HealthDay News — Following a 4-day raid, Mexico has closed 23 pharmacies in Caribbean resorts of Cancun, Playa del Carmen, and Tulum for irregular pill sales.

Last spring, the US warned of dangerous pill sales to foreigners and tourists where counterfeit drugs contained fentanyl, heroin, and methamphetamine. Mexican investigators went to 55 drug stores, finding irregular sales at 23 of them, according to the Mexican Navy Department.

In a study from researchers at the University of California in Los Angeles, the scientists said they visited 40 pharmacies in four Northern Mexico cities, finding that 68% sold oxycodone, Xanax, or Adderall. About 27% of those pharmacies were selling fake pills, according to the report, which said “brick and mortar pharmacies in Northern Mexican tourist towns are selling counterfeit pills containing fentanyl, heroin, and methamphetamine. These pills are sold mainly to US tourists, and are often passed off as controlled substances such as oxycodone, Percocet and Adderall.”

In the raids, the Navy said it found outdated medications and those with no supplier record, the Associated Press reported. Also found were blank and unsigned prescription forms. The Navy did not confirm finding fentanyl-laced pills, but it did say that the medications would be tested for the presence of fentanyl.

Fentanyl is responsible for about 70,000 deaths each year in the US, the AP reported, noting that Mexican cartels produce it from chemicals smuggled in from China.

“These counterfeit pills represent a serious overdose risk to buyers who think they are getting a known quantity of a weaker drug,” researcher Chelsea Shover, PhD, an assistant professor-in-residence of medicine at the David Geffen School of Medicine at UCLA, told the AP in February.

Associated Press Article

The Food and Drug Administration (FDA) has approved Amphastar’s New Drug Application (NDA) for naloxone hydrochloride nasal spray 4mg for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression for adult and pediatric patients.

Naloxone hydrochloride nasal spray is an opioid antagonist designed using the Company’s proprietary nasal delivery device. It is a prescription medication intended for immediate administration as emergency therapy in settings where opioids may be present.

The product is supplied as a carton containing 2 unit-dose devices; each device delivers a single spray containing 4mg of naloxone hydrochloride (equivalent to 3.6mg of naloxone). The device is ready to use and does not require priming or testing prior to administration.

Commenting on the FDA nod, Dr Jack Zhang, Amphastar’s President and Chief Executive Officer, said: “The approval of our naloxone hydrochloride nasal spray marks an important step in helping alleviate the opioids crisis as patients can further broaden their access to a critical product.”

References

1. Amphastar Pharmaceuticals receives FDA approval for Naloxone Hydrochloride Nasal Spray 4mg. News release. Amphastar Pharmaceuticals. March 8, 2023. Accessed March 9, 2023. https://ir.amphastar.com/websites/amphastar/English/2110/news-detail.html?airportNewsID=fd568d0c-36f7-43b9-a888-87c8afa3e096.
2. Naloxone Hydrochloride Nasal Spray. Package insert. Amphastar Pharmaceuticals; 2023. Accessed March 9, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s000lbl.pdf.

CSX-1004 works by binding to fentanyl and fentanyl analogs in the bloodstream, thereby sequestering the fentanyl molecules and neutralizing them before they reach the brain. The Fast Track designation was based on nonhuman data demonstrating that a single dose of CSX-1004 could block the respiratory depressant effects of high doses of fentanyl for up to 28 days.

A first-in-human study (ClinicalTrials.gov Identifier: NCT06005402) has been initiated and will evaluate the safety, tolerability, and pharmacokinetics of CSX-1004 in healthy volunteers. The study is expected to enroll 32 individuals aged 18 to 50 years. The investigational treatment will be administered as an intravenous infusion across a range of doses.

“Fast Track designation by the FDA is an important milestone and recognizes the potential for CSX-1004 to help address an unprecedented public health crisis that claims a life every seven minutes in the US,” said Andy Barrett, PhD, Chief Scientific Officer at Cessation. “We are encouraged by the FDA’s decision as it reflects the need for novel treatments that can potentially stem the tide of untimely fentanyl-related deaths.”

HealthDay News — In the US, the monthly buprenorphine initiation rate increased from January 2016 through September 2018, then flattened through October 2022, according to a research letter published in the April 25 issue of the Journal of the American Medical Association.

Kao-Ping Chua, MD, PhD, from the University of Michigan Medical School in Ann Arbor, and colleagues examined trends in buprenorphine initiation and retention during 2016 to 2022. Data were included for 93,713,163 buprenorphine prescriptions.

The researchers found that the monthly buprenorphine initiation rate increased from 12.5 to 15.9 per 100,000 during January 2016 through September 2018 (monthly percentage change, 0.62%). The slope was flat during October 2018 through October 2022 (monthly percentage change, −0.03 percent). During March 2020 through December 2020, the median monthly buprenorphine initiation rate was slightly lower than during January 2019 through February 2020 and January 2021 through October 2022 (14.4 per 100,000 versus 15.5 and 15.0 per 100,000, respectively). The median monthly retention rate, defined as 180 days or more of continuous buprenorphine treatment without gaps exceeding seven days, was 22.2%% during January 2016 through April 2022. A minimal increase in the retention rate was seen, without any slope changes (monthly percentage change, 0.08 percent).

“These findings suggest that recent clinical and policy efforts to increase buprenorphine use have been insufficient to meet the need for this medication,” the authors write.

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HealthDay News — During the COVID-19 pandemic in 2020, 2021, and 2022, the mean weekly cannabis-involved emergency department visit rates among young persons were higher than the corresponding periods in 2019, according to research published in the July 14 issue of the US Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

Douglas R. Roehler, PhD, from the CDC in Atlanta, and colleagues used National Syndromic Surveillance Program data to examine changes in cannabis-involved emergency department visits among young persons (younger than 25 years) during 2019 to 2022.

The researchers found that among all young people, mean weekly cannabis-involved emergency department visits were higher during the COVID-19 pandemic in 2020, 2021, and 2022 compared with corresponding periods in 2019. Among persons aged 10 years and younger, there were large increases seen in cannabis-involved emergency department visits throughout the COVID-19 pandemic compared with prepandemic surveillance periods in 2019. Among children and adolescents aged 11 to 14 years, emergency department visit rates did not differ by sex until the first half of the 2020-2021 school year when emergency department visit rates among females surpassed those among males.

“Cannabis-involved emergency department visits among young persons increased during the COVID-19 pandemic and remained elevated above prepandemic levels,” the authors write. “To protect against unintentional ingestions of cannabis, it is important for adults who use cannabis to safely and securely store cannabis products in places inaccessible to children.”

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Physician’s Unlawful Prescribing of Controlled Substances Leads to Patient Death 

A primary care physician from Pennsylvania has been sentenced to 22 years in prison for unlawfully prescribing oxycodone, fentanyl, and methadone to 3 patients. A jury found the doctor guilty on 71 counts of unlawful distribution of controlled substances, one of which resulted in the death of a 48-year old woman. The 3-week trial included testimony from the Drug Enforcement Administration (DEA)-Diversion Division, multiple pharmacists who refused to fill the doctor’s prescriptions, as well as experts in pain medicine, toxicology, and pathology. In addition to the prison term, the doctor was ordered to pay a fine of $50,000. Following his release from prison, he will be supervised by a probation officer for 3 years.

Prescription Drug Conspiracy Lands Nurse in Federal Prison

A Florida nurse has been sentenced to 3 years in federal prison for conspiring with another individual to distribute controlled substances in the names of individuals without lawful authority. Prior to forfeiting her licenses, the nurse was an advanced practice registered nurse, registered nurse, and DEA registrant, which gave her the authority to issue prescriptions for controlled substances. After her licensing became delinquent, she conspired with another individual who provided her with more than a dozen identifications and drivers licenses. She then proceeded to issue prescriptions for promethazine with codeine and oxycodone in exchange for payment. Thirty-four of these illegally issued prescriptions were for oxycodone and hydromorphone written for her deceased husband.

Psychiatrist Convicted of Money Laundering and Importing Illegal, Misbranded Drugs

A psychiatrist from Massachusetts has been convicted of international money laundering, illegally importing merchandise contrary to law and receiving and delivering misbranded drugs. For approximately 10 years, the physician purchased naltrexone pellet implants and disulfiram pellet implants and injections from Hong Kong. While both naltrexone and disulfiram have been approved by the Food and Drug Administration for the treatment of alcohol and opioid dependence and alcohol dependence, respectively, neither product is available in an implantable pellet formulation in the US. To conceal that the packages contained drugs, the doctor falsified shipping documents claiming that the packages contained “plastic beads in plastic tubes.” The psychiatrist then proceeded to implant these drugs into patients, who later testified that they experienced infections and complications related to the pellet implantation procedure. In addition to large fines, the charges of money laundering and importation of merchandise contrary to law each provide a sentence of up to 20 years in prison. 

NP Charged With Writing Amphetamine Rxs for No Legitimate Medical Reason

A New York psychiatric nurse practitioner (NP) has been arrested and charged with unlawful distribution of a controlled substance. He is being accused of prescribing amphetamine on 40 occasions to an individual who was never his patient. The charge of distributing controlled substances outside the course of professional practice and for no legitimate medical purpose carries a prison sentence of up to 20 years and a fine of up to $1 million.

Nurse Removes Fentanyl From IV Bag, Replaces With Saline 

A former nurse from Massachusetts has pleaded guilty to adulteration of a prescription drug. While working at a Massachusetts hospital, the nurse removed a bag of intravenous (IV) fentanyl solution from an automated dispensing machine and using a syringe, removed fentanyl from the bag. She then injected the bag with saline to replace the missing solution and returned the bag to its drawer in the machine. The bag was subsequently removed by a hospital employee before it was able to reach any patient. Testing confirmed that the bag contained less than the declared concentration of fentanyl and the nurse later admitted what she had done. Based on the charge, the nurse may face up to 3 years in prison, 1 year of supervised release, and a fine of up to $10,000. 

Pharmacist Gets Prison Time for Illegally Selling Prescription Cough Syrup

A Michigan pharmacist has been sentenced to 3 years in federal prison for illegally dispensing promethazine cough syrup. The pharmacist ordered more than $2.5 million dollars worth of the prescription syrup from various wholesale distributors and then sold it to drug dealers. When consumed at higher than recommended dosages, promethazine cough syrup can produce tranquilizing and euphoric effects. On the illegal street market, the drug is often referred to as “Green Drink” or “Purple Drink.” The pharmacist was ordered to forfeit approximately $9 million dollars of his earnings from these illegal transactions. 

Doctor Fraudulently Issues Over 500 Prescriptions for Opioids

A former doctor from Texas was sentenced to 30 months in federal prison for dispensing controlled substances without a legitimate medical purpose. The doctor admitted that he fraudulently issued more than 500 prescriptions, most of which were for opioids, in the names of family members (both living and deceased), former patients and other individuals after his medical license had expired and then been suspended. He then conspired with others to distribute the medications to unknown individuals.

Distributing Misbranded Drug Lands Clinician in Hot Water

A doctor from Louisiana was charged with distributing misbranded drugs, including medroxyprogesterone. According to the US Attorney’s Office, Eastern District of Louisiana, the physician had introduced the misbranded drugs, which lacked adequate directions for use, into interstate commerce between April 2018 and March 2023. A conviction could result in 1 year of prison time for the doctor and up to 1 year of supervised release.

Doctor Establishes Pain Management Clinic for Unlawful Purposes

A Florida doctor has been convicted of unlawfully dispensing and distributing controlled substances. The doctor established a pain management clinic from which he then issued prescriptions for controlled substances such as oxycodone, morphine, and alprazolam to patients without a legitimate medical need. Some prescriptions were even prewritten and handed to office managers to sell for cash payments of $250 to patients. Data from Florida’s prescription drug monitoring program showed that the doctor prescribed opioids to more than 1000 patients, almost a third of whom were found to have criminal records related to drug dealing.

Two Doctors Rack Up Multiple Charges for Illegal Ketamine Administration

Two Missouri doctors, a psychiatrist and an internal medicine specialist, were indicted and accused of illegally administering ketamine to patients. Though the psychiatrist was authorized by the Drug Enforcement Administration (DEA) to administer controlled substances, the clinic that was set up to provide the intravenous ketamine infusions for patients with serious mental health illnesses was not registered for this type of treatment. The indictment also alleges that the psychiatrist allowed the internal medicine specialist to use his DEA registration to administer ketamine infusions and esketamine nasal spray without direct supervision and that the ketamine and esketamine were unlawfully stored in the facility. The internal medicine specialist was also charged with Medicare fraud because he falsely used the psychiatrist’s name to bill for the services.

Foot Bath Medication Scheme Lands Podiatrist in Hot Water

A podiatrist from Tennessee was convicted of 5 counts of health care fraud related to a scheme where he prescribed and dispensed medically unnecessary foot bath medications.  The podiatrist owned and operated a podiatry clinic and 2 in-house pharmacies; these pharmacies submitted nearly $4 million in claims to Medicare and TennCare for dispensing expensive antibiotic and antifungal drugs to be mixed into a tub of water for patients to soak their feet. These medications, which were dispensed as capsules, creams, and powders, were not even water soluble. The pharmacies were reimbursed over $3 million for these unnecessary treatments. The podiatrist faces up to 10 years in prison on each count of fraud.

Nurse Practitioner Trades Opioids for Money, Sex, and Fame 

A Tennessee nurse practitioner (NP) was sentenced to 20 years in prison for illegally prescribing medically unnecessary controlled substances to patients through his medical practice. Known locally as the “Rock Doc”, the NP prescribed more than 100,000 doses of hydrocodone, oxycodone, and fentanyl to his patients, including a pregnant woman. According to the US Attorney’s Office for the Western District of Tennessee, the NP maintained “a party-type atmosphere” at his medical practice and was known to engage in inappropriate physical relationships with some of his female patients. It is believed that part of the reason he prescribed these drugs was to improve his popularity on social media and promote a self-produced reality TV show pilot.

Drug Dealing Pharmacist Gets Prison Time for Unlawful Distribution

A Michigan pharmacist was sentenced to 8 years and 4 months in federal prison for filling fake prescriptions for controlled substances that totalled over 300,000 dosage units. These prescriptions were issued by a local doctor who was charged with unlawfully writing for controlled substances. The doctor pleaded guilty to the charge but died before sentencing. The pharmacist made over $780,000 from the distribution of these drugs from her pharmacy; the estimated street value was reported to be between $1.8 and $3.3 million. In addition to prison time, she was ordered to forfeit the proceeds of her drug dealing scheme.

Doctor Writes Undercover Agent Opioid Rx Without Legit Medical Purpose

A California doctor was sentenced to 1 year and 1 day in federal prison for distributing opioids outside the scope of medical practice. The internal medicine physician operated her practice from her home and was authorized to prescribe controlled substances. Concerning information obtained from a family member of one of the doctor’s former patients prompted an investigation into the doctor’s prescribing practices. An undercover agent was sent to her home complaining of leg pain and asking for hydrocodone 10mg tablets. The doctor prescribed the undercover agent 60 high dose hydrocodone tablets. No physical examination was conducted and no follow-up questions were asked; the doctor did not obtain medical records or provide an alternative treatment plan. In court, the doctor admitted that she knew she was prescribing an addictive medication outside the usual course of medical practice. According to the US Attorney’s Office of the Northern District of California, the doctor wrote these prescriptions in exchange for cash and street drugs, including cocaine and methamphetamine. In addition to her prison sentence, she was ordered to forfeit her medical license and pay a $4000 fine.

Physician Forks Over Thousands of Dollars for Genetic Testing Scheme

A Pennsylvania physician was ordered to pay a large sum of money for violating the False Claims Act by ordering unnecessary genetic testing for Medicare beneficiaries. The doctor referred more than 400 patients, with whom he had no medical relationship with, for these medically unnecessary genetic tests. Most referrals were done through brief telemedicine consultations and some were done without consultation at all. These genetic tests were reported to cost thousands of dollars per patient and were paid for by Medicare. According to the US Attorney’s Office for the Eastern District of Pennsylvania, the physician is responsible for paying $95,000 to resolve the allegations. Commenting on the case, Maureen R. Dixon, Special Agent in Charge for the US Department of Health and Human Services, Office of the Inspector General, Region III, said: “Accurately billing for services provided to Medicare beneficiaries is required of all health care providers. HHS-OIG and the US Attorney’s Office will continue to evaluate and pursue allegations of medically unnecessary services.”

Alyssa F. Harlow, PhD, from the University of Southern California in Los Angeles, and colleagues conducted a nationally representative cross-sectional analysis of a randomly selected subset of 12th-grade students in 27 US states to estimate the self-reported prevalence of and factors associated with Δ⁸-THC and marijuana use in the past 12 months.

The researchers found that the prevalence of self-reported use in the past 12 months was 11.4 and 30.4% for Δ⁸-THC and marijuana, respectively, in the sample of 2186 12th-grade students. Overall, 35.4% of the 295 participants reporting Δ⁸-THC use used it at least 10 times in the past 12 months. The prevalence of Δ⁸-THC use was lower in Western versus Southern census regions, states in which Δ⁸-THC was versus was not regulated, and states with versus without legal adult-use marijuana (adjusted relative risks, 0.35, 0.42, and 0.56, respectively). Past 12-month use was lower for Hispanic than White participants for both Δ⁸-THC and marijuana (adjusted relative risks, 0.54 and 0.74, respectively). There was no difference seen in the prevalence of Δ⁸-THC and marijuana use by sex or parental education.

“Δ⁸-THC use prevalence is appreciable among U.S. adolescents and is higher in states without marijuana legalization or existing Δ⁸-THC regulations,” the authors write. “Prioritizing surveillance, policy, and public health efforts addressing adolescent Δ⁸-THC use may be warranted.”

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Electronic prescriptions for schedules II-V controlled substances can be transferred between registered retail pharmacies for initial filling effective August 28, 2023, according to the Drug Enforcement Administration (DEA). The transfer is permissible only if allowable under existing State or other applicable law.

The final rule requires that the transfer of a controlled substance prescription in schedule II-V be communicated between 2 licensed pharmacists and that the prescription remains in electronic form with no changes during the transmission. The transfer can only be done once; any refills on the prescription (schedule III, IV, or V drugs) will be transferred to the receiving pharmacy as well. Electronic records of the transfer must be maintained by both pharmacies for 2 years from the date of the transfer.

Prior to the amendment, a pharmacy that could not fill an electronic prescription for a controlled substance could only inform the patient that it could not be filled. Since an electronic prescription cannot be printed and given to the patient by the pharmacist, the patient would need to call their doctor and request another prescription be sent to a different pharmacy. The DEA revised its regulations in an effort to reduce the potential for duplicate controlled substance prescriptions.

The final rule has been published in the Federal Register and provides additional information on the regulations, including procedures for proper documentation of the transfer.

HealthDay News — The US Drug Enforcement Administration on Wednesday issued a 6-month extension for people seeking to fill controlled medication prescriptions via telehealth. That ability had been set to expire along with the ending of the pandemic public health emergency on May 11.

“These medications, including those used to treat opioid use disorder, are a vital form of care for millions of Americans who have come to rely on safe and effective telemedicine appointments,” Bobby Mukkamala, MD, chair of the American Medical Association Substance Use and Pain Care Task Force, said in a statement. “Patients being treated with these medications often have challenges securing and traveling to in-person appointments. We are grateful the DEA is approaching this issue with the gravity it deserves, and we look forward to reviewing the details of the policy when they become available.”

Prior to the pandemic, patients had to see a doctor for at least one in-person appointment before being able to access prescriptions for a long list of medications, including stimulants for attention-deficit/hyperactivity disorder, benzodiazepines for anxiety, and medications for opioid use disorder, sleep, or pain.

The DEA had offered proposals on March 1 that would allow prescribers to prescribe one 30-day supply of these controlled medications or the opioid use disorder buprenorphine without an in-person exam. Then an exam would be required before the next prescription. In the public comment period ending in March, the DEA received 38,000 messages about the proposals. The extension through November 11, 2023, gives the DEA and the US Department of Health and Human Services the chance to consider the revisions and the public comments.

“We take those comments seriously and are considering them carefully,” DEA Administrator Anne Milgram said in an agency news release. “We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities for 6 months while we work to find a way forward to give Americans that access with appropriate safeguards.”

The extension also allows that “if a patient and a practitioner have established a telemedicine relationship on or before November 11, 2023, the same telemedicine flexibilities that governed the relationship to that point are permitted until November 11, 2024,” according to the DEA.

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Aurora N. Quaye, MD, from Maine Medical Center in Portland, and colleagues conducted a retrospective cohort study using observational data for patients aged older than 50 years with screening or surveillance colonoscopies between January 1, 2015, and February 28, 2020. The differences in polyp detection between propofol and moderate sedation were examined in the full sample (54,063 colonoscopies). In a restricted sample that included endoscopists and facilities with between 5 and 95% propofol sedation use (18,998 coloscopies), propensity score adjustment and clustering at the endoscopist level were used.

The researchers found that the prevalence of serrated polyps was significantly higher using propofol than moderate sedation in the full sample (34.0 vs 24.5%) and in the restricted sample (30.3 vs 25.7%). Propofol was associated with higher neoplasm, adenoma, and serrated polyp detection in the full-sample multivariate logistic regression (adjusted odds ratios, 1.25, 1.07, and 1.51, respectively). An attenuated but statistically significant effect size was seen for serrated polyps (odds ratio, 1.13), but not for adenomas or any neoplastic lesion in the restricted sample using inverse probability of treatment-weighted propensity score adjustment and clustering at the endoscopist level.

“It may be that propofol increases patient comfort and relaxation, optimizing detection of polyps that are more difficult to see,” Quaye said in a statement. “Additionally, propofol may cause smooth muscle relaxation in the colon, allowing more careful inspection and improved visualization.”

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