Paregoric and the Opioid Crisis: Regulating OTC Sales Before 1970s

Introduction

The opioid crisis that continues to plague many parts of the world is a complex issue with multi-faceted origins. One intriguing question is why the over-the-counter (OTC) sales of Paregoric did not lead to a serious opioid crisis in the pre-1970s United States. This article will explore the historical context, regulation, and the limitations of Paregoric's accessibility during this period, shedding light on why it did not contribute significantly to the contemporary crisis.

Understanding Paregoric

Paregoric is a historically significant opiate-based medication. Typically, it is an opium tincture available in two concentrations: 2 mg/5 ml and 50 mg/5 ml. The active opioid in opium is morphine, and Paregoric’s potency can be compared to opium tincture, which is 25 times the strength of paregoric. Historically, the 2 mg/5 ml version was classified as a class III controlled substance, while the 50 mg/5 ml was reclassified as a class II.

Regulation and Accessibility

During the period from the 1950s to the early 1970s, Paregoric was available as an OTC medication, but it was closely regulated. A key regulation was that no more than two ounces could be dispensed to the same person within a 48-hour period according to federal law. Additionally, many pharmacies required patients to sign a register and present identification if the patient was not known. Pharmacists were given significant discretion in dispensing the drug, allowing them to refuse to sell it if they suspected an addiction was developing.

Limitations in Accessibility

The regulation of Paregoric did not make it easy for individuals to obtain it, especially in large quantities. This limited the potential for addiction and misuse. Moreover, the drug was not available to everyone, as it was fairly difficult to obtain due to these strict regulations. For instance, while Paregoric might have been used for pain relief in some medical conditions, it was predominantly used to treat diarrhea and related conditions. As a result, its distribution was not as widespread as modern pharmaceutical opioids.

Comparison with Modern Opioids

In contrast to modern opioids, Paregoric was more difficult to obtain and abused. It was indeed harder to become addicted due to its lower concentration and stricter regulation. This is evidenced by the fact that Paregoric use was primarily among alcoholics, illustrating that the drug was not an appealing choice for the general population.

Historical Context and Public Perception

The public perception of drug addiction has changed significantly over the decades. Historically, drug addiction was often stigmatized and less commonly discussed in public forums. This shift in public perception, coupled with the discovery of the addictive qualities of drugs such as heroin, methamphetamine, and cannabis, contributed to a change in how opioids were regulated.

Conclusion

While Paregoric was available as an OTC drug for a considerable period, its regulation and limited accessibility significantly mitigated the risk of an opioid crisis during that era. The current opioid crisis, characterized by widespread addiction and deaths, has its roots in a combination of factors including shifts in drug policy, changing public perception, and pharmaceutical company practices. Understanding the historical context of Paregoric’s regulation and accessibility can provide valuable insights into the complexities of the opioid crisis.