Drug Shortages Mostly Involve Low-Cost Generics

By Pat Anson, PNN Editor

Drug shortages in the United States are primarily being driven by low profit margins – not supply chain problems – according to a new analysis that found 84% of medicines currently in shortage are low-cost generics. Prices for some generic medicines are so low that manufacturers have stopped making the drugs.

The study by the IQVIA Institute, a healthcare data tracking firm, identified 132 medications in shortage as of June 2023, with pain/anesthesia drugs as the therapy area with the greatest number (21) of shortages. The shortages are so acute that elective procedures requiring anesthesia are being cancelled or postponed.

“Anesthesia medicines, including general, local, and muscle relaxants, are foundational to inpatient and outpatient surgical procedures, and shortages in these medicines can result in delays for patients receiving procedures and hospitals making prioritization decisions based on available supply,” the IQVIA said.

“Shortages across these medicines complicate scheduling of a wide range of procedures and surgeries, which may be part of a broad-based reduction observed in elective procedures in post-pandemic periods.”

One weakness of the IQVIA report is that it relies solely on drug shortage data from the Food and Drug Administration.  The American Society of Health-System Pharmacists (ASHP) currently lists 242 medicines in short supply, nearly twice the number listed by the FDA.

Three generic opioid medications commonly taken for pain, immediate-release oxycodone, oxycodone-acetaminophen, and hydrocodone-acetaminophen tablets have been on the ASHP shortage list for months, but have yet to appear on the FDA’s shortage list.  

Pain patients are feeling the impact of short supplies. In recent months, many have complained about problems or delays getting their opioid prescriptions filled at U.S. pharmacies.

“It has been a month since I had my last refill and no pharmacy can give me an answer as to when they may be back in stock. In the meantime, I just live in misery,” one patient told us.

“Mobile, Alabama seems to be almost completely out of pain medication, specifically the most widely used mg of oxycodone-acetaminophen and hydrocodone. I was supposed to get my refill from Walgreens… and they are not only out but cannot order more,” another patient said. “This is such a serious issue with a lot of people probably going through withdrawals in our county and nobody seems to care.”

‘Prices May Be Too Low’

Teva Pharmaceuticals, a large generic drug maker, has informed the FDA that it is discontinuing production of immediate-release oxycodone tablets. The move appears to be in line with Teva's announcement that it would reduce its production of generics from 80% of its drug portfolio to 60% over the next few years.  

“The drugs we’re pulling out of are drugs which are low-margin,” Teva CEO Richard Francis recently told Bloomberg.

The IQVIA found that over half (56%) the medicines in short supply are low-cost generics priced at less than $1 per unit. In many cases, that’s below the manufacturer’s cost of production and distribution. Because the generic drug industry is highly concentrated with few suppliers, any disruption or discontinuation of a generic can have an outsized impact.

“Generic medicines are much lower cost than brands and some observers have begun to suggest that some generic prices may be too low to support sustainable markets,” IQVIA found. “Prices driven below the cost of manufacturing and distributing can result in some competitors discontinuing production of molecules (medicines), reducing necessary maintenance activities and generally contributing to less resilience in manufacturing supply of those medicines.”

Other highlights of the IQVIA report:

• 120 of the 132 drug shortages listed by FDA involve generics. Only 12 drugs are brand name

• 75% of current drug shortages have been active for over a year and 58% have lasted at least two years

• Three times as many new drug shortages have been reported than have been resolved in recent years

• 67% of shortages involve injectable drugs

• Shortages of antibacterial medication “are a significant concern affecting multiple aspects of healthcare delivery”

• Shortages of cancer treatment drugs have forced some oncology providers to suspend or delay treatments

Federal agencies appear to have inadvertently contributed to some of the shortages. The IQVIA said FDA inspections of drug manufacturing plants have triggered shutdowns of some sites due to safety or sanitation issues. Those shortages “are difficult for their peers to resolve,” according to IQVIA, because few other companies can pick up the slack.

A generic manufacturer of oxycodone, hydrocodone and ADHD medication recently sued the DEA after the agency suspended its drug production license over record-keeping issues. The lawsuit by Ascent Pharmaceuticals accused the DEA of incompetence and heavy-handed regulation of the nation’s drug supply.

In the past year, under the DEA’s ironically named “Operation Bottleneck” initiative, the agency has taken administrative actions against 143 DEA-registered doctors, pharmacies, drug makers and drug distributors, largely over allegations of poor record-keeping and inadequate controls to prevent the diversion and theft of opioids and other controlled substances.

“These companies have a legal obligation to account for every dose and every pill to protect the safety and health of the American people,” said DEA Administrator Anne Milgram. “DEA will continue using every available tool to prevent the diversion and misuse of opioids and other highly addictive controlled substances.”

DEA recently announced plans to further reduce the supply of opioid pain medication in 2024 -- which would be the eighth consecutive year the agency has reduced opioid production quotas for drug manufacturers. DEA said it was acting on the advice of the FDA, which estimates that medical need for Schedule II opioids will decline on average 7.9 percent from 2023 levels.

U.S. Prescription Opioid Use Fell 7.4% in 2022

By Pat Anson, PNN Editor

The amount of prescription opioids sold in the United States fell another 7.4% last year, according to a new report by the IQVIA Institute, a healthcare data tracking firm.

Since their peak in 2011, per capita use of prescription opioids by Americans has declined 64 percent, falling to levels last seen in the year 2000. Despite that historic decline, fatal overdoses in the U.S. have climbed to record levels, fueled primarily by illicit fentanyl and other street drugs.

“The greatest reductions in prescription opioid volume — measured in morphine milligram equivalents (MME) — have been in higher-risk segments receiving greater than 90 MMEs per day,” the IQVIA report found. “Despite significant progress in reducing opioid prescriptions to combat the opioid overdose epidemic, overdose deaths have been rising, primarily due to illicit synthetic opioids.”

The CDC estimates there were 108,712 overdose deaths in the 12-month period ending in November, 2022. About 72,000 of those deaths involved heroin or synthetic opioids such as fentanyl.

By comparison, drug deaths involving legal prescription opioids have remained relatively flat, averaging about 16,000 a year since 2017. They ticked upwards in 2020 and 2021, but appear have trended downward again in 2022, according to the IQVIA.

Prescription Opioid Use and Opioid Overdose Deaths

It appears likely that prescription opioid use will fall again in 2023, due in part to further cuts in opioid production quotas imposed on drug makers by the Drug Enforcement Administration. The DEA says the opioid supply will still be “sufficient to meet all legitimate needs,” but as PNN has reported, some manufacturers are currently reporting shortages of oxycodone and hydrocodone.      

Pain patients have complained for years about chain pharmacies being unable or unwilling to fill their opioid prescriptions, but the problem seems to have grown worse in recent months, particularly at CVS.

“Every month I have to spend hours on the phone trying to find a location that has them in stock,” a CVS customer in Indiana told us. “We should not have to be subjected to this every month!” 

“Some pharmacists are anti opiate. No matter what. She was rude and she is the manager. While it’s hard every month to fill, this time her rude attitude was over the top,” said another CVS customer in Colorado.

Medication Costs Declining 

There is some good news in the IQVIA report: medications are getting cheaper. The average amount paid out-of-pocket for a retail prescription fell from $10.15 in 2017 to $9.38 in 2022. Uninsured patients who pay the full amount in cash have also seen their drug costs decline slightly.

The use of manufacturer copay assistance programs and coupons is growing, collectively saving patients about $19 billion in 2022.

Over the next five years, growth in the use of biosimilar drugs to treat autoimmune conditions, diabetes and cancer is expected to save consumers over $180 billion. Like generic drugs, biosimilars are medications that can replace more expensive biologics such as Humira, which are losing patient protection.

Altogether, spending on medicines for the next five years is expected to be flat, according to the IQVIA, with rising costs in some drug classes offset by declines in others.

Prescription Opioid Use Fell Nearly 7% in 2021

By Pat Anson, PNN Editor

Prescription opioid use in the United States fell by 6.9% in 2021, the tenth consecutive year the volume of opioid pain medication has declined, according to a new report by the IQVIA Institute, a healthcare data tracking firm.

The decline in opioid consumption came even as prescription drug use overall reached record levels in 2021, fueled in part by new COVID-19 vaccines and therapeutics. Spending on medicines rose 12% to $407 billion last year, according to IQVIA, with 194 billion doses of medication dispensed.

While longer opioid prescriptions were written in the early stages of the pandemic to accommodate patients who didn’t see their doctors as often, prescribing quickly returned to its decade-long downward trend.

“Prescription opioid use has fallen by 48% over the past five years and is now at levels last seen in 2000, reflecting efforts by many stakeholders to limit and manage appropriate prescription opioid use,” IQVIA said in its annual report on medicines in the U.S.      

IQVIA tracks opioid prescriptions in morphine milligram equivalents (MMEs). The company estimates that per capita opioid use fell to 309 MME last year (about 0.84 MME per day), down from a peak of nearly 800 MME in 2011.

Some providers have reduced their opioid prescribing more than others. Since 2016, surgeons, anesthesiologists, dentists and general practitioners have cut their opioid prescribing by over 50 percent, while nurse practitioners and physician assistants have reduced their prescribing by 27 percent.

Prescription Opioid Use and by Prescriber Specialty

Opioid consumption by Americans has fallen so sharply in recent years that Canada, Australia and several European countries have overtaken the U.S. and become the highest consumers of opioid medication. A recent study ranks the U.S. as 8th globally in per capita opioid sales.

The decline in U.S. opioid prescribing has failed to stop the surge in overdoses. The CDC estimates that 106,854 people died from drug overdoses in the 12-month period ending November 2021, with drug deaths more than doubling in the last six years. Synthetic opioids – primarily illicit fentanyl – were involved in about two-thirds of fatal overdoses in the past year.

Patients Blamed for Diversion 

Despite the historic decline in prescription opioid use, some politicians continue to blame opioid medication, prescribers and even patients for the nation’s overdose epidemic.

In comments recently submitted to the CDC on its revised opioid guideline, West Virginia Attorney General Patrick Morrisey and 10 other state attorneys general said the agency needs to do more to prevent the diversion of prescription opioids.

“Diversion must remain a key consideration of any prescribing guideline,” said Morrisey.

“Although drug dealers and unethical physicians are responsible for much of the opioid diversion nationwide, legitimate prescriptions remain a prime source of diversion, too. Diverted opioids most commonly reach drug abusers through friends and family members who filled a legitimate prescription.

“The amount of opioids prescribed in recent years has been excessive and far beyond the amount necessary to support legitimate medical need.”

— Patrick Morrisey, West Virginia Attorney General

“Indeed, the amount of opioids prescribed in recent years has been excessive and far beyond the amount necessary to support legitimate medical need. And over-prescription allows legitimate prescriptions to fall into the hands of patients’ family and friends.”

How common is it for prescription opioids to be diverted? Not common at all, according to the DEA’s National Drug Threat Assessment, an annual report that estimates less than 1% of legally prescribed opioids are diverted.  “The number of opioid dosage units available on the retail market and opioid thefts and losses reached their lowest levels in nine years,” the DEA’s 2020 report found.

Despite this, Morrisey puts the onus on pain patients to prove that they’re not abusing or selling their prescriptions. He and the other attorneys general called for routine drug testing of pain patients – rejecting evidence that fraud is common is the drug testing industry and that widely used point-of-care urine tests often give false results that lead to patient abandonment.

“The given reasons that toxicology screenings might lead to ‘stigmatization,’ encourage ‘inappropriate termination from care,’ or be ‘misinterpreted’ are unsatisfactory,” Morrisey wrote. “First, what stigma would the patient face? Diagnostic results are private information. The only people who would know that the test is performed are the patient and the prescriber. The prescriber is already familiar with the patient’s prescriptions, so this process would not reveal any new information -- unless, of course, the patient had lied or not followed the prescriber’s directions.”

Remarkably, the 7-page letter from Morrisey never acknowledges that most drug deaths involve street drugs, not prescription opioids, and makes no mention of fentanyl. The most recent overdose data from West Virginia – Morrisey’s home state – indicates nearly 3 out of 4 drug deaths involve fentanyl.    

Morrisey’s letter was co-signed by the attorneys general of Arkansas, Indiana, Kansas, Mississippi,
Nebraska, South Carolina, South Dakota, Utah, Kentucky and Virginia.

Prescription Opioid Use at 20-Year Lows

By Pat Anson, PNN Editor

Prescription opioid use in the United States is expected to decline for the ninth consecutive year in 2020, with per capita consumption of opioid medication falling to its lowest level in two decades, according to a new report by the IQVIA Institute, a data analytics firm.

Although fewer opioids are being prescribed, U.S. drug overdose deaths have reached record levels, driven largely by illicit fentanyl and other streets drugs, not pain medication.

In the past year alone, IQVIA estimates there was a 17 percent decline in the amount of prescription opioids dispensed in morphine milligram equivalent (MME) units. The decrease is being driven by changes in prescribing policy, government regulation and insurance reimbursement policies, as well as disruptions in healthcare caused by the COVID-19 pandemic.

In the early stages of the pandemic, IQVIA researchers say there was a 44% decline in the number of new patients prescribed opioids, likely the result of providers and patients canceling non-emergency visits, dental appointments and elective surgeries. As the economy reopened in early summer and healthcare visits resumed, opioid prescribing for pain returned to baseline levels, as did prescriptions for addiction treatment drugs.

“The opioid epidemic has captivated the country for a decade, although it lost attention this year in the face of the COVID-19 pandemic. Patients with chronic pain and addiction have also been affected by disruptions to life and healthcare during COVID, when hospitals, doctors’ offices, and drug treatment facilities were closed,” Murray Aitken, Executive Director IQVIA Institute for Human Data Science, said in a statement.

“While the human toll of the opioid epidemic is being addressed differently across the country, efforts in managing prescription opioids and in supporting medication-assisted treatment are showing measurable progress in many states.”

Prescription opioid use peaked in 2011 and has been in steep decline ever since. By the end of 2020, IQVIA projects per capita annual opioid consumption to fall to 298 MME, nearing a level last seen in 2000.

SOURCE: iqvia iNSTITUTE

“Based on usage in the mid-1990s, it may be difficult to reduce current prescription opioid levels further, as pain medications are necessary for some patients, including cancer patients, until other non-addictive or disease-modifying treatments are available,” the IQVIA report found.

Over the past decade, the greatest decline in prescription opioid use has been in the highest risk categories. Prescriptions written for 90 MME or more per day – a level considered risky by the CDC – have fallen by 70 percent since 2011.

Co-prescribing of opioids with benzodiazepines – an anti-anxiety medication – is also falling rapidly. The number of patients taking both drugs has declined from 86 million in 2016 to less than 60 million in 2020. Opioids and benzodiazepines both slow respiration, and patients who take them in combination are believed to be at higher risk of an overdose.

Overdoses Still Rising

Despite the historic decline in prescription opioid use, U.S. overdose deaths hit a record high last spring, according to a new report from the CDC.  For the 12 months ending in May 2020, over 81,000 people died of a drug overdose.

"This represents a worsening of the drug overdose epidemic in the United States and is the largest number of drug overdoses for a 12-month period ever recorded," the CDC said in a health advisory, adding that the deaths were largely driven by illicit fentanyl, heroin, cocaine and psychostimulants such as methamphetamine. Opioid pain medication is not even mentioned in the CDC report.

“The disruption to daily life due to the Covid-19 pandemic has hit those with substance use disorder hard,” CDC director Robert Redfield said in a statement. “As we continue the fight to end this pandemic, it’s important to not lose sight of different groups being affected in other ways. We need to take care of people suffering from unintended consequences.”

Some federal agencies haven’t gotten the message and continue to blame opioid medication and prescribers for the nation’s overdose epidemic.

A new report released this week by the Office of Inspector General (OIG) for Health and Human Services warns that thousands of Medicaid patients in six Appalachian states are being prescribed “harmful amounts” of opioids. The report also identifies 19 physicians with “questionable prescribing practices” and said they will be referred to law enforcement.  

“OIG, along with its law enforcement partners, will review the prescribers with questionable prescribing patterns for possible investigation. OIG will also refer the beneficiaries at serious risk for opioid misuse or overdose to their respective State Medicaid agencies for review and possible followup to ensure that they are receiving appropriate care,” the report states.

“Further, we encourage States to provide greater access to data from prescription drug monitoring programs, including sharing these data with State Medicaid agencies. We also encourage States to analyze data to help identify patients who may be at risk and to promote appropriate opioid prescribing practices.”

Record Decline in Opioid Prescriptions

By Pat Anson, PNN Editor

Often lost in the debate over opioid medication is that prescriptions for the drugs have been falling for years — a trend that appears to be accelerating. The volume of prescription opioids dispensed in the U.S. last year fell 17 percent, the largest annual decline ever recorded, according to a new study by the health analytics firm IQVIA. Opioid prescriptions have dropped 43% since their peak in 2011.

“Decreases in prescription opioid volume have been driven by changes in clinical use, regulatory and reimbursement policies and legislation, all of which have increasingly restricted prescription opioid use since 2012,” the report found.

The biggest drop was in high dose opioid prescriptions of 90 MME (morphine milligram equivalent) or more, which account for 43% of the decline. Low dose prescriptions of 20 MME or less have remained relatively stable, falling just 4 percent.

While opioid prescriptions have fallen significantly, addiction and overdose rates continue to soar, fueled in large part by illicit fentanyl, heroin and other black market opioids.

“We saw many more people receiving medication-assisted treatment (MAT) for opioid addiction. Our research shows new therapy starts for MATs increased to 1.2 million people in 2018, nearly a 300 percent increase compared with those seeking addiction help in 2014,” said Murray Aitken, IQVIA senior vice president.

“This is an important indicator of the effects of increased funding and support for treatment programs to address addiction.”

A recent report by the Bipartisan Policy Center estimates the federal government spent nearly $11 billion since 2017 subsidizing the addiction treatment industry, much of it spent on MAT drugs such as buprenorphine (Suboxone).

Drug maker Indivior recently reported the buprenorphine market had double digit growth in the first quarter of 2019, and that “growth continues to be driven primarily by Government channels.”

Hydrocodone Prescriptions Drop

For the 7th consecutive year, prescriptions fell for hydrocodone-acetaminophen combinations such as Vicodin, Lortab and Norco. Once the #1 most widely dispensed drug in the nation, hydrocodone now ranks fifth, behind drugs used to treat thyroid deficiency, high blood pressure and high cholesterol.

Only 68 million prescriptions for hydrocodone were dispensed last year, half the number that were filled in 2011.

U.S. HYDROCODONE PRESCRIPTIONS (MILLIONS)

Source: IQVIA

Due to fears about addiction and overdose, hydrocodone was reclassified by the DEA as a Schedule II controlled substance in 2014, requiring new prescriptions for every refill.

“My hydrocodone has been cut in half and my pain is out of control. I feel like a criminal, like I am committing a crime each time I pick up my prescription. I now have to visit my doctor once a month to receive my script,” one patient told us.

“I was prescribed hydrocodone over the last couple of decades for severe chronic pain with very positive effects. Now I am unable to carry out a lifestyle for a man my age, I'm basically done/finished.  My way of life is over,” a disabled veteran wrote.

“Stop denying the patients that have real pain. I don’t use it to get high. Hydrocodone is the only thing that has helped my back pain. I’ve tried a lot of things but nothing helps. It frees me of enough of the pain that I can function like a normal person,” another patient said.

The shift away from hydrocodone and other opioids has benefited pharmaceutical companies that make non-opioid medications such as Neurontin (gabapentin) and Lyrica (pregabalin).  Prescriptions for gabapentin reached 67 million last year – nearly the same as hydrocodone.

These trends have yet to show much benefit for pain patients, who increasingly report their pain is poorly treated. In a recent PNN survey of nearly 6,000 patients, over 85% said their pain and quality of life are worse since the release of the CDC opioid prescribing guideline. One in five say they are hoarding opioid medication because they fear losing access to it in the future.

Mayo Clinic: Opioid Prescribing Has Not Changed

By Pat Anson, Editor

Numerous studies have shown that opioid prescriptions are falling. The trend started in 2011 and appears to have accelerated since the release of the CDC’s 2016 opioid prescribing guidelines.

The volume of opioid medication filled last year fell by 12 percent, the largest decline in 25 years, according to the IQVIA Institute.  Prescriptions for hydrocodone – once the most widely prescribed drug in the country – have fallen by a third since their peak. Even the CDC has reported that opioid prescriptions have dropped by about 5% each year between 2012 and 2016.

Anecdotally, many patients tell us opioids are harder, if not impossible, to obtain. Nearly half of the 3,100 patients PNN surveyed last year said they were getting a lower dose. And one in four said they were no longer prescribed opioids.

But according to Mayo Clinic researchers, opioid prescribing hasn't changed that much and remains at high levels. In a study published in the British Medical Journal (BMJ), they report that opioid prescriptions for Medicare and privately insured patients have remained relatively stable over the past few years. And the average daily dose of opioids is well above what it was 10 years ago.

“If you’re hearing the message that prescription opioid use is starting to decline, I think we need to counter that message and say in most populations it really isn’t moving very much.” says lead author Molly Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Our data suggest not much has changed in prescription opioid use since about five years ago.”

Why the discrepancy? Jeffrey says most of the previous studies only looked at market-level data – the amount of opioids that drug makers reported producing and selling. She and her colleagues dug a little deeper, looking at insurance claims for 48 million U.S. patients between 2007 and 2016.  

Over that 10-year period, the rate of opioid use by privately insured patients remained relatively flat at 6 to 7 percent. The average daily dose for that group, about two pills of 5-milligram oxycodone, remained the same.

The rate of opioid use by Medicare patients 65 and older peaked at 15% in 2010 and decreased slightly to 14% by 2016. Their average daily dose, three 5 mg pills of oxycodone, also remained relatively unchanged.

Rates of opioid use by disabled Medicare patients also haven't changed much, peaking at 41% in 2013 and falling to 39% in 2016. Their average daily dose remains relatively high, about eight 5 mg oxycodone pills. 

“Our research of patient-level data doesn’t show the decline that was found in previous research,” says Jeffery. “We wanted to know how the declines were experienced by individual people. Did fewer people have opioid prescriptions? Did people taking opioids take less over time? When we looked at it that way, we found a different picture.”

The Mayo study includes an interesting disclaimer. While the researchers looked at data from patient insurance claims, they never surveyed or spoke to any patients about their opioid use. The researchers said they would “engage” with patients in future blog posts and press releases.

You can share your views with Molly Jeffery by email at jeffery.molly@mayo.edu or @mollyjeffery on Twitter.

FDA Uncovers Errors in Opioid Database

By Pat Anson, Editor

The U.S. Food and Drug Administration has identified potentially serious errors in a database of opioid sales maintained by IQVIA - a private company that provides data to the federal government on the volume of drugs sold by manufacturers and wholesalers to pharmacies and hospitals.

The FDA said the errors “raise serious questions” about the reliability of IQVIA’s database, which is used by the Drug Enforcement Administration to set opioid production quotas for drug makers. In the last two years, the DEA has reduced opioid production quotas by as much as 45 percent, claiming there was less demand for opioids and that the market was oversupplied with them.

“When we discover irregularities or inconsistencies in the data we use, we take such deficiencies very seriously,” the FDA said in a statement. "The FDA uses these data to assist the DEA in determining the medical and research needs for Schedule I and II controlled substances in the U.S. for the upcoming year."

The FDA believes the error was caused when IQVIA incorrectly converted into kilograms the amount of prescription fentanyl contained in transdermal skin patches and other fentanyl products. As a result, FDA researchers believe the company overestimated the amount of fentanyl sold in the U.S. in the last five years by over 20 percent.

“This error caused IQVIA to overestimate the total amount of fentanyl distributed into the marketplace,” the FDA said. “As a result of this work, we identified additional data quality issues related to several other controlled substances with similar weight-based conversion factors, including oxymorphone and hydrocodone. These additional errors raise serious concerns about systemic issues with IQVIA’s data and quality control procedures.”

Fentanyl is a potent synthetic opioid that is used to treat severe chronic pain and acute pain in patients recovering from surgery and trauma. There is currently a nationwide shortage of intravenous fentanyl and other opioids that has forced some hospitals to postpone surgeries or use other pain medications that are less effective.   

FDA Commissioner Scott Gottlieb, MD, called on IQVIA to immediately hire an independent, third party auditor to conduct a review of its database. Gottlieb said he would brief members of Congress about the data issues and their potential impact on public health.

IQVIA was formed in 2016 after the merger of IMS Health and Quintiles, two prominent healthcare research firms. The company released a statement saying it identified the problems in its opioid database last month and notified customers.  

“Recently, we made a correction to a kilogram conversion measurement in the United States IQVIA National Sales Perspective (NSP) market research service affecting reported measurements for transdermal patches in the opioid market,” the company said. “IQVIA’s internal processes had already identified the measurement conversion issue prior to the FDA’s notification. We notified our clients about this measurement conversion issue in April of this year. Ongoing steps have been undertaken to correct this measurement conversion issue.

“We stand behind our data methodologies. We value our long-standing relationship with the FDA. We take the FDA’s concerns seriously and will continue working with the FDA to resolve these concerns to its satisfaction.”

If confirmed, the database errors would be the second admission by federal agencies this year that their analysis of opioid prescriptions relied on faulty data. In March, four researchers in the CDC’s ironically named Division of Unintentional Injury Prevention acknowledged that many overdoses involving illicit fentanyl and other synthetic black market opioids were erroneously counted as prescription drug deaths.