Uttar Pradesh reported better availability–66% of the pharmacists interviewed said they stock the drugs–as did Bihar at 37.8%.

These prescription drugs, mifespristone and misoprostol, commonly referred to as medical methods of abortion (MMA), account for four out of five abortions in India undertaken by 10 million women every year, as reported by IndiaSpend in 2016. This implies a clandestine market in MMA, activists working in the field of women’s reproductive health alleged.

When asked why they did not stock MMA, 69.4% pharmacists cited “legal barriers”, said the study conducted by Pratigya, a network dedicated to women’s rights and their access to safe abortion care. This reason was quoted by 90.4% of those surveyed in Maharashtra and 75.6% in Rajasthan.

These “legal barriers” refer to concerns about sex-selective abortions that ensure the birth of only a male child, a practice common in countries such as India and China with a marked son preference in families. But, as we explain later, these fears about MMA’s misuse are misplaced–it cannot be used for sex selection because it is effective only in early pregnancy when the foetus’ gender cannot be determined.

“For women in India, access to abortion has been marred by extreme stigma, lack of awareness about its legality, unavailability of safe services near the community, and high costs charged by providers,” said Vinoj Manning, CEO Ipas Development Foundation, a not-for-profit organisation that works for safe abortion and contraception.

Abortion was legalised in India almost half a century ago, yet unsafe abortions–performed in unhygienic conditions by untrained providers–are the third largest cause of maternal death. An estimated 56% of abortions in India are unsafe, IndiaSpend reported in 2017.

MMA has a success rate of 95%-98% if administered properly, but the lack of medical supervision has resulted in a significant number of botched abortions in India.

The study surveyed 1,008 retail chemists across four states, interviewing at least 250 in each. The cities included were Bhagalpur, Darbhanga, Gaya, Muzaffarpur, and Patna in Bihar; Aurangabad, Mumbai, Nagpur, Pune, and Solapur in Maharashtra; Ajmer, Bikaner, Jaipur, Jodhpur, and Kota in Rajasthan and Agra, Ghaziabad, Kanpur, Lucknow, and Varanasi in Uttar Pradesh.

Rajasthan and Maharashtra were chosen for the study because there were reports of shortage of MMA in the market, VS Chandrashekar, CEO of Foundation for Reproductive Health Services, and Pratigya Campaign for Gender Equality and Safe Abortion, and writer of the study. Bihar and UP were chosen because they are highly populated and have poor socio-economic and health indicators, he added.

Most sales without prescription, study

Medical abortion pills are currently classified as Schedule H drugs, and therefore are legally available at pharamacists with prescription. But most clients come to ask for medical abortion drugs without a prescription, the study found, and therefore without information about the drugs.
“In this case, the obligation to give clients the right information about dosage and side-effects lies with the doctor and the chemists,” said Chandrashekar. “Many chemists also sell the medicine out of packs, in that case it is difficult for women or men to read the inserts.”

This form of abortion has prompted a new classification of “less safe” abortion by the World Health Organization. It is seen as better than “least safe” abortion, because it uses prescribed medication, rather than the introduction of foreign objects and use of herbal concoctions. But it is still not safe due to the absence of a trained provider.

‘Secret sales because of overregulation’

Why do authorities warn pharmacists against supplying MMA? The answer lies in the practice of sex-selective abortions in India.

From 2001 to 2011, India’s child sex ratio declined from 927 to 919 females per 1,000 males. In Rajasthan, it fell to 888 per 1,000, spurring the state into setting a target sex ratio of 940 by 2021, as reported by The Times of India in 2018. The Pre Conception and Pre Natal Diagnostics Techniques Act (PCPNDT), 1994, was brought in to tackle gender-biased sex selection in India, and raids and crackdowns were conducted on retail pharmacists and provider sites stocking MMA.

This conflict between providing abortions and fighting the declining sex ratio in Rajasthan and Maharshtra has “created barriers and roadblocks to women’s access to abortion care”, the study said.

Whilst 31.8% of pharmacists were told by drug authorities to sell them on prescription, 45% (and as much as 73.3% in Rajasthan) were told to not sell or keep the drug, the study found.  Most (56%) retail pharmacists interviewed for the study considered MMA to be overregulated compared to other Schedule H drugs. In Maharashtra, this response came from nearly all pharmacists (91.7%).

“As a result, medical abortion drugs are often secretely sold at chemists in Rajasthan off-record, for five or six times the price,” said Rajan Chowdhury, a Jaipur-based social activist who works in the field of women’s rights.

But the regulatory pressure on pharmacists stocking MMA is misplaced, said Chandrashekar. MMA cannot be used to facilitate sex selection because foetus’ sex can only be determined after the 13th-14th week of pregnancy while MMA has to be used within nine weeks.

Sex selection makes up 9% of abortions in India, it was found in 2015.

Ill-informed pharmacists

The overregulation of MMA not only prevents access to abortions, but also results in low knowledge about the pills as well as the legality of abortions among pharmacists. “The Pratigya Campaign is very concerned about this,” said Chandrashekhar.

The number of retail druggists who reported being trained on MMA was low–15% in Bihar and 9% in Uttar Pradesh, for example. Upto 64.5% reported getting information on the drugs from brochures and booklets. When asked, 35% of pharmacists could not recall the name of the drugs used for medical abortion. More than half of retail chemists thought that abortion medication is not useful for women.

There were signifacant gaps in awareness about abortion among pharmacists–43% thought that they are illegal in India despite its legalisation through The Medical Termination Of Preganancy Act in 1971. In Rajasthan, upto 60.7% thought abortion is illegal.

Three of four who stocked MMA were not aware that abortion is legal up to 20 weeks of gestation. A higher proportion of them (40%) considered abortion to be legal only upto 12 weeks of gestation. Awareness of this detail was the least in Uttar Pradesh at 9.5% though the state had the highest number of pharmacists stocking MMA (66%).

Less than a third (30%) of pharmacists were aware that the MMA drugs have to be taken within the nine-week limit. Just as many retail chemists misunderstood this period to be seven weeks.

No awareness among users

Since the providers are untrained, few women who buy MMA without a prescription get necessary counselling about the drug, its usage and side-effects. This is the “biggest problem women are facing”, said Kalpana Apte, secretary general, Family Planning Association of India and a member of the technical advisory group at the Pratigya Campaign.

Less than half the respondents (45.7%) were able to recommend the correct dosage of MMA to clients, 29.8% knew nothing of how it was to be taken, and 43.4% when. Upto 80.8% reported that they gave no information about the side-effects associated with the drug and this was despite the fact that 29.5% of clients returned to complain about side-effects. To those who complained, nine out of 10 druggists suggested that they consult a doctor.

“Currently, there is no training for Rajasthan chemists and when they give the pills it is without any guidance or instructions,” social activist Chowdhury said. “Going forward chemists must become more responsible for the sale of MMA, and give adequate warnings about its use.”

Upon purchase, 63.8% of pharmacists did not ask clients about their last menstrual period–necessary for calculating the term of the pregnancy–43% did not ask about the duration of the pregnancy, 54.2% did not ask for a doctor’s prescription. On average, 60% of clients who came to purchase the pills were men.

Apte and Chandrashekar both recommended increasing the base of doctors and nurses who can prescribe medical abortions, in line with recomendations from the World Health Organization.

“At present, only 60,000/70,000 doctors can prescribe MMA drug in the whole of India,” said Chandrashekar. “Widening the pool of providers to all doctors can increase doctors in India able to prescribe this drug to 800,000-1 million.”

This story was first published here on Healthcheck.

(Habershon, a graduate from the University of Manchester, is an intern with IndiaSpend.)
 

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TB screening and doctor referrals increased eight times, microbiological confirmations for TB rose almost seven times and TB registrations were 62 times higher when those with symptoms visited pharmacies with trained staff compared to those without, said the study commissioned by BMJ Global Health, a repository of journals specialising in non-communicable diseases.

With 18% of the global population, India currently reports the highest incidence of TB in the world–23% or nearly a quarter of all cases.

The study was based on an intervention conducted in Patna, capital of the eastern state of Bihar, where 105 trained pharmacies successfully diagnosed 255 TB cases, three times the number of patients (83) identified with TB symptoms by 699 untrained pharmacies in the control group.

Retail pharmacies—around 750,000 nationwide—often provide the first point of medical contact for potential patients. Given that the treatment for TB, a curable disease, reaches only about 59% of patients, as IndiaSpend  reported in March 2017, pharmacies could play an integral role in India’s fight against TB.

“Pharmacies as ‘gatekeepers’ have a role to play in helping potential patients,” said Amrita Daftary, one of the authors of the study. “They are usually the first point of contact for many people. People go to them when they develop any medical condition.”

Patients who were referred by trained pharmacists visited doctors 42% more often than they otherwise would have, the study found, and TB registrations, mandatory for private medical service providers after a 2012 government directive, were 62 times higher among those referred by the intervention group.

Completion rates for chest-radiograph (chest X-ray), sputum smear and GeneXpert test—three important steps in TB diagnosis—were higher for those who received referrals from trained pharmacists by margins of 37%, 13% and 23%, respectively.

Why private sector participation

TB is among India’s most deadly infectious diseases, with an estimated 2.8 million confirmed cases in 2015, according to a World Health Organization (WHO) report. Caused by the Mycobacterium tuberculosis bacteria, its transmission is airborne and occurs when an infected person coughs or sneezes.

India’s TB burden is the highest in the world, as we mentioned earlier, followed by Indonesia (10%) and China (10%).

The National Strategic Plan for Tuberculosis Elimination launched in March 2017 gave particular importance to the role of the private sector in the eradication of TB in India. The screening and referral intervention involving private retail pharmacies is meant to be a critical part of this plan.

Public-health facilities that specialise in TB in India are already overstressed, with little political will to change the situation, said a 2011 study by the National Center for Biotechnology Information.

Rural areas have poor medical infrastructure to treat the disease and private healthcare units remain unregulated, said the 2011 study, which added that “irrational” use of first-line and second-line anti-TB drugs was the other problem with TB care in India.

Patna’s TB rate exceeds Sub-Saharan Africa’s

Along with lower-than-average rates of health, income and literacy, Patna reports a TB incidence rate of 326 per 100,000 population. This is well over the incidence rate of Sub-Saharan Africa (237) and higher than the Indian average of 204. This made the city an ideal location for the project.

The intervention was carried out within an ongoing “public-private mix programme” in Patna. “Piggybacking on the PPM provided access to a vast majority of the private pharmacy providers in Patna,” Daftary said.

Of 804 private pharmacies enrolled in the programme, a random sample of 105 participated in the pilot event. They were recruited in phases:
The first set of 30 pharmacists was trained in December 2015, the second in February 2016, and the last set of 45 pharmacists in May 2016.
Their training comprised five components: (i) identifying TB through tell-tale symptoms, screening and diagnostic testing, and stewardship of antibiotics, (ii) referring potential TB patients for doctor consultations and chest X-rays, (iii) offering a financial incentive of Rs 50 for every completed doctor referral and chest test, (iv) added incentive of Rs 200 for positively diagnosed cases, and (v) field support with SMS reminders to reinforce the pharmacists’ training and screening process.

In parallel, 699 of 804 pharmacies, which did not receive the training, were observed for referral rates.

Trained group spotted 725% more cases

During the 18-month pilot period, 81% or 84 pharmacies in the intervention group referred at least one customer for a TB screening, followed by one of two pathways: chest X-ray and a medical consultation, or a direct doctor consultation.

Overall, the trained group identified 1,674 potential TB patients based on their symptoms, while untrained pharmacists could only find 203 (fewer by 725%), according to the study. Of those identified,  255 cases referred by the intervention group and 83 cases from the control group respectively, were registered as confirmed TB notifications.

A TB notification is created when the doctor or diagnostician registers a person with symptoms on to the National TB Surveillance System, and then on to WHO.

The final stage of diagnosing TB involves the microbiological tests (MB) — the intervention group reported 24% MB positive cases (61), while the control group reported 11% MB positive cases (9).

Why the intervention worked

Periodic group discussions and private interviews helped improve the intervention programme for pharmacists, the study found. The newly acquired ability to ‘dispense’ a screening test gave trained pharmacists a greater sense of professional responsibility towards TB patients.

“I feel good that I am able to serve my society,” said one unnamed pharmacist quoted in the study. “People are benefitting. We are able to provide care and people are getting better.”

Providers catering to customers in relatively poorer sections of the city reported a growing relationship with patients, often by way of repeated visits.

Successful doctor referrals were attributed to a sense of trust among customers for trained pharmacists. The free TB screening drove up chest X-ray referrals, and positive results from these, in turn, drove up doctor referrals.

These initiatives were seen as major facilitators for achieving a 81% referral rate among pharmacists, especially in comparison to similar studies in 2003, 2014, 2016 and 2018 which saw rather dismal referral rates of around 30-40%.

“This was a practical procedure nested into an ongoing PPM programme, providing access to their inventory of doctors and test labs,” Daftary explained. “Financial incentives were important to tap the private pharmacy sector. Individualised feedback systems for pharmacists with updates on successful doctor referrals and diagnosis also helped.”

What needs to change in the programme

Pharmacists in the study group sometimes delayed referrals to patients who demanded short-term antibiotic courses instead of sustained treatment. A solution to this could be the “creation of general public awareness about antimicrobial stewardship and the threat of drug resistance”, Daftary said.

Another roadblock was the documentation process. It was the standard practice in many pharmacies to verbally refer patients for doctor consultations. These cases did not find their way into the programme tally.

Some customers were also deterred by the distance they would have to travel to visit the contracted doctor or laboratory. “If I send [them] from here to [far], patients will say they may save money on test but transportation will cost them more (sic),” said a pharmacist quoted in the study. “So they feel better to get tested at a nearby lab.”

Some of the other barriers identified include increased workload for pharmacies, the absence of identifiable symptoms, doctor consultation fees and customer discomfort with the unknown doctor or lab they may be referred to, the study showed.

“The government should capitalise on the trust people place on pharmacies and chemists,” said Daftary. “There should be greater investment in pharmacy training to enable them to screen and refer potential TB patients.”

This story was first published here on HealthCheck.

(Saha, an MSc student at the Symbiosis School of Economics, Pune, is an intern with IndiaSpend.)

Courtesy: India Spend

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