A Los Alamos-Local Pharmacy: Finding a Pharmacy in India to Help With Kids’ Prescriptions in the Presence of Drug Uncertainty

With children’s medications, drug manufacturers say they are running full-tilt, and they planned for some increase in sales over the winter months. But they didn’t know it would be this bad or start this early.

The American Society of Health-Systems Pharmacists tracks drug shortages in the US by taking reports of them from anyone and then checking to see if they are still available. Drug shortages are defined as issues that affect how a pharmacy prepares or stores a drug product or affects the care of patients if they have to go elsewhere.

“They’re all a different tale,” Margraf said. The similarities are there but each one is a bit different and it is hard to know what is going on.

Many of the raw ingredients that go in to making drugs are sourced from just two countries, China and India, says Bindiya Vakil, chief executive officer of Resilinc, a company that maps and monitors pharmaceutical supply chains with the aim of giving an early warning to clients when trouble is on the way. There is a chance that the supplies of drugs in India or China will be affected by the work interruption at a factory in China because of China’s zero Covid policy.

Even with normal levels of production, high demand during a tough cold and flu season – like the one the US is experiencing – can make it hard for families to find what they’re looking for.

Whitney Hemsath, a writer with four children, said that she was not worried about the shortage of kids’ medication because the family still had some at home.

Later that day, their pediatrician confirmed the ear infection and prescribed the antibiotic amoxicillin. He called the pharmacy and gave her a written copy in case it was difficult to find. Sure enough, the first pharmacy was out, and so was the next. Based on the pharmacist’s list, she called her doctor to change her son’s prescription – but the pharmacy didn’t take their Medicaid insurance and the alternative medication was too expensive.

She started looking for a store that was open at 5:30 a.m., and found one with three bottles of children’s acetaminophen left. There was no generics or store brands. She was grateful to find a thing, but she said the family was on a tight budget and paying for medicine was frustrating.

She said she felt bad complaining because she was lucky to find what she needed, but it took a lot of time and effort.

“It never used to be like this,” she said. You’re lucky if they have one brand of medicine that you want, since they used to have many options.

Bare shelves in some stores may seem reminiscent of this year’s baby formula shortage, but the situations aren’t quite the same. With formula, a major manufacturer recalled products and shut down one of its factories and conducted a nationwide recall after the government found quality problems at the production facility, taking it offline for months. Existing supply chain problems were worsened by the shutdown, leaving shelves empty.

According to the Consumer Healthcare Products Association, which represents producers of over-the-counter medications, major US manufacturers of children’s medications – including Perrigo in Michigan and Johnson & Johnson in Pennsylvania – are “operating facilities 24 hours a day, 7 days a week” to keep up.

The FDA is able to help increase supply by identifying new sources of raw materials. The agency can help with finding additional manufacturing sites, and even review anything related to increase in production.

The FDA is monitoring children’sNSAIDs at this time and is not authorized to share details of their work, an FDA official told CNN on the condition of anonymity.

An official on the supply disruptions of generic medications, including Adderall, Amoxicillin, and the Medicine Supply Map of the U.S.

There aren’t any manufacturing problems that are slowing production down or causing shortages. In fact, manufacturers are working very closely with us and increasing supply so that we can get the demand where the priority needs to be,” the official said.

The official would not confirm details of specific requests from the companies for help. “I can say they are picking up on those offers, and they’re working very closely with us,” the official said.

The FDA says that by its count, the number of drugs reported in shortage has actually fallen from a high of 251 in 2011. There were drugs shortages tracked by the FDA. The agency says it averted hundreds of shortages in the same year.

The demand for Adderall increased from 2020 to 2021. delays due to worker shortages were reported by a leading manufacturer. The company told CNN that the worker shortage is over.

Because Adderall is a controlled substance, it is tightly regulated by the government. The Drug Enforcement Administration limits how much can be produced to avoid patient abuse.

Generic drugs given by injection seem to be the most common drugs that disappear. These “sterile injectables” have stringent manufacturing requirements that make them costly to produce, and they have slimmer profit margins, so there’s less economic incentive for companies to make them.

Other generics – like many antibiotics – are vulnerable to shortages, too. Experts say that’s what happened recently to some formulations of amoxicillin.

“Really, it comes down to economics,” said Vimala Raghavendran, senior director of the Pharmaceutical Supply Chain Center at the U.S. Pharmacopeia, a nonprofit that at sets quality standards for dietary supplements, food and medications.

The Medicine Supply Map was created by the United States Pharmacy in order to identify and head off potential shortages.

“And then you throw in an unexpected shock, like a demand increase because of the surge in RSV and the flu and Covid, and the supply chain is not able to absorb that shock,” she added.

“But that’s something we’re really encouraging companies to do, let us know if there’s a spike in demand so that we can work with them early on, just as they can with supply disruptions,” the official told CNN.

It points to Biden’s Executive Order on America’s Supply Chains, signed in February 2021, which directed the secretary of the Department of Health and Human Services to identify and report risks in the supply chain for pharmaceuticals and their active ingredients and to make recommendations to address those risks.

“HHS, for the first time in its history, has established a new dedicated public health industrial base expansion and supply chain management office, with the goal of building resilience,” White House spokesperson Kevin Munoz wrote in an email to CNN.

A Cancer Patient with Great Therapy, Dr. Dino Carlone: The BCG Dose and the Outcome of a Scarce Case

Three years after he was diagnosed with bladder cancer, Dino Carlone had learned he could get help with a highly effective drug that he had used for many years.

“You’re telling yourself, ‘OK, I have cancer, and it’s a very aggressive cancer, but I’ve got great therapy. Carlone said there was great numbers.

Carlone, of Vero Beach, Florida, said he was supposed to receive BCG doses over a period of about two years. But he said after receiving doses for a few months in early 2020, his urologist told him he wouldn’t be able to get his remaining doses because of the shortage.

Bladder cancer patients get six rounds of the BCG after surgery and get888-607-888-607-888-607- referrals every few months for a year or two according to Davies. The treatment takes place in a doctor’s office, using a catheter that goes to the bladder.

This is a crisis that is terrible. Laura Bray is a board member of the End Drug Shortages Alliance and she said that they should be doing everything they can to give every patient the best chance of survival. “It’s heartbreaking, and we must do better.”

Source: https://www.cnn.com/2023/02/15/health/cancer-drug-shortage-bcg/index.html

Merck is interested in reducing the BCG shortage, and how pharmaceutical companies can be responsible for ensuring access to lifesaving medicines,” Dr. Yoram Unguru, MD, M.A., C.M. Wosisk

Merck is building a facility to expand production of BCG, but it could take five or six years for construction, inspection and regulatory approvals, according to the statement.

It is still a small market and making the drug requires a large investment.

It was a breakthrough strategy, when it became available in 1976. First used as a tuberculosis vaccine, it contains a weakened bacteria that triggers the immune system to fight the cancer.

“It’s a very, very frightening circumstance to realize that at that point, what they deem to be an aggressive cancer could in fact come right back,” he said.

All of them said they had to use at least one strategy to deal with the BCG shortage, and four of the centers said they couldn’t give BCG at all, according to the report.

Medical centers told the survey they are splitting their medicine. A vial is supposed to be used for one dose for one patient, but instead, they use it for more than one patient. According to Fox, it is necessary for the entire container to be used within six hours of opening.

According to the FDA statement, the agency “cannot require a pharmaceutical company to make a drug – or make more of a drug – even if it is medically necessary. In addition, we cannot control how much of a drug is distributed – or which purchasers will be given priority.”

It would be difficult to expect pharmaceutical companies to make drugs or increase production that aren’t profitable, according to Wosiska.

Dr. Yoram Unguru, a member of the core faculty at the Johns Hopkins Berman Institute of Bioethics, said that “pharmaceutical companies can continue to generate profits while ensuring access to essential medicines.”

“The federal government must take a more hands-on approach and maintain a critical stockpile of essential lifesaving medicines and set prices for medications, akin to existing rate-setting bodies that oversee public utilities,” he said.