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Tackling Coronavirus-Induced drug, medical supplies scarcity

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As the novel coronavirus (COVID-19) moves towards a pandemic, medical experts have warned that shortage or rather scarcity of essential drugs and medical supplies is imminent.

A pandemic is an epidemic of disease that has spread across a large region; for instance multiple continents, or worldwide. A widespread endemic disease that is stable in terms of how many people are getting sick from it is not a pandemic. Further, flu pandemics generally exclude recurrences of seasonal flu. Throughout history, there have been a number of pandemics, such as smallpox and tuberculosis. One of the most devastating pandemics was the Black Death, which killed an estimated 75–200 million people in the 14th century.

The only current pandemic is Human Immuno-deficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS), which started in the 1980s. Other recent pandemics are the 1918 influenza pandemic (Spanish flu) and the 2009 flu pandemic (H1N1).

Is the coronavirus a pandemic? For now the World Health Organisation (WHO) says no. It argues the number of countries with outbreaks; the severity of the

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disease and the impact on society has not reached pandemic-level.

But the global spread of COVID-19 is already threatening drug and medical supplies worldwide.The WHO on Tuesday warned that severe and mounting disruption to the global supply of personal protective equipment (PPE) – caused by rising demand, panic buying, hoarding and misuse – is putting lives at risk from the new coronavirus and other infectious diseases.

Healthcare workers rely on personal protective equipment to protect themselves and their patients from being infected and infecting others.

But shortages are leaving doctors, nurses and other frontline workers dangerously ill-equipped to care for COVID-19 patients, due to limited access to supplies such as gloves, medical masks, respirators, goggles, face shields, gowns, and aprons.

Director-General, WHO, Dr. Tedros Adhanom Ghebreyesus said: “Without secure supply chains, the risk to healthcare workers around the world is real. Industry and governments must act quickly to boost supply, ease export restrictions and put measures in place to stop speculation and hoarding. We can’t stop COVID-19 without protecting health workers first.”

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Since the start of the COVID-19 outbreak, prices have surged. Surgical masks have seen a six-fold increase; N95 respirators have trebled and gowns have doubled.

Supplies can take months to deliver and market manipulation is widespread, with stocks frequently sold to the highest bidder.Also, the Global Fund on Wednesday warned that the COVID-19 could derail progress on HIV, Tuberculosis (TB) and malaria, through disruption to treatment or other interventions or supply chains of critical medicines and medical supplies.

The Global Fund, yesterday, said experience from the 2015 Ebola outbreak in West Africa suggests that unless mitigating action is taken, additional deaths from existing diseases such as malaria can be at least as high as those from the outbreak itself.

The United States Food and Drug Administration (FDA) on Friday reported it has been alerted to one shortage by a drug-maker due to the outbreak without identifying the drug or the drug-maker but said alternatives to the drug were available.

It said it is in contact with more than 180 producers and is closely monitoring 20 products with APIs or formulations sourced solely from China. It has said it will look for alternative supplies if shortages occur.

The agency pointed out there is no vaccines, gene therapies or blood derivatives licensed by the FDA that are manufactured in China.But India is another matter. India gets nearly 70 per cent of its ingredients and drugs from China and then manufactures many of them for export to the rest of the world. A serious interruption in its supply lines could track directly to the US, creating shortages or forcing up prices.

Bernstein analyst Ronny Gal in a note last week said his team was told prices of “key starting materials” are already up 10 per cent to 50 per cent depending on who is asked, and generics producers are beginning to look to their clients to absorb those increases.

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The US relies on China for some or all-raw ingredients for 370 drugs dubbed ‘essential’ by the WHO. Among the drugs the US sources from Chin are 97 percent of all antibiotics, crucial medicines for treating bacterial infections.

Earlier on in the outbreak – which began in China in December 2019 – FDA regulators warned that disruption to the supply chain was all but inevitable. Also, the US FDA has contacted dozens of medical device manufacturers whose facilities in China may be at risk of creating shortages in the supply chain- and indeed, some facilities have already been disrupted by the coronavirus outbreak.

Masks can’t stop the coronavirus in the US, but hysteria has led to bulk-buying, price-gouging and serious fear for the future.The agency reached out to 63 companies with a total of 72 facilities in China that make essential medical devices, according to a statement late by FDA Commissioner, Dr. Stephen Hahn.

Also, medical experts in Nigeria have warned that the shortage of essential drugs and medical supplies in the country is imminent due to the global spread of coronavirus.

They however said the development of the petrochemical sector would have prevented the over dependence on imported raw materials for the local production of drugs. In fact they said that about 90 per cent of what is needed to produce medicines locally are sourced from petrochemicals and plants.

The Guardian reliably gathered that both local drug manufacturers and importers in Nigeria depend heavily on China and India for their raw materials or finished drug and medical products.

It was learnt that several of these facilities in China, India and elsewhere are adversely affected by the epidemic and their workforces have taken a hit from the outbreak, including employees being quarantined.

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The medical experts said the country losses $1 billion yearly to other nations because no local drug manufacturing company or their products are pre-qualified by the WHO to supply the medicines the agency uses in the country.

The medical experts include: Registrar, Pharmacists Council of Nigeria (PCN), Elijah Mohammed; Executive Secretary, Pharmaceutical Manufacturers Group of the Manufacturing Association of Nigeria (PMG-MAN), Frank Muonemeh; President, Pharmaceutical Society of Nigeria (PSN), Mazi Sam Ohuabunwa, and the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Christianah Mojisola Adeyeye.

Ohuabunwa told The Guardian: “There is a clear danger of drug shortages occurring in the medium term if the epidemic continues. Two of our main supply sources for raw materials and finished goods are currently challenged. China is facing business down turn due to the coronavirus epidemic and the restriction in manufacturing and trading activities, while India now overburdened by demand, has decided to restrict export, so they can satisfy local demand. Both factors are lethal to global supply chain of pharmaceuticals and Nigeria is one of the most exposed countries because of our over reliance on importation. A situation we have continuously drawn attention to.”

Ohuabunwa said it is unfortunate that the war we had long predicted has come on us unprepared. Interestingly, the pharmacist said Nigeria is currently producing 30 to 40 per cent of its essential drug needs but it certainly has the capacity to produce more. Ohuabunwa said with the right fiscal incentives, the capacity could be enhanced. “As at today, we can produce up to 50 per cent of our essential needs. But as previously indicated, we still import up to 80 per cent of the inputs (directly or indirectly). Thus should the restriction in China and India continue much longer, our out put will decline resulting in reduced installed capacity utilisation,” he said.

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The NAFDAC DG told The Guardian: “Nigeria needs to increase local manufacturing of drugs to avoid drug shortage that reflects drug insecurity. We import about 65-70 per cent from South-east Asia countries, mostly from China and India. If an epidemic like coronavirus persists, there could be drug shortages.”

Countries stop export of some drugs and medical supplies
While eyes have been on China for signs that COVID-19 might result in drug shortages, India has come up with a surprise of its own. The country, which accounts for about 70 per cent of generic drugs used in Nigeria especially the Anti Retro Viral (ARV) drug for HIV, has halted exports of more than two dozen Active Pharmaceutical Ingredients (APIs) and drugs.

India’s Directorate General of Foreign Trade yesterday (Tuesday) announced it was restricting 26 APIs and formulations until further notice. They range from paracetamol- the ingredient in Tylenol- to antivirals like acyclovir for treating shingles and antibiotic neomycin.Earlier on Wednesday, the German government had banned the export of medical gear and adjusted a national travel advisory to warn of an “elevated quarantine risk” associated with cruise ship travel.

Meanwhile, the Indian government gave no further explanation, but Dinesh Dua, chairman of the Pharmaceuticals Export Promotion Council of India, told Reuters, “Irrespective of the ban, some of these molecules may face shortages for the next couple of months.” If interruptions from the virus get worse, he said, some shortages might become “acute.”

According to The Independent UK, the move has led to “panicking” in European markets where India accounts for 26 per cent of generic drug imports, one industry group said, while the United States (U.S.), which also relies on India for generic pharmaceuticals, said it was assessing what impact the move would have.

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The Indian government has not provided a reason for the export ban, simply stating that the export of 26 APIs, and the medicines made from them, was “hereby restricted with immediate effect and till further orders”.

But with India itself sourcing 13 of the 26 APIs from Hubei province in China, the epicentre of the coronavirus outbreak, it is widely assumed that India is moving to protect its own populace from any possible shortages.

Dinesh Dua, chairman of the Pharmaceuticals Export Promotion Council of India (Pharmexcil), told Reuters that “if coronavirus is not contained, then in that case there could be acute shortages” of the drugs in question.

British officials moved on Wednesday to reassure the public that it was not currently experiencing any drug shortages, and that plans already in place to prepare for the possibility of a no-deal Brexit meant the United Kingdom (U.K.) was already fairly resilient to disruptions in the global supply of medicines.

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And the chief of WHO operations support and logistics, Paul Molinaro, said the organisation was setting up a group to look at further repercussions in the market that might stem from India’s move.

“At the moment it’s not as restrictive as we see right now with personal protective equipment, but the fear is that the ripple effects will make shortages in those medicines as well,” Molinaro told a Geneva news conference.

Developing the petrochemical industry will ensure drug security
The medical experts, however, said the development of the petrochemical sector would have prevented the over dependence on imported raw materials for the local production of drugs.

In fact they said that about 90 per cent of what is needed to produce medicines locally are sourced from petrochemicals and plants. Mohammed told The Guardian yesterday: “We are faced by two very big problems- drug shortage and coronavirus. Most of the drugs in the country either source all of their main ingredients or finished products from China. Most of the raw materials or excipients imported for local drug manufacturing are sourced from petrochemical industries in China and India.

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“We would have prevented the situation of imminent drug shortage if we had developed the petrochemical industry. It can confidently tell you that a developed petrochemical sector will provide 90 per cent of import-dependent products locally and save the country scare foreign exchange.”

Petrochemicals (also known as petroleum distillates) are the chemical products obtained from petroleum by refining. Some chemical compounds made from petroleum are also obtained from other fossil fuels, such as coal or natural gas, or renewable sources such as maize, palm fruit or sugar cane.

The two most common petrochemical classes are olefins (including ethylene and propylene) and aromatics (including benzene, toluene and xylene isomers). Mohammed said petrochemicals cumene, phenol, benzene, and other aromatics are used to make not only aspirin, but also penicillin and cancer-fighting drugs. Ultimately, he said, most drugs are organic molecules made using petrochemical polymer.

The PCN boss, however, said some of the major players in this industry include: BASF (Ludwigshafen, Germany), Dow Chemical (Midland, MI), Sinopec (Beijing, China), ExxonMobil Chemical (Houston, TX), Royal Dutch/Shell (The Hague, The Netherlands), LyondellBasell Industries (Rotterdam, The Netherlands), SABIC (Riyadh, Saudi Arabia), Mitsubishi Chemical (Tokyo, Japan), Ineos (Lausanne, Switzerland), and DuPont (Wilmington, DE).

It would be recalled that Ohuabunwa, and Adeyeye, told The Guardian that the country may suffer shortage of drugs if the coronavirus outbreak persists.

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Ohuabunwa said: “Development of petrochemicals is the foundation of our ability to produce raw materials, Active Pharmaceuticals Ingredients (APIs) and excipients. Nigeria is still at phase 2 of the National Petrochemical Development master plan. After building the Ekpan plant in Warri, sections of the Kaduna refinery and Petrochemical plant, and the Eleme Petrochemical plant, which now produces Alkyl benzenes, carbon black and urea used in making polyethylene, nylons, printing Ink and fertilizers, the implementation of the master plan seemed to have been stopped. When Government divested from the Eleme Petrochemicals, it seems to have abandoned further investing in this area.

“The third phase called the Aromatic Phase which would have produced things like Xylene and Toluene, precursors for synthesis of active pharmaceuticals like acetylsalicylic acid and para-amino benzoic acid seem to have been stalled.I recommend that the Government should dust up the master plan and reengage the implementation. There is no more time to wait or to beat about the bush.”

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Muonemeh said: “The pharmaceutical sector needs to be priortised. We need access to finance to live up to our responsibility of drug security. It closes the gap to access to medicine. It is only when the pharmaceutical industry is growing that it can produce essential medicines.

“Government needs to encourage local drug producers by patronage and providing access to finance. Other countries are paying attention to medicines’ security unlike Nigeria. It is like going to war not prepared. This coronavirus outbreak is a wake up call. We can produce simple things like hand sanitisers but because before now there was no patronage so most companies did not go into the production because they would suffer huge losses.”

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He added: “Nigeria losses up to $1 billion to the controversial WHO-prequalification. The WHO and other international agencies working in Nigeria procure drugs worth $1 billion from countries outside Nigeria for their health programmes in Nigeria. If our local industries were WHO-prequalified may be they would have been patronised.”

Ohuabunwa said: “Well our best option is to go back to the drawing board and revisit our plans and begin implementation immediately. First is to encourage local manufacturers to hasten the ongoing new investments into the sector and to accelerate plant refurbishments. And to aid this, the long demanded Pharmaceutical Development Fund should now be approved to enable investors in the sector access cheaper and long – tenured funds to execute planned and on- going projects.

“Secondly, is to ensure that all pharmaceutical raw materials and excipients will enjoy concessional tariff classification so that overall cost of production will go down and make locally manufactured medicines and commodities competitive

“Thirdly, we should provide specific intervention fund to the National Institute of Pharmaceutical Research and Development (NIPRD) to quickly ramp up on going research especially in phytomedicines and excipients. Fourthly, new investment must be driven into local production of Active Pharmaceutical Ingredients (APIs) for which we are currently wholly dependent on India and China.”

Ohuabunwa said as part of efforts to ensure drug security and contain the coronavirus, the PSN has already held a round table last year with all stakeholder groups in the pharmaceutical Industry, including researchers and academics where targets that must be achieved by 2022 were set.

These targets include: ramping up production to reach at least 50 per cent of national essential drugs need; production of at least five excipients from natural resources to replace imported raw materials; commercialisation of at least five new products all from locally sourced materials through partnership between the National Association of Industrial Pharmacists and the National Association of Academic Pharmacists; and establishment of a task team to midwife the establishment of an API Plant in Nigeria.

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The PSN President said, currently, the Society has issued advisories to pharmaceutical companies and distributors to release stocks of critical items for fighting coronavirus to the retail outlets, to mitigate scarcity. He said they have also counseled all pharmacists, especially those in the hospitals and in community practice to get involved in the enlightenment of Nigerians on coronavirus and how to prevent and mitigate impact.

Ohuabunwa said the PSN has agreed with pharmacists that there will be no undue price hikes or undue exploitation of the public and that pharmacists have resolved to support the government efforts to prevent and combat coronavirus.

“This is the time, all patients and members of the public must take care that they deal only with registered pharmacy outlets to avoid moving from frying pan into fire,” he said.

The WHO has called on industry and governments to increase manufacturing by 40 per cent to meet rising global demand
The WHO said it has so far shipped nearly half a million sets of personal protective equipment to 47 countries, but supplies are rapidly depleting.

Based on WHO modelling, an estimated 89 million medical masks are required for the COVID-19 response each month. For examination gloves, that figure goes up to 76 million, while international demand for goggles stands at 1.6 million per month.

Recent WHO guidance calls for the rational and appropriate use of PPE in healthcare settings, and the effective management of supply chains.WHO is working with governments, industry and the Pandemic Supply Chain Network to boost production and secure allocations for critically affected and at-risk countries.

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To meet rising global demand, WHO estimates that industry must increase manufacturing by 40 percent. Governments should develop incentives for industry to ramp up production. This includes easing restrictions on the export and distribution of personal protective equipment and other medical supplies.

Every day, WHO is providing guidance, supporting secure supply chains, and delivering critical equipment to countries in need.

According to the WHO, since the start of the COVID-19 outbreak, Nigeria and some other countries have received the WHO PPE supplies.

To address the situation, the Global Fund announced new guidance to enable countries to strengthen their response to the new coronavirus, COVID-19, by using existing grants in a swift, nimble and pragmatic way.

The Global Fund to Fight AIDS, Tuberculosis and Malaria (or simply the Global Fund) is an international financing and partnership organisation that aims to “attract, leverage and invest additional resources to end the epidemics of HIV/Acquired Immune Deficiency Syndrome (AIDS), tuberculosis and malaria to support attainment of the Sustainable Development Goals established by the United Nations.”

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Working within its mandate to fight HIV, TB and malaria and to strengthen systems for health, the Global Fund is encouraging countries to reprogramme savings from existing grants and to redeploy underutilised resources to mitigate the potential negative consequences of COVID-19 on health and health systems. In exceptional cases, countries may be able to reprogramme funding from existing grants to COVID-19 response.

Executive Director of the Global Fund, Peter Sands, said: “As was the case with Ebola, the Global Fund is committed to a pragmatic and flexible approach in supporting countries in the fight against COVID-19.

“Our priority is to ensure continuity of lifesaving programs to end HIV, TB and malaria. However, COVID-19 could knock us off track. People infected with HIV, TB and malaria could prove more vulnerable to the new virus given that their immune systems are already under strain.”

Strong health systems are critical to help countries respond to COVID-19, and to reinforce health security. The Global Fund is the largest multilateral provider of grants to strengthen health systems, investing over $1 billion a year in key components such as community health workers, disease surveillance systems, supply chains, laboratory networks.

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The Global Fund strongly encourages countries to consider and take prompt action under WHO guidance. Particular attention should be given to health worker protection, communication to affected communities, maintenance of essential services, supply chain coordination, early replenishment of stocks, disinfection of assets, and waste management.

Additional activities under the new COVID-19 guidelines include, but are not limited to, epidemic preparedness assessment, laboratory testing, sample transportation, use of surveillance infrastructure, infection control in health facilities, and information campaigns.

The Global Fund said it will deploy a fast-track decision making process for COVID-19-related requests for support.The Global Fund said it continues to work closely with partners at global, regional and country levels on COVID-19 preparedness and response, from resource mobilisation for CEPI (Coalition for Epidemic Preparedness Innovation), mobilising the private sector, securing the supply of vital medical products and expediting the development of diagnostics, to support WHO’s overall leadership of the global response.

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