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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.

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

Approximately 10% of available drugs worldwide are counterfeit, which may lead to decreased wellness, increased morbidity, and deaths.15 For instance, 60% of “legitimate” or “legal” antimicrobials have been reported to have substandard or fraudulent quality,16-18 in turn, potentially leading to ineffective antibiotic treatment or the need for a second round of antibiotics. Counterfeit pain medications have not been as well studied or documented as antibiotics. This may simply be because very few people have recognized this epidemic. Fast forward a few years (or decades, depending on apathy and arrogance), and I predict that the counterfeit problem will be widely discussed.

As a result of counterfeiting, the following are examples of compounds that patients in the United States and around the world may be involuntarily and unknowingly ingesting:19

  • Heavy metals: mercury, aluminum, lead, cadmium, arsenic, chrome, uranium, strontium, selenium
  • Poison: polychlorinated biphenyl, benzopyrenes, rat poison, boric acid, antifreeze
  • Common household items: road paint, wall paint, brick dust, floor wax, sheet rock, paint thinner
  • Unprescribed active ingredients: aminotadalafil, homosildenafil, xanthoanthrafil, pseudovardenafil, hongdenafil, sibutramine, haloperidol
  • No active ingredients (fillers): dextrose, dextrin, lactose, starch, saline, salt.

This unfortunate reality is not only concerning, but also life-threatening. Years of research, thousands of trials, countless meetings, and FDA approvals are required to produce legal, safe, effective medications, but illegal counterfeit medications fall outside of these standards. When a practitioner writes a script, he or she may not know what the patient will actually receive from the pharmacy. Thus, the practitioner becomes an involuntary vehicle for the counterfeit. Of note, this may be true of any product within healthcare, including supplies, medical devices, medical hardware, and more.

The Practitioner’s Role

Despite increased law enforcement and growing media focus around fake medications, counterfeiting remains a significant problem for the healthcare provider. Pain practitioners can play a significant role in changing the future landscape by demanding more attention be paid to this issue, and encouraging the FDA to: a) force illegal manufacturers to cease production; and b) require that legal manufacturers integrate anti-counterfeiting technologies.

Call on Policy Makers & Providers

Clinicians may begin this process by informing insurance providers of their concerns with potential counterfeit medications. Speak to them about the importance of authenticated prescriptions, legal counterfeits, and illegal counterfeits. Insurance companies have a reputation for employing strategies to save money. Thus, it may be wise to share viewpoints on how they may actually save funds by providing a legitimate treatment from a legitimate clinician prescribing legitimate medications. When patients receive medications that actually work, insurance companies are likely to save money in the long run via improved outcomes and reduced morbidity and mortality.

Make Patients Aware

To be catalysts for change, physicians must also speak to their patients and staff members about this issue and offer ways to help prevent the receipt or use of a counterfeit drug. For example, prescribers may ask their patients to keep them informed if and when a pharmacist switches them to a generic. As noted, most generics are legitimate equivalents to the brand name product, but in some cases, they may be legal counterfeits. Counterfeiters are quite good at creating pills that look like the original,16 so when applicable, physicians may encourage their patients to pay closer attention to a generic product to help ensure its legitimacy.

Clinicians, for instance, may instruct patients to look at a medication’s appearance and track its effect. For example, if a patient has had success with a pharmaceutical treatment and suddenly the pill looks or feels different (eg, in color, shape, or texture), seems to “no longer work,” or causes new and unusual side effects, the patient should report the change. Encouraging patients to be vigilant and communicative when taking any medication is crucial.

Hold Manufacturers Accountable

I have spoken to many pharmaceutical companies about anti-counterfeiting technology and there is strong pushback that financial incentives are needed in order for them to make such investments. Ironically, these same companies are losing billions of dollars a year in potential revenue due to unauthenticated medications filling the pharmacy shelves in their place.

The manufacturing industry has an opportunity to halt the production of counterfeit pain medication and practitioners need to hold these companies accountable. Beyond implementing anti-counterfeiting technologies that go beyond a simple barcode and holding high standards to produce legitimate medications, manufacturers and distributors should also focus more on their increasingly global supply chains, which can be infiltrated at any point.

In 2014, for example, FedEx was federally indicted for shipping counterfeit medications. The company faced up to $1.6 billion in fines,20 but after two years, the case was dismissed due to a lack of evidence that Federal Express was a co-conspirator or had any knowledge or intention to ship counterfeit drugs. In other words, the counterfeiters were so good at infiltrating the supply chain that FedEx and the government had no idea who they were or how to stop them.

Distributors like Federal Express are now part of the opioid conversation, and practitioners need to demand that they too keep an eye on authenticated medication. As drug manufacturers’ most fruitful audience, companies will need to listen to pain care prescribers in order to protect their bottom line. Physician advocacy, combined with regulatory and patient demand, may lead to the implementation of a solution to a problem the pharmaceutical manufacturing industry has known about for years.

Conclusion

As demonstrated by the now-declared public health emergency on opioids, allowing a problem to persist without decisive intervention may continue to produce catastrophic results. Just as a small group of players managed to misuse beneficial pain medications—leaving society with a bad taste in their mouths when it comes to these potent pain medications, an inactive group of players may enable the counterfeit problem to lay questions around the entire medicinal industry. Physicians, patients, and the government alike need to demand authentication and anti-counterfeiting technologies that are un-hackable and un-duplicable—and they need to do so now.

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