Prescription Drug Shortages: Understanding Trends in Off-label Utilization

Updated on April 3, 2023
Two friendly pharmacists working in a drugstore.

The Covid-19 pandemic changed the rules of how we live and work. Trips to the grocery store became less frequent; our dining tables doubled as desks. Laptops and mobile devices became conduits for our routine in-person appointments with the outside world—like doctor’s visits. 

Participation in telehealth services increased dramatically over the course of the pandemic. The U.S. Government Accountability Office, a nonpartisan agency reporting to Congress, found that telehealth use under Medicare alone increased tenfold between 2019 and 2020, from 5 million services to more than 53 million services. Market growth has surged, consequently: Research indicates the telehealth services industry has expanded faster in the last five years than the U.S. economy as a whole. By 2030, global telemedicine is projected to be worth $455 billion.

This expansion in virtual care, which ranges from live video consultations to prescription treatment and patient monitoring, was accompanied by action from the departments of Health & Human Services (HHS) and Drug Enforcement Administration (DEA) to make it easier for doctors to provide care. Since 2020, practitioners have been able to evaluate, treat, and prescribe controlled substances to patients virtually without prior consultation (and across state lines). As a result, there’s been an increase in demand of certain prescription drugs owing to off-label utilization.

Two drugs in particular, Adderall and Ozempic, are making headlines for their short supply in the market following an uptick in prescriptions. A drug shortage can be down to several reasons—quality control issues, difficulty procuring active ingredients, or simply an executive business decision on behalf of manufacturer or pharmacy. In this instance, prescription abuse and cosmetic use are to blame. 

Let’s take a closer look at how the off-label uses of Adderall (as a stimulant) and Ozempic (for weight loss) have triggered mass shortages—and what it means for physicians, pharmacists and patients.

Due to the current Ozempic shortage, some people may be wondering “Can I buy Ozempic in Mexico?” as a potential solution.

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The use of stimulants like Adderall has been on the rise in recent years for both prescription and recreational purposes, with rate of usage increasing by 33% between 2020 and 2021. This increase is largely due to increased utilization of telehealth services for mental health treatment, including a rise in ADHD diagnoses, and to combat chronic fatigue caused by long-haul COVID. (Interestingly, Adderall has emerged as a treatment for people experiencing brain fog, an oft-cited symptom of “long Covid.”) This increase in demand for the medication has led to a nationwide shortage.

Adderall has a history of abuse—it is often used when not prescribed. The American Professional Society of ADHD and Related Disorders recently released research that found half of respondents reported using a prescription stimulant when not prescribed, with 32% snorting, 2% injecting and 4% vaping stimulants versus taking them orally. Nonmedically, Adderall is known under different names like crank, speed, black beauties and uppers.  

Fortunately, for patients with a true diagnosis of ADHD, as outlined by DSM-V, in times of shortage, there are other non-inferior stimulants and nonstimulants that can be prescribed for symptom management. 

Also in short supply currently is Ozempic, a medication for diabetes patients that’s, easier to use, and proven to have better outcomes. The industry saw a drastic increase in the prescription of Ozempic during the pandemic via telehealth services, but for a uniquely off-label application: weight loss. Fast-forward to present day, where social media is rife with celebrities like Elon Musk and Mindy Kaling touting their weight-loss success with the medication. 

Ozempic, an injectable, was a breakthrough in medical society when it was approved by the FDA in 2017. Indications in clinical trials showed great success in lowering blood sugar levels when combined with, or even substituted for, metformin, an oral treatment recognized as the cornerstone of diabetes treatment. Trials also showed 15%-18% weight loss among participants.

Just four years later, in 2021, the FDA approval Wegovy, the exact same drug as Ozempic (and made by the same manufacturer) but registered expressly as a treatment for obesity. Nevertheless, Ozempic went viral as a quick-fix solution for weight loss, beginning in Australia in early 2022, where it is illegal to advertise prescription drugs, before word reached U.S. shores late last year. Despite side effects (beyond rapid weight loss) that may include kidney failure and thyroid tumors, both drugs are now hard to find in pharmacies stateside.

The role health professionals play in drug shortages

When it comes to preventing a drug shortage, the potential exists for AI-enabled technology to help predict changes in prescription trends. But a complete picture of market supply and demand would only be possible if every healthcare professional along the prescription-fulfillment chain were to share their data in an interconnected way. Until then, it’s up to the prescriber to do their due diligence in prescribing the right medication for their patients.

Pharmacists, for their part, face a major hurdle in helping to mitigate foreseen shortages. In the U.S., pharmacy is the only healthcare field that does not require a diagnosis code be included on prescriptions by law. (The Centers for Medicare & Medicaid Services (CMS), the federal agency that oversees both of those programs, does not require it.) However, pharmacists facing an inventory crisis who do have a prescription with a diagnosis code—let’s say, specifying type II diabetes—may make the executive decision to give their last carton of Ozempic to the patient with diabetes. 

Proper diagnosis and understanding of the side effects of medications are key to patient safety. As always, prescribers and pharmacists should counsel the patient on the medication and its dangers, especially what can happen if the medication is shared with others who don’t need it.

Best practices moving forward

In February, the Department of Drug Enforcement Administration (DEA) proposed permanent flexibility for clinicians in prescribing controlled medications via telehealth services to patients without a referral or initial in-person appointment. As the healthcare industry awaits word on the regulation, patients await fulfillment of their prescriptions: More Ozempic is expected to hit the market soon, but Adderall is likely to be in short supply for longer due to manufacturing limits by the DEA and FDA. 

It’s important to remember that when there is a shortage of medication, those in need of treatment are most at risk of adverse health effects; focus must be placed on allocating limited resources. It can be said that those patients seeking off-label benefits—sometimes called “artificial demand”—are indirectly harming people who might need the medication in question. (One only need look to TikTok and Instagram to see stories of patients with type 2 diabetes struggling to find their prescribed treatment locally.)

Off-label applications for registered medications are discovered all the time. In the workers’ compensation arena, one of the top five most-prescribed medications is gabapentin, approved by the FDA to treat postherpetic neuralgia and seizure disorders; its number-one utilization is off-label (for chronic neuropathic pain). Off-label utilization can be legal and ethical, but documentation of diagnosis and treatment plan, as well as ongoing patient monitoring, must be in place to ensure patient safety and an effective course of therapy. It is the physician’s responsibility to take the time to understand what the patient needs and prescribe the best, most appropriate treatment. 

Rheema Hammoud
Dr. Reema Hammoud
Dr. Reema Hammoud, AVP of Clinical Pharmacy at Sedgwick, a leading global provider of technology-enabled risk, benefits and integrated business solutions, where she has been advising major companies and institutions across the US (including 78 of the Fortune 100) on pharmaceutical strategies.