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Drug shortages problem in US comes into spotlight

Drug shortages
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Due to drug shortages, customers are scouring pharmacies throughout the United States as demand rises.

Pharmacies are being forced to limit pill supply due to the shortage of renowned prescription medications like Adderall and amoxicillin.

The search for over-the-counter medicines is another reason why parents of sick children travel.

Shortages

Experts claim that drug shortages are not very unusual.

They claim that although it typically occurs more subtly, it frequently occurs in the US.

David Margraf, a pharmaceutical research scientist from the Resilient Drug Supply Project at the University of Minnesota’s Center for Infectious Disease Research and Policy, stated:

“Shortages hit a lot of different patient populations with different drugs and whatnot, but many of those don’t get a lot of headline news because they’re very niche.”

Since every scarcity has its own distinct causes, the explanation for the bare shelves can change depending on the location and the substance at any given time.

“They’re all a different tale,” said Margraf.

“There’s commonalities between them, but each one is a little bit different, and it’s very tedious trying to figure out what’s going on sometimes.”

Factors

Due to a lack of economic incentives to produce them, drugs are typically susceptible to shortages.

However, a lack of ingredients, labor disputes, or manufacturing interruptions can also affect availability.

While the US is a leader in developing new treatments, it also depends on other nations for drug manufacturing.

Many of the raw materials used to create new medications, according to Bindiya Vakil, are imported from China and India.

Vakil is the CEO of Resilinc, a business that maps and tracks supply chains to alert customers as soon as danger develops.

A rippling effect on product supplies could result from disruptions in China or India (such as a work stoppage at a Chinese firm because of its recently relaxed zero Covid policy).

Despite regular product levels, it might be challenging for families to find what they need during the current cold and flu season in the US due to strong demand.

Read also: Flavored tobacco banned in California law, health signs required across country

Reports

Several organizations are monitoring and keeping an eye out for drug shortages across the country.

Hospital pharmacists are represented by the nonprofit American Society of Health-Systems Pharmacists.

It monitors drug shortages in the US by taking into account any allegations of shortages and confirming the information by contacting manufacturers.

The nonprofit organization defines drug shortages as supply problems that impact how a pharmacy prepares or dispenses medicinal products or impact patient care if clinicians are forced to choose an alternative.

In late September, there were 260 active drug shortages, down from the 264 shortages reported in the second quarter of 2022, according to data from the American Society of Health-Systems Pharmacists.

The second quarter of 2019 saw 282 active shortages, which was close to the record high.

Drug shortages are also monitored by the FDA, which receives information directly from producers.

However, it has a different definition of shortages.

When the overall supply of all varieties of commercially accessible products is insufficient to match the current demand, pharmaceuticals are said to be in short supply.

Furthermore, shortages happen when a licensed substitute producer cannot keep up with current or anticipated demand, keeping patients in the dark.

The FDA reports that there are now fewer medications in short supply than in 2011, which was 251.

In 2021, they monitored 41 medication shortages.

In the same year, 317 shortages were avoided.

The FDA commissioned a task force in 2019 to address the “persistent problem” of drug shortages.

When they do happen, it might be difficult to fix because some cases endure for years.

For instance, between 2020 and 2021, the demand for Adderall significantly increased.

Leading producer Teva said that worker shortages were to blame for the delays.

The issue, though, has subsequently been fixed.

Adderall is subject to strict regulations from the government because it is a prohibited substance.

To prevent patient abuse, the Drug Enforcement Administration sets production restrictions.

David Margraf predicts that Adderall shortages will likely persist into 2023.

Vulnerability

The medicines that run out are usually cheap generic shots.

They are expensive to make because of their demanding manufacturing specifications.

They also have smaller profit margins, which makes it less profitable for businesses to produce them.

However, some generics, such as antibiotics, are susceptible to shortages.

A few amoxicillin formulations recently experienced the issue, according to researchers.

Instead of holding stock on the shelves in warehouses, companies typically make generic medications on demand.

According to several manufacturers, the 2022 orders did not account for the increased demand.

Even when businesses notice a shortage, manufacturing and transporting additional products takes weeks or months.

Vimala Raghavendran is the senior director of the US Pharmacopeia (USP), a nonprofit organization that establishes standards of excellence for the following:

  • Dietary supplements
  • Food¬†
  • Medications

“Really, it comes down to economics,” offered Raghavendran.

Through its Medicine Supply Map, USP has tracked pharmaceutical supply chains for the past three years to spot and prevent any shortages.

“Antibiotics are 42% more likely to be in shortage compared to other classes of drugs,” said Raghavendran.

“They have lower price points, so there’s less incentive for manufacturers to invest in excess capacity.”

“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.”

Read also: World Health Organization urged to change monkeypox name due to stigma

Staying ahead

Systems and backup plans are available to prevent drug shortages.

Manufacturers must notify the FDA if there is a disruption in a drug’s supply or production.

It frequently enables the organization to prevent issues.

Nevertheless, businesses are not currently compelled to inform the FDA of rising demand.

“But that’s something we’re really encouraging companies to do,” said an official.

“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.”

According to the White House, the Biden administration has drug shortages as a top priority.

The government emphasized President Joe Biden’s Executive Order on America’s Supply Chains, which Biden signed in February of the previous year.

It gave the Department of Health and Human Services secretary instructions to find and document hazards in the supply chain for pharmaceuticals and their active components and to offer suggestions for mitigating those risks.

Reference:

Empty pharmacy shelves shine a light on vulnerabilities in US drug supplies

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