Hospitals around the country are scrambling to stockpile vials of a critical drug — even postponing operations or putting off chemotherapy treatments — because the country’s only two suppliers have run out.

The medicine? Sodium bicarbonate solution. Yes, baking soda.

Sodium bicarbonate is the simplest of drugs — its base ingredient, after all, is found in most kitchen cabinets — but it is vitally important for all kinds of patients whose blood has become too acidic. It is found on emergency crash carts and is used in open-heart surgery and as an antidote to certain poisons. Patients whose organs are failing are given the drug, and it is used in some types of chemotherapy. A little sodium bicarbonate can even take the sting out of getting stitches.

“As I talk to colleagues around the country, this is really a problem we’re all struggling with right now,” said Mark Sullivan, the head of pharmacy operations at Vanderbilt University Hospital and Clinics in Nashville.

Hospitals have been struggling with a dwindling supply of the medicine for months — one of the suppliers, Pfizer, has said that it had a problem with an outside supplier but that the situation worsened a few weeks ago. Pfizer and the other manufacturer, Amphastar, have said they don’t know precisely when the problem will be fixed, but it will not be before June for some forms of the drug, and in August or later for other formulations. </s> Amid a national shortage of a critical medicine, US hospitals are hoarding vials, delaying surgeries, and turning away patients, The New York Times reports. The medicine in short supply: solutions of sodium bicarbonate—aka, baking soda.

The simple drug is used in all sorts of treatments, from chemotherapies to those for organ failure. It can help correct the pH of blood and ease the pain of stitches. It is used in open-heart surgery, can help reverse poisonings, and is kept on emergency crash carts. But, however basic and life-saving, the drug has been in short supply since around February.

The country’s two suppliers, Pfizer and Amphastar, ran low following an issue with one of Pfizer’s suppliers—the issue was undisclosed due to confidentiality agreements. Amphastar’s supplies took a hit with a spike in demand from desperate Pfizer customers. Both companies told the NYT that they don’t know when exactly supplies will be restored. They speculate that it will be no earlier than June or August.

As hospitals and pharmacists struggle with the sodium bicarbonate shortage, experts note that it’s just the latest example of stocks of inexpensive, essential generic medicines hitting alarming lows. For example, there was a sodium bicarbonate scarcity in 2012 and a similarly alarming shortage of saline solution in 2014.

Dangerous shortage of essential antibiotics is all about $$ Experts blame the shortages on a combination of factors, including problems getting raw materials, issues with aging facilities where many old drugs are manufactured, and consolidation in the industry that reduces the number of potential suppliers. There’s also the concern that because generic drugs are unlikely to drive profits, drug companies may not make necessary investments to maintain supplies.

But when there isn’t a steady supply, patients suffer. With the shortage of sodium bicarbonate, hospitals are postponing surgeries and chemotherapy treatments. A hospital in Mobile, Alabama, for example, postponed seven open-heart surgeries and sent one critically ill patient to another hospital due to the shortage.

The Food and Drug Administration is working with Pfizer and Amphastar to try to mitigate the effects of the scarcity. A spokesperson for the agency said that it is “exploring all possible solutions to this critical shortage, including temporary importation, to help with this shortage until it’s resolved.”

In recent years, the agency has been addressing the problem of shortages and has made progress. In 2011, there were 251 shortages, while there were only 23 in 2016. There are currently 50 drugs listed in short supply. </s> Hospitals are dealing with a shortage of sodium bicarbonate, a drug whose active ingredient is essentially the same one that cooks know as baking soda. Healthcare providers, which need the drug for uses that include heart surgery and chemo, are having to ration it right now because of supply issues reported by its primary producers, Amphastar and Pfizer.

“As I talk to colleagues around the country, this is really a problem we’re all struggling with right now,” Mark Sullivan, the head of pharmacy operations at Vanderbilt University Hospital and Clinics in Nashville, Tennessee, told the New York Times.

Providence Hospital in Mobile, Alabama, had to postpone seven open heart surgeries because of the shortage, officials told the newspaper.

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Amphastar is indicating it now has some supply available, but Pfizer said in a “Dear Customer” letter last week that it will be late June to sometime in August before it can provide clients with the simple but essential drug. It will be August into next year before it will have full recovery of supplies of some doses. In an email, a spokesman said the shortage is due to issues with a third-party supplier but not the API supplier.

Shortages of low-priced, stable drugs like sodium bicarbonate and saline solution have become a fact of life for hospital pharmacies. Often with just a few suppliers, if one has supply chain issues, increased demand can quickly overwhelm the inventories of other producers.

RELATED: Shortages, soaring generic injectable drug prices leave hospitals scrambling

In fact, Pfizer said in its letter last week, the shortage of sodium bicarbonate is one of eight it is dealing with right now. Also in short supply are Bicillin, labetalol hydrochloride, sodium acetate, calcium chloride, dextrose, atropine sulfate and epinephrine.

Pfizer told clients that the causes of individual shortages vary but the majority are due to three main factors: manufacturing, distribution, and third-party supplier delays.

Because of the supply-and-demand factors involved, when hospitals can get their hands on product from other producers, it comes at a much higher cost. That is what happened several years ago when a shortage of saline solution, another common but essential hospital product, plagued hospitals. In that case, however, hospitals got suspicious because there were a number of producers and ever-rising prices didn’t solve the supply issue. Some complained that producers were also tying sales of infusion supplies to availability of product.

RELATED: Prescription drug supply shortages fuel price hikes, new research shows

This all led to a congressional hearing and a federal investigation, with evidence now being heard by a federal grand jury. Baxter International, B. Braun and Hospira, now owned by Pfizer, are the major suppliers of saline. Pfizer and Baxter have reported that employees have been subpoenaed to testify before the grand jury. The companies have vigorously denied collusion and pointed to their efforts to increase supplies when the shortage materialized.

RELATED: Pfizer subpoenaed to testify in DOJ's antitrust probe of saline shortages

In the matter of the current shortages, Pfizer said that it has a “dedicated team focused on addressing these delays” and has taken eight steps to speed the recovery of supplies, including allocating some medicines to minimize stockouts, increasing production at key injectable plants and qualifying alternative third-party suppliers who meet the company’s standards.

As for hospitals awaiting supplies, it is more of the same, Kuldip Patel, the associate chief pharmacy officer at Duke University Hospital in North Carolina, told the Times: “It’s not like we haven’t been here before.” </s> An inexpensive generic drug that saves the lives of wounded soldiers and civilian car crash victims has now been shown to rescue women suffering hemorrhages in childbirth.

Postpartum hemorrhage, in which women bleed uncontrollably after childbirth, kills an estimated 100,000 women a year in poor and middle-income countries. The complication also forces doctors to perform emergency hysterectomies, especially when hospitals have too little blood on hand to provide transfusions.

In a major six-year trial involving over 20,000 women in 21 countries, researchers showed that tranexamic acid, a little-known blood-clotter invented in the 1950s, reduced maternal bleeding deaths by a third if it was given within three hours. It costs less than $2 a dose and does not require refrigeration.

The trial — known as Woman, short for World Maternal Antifibrinolytic — was led by doctors at the London School of Hygiene and Tropical Medicine and paid for by the Wellcome Trust, Pfizer, Britain’s health department and the Bill and Melinda Gates Foundation. Results were published in The Lancet on Wednesday. </s> Police in Japan are investigating whether a serial poisoner is responsible for killing as many as 48 elderly patients by injecting disinfectant into their intravenous drips.

Suspicions began after an autopsy showed two elderly patients had been poisoned in Oguchi Hospital, Yokohama.

Sozo Nishikawa and Nobuo Yamaki, both 88, died on 18 and 20 September respectively after having a drip administered.

Investigators found 10 unused intravenous drip bags with small holes in their rubber seals on the fourth floor of the hospital, where the two elderly patients had died, The Japan Times reports.

Police believe the suspect may be an insider with medical knowledge.

They are now also investigating the deaths of 46 elderly patients since July, who were being treated on the same floor as the two deceased men.

Hospital staff told the newspaper there had been no outbreaks of infection which could account for the deaths.

The two patients died around a lightly staffed three-day public holiday. The entrance to the hospital was locked and guarded at night.

Last month, a staff member's lips became blistered after they consumed a drink that may have been laced with bleach, The Japan Times said in another report.

It is unknown whether the incidents are related.

The investigation comes two months after the killing of 19 people at a facility for the disabled near Tokyo. </s> A cheap and widely available drug could save the lives of thousands of women who die in childbirth from excessive bleeding, one of the main killers of women worldwide.

The drug, tranexamic acid, is available over the counter in the UK to women suffering from heavy periods. In Japan and the far east, it is used as a skin whitener. But now a very large study of 20,000 women in 21 countries has shown it can stop a third of cases of bleeding to death after giving birth.

Haemorrhage after childbirth kills 100,000 women a year, mostly in low and middle-income countries. “It is not only the women dying – it is the impact on the child that has to grow up without a mother, children who might already be in the family and the husband,” said associate professor Haleema Shakur from the London School of Hygiene & Tropical Medicine who led the trial.

“This is of absolutely huge importance. While a single mother is dying, we need to keep fighting for them.”

The drug has already been proven to cut the death toll from bleeding after accidents in a trial of similar size. The latest trial, published in the Lancet medical journal, recruited more than 20,000 women who either gave birth in one of 193 hospitals involved or managed to get there after starting to bleed. They were randomly assigned either tranexamic acid or a placebo.

The researchers found that tranexamic acid was most effective when it was given soon after the bleeding began. The trial was originally intended also to find out whether the drug saved women from having to undergo a hysterectomy – the removal of the womb. But the scientists discovered that in many countries, where anaemia is common and blood supplies are limited, surgeons operated immediately as the surest way to save the woman’s life.

If all women who haemorrhage after childbirth were given the drug, the trial suggests that 30,000 lives could be saved a year. In practice, that will be more difficult. Tranexamic acid was given in an intravenous injection in the hospitals, as the quickest way to have an effect. Many women give birth at home and may not get to a hospital in time.

“It is available in the form of a tablet for heavy periods, but absorption may take too long,” said Shakur. They are now working on new ways to get it rapidly into women’s systems – perhaps as an injection in the arm muscle or as a capsule under the tongue. It is also possible that women deemed to be at high risk of haemorrhage could be given a tablet before they give birth. The trials have shown no side-effects, making the drug very safe.

Of the two-thirds of women who died in spite of being given the drug, Shakur said some arrived at hospital too late, while others had underlying illness including severe malaria and anaemia which may have been the cause of death.

It has taken a long time to show that the drug does work in the context it was designed for. Professor Ian Roberts from the London School, who co-led the study, said: “The researchers who invented tranexamic acid more than 50 years ago hoped it would reduce deaths from postpartum haemorrhage, but they couldn’t persuade obstetricians at the time to conduct a trial. Now we finally have these results that we hope can help save women’s lives around the world.”



There are many next steps, said Shakur. “We have to make sure tranexamic acid is available wherever a woman gives birth and is at risk,” she said. “We must make sure doctors and midwives are aware of the results of the study. And we need health ministers to make sure that the drug is available in their country and is on their shopping list of essential medicines.” </s> Trial of 20,000 women shows deaths from heavy bleeding after giving birth reduced by 30 percent with tranexamic acid.

Heavy bleeding after giving birth is the leading cause of maternal deaths worldwide, killing more than 100,000 women each year.

Around six percent of women suffer from postpartum hemorrhaging (PPH) - uncontrollable bleeding after giving birth.

In many cases, the lack of access to basic healthcare and medication is the difference between life and death.

But there is new evidence that a low-cost drug could save a third of those lives.

A trial involving 20,000 women in 193 hospitals across 21 countries - mainly in Africa and Asia - found that a widely available drug called tranexamic acid (TXA) could help save lives.

Within three hours of birth, women diagnosed with PPH were either given TXA or a placebo intravenously.

READ MORE: Why Sri Lanka beats India in maternal mortality ratios

Those who took the medicine - which stops bloodclots from breaking down - were significantly more likely to survive.

"We now have important evidence that the early use of tranexamic acid can save women's lives and ensure more children grow up with a mother," said Haleema Shakur of the London School of Hygiene and Tropical Medicine, which coordinated the trial.

"The need for an operation where you explore why a woman is bleeding can be reduced by a third and there are no side effects. It's really fantastic news for women all over the world."

TXA was invented in the 1960s by a Japanese husband-and-wife research team, Shosuke and Utako Okamoto.

According to the study published in The Lancet, almost all of the deaths from PPH took place in low-and middle-income countries.

"Mothers [in Pakistan] are faced with poverty and our social norms also don't encourage us to visit hospitals or doctors for regular checkups," Sajida Begum, a resident of Sher Garh Mardan in Pakistan's Khyber Pakhtunkhwa province told Al Jazeera. </s> A drug that costs just £3 could slash the risk of death by a third among mothers who suffer major bleeding after childbirth.

The cheap drug, called tranexamic acid or TXA, is only currently used as a last resort for women who suffer a major haemorrhage soon after giving birth.

But experts have called for the medicine to be become the 'frontline' treatment for post-partum haemorrhage, after a major international trial found it reduced deaths by 31 per cent.

Using the drug within three hours of a bleed also reduced the need for major surgery by 36 per cent, the team at the London School of Hygiene and Tropical Medicine found.

Every year 35,000 women in England and Wales suffer a haemorrhage after labour - one in 20 of all births.

The vast majority of these are resolved safely, but 13 or 14 times a year women die as a result, making it the third leading direct cause of maternal death in the country.

In many more cases women undergo major surgery to stop the bleeding, and in extreme cases doctors perform a hysterectomy to save the mother's life, removing their womb and spelling an end to their chances of having more children.

The new study, published last night in the Lancet medical journal, found that many of these tragedies could be avoided if women were given TXA as soon as possible.

The trial of 20,000 women - 500 of them in the UK - found no side effects from the drug for either mothers or babies.

Study leader Dr Haleema Shakur, associate professor of clinical trials at the London School of Hygiene & Tropical Medicine, said: 'We now have important evidence that the early use of tranexamic acid can save women's lives and ensure more children grow up with a mother.

Tranexamic acid was invented in the 1960s by a Japanese husband and wife research team, Shosuke and Utako Okamoto. But the drug, which works by stopping blood clots from breaking down, was neglected for decades because the inventors could not persuade a company to fund a major trial. In recent years, however, experts have rediscovered the drug's potential. A major trial of its use for trauma patients in 2010, also led by the London team, found it had huge value in stopping emergency bleeding. Within two weeks of that study's publication, TXA was being used by the British Army in Afghanistan, and it has now been adopted by UK ambulance services for roadside accidents. Its use in childbirth emergencies, however, has been slow to catch up. Part of the reason for this is the World Health Organisation only recommends it after all other treatments have failed.

'It's safe, affordable and easy to administer, and we hope that doctors will use it as early as possible following the onset of severe bleeding after childbirth.'

Dr Shakur said: 'That's too late - it has to be given as early as possible. We would like to see it used as a frontline treatment. At the moment it is being used ad hoc and not according to any clear guidelines.'

She said the new trial - which was funded by the UK Department of Health, the Wellcome Trust and the Bill & Melinda Gates Foundation - provides the evidence for new guidance.

Dr Shakur said: 'It has taken 50 years to get to this position, it is out of patent, and nobody is going to make a lot of money from it, so it has taken funding mostly from British taxpayers to get here.'

Professor Ian Roberts, who co-led the study, added: 'Now we finally have these results that we hope can help save women's lives around the world.'

Professor Lesley Regan, president of the Royal College of Obstetricians and Gynaecologists, said: 'The results of this important trial are very welcome and show that early administration of a cheap, widely available and heat-stable drug can reduce the number of maternal deaths from excessive bleeding after childbirth.

'Although post-partum haemorrhage is rare in the UK, there hasn't been a significant reduction in the number of deaths from the condition since 2009.'

The Royal College of Obstetricians and Gynaecologists, which sets guidance for British doctors, recommends that doctors ‘consider’ use of TXA.

But a spokesman for the college last night said: ‘We will now review our guidance in light of the study findings and make any appropriate changes.’ </s> A low-cost and widely available drug could save the lives of 1 in 3 mothers who would otherwise bleed to death after childbirth, according to a new study.

Severe bleeding, known as postpartum hemorrhage, or PPH, is the leading cause of maternal death worldwide, killing more than 100,000 women every year. Even for mothers who survive, it is a painful and traumatic experience.

The world's poorest countries, especially in Africa and India, are the worst hit.

But there is new hope. In the 1960s, Japanese researchers developed a drug called tranexamic acid, which works by stopping blood clots from breaking down. But they could not persuade doctors to try the drug for treating PPH.

The London School of Hygiene and Tropical Medicine has done just that, in a trial involving 20,000 women in 21 countries, mainly in Africa and Asia. The results show tranexamic acid reduces the risk of bleeding to death by almost a third, with no side effects for either mothers or babies.

Dr. Nike Bello, a consultant obstetrician and gynecologist in Nigeria, said that "if a drug can prevent hysterectomies, a drug can prevent death, a drug can minimize the amount of blood we need, then that is a good thing, all over the world."

But there are challenges to getting the drug where it is needed. First, the doctors must know about its effectiveness, said professor Ian Roberts of the London tropical medicine school, who led the latest research.

"We want everyone to hear about the results," he said. "But then there are the nitty-gritty issues. Is the treatment available in the hospital? Do doctors and midwives know how to use it? It is heat stable, so it does not have to be kept in the fridge. It is relatively inexpensive — it is about a dollar. And no child should grow up without a mother for lack of a treatment that costs a dollar."

In the trial, tranexamic acid was given via a drip. Researchers say the next step is to find an easier way to administer the drug so it can be used in clinics and rural settings across the world.
Because of a nationwide shortage of intravenous sodium bicarbonate (i.e., baking soda solution), United States hospitals are rationing its use in heart surgery, chemotherapy, for patients whose blood is too acidic, and as an antidote to certain poisons. The two primary producers, Amphastar and Pfizer, indicate that supplies will not increase until late June.