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10 Articles in Volume 17, Issue #10
A Guest Editorial on Counterfeit Pain Medication: The Other Epidemic
A Model to Incorporate Functional Medicine into Chronic Pain Care
Chronic Pain and Substance-Related Disorders
Getting at the Root of Opioid-Induced Constipation (OIC) with an Osteopathic Approach
Inside FDA's Guidance on Generic Abuse-Deterrent Opioids
Neural Pathway Pain — A Call for More Accurate Diagnoses
Pain Care in a Natural Disaster
Pharmacological Interventions in Sport-Related Concussion
The Internet of Medical Things
What Type of Withdrawal Symptoms from Tramadol Might a Patient Experience?

A Guest Editorial on Counterfeit Pain Medication: The Other Epidemic

Prescribers must educate their patients about the risks of ingesting substandard or illegitimate drugs.
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Author's introduction: About two decades ago, I unknowingly witnessed the beginning of what would become two separate yet related deadly epidemics. It was the 1990s, and I was in medical school. A new medication, Oxycontin, had just entered the market with questionable pharmacokinetics and sustained-release technology, and I was afraid it might lead to more substance abuse. The thought prompted me to make a very bold move. I created the first externship by a (future) pain management physician at the World Health Organization’s (WHO) Department of Substance Abuse. At the time, my classmates and professors could not understand why I wanted to work at the WHO, much less in the field of substance abuse. Remember, this was the time when many “expert professors” were stating that opiates were not addictive.  

Our group went on to craft international handbooks, educational materials, and guidelines for healthcare providers throughout the world, and I am certain these initiatives have since saved countless lives from the physical and mental costs of substance abuse. While at the WHO, I was exposed to another clear and present problem: counterfeit medication. With millions of individuals affected by counterfeit medications worldwide, raising awareness of and putting an end to the development and distribution of these dangerous drugs became—and remains—a significant global initiative and, for me, a personal mandate. Today, it is becoming more and more difficult to separate the relationship between the rise of counterfeit drugs and the current opioid epidemic. This viewpoint article provides an overview of this often-overlooked illegitimate industry and its potential impact on healthcare providers working to treat patients with chronic pain.

 
Over the past few years, there have been countless headlines surrounding the growth of counterfeit pain medication,1-6 but not all healthcare providers may realize how this underground drug situation may impact their practices. It’s no secret that counterfeit pharmaceuticals are a multi-billion dollar industry. According to the World Economic Forum, counterfeit medications accounted for $200 billion in sales.7 More than 8% of the medical devices in circulation are counterfeit, and global sales of counterfeit products in the pharmaceutical industry alone accounted for $431 billion, according to the World Health Organization.8,9

Counterfeit Medication Categories

In the current pharmaceutical marketplace, there are five medication categories that distinguish between legal and counterfeit products, described below.

Legitimate brand names and legitimate generics contain exactly what they advertise, down to the fillers (eg, excipients) used in studies submitted to FDA for approval.

Counterfeit brand names are fake or “knock-off” medications produced by counterfeiters (individuals or companies) but packaged to match the legitimate brand name medication and sold as such. These medications penetrate the supply chain, leaving distributors, pharmacies, physicians, and patients with no idea that they are receiving or working with counterfeit drugs.

Legal counterfeit generics are generic medications made by recognized manufacturers and sold through legitimate channels. However, these products may not have the exact active ingredient amount, pharmacokinetics, bioavailability, bioequivalence, or type and amount of fillers as the brand name medication. In some cases, these inexpensive substitutes can lead to adverse reactions in the patient. Many generic medications may fall into this category, but since they met FDA’s standards for generics the time of FDA filing, they are legal.10 Unfortunately, the FDA does not monitor every generic facility around the world and there have been numerous cases of large generic manufacturers manipulating FDA rules and selling counterfeit or substandard medications.11

Illegal counterfeit generics are medications made by black-market counterfeiters that are knockoffs of legitimate generic medications, yet packaged and sold as the branded products. These manufacturers do not attempt to manipulate the FDA rules. They bypass every legal channel.

The risks of counterfeit pain management medications include reduced efficacy, resulting in decreased quality of life and functionality, and adverse effects ranging from seizures and overdose to addiction and even death. In fact, many people do not know that the artist Prince was reported to die from taking tablets incorrectly labeled as hydrocodone which contained U-47700 and counterfeit fentanyl.12,13

Market Infiltration

Many companies make far more money producing counterfeit products than branded companies make selling legitimate products. It is these deep pockets that have managed to convince some physicians and the public that all brand name medications and their generic versions are one and the same. For instance, clinicians and patients have reported seeing “identical” medications obtained from different sources yield widely different efficacy and tolerability profiles. Most of the time, this variability may be assumed based on a patient’s biological differences, but the reality may be that these medications are, in fact, not identical.

According to FDA, counterfeit medications “may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose.”10 The World Health Organization further defines counterfeit medications as “substandard/spurious/falsely labeled/falsified/counterfeit drugs.”14

Last updated on: December 7, 2017
Continue Reading:
Editorial: Moving Forward from Trump's Opioid Declaration
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