Opioids, Recalls and Medical Error at the Forefront of Patient Safety

Today, patient safety is at the forefront of the medical profession. The issues most pressing are the urgency of addressing the proliferation of both prescription and illicit drugs taken both wittingly and unwittingly by consumers that are obtained from online pharmacies or other means; the ability of the U.S. Food and Drug Administration (FDA) to monitor the safety of prescription medicines after they enter the market; and the need to accurately track the number of deaths caused by medical mistakes.

While the opioid crisis has been a growing problem for some time due to addiction and overdose, the issue is now being compounded by synthetic opioids, most notably fentanyl, that are often taken for recreational purposes, but are also sometimes added to counterfeit pills made to look like legitimate prescription narcotic medications. As we explain in our article “The Opioid Crisis: Fentanyl and the Safety of Prescription Drugs” (p.16), while legitimate prescriptions are many times obtained via legal means, there is growth of rogue online pharmacies selling fentanyl-laced fake pills made to look like the real drug, and consumers often can’t tell the difference until it’s too late. Data show that teens increasingly obtain counterfeit prescription opioids via social media sites that target this population. And, due to the high cost of medication in the U.S., a growing number of consumers unknowingly rely on rogue online pharmacies because of their purported convenience, including lower costs and home delivery. Even though the U.S. drug supply is “among the safest in the world,” according to FDA, a safety net is critical to curtail the number of deaths. Enter: naloxone (generic for Narcan), which reverses the effects of opioids. Naloxone is available free of charge through various programs nationwide and is covered by Good Samaritan laws.

Aside from opioids, pharmaceuticals in general can pose health risks for a number of reasons. Thousands of drugs are recalled or withdrawn from the market every year in the U.S. We outline the reasons for this in our article “Pharmaceutical Market Withdrawals and Recalls: Expect the Unexpected” (p.24), which explains FDA’s role, including overview and reporting, and manufacturers’ role, including notification of the public and, most importantly, standard operating procedures they must have in place, especially since unanticipated issues often arise.

Unfortunately, unsafe medicines are not the only cause of patient death. Since 2016, reports of deaths due to medical error and misdiagnosis have made alarming headlines, mounting criticism on the healthcare system. But, as we examine in our article “Tracking Medical Error and Misdiagnosis” (p.28), whether these numbers are correct is a matter of intense dispute. Questions have been raised about significant flaws in the research methodology used to arrive at these numbers. To account for this, the Agency for Healthcare Research and Quality was established to issue annual reports on patient safety, but the agency’s reporting system has yet to publish actual numbers of deaths from medical error. So, without any proof of these numbers’ validity, physicians will continue to fight conjecture without any recourse.

As always, we hope you enjoy the additional articles in this issue of BioSupply Trends Quarterly, and find them both relevant and helpful to your practice.

Helping Healthcare Care,

Patrick M. Schmidt
Publisher