US prescription drug supply chains face coronavirus stress test | World news

The United States’ vital prescription drug supply chains could bend as the coronavirus outbreak highlights the global pharmaceutical syst...

The United States’ vital prescription drug supply chains could bend as the coronavirus outbreak highlights the global pharmaceutical system’s fragility, but they probably won’t break, experts said.

Health organizations are advising patients to secure 30- or 90-day supplies of maintenance medications. Some insurance companies are allowing early refills. But experts say Americans don’t need to worry yet – those recommendations are largely so that patients will have their medicines if they can’t go to the pharmacy and so they can maintain social distancing.

“If you’re in the US, you have a trustworthy and reliable supply of medicines. That hasn’t changed in the last two months,” said Ronald Piervincenzi, the CEO of US Pharmacopeia, an independent not-for-profit organization that develops medicine standards.

China saw a dip in drug production, but factories there are now getting back to work. India, another huge supplier, has announced it will keep some of the medications it makes on reserve. The US Food and Drug Administration has announced one drug shortage caused by the coronavirus but will not disclose what drug or where it is made.

What is Covid-19 – the illness that started in Wuhan?

It is caused by a member of the coronavirus family that has never been encountered before. Like other coronaviruses, it has come from animals.

What are the symptoms this coronavirus causes?

The virus can cause pneumonia. Those who have fallen ill are reported to suffer coughs, fever and breathing difficulties. In severe cases there can be organ failure. As this is viral pneumonia, antibiotics are of no use. The antiviral drugs we have against flu will not work. Recovery depends on the strength of the immune system. Many of those who have died were already in poor health.

Should I go to the doctor if I have a cough?

In the UK you and your household should stay at home for 14 days if you have either:

  • a high temperature
  • a new continuous cough

This will help to protect others in your community while you are infectious. Do not go to a GP surgery, pharmacy or hospital.

You do not need to contact NHS 111 to tell them you’re staying at home.

People who are self-isolating with mild symptoms will not be tested.

Is the virus being transmitted from one person to another?

China’s national health commission confirmed human-to-human transmission in January, and there have been such transmissions elsewhere.

How many people have been affected?

As of 17 March, more than 180,000 people have been infected in more than 80 countries, according to the Johns Hopkins University Center for Systems Science and Engineering.

There have been over 7,150 deaths globally. Just over 3,000 of those deaths have occurred in mainland China. 79,000 people have recovered from the coronavirus.

Why is this worse than normal influenza, and how worried are the experts?

We don’t yet know how dangerous the new coronavirus is, and we won’t know until more data comes in. Seasonal flu typically has a mortality rate below 1% and is thought to cause about 400,000 deaths each year globally. Sars had a death rate of more than 10%.

Another key unknown is how contagious the coronavirus is. A crucial difference is that unlike flu, there is no vaccine for the new coronavirus, which means it is more difficult for vulnerable members of the population – elderly people or those with existing respiratory or immune problems – to protect themselves. Hand-washing and avoiding other people if you feel unwell are important. One sensible step is to get the flu vaccine, which will reduce the burden on health services if the outbreak turns into a wider epidemic.

Have there been other coronaviruses?

Severe acute respiratory syndrome (Sars) and Middle Eastern respiratory syndrome (Mers) are both caused by coronaviruses that came from animals. In 2002, Sars spread virtually unchecked to 37 countries, causing global panic, infecting more than 8,000 people and killing more than 750. Mers appears to be less easily passed from human to human, but has greater lethality, killing 35% of about 2,500 people who have been infected.

Sarah BoseleyHannah Devlin and Martin Belam

Most pharmacies keep at least a month or two of drugs on hand, and the wholesalers who supply them have another month or two in stock, multiple experts said. Companies that produce completed medications also keep extra ingredients to ensure they can make their products. After that, the forecast is less clear.

“The vulnerability of supply for drugs that people take every day is an issue,” said Rena Conti, a health economist at Boston University. “And as China, Korea, Japan and Italy reduce exports of products, either because of facility problems in manufacturing or of staffing their facilities, or for their own national security purposes … we should expect there to be potential supply shortfalls, which might lead to shortages.

But, she emphasized: “You can have a supply shortfall that doesn’t ultimately lead to a shortage.”

While the US does have a strategic stockpile of pharmaceuticals and medical supplies, it contains things like respirators and antibiotics, not blood pressure medications or birth control pills.

One drug company, Merck, said it was not aware of any significant near-term impacts on the availability of its medicines and vaccines.

“We have also assessed potential longer-term impacts,” said spokesman Patrick Ryan. “The situation is fluid, but at this point we do not anticipate impacts to our supply chain unless disruption due to the Covid-19 outbreak is sustained over the next several months.”

Ryan added that for clinical trials, which are often the last option for critically ill people to seeking treatment, “the situation is evolving,” but the effects have been minor and manageable.

“At this point, we do not believe that any of our global studies are at risk,” he said.

Erin Fox, a drug shortage expert and senior pharmacy director at the University of Chicago, said the situation is “highlighting how fragile our direct supply chain can be”.

The US has long faced drug shortages, but mostly in hospitals, where doctors cannot always find drugs in their preferred dosage or have to use substitutes that serve the same purpose, she said. That is time-consuming and difficult.

“I think the main concern is are we going to pile on a whole bunch of new shortages on top of what we already have,” Fox said.

Drug experts say the FDA has far too little information about the percentage of drugs in use in the US that are reliant on facilities abroad.

Medicines are manufactured in three steps. First, raw biochemical ingredients are made and turned into ‘intermediaries’. Second, the intermediaries are then turned into an active form that is not readily consumable by patients. Last, those active ingredients are converted into consumable forms. Each step can happen in a different country.

US regulators know what facilities are licensed to produce medications, but they do not know how much of a given ingredient or drug they are making in a particular month.

The US has only about 14% of the sites that turn ingredients into their active forms, and India and China have nearly half, according to a study on generic drugs – which are the vast majority of what Americans take – that Conti and other researchers presented to the FDA earlier this month.

“The only way that we know where specific products are made is to go and ask the companies themselves who are making them,” Conti said. “Historically, pharmaceutical companies have viewed the location of manufacturing of their individual products as being a trade secret and the FDA has generally agreed with them.”

US lawmakers have for years been aware of the regulatory system’s knowledge gaps about drug supplies. They highlighted the problems as recently as October in a House committee hearing. Several legislators earlier this month proposed measures aimed at preventing shortages.

“The coronavirus outbreak has demonstrated how susceptible our nation’s drug supply chain is to disruptions that could have devastating impacts on our public health because of our overreliance on China for generic drugs …” said sponsor Anna Eshoo, a California congresswoman. “This legislation takes some first steps to increase what information the federal government needs to receive from drug manufacturers about ongoing shortages and requires manufacturers to have risk management plans to mitigate the impact of drug shortages that affect the American people.”

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Newsrust: US prescription drug supply chains face coronavirus stress test | World news
US prescription drug supply chains face coronavirus stress test | World news
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