Severe shortage of high-priced drugs to treat COVID-19
As Jamaica’s coronavirus crisis worsens, with surging infection numbers and deaths, the fight to save lives has got harder with the global shortage of the medication tocilizumab, an anti-inflammatory drug widely used in the treatment of COVID-19...
As Jamaica’s coronavirus crisis worsens, with surging infection numbers and deaths, the fight to save lives has got harder with the global shortage of the medication tocilizumab, an anti-inflammatory drug widely used in the treatment of COVID-19 patients who are moderately to critically ill.
Doctors, pharmacists, and hospital administrators have been reporting a shortage of the medication over the last month. Tocilizumab, which trades under the brand Actemra and which is manufactured by Roche, is traditionally used in the treatment of conditions such as lupus and rheumatoid arthritis. However, since the onset of COVID-19, doctors have been prescribing it for patients infected with the virus and have reported successful outcomes.
To complicate matters, the demand for another medication used to treat COVID-19 patients, remdesivir – an antiviral drug given through an IV for patients needing hospitalisation and distributed by Lasco Pharmaceuticals under special conditions locally – has also now outstripped supply.
Both medications are critical tools in the COVID-19 fight to save lives, especially given that Jamaica is now experiencing a devastating impact from a third wave of the virus, president of the Jamaica Association of Pharmacy Owners (JAPPO) and owner of Three Angels Pharmacy in Mandeville, Rohan McNellie, told The Gleaner.
The supply challenges now means that lives may be hanging in the balance, he said.
“There is no remdesivir, there is no Actemra, which are critical drugs that are needed,” he said.
The shortages of these key COVID-19-fighting drugs has again given rise to calls for the Ministry of Nealth to update its approved list of medications to allow for more options to treat COVID-19.
Speaking with The Gleaner on Friday, president of the Pharmaceutical Society of Jamaica, and chief pharmacist at Sunshine Pharmacy in Clarendon, Winsome Christie, said demand for remdesivir has now outstripped supply. The challenges are also complicated by the conditions under which remdesivir is imported, she said.
“It is still under emergency use. Lasco is the one that is allowed to bring it in; however, they have to get a special permit. So the demand is more than they can be allowed to supply in any one shipment [right now],” she said.
Hortense Edwards, a representative of Lasco Pharmaceuticals, declined to comment on the drug shortage, referring The Gleaner to the Ministry of Health and Wellness. However, no comment was forthcoming from the ministry up to press time.
While conceding that stocks of remdesivir are currently “very low”, CEO of the National Health Fund (NHF), Everton Anderson, told The Gleaner that a shipment was expected on Friday, with another set for next week.
As the government intermediary for the procurement of pharmaceuticals, the NHF buys the drug from Lasco and other suppliers, Anderson said.
Remdesivir was the first US Food and Drug Administration-approved drug for the treatment of COVID-19 and was administered to former United States President Donald Trump during his challenge with the virus.
While confirming the shortage of tocilizumab, CEO of the local distributor CARIMED, Glen Christian, is calling for the health ministry to take another serious look at its approved list of drugs for COVID-19 treatment.
“Just like ivermectin, remdesivir, I believe it is something that the health ministry needs to free up,” he said.
Manufacturing challenges have led to the local shortage of tocilizumab, he said. “It is a new-purpose drug. The problem is a manufacturing situation, a supply problem.”
Tocilizumab is “used either for persons who are coming in moderately ill [with COVID-19] and you are trying to rescue them before they get to severe, or persons who come to you very sick and you are trying to prevent them from getting worse because as they progress they need mechanical ventilation”, one doctor at the May Pen Hospital, who wished not to be named, explained.
SHELLING OUT BIG BUCKS
Families of COVID-19 patients have been scrambling to get doses of tocilizumab, shelling out close to $300,000 per dose.
A dose of remdesivir sells privately for $200,000.
“It is not cheap, but there are people who will buy it to save a life even if they have to pool their funds,” McNellie said.
“I get calls for these drugs every day. The calls mean somebody is dying, and when you say no, you don’t have it, you can hear their deep sigh.”
He added, “Those [drugs] are your last sources for hope. You know if they don’t get them, they are going to die. I had 15 people who needed my last set of Actemra, and I didn’t know who to give it to. One person needed it for her grandfather, and then another lady needed it. It is rough and [emotionally] taxing on you.”
He recounted an urgent call he received from a prominent person who was trying to source a dose of tocilizumab for someone.
“He sent his son to Mandeville to borrow a dose. I don’t know who they needed it, for but it was that critical that he drove to Mandeville with an Igloo to get it on a Sabbath morning when I was at church,” the pharmacist said, also noting the need for the health ministry to urgently revisit its list of approved treatment drugs for COVID-19 patients.
Also unfortunate is that rheumatoid patients for whom tocilizumab is actually approved will suffer, McNellie reasoned.
In a June 24, 2021, news release, the Food and Drug Adminsitration advised that it had given emergency authorisation for the use of tocilizumab in the treatment of COVID-19 for hospitalised patients.
It said that in clinical trials, the drug proved to “reduce the risk of death through 28 days of follow-up and decrease the amount of time patients remained hospitalised. The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased”.
While tocilizumab is not provided for patients in the public healthcare system locally, doctors have been recommending that families of COVID-19 patients purchase it privately “because COVID essentially triggers inflammation all over the body – the lungs, blood vessels, everything – so tocilizumab is a part of reducing that”, one doctor said.
Responding to The Gleaner via written responses, Roche, Actemra’s manufacturer, said despite its best efforts, “the unfortunate reality is that due to the unprecedented surge in worldwide demand – with [the] US demand spiking to well beyond 400 per cent of pre-COVID levels over the last two weeks alone – we will experience shortages of Actemra globally over the weeks and months ahead”.
It attributed the shortage to “global manufacturing capacity limits; raw material supply constraints; the complex, labour-intensive process of manufacturing biologics; and the dynamically evolving nature of the pandemic”, adding that its teams have been working around the clock to make Actemra available as quickly and widely as possible.
“So far, approximately 60 per cent of our estimated COVID-19 supply has gone to developing countries, following the urgent need and representing 300 per cent growth compared to the pre-pandemic supply to these countries,” the company said.
‘WHAT IS THE PRESCRIBED TREATMENT?’
CEO of the Kingston Public Hospital, Burknell Stewart, also noted the impact the shortage of the medications will have on fighting COVID-19 infections, which has so far led to an overall case count of almost 70,000 and more than 1,500 deaths locally.
“Do we have a best practice in terms of how we treat these patients? This [tocilizumab] is the medication that they use for COVID patients,” he said. “My acting SMO says they don’t have it at the pharmacy, and it is not coming into the island until September. Ivermectin is [also] prescribed by a lot of private doctors [while] patients are being given rehydration fluids, so what is the prescribed treatment?”
Since the onset of the pandemic, doctors have called for the authorised use of Ivermectin to treat COVID-19 patients. But the health ministry has held firm to its position that it will not approve the drug in this regard because the Government believes that its safety and efficacy for treating COVID-19 needs better research. The Ministry of Health’s website says it is still awaiting the outcome of large-scale studies that are currently ongoing to provide further guidance on safety and efficacy.
Meanwhile, the health sector is also looking at other drugs aimed at treating COVID-19 patients. One such, ronapreve, has been authorised for emergency use or temporary pandemic use in territories and regions, including the European Union, the US, India, Switzerland, and Canada, and has been approved in Japan.