9 minute read
ADHD Meds? You May Have to Wait
from February/March 2023
A shortage began with Adderall and spread to Ritalin. A government crackdown made it worse.
BY JAMES MELTON
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As 2023 began, the national Adderall shortage had spread to other drugs used to treat attention-deficit/hyperactivity disorder (ADHD). Experts expect the mess to continue for much of the year.
The shortages started with Adderall—known generically as amphetamine mixed salts—which became harder to get because of a surge in demand during the pandemic, coupled with manufacturing bottlenecks.
The U.S. Food and Drug Administration (FDA) acknowledged the drug shortage last October, saying Teva Pharmaceutical Industries Ltd. (TEVA), the largest Adderall manufacturer, was “experiencing ongoing intermittent manufacturing delays.” Other manufacturers were unable to fill the void, the FDA said.
Teva, one of nine companies supplying generic Adderall in the U.S., controls about 30% of the market here, making it—by a long shot—the largest manufacturer.
In October, generic Adderall makers Camber Pharmaceuticals (a division of Hetero Drugs) and Sun Pharmaceutical Industries (SUNPHARMA) also reported supply chain problems related to Adderall.
At the same time, Fierce Pharma, a news website covering the pharmaceutical business, reported the Adderall suppliers serving the U.S. had supply chain problems affecting their ability to produce the drug.
Teva does not break out sales for individual generic drugs and did not respond to requests for more information about the status of its Adderall production.
MAKE MORE ADDERALL?
The seemingly obvious solution to the shortage of ADHD drugs would be to boost the supply. But the pharmaceutical market works differently from markets for consumer products like cars, washing machines or ginger ale. Big Pharma cannot just make more ADHD drugs—at least not without clearance from the Drug Enforcement Administration (DEA).
The active ingredient in Adderall—an amphetamine—is a Schedule II controlled substance. That’s a classification of prescription drugs with medically acceptable uses that also have a high potential for abuse and/or addiction.
By law, the DEA regulates the production of all legal controlled substances in the U.S., says Erin Fox, senior pharmacy director at University of Utah Health.
“The DEA allows drug companies a certain amount of raw material each year ... And so, they say, OK, you could have ‘X’ amount, and that’s what the drug companies have to work with,” Fox says.
As supplies of Adderall run low, she notes, doctors and patients have turned to alternatives like the brand-name and generic versions of the popular ADHD drugs Ritalin and Concerta.
But Ritalin and Concerta rely on a stimulant called methylphenidate. Like amphetamines, methylphenidate is a Schedule II substance regulated by the DEA. As with Adderall, drug makers can’t quickly boost the supply of methylphenidate-based drugs. The result has been a shortage of all three medications.
DEA AND FDA CRACK DOWN
The DEA could loosen the screws and allow manufacturers to boost the production of ADHD drugs, right? Yes, it could. But first, the agency wants to reduce illicit use, which regulators believe accounts for much of the increased demand.
In April 2022, the FDA and DEA issued joint warning letters to operators of two websites the agencies said were illegally selling Schedule II stimulants. The agencies said Kubapharm.com and premiumlightssupplier.com sold Adderall without prescriptions. Also, the feds said, some of the products might have been “counterfeit, contaminated, expired or otherwise harmful.”
The crackdown continues. The Wall Street Journal reported on Dec. 31, 2022, that the DEA sent a letter to the makers of ADHD drugs saying it feared that “aggressive marketing practices” had driven prescriptions to excessive levels. The DEA’s concerns included how telehealth medical providers promote ADHD drugs, the Journal reported, based on its analysis of the DEA letter.
In December, the DEA said it was considering whether to revoke mail-order pharmacy Truepill’s ability to handle controlled substances because of allegedly unlawful prescriptions.
Other sources buttress the DEA’s concerns. A June 2022 report from healthcare data analytics firm Trilliant Health concluded that “there are more adults receiving prescription Adderall than there are with a formal ADHD diagnosis. This discrepancy likely speaks to the number of individuals using a direct-to-consumer, self-pay service in this clinical scenario.”
A study by the University of North Carolina at Chapel Hill found 62 online pharmacies sold Adderall online in late 2019 and early 2020. Researchers classified 61 of those sites as “rogue or unclassified” sellers.
DRUG SHORTAGES RISING
It’s not just ADHD drugs that are in short supply. As of year-end 2022, the U.S. had 295 active drug shortages—the most since 2014, according to the University of Utah Drug Information Service and the American Society of Health-System Pharmacists.
Fox says transparency will be a large part of avoiding, mitigating and responding to drug shortages in the future. In many cases, Fox says, it’s unclear why any drug is in short supply because drug companies do not have to report why shortfalls happen. That lack of information, she says, makes it hard for the public to estimate how long a shortage might last.
As part of a committee of the National Academies of Sciences, Engineering and Medicine, Fox was among the authors of a 2022 report that made seven detailed recommendations for making the drug supply chain more resilient.
Among the suggestions: “Make sourcing, quality, volume and capacity information publicly available for all medical products approved or cleared for sale in the United States.”
Doing that alone, the committee said, would give government agencies a firmer grasp of medical product supply chain vulnerabilities. Among other things, that could create better risk assessments and make it easier to predict future drug shortages.
The need for more transparency is a problem. But the performance of pharma
stocks, as measured by the S&P 500 Pharmaceuticals Industry Index, handily beat the S&P 500 over the past year. For the 12 months that ended Jan. 19, the pharma index grew 7.48%. For the same period, SPX dropped 14.14%.
GROWTH OF PHARMA SALES
In 2021, U.S. prescription drug spending reached $576.87 billion, according to the American Society of Health-System Pharmacists. To put it another way, American spending on prescription drugs is nearly as big as the entire Belgian economy.
Unsurprisingly, traditional, walk-in retail pharmacies represented the largest share (42.2%) of those 2021 sales. But the fastest-growing sectors were online, mail-order pharmacies—some of which are operated by health-insurance companies or brick-and-mortar retailers. Online channels experienced sales growth of 10.4% in 2021. Sales growth of home health care providers was in second place, up 10.1% year over year. If trends continue, the future of online pharmacy services looks bright. In a June 2022 survey of 1,482 U.S. adults by the research company Software Advice, 58% of respondents cited “I don’t have to leave my home” as an important benefit of using a web pharmacy, and 51% said the online prices were lower than at traditional pharmacies. Also, half said online pharmacies could fill prescriptions faster than other retailers.
Software Advice, part of the consulting firm Gartner (IT), provides advisory services, research and user reviews on software applications for businesses.
Across all distribution channels, experts expect prescription drug sales to continue at a respectable, but not stunning, rate. Fortune Business Insights, a market data and analysis firm, projects U.S. prescription drug sales to see a compound annual growth rate of 6.3% through 2028, reaching $861.67 billion.
According to the Drug Channels Institute, the top seven players accounted for more than 70% of U.S. prescription dispensing revenues in 2021. The top dispensing pharmacies in the U.S., in order, are:
CVS Health (CVS)
Walgreens Boots Alliance (WBA)
Cigna (parent of Express Scripts, an online pharmacy and a pharmacy benefit manager) (CI)
UnitedHealth Group (parent of OptumRX, a pharmacy services manager and mail-order pharmacy) (UNH)
Walmart (WMT)
Kroger (KR)
Rite Aid (RAD)
Sketchy Adderall Web Sales
From December 2019 to February 2020, researchers at the Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, searched the web by typing the phrase “buy Adderall online” into the Google, Bing, Yahoo and DuckDuckGo search engines.
The findings were eye-opening:
• Of the 62 online pharmacies they found selling Adderall, the researchers believed 61 were “rogue or unclassified” sellers.
• None of the rogue or unclassified online pharmacies required prescriptions, offered pharmacist services or placed limits on Adderall purchases.
• Among the rogue and unclassified online pharmacies, most offered price discounts (61%), bulk discounts (67%) and coupon codes (70%).
• Contrary to the claims made on those sites, lower prices were available for all formulations and dosages of Adderall from GoodRx—an online platform that offers free coupons for discounts on medications.
• 74% of the rogue and unclassified online pharmacies accepted cryptocurrencies for purchases.
–Source: Journal of the American Pharmacists Association
Drug Scheduling
Schedule I: Schedule I drugs, substances or chemicals have no accepted medical use and high potential for abuse. Examples include heroin, lysergic acid diethylamide (LSD), marijuana (cannabis) and peyote.
Schedule II: Schedule II drugs, substances or chemicals have high potential for abuse and could lead to severe psychological or physical dependence. Examples include combination products with less than 15 milligrams of hydrocodone per dose (Vicodin), cocaine, fentanyl, Dexedrine, Adderall and Ritalin.
Schedule III: Schedule III drugs, substances or chemicals have low potential for physical or psychological dependence. They have less potential for abuse than Schedule I and Schedule II drugs but more than Schedule IV. Examples are Tylenol and codeine products containing less than 90 milligrams of codeine and ketamine, anabolic steroids and testosterone.
Schedule IV: Schedule IV drugs, substances or chemicals have low potential for abuse and low risk of dependence. Examples are Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien and Tramadol.
Schedule V: Schedule V drugs, substances or chemicals have lower potential for abuse than Schedule IV and contain limited quantities of certain narcotics. They’re used for antidiarrheal, antitussive and analgesic purposes, and examples include cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica and Parepectolin.
–Source: Drug Enforcement Administration
ADHD
Attention-deficit/hyperactivity disorder—better known as ADHD—is among the most common neurodevelopmental disorders in children, the Centers for Disease Control (CDC) says. Kids with ADHD may have trouble paying attention, controlling impulsive behavior or refraining from overactivity. The CDC estimates 9.8% of children aged 3–17 have been diagnosed with ADHD at some point, according to a 2016-2019 annual national survey of parents. ADHD-related hyperactivity can decrease in adulthood, but patients may continue to struggle with impulsiveness, restlessness and difficulty paying attention. ADHD costs the United States $156 billion annually, the National Library of Medicine website says. That includes the price of healthcare and the cost of absences from work for ADHD patients and their families.
