FDA OKs New Packaging for OTC Loperamide to Help Stem Misuse, Abuse

https://www.medscape.com/viewarticle/918786

In its ongoing effort to stem misuse and abuse of loperamide (Imodium, Johnson & Johnson), the US Food and Drug Administration (FDA) has approved changes to the packaging for brand-name, over-the-counter (OTC) tablet and capsule formulations of the opioid-based antidiarrheal medication.

The changes to Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCl Capsules limit each carton to no more than 48 mg of loperamide and require the tablets and capsules to be packaged in individual (unit-dose) blister packs, according to an FDA safety communication. 

The maximum approved daily dose for adults is 8 mg/day for OTC use and 16 mg/day for prescription use. Abuse and misuse of loperamide is an ongoing problem in the US, the FDA said, with some individuals taking higher-than-recommended doses of loperamide to treat symptoms of opioid withdrawal or to achieve euphoric effects of opioid use.

“The FDA has worked with manufacturers to approve package size limitations and unit-dose packaging for certain over-the-counter loperamide products. These changes are intended to increase the safe use of loperamide products without limiting over-the-counter access for consumers who use these products for their approved uses at the approved dose, according to labeling,” Acting FDA Commissioner Ned Sharpless, MD, said in a statement.

He said the agency is also asking online distributors to take “voluntary steps to help reduce the risks of loperamide abuse and misuse by not selling more than one package of these drugs to each customer.” 

The FDA is also taking steps to ensure that consumers can easily access and read the product labeling and warnings for drugs sold on shelves or on websites before purchase.

In 2016, the FDA warned about life-threatening cardiac events, including QT interval prolongation, torsades de pointes or other ventricular arrhythmias, syncope, and cardiac arrest, with loperamide misuse and abuse, as reported by Medscape Medical News.   

In 2017, the FDA added a warning to the product label about the risk of taking high doses of loperamide. They noted that some individuals are taking higher-than-recommended doses of loperamide to treat symptoms of opioid withdrawal or to achieve euphoric effects of opioid use.

Also in 2017, the FDA added a Heart Alert warning to loperamide “drug facts” labels that warned consumers about the risks of taking higher-than-recommended doses.

The FDA said evidence suggests that package size limits and unit-dose packaging may reduce medication overdose and death.

In 2018, the agency asked manufacturers and packagers of OTC loperamide products to make these changes, as Medscape Medical News reported. Today, the FDA formally notified the public of these approved changes. 

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Baltimore’s drug problem is all about crime and open borders, NOT opioid prescriptions

https://www.conservativereview.com/news/baltimores-drug-problem-crime-open-borders-not-opioid-prescriptions/

As you can see, the entire surge since 2014 was all driven by fentanyl and cocaine. It was also initially driven by heroin overdoses, but much of that was because the cartels began lacing the heroin with fentanyl, just as they are doing today with cocaine. Every DEA and CBP agent I’ve spoken to tells me those are the biggest problems, and they are all coming from the Mexican cartels. Meth, another non-opioid, is also a big problem in the more rural states. The drugs are then processed and distributed primarily through criminal alien networks trafficking them without any fear of either being deported or serving hard time.

But the entire political class is focusing on prescription drugs and lawsuits against pharmaceutical companies. The reality is that opioid prescriptions have plummeted in Maryland, even as the fatalities surge. The prescribing rate in Maryland has dropped by 29 percent since 2011 and is now below the national average.

As you can see from the chart, just 379 of the overall 2,406 decedents in 2018 had prescription drugs in their toxicology reports. That is just 16 percent. But it’s really less than that. According to the annual report, almost all of those people also had other illicit drugs or alcohol in their blood. So, these were drug addicts, not chronic, stable pain patients who were wrongly prescribed by doctors or who were made addicted by the evil pharmaceutical companies.

This is why the trajectory of prescription overdoses has actually stayed fairly stable, unlike the fatalities for cocaine and fentanyl. Here are some more charts from the Maryland Department of Health report:

This is also why 73 percent of all decedents were male. If anything, there are more female chronic pain patients. The fact that most of the deaths are males demonstrates once again that this is not a painkiller addiction problem but more of a cultural problem of drugs and alcohol of all sorts, which overwhelmingly affects males more than females.

The 800-pound gorilla in the room when discussing Maryland’s illicit poly-drug crisis, not prescription opioid crisis, is of course Baltimore City. It accounted for 37 percent of all drug deaths in Maryland last year, even though it is just 10 percent of the state’s population of six million. Nearly half of those fatalities were from cocaine, which is not even an opioid. Drug traffickers are lacing the psychostimulant (cocaine) with a killer depressant (fentanyl).

Baltimore City is where one can find the worst convergence of “criminal justice reform,” aka not locking up drug traffickers, and sanctuary cities, aka not turning over criminal aliens to ICE. The most common “low-level” crime that illegal aliens are picked up on is drugs. To begin with, American drug traffickers barely serve any time in prison any more, particularly in Baltimore. Maryland’s prison population has plummeted by 29 percent over the past decade and is now lower than at any time since the 1980s. No wonder crime is now spiking to pre-1990s levels and Baltimore is now on pace for another year of record homicides. It’s the same reason why the drug crisis is worse than ever. Finding аn affordable bail bondsman does nоt hаvе tо bе difficult but іt does require a little research. Thіѕ саn easily bе dоnе bу checking wіth thе local authorities оr thе convenience оf thе internet. If a bail bond company саn provide a lоng list оf satisfied clients, оnе саn rеѕt assured thаt thе fate оf thеіr loved оnе іѕ іn thе hands оf a trustworthy company. A dependable bail bonds agent wіll gіvе thе help thаt іѕ needed durіng thіѕ stressful, difficult tіmе.

In mоѕt cases thіѕ bail bond service companies аrе available 24 hours a day аnd уоu саn just gіvе thеm a саll. Make sure tо bе rеаdу wіth thе documentation thаt іѕ needed аѕ wеll аѕ thе fees thаt need tо bе given tо thе bail bond agent. Thе bets thіng tо dо іѕ tо gо fоr a local person whо іѕ reputed аnd hаѕ еnоugh contacts wіth thе jail authorities аѕ thаt саn help secure thе release vеrу quick аnd fast.

But removing the criminal alien gangs and cartel networks from the country would increase the prices of these drugs because the networks would be disrupted. As Robert Murphy, the DEA special agent in charge of Atlanta, told me earlier this year: “The people who are here operating the networks are all illegal immigrants. … Without the people, the cartels have no success.”

Why did the prices decrease so much right around the surge of Central American migrants in 2013-2014? The amalgamation of Obama’s border policies together with sanctuary policies has protected all of these trafficking networks. No wonder Baltimore City has a higher drug mortality rate (56.6 per 100,000) than any county even in hard-hit New Hampshire.

So, the next time Baltimore politicians want to discuss “low-level” drug offenses and the need to protect criminal aliens from ICE, just remember this is the true source of thousands of dead residents of Baltimore. Any focus on health care is a distraction of epic proportions from open borders, sanctuary cities, and weak-on-crime policies the politicians don’t want you to know about.

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Coast Guard Commander Charged with Importing Narcotics

https://www.military.com/daily-news/2019/09/19/coast-guard-commander-charged-importing-narcotics.html

OAKLAND — A United States Coast Guard commander was charged with illegal importation of controlled substances Wednesday, a U.S. Justice Department spokesman said.

According to a complaint, James Silcox III, 41, received three shipments of Tramadol, a controlled substance and narcotic, to post-office boxes over the summer.

In July, an 865-gram package from Singapore headed for a post-office box was flagged by Customs and Border Protections officers at the U.S. Postal Service’s international mail facility at New York’s John F. Kennedy Airport.

Officers at the postal service’s San Francisco air-mail facility intercepted another 650-tablet Tramadol package from Singapore in August, before receiving another package September 13 that held 458 grams of Tramadol.

After law-enforcement officers swapped out the August package’s Tramadol for substitute material, they delivered it to Silcox’s post-office box Monday. He picked up the package the same day, and officers arrested him Tuesday at his Coast Guard Island residence.

Silcox was released on a personal-recognizance bond after appearing in San Francisco federal court Wednesday morning, and he will return Sept. 26 to identity counsel and attend a preliminary hearing before U.S. Magistrate Judge Kandis Westmore.

He faces up to five years in prison and a $250,000 fine for each violation, but federal sentencing guidelines will ultimately affect any imposed sentence.

In addition, indictments are only allegations of committed crimes and Silcox is considered innocent until proven guilty beyond a reasonable doubt.

Assistant U.S. Attorney Sarah Griswold is prosecuting the case, which came from an investigation by the Homeland Security Investigations; the High Intensity Drug Trafficking Area-Transnational Narcotics Team; the U.S. Postal Inspection Service; the Department of Homeland Security Office of Inspector General; and the Coast Guard Investigation Service,

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https://lookaside.fbsbx.com/file/DEA%20Quota.pdf?token=AWzUGmSNaWNztF1-OwxoYDqgeKVT5RLNGdMtrYWDhQsG8V5RUnPTkGMPbDJE-vnXJ1syacnixAPNGqYl7v1z7qC2Yp7UD4UmhNP-8655nNvhbNY6EYr14GUNGL-I8iTM-v9-nOxYqnyo13fnSfJnnkibl74DACLra0vaA5lS8rHZ-awLTKdz7epJIXfehvWi95R2NZSQYBxi_7nTQ2bfRiS-

a couple of interesting quotes:

The NSS and NFLIS data reports included total seized Weight without reference to whether it is finished dosage forms. container weight. tablets or pill weight provides no reference to specific API concentrations; and the databases do not distinguish between pharmaceutically and illicitly manufactured controlled substances …..

As a result of considering the extent of diversion, DEA notes that the quantity of FDA-approved drug products that correlate to diverted controlled substances in 2018 represents less than one percent of the total quantity of controlled substances distributed to retail purchasers.

This is a 22 page document dates Sept 2019… the above is just a couple of quotes that I pulled out of the report…  Appears to show how convoluted the mythology in how they come to final conclusions on the legit use and abuse of various legal and illegal opiates.

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“Just doing my job harassing and searching a stage 4 cancer patients bags for a plant.” This is TRULY pathetic. Not bravery. Not protecting the community. Just pathetic! This man could have days to live but you waste his time searching his possessions because ‘it’s the law?’ Disgusting!

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Dispensing Wrong Medications Leads to Patient’s Death

https://www.pharmacytimes.com/publications/issue/2019/september2019/dispensing-wrong-medications-leads-to-patients-death

ISSUE OF THE CASE
When a transcription error by a pharmacy technician while taking medication orders over the phone led to the death of a patient, did the trial court judge make an error when disallowing the surviving family members to seek damages based on aggravating circumstances?

FACTS OF THE CASE
A female patient was hospitalized in a Midwestern state for fluid buildup in her lungs. When the time came for her to be discharged, a nurse at the hospital called in prescriptions for multiple medications to a local chain pharmacy. One of those orders was for a diuretic, metolazone.

The call was taken by a tech who, the court emphasized, “had no formal pharmacy training or education before becoming a pharmacy technician. She had worked in the floral department before moving to the pharmacy.”

The tech made numerous transcription errors, misspelling the names of several medications being ordered, misspelling the name of the nurse on the other end of the phone call, and recording an incorrect birth date for the patient. The tech also made an error related to the dosage of an inhaler being prescribed, with what she recorded being 10 times the correct dosage.

The gravest hazard, however, came from misrecording a daily dosage of methotrexate instead of the metolazone that was intended. How could that occur? The pharmacy expert retained by the family testified that the approach used in the pharmacy was for the tech to look in the computer where the medications were arranged alphabetically by name. A drop-down menu would appear after the first 3 letters or so of the drug name that had been entered. The pharmacy expert opined that entering m-e-t and a dosage strength of 2.5 mg would bring up methotrexate before metolazone.

The pharmacist who had been on duty the day the dispensing error was made testified that he had approved the prescription before it was dispensed. He stated that the dosage being prescribed would have been safe if administered once or twice per week but not on a daily basis. His statement at trial was that “for some reason, I didn’t recognize the weekly versus daily. It didn’t click in my mind.”

The pharmacy expert testified that the Institute for Safe Medication Practices classifies methotrexate as a “high-alert” drug product and that many pharmacy computer systems include a “hard stop” that prevents printing a label indicating that it should be taken once per day.

When the husband picked up the medication, he was asked whether he had any questions for the pharmacist. When he responded that he did not, the pharmacy staff member provided no further counseling or warning about the medication, even though the pharmacy manual of the chain specified that it “strongly recommends” that all patients with new prescriptions receive patient counseling, even if not required by state law. The pharmacy expert opined that such counseling should be provided with high-alert drugs.

The family filed the lawsuit based on wrongful death reasoning, naming the hospital and pharmacy as defendants. They also sought additional damages, due to aggravating circumstances (ie, those present in the transaction that increase the culpability or severity of the action). The hospital settled the claim, and the matter against the pharmacy chain proceeded to court. The trial court jury returned a verdict in favor of the plaintiffs in the amount of $2 million, but that amount was reduced to $125,000, pursuant to damage caps included in state law. The pharmacy chain made a motion that the aggravating circumstances portion of the case be dismissed, and the judge granted that motion. The family appealed the judge’s denial of that portion of the case.

THE RULING
The 3-judge panel of the state court of appeals concluded that the trial court erred when deciding in favor of the pharmacy chain on the aggravating circumstances damages issue. The case was remanded to the trial court for a new trial on the sole issue of aggravating circumstances.

THE COURT’S REASONING
The court looked at several issues related to the aggravating circumstances. The judges said that a jury could conclude that the chain’s “decision to leave the decision whether to counsel patients to the discretion of individual pharmacists exhibited conscious indifference to patient safety, when the consequences of prescription errors were potentially lethal.” Further, the evidence “would have permitted the jury to conclude that [the chain] has made no meaningful changes to its proce- dures as a result of [the woman’s] death.”

The court stated that the chain’s “failure to take any meaningful corrective action following [the woman’s] death supports the conclusion that its conduct exhibited complete indifference or conscious disregard for [her] safety.”
 

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Three Felonies A Day: How the Feds Target the Innocent

https://www.amazon.com/Three-Felonies-Day-Target-Innocent/dp/B07J488Q3B/ref=sr_1_1

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Zantac Generic Pulled From Markets Worldwide

Novartis unit says it’s stopping distribution while contamination is investigated

https://www.medpagetoday.com/gastroenterology/gerd/82238

One manufacturer of generic ranitidine (Zantac), Novartis’s Sandoz unit, has reportedly decided to halt distribution of the antacid drug until a contamination issue is resolved.

Last week, the FDA said some lots of ranitidine, a histamine H2 inhibitor, were found to contain small amounts of N-nitrosodimethylamine (NDMA), considered to be a human carcinogen. NDMA is a member of the nitrosamine family of chemicals also found to have contaminated some angiotensin receptor blocker drugs, sparking an uproar that still hasn’t died down.

“A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification, this includes capsules in the USA,” according to a Novartis statement quoted in the Wall Street Journal. “Our internal investigation is ongoing to determine further details. In case of concerns, adequate additional measures will be implemented in alignment with relevant Health Authorities as required.”

Ranitidine is sold in both prescription and over-the-counter (OTC) forms primarily to relieve gastroesophageal reflux and for gastric and intestinal ulcer prevention. The FDA didn’t indicate which particular products were affected since they are not being recalled at this time; the generic drug is available from other companies besides Sandoz.

Although no recall was ordered, the FDA said last week that patients using OTC ranitidine “could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”

Patients taking prescription ranitidine who wish to switch to another medication should consult their physicians, the FDA said.

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DEA Serves Inspection Warrants at Kaiser Pharmacies Across the Country

https://ktla.com/2019/09/17/dea-serves-inspection-warrants-at-kaiser-pharmacies-across-the-country/

The Drug Enforcement Administration served inspection warrants at Kaiser Permanente pharmacies across the country, officials said Tuesday.

Agents are monitoring the prescription and administering of controlled substances and inspecting pharmacy records, Special Agent Kyle Mori, a spokesman for the DEA, told KTLA.

It is unclear how many warrants were issued Tuesday, but some Southern California locations include Woodland Hills, Riverside and Victorville.

Mori said the warrants are under seal and he couldn’t comment on the investigation.

He added, however, that inspections are typically conducted to help officials regulate the health care and pharmaceutical industry and those involved in prescribing, manufacturing or handling controlled substances.

The inspections tend to take a few hours and at the conclusion, the affected pharmacies will reopen.

In a statement, Kaiser said officials are cooperating fully with the federal agency.

“As always, we are committed to complying with state and federal regulations and ensuring the safety of our patients and members,” the statement read.

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