Utter Desperation for Amphotericin B: Mucormycosis Drug Shortages
“Currently, we have 84 patients with mucormycosis. We didn’t have this many ever even in a whole year.”
“A friend’s father is still in the hospital. The doctor asked for a particular drug, but mentioned it was out of stock even in the prescription,” says Gaurav Suryawanshi, a Fifth Year Undergraduate at IIT Kharagpur currently residing in Indore.
As cases of mucormycosis rise in the country, we are faced with an acute shortage of the life-saving drug Amphotericin B, an antifungal medication used to treat serious fungal infections.
The pandemic is not over, urban cities have only just moved past a severe oxygen shortage - so why are we seeing shortages in essential drugs all over again?
And more importantly, will we be able to increase supply in time? How many patients will we lose due to a lack of essential medicines?
FIT talks to relatives of patients, doctors and attempts to talk to pharmaceutical representatives to get the full picture of what’s going on.
Why Are We Seeing a Shortage of a ‘Life-Saving Drug’?
Dr Abhishek Tandon, a Pulmonary, Critical Care and Sleep Medicine Resident at AIIMS Jodhpur explains that no one is really to blame, “it’s an impossible situation.”
He says while mucormycosis is a known disease, it was not very prevalent ever- especially not in the numbers we are seeing now.
“Currently, we have 84 patients with mucormycosis. We didn’t have this many ever even in a whole year.”Dr Abhishek Tandon, Pulmonary, Critical Care and Sleep Medicine Resident, AIIMS Jodhpur
Currently, the patients range from 20-70-year-olds but are “mostly in the 20-40 age range,” adds Dr Tandon.
AIIMS Indore is planning a mucormycosis ward soon too.
He explains that no one foresaw it as a complication of COVID-19. While there were reports from Gujarat and Delhi’s Sir Ganga Ram Hospital Hospital last year, there were fewer cases. “The volume was much less and further investigations found they were a result of the injudicious use of steroids - either given too early or too much. We couldn't have anticipated this surge in mucor cases this year.”
So why are we seeing more cases then? Two reasons:
- A surge in COVID cases, especially among young patients
- Cases with more complications
Dr Aparna Mahajan, Consultant, ENT, Fortis Hospital, Faridabad explains that earlier the infection in COVID patients was largely restricted to people with severe diabetes, cancer, or those on immunosuppressants for other illnesses.
Dr Mahajan explains that the reason for mucormycosis spreading rapidly now, in otherwise healthy COVID patients, is the indiscriminate use of steroids.
Dr Tandon concurs and adds that “mucor is inherently a virulent disease that spreads like wildfire - it can start from the nose and affect the cheek and brain. So early diagnosis and the life-saving drug becomes essential to start from day 1.”
“It spreads so fast that people die on day 3. Even if they don’t die, the infection can infect vital organs. The shortage of the drug means we are allowing the disease to propagate but it’s an impossible situation right now.”Dr Abhishek Tandon, Pulmonary, Critical Care and Sleep Medicine Resident, AIIMS Jodhpur
As per Healthline, Amphotericin B kills the “fungal cells by making the fungal cell wall more porous, which makes the fungal cell prone to bursting.”
So how are doctors dealing with the supply crunch? “We are using Posaconazole (triazole antifungal medication) while we wait. Recent evidence says it works for mucormycosis but there are no large scale studies on this and not enough data to compare efficacy head-to-head with Amphotericin. So it works, but we are not sure of the efficacy yet.”
Another complication? Most patients need the drug for 4-6 weeks and this long-term use of Amphotericin can take a toll on your kidneys. There is a liposomal formulation of it that doesn't harm the kidneys and has lesser side effects. But it’s costly and hard to get, especially in a supply crunch.
“Since we cannot get this version, we take consent from the patient saying Amphotericin B will harm your kidney but we explain the risk-benefits,” says Dr Tandon.
Where Are the Drugs?
Typically, the demand for Amphotericin B was less and the supply matched this. In 2021, the supply is struggling to catch up.
An official statement from Cipla reads, “There is an unprecedented surge in L Amphotericin B demand and we have already ramped up our production,” and offers no other tangible details of when the drug can be available.
There are five existing manufacturers of the drug in the country – Bharat Serums & Vaccines, BDR Pharmaceuticals, Sun Pharma, Cipla and Life Care Innovations. In addition, there is Mylan Labs, which only imports this drug, reports Financial Express.
Dr Tandon adds that almost every hospital is already running out in his city and local pharmacies and pharmaceutical representatives offer the same vague statements as Cipla. “They are assuring us they will have the stock by June first week, but these are just verbal assurances so far.”
He explains how their initial stock lasted for the first set of patients - but now they are running out.
The government is taking stock of the situation though, and five companies - namely NATCO Pharmaceuticals, Hyderabad; Alembic Pharmaceuticals, Vadodara; Gufic Biosciences, Gujarat; Emcure Pharmaceuticals, Pune and Lyka, Gujarat - have been given a license to manufacture the drug.
‘Putting the Onus on the Patient’
A quick scroll through social media, and we find the SOS calls for oxygen have been replaced by pleas for Amphotericin B.
As with treatments like Remdesivir and Ivermectin, the onus is once again on the patient to miraculously procure the drug. “But unlike Remdesivir and Plasma, Amphotericin B has proven efficacies against mucormycosis.”
Gaurav Suryawanshi tells me that the struggle for procuring the drug becomes a game of luck, networks and access. But many people inevitably get left out to die. “Patients kin are extremely stressed and worried, threatening to commit suicide in case medicines are not provided etc.”
“A lot of people are frantically getting and paying exorbitant prices. There is heavy regulated export from states but we are helping my friends father through our pan-India IIT network.Gaurav Suryawanshi, student
He explains how the better version of the drug -liposomal Amphotericin B - is also more expensive and running in short supply too.
So as supplies are being ramped up, and relatives are panicking, patients are still waiting in limbo for a life-saving drug.
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