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Who Should Get Experimental Covid Pills?

“It will probably be a very limited subset of even qualified individuals. [for the drug]”Linawen, an emergency physician and professor of public health at George Washington University, said. Qualified patients must jump over several hoops in an incredibly short period of time to use effectively, including onset of symptoms, positive tests, contacting a healthcare provider, searching for a pharmacy, etc. She added that it wouldn’t be.

With pills that you can take at home, you can fill the big gap in pandemic toolkits. Currently, healthcare providers have a limited number of Covid-19 treatments, each of which must be administered in a clinic or hospital. Effective use of Merck’s pills, combined with public health measures such as vaccines and masks, can mitigate future outbreaks and reduce the burden on the healthcare system.

“Time is important to the effectiveness of this product,” said B. Douglas Hoey, CEO of the National Community Pharmacists Association.

However, the supply of pills will be limited at first. The federal government has purchased 3.1 million courses of Molnupiravir. It will be obtained from the FDA approval date to early next year. You have the option to purchase another 2 million doses later if needed.

Federal health officials said, if permitted, federal-purchased tablets will be provided free of charge to areas that can be distributed through the health sector, community health centers, and pharmacies. “We will continue to work with the jurisdiction to plan the distribution and use of these products in line with clinical guidelines and recommendations on who should receive them,” officials said.

The state plans to use the distribution strategy adopted in previous Covid-19 therapy. Jim Blumenstock, Senior Vice President of Pandemic Response and Recovery for the State and Territory Health Officials Association, said: Their biggest job to date has been to set up an ordering system and help determine which facilities serve as a one-stop shop for patients, he added.

However, in Merck’s trial, the pill was tested only in unvaccinated adults, so some health professionals are wondering if the pill will be available only to that group. According to the Centers for Disease Control and Prevention, the unvaccinated population is just over 99 million, with 3 million doses being a “drop in a bucket.”

Meanwhile, Merck is assessing whether molnupiravir is effective against the Omicron mutant. Carlos Del Rio, Executive Associate Dean and Infectious Disease Specialist at Emory University School of Medicine, said the pill should “work” against other variants because of the way it blocks viral replication. However, he added, it would be important to collect more clinical data to ensure it.

Also, it is not yet clear how the pills will be distributed to patients. The pharmacy group warns that access may be further restricted if Medicare and Medicaid Service Centers do not guarantee that pharmacists will be paid to evaluate patients to dispense their medications. The Department of Health and Human Services allows pharmacists to evaluate patients and prescribe Covid treatments under the PREP Act, but the CMS has not developed a way to compensate for their clinical services.

“It’s time consuming and time isn’t free,” said Kurt Proctor, senior vice president of strategic initiatives for the regional pharmacist group.

If the pharmacist does not participate, the patient may have to make an appointment with a doctor, delaying the time to start the regimen.

“For what needs to be an agile and agile process, it actually pushes it into a more clumsy and time-consuming process,” he said.

Due to all possible distribution difficulties, some healthcare providers are concerned that efforts to distribute molnupiravir may not be worth it given the limited efficacy of the drug. increase.

In late clinical trials, molnupiravir is about Compared to placebo, it is 30% more effective in preventing hospitalization of at-risk patients. For comparison, antibody treatments given in clinics and hospitals are about 70 percent more effective.

Dolly Segeff, a surgeon and professor at Johns Hopkins University, said: He acknowledged that due to inequality in the healthcare system, some people may benefit from oral tablets that can be taken at home rather than in the medical setting.

At this week’s advisory board, experts also discussed drug safety concerns. Because it works by mutating the SARS-CoV-2 virus, just as an incomplete course of antibiotics can cause drug-resistant infections, if the patient does not take the full course, the virus New variants may escape. ..

Experts have also expressed concern about pregnant individuals who may need the drug. Pregnancy increases a person’s risk of developing severe Covid. However, in animal studies, molnupiravir appeared to lead to miscarriage and severe birth defects. Merck is urging the FDA to help healthcare providers work with pregnant patients to determine if their benefits are worth the risk, rather than banning pregnant individuals from taking them altogether. I asked.

Health providers consider experimental tablets as a weapon, but not a game changer. “It works, but it’s not as effective as some other tools,” Neely said.

The most important thing they claim is to stop future infections before they occur. “This is a cure, not a prevention, so it doesn’t help us get out of the pandemic,” Segev said. “The way out of this pandemic is prevention.”

Who Should Get Experimental Covid Pills?

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