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PLOS One logoLink to PLOS One
. 2022 Nov 23;17(11):e0278132. doi: 10.1371/journal.pone.0278132

Medical abortion drug dispensing practices among private pharmacy workers in Nepal: A mystery client study

Anil Sigdel 1, Mirak Raj Angdembe 1, Pratik Khanal 1,*, Nilaramba Adhikari 1, Alina Maharjan 1, Mahesh Paudel 1
Editor: Tatiane da Silva Dal Pizzol2
PMCID: PMC9683563  PMID: 36417473

Abstract

Background

Pharmacies are the first point of contact for women seeking medical abortion (MA) and act as important sources of information and referral in Nepal. Over the counter sale of MA drugs is not currently allowed in Nepal. This study aimed to assess the MA drug dispensing practices of pharmacy workers using mystery clients in Nepal.

Methods

A cross-sectional study using the mystery client approach was conducted in 266 pharmacies in September-October 2019. These pharmacies had either received harm reduction training or medical detailing visits. A total of 532 visits were conducted by six male and six female mystery clients. Mystery clients without prescription approached the sample pharmacy and filled out a standard digital survey questionnaire using the SurveyCTO application immediately after each interaction.

Results

Pharmacy workers dispensed MA drugs in 35.7% of the visits while they refused to provide MA drugs to the mystery clients in 39.3% of visits. Lack of evidence of prior consultation with a physician (27.5%), referral to other health facilities (21.8%), unavailability of MA drugs in the pharmacy (21.3%) and lack of prescription (16.4%) were the main reasons for refusal. Seventy percent of the pharmacy workers inquired clients about last menstrual period/months of pregnancy while 38.1% asked whether the pregnancy status was confirmed. During 65.1% of the visits, mystery clients were told about when to take the MA drugs while in 66.4% of visits, they were told about the route of drug administration. Similarly, mystery clients were briefed about what to expect during the abortion process in half of the visits, and information about the possible side effects of the MA drug was provided in 55.9% of the visits. Pharmacy workers provided correct information on taking MA drugs to mystery clients in 70.7% of visits.

Conclusion

Despite legal provision of sale of MA drugs only on prescription, pharmacy workers dispensed MA drug in one out of three visits. As pharmacies are the initial contacts of women for abortion services in Nepal, correct supplementary information through pharmacy workers can be an effective strategy to expand access to quality safe abortion services.

Introduction

There were around 121 million unintended pregnancies each year globally between 2015 and 2019 [1]. Of these unintended pregnancies, about 61% ended in abortion, which translates to 73 million abortions per year [1]. Among these abortions, 45% were unsafe and occurred globally each year, mostly (97%) in developing countries in Africa, Asia, and Latin America [2]. Unsafe abortion was one of the leading causes of maternal mortality and morbidity globally, accounting for about 18% of maternal deaths in the developing world in 2012 [3, 4].

The government of Nepal legalized abortion in 2002 [5] and medical abortion (MA) in 2009 [6]. The guideline to allow MA drugs through mid-level providers (paramedics) was introduced in the same year [6]. Under the current law, abortion is legalized up to 12 weeks gestational age on the request of pregnant women and up to 28 weeks of gestational age in the case of rape or incest, if the pregnancy is detrimental to a woman’s health and life or if there is fetal impairment [7, 8]. Of all unintended pregnancies in Nepal, 69% end in abortion [9]. Out of an estimated 323,100 abortions performed in Nepal during 2014, about 58% (186,100) were considered unsafe i.e., conducted by untrained or unregistered providers or self-induced [10]. Unsafe abortion accounted for about 7% of maternal mortality in 2009, with most deaths in rural regions in Nepal [11].

In Nepal, government registered MA drug brands (combination regimen) are available only on prescription through government-accredited safe abortion providers [12, 13]. The new safe abortion services guideline of the Ministry of Health and Population (MoHP) in 2021 allowed the provision of MA by skilled birth attendants (SBAs) and trained auxiliary nurse midwives (ANMs) up to ten weeks of gestation [8]. Combination MA drugs contain mifepristone and misoprostol, the two drugs when used one after the other can cause termination of pregnancy [14]. According to the WHO [15], the combination regimen of MA drugs (mifepristone and misoprostol) are more effective than misoprostol alone and is recommended for medical abortion at <12 weeks. The safety and effectiveness of MA drugs when provided by paramedical health workers, including nurses and ANMs have been well-established in low-resource settings [1618] and WHO guidelines recommend nurses/ANM provision of MA at scale [19].

Off-label or over the counter sales of MA drugs at pharmacies are not permitted in Nepal [20]. There are currently six registered MA products for sale in Nepal [21]. However, studies conducted by Population Services International in Nepal (PSI/Nepal) in the year 2017 reported that there are 17 different brands of MA drugs available in the Nepal market [12]. The unregistered brands of MA drugs enter the Nepalese market from India due to the open border and are generally sold at cheaper prices than the registered brands [12].

Pharmacies in Nepal are operated by varied professionals including pharmacists, pharmacy assistants, and health workers who have received 48–72 hours orientation on pharmacy. Drug dispensing is also common among paramedics in Nepal [22]. Pharmacy workers and more informal drug sellers have been the primary sources of information and medication for the treatment and prevention of any illness in developing countries including Nepal [23]. The Nepal Demographic and Health Survey (NDHS) 2016 data shows that 72.1% of women who had an abortion preceding 5 years adopted medical abortion procedure and about one-fifth of women who had an abortion reported receiving abortion services from pharmacies/pharmacists [24]. This is because pharmacies are more accessible for women who have limited autonomy and mobility and those in rural areas, and may offer more confidentiality than public sector health facilities [23, 25]. Women can self-administer MA drugs, complete the abortion and self-evaluate the completion of the abortion at home [2628]. Despite these benefits, the government of Nepal does not currently recommend the pharmacy provision of MA in Nepal [13, 19].

Several studies in Nepal and elsewhere have reported that untrained pharmacy workers often provide incomplete or inaccurate information and dispense unsafe and ineffective MA drugs [2931]. Nevertheless, women in Nepal will continue to seek MA drugs from pharmacies and since there is an increasing demand, pharmacies will continue to sell MA drugs, both registered and unregistered [32, 33]. It is therefore important to understand the pharmacy workers’ practice of determining clients’ gestational ages and medical eligibility for MA drugs, the accuracy of the information they provide to clients regarding the MA drug regimen, and complications including referrals in case of complications.

The Women’s Health Project (WHP) is a multi-regional project implemented in countries across Africa, Asia, and Latin America whose goal is to prevent unintended pregnancies and increase access to legal abortion, post-abortion care and post-abortion contraception [34]. In support of the Government of Nepal’s strategies and priorities, Population Services International (PSI) (US-based non-profit organization) has been implementing WHP since 2009 in Nepal to increase access to quality and safe MA drugs and services. PSI/Nepal has been facilitating the import and supply of Medabon® which can be used for MA [14]. PSI/Nepal also conducts medical detailing visits and provides a harm-reduction orientation to pharmacy workers who stock Medabon to educate them on the correct drug regimen and dispensing practices. This study aimed to assess the MA drug dispensing practices of private sector pharmacy workers in Nepal.

Materials and methods

Study design

A cross-sectional study was conducted in 267 pharmacies in Nepal where WHP was operational. As interview responses do not always reflect real-life practice, the study used a mystery client approach to collect the data [35]. In this study, mystery clients were trained people usually from the local community who visited the selected pharmacies in the assumed role of clients and then reported on their experience. Mystery clients were deployed under two scenarios in each pharmacy: i) A male mystery client seeking abortion for his wife within nine weeks of gestation and ii) A female mystery client seeking medication for an unmarried friend to induce an abortion within nine weeks of gestation.

Study population

The study population included pharmacy workers oriented by Nepal Chemists and Druggists Association (NCDA) on harm reduction in 2017 and/or those who have received medical detailing visits from market promoters of PSI/Nepal and had a stock of Medabon [36].

Sample size and sampling technique

The sampling frame prepared in Microsoft Excel included eligible 886 pharmacies spread across 27 districts and covering six out of seven provinces of Nepal (except Karnali province). A systematic random sampling method was used to select sample pharmacies. We calculated the required sample size, sampling interval (n = number of pharmacies in the sampling frame/required sample pharmacies), and a random starting point. The sample size of the required pharmacies was calculated using the formula for a cross-sectional survey. With a 95% confidence level and expected population proportion of dispensing MA drugs by pharmacy workers as 50% (conservative estimate) and a 10% margin of error, the required sample size was 268 pharmacies. After the random starting point was determined, we selected sample pharmacies after every nth interval. Considering a non-response rate of 5%, the final sample size was 281 pharmacies. A total of 562 mystery client visits were planned considering that each pharmacy received two mystery clients. However, only 532 mystery client visits (265 male and 267 female visits) were possible in the field. Data could not be collected from 14 pharmacies either because they were closed during the survey period despite follow-up visits or were wholesalers.

Training and data collection

The study team recruited and trained twelve young field researchers (six males and six females) aged 20–25 years as mystery clients. They were knowledgeable in reproductive health and belonged to similar communities like the ones where the sampled pharmacies were located. This was important to assure that they would blend in and not raise suspicion, which would have otherwise jeopardized the study. All of them had some experience in survey data collection and were from a health-related academic background (bachelor’s degree in public health or nursing). The mystery clients completed three days of training which included information on abortion and provision of MA drugs; survey objectives and methodology; learning and practice of predetermined scripts; and practice in the use of the digital data collection tool- SurveyCTO, to record visit reports. The mystery clients also practised role-play in pharmacies (excluded from the sample) in the Kathmandu Valley.

Mystery clients approached each sample pharmacy by saying that her/his friend/wife’s menstrual period was missed for nine weeks, and probed on specifics (MA drugs, side effects, route of administration, etc.) only if the pharmacy worker did not counsel on that information. Immediately after interaction with the pharmacy worker, the mystery clients went to a secure location and fill out a standard digital survey questionnaire using the SurveyCTO application on a smartphone. The questionnaire collected information on the background characteristics of the pharmacy worker, behavior, brand, and type of MA drugs offered, counselling practices, and use of communication materials. The questionnaire also included an open-ended section for additional notes. Each interaction of the mystery client with the pharmacy workers was about 25 minutes. Confidentiality of the mystery client was maintained throughout the study to prevent any leakage of identity or information disclosed. Mystery clients visited pharmacy workers during non-peak times to reduce interference from other customers. The mystery clients paused their interaction with the pharmacy workers when other customers arrived and re-initiated it when they left. In cases where the pharmacy worker offered the purchase of the MA drug, mystery clients were instructed to buy the drug and then return it to the study team. The study team had provided the money for buying the MA drugs.

The data collection took place from September to October 2019. Once data collection was completed, a focus group discussion (FGD) was conducted with the mystery clients to explore their experiences and insights. An FGD guideline was used to explore their experience of locating pharmacies, the physical setting of the pharmacies, behavior of the pharmacy workers, quoted cost of MA drugs, suggestions from pharmacy workers for additional services and gender differences in access to MA drugs (differential behavior of pharmacy workers towards male and female mystery clients). Information collected from the FGD has been presented as verbatim to supplement quantitative data wherever appropriate.

Data analysis

The datasets were downloaded from the SurveyCTO server and imported into Stata version 15 for analysis. Data were checked for missing values, outliers, and completeness of responses; thus, cleaned and labeled. Descriptive analysis was conducted by calculating frequency and percentages for categorical variables. Median (Interquartile range) was calculated for continuous variables that were skewed and open-ended questions were manually transcribed, coded, and analyzed under different themes and categories.

Ethical approval

Informed consent was not obtained from the pharmacy workers during the time of data collection and neither debriefing was conducted following the data collection because the mystery clients do not reveal their identities at the time of this study. However, the memorandum of understanding (MoU) between PSI/Nepal and the pharmacies already includes their consent on mystery client survey and other data/service quality monitoring procedures. Additionally, PSI’s market promoters had pre-informed pharmacy workers about the possible mystery client visits as a part of service evaluation process. No personal identifiers were disclosed anywhere in the study and strict mechanisms were put in place to protect the confidentiality of the pharmacy workers. Similarly, facility level analysis was not conducted. Ethical approval for this study including the waiver of consent procedure was obtained from the Ethical Review Board of Nepal Health Research Council (Ref: 800/2019).

Results

Outcome of mystery client visits

More male clients (38.1%) were dispensed MA drugs compared to female mystery clients (33.3%) Pharmacy workers refused to provide MA drugs to the mystery clients in nearly two of five (39.3%) visits (Table 1). Similarly, male pharmacy workers dispensed MA drugs (42.5% male and 35.4% female) in higher proportions than female pharmacy workers (25.7% male and 29.5% female) in mystery client visits. Interestingly, male pharmacy workers favored male while female pharmacy workers slightly preferred female while dispensing MA drugs. (Table not shown)

Table 1. Outcome of mystery client visits.

Outcome of mystery client (MC) visits Male MC visits Female MC visits Total MC visits
N (%) N (%) N (%)
Dispensed and bought MA drugs1 32 (12.1) 26 (9.7) 58 (10.9)
Dispensed but not bought MA drugs2 69 (26.0) 63 (23.6) 132 (24.8)
Referred3 37 (14.0) 57 (21.3) 94 (17.7)
Provided counseling and referred4 20 (7.5) 19 (7.1) 39 (7.3)
Refused MA drugs5 107 (40.4) 102 (38.2) 209 (39.3)
Total 265 (100) 267 (100) 532 (100)

1 Was counseled, offered, and sold MA drug

2 Was offered and counseled about MA but the client did not buy the drug

3 Was asked to seek services elsewhere and was not counseled

4Was provided and offered counselling and was referred to doctor/pharmacies

5No counselling or, MA offered, no referrals.

Lack of evidence of prior consultation with a physician (27.5%), referral to other health facilities (21.8%), unavailability of MA drugs in the pharmacy (21.3%) and lack of prescription (16.4%) were the main reasons for refusing to dispense MA drugs to mystery clients. Likewise, unavailability of MA drugs in the pharmacy (59.4%), lack of prescription (22%) and absence of partner (12.4%) were the prime reasons provided by pharmacy workers for referring mystery clients to other clinics/pharmacies.

“A female pharmacy worker took me into a private room within the pharmacy and asked for my signature before dispensing the MA drug. She then told me that I was too young to commit such a mistake.”- A female mystery client during her visit to Nawalparasi district

“Some pharmacy workers said that the MA drugs were kept hidden because they were illegal. In border towns, mystery clients were also told that they could be referred to pharmacies in India.”- A male mystery client during his visit to Kailali district

Information sought by pharmacy workers

A higher proportion of females (71.5%) were asked about the last menstrual period/months of pregnancy compared to male mystery clients (68.4%). Likewise, in 38.1% of visits, pharmacy workers inquired about whether the pregnancy had been confirmed and in 15.2% of visits, they wanted to know about how the pregnancy status was confirmed. In 2.8% of visits, the pharmacy workers asked clients about the reasons for abortion (Table 2).

Table 2. Information sought by pharmacy workers when asked for MA drugs (N = 323) (multiple choice).

Types of information sought from clients Male MC visits Female MC visits Total MC visits
N (%) N (%) N (%)
Last menstrual period/month of pregnancy 108 (68.4) 118 (71.5) 226 (70.0)
Whether the pregnancy had been confirmed 76 (48.1) 47 (28.5) 123 (38.1)
How the pregnancy was confirmed 22 (13.9) 27 (16.4) 49 (15.2)
Reasons for abortion 8 (5.1) 1(0.6) 9 (2.8)

Information provided to mystery clients

During 65.1% of the visits, mystery clients were told about when to take the MA drugs, while in 66.4% of visits, they were told about the route of drug administration. Information about the possible side effects was provided in 55.9% of the visits whereas in 23.6% of visits, they were informed about complications that may occur during the abortion process. Likewise, in 13.1% of visits, they were told where to go in case of complications. (Table 3).

Table 3. Information provided to mystery clients about MA drugs by pharmacy workers (N = 229) (multiple choice).

Information provided to MCs about MA drugs* Male MC visits Female MC visits Total MC visits
N (%) N (%) N (%)
When to take the drugs 80 (66.1) 69 (63.9) 149 (65.1)
Route of administration 87 (71.9) 65 (60.2) 152 (66.4)
What to expect during the abortion process 39 (32.2) 76 (70.4) 115 (50.2)
Possible side effects that may be seen during the abortion process 67 (55.4) 61 (56.5) 128 (55.9)
Complications that may occur during the abortion process 22 (18.2) 32 (29.6) 54 (23.6)
Where to go in case of complications 13 (10.7) 17 (15.7) 30 (13.1)
To consult the doctor on the fifteenth day to confirm whether the abortion is complete 7 (5.8) 12 (11.1) 19 (8.3)
The risks to the ongoing pregnancy 6 (5) 11 (10.2) 17 (7.4)

*includes those mystery clients who were dispensed and bought MA, dispensed but not bought MA drugs and those who were provided counseling and referred.

In 70.7% of visits, pharmacy workers provided correct information on taking MA drugs to the mystery clients (to take one 200 mg mifepristone pill on the first day orally and four 200 mg misoprostol pills after 24 hours or same time the next day either sublingually or vaginally). In most of the visits (95.7%), pharmacy workers told the mystery clients that vaginal bleeding could be heavier than during menstruation, but only half (56.5%) of them were told about stomach cramps. Vomiting and headache were the most common side effects mentioned by the pharmacy workers (Table 4).

Table 4. Information on how to take MA drugs, and side effects.

Information on MA drugs Male MC visits Female MC visits Total MC visits
N (%) N (%) N (%)
Information on how to take MA drugs* (N = 229)
Correct information 86 (71.1) 76 (70.4) 162 (70.7)
Incorrect information 35 (28.9) 32 (29.6) 67 (29.3)
What to expect during the abortion process (N = 115)
Vaginal bleeding heavier than menstruation 38 (97.4) 72 (94.7) 110 (95.7)
Stomach cramps 13 (33.3) 52 (68.4) 65 (56.5)
Nausea 6 (15.4) 24 (31.6) 30 (26.1)
Others** 0 (0.0) 2 (2.6) 2 (1.7)
Side effects mentioned (N = 128)
Vomiting 24 (34.3) 46 (65.7) 70 (54.7)
Diarrhea 5 (7.1) 11 (15.7) 16 (12.5)
Headaches 47 (67.1) 15 (21.4) 62 (48.4)
Chills and shivering 19 (27.1) 15 (21.4) 34 (26.6)
Transient fever 1 (1.4) 12 (17.1) 13 (10.2)
Others 11 (15.7) 10 (14.3) 21 (16.4)

*includes those mystery clients who were dispensed and bought MA, dispensed but not bought MA drugs and those who were provided counseling and referred.

** not mentioned, the patient may faint due to heavy bleeding

Regarding the use of information education communication (IEC) materials, pharmacy workers displayed MA strips in one-third (33.6%) of visits while explaining the process of taking MA drugs, leaflet was shown in 17%, and leaflet was given in 6.6% of the visits while dispensing the drug (Table 5).

Table 5. Availability and use of IEC materials by pharmacy worker while counseling on MA (N = 229).

Availability and use of IEC materials Male MC visits Female MC visits Total MC visits
N (%) N (%) N (%)
Showed MA strips* while explaining the process of taking the drug 31 (25.6) 46 (42.6) 77 (33.6)
Showed MA leaflets** while explaining how to take the drug 16 (13.2) 23 (21.3) 39 (17.0)
Gave MA leaflets while dispensing the drug 7 (5.8) 8 (7.4) 15 (6.6)
Showed IEC materials*** while counselling about the side effects of MA 4 (3.3) 4 (3.7) 8 (3.5)

*are the original MA drugs where pharmacy workers show the mystery clients about mifepristone and misoprostol.

**leaflets are the printed sheet of paper containing information about different aspects (side effects, indication, contra-indication, etc.) of MA drugs

*** these are IEC materials other than strips and leaflets.

In only two out of 323 visits, the mystery clients were informed about post-abortion family planning (one implant and one intra-uterine contraceptive device) by the pharmacy workers (results not shown in table).

Type and price of MA drugs offered to mystery clients

In nearly 80% of the visits, pharmacy workers mentioned the price of MA drugs to the mystery clients. In two out of three visits, pharmacy workers dispensed MA combi-packs, in 30.6% of visits they did not show any MA drugs, while in 3.5% of the visits they offered non-combination (separately packaged misoprostol and mifepristone) drugs to the mystery clients. The median price of the MA drugs, as quoted by the pharmacy workers was NRs. 942, higher than the MRP of NRs. 800 during the time of the study (Table 6).

Table 6. Type and price of MA drugs.

Characteristics Male MC visits Female MC visits Total MC visits
N (%) N (%) N (%)
Pharmacy workers informed clients about the price of MA drugs (N = 229)
Yes 90 (74.4) 93 (86.1) 183 (79.9)
No 31 (25.6) 15 (13.9) 46 (20.1)
Types of MA drugs offered (N = 229)
Combi packs 77 (64.2) 73 (67.0) 150 (65.5)
Separate packs 4 (3.3) 4 (3.7) 8 (3.5)
Didn’t show MA drugs 38 (31.7) 32 (29.4) 70 (30.6)
Misoprostol Only 1 (0.8) 0 (0.0) 1 (0.4)
Price of MA drugs (NRs.) (N = 183)
1–500 10 (11.0) 15 (16.3) 25 (13.7)
501–1000 49 (53.8) 42 (45.7) 91 (49.7)
1001–1500 23 (26.4) 27 (29.3) 50 (27.9)
>1500 8 (8.8) 8 (8.7) 15 (8.7)
Median Price NRs. 942

“In many cases, the quoted price was higher than the maximum retail price, and we were asked to pay more if we needed the medicine. Some asked for extra charges citing the potential risks of MA drugs.”- A male mystery client during FGD

“The quoted price of MA drug was usually higher for mystery clients posing as a friend of an unmarried pregnant girl. Also, the pharmacy workers said that in the absence of prescription the price of the drug will be higher."–A female mystery client during FGD

Discussion

Since the legalization of abortion in 2002, Nepal has made remarkable progress in the rapid scale-up of safe abortion services and is often regarded as a model for successful implementation [37]. Recently, the Government of Nepal through the ‘Right to Safe Motherhood and Reproductive Health Act 2018 [7] has further increased the indications under which abortion is legal, thus ensuring the right to safe abortion services. The National Roadmap to Improve Maternal and Newborn Health in Nepal (2019–2030) [38] acknowledges the rapidly expanding MA through pharmacies and recommends that mid-level health workers (ANMs, staff nurses and paramedics) working in the pharmacies be trained and certified to provide MA services. Among all safe abortion service users, the proportion of MA has increased over the last few years, from 53% in 2015/16 to 66% in the 2018/19 Nepali fiscal year [39]. Pharmacies are thus increasingly becoming the desired pathway for accessing MA drugs for abortion services among women in Nepal.

The over-the-counter sale of MA drugs is prohibited under the existing regulations of the Government of Nepal. Regardless, pharmacy workers dispensed MA drugs to mystery clients in more than one-third of the visits. In contrast, a study conducted in Kenya reported that only 4.3% of pharmacy workers provided abortion methods [40]. Nearly one in five mystery clients in our study were refused MA drug by the pharmacy workers during their visits because they did not have a prescription. Zambia in 2011 reported a higher proportion of refusal where nearly two in five mystery clients were not provided with the MA drugs because of legal reasons of not having the prescription [41].

In our study, male mystery clients were offered MA drugs more easily without much probing compared to females in the same pharmacies which reflects gender discrepancies in behavior of pharmacy workers. This might be due to unequal power relations between males and females in Nepal’s patriarchal dominant society and abortion stigma which also affects women’s reproductive health decision making [33, 42, 43]. A good interpersonal relationship between a patient and provider—as characterized by mutual respect, openness and a balance in their respective roles in decision-making–is an important marker of quality of care [44]. However, gender bias as such could affect trust in the health facilities and might force women to access unsafe abortions. Importantly, pharmacy workers should be trained to counsel male clients so that correct information be provided to MA user [45].

Given the effectiveness of MA drugs up to only nine to 10 weeks of gestation, the time since last menstruation must be investigated to determine the gestational age of the fetus. Ideally, confirmation of pregnancy by gynecological examination, ultrasound scan or biological tests is recommended. In most visits, pharmacy workers asked about the last menstrual period/month of pregnancy of their friends/wives to determine the gestational age. This result is similar to that of a study conducted in Uttar Pradesh, India where 76.6% of mystery clients were asked about their last menstrual period to confirm their gestational age [46].

Information on the correct time for taking MA drugs, route of administration and dosage, abortion process, side effects/complications and appropriate referral information are fundamental for ensuring safe MA. Studies elsewhere have shown that a significant proportion of pharmacy workers fail to provide this information to the clients while dispensing MA drugs [30, 32, 40, 4650]. One possible reason might be that the pharmacy workers might not be adequately trained in communicating this vital information while dispensing MA drugs [45]. In seven out of ten visits, pharmacy workers in this study correctly informed the mystery clients about the timing, dose and route of administration of MA drugs compared to a very limited proportion of the pharmacy workers in India (35.3%), Kenya (6.3%) and Zambia (21%) [40, 41, 50]. The harm reduction orientation provided by NCDA and medical detailing visits by PSI/Nepal’s staff does cover these topics which might have improved pharmacy workers’ skills in providing information about MA.

Pharmacy workers dispensed MA drugs to more than a quarter of mystery clients during their visits in this study. Most of them were offered the combi-pack (mifepristone and misoprostol) drugs for MA and more than half of them were informed about the side effects of MA drugs. But still, some of the pharmacies are offering separate packs for medical abortion which are considered illegal in Nepal. This might be because of the high influx of those medical drugs from India and high-cost margins [46]. The quality and source of these drugs are also questionable which can affect women’s health. We can assume that clients coming to buy MA drugs from pharmacies are usually seeking clandestine and quick abortion solutions at any cost. Pharmacy workers can take advantage of their desperate situation by quoting a price that is higher than the maximum retail price (MRP) and someone in dire need can be expected to oblige. In this study, the median price of MA drugs (NRs. 942) quoted by the pharmacy workers was much higher than the MRP (NRs. 800 similar to a study done in Pokhara, Nepal where seven out of nine MA drugs were sold at higher price than the labelled [32]. According to the mystery clients, pharmacy workers quoted a higher price citing the potential risks with MA drugs and the lack of prescription. The Department of Drug Administration (DDA) under the MoHP thus need to regulate the registration and pricing of drugs in Nepal.

By using a mystery client approach, this study has revealed the MA drug dispensing practices of pharmacy workers in Nepal and has some important implications. Even though pharmacy provision of MA drugs is not recommended in Nepal [7], pharmacy workers dispensed MA drugs and provided correct information most of the time in this study. Most of these pharmacies stock Medabon, a combination drug and have received training from NCDA and PSI/Nepal on the proper use and dispensing of MA drugs. This indicates that with proper training and orientation pharmacy workers may be able to safely provide MA drugs over the counter without a prescription. Similar recommendation was provided by a study done in Eastern Nepal in 2011 where pharmacy workers after harm reduction training provided correct information on use of medical abortion drug [51]. In a previous study done in Nepal, MA services provided by pharmacy workers were acceptable to women and were satisfied with the service they had received [20]. However, it will be essential to regularly monitor the pharmacies to check if they are following the national guidelines and are engaging in lawful practices.

This study has some limitations. First, there was a possibility of misreporting or recall bias by the mystery clients, although it was minimized through the completion of the structured survey questionnaire immediately after their exit from the pharmacy. Second, the identity of the mystery clients could have been compromised and the pharmacy workers may have behaved differently toward them. We minimized this by recruiting mystery clients from the local community and ensuring the local dialect and dress-up during their visit to the pharmacy. Third, the sample of pharmacies assessed in this study may not be representative of all pharmacies in Nepal. Since the pharmacy workers were trained by NCDA and PSI/Nepal in the past, their MA drug dispensing behavior can be assumed to be better than the rest of the pharmacies in Nepal.

The ubiquitous presence of pharmacies and relatively easier access in hard-to-reach areas, make pharmacy provision of MA drugs a viable option for bringing MA services closer to women in need. Recently in 2022, WHO in its new abortion care guideline recommended pharmacy provision of MA including self-management for induced abortion up to 10 weeks which was previously not recommended [52]. The new guideline recognized the skills and knowledge of these cadres for dispensing MA drugs. Given the involvement of varied professionals in dispensing drugs in Nepal at the pharmacy level, it would be important to orient these cadres especially with non-pharmacy background in dispensing MA drugs. During the COVID-19 pandemic, the family welfare division under the MoHP through the ‘Interim Guidance for RMNCH services in COVID-19 Pandemic’ [53] allowed all registered pharmacists to store and dispense MA drugs on prescription. Previously, only pharmacists within 100 meters of a registered safe abortion site were allowed to do so [13]. Although interim, this was a progressive policy change that if replicated in regular guidelines would further improve abortion access.

Considering the existing recommendations provided by WHO and country-level evidence, Government of Nepal should reflect and review the existing policies related to medical management of induced abortion to ensure universal access to sexual and reproductive health services. The relatively confidential setup and ease of access within communities make pharmacies an attractive option for women who want to seek abortion services. It would be best not to keep these services in the grey area as far as legislation is concerned but regulate them through adequate training and supervision.

Conclusions

In more than one-third of the visits, pharmacy workers dispensed MA drugs to the mystery clients regardless of the legal provision for dispensing MA drugs upon prescription. In seven out of ten visits, pharmacy workers correctly informed the mystery clients about the timing, dose, and route of administration of MA drugs. The figures could be different in pharmacies who have not received harm reduction training or medical detailing visits. Engaging pharmacy workers as first contacts of women for safe abortion services, particularly MA would thus be an effective strategy to reduce the incidence of unsafe abortion. For this, regular and effective training/orientation of pharmacy workers is pivotal which will also ensure conformity to existing legal standards. Training/orientation program should be focused on critical areas, including the provision of basic information on MA drugs, complications, and referral in case of complications, screening to determine a client’s eligibility for MA and informing clients about the possible side effects, mode of action, possible danger signs and the options for post-abortion family planning.

Acknowledgments

The authors would like to acknowledge the study participants for their participation in the survey. Similarly, we would like to thank field research team, and Health Foundation Nepal for their support in the implementation of the survey.

Data Availability

All relevant data are within the manuscript.

Funding Statement

The study is funded by the Women’s Health project implemented by Population Services International (PSI)/Nepal office. Neither the study nor the author’s salaries are funded in whole or in part by a tobacco company. All the authors are PSI Nepal staffs. The authors declare no competing interests in relation to this work. The donors are anonymous and are related to philanthropic organizations. The authors are not aware of any competing interests.

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Decision Letter 0

Tatiane da Silva Dal Pizzol

8 Aug 2022

PONE-D-22-11126Medical abortion drug dispensing practices among private pharmacy workers in Nepal: a mystery client studyPLOS ONE

Dear Dr. Pratik Khanal,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. The revised version of the manuscript must addresses all points raised during the review process by #Reviewer1 and #Reviewer2, besides the following points:

Introduction

Please review and clarify the following sentences:

-WHO Model List of Essential Medicine (reference 15) does not present data about the effectiveness of MA drugs; it just list the drugs.

-“The Nepal Demographic and Health Survey (NDHS) 2016 data shows that about one fifth of women who had an abortion reported receiving abortion services from pharmacies”. According to the NDHS, from pharmacies and health providers, right?

Methods

“A total of 15 pharmacies were considered as non-response as these pharmacies were closed even after approaching three times during mystery client visits.” Did not the information on opening hours of pharmacies available to mystery clients before the visit?

Discussion and Conclusion

“Recently in 2022, WHO in its new abortion care guideline recommended for pharmacy provision of MA including self-management.” It is essential to present details of this recommendation according to the WHO guideline (gestational condition, medical abortion regimens, etc.)

You pointed out in the Discussion that the study population selected (“pharmacy workers oriented by NCDA on harm reduction in 2017 and/or those who have received medical detailing visits from market promoters of PSI/Nepal”) would not represent the Nepal pharmacies.  The selection bias needs to be warned in the abstract and conclusion, mentioning that this selective sample does not represent all pharmacies in Nepal.

Tables: Consider joint tables 4, 5, and 6.

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2. Thank you for indicating that informed consent was not obtained due to the mystery client aspect of the study, and your statement:  Ethical approval for this study including the permission for consent procedure was obtained from the Ethical Review Board of Nepal Health Research Council (Ref: 800/2019)" Please could you revise this statement to indicate whether the IRB had waived the need for informed consent.

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The study is funded under the Women's Health Project implemented by Population Service International. The project receives fund from anonymous donors. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. 

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: N/A

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

**********

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Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The authors report on an important public health issue for women globally and especially in low- and middle-income countries. The role of pharmacies and their staff providing an often-illegal medication for abortion and the consequences of their lack of quality care for maternal mortality and morbidity are vital issues for critical research. There is however a lack of clarity in some descriptions of the methodology and additional suggestions for improvement below.

Introduction

This intro does give a good overview of the legal MA situation in Nepal and makes a good argument for the current study; however I find it odd that you haven’t referenced relevant studies in Nepal and India published in this journal either here or in the discussion – e.g.

1. Medical abortion kit dispensing practices of community pharmacies in Pokhara Metropolitan, Nepal Nim Bahadur Dangi, Sangam Subedi, Mahasagar Gyawali, Aashish Bhattarai, Tulsi Ram Bhandari | published 13 Jan 2021 PLOS ONE

2. Delivering Medical Abortion at Scale: A Study of the Retail Market for Medical Abortion in Madhya Pradesh, India Powell-Jackson T, Acharya R, Filippi V, Ronsmans C (2015) Delivering Medical Abortion at Scale: A Study of the Retail Market for Medical Abortion in Madhya Pradesh, India. PLOS ONE 10(3):0120637. https://doi.org/10.1371/journal.pone.0120637

3. Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial Mandira Paul, Kirti Iyengar, Birgitta Essén, Kristina Gemzell-Danielsson, Sharad D. Iyengar, Johan Bring, Sunita Soni, Marie Klingberg-Allvin Research Article | published 01 Sep 2015 PLOS ONE https://doi.org/10.1371/journal.pone.0133354

4. Pathways to seeking medication abortion care: A qualitative research in Uttar Pradesh, India

Aradhana Srivastava, Malvika Saxena, Joanna Percher, Nadia Diamond-Smith Research Article | published 13 May 2019 PLOS ONE

Materials and methods

Both the population and mystery shopper methodology seem highly appropriate for this study.

Study design

1. However, if the study population is ‘oriented’ (please clarify what that means) by NCDA and have received detailing from PSI and stock Medabon, what is the relation between the 266 pharmacies surveyed (mentioned in the opening line 116 on P 6) and the 886 pharmacies outlined as the eligible sampling frame on p7? Please give the year and numbers of pharmacies where PSI did medical detailing.

2. Page 7. L127. What is the relevance of this reference (33) to the sentence? Suggest drop

Sampling size and sampling technique –

3. Please reference your random sampling method. How was it implemented?

4. L.133 what variable was your 50% estimate based on – can you please state? For example, was it medication dispensed, gestational age asked?

Training and data collection. The training you have offered your mystery shopper (MS) staff sounds thorough. Your focus group discussion after was also a good strategy to gather feedback data. Can you please however add more clarity to the following:

5. Did you collect gender of pharmacy worker and breakdown the responses further? It would be relevant to see whether there were gendered behaviours and attitudes between differently gendered MS and pharmacy workers for a stigmatised, gendered and illegal activity.

6. What pharmacy worker behaviours did you record – can you please clarify even if giving examples in brackets. Did it include attitudes?

7. It appears that ‘counselling practices’ means giving vital information? Pls give examples and clarify what you mean.

8. Also what factors are included in ‘quality of care’?

9. How did you maintain confidentiality? Do you mean the MS never gave any personal information?

Data analysis and ethics are all appropriate.

10. Line 188 Can you please include what timeframe PSI gave pharmacy-workers about the possible mystery client (MC) visits (i.e. how long before you conducted the survey?)

Results

11. As indicated above, it would be helpful if you described, even if not tabulated whether there was a difference in female to female MC provision or female to male MC provision etc. Especially as more women were referred as well.

12. The information about gender of pharmacy worker would seem important if asking about LMP also. Consider providing this information if possible.

13. You provide a quote about cesarian births and MA (P.14 L242), but there does not appear to be a reason for it, not comment about whether this was wise or unwise information.

14. As you are commenting on price (p.17), it is useful to provide the either mean retail of legal provision or range in US dollars and Nepalese currency to compare to the median MCs are asked for. You could do this in the intro or on Table 8 or below it, as well as in the discussion.

Discussion

15. P19 L 302, suggest ‘provocations’ is unclear. Can you clarify whether you mean judgmental questions or comments?

16. You make very important comments here about the gender disparities. Can you comment on how this was enacted with genders between pharmacy workers and MCs as previously suggested?

17. P.19. Suggest moving para re over-the-counter sales L310 above L302 re gender of provider, so you introduce general findings before gender specific provision.

18. P. 19 L 314. The sentence reads more clearly if you omit ‘to provide’.

19. P. 19 L 316-7. Suggest ‘..not provided with the MA drugs because they did not have a prescription’.

20. P 20 L 333-5 Please detail what proportion of these pharmacies were provide with training and when and then comment on the role of training.

21. P 21 L343 MRP – please tell us what this is so we can compare.

22. Suggest you comment that if drugs are illegal, their quality and sources are also suspect and that this is dangerous, as well as price gouging possible

23. P22, L 373, no need for ‘for’ pharmacy provision. Omit ‘for’.

This is an important study. Well done

Reviewer #2: This study aimed to assess the medical abortion

drug dispensing practices of private sector pharmacy workers in Nepal using the mystery client method.

Introduction

Lines 94-98: The study involves pharmacy workers, but the authors cite a reference with data obtained from pharmacists (Rogers et al. 2019 - reference 30).

A. Please explain in the article how the service provided in Nepalese pharmacies is carried out (only by pharmacists, only by attendants?)

B. I suggest lines 94-98 revision: it was not clear whether what is being highlighted is the different performance between these two professionals or between the different scenarios (pharmacy-medication x surgical procedure).

Materials and Methods

Lines 137-138: I am unsure if this sentence is clear. I suggest text review.

Results

This section presents the same results in table and text. Please, review.

Discussion and Conclusion

The pharmacist's role in pharmacies should also be discussed. The introduction does not give us elements for a complete comprehension of the performance of this professional in private pharmacies in Nepal.

Please, present and discuss the limitations of the research.

**********

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Reviewer #1: Yes: Angela Taft MPH PhD

Reviewer #2: Yes: Elisangela Costa Lima

**********

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PLoS One. 2022 Nov 23;17(11):e0278132. doi: 10.1371/journal.pone.0278132.r002

Author response to Decision Letter 0


21 Oct 2022

October 04, 2022

To,

Editorial Board

Plos One

Subject: Submission of revised manuscript PONE-D-22-11126 titled ‘Medical abortion drug dispensing practices among private pharmacy workers in Nepal: a mystery client study’

The study team would like to thank editor and reviewers for providing their feedback on the manuscript and we are confident that the reviewer’s comment has helped to improve the quality of the manuscript. Please find the response to the reviewer’s comment below.

Editorial comments

Introduction

Please review and clarify the following sentences:

WHO Model List of Essential Medicine (reference 15) does not present data about the effectiveness of MA drugs; it just list the drugs.

Thank you for the observation. We have removed the reference and added another reference related to the effectiveness of medical abortion drugs.

“The Nepal Demographic and Health Survey (NDHS) 2016 data shows that about one fifth of women who had an abortion reported receiving abortion services from pharmacies”. According to the NDHS, from pharmacies and health providers, right?

Thank you for the query. As per NDHS, 19% received abortion services from pharmacies/pharmacists while 71% received services from doctors and nurses, and the remaining received from others.

Methods

“A total of 15 pharmacies were considered as non-response as these pharmacies were closed even after approaching three times during mystery client visits.” Did not the information on opening hours of pharmacies available to mystery clients before the visit?

The opening hours of pharmacies were not available to mystery clients before the visit. The non-response was because these pharmacies were closed during the study period or were wholesalers.

Discussion and Conclusion

“Recently in 2022, WHO in its new abortion care guideline recommended for pharmacy provision of MA including self-management.” It is essential to present details of this recommendation according to the WHO guideline (gestational condition, medical abortion regimens, etc.)

Thank you for the suggestion. We have now added this information.

You pointed out in the Discussion that the study population selected (“pharmacy workers oriented by NCDA on harm reduction in 2017 and/or those who have received medical detailing visits from market promoters of PSI/Nepal”) would not represent the Nepal pharmacies. The selection bias needs to be warned in the abstract and conclusion, mentioning that this selective sample does not represent all pharmacies in Nepal.

Thank you for the suggestion. We now have added the information in the abstract and conclusion section.

Tables: Consider joint tables 4, 5, and 6.

Thank you. We have joined table 4,5 and 6.

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2. Thank you for indicating that informed consent was not obtained due to the mystery client aspect of the study, and your statement: Ethical approval for this study including the permission for consent procedure was obtained from the Ethical Review Board of Nepal Health Research Council (Ref: 800/2019)" Please could you revise this statement to indicate whether the IRB had waived the need for informed consent.

We have revised the ethics statement to indicate that the Nepal’s ethical review board had waived the need for informed consent.

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The study is funded under the Women's Health Project implemented by Population Service International. The project receives fund from anonymous donors. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Neither the study nor the author’s salaries are funded in whole or in part by a tobacco company. All the authors are PSI Nepal staffs.

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Reviewer #1: The authors report on an important public health issue for women globally and especially in low- and middle-income countries. The role of pharmacies and their staff providing an often-illegal medication for abortion and the consequences of their lack of quality care for maternal mortality and morbidity are vital issues for critical research. There is however a lack of clarity in some descriptions of the methodology and additional suggestions for improvement below.

Introduction

This intro does give a good overview of the legal MA situation in Nepal and makes a good argument for the current study; however I find it odd that you haven’t referenced relevant studies in Nepal and India published in this journal either here or in the discussion – e.g.

1. Medical abortion kit dispensing practices of community pharmacies in Pokhara Metropolitan, Nepal Nim Bahadur Dangi, Sangam Subedi, Mahasagar Gyawali, Aashish Bhattarai, Tulsi Ram Bhandari | published 13 Jan 2021 PLOS ONE

2. Delivering Medical Abortion at Scale: A Study of the Retail Market for Medical Abortion in Madhya Pradesh, India Powell-Jackson T, Acharya R, Filippi V, Ronsmans C (2015) Delivering Medical Abortion at Scale: A Study of the Retail Market for Medical Abortion in Madhya Pradesh, India. PLOS ONE 10(3):0120637. https://doi.org/10.1371/journal.pone.0120637

3. Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial Mandira Paul, Kirti Iyengar, Birgitta Essén, Kristina Gemzell-Danielsson, Sharad D. Iyengar, Johan Bring, Sunita Soni, Marie Klingberg-Allvin Research Article | published 01 Sep 2015 PLOS ONE https://doi.org/10.1371/journal.pone.0133354

4. Pathways to seeking medication abortion care: A qualitative research in Uttar Pradesh, India

Aradhana Srivastava, Malvika Saxena, Joanna Percher, Nadia Diamond-Smith Research Article | published 13 May 2019 PLOS ONE

Thank you very much for the suggestion. We have missed to include these useful references which now have been included in the paper.

Materials and methods

Both the population and mystery shopper methodology seem highly appropriate for this study.

Study design

1. However, if the study population is ‘oriented’ (please clarify what that means) by NCDA and have received detailing from PSI and stock Medabon, what is the relation between the 266 pharmacies surveyed (mentioned in the opening line 116 on P 6) and the 886 pharmacies outlined as the eligible sampling frame on p7? Please give the year and numbers of pharmacies where PSI did medical detailing.

The sampling frame included all pharmacies which had a stock of Medabon. The pharmacies surveyed are sampled pharmacies from the sampling frame. All these pharmacies have received medical detailing visits at least once a year since they had stocked Medabon. NCDA had provided harm reduction training in 2017 to some of these pharmacies.

2. Page 7. L127. What is the relevance of this reference (33) to the sentence? Suggest drop

We have decided to include this reference as this provides reference for the readers to understand more about the mystery client approach.

Sampling size and sampling technique –

3. Please reference your random sampling method. How was it implemented?

Thank you for the feedback. We have included a detailed information about the sampling strategy in the sample size section.

4. L.133 what variable was your 50% estimate based on – can you please state? For example, was it medication dispensed, gestational age asked?

The 50% estimate was based on medication dispensing behavior of pharmacy workers. Since we did not have recent estimate, we used the conservative estimate of 50% to obtain maximum sample of pharmacies.

Training and data collection. The training you have offered your mystery shopper (MS) staff sounds thorough. Your focus group discussion after was also a good strategy to gather feedback data. Can you please however add more clarity to the following:

5. Did you collect gender of pharmacy worker and breakdown the responses further? It would be relevant to see whether there were gendered behaviours and attitudes between differently gendered MS and pharmacy workers for a stigmatised, gendered and illegal activity.

Yes, we collected gender of pharmacy workers in the study. In the 267 pharmacies surveyed, 69% were male and 31% were female pharmacy workers. During the further analysis, we found that male pharmacy workers dispensed MA drugs in higher proportions to the mystery clients than the female pharmacy workers. Interestingly, male pharmacy workers favored male while female pharmacy workers slightly preferred female while dispensing MA drugs. We have added this information in the manuscript.

6. What pharmacy worker behaviours did you record – can you please clarify even if giving examples in brackets. Did it include attitudes?

Dispensing behavior of pharmacy workers towards medical abortion seeking clients were recorded through questionnaire. Focus group discussion collected counseling related behavior of pharmacy workers towards clients which was immediately recorded after the interaction between provider and client.

7. It appears that ‘counselling practices’ means giving vital information? Pls give examples and clarify what you mean.

Counseling practices are related to the dosage and administration of MA drugs, what to expect during the abortion process, possible side effects and complications, where to go in case of complications, what to do to assess completion of abortion, and post-abortion family planning use.

8. Also what factors are included in ‘quality of care’?

We assessed the quality of care received by the mystery clients on different domains of services received through Likert scale. These were related to attitude of pharmacy workers, attitude of other staff, satisfaction with the counseling, had the opportunity to talk with the provider, had the opportunity to tell what they wanted, had the opportunity to ask questions and comfort level when talking with the provider. Similarly, perceived quality of physical domain of pharmacy such as visual and auditory privacy, adequate privacy at reception, waiting time, comfortable waiting area, location of the facility, and overall satisfaction with the facility was also assessed. However, we have not included this information on the manuscript. Hence, we would like to remove this variable.

9. How did you maintain confidentiality? Do you mean the MS never gave any personal information?

Yes, mystery client never revealed their identity to the pharmacy worker during their interaction.

Data analysis and ethics are all appropriate.

Thank you for your observation.

10. Line 188 Can you please include what timeframe PSI gave pharmacy-workers about the possible mystery client (MC) visits (i.e. how long before you conducted the survey?)

It was during the facility contracting process that PSI gave information to the pharmacy workers about the possible mystery client visits. Facilities are usually contracted at the starting of the year (January). For facilities which are not a part of the PSI network but stock medabon, market promoters conduct medical detailing visits at least once a year (usually in the first half of the year, January-June) who also inform about the mystery client visits as a part of quality evaluation procedure. Data collection of the study was done in between September to October 2019.

Results

11. As indicated above, it would be helpful if you described, even if not tabulated whether there was a difference in female to female MC provision or female to male MC provision etc. Especially as more women were referred as well.

Thank you for the suggestion. We have included this information in the dispensing behavior of pharmacy workers.

12. The information about gender of pharmacy worker would seem important if asking about LMP also. Consider providing this information if possible.

There was not much difference in asking about LMP by gender of pharmacy workers. While male pharmacy workers asked about LMP in 71% of the visits while female pharmacy workers inquired about LMP in 68% of the visits.

13. You provide a quote about cesarian births and MA (P.14 L242), but there does not appear to be a reason for it, not comment about whether this was wise or unwise information.

We have decided to not to use this quote considering ambiguity.

14. As you are commenting on price (p.17), it is useful to provide the either mean retail of legal provision or range in US dollars and Nepalese currency to compare to the median MCs are asked for. You could do this in the intro or on Table 8 or below it, as well as in the discussion.

Thank you for the feedback. We have included in the results section.

Discussion

15. P19 L 302, suggest ‘provocations’ is unclear. Can you clarify whether you mean judgmental questions or comments?

We have rephrased the word ‘provocations’ to ‘probing’. This indicates towards the dispensing behavior of pharmacy workers.

16. You make very important comments here about the gender disparities. Can you comment on how this was enacted with genders between pharmacy workers and MCs as previously suggested?

We have now included information about variation in dispensing behavior towards male and female mystery clients by gender of pharmacy workers. We found that male pharmacy workers dispense MA drugs to the mystery clients in higher proportions than the female pharmacy workers. Considering gender of mystery clients, female pharmacy workers dispensed MA drug slightly higher to the female mystery clients than the male mystery clients.

17. P.19. Suggest moving para re over-the-counter sales L310 above L302 re gender of provider, so you introduce general findings before gender specific provision.

Done

18. P. 19 L 314. The sentence reads more clearly if you omit ‘to provide’.

Done

19. P. 19 L 316-7. Suggest ‘..not provided with the MA drugs because they did not have a prescription’.

Done

20. P 20 L 333-5 Please detail what proportion of these pharmacies were provide with training and when and then comment on the role of training.

All these pharmacies received medical detailing visits from market promoters since they had a stock of Medabon- a MA drug. Among the pharmacies surveyed, 39 (14.6%) pharmacies were oriented on harm reduction orientation. The role of both these activities is to educate pharmacy workers about the dosage and administration of MA drugs along with its side effects so that they can counsel clients while dispensing.

21. P 21 L343 MRP – please tell us what this is so we can compare.

The information about the MRP has now been included. The MRP was NRs. 800 during the time of the survey while the median price offered to the clients was NRs. 942.

22. Suggest you comment that if drugs are illegal, their quality and sources are also suspect and that this is dangerous, as well as price gouging possible

We appreciate your thoughts and have added this statement. The quality and source of these drugs are also questionable which can affect women’s health.

23. P22, L 373, no need for ‘for’ pharmacy provision. Omit ‘for’.

Done

This is an important study. Well done

Thank you for your acknowledgement on our paper.

Reviewer #2: This study aimed to assess the medical abortion drug dispensing practices of private sector pharmacy workers in Nepal using the mystery client method.

Introduction

Lines 94-98: The study involves pharmacy workers, but the authors cite a reference with data obtained from pharmacists (Rogers et al. 2019 - reference 30).

We have removed this reference.

A. Please explain in the article how the service provided in Nepalese pharmacies is carried out (only by pharmacists, only by attendants?)

Thank you for the feedback, We have included this information in introduction section.

Pharmacies in Nepal are operated by varied professionals including pharmacists, pharmacy assistants, and health workers who have received 48-72 hours orientation on pharmacy. Drug dispensing is also common among paramedics in Nepal

B. I suggest lines 94-98 revision: it was not clear whether what is being highlighted is the different performance between these two professionals or between the different scenarios (pharmacy-medication x surgical procedure).

We have removed the statement and hence the reference.

Materials and Methods

Lines 137-138: I am unsure if this sentence is clear. I suggest text review.

We have revised the sentence and we hope that the sentence is now clear.

Results

This section presents the same results in table and text. Please, review.

The results section is now slightly revised. As the table is self-explanatory, we have not described the results to a full extent.

Discussion and Conclusion

The pharmacist's role in pharmacies should also be discussed. The introduction does not give us elements for a complete comprehension of the performance of this professional in private pharmacies in Nepal.

Thank you for the suggestion. Pharmacies in Nepal are operated by varied professionals ranging from pharmacists (those with bachelor’s degree in pharmacy), pharmacy assistants (3 years course after school level), other health workers with 48-72 hours of orientation on dispensing, and even paramedics without any orientation. Pharmacists are mostly available in hospital pharmacies. However, where pharmacies are operated standalone, pharmacists are almost non-existent. Given the involvement of varied professionals in dispensing drugs in Nepal at the pharmacy level, it would be important to orient these cadres especially with non-pharmacy background in dispensing MA drugs. We now have included this information in the introduction and discussion section and hence it would allow readers to obtain some insights on how pharmacies are operated in Nepal.

Please, present and discuss the limitations of the research.

Thank you for the suggestion. We have discussed the limitations of the study in the discussion section.

Attachment

Submitted filename: Response to Reviewers comment.docx

Decision Letter 1

Tatiane da Silva Dal Pizzol

10 Nov 2022

Medical abortion drug dispensing practices among private pharmacy workers in Nepal: a mystery client study

PONE-D-22-11126R1

Dear Dr. Pratik Khanal,

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Reviewer #1: All comments have been addressed

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Reviewer #1: I did find it difficult to see where comments have been changed without any highlighting or track changes.

Nevertheless, I believe this reads better and more clearly. I am sorry that I did not request this in the previous review but I do believe it would help if you could indicate what proportion and number of clinics were urban, rural and remote, as this helps to strengthen your comment about access.

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Reviewer #1: Yes: Angela Taft MPG PhD Adjunct Professor

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Acceptance letter

Tatiane da Silva Dal Pizzol

14 Nov 2022

PONE-D-22-11126R1

Medical abortion drug dispensing practices among private pharmacy workers in Nepal: a mystery client study

Dear Dr. Khanal:

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