A record 323 drug shortages in 2024 affected over half a million patients, highlighting the significant impact on public health.

Manufacturing and quality problems are the primary causes of most drug shortages, highlighting the need for improved quality control.

The COVID-19 pandemic and Russia-Ukraine conflict have disrupted global supply chains, causing shortages of essential medications and economic impacts.

The FDA has declared a nationwide Adderall shortage due to manufacturing issues and delays.

Healthcare systems have implemented strategies like alternative medications and delayed exams to mitigate medication shortage effects.

International collaborations, like the Pandemic Supply Chain Network, aim to mitigate supply chain disruptions' impact on medication availability.

The European Union has proposed a voluntary solidarity mechanism to address medication shortages, including an early warning system and an EU-funded emergency stockpile.

Addressing drug shortages requires a multi-faceted response from pharmaceutical companies, governments, and healthcare systems.

The World Health Organization has improved access to essential medications through global health governance and cooperation, and has set up an mRNA centre in South Africa, while Kenya is building a manufacturing facility with international support.

The COVID-19 Accelerating Access initiative has delivered 2 billion vaccine doses and the WHO has added 37 new medicines to its essential list, and the US and EU have donated over 1.1 billion and 500 million vaccine doses, respectively, to low-income countries. [9].

The COVAX initiative has delivered its one-billionth vaccine dose, and the WHO has recommended baricitinib and sotrovimab as new COVID-19 treatments, and is working to lower COVID-19 treatment prices and increase global production capacity to improve access to essential medications.

A record 323 drug shortages in 2024 affected over half a million patients, highlighting the significant impact on public health.

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Content: General Supervision
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General Supervision
Elham Aboul Fath
Editor-in-Chief
Thank you for your patience.
An Unexpected Catastrophe in the World ’ s Largest Country: The Complete Story of U.S. Drug Shortages
The deficit is at a record level.
According to data from the American Society of Health System Pharmacists and the University of Utah Drug Information Service, organizations began tracking drug shortages for the first time in 2001. Steady since 2021 – now reaching a record high of 323 drugs in the first three months of 2024.
Paul Abramowitz, CEO of the American Society of Health System Pharmacists, wrote in a blog post on Thursday: “It ’ s been a long time to end drug shortages, ” and wrote:“ All drug classes are vulnerable to shortages, some of the most worrisome shortages include sterile injectable generic drugs, including cancer chemotherapy drugs and emergency drugs stored in hospital vans and procedural areas. It is dangerous for doctors and patients. ”
In addition to the 32 chemotherapy drugs that are deficient, the five categories of drugs with the greatest deficiency include central nervous system stimulants, antimicrobials, hormonal agents, and intravenous fluids. [1] The Drug Deficiency Database maintained by the American Society of Health System Pharmacists and the University of Utah is based on voluntary reports from practitioners, patients, and others that have been confirmed by manufacturers. The U.S. drug is in short supply, because it captures broader effects on service providers and patients.
The crisis has lasted a year and a half.
More than half of the treatment shortages have lasted for more than two years, according to an analysis by health consultancy IQVIA, and the average shortage affects at least half a million patients, many of them elderly, according to the US Office of Health and Human Services under the Assistant Secretary for Planning and Evaluation, which shared its analysis with Congress in May.
Growing demand can play a role in drug shortages, as with the recent shortage of weight-loss drugs, but often manufacturing and quality problems, such as supply chain gaps and downtime, are the root cause. And varied.
But the American Society of Health System Pharmacists has “serious concerns ” about parts of this proposal, especially financial sanctions imposed on hospitals that lack the resources to comply with the recommendations, Abramowitz wrote:“ We all know that managing shortages is not enough and is not a sustainable solution to the worsening crisis, and there is still a lot of work to be done at the federal level to fix the root causes of drug shortages. ”
Why Shortage Occurs
Shortages can be caused by high demand, as with the recent shortage of weight-loss drugs, but this is not usually the main problem.
The FDA also blames manufacturing and quality problems, supply chain gaps, and downtime, and Dr. Emily Tucker, a drug shortage expert and an assistant professor of industrial engineering at Clemson University, says that when there is an indication of shortages, large health systems often also proactively place large orders, adding to the system ’ s stress.
“I don ’ t blame anyone.
“When I talk to all the stakeholders – whether it ’ s wholesalers, manufacturers, or the government – everyone wants this problem to end, ” she said.
Lack of transparency
Dr. Julie Grallo, chief medical officer and executive vice president of the American Society of Clinical Oncology, told the House Committee earlier that the shortage puts providers in a terrible position: “The drug shortage crisis is forcing providers to make impossible choices, and it is also hindering the development of new drugs. Health drugs are purchased only on a price basis, and manufacturers do not have to disclose the source of their acquisition of the ingredients.
The shortage of this generic chemical drug came due to the closure of one factory in India that manufactures the active ingredient after a surprise FDA inspection found “significant quality issues, ” says Jarallo:“ We didn ’ t know, and there was no transparency regarding the company ’ s supply of the majority of active pharmaceutical ingredients to all manufacturers across the board.
Knowing this in advance, we could have responded much faster, ” Dr. Steven Schundlemeyer, director of the PRIME Institute of the University of Minnesota School of Pharmacy, which focuses on economic and management issues, told the committee that as with defense contractors in the United States, New Zealand requires manufacturers to disclose their suppliers, and that information is required.
Easily accessible in the database.
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Manufacturing and quality problems are the primary causes of most drug shortages, highlighting the need for improved quality control.

The COVID-19 pandemic and Russia-Ukraine conflict have disrupted global supply chains, causing shortages of essential medications and economic impacts.

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Content: HealthIn-Depth AnalysisSocial Affairs
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In-depth: A Dollar a Dose, a Life Saved: The search for safer pharmaceuticals amid the challenge of widespread substandard medications

By Million Beyene @MillionBeyene

Addis Abeba – In the world of illicit trade, a dangerous threat looms in the form of substandard and illegally sold pharmaceuticals that endanger millions of lives worldwide.

A recent study conducted by the World Health Organization (WHO) has uncovered the massive scale of this problem, revealing that the illicit drug trade generates nearly a trillion dollars annually.

Surprisingly, this makes it the second-largest illicit financial stream globally, coming in just behind arms sales. However, the true impact of this hidden industry extends far beyond just monetary value.

In sub-Saharan Africa, including Ethiopia, the cost is counted in human lives.

Every year, almost half a million individuals fall victim to the dangerous consequences of using substandard and counterfeit medical products.

The ramifications of this issue are severe, as individuals often unwittingly procure and consume medications that prove to be ineffectual or even detrimental to their well-being.

The recent experience of Getachew Belay, a resident of Addis Abeba, serves as a poignant illustration of the predicament faced by such individuals.

He told Addis Standard about the distressing ordeal of procuring medications at a substantial cost of 90,000 birr, only to find them ineffective in treating his mother’s liver disease.

Regrettably, despite the doctor’s acknowledgment of the ineffectiveness of the “albumin” medication and subsequent refusal to administer it, this intervention was belated.

“Consequently, my mother succumbed to her condition shortly after discontinuing the ineffective treatment and before a suitable alternative could be provided,” recounted Getachew, reflecting on the most devastating experience of his life.

Dr. Mehari Tesfaye (name changed), a prominent medical director at a public hospital in Addis Abeba, shared insights with Addis Standard regarding Ethiopia’s escalating issue of substandard medications.

According to him, a notable example is “albumin,” a vital medicine employed in treating liver disease.

“The substandard variants of this medication are not only ineffective but also potentially harmful,” he emphasized, underscoring the peril associated with such drugs.

A nationwide study conducted in 2013 found that 7.8% of medications in Ethiopia were substandard.

Nevertheless, medical experts interviewed by Addis Standard disclosed that the incidence of substandard drugs has notably increased in Ethiopia over the past decade.

This observation aligns with research findings.

According to a study published last year, 21.8% of the drugs sampled in Ethiopia exhibited failures in one of the product quality parameters: dissolution, disintegration, identity, or chemical assay.

An anonymous medical expert disclosed the extensive availability of substandard, illicitly manufactured, or imported drugs in numerous pharmacies throughout Addis Abeba.

The expert highlighted a particularly troubling trend: the heightened involvement of licensed drug importers in the illicit drug trade, particularly over the past two years.

In Ethiopia, a particularly troubling issue arises from the presence of ineffective medications, even among those legally imported.

Medical experts have apprised Addis Standard of instances where drugs lack medicinal properties, aligning with public grievances about medications failing to provide therapeutic benefits.

Dr. Solomon Tezera (name changed), an infectious disease specialist, is among the medical professionals who express profound concern regarding the prevalence of ineffective medications.

“These concerns extend beyond smuggled drugs to encompass medications legally imported by some organizations,” he states. “Patients diagnosed through lab tests and prescribed medication often fail to experience improvement due to these defective products, resulting in a frustrating situation for both patients and medical staff.”

Patients diagnosed through lab tests and prescribed medication often fail to experience improvement due to substandard medications.”

An infectious disease specialist

Dr. Solomon further emphasizes the critical role of effective medications in managing chronic conditions such as diabetes, hypertension, and heart disease. He underscores that substandard medications for these illnesses can lead to a rapid exacerbation of symptoms.

“Medical professionals have recently identified and reported these problematic drugs to the appropriate regulatory bodies,” he added.

Recently, the Ethiopian Diabetic Association (EDA) also raised concerns about the efficacy of a medication named ‘Galvanez’.

Tackling substandard medications

The Ethiopian Food and Drug Authority (EFDA), a governmental regulatory body responsible for ensuring the safety, quality, and efficacy of medicines, has addressed these concerns.

Officials from the EFDA have stated that no official reports regarding the specific medication in question have been filed.

Gezahegn Endale, the head of the EFDA’s South East Addis Abeba Branch Office, affirmed, “No reports of substandard or defective medications related to Galvanez have been presented to the authority thus far.”

While no issues with Galvanez have been reported, the EFDA has noted a concerning trend of unauthorized drugs entering the country. These drugs often lack registration, approval from their country of origin, and information about their manufacturers.

Additionally, the EFDA recognizes the ongoing challenge of smuggled medications, particularly those targeting critical areas such as cancer treatment. The Authority has stated its active efforts to strengthen controls at border entry and exit points.

In a recent statement, the EFDA underscored its commitment to “identifying and removing any smuggled drugs to safeguard public health.” The authority highlighted its rigorous protocols for ensuring the safety and efficacy of all medications entering the Ethiopian market.

This includes thorough pre-market registration checks, which meticulously examine a drug’s production methods, ingredient lists, and accompanying scientific documentation before granting a market license.

Furthermore, to ensure quality, imported medications undergo extensive sampling, testing, and verification procedures beyond registration. Additionally, the EFDA conducts physical inspections at entry and exit points to enhance its safeguards.

Acknowledging the challenge of precisely quantifying the volume of smuggled drugs, officials at the EFDA assert that their regulatory measures are more stringent compared to those of neighboring countries. They underscore their “continuous endeavors to ensure the quality, safety, and efficacy of medications” across the entire supply chain.

However, stakeholders emphasize that the shortage of legally imported medications has compelled certain private pharmacies, licensed drug importers, and domestic drug producers to resort to smuggled alternatives.

Dr. Mehari underscored the challenges Ethiopia encounters in securing an adequate supply of legal medications.

“This susceptibility exposes the population to the hazards of smuggled drugs,” he elucidated. “Patients who unwittingly depend on substandard medications are at an elevated risk of complications.”

Gezahegn acknowledges the potential vulnerabilities within the distribution system and unethical practices by some wholesalers, such as auctioning off medications of dubious origin to retailers, which could introduce smuggled or unregistered drugs.

“The recent license revocation of four wholesalers supplying unregistered drugs to St. Paul Millennium Medical College’s Hospital exemplifies the EFDA’s commitment to addressing such practices,” he highlights.

Forex shortage, soaring prices

However, Gezahegn attributes a significant factor in such health risks to the scarcity of foreign currency in the country.

“This limitation restricts the ability of importers to acquire essential medications in sufficient quantities, potentially leading to drug shortages,” he explains.

Ethiopia meets the yearly requirement for medications and medical equipment primarily through imports, as domestic production satisfies only 15% of the national demand.

The Ethiopian Pharmaceuticals Supply Service (EPSS) oversees the acquisition of drugs and medical equipment, whether sourced locally or imported.

The scarcity of foreign currency in the country restricts the ability of importers to acquire essential medications in sufficient quantities, potentially leading to drug shortages.”

Gezahegn Endale, the head of the EFDA’s South East Addis Abeba Branch Office

Annually, EPSS supplies over 1,000 medicines and medical equipment to more than 5,000 public health institutions. In the previous year, it allocated over 40 billion birr for the procurement of drugs and medical equipment, with drug procurement alone amounting to over 15 billion birr.

Dr. Solomon further contends that the limited availability of foreign currency is hampering the capacity of local pharmaceutical manufacturers to import essential raw materials necessary for drug production.

Leaders of the Ethiopian Pharmaceutical Manufacturers Association also attribute their underperformance to the unavailability of foreign currency. They highlighted that 85% of the challenges they face are related to foreign currency shortages.

Mukamil Abdella, vice president of the association, recently stated in a state media interview that foreign currency is not accessible in the required quantity and timeframe for procuring raw materials essential for medicine production, adversely affecting their operations.

Another senior manager from a local pharmaceutical company disclosed that his firm requested $21 million for the acquisition of raw materials and other essentials. However, after an 11-month waiting period, the company was only allocated $5 million, which proved insufficient.

The persistent scarcity of foreign currency in Ethiopia continues to render the nation vulnerable to the influx of smuggled drugs, exacerbated by disruptions in the global supply chain that have led to inflated prices for pharmaceutical products.

Studies indicate that disruptions caused by the COVID-19 pandemic, further compounded by the Russia-Ukraine conflict, have resulted in a more than 200% increase in drug costs.

During his appearance before parliament to present the central bank’s quarterly report in November 2023, Mamo Mihretu, the governor of the National Bank of Ethiopia (NBE), acknowledged the escalating pharmaceutical costs, which are depleting the country’s foreign currency reserves.

According to Mamo, the costs of three key import items for Ethiopia—pharmaceuticals, petroleum, and fertilizers—have more than doubled in the past three years.

Although acknowledging that Ethiopia encounters obstacles in ensuring a consistent provision of legally imported medications due to factors such as limited foreign currency reserves, public health experts contend that these challenges should not serve as justification for the increase in illegal drug trafficking and the availability of substandard drugs in pharmacies.

Officials, however, assert that they are actively addressing the issue of smuggled medications despite the persistent challenge of detecting and eliminating any illicit drugs that may already be present within the country.

“The Authority is intensifying surveillance at entry points to deter smuggling,” stated Gezahegn. AS

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The FDA has declared a nationwide Adderall shortage due to manufacturing issues and delays.

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Content: Nationwide Adderall shortage impacting area pharmacies in the Panhandle

Published: Oct. 19, 2022 at 5:07 PM CDT|Updated: 19 minutes ago

AMARILLO, Texas (KFDA) - The Food and Drug Administration has declared a nationwide Adderall shortage and the Panhandle is feeling the affects.

The FDA blames the shortage on manufacturing delays.

Health experts say a shortage in stimulant medications is actually not a rare occurrence.

“The amount of medication that is produced is limited and regulated by the government, so there have been other years where towards the end of the year in particular, we start to struggle with supply issues. In this case, however, while that does seem to be probably one of the contributing factors, the other issue we’re facing, at least what we’re hearing about it right now, is that the manufacturing delays have been an issue and some of that has been secondary to the labor shortages,” said Dr. Carolyn Lentsch-Parcells, pediatrician and assistant professor at Burnett School of Medicine at TCU.

Martin Tipton Pharmacy is being impacted by this shortage.

“We’re having to order from various manufacturers right now, not our normal manufactures just because we cannot get them from our normal ones,” said Mark Vogler, Martin Tipton Pharmacy.

Fortunately its patients have been able to get their needed medication, just a different brand.

Amarillo Pharmacy is also being impacted, saying the drug has been back ordered for the past two months.

The Amarillo Pharmaceutical Care Center at Texas Tech Physicians is also seeing a back order on one of the strengths of the drug.

“The drug company manufacturers short-acting and extended-release, for example. So, a pharmacist, in this situation, will work collaboratively with the patient’s provider to find an available strength and dosage to meet the patient’s needs until the original strength becomes available again,” said Amarillo Pharmaceutical Care Center at Texas Tech Physicians.

Dr. Lentsch-Parcells acknowledged this may be an uneasy time for those depending on Adderall, especially with the end of the semester and holidays approaching. She encourages you to reach out to your providers.

“There are various strategies that we will sometimes use to help our patients get the best care possible, while we are trying to ride out the shortage, so that might be changing dosage or using dosage forms that are available to replace their typical medication,” said Dr. Lentsch-Parcells

She emphasizes not to make any changes to your medications without speaking to your providers first.

Pharmacy chains, like CVS and Walgreens, both confirm they are seeing intermittent supply issues with the generic form of the drug.

Healthcare systems have implemented strategies like alternative medications and delayed exams to mitigate medication shortage effects.

Title:

Content: NORTHAMPTON, Mass. (WWLP) – While this shortage of chemotherapy drugs stretches across the country, 22News looks at how the limited amounts of potentially life-saving drugs are impacting cancer care in our area.

It’s a problem, so acute it was recognized by the Biden Administration just last month. The White House noted there’s a shortage of 15 cancer drugs due to manufacturing and supply chain issues.

22News asked Pharmacy Director Michelle Kososki at Mass General Brigham Cooley Dickinson Hospital, to rate the shortage experienced locally on a scale, 5 being a critical shortage and 1 being no shortage at all, “right now I would probably say it is a four. We only have a very small supply of one particular drug.”

Pharmacy Director Michelle Kososki said drug shortages are not uncommon in the healthcare industry however, when faced with potentially life-saving drugs it can get complicated, “Anytime there is a shortage, there’s a risk of not being able to treat patients. Obviously, that is something we want to avoid and we work to the best of our ability with creative solutions to make sure that doesn’t happen.”

Nurse Manager Lisa Martensson at Mass General Care Center at Cooley Dickinson Hospital told 22News, “There’s always the ethical issues of who gets the drug that’s available. It’s supply and demand as you said and looking at what folks had for their disease which ones needed to be treated faster than others based on the aggressiveness of their disease. Those things played in but it was a really difficult decision to sit down and try and decide who would get the drug. We were never in a position where we had to deny anybody.”

Cancer patient Norman Uzdavinis of Whately said he was very concerned when he first heard of the shortage, “I had wondered where in the chemotherapy I would be at, would it have to be delayed for months or years if possible.”

Uzdavinis has not had his medical care compromised but feels for those who have, “I feel for them. I know what I’m going through and that everything is here so it’s perfect for me, but there’s a lot out there that are not as fortunate. I know that.”

“Healthcare providers here were able to mitigate the shortage by using a couple of different tactics. For example, they could switch up a patient’s medication regimen,” Nurse Manager Lisa Martensson said.

“What we did do was use drugs that were in the same classification but not necessarily that specific drug. There are also drug regimens where we could switch around the order to which we gave the drugs so if there was a drug that wasn’t available we are able to do one of the drugs that was available first and do that second drug second. That was able to work out so people didn’t do without and they were able to get what they needed,” Martensson continued.

According to the FDA, the shortage started when one of the major manufacturers of the chemo drug, Accord Healthcare, a company based in India, had to shut down after problems complying with good manufacturing practices were found during an inspection. Now, there is an increased demand from other companies that make these kinds of drugs.

22News contacted some other of the manufacturers of these drugs. Pfizer said they are increasing production by about 40 percent to meet this increased demand.

Local News

Alanna Flood is a reporter who has been a part of the 22News team since 2022. Follow Alanna on X @alannafloodnews and view her bio to see more of her work.

International collaborations, like the Pandemic Supply Chain Network, aim to mitigate supply chain disruptions' impact on medication availability.

Title:

Content: 7 essentials to create a resilient global healthcare supply chain

  • SARS, Ebola and COVID-19 have tested the world’s ability to deal with outbreaks and pandemics.
  • A global pandemic preparedness system needs sustained political will and investment to ensure the global healthcare supply chain can effectively respond to a crisis.
  • If we don’t get serious about pandemic preparedness now, millions more lives will be at stake.

It was 20 years ago, when the SARS outbreak exposed key fragilities in the global healthcare supply chain, that people internationally began to talk seriously about pandemic preparedness.

Eight years ago, when the Ebola outbreak proved the world no better prepared to address outbreaks, there was more talk and some action. This included the founding of the Pandemic Supply Chain Network (PSCN), by the World Health Organization, World Economic Forum, World Bank, World Food Programme, US Centers for Disease Control and Prevention, Henry Schein and more than 60 companies. The PSCN was established to make it easier to anticipate and respond to global healthcare supply chain disruptions.

Yet today, nearly three years into the COVID-19 pandemic – the worst global health crisis in a century – many of the same supply-chain fragilities remain. Although partnerships, such as the PSCN, and national efforts somewhat blunted the severity of supply chain disruptions during the pandemic, the effort to develop a global pandemic preparedness system has yet to garner the sustained political will and investment needed to ensure that the global healthcare supply chain can effectively respond to a crisis.

3. Improved stockpiles and inventory management

In addition to enhancing stockpiles of personal protective equipment (PPE) at the local, regional and national levels, we must manage inventory more intelligently – from cycling inventory to deal with product expiry to coordinating and harmonising responses across jurisdictions.

4. Platforms for data sharing and enhanced transparency

Through the globally-focused PSCN and various national efforts, including the US Supply Chain Control Tower, Henry Schein has been working across sectors to support the creation of market intelligence platforms that enable the appropriate sharing of real-time supply chain data. While progress has been made, encouraging responsible information sharing across public and private partners requires significant additional funding.

5. Fostering the free flow of goods

Over the past three years, government restrictions on exports played a significant role in exacerbating product distribution shortages. While the desire of governments to protect their populations in times of crisis is understandable, international cooperation to allow the free flow of key products lessens the risk of panic buying, hoarding and, ultimately, viral spread.

6. Coordinated early-warning system for outbreaks

Detecting the next outbreak early is essential to mitigating its impact, protecting global healthcare supply chains and saving lives. Strengthening our global surveillance capacity requires significant investment and better coordination across governments, international organizations and the private sector.

7. Strengthened health systems and better primary care

As Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, famously said: “Universal health coverage and health emergencies are cousins — two sides of the same coin.” Major and sustained investment is needed if we are to reap the benefits of expanded access to care.

Let’s conclude with another number: one. This is the number of viruses it could take to shut down our world again. If ever there was an issue to unite us – one for which we all share the same risk – pandemic preparedness is it. If we don’t get serious now, millions more lives are surely at stake.

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The European Union has proposed a voluntary solidarity mechanism to address medication shortages, including an early warning system and an EU-funded emergency stockpile.

Title:

Content: Brussels is planning for EU countries to share vital medicines and take emergency measures to avoid a repeat of shortages that hit the bloc a year ago.

The European Commission is proposing a “voluntary solidarity mechanism” requested by France and Germany and an early warning system flagging when drugs become scarce, according to draft proposals seen by the Financial Times. If insufficient donors come forward, EU capitals will be allowed to tap into an EU-funded stockpile set up during the Covid-19 pandemic and take other emergency measures.

In December and January western countries suffered a shortage of antibiotics including penicillin and amoxicillin, and painkillers such as paracetamol, especially in medicines used by children.

Among the emergency measures floated to prevent a repeat of that crisis, the commission could allow the extension of a drug’s shelf life, fast track approvals of alternative suppliers and support production increases.

Brussels will also encourage joint procurement of drugs from 2024 and medicine swaps with countries in the southern hemisphere, where peak winter demand happens at a different time.

The commission will draw up guidance for national stockpiles in 2024 and establish a Critical Medicines Alliance bringing governments, industry and civil society together. The commission declined to comment.

Three-quarters of countries reported a worsening of drug shortages in 2022, according to an industry survey. EU manufacturing is heavily reliant on imported active pharmaceutical ingredients from China and India.

Rising demand and disruption to supply chains have been compounded by inflation hitting the production of generic drugs, which typically sell at much lower prices than branded versions.

France has been actively encouraging the reshoring of basic medicine supply, with a giant paracetamol factory set to open in the country next year.

The EU is discussing whether to provide more funding for domestic production.

The commission’s proposal is scheduled to be approved on October 25 and could still change. Initially non-binding, it could lead to a Critical Medicines Act, with Brussels drawing up a list of vital medicines by year-end.

The commission also urges member states and the European parliament to approve its overhaul of pharmaceutical legislation, put forward in April. It includes plans to take control of drug production in the event of a public health emergency, a requirement for stockholders to inform Brussels of supply levels and for manufacturers to give early warnings of shortages.

An analysis by the European Medicines Agency and the commission found that unless there is unexpected demand the EU should avoid an antibiotics shortage this year.

“The information available today suggests that — if demand in the coming winter season does not differ significantly from the demand of recent years — the supply to the EU of key antibiotics seems to generally match demand,” the analysis said.

“However, this depends strongly on the compliance of industry with their legal obligations to ensure supply and their ability to adapt.”

Copyright The Financial Times Limited 2023. All rights reserved.
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Addressing drug shortages requires a multi-faceted response from pharmaceutical companies, governments, and healthcare systems.

Title:

Content: Ireland has been suffering a paracetamol shortage as cases of Covid-19 and the winter flu in the country soared over the festive and new year period.

The revelation was made by Health Minister Stephen Donnelly after his department received notification of a supply issue from the Health Products Regulatory Authority.

It is understood the shortage impacted some prescription paracetamol products.

Read More:Irish people complain of ‘worst ever’ winter bug sweeping country that feels like Covid but isn’t

Two suppliers affected have stated that resupply will be sometime in January 2023.

However, there are other prescription paracetamol suppliers with some stock available on the shelves.

Paracetamol is one of the medicines used most often in Ireland and especially for the flu, aches and pain.

But Mr Donnelly pointed out that there are multiple forms of the drug with different strengths and brands available from various sources.

He said: "In the event that there are some supply issues for individual medicines, alternative options such as alternative strengths and brands, generic medicines will usually be available to ensure continuity of treatment.

"In some cases where the medicine initially prescribed for the patient is unavailable, patients may be switched to a suitable therapeutic alternative following appropriate consultation with a healthcare professional."

The Health Minister said medicine shortages have been increasingly prevalent worldwide over the past decade. The causes of such shortages are multifactorial including shortage of raw materials, manufacturing difficulties and industry consolidations.

He stated: "Medicine shortages can originate at any point in the supply chain. They can involve and impact many stakeholders in different ways as the supply models and clinical use of therapies can vary across national health systems.

"Management of medicines shortages necessitates a multi-faceted, multi stakeholder response to ensure patient safety , continuity of care and protection of public health.

"Patients or their carers who have any concerns in relation to temporary alternative products provided because of medical shortages are advised to speak with their pharmacist or other healthcare [professionals] involved in their care."

Mr Donnelly was responding to a number of written Dail questions on the shortage of medicines.

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The World Health Organization has improved access to essential medications through global health governance and cooperation, and has set up an mRNA centre in South Africa, while Kenya is building a manufacturing facility with international support.

Title:

Content: Tuesday, 07 November 2023 01: 24 GMT
WHO: Egypt has developed its national vaccine capacity and reached maturity level 3
Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), said in a statement: “The coronavirus pandemic has shown the incredible power of vaccines, tests, treatments and other medical technologies to save lives, but it has also revealed the enormous inequalities in our world, in terms of access to those products, and, of course, this is not the first time. ” When HIV emerged more than 40 years ago, life-saving drugs were developed, but it was more than a decade before the world ’ s poor had access to them.
Egypt, for example, has launched a program.
In January this year, which brings together public and private sector manufacturers with different areas of expertise, Egypt has also developed its national capabilities, and has now reached the third maturity level of the World Health Organization (WHO) regarding vaccine regulation, I congratulate the Minister of Health and Population Dr. Khaled Abdel Ghaffar for the remarkable progress achieved.
Tedros said the program now includes a network of 15 recipient countries around the world, including five in Africa, adding that at the World Health Assembly in 2021, member states agreed on a resolution to boost local production of medicines and other health technologies.
In the same year, WHO and its partners established the mRNA Technology Transfer Centre in South Africa, to build sustainable manufacturing capacity in low- and middle-income countries to combat coronavirus and other global health threats including malaria, tuberculosis and cancer.
He noted that Kenya is also setting up a manufacturing facility from scratch.
During the construction of the KEMRI National Research Institute, he will receive mRNA technology on a research scale to promote the search for new vaccines tailored to the needs of the country and the region.
In India, the BiologocalE Technology Receiving Program is one of the program ’ s most advanced partners, and we have recently begun expanding the Indian network to include academic institutions.
We have also established the first global bio-manufacturing training centre in the Republic of Korea, so that the new facilities can be equipped with a skilled workforce, trained in general bio-manufacturing processes in an industrial environment.
Based on the lessons learned from the COVID-19 pandemic, we have also developed a proposal for a temporary mechanism for equitable access to medical countermeasures.
Commitment to local production and equitable access is also a key part of the epidemic agreement that countries are now negotiating, and the Second Global Forum on Local Production again brings together health, industry, trade and other sectors with manufacturers, civil societies, associations and other key actors.
We expect this forum to stimulate coordination, collective action and partnerships within national and regional ecosystems for technology transfer and sustainable local production.
There are many practical things governments can do, with the support of WHO and other partners, to strengthen the ecosystem for local production.
Provide an enabling environment, with policies and regulations to streamline approval processes, provide incentives for local production, and ensure compliance with quality standards.
Second: Provide investment and financing, through grants, tax incentives or low-interest loans to encourage private sector participation in local manufacturing.
Third, facilitate the exchange of knowledge and technology between the public and private sectors, through the promotion of research cooperation, and support the transfer of industrial knowledge.
Fourth: Building the capacity of the workforce, through training programs to increase quality, improve efficiency, and encourage innovation.
Fifth, ensure market access for local manufacturers by improving supply chain management and expanding market access.
When the H1N1 pandemic broke out 14 years ago, vaccines were developed, but by the time the world ’ s poor had access to vaccines, the pandemic was over.
The COVID-19 Accelerating Access to Anti-Coronavirus Tools Program and the Kovacs facility have delivered nearly 2 billion doses of vaccine to 146 countries, in addition to millions of tests, treatment cycles, medical oxygen and personal protective equipment, but narrow nationalism and hoarding by high-income countries meant many low-income countries got too little and too far. Time. Time.
Similarly, the Korona-19 technology access complex, or C-TAP, was created as an innovative platform for vaccine, testing and treatment developers to share their intellectual property and knowledge with manufacturers in low-income countries, but few manufacturers were willing to participate, so one of the most important lessons learned from the epidemic is that the ability to manufacture drugs, diagnostic vaccines and other technologies is a key component of the epidemic. The tools are concentrated in very few countries.
Expanding domestic production, and strengthening domestic regulatory capacity, is essential to reducing health inequalities between and within countries – not only for tomorrow ’ s environments, but also for today ’ s diseases.
“Access to high-quality medicines is a key priority for WHO and our Member States, ” he said, explaining that since 2018, WHO has supported more than 7,000 manufacturers, regulators and other stakeholders from more than 70 countries around the world to build their local manufacturing capacity. Coronavirus outbreak.
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The COVID-19 Accelerating Access initiative has delivered 2 billion vaccine doses and the WHO has added 37 new medicines to its essential list, and the US and EU have donated over 1.1 billion and 500 million vaccine doses, respectively, to low-income countries. [9].

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A U.S.-EU Agenda for Beating the Global Pandemic Vaccinating the World, Saving Lives Now, and Building Back Better Health Security

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Vaccination is the most effective response to the COVID pandemic. The United States and the EU are technological leaders in advanced vaccine platforms, given decades of investments in research and development.

It is vital that we aggressively pursue an agenda to vaccinate the world. Coordinated U.S. and EU leadership will help expand supply, deliver in a more coordinated and efficient manner, and manage constraints to supply chains. This will showcase the force of a Transatlantic partnership in facilitating global vaccination while enabling more progress by multilateral and regional initiatives.

Building on the outcome of the May 2021 G20 Global Health Summit, the G7 and U.S.-EU Summits in June, and on the upcoming G20 Summit, U.S. and the EU will expand cooperation for global action toward vaccinating the world, saving lives now, and building better health security.

Pillar I: A Joint EU/US Vaccine Sharing Commitment: the United States and the EU will share doses globally to enhance vaccination rates, with a priority on sharing through COVAX and improving vaccination rates urgently in low and lower-middle income countries. The United States is donating over 1.1 billion doses, and the EU will donate over 500 million doses. This is in addition to the doses we have financed through COVAX.

We call for nations that are able to vaccinate their populations to double their dose-sharing commitments or to make meaningful contributions to vaccine readiness. They will place a premium on predictable and effective dose-sharing to maximize sustainability and minimize waste.

Pillar II: A Joint EU/US Commitment to Vaccine Readiness: the United States and the EU will both support and coordinate with relevant organizations for vaccine delivery, cold chain, logistics, and immunization programs to translate doses in vials into shots in arms. They will share lessons learned from dose sharing, including delivery via COVAX, and promote equitable distribution of vaccines.

Pillar III: A Joint EU/US partnership on bolstering global vaccine supply and therapeutics: the EU and the United States will leverage their newly launched Joint COVID-19 Manufacturing and Supply Chain Taskforce to support vaccine and therapeutic manufacturing and distribution and overcome supply chain challenges. Collaborative efforts, outlined below, will include monitoring global supply chains, assessing global demand against the supply of ingredients and production materials, and identifying and addressing in real time bottlenecks and other disruptive factors for global vaccine and therapeutics production, as well as coordinating potential solutions and initiatives to boost global production of vaccines, critical inputs, and ancillary supplies.

Pillar IV: A Joint EU/US Proposal to achieve Global Health Security. The United States and the EU will support the establishment of a Financial Intermediary Fund (FIF) by the end of 2021 and will support its sustainable capitalization. The EU and United States will also support global pandemic surveillance, including the concept of a global pandemic radar. The EU and the United States, through the European Health Emergency preparedness and Response Authority, and the Department of Health and Human Services Biomedical Advanced Research and Development Authority, respectively, will cooperate in line with our G7 commitment to expedite the development of new vaccines and make recommendations on enhancing the world’s capacity to deliver these vaccines in real time.

We call on partners to join in establishing and financing the FIF to support to prepare countries for COVID-19 and future biological threats.

Pillar V: A Joint EU/US/Partners Roadmap for regional vaccine production. The EU and the United States will coordinate investments in regional manufacturing capacity with low and lower-middle income countries, as well as targeted efforts to enhance capacity for medical countermeasures under the Build Back Better World infrastructure and the newly established Global Gateway partnership. The EU and the United States will align efforts to bolster local vaccine manufacturing capacity in Africa and forge ahead on discussions on expanding the production of COVID-19 vaccines and treatments and ensure their equitable access.

We call on partners to join in supporting coordinated investments to expand global and regional manufacturing, including for mRNA, viral vector, and/or protein subunit COVID-19 vaccines.

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The COVAX initiative has delivered its one-billionth vaccine dose, and the WHO has recommended baricitinib and sotrovimab as new COVID-19 treatments, and is working to lower COVID-19 treatment prices and increase global production capacity to improve access to essential medications.

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WHO Director-General's opening remarks at the media briefing on COVID-19 - 18 January 2022

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Good morning, good afternoon and good evening,

The volcanic eruption near Tonga and subsequent tsunami requires an urgent response.

With telecommunications down, WHO is on the ground in Tonga helping coordinate the response by channelling information between UN agencies, humanitarian partners and the Tongan government.

Information on the degree of destruction is still being gathered but WHO will do all it can to support the people and government of Tonga.

I visited Tonga myself in 2019. I recognize how vulnerable to natural disaster and the climate crisis the country is but also how resilient and resourceful the people are.

We will do everything we can to support Tonga.

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Omicron continues to sweep the world.

Last week, there were more than 18 million reported cases.

The number of deaths remains stable for the moment but we are concerned about the impact Omicron is having on already exhausted health workers and overburdened health systems.

In some countries, cases seem to have peaked, which gives hope that the worst of this latest wave is done with, but no country is out of the woods yet.

I remain particularly concerned about many countries that have low vaccination rates, as people are many times more at risk of severe illness and death if they’re unvaccinated.

Omicron may be less severe, on average of course, but the narrative that it is mild disease is misleading, hurts the overall response and costs more lives.

Make no mistake, Omicron is causing hospitalizations and deaths, and even the less severe cases are inundating health facilities.

The virus is circulating far too intensely with many still vulnerable.

For many countries, the next few weeks remain really critical for health workers and health systems.

I urge everyone to do their best to reduce risk of infection so that you can help take pressure off the system.

Now is not the time to give up and wave the white flag.

We can still significantly reduce the impact of the current wave by sharing and using health tools effectively and implementing public health and social measures that we know work.

I am proud COVAX delivered its one-billionth dose over the weekend.

Of course it’s not enough and we should do more.

At a time of Omicron, it remains more important than ever to get vaccines to the unvaccinated.

Vaccines may be less effective at preventing infection and transmission of Omicron than they were for previous variants, but they still are exceptionally good at preventing serious disease and death.

This is key to protecting hospitals from becoming overwhelmed.

We’ve been able to track new variants like Omicron and this virus’ evolution in real time thanks to efforts of thousands of scientists and experts around the world.

More than 7 million whole genome sequences from 180 countries have now been submitted to GISAID, which was initially set up to track flu.

This pandemic is nowhere near over and with the incredible growth of Omicron globally, new variants are likely to emerge, which is why tracking and assessment remain critical.

New formulations of vaccines are being developed and assessed for how they perform against Omicron and other strains.

I am concerned that unless that if we change the current model we’ll enter a second and even more destructive phase of vaccine inequity.

We need to make sure we share current vaccines equitably and we develop distributed manufacturing around the world.

We can only beat this virus if we work together and share health tools equitably. It’s really that simple.

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On Friday, WHO recommended two new COVID-19 treatments, based on data from seven trials, again increasing the arsenal of tools used to fight severe illness and death: a rheumatoid arthritis drug called baricitinib and a monoclonal antibody called sotrovimab.

Again, the challenge is that high prices and limited supply means access is limited.

WHO is working with our partners in ACT-Accelerator to negotiate lower prices with manufacturers and ensure supply will be available for low- and middle-income countries.

We urge manufacturers to use WHO’s COVID-19 Technology Access Pool to share technology, know-how and voluntary licensing in order to facilitate increased production capacity globally, which would save the most lives.

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WHO’s COVID-19 clinical management guidelines have been critical to policy makers and health workers so that they can access the latest information on how best to treat patients with COVID-19.

Sharing clinical data remains critical so that WHO can generate up-to-date scientific evidence regarding Omicron.

WHO invites all Member States, health facilities and research networks to voluntarily contribute to the WHO Global Clinical Platform for COVID-19, which is available through our website.

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Next week, the WHO Executive Board, which is made up of 34 Member States, will meet to discuss the world’s health challenges.

The pandemic will remain at the forefront, particularly how to more effectively share tests, treatments and vaccines equitably and to meet the 70 per cent vaccine target by July 2022.

However, the impact of the pandemic on other health issues has also been devastating and Member States will be discussing how we can stop the backsliding and recover together.

WHO will be working to accelerate progress on negotiations around a pandemic accord, as well as sustainable financing.

If we’re serious about strengthening health systems, preparing for future pandemics and tackling the litany of health challenges we collectively face in a heating world, WHO and the whole global health infrastructure will need to be sustainably financed.

Reports from the Global Pandemic Monitoring Board, the Independent Panel for Pandemic Preparedness and Response and the Review Committee on the Functioning of the International Health Regulations all recognized the need for predictable and sustainable financing at all levels of the organization.

We don’t need more reports or speeches, now is the moment for financing that fits the health challenges of our time.

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This month is Cervical Cancer Awareness month and I am pleased to see both action and advocacy taking place.

Yesterday, Serbia announced that this year they would introduce vaccination against human papillomavirus, or HPV, the pathogen responsible for 99% of cervical cancers.

Serbia will join 116 countries worldwide that are vaccinating against this cancer causing virus.

And my sister Princess Dina Mired, who is a Member of WHO Expert Group for the Elimination of Cervical Cancer marked the anniversary of WHO’s global strategy by calling for a comprehensive approach to vaccination, screening and treatment.

Princess Mired rightly concluded that cervical cancer elimination is both possible and smart economics.

Christian, back to you.

I thank you.