Poor dissemination and discrepancies in Union and state governments’ versions have made doctors lose faith in COVID-19 treatment protocol, leading to steroid misuse across the country
One common reason for the flagrant misuse of steroids during the second wave of the novel coronavirus disease (COVID-19) pandemic was the fear of the contagion, further stoked by the lack of immediate or assured access to healthcare.
So in many cases, a prescription given to one family member also became the prescription for his or her immediate family, extended family and even friend circles. There were several prescriptions widely circulated over social media and messaging applications.
Despite being a Schedule H drug under the Drugs and Cosmetics Rules, 1945, which prohibits over-the-counter purchase of several corticosteroids, including those crucial in the fight against COVID-19, without the prescription of a qualified doctor, patients recount that obtaining the drug over the phone was not difficult.
The situation worsened as most home-bound COVID-19 patients on steroid therapy did not get blood tests done to monitor their blood sugar level or markers of inflammation either due to lack of knowledge or due to lack of access to pathological laboratories, which were already overwhelmed with COVID-19 diagnosis.
As patients flooded hospitals, physicians too reached for any therapy in a desperate bid to save lives.
“In the intense second wave, when finding a bed was a luxury, mild use of steroids on moderate patients whose oxygen saturation levels had depleted ensured that their condition did not turn severe,” Ujjwal Parakh, a senior pulmonologist at Delhi-based Sir Ganga Ram Hospital, said.
This ensured that moderate patients did not require hospital beds, which were already running short to accommodate severe patients,” he added.
To avert a chaos like this, the Union health ministry had put in place the clinical management protocol for COVID-19 since the beginning of the pandemic. But as its engagement remained limited to updating or revising the guidelines and releasing them at press conferences in the national capital, the guidelines rarely reached doctors working overtime to treat COVID-19 patients.
Left in the lurch
“During the pandemic, the Union health ministry did update and revise its COVID-19 clinical management protocol to accommodate latest scientific understanding related to treatment. But most doctors, particularly in rural areas and even in tier II cities, were not aware of them. So, many relied on their experiences,” SP Kalantri, medical superintendent at Mahatma Gandhi Institute of Medical Sciences in Maharashtra’s Sevagram, said.
“As such in India, the tendency to prescribe or consume evidence-based medicine is low. This tendency became accentuated during the pandemic and created a situation for rampant steroid misuse,” Kalantri added.
The lack of adherence to the protocol was also because of a general sense of confusion and distrust about it. Consider this. The Union health ministry did not update the protocols for nearly six months after the first wave.
And then, during the peak of the second wave, it revised the guidelines twice — first on May 17 and on May 24. The discrepancy between the protocols set by the Union health ministry and those by state governments further added to the confusion.
For example, while revising the treatment protocols on May 24, the Union health ministry removed ivermectin, an anti-parasite medication, from its recommended list of drugs. However, Maharashtra continued to recommend it for treatment while Goa and Assam recommended it as a preventive medicine.
Jacob John, an infectious diseases expert at the Christian Medical College in Vellore, Tamil Nadu, cited another reason for the misuse of corticosteroids during the second wave.
He said India’s COVID-19 guidelines were too prescriptive. “They have just one treatment protocol for each one of three patient categories (mild, moderate and severe). But what would a doctor do if the prescribed treatment did not work with his patients?” he asked.
A sensible step would have been to recommend multiple treatment options, giving doctors the flexibility to choose the appropriate course of action according to the patient’s specific condition and response.
Such a flexible template exists in almost all developed countries. The UK guidelines, for example, provide three treatment options for each of the patient categories: recommended, conditional recommended and consensus recommended.
Recommended treatment includes interventions backed by solid research evidence. Conditional recommendation is given to interventions that have greater advantages than disadvantages, based on partial research available so far.
A consensus recommendation is given to interventions that the panel of doctors thinks is important even though enough research or evidence does not exist for it to be either accepted or rejected.
The other global trend is that the recommendations are backed by clinical evidence. In countries like the UK, all treatment protocols provide links to research papers based on which the guideline has been drafted.
“This makes the doctors more confident about their recommendations,” John said. No such clinical evidence finds a mention in India’s COVID-19 treatment protocol.
The World Health Organization guidelines also have a section titled “practicalities/implementation cons iderations” that discuss real-life problems doctors are likely to face and offers solution.
For example, while recommending that steroids should be administered after seven days of symptoms, the section acknowledges the difficulty doctors are likely to face in ascertaining the same.
So, it says “it was preferable to err on the side of administering corticosteroids when treating patients with severe or critical COVID-19 (even if within seven days of the onset of symptoms) and to err on the side of not giving corticosteroids when treating patients with non-severe disease”.
Where’s Schedule H?
What also appears to have compounded the problem of steroid misuse is the cheap and easy access to corticosteroids.
Though COVID-19 has put the spotlight on cortisteroids with India reporting the most alarming cases of widespread steroid abuse during the second wave, corticosteroid abuse has been a long-standing problem in the country.
A review of available research papers by Down To Earth shows that corticosteroids meant for topical application to cure skin ailments are highly abused. Though little study is available to understand the extent of misuse of orally consumed corticosteroids, vital in the treatment of infectious and a range of other life-threatening diseases, its possibility cannot be ruled out as studies elsewhere suggest a growing trend of reckless use of the medicine.
The consumption of prednisone, a kind of steroid used to treat acute respiratory ailments nearly doubled from 2007 to 2016 in the US, suggests a study published in PLOS Medicine in March 2020.
The study, which looked at over 9 million patients, found that almost 12 per cent of them were prescribed systemic steroids even though existing evidence and guidelines do not support their use.
A little more than 46 per cent of the patients received their steroids intravenously, which is known to cause stronger side effects and almost seven per cent received both oral and intravenous doses.
Could this also be the trend in India? Obtaining a Schedule H drug just over a phone call or by showing a text message on the mobile phone might have helped save some lives during the pandemic, but they could also be the reason behind many deaths.
Should the practice be left unchecked? Moreover, is this a practice that began during the pandemic or has been there before? All these questions need to be resolved as the government prepares for the imminent third wave.
The National Pharmaceutical Autho rity of India has already asked the manufacturers of two types of steroids, dexamethasone and methylprednisolone, to scale up production.
Its letter says the country is expected to require 3.3 million tablets of dexamethasone and 0.1 million tablets of methylprednisolone by August 15. Until the government learns from the mistakes made during the second wave, the risks of steroids may once again outweigh the benefits.
This was first published in the 1-15 August, 2021 edition of Down To Earth
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