The responsible authority to properly enforce marketing regulations was further highlighted on a 60-minute televised programme. However, by law, the regulators are not responsible for the continuing medical education of prescribers, their prescribing influence and evaluation of risks.

These responsibilities are usually the prerogative of the manufacturers, who employ and train medical representatives as sales agents, to generate business for their companies. The marketing campaigns by the opioid drug manufacturers were classified as aggressive, irresponsible and unethical. Generally, there is a notable gap in the system between the approval of a drug by the FDA and the marketing of the drug. This opportunity was utilised indiscriminately by the opioid manufacturer resulting in the promotion of its off-licence indication. Additionally, monetary donations and free samples of opioids were baited for sales.

The culture of the opioid prescribing trend was influenced significantly, as other new manufacturers wanted to cash in on the billions, which the first company had breakthrough, leveraging the off-label or unauthorised use of opioids, not only limiting to pain caused by fatal diseases. So, opioids were irrationally prescribed (against treatment protocols) for common pain related conditions such as lower back pain and fibromyalgia, for persons who were far from facing end of life crisis.

The spin off effects witnessed in this epidemic were overdose, addiction and accidental death. Some babies were born having been exposed by their mothers’ use of opioids causing a spike in neonatal opioid withdrawal syndrome. Other associated social phenomena were evident such as foster care requirement for children of addicted parents, heroin and fentanyl addiction, injection related diseases and decline in workforce participation and homelessness.

The American Addiction Centers indicated that, in 2013, almost 59 million prescriptions were written for oxycodone despite the concern for potential abuse flagged since 1960. Today, it is estimated that 25 million persons are in recovery financed under the Affordable Care Act.

The American Bar Association highlighted that fines to the tune of US$635 million were paid in 2007 by the opioid manufacturing company for misleading marketing. Thereafter, numerous subsequent orders from 23 states, totaling a tentative settlement US$12 billion over time were negotiated, with the company filing for bankruptcy simultaneously.

So, moving forward, twelve recommendations were currently made to clinicians for prescribing opioids, according to a CNN report dated November 7, 2022; an update to the 2016 CDC guidelines which was designed to reduce inappropriate and dangerous prescribing. The old guidelines had created a barrier for some genuine cases over the past six years. So from patients’ feedback and participation, review of new pain management strategies and evaluation of the statistics of addictions and deaths from substance overdose, the following revised strategies were implemented with the aim to eliminate the “unintended consequences”:

> Three distinct categories of pain were differentiated — acute (pain lasting less than 1 month), subacute (one to three months of pain) and chronic (pain for more than 3 months).
> Non-opioids pain medications to be considered as the preferred first-line of treatment for all three categories of pain except in indicated cases
> Immediate release versions of these pills were preferred over extended or slow release formula
> The lowest dose should be prescribed to reach the maximum effect for naive patients
> Only prescribe enough to last the short course of treatment
> The gradual withdrawal of opioids is recommended to wean off effects; treatment cessation should not be abrupt
> Evaluation of benefits versus risks and individual patients’ response to opioids must be done within a four-week period
> Patient history on controlled substances must be ascertained from patient records

On November 2, 2022, on Voice of America news, it was announced that, as the legal battle against abuse of opioid continues, two of the biggest chains of pharmacies in the United States, namely CVS and Walgreens, pleaded no admission of wrong doing or liability but indicated the intent to pay almost US$10 billion collectively over a decade and to work along on strategies to eliminate the illegitimate opioid use.

The only way forward is opioid stewardship or the responsible use and safe prescribing initiatives for those persons who really need it.

For further discussion, contact the pharmacist of Medicine Express PHARMACY located at 223 Camp Street, between Lamaha and New Market Streets. If you have any queries, comments or further information on the above topic kindly forward them to medicine.express@gmail.com or send them to 223 Camp Street, N/burg. Tel #225-5142.