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Availability and provision of misoprostol and other medicines for menstrual regulation among pharmacies in Bangladesh via mystery client survey
International Journal of Gynecology and Obstetrics 124 (2014) 164–168
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International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Availability and provision of misoprostol and other medicines for menstrual regulation among pharmacies in Bangladesh via mystery client survey Fauzia A. Huda a,⁎, Thoai D. Ngo b, Anisuddin Ahmed a, Anadil Alam a, Laura Reichenbach a a b
Centre for Reproductive Health, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh Research, Monitoring and Evaluation Team, Health System Department, Marie Stopes International, London, UK
a r t i c l e
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Article history: Received 6 April 2013 Received in revised form 22 July 2013 Accepted 25 October 2013 Keywords: Abortion Bangladesh Menstrual regulation Misoprostol Pharmacy workers
a b s t r a c t Objective: To explore the availability and provision of misoprostol and other medicines for menstrual regulation (MR) among pharmacies in Bangladesh. Methods: Between March and November 2011, a cross-sectional study using mystery client visits was conducted among pharmacy workers in Dhaka and Gazipur Districts, Bangladesh. Mystery clients were trained to present 1 of 4 pre-developed situations to pharmacy workers to elicit information on the regimen, adverse effects, and complications of misoprostol use. Results: Mystery clients visited 331 pharmacies. Among the 331 pharmacy workers, 45.8% offered the mystery clients misoprostol and/or other medicines for MR; 25.7% referred them to private clinics or hospitals. Only 7% recommended an effective regimen of misoprostol for MR; 65% suggested administering vaginal and oral misoprostol together. Overall, 72.4% did not provide any advice on complications; the remainder suggested visiting trained providers for complications. Counseling on excessive bleeding as a danger sign was provided by 46% of pharmacy workers. Most (94%) did not provide or refer for post-MR family planning. Conclusion: Pharmacy workers in urban Bangladesh are providing ineffective drugs and regimens for MR. A training package is needed to strengthen service delivery by providing accurate information, high-quality products, and referral mechanisms for women seeking MR through pharmacies. © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Pharmacy workers often serve as preferred healthcare providers. With long service hours and ready access to medicines, pharmacies have an essential role in providing services for stigmatized health issues, including sexually transmitted infections, family planning, emergency contraception, and menstrual regulation (MR) [1–4]. In countries where legal and social restrictions present obstacles for women trying to access appropriate methods for terminating unwanted pregnancies, misoprostol has been found to be an appealing alternative to both women and providers. Women often use misoprostol and/or other medicines obtained from pharmacies to self-induce abortion with varying effects [5,6]. Using misoprostol for termination of pregnancy is considered by women to be more “natural” and private compared with surgical procedures [7]. Because pharmacies provide relative anonymity for clients [6,8–10], and there is an increasing awareness of misoprostol as an effective treatment for medical abortion, misoprostol and other abortifacients are being provided by pharmacy workers on demand [5]. ⁎ Corresponding author at: 68, Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka 1212, Bangladesh. Tel.: +880 2 9827048, +880 1716962841; fax: +880 2 9827070. E-mail address: [email protected] (F.A. Huda).
Abortion is illegal in Bangladesh except when used to save a women’s life. Since the 1970s, the country has maintained a program of menstrual regulation (MR)—an interim method of establishing non-pregnancy among women at risk of becoming pregnant [11]. Although MR services have become widespread and decentralized, approximately 231 000 women were treated for complications of induced abortion in 2010 [12]. In Bangladesh, misoprostol is registered for the treatment of peptic ulcer and prevention of postpartum hemorrhage, and is produced by 4 local pharmaceutical companies. Anecdotal evidence suggests that, owing to its availability, women may be using misoprostol and/or other medicines obtained from pharmacies to self-induce MR. Documenting the provision and use of medications for MR via pharmacies is difficult owing to the estimated 30 000 unregistered drug retailers in Bangladesh (Directorate of Drug Administration, personal communication). Although pharmacy workers may serve as a first point of care at the community level, most of them lack formal training, leading to variability in the quality of service provision [13]. If prescribed and used correctly, misoprostol is an effective and safe method for MR in low-resource settings where mifepristone is not available [14]. Evidence from other settings has shown that misoprostol is often wrongly prescribed by untrained pharmacy workers [15,16]; therefore,
0020-7292/$ – see front matter © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijgo.2013.07.037
F.A. Huda et al. / International Journal of Gynecology and Obstetrics 124 (2014) 164–168
understanding the knowledge and practices of pharmacy workers in prescribing misoprostol is important to better inform health service provision in Bangladesh [10]. The aim of the present study was to explore the knowledge and provision practices of pharmacy workers regarding the use of misoprostol and other medicines for induction of MR in Bangladesh. Three study areas were purposively selected to capture a range of sociodemographic characteristics in urban settings: the Mirpur and Badda areas of Dhaka have slums and are populated by 500 373 and 536 621 individuals, respectively [17]; the Sadar area of Gazipur has a population of 123 531, and represents an industrial area with significant garment factories employing mainly women [17]. 2. Materials and methods A cross-sectional study using mystery client visits was conducted among pharmacies in the Mirpur and Badda areas of Dhaka district, and in the Sadar area of Gazipur district, Bangladesh, between March 1 and November 30, 2011. The study was approved by the ethics review committee of the International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh. The study was conducted in 4 steps. Step 1 involved physical identification of each study area. A central point on a detailed map of each of the study areas was purposively selected, and a concentric circle of 1 km in radius was drawn from this point. This circle represented the boundary of the study area. Step 2 comprised mapping of pharmacies. Because there was no approved registry or logbook including all pharmacies in the study areas, 6 field workers visited each area and physically mapped all pharmacies within the 1-km radius. Only outlets that had a static physical space with medicines clearly displayed, had been established for at least 6 months, and had regular opening hours each day were mapped. Step 3 involved a rapid assessment survey. The mapping exercise in step 2 identified 766 pharmacies (251 in Gazipur, 250 in Mirpur, and 265 in Badda). A random sample of the enumerated pharmacies was selected from this list, yielding a sample size of 111 pharmacies per study area. The rapid assessment survey was administered among pharmacy workers at the selected outlets to ascertain information on pharmacy workers’ background, knowledge, and practice provision of misoprostol and/or other medicines for MR. The results of this assessment will be reported elsewhere. Step 4 comprised mystery client visits. One month after starting the rapid assessment survey, mystery clients visited all 111 pharmacies per study area to assess the actual availability and provision of misoprostol and other medicines by pharmacy workers. This method has been widely used in pharmacy-based studies as an effective way of minimizing observer bias [15,18,19]. Individuals who served as mystery clients could not be a resident of the study area, but could possess characteristics of local persons (e.g. language skills, appearance) and had the ability to assume fictitious identities. There were 4 mystery client situations: (1) a young (18–25 years) female seeking misoprostol because her friend recommended the drug for MR; (2) a young male seeking misoprostol for his female friend because another friend recommended the drug for MR; (3) a middle-aged female seeking a drug to induce menstruation because she believed that she was pregnant owing to a delayed period; and (4) a middle-aged male seeking a drug to induce his wife’s menstruation in a situation similar to the third one. Five mystery clients (3 males and 2 females) and 6 interviewers (3 males and 3 females) were trained to present the different situations. Training entailed the criteria used to evaluate outlets; the assignment of situations; extensive practice and/or role-playing to enact the assigned situations; tips for recalling details of the encounter during postencounter interview; scheduling of area visits; and signature of consent form and confidentiality agreement. Each mystery client situation was pre-tested twice to assess its feasibility.
165
Each mystery client visited different pharmacies with a specific predeveloped situation. During their visit to pharmacies, mystery clients inquired about the availability, cost, dosages, route of administration, effectiveness, possible adverse effects, and complications of misoprostol and other medicines; family planning methods; and counseling. If the pharmacy workers asked whether or not the woman in the situation had taken a pregnancy test, mystery clients responded negatively. The same mystery client did not visit a particular outlet more than once. Pharmacy workers who offered any medication to the mystery clients for MR were considered as “unprompted;” those who were asked directly for misoprostol for MR by the mystery clients were considered as “prompted.” In some instances, the mystery clients purchased the drugs suggested by the pharmacy workers to avoid suspicion and to complete their visit. In other cases, the mystery clients completed their visit by stating that they would return to purchase the drug at later time because they did not have enough money. Immediately on completion of their visit, each mystery client was interviewed by a study interviewer using a standardized checklist to capture a detailed account of the mystery client’s interaction with the pharmacy worker. Data were analyzed via STATA version 11.1 (Stata, College Station, TX, USA). Differences in the outcomes by characteristics were assessed via χ2 tests with a 95% level of significance for categorical variables. 3. Results Among the 333 pharmacies selected, 331 mystery client visits were conducted (111 in Mirpur, 110 in Badda, and 110 in Gazipur). Two pharmacies were closed on repeated visits (1 in Gazipur, and 1 in Badda). On average, each mystery client visited 66 pharmacies and interacted with 1 pharmacy worker. All pharmacy workers were male. The mean number of customers at the pharmacy was 2 during a mystery client visit. During the 331 visits, 38.6% of the mystery clients were offered only misoprostol, 45.8% were offered misoprostol and other medicines (e.g. combination of methylestrenolone and methylestradiol; emergency contraceptive pills; oral pill; herbal medicines; and hormonal preparations), and 15.5% were offered other medicines. Among 138 unprompted situations, 41.7% of the mystery clients were offered and/or advised to take misoprostol or other medicines for MR. Among 113 prompted situations, 34.1% were offered misoprostol and other drugs by pharmacy workers. Overall, 94% of the mystery clients were not taken to a separate counseling room by the pharmacy workers to discuss their inquiries. In total, 22.6% of the mystery clients were referred to other places (public and private hospitals, NGO clinics, doctors, traditional healers, and other pharmacies), and 85% of the referred mystery clients were asked to seek care at private clinics or hospitals (Table 1). Only 7.1% of the pharmacy workers, either unprompted or prompted, advised an effective regimen of misoprostol for MR (4 pills of 200 μg a day for 2 days). By contrast, 65% suggested administration of misoprostol by vaginal and oral routes together (Table 1). Overall, 17% of the mystery clients were cautioned about the adverse effects of misoprostol such as nausea and vomiting, 46% were counseled on excessive bleeding, and 4.2% were advised about infection. Approximately three-quarters (72.4%) of the mystery clients did not receive any advice regarding where to go in case of complications, whereas 27.6% were told to go to trained providers (i.e. doctors, nurses, and midwives) for complications (Table 1). Overall, 94% of the pharmacy workers did not provide post-MR family planning methods. In Gazipur, a significantly higher proportion of male mystery clients were offered misoprostol and other medicines for MR compared with their female counterparts (75.2% vs 24.7%, P ≤ 0.001). A similar distribution was observed when comparing Gazipur to the other 2 regions. The proportion of pharmacy workers who offered other medicines in addition to misoprostol was higher in Badda (58.1%) than in Mirpur (41.9%) or Gazipur (41.7%, P = 0.03). A higher percentage of pharmacy workers in Gazipur recommended both oral and vaginal routes together
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Table 1 Overall provision practices among pharmacy workers regarding medicines for MR (n = 331). Provision practices of pharmacy workers Response to mystery clients (n = 331) Mystery clients were offered misoprostol/other medicines (unprompted) Mystery clients were given misoprostol when they asked (prompted) No medicines offered Referred after giving information Mystery clients were referred to health facility (n = 331) Government hospital Private clinic/hospital NGO clinic General practitioners Homeopath/Kabiraja Another pharmacy Medicines offered to the mystery clients (overall) (n = 251) Misoprostol only Misoprostol in addition to other medicinesb Medicines other than misoprostol Misoprostol provided (n = 212) Effective dosage (4 pills/d for 2 d) Non-effective dosage Suggested route of administration of misoprostol (n = 212) Oral only Vaginal and oral Don’t know Counseling on adverse effects of misoprostolc (n = 212) Diarrhea Nausea/vomiting Fever/chills Counseling on danger signs of misoprostol usec (n = 212) Excessive bleeding Infection (fever N1 d) Where to go in case of complication (n = 212) Referral to trained providers No referral/counseling for advice or treatment
No. (%) of workers 138 (41.7) 113 (34.1) 5 (1.5) 75 (22.7) 2 (0.6) 64 (19.3) 2 (0.6) 4 (1.2) 1 (0.3) 2 (0.6) 97 (38.6) 115 (45.8) 39 (15.5) 15 (7.1) 197 (92.9) 67 (31.9) 137 (65.2) 8 (2.9) 3 (1.4) 36 (17.0) 11 (5.2) 98 (46.2) 9 (4.2) 58 (27.6) 154 (72.4)
Abbreviation: MR, menstrual regulation. a Kabiraj, traditional healer. b For example, combination of methylestrenolone and methylestradiol; emergency contraceptive pill; oral pills; herbal medicines; and hormonal preparations. c Multiple responses.
for misoprostol administration compared with Mirpur or Badda (90.1% vs 45.6% or 47.1%, respectively; P ≤ 0.001) (Table 2). The age and sex of mystery clients were significantly associated with the pharmacy worker’s provision of misoprostol and other medicines. In prompted situations, a higher percentage of young (b25 years) male mystery clients (60.4%) were offered misoprostol and other medicines compared with young female mystery clients (39.6%, P ≤ 0.001) (Table 3). On the other hand, pharmacy workers offered misoprostol and other medicines for MR to a higher portion of the older (≥25 years) males (52.2%) compared with older females (32.6%, P ≤ 0.001).
4. Discussion The present study found that misoprostol is widely available in pharmacies in Dhaka and Gazipur districts of Bangladesh, and that pharmacy workers are willing to provide it to mystery clients who seek it for selfinduction of MR. However, the pharmacy workers had considerable knowledge gaps in terms of the correct dosing regimen, route of administration, adverse effects, referral for complications, and provision of information about post-MR family planning. This is not unexpected because the pharmacy workers included in the present study did not receive any formal training on the off-label use of misoprostol and many of them had limited training in general. The findings are similar to studies in other countries that document variations in knowledge of protocols, drug combinations, dosage, routes of administration, and complications among pharmacy workers and other providers [15,20,21].
There were significant differences in misoprostol provision by study area. Gazipur was consistently different in provision practices in terms of the drug, regimen, route of administration, and adverse effects mentioned. Pharmacy workers in Gazipur were significantly more likely to offer misoprostol only, and to suggest simultaneous vaginal and oral routes of administration. Although there is no direct evidence from the study to explain these findings, we speculate that misoprostol may be more popular among women working in garment factories in this area owing to its relatively simpler regimen and low cost (10–15 Taka/US $0.13 per tablet). The dual route of administration may suggest that there is a perception among providers that using both routes together is quicker and more private, which might be more convenient for women. The study has some limitations. First, there was potential for recall bias or misreporting by the mystery clients during the debriefing process. Although the mystery clients were debriefed immediately via a standardized questionnaire, the possibility for recall bias, particularly on information such as dosage and route of administration, remains. Second, the pre-developed mystery client situations might not be representative of actual situations and might have raised the suspicions of the pharmacy workers, leading them to report incorrect information. To minimize this, mystery clients were rigorously trained, mystery client situations were pre-tested, and mystery clients with prior knowledge of MR were hired. Third, the findings might not be representative of pharmacy worker’s practices in rural areas. Last, the pharmacy workers in the study had no formal training on the misoprostol-only regimen for MR, which may explain their limited knowledge about effective dosage, adverse effects, and complications [15,16,22]. Pharmacy workers have an important role in health service provision for many women. Studies from Latin America demonstrate that
Table 2 Differences in provision practices among pharmacy workers regarding misoprostol for MR by study area (n = 331).a Characteristics
Gazipur
Mirpur
Badda
Mystery clients by age and sex Female aged b25 y Male aged b25 y Female aged ≥25 y Male aged ≥25 y Medicines offered Misoprostol only Misoprostol in addition to other medicinesb Medicines other than misoprostol Misoprostol provided Effective dosage (4 pills/d for 2 d) Non-effective dosage Suggested route of administration of misoprostol Oral only Vaginal and oral Don’t know Counseling on adverse effects of misoprostolc Diarrhea Nausea/vomiting Fever/chills Counseling on danger signs misoprostolc Excessive bleeding Infection (fever N1 d) Where to go in case of complication Referral to trained providers No referral/counseling for advice or treatment
110 14 (12.8) 36 (33.0) 14 (11.9) 46 (42.2) 103 49 (47.6) 43 (41.7)
111 26 (23.4) 32 (28.8) 26 (23.4) 27 (24.3) 86 32 (37.2) 36 (41.9)
110 33 (30.3) 24 (21.1) 28 (25.7) 25 (22.9) 62 16 (25.8) 36 (58.1)
P value
11 (10.7) 91 7 (7.7) 84 (92.3)
18 (20.9) 68 5 (7.4) 63 (92.6)
10 (16.1) 51 3 (5.9) 48 (94.1)
7 (7.7) 82 (90.1) 2 (2.2)
35 (51.5) 31 (45.6) 2 (2.9)
25 (49.0) 24 (47.1) 2 (3.9)
b0.001
1 (1.1) 15 (16.1) 7 (7.5)
2 (2.9) 16 (23.5) 2 (2.9)
0 (0.0) 5 (9.8) 2 (3.9)
0.40 0.14 0.40
51 (54.8) 3 (3.2)
27 (39.7) 6 (8.8)
20 (39.2) 0 (0.0)
0.08 0.05
31 (34.4) 60 (65.6)
19 (27.9) 49 (72.1)
8 (15.4) 43 (84.6)
0.11
b0.001
0.03
0.92
Abbreviation: MR, menstrual regulation. a Values are given as number (percentage) or number unless stated otherwise. b For example, combination of methylestrenolone and methylestradiol; emergency contraceptive pill; oral pills; herbal medicines; and hormonal preparations. c Multiple responses.
F.A. Huda et al. / International Journal of Gynecology and Obstetrics 124 (2014) 164–168 Table 3 Differences in provision practices among pharmacy workers regarding misoprostol for MR by prompted and unprompted provision (n = 251).a Characteristics
Unprompted for misoprostol
Prompted for misoprostol
P value
Medicines were offered by age and sex of the mystery clients Female aged b25 y Male aged b25 y Female aged ≥25 y Male aged ≥25 y Medicine offered to the mystery clients (overall) Misoprostol only Misoprostol along with other medicineb Medicines other than misoprostol Misoprostol provided Effective dosage (4 pills/d for 2 d) Non-effective dosage Suggested route of administration of misoprostol Oral only Vaginal and oral Don’t know Counseling on adverse effects of misoprostolc Diarrhea Nausea/vomiting Fever/chills Counseling on danger signs of misoprostol usec Excessive bleeding Infection (fever N1 d) Where to go in case of complication Referral to trained providers No referral/counseling for advice or treatment
138
113
10 (7.2) 11 (8.0) 45 (32.6) 72 (52.2)
44 (39.6) 69 (60.4) 0 (0.0) 0 (0.0)
b0.001
89 (64.5) 14 (10.1)
8 (7.1) 101 (89.4)
b0.001
35 (25.4) 103 6 (5.8) 97 (94.2)
4 (3.5) 109 9 (8.4) 100 (91.6)
33 (32.0) 67 (65.0) 3 (2.9)
34 (31.8) 70 (65.4) 5 (2.8)
0.99
2 (2.0) 23 (23.2) 6 (6.1)
1 (0.9) 13 (12.3) 5 (4.7)
0.52 0.04 0.70
47 (47.5) 4 (4.0)
50 (47.2) 5 (4.7)
0.97 0.81
28 (28.9) 75 (71.1)
30 (27.8) 79 (72.2)
0.95
0.50
167
self-induction of MR are most in need of family planning to prevent future unintended pregnancies; therefore, contraceptive counseling must be a mandatory part of a comprehensive MR service package. Further assessments on the knowledge and provision practices of MR among pharmacy workers are needed in rural and urban settings. Future research should focus on the safety, effectiveness, and feasibility of training of pharmacy workers in the provision of a misoprostol-only regimen for MR. Research on the provision of mifepristone–misoprostol will also be necessary. Referral mechanisms for complications and intervention to improve post-MR family planning should be evaluated. Pharmacy workers have the potential to expand access to safe MR with medication in Bangladesh in the future, particularly with the recent approval of mifepristone–misoprostol. Training pharmacy workers and increasing their awareness of appropriate referral networks will help to ensure safe, effective, and quality MR services. Acknowledgments The present research study was funded by the Research, Monitoring and Evaluation Team within the Health System Department at Marie Stopes International (grant number GR #00834). Conflict of interest The authors have no conflicts of interest. References
Abbreviation: MR, menstrual regulation. a Pharmacy workers who offered any medication to the mystery clients for MR were considered as “unprompted;” those who were asked directly for misoprostol for MR by the mystery clients were considered as “prompted.” Values are given as number (percentage) or number unless stated otherwise. b For example, combination of methylestrenolone and methylestradiol; emergency contraceptive pill; oral pills; herbal medicines; and hormonal preparations. c Multiple responses.
an increase in both the availability of misoprostol in pharmacies and its use has resulted in a decrease in the rate and severity of complications associated with unsafe abortion [15]. A large proportion of Bangladeshi women still present at health facilities with complications from unsafely performed abortions [23,24]. Training of pharmacy workers to provide a safe and effective misoprostol-only regimen for MR in Bangladesh might be an effective strategy to prevent women from experiencing unnecessary harm to their health. Recently, the Directorate of Drug Administration approved the use of a mifepristone–misoprostol combination for MR in Bangladesh. This combination is being produced locally and will be available in pharmacies with a prescription. It is important to increase awareness of this policy among women and pharmacies, while bearing in mind that mifepristone is more costly than misoprostol and is not yet widely accessible in pharmacies. Misoprostol and other drugs are already being provided for MR in a large number of registered and unregistered pharmacies. Bangladesh should adopt the “harm reduction” approach [25] to train pharmacy workers to provide accurate information, highquality products, and referral mechanisms for women seeking MR through pharmacies. Because MR and post-MR services are provided free of charge by the government of Bangladesh, it is also important that pharmacy workers establish a referral mechanism to these facilities. Women presenting at pharmacies seeking medicines for
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Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Availability and provision of misoprostol and other medicines for menstrual regulation among pharmacies in Bangladesh via mystery client survey Fauzia A. Huda a,⁎, Thoai D. Ngo b, Anisuddin Ahmed a, Anadil Alam a, Laura Reichenbach a a b
Centre for Reproductive Health, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh Research, Monitoring and Evaluation Team, Health System Department, Marie Stopes International, London, UK
a r t i c l e
i n f o
Article history: Received 6 April 2013 Received in revised form 22 July 2013 Accepted 25 October 2013 Keywords: Abortion Bangladesh Menstrual regulation Misoprostol Pharmacy workers
a b s t r a c t Objective: To explore the availability and provision of misoprostol and other medicines for menstrual regulation (MR) among pharmacies in Bangladesh. Methods: Between March and November 2011, a cross-sectional study using mystery client visits was conducted among pharmacy workers in Dhaka and Gazipur Districts, Bangladesh. Mystery clients were trained to present 1 of 4 pre-developed situations to pharmacy workers to elicit information on the regimen, adverse effects, and complications of misoprostol use. Results: Mystery clients visited 331 pharmacies. Among the 331 pharmacy workers, 45.8% offered the mystery clients misoprostol and/or other medicines for MR; 25.7% referred them to private clinics or hospitals. Only 7% recommended an effective regimen of misoprostol for MR; 65% suggested administering vaginal and oral misoprostol together. Overall, 72.4% did not provide any advice on complications; the remainder suggested visiting trained providers for complications. Counseling on excessive bleeding as a danger sign was provided by 46% of pharmacy workers. Most (94%) did not provide or refer for post-MR family planning. Conclusion: Pharmacy workers in urban Bangladesh are providing ineffective drugs and regimens for MR. A training package is needed to strengthen service delivery by providing accurate information, high-quality products, and referral mechanisms for women seeking MR through pharmacies. © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Pharmacy workers often serve as preferred healthcare providers. With long service hours and ready access to medicines, pharmacies have an essential role in providing services for stigmatized health issues, including sexually transmitted infections, family planning, emergency contraception, and menstrual regulation (MR) [1–4]. In countries where legal and social restrictions present obstacles for women trying to access appropriate methods for terminating unwanted pregnancies, misoprostol has been found to be an appealing alternative to both women and providers. Women often use misoprostol and/or other medicines obtained from pharmacies to self-induce abortion with varying effects [5,6]. Using misoprostol for termination of pregnancy is considered by women to be more “natural” and private compared with surgical procedures [7]. Because pharmacies provide relative anonymity for clients [6,8–10], and there is an increasing awareness of misoprostol as an effective treatment for medical abortion, misoprostol and other abortifacients are being provided by pharmacy workers on demand [5]. ⁎ Corresponding author at: 68, Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka 1212, Bangladesh. Tel.: +880 2 9827048, +880 1716962841; fax: +880 2 9827070. E-mail address: [email protected] (F.A. Huda).
Abortion is illegal in Bangladesh except when used to save a women’s life. Since the 1970s, the country has maintained a program of menstrual regulation (MR)—an interim method of establishing non-pregnancy among women at risk of becoming pregnant [11]. Although MR services have become widespread and decentralized, approximately 231 000 women were treated for complications of induced abortion in 2010 [12]. In Bangladesh, misoprostol is registered for the treatment of peptic ulcer and prevention of postpartum hemorrhage, and is produced by 4 local pharmaceutical companies. Anecdotal evidence suggests that, owing to its availability, women may be using misoprostol and/or other medicines obtained from pharmacies to self-induce MR. Documenting the provision and use of medications for MR via pharmacies is difficult owing to the estimated 30 000 unregistered drug retailers in Bangladesh (Directorate of Drug Administration, personal communication). Although pharmacy workers may serve as a first point of care at the community level, most of them lack formal training, leading to variability in the quality of service provision [13]. If prescribed and used correctly, misoprostol is an effective and safe method for MR in low-resource settings where mifepristone is not available [14]. Evidence from other settings has shown that misoprostol is often wrongly prescribed by untrained pharmacy workers [15,16]; therefore,
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F.A. Huda et al. / International Journal of Gynecology and Obstetrics 124 (2014) 164–168
understanding the knowledge and practices of pharmacy workers in prescribing misoprostol is important to better inform health service provision in Bangladesh [10]. The aim of the present study was to explore the knowledge and provision practices of pharmacy workers regarding the use of misoprostol and other medicines for induction of MR in Bangladesh. Three study areas were purposively selected to capture a range of sociodemographic characteristics in urban settings: the Mirpur and Badda areas of Dhaka have slums and are populated by 500 373 and 536 621 individuals, respectively [17]; the Sadar area of Gazipur has a population of 123 531, and represents an industrial area with significant garment factories employing mainly women [17]. 2. Materials and methods A cross-sectional study using mystery client visits was conducted among pharmacies in the Mirpur and Badda areas of Dhaka district, and in the Sadar area of Gazipur district, Bangladesh, between March 1 and November 30, 2011. The study was approved by the ethics review committee of the International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh. The study was conducted in 4 steps. Step 1 involved physical identification of each study area. A central point on a detailed map of each of the study areas was purposively selected, and a concentric circle of 1 km in radius was drawn from this point. This circle represented the boundary of the study area. Step 2 comprised mapping of pharmacies. Because there was no approved registry or logbook including all pharmacies in the study areas, 6 field workers visited each area and physically mapped all pharmacies within the 1-km radius. Only outlets that had a static physical space with medicines clearly displayed, had been established for at least 6 months, and had regular opening hours each day were mapped. Step 3 involved a rapid assessment survey. The mapping exercise in step 2 identified 766 pharmacies (251 in Gazipur, 250 in Mirpur, and 265 in Badda). A random sample of the enumerated pharmacies was selected from this list, yielding a sample size of 111 pharmacies per study area. The rapid assessment survey was administered among pharmacy workers at the selected outlets to ascertain information on pharmacy workers’ background, knowledge, and practice provision of misoprostol and/or other medicines for MR. The results of this assessment will be reported elsewhere. Step 4 comprised mystery client visits. One month after starting the rapid assessment survey, mystery clients visited all 111 pharmacies per study area to assess the actual availability and provision of misoprostol and other medicines by pharmacy workers. This method has been widely used in pharmacy-based studies as an effective way of minimizing observer bias [15,18,19]. Individuals who served as mystery clients could not be a resident of the study area, but could possess characteristics of local persons (e.g. language skills, appearance) and had the ability to assume fictitious identities. There were 4 mystery client situations: (1) a young (18–25 years) female seeking misoprostol because her friend recommended the drug for MR; (2) a young male seeking misoprostol for his female friend because another friend recommended the drug for MR; (3) a middle-aged female seeking a drug to induce menstruation because she believed that she was pregnant owing to a delayed period; and (4) a middle-aged male seeking a drug to induce his wife’s menstruation in a situation similar to the third one. Five mystery clients (3 males and 2 females) and 6 interviewers (3 males and 3 females) were trained to present the different situations. Training entailed the criteria used to evaluate outlets; the assignment of situations; extensive practice and/or role-playing to enact the assigned situations; tips for recalling details of the encounter during postencounter interview; scheduling of area visits; and signature of consent form and confidentiality agreement. Each mystery client situation was pre-tested twice to assess its feasibility.
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Each mystery client visited different pharmacies with a specific predeveloped situation. During their visit to pharmacies, mystery clients inquired about the availability, cost, dosages, route of administration, effectiveness, possible adverse effects, and complications of misoprostol and other medicines; family planning methods; and counseling. If the pharmacy workers asked whether or not the woman in the situation had taken a pregnancy test, mystery clients responded negatively. The same mystery client did not visit a particular outlet more than once. Pharmacy workers who offered any medication to the mystery clients for MR were considered as “unprompted;” those who were asked directly for misoprostol for MR by the mystery clients were considered as “prompted.” In some instances, the mystery clients purchased the drugs suggested by the pharmacy workers to avoid suspicion and to complete their visit. In other cases, the mystery clients completed their visit by stating that they would return to purchase the drug at later time because they did not have enough money. Immediately on completion of their visit, each mystery client was interviewed by a study interviewer using a standardized checklist to capture a detailed account of the mystery client’s interaction with the pharmacy worker. Data were analyzed via STATA version 11.1 (Stata, College Station, TX, USA). Differences in the outcomes by characteristics were assessed via χ2 tests with a 95% level of significance for categorical variables. 3. Results Among the 333 pharmacies selected, 331 mystery client visits were conducted (111 in Mirpur, 110 in Badda, and 110 in Gazipur). Two pharmacies were closed on repeated visits (1 in Gazipur, and 1 in Badda). On average, each mystery client visited 66 pharmacies and interacted with 1 pharmacy worker. All pharmacy workers were male. The mean number of customers at the pharmacy was 2 during a mystery client visit. During the 331 visits, 38.6% of the mystery clients were offered only misoprostol, 45.8% were offered misoprostol and other medicines (e.g. combination of methylestrenolone and methylestradiol; emergency contraceptive pills; oral pill; herbal medicines; and hormonal preparations), and 15.5% were offered other medicines. Among 138 unprompted situations, 41.7% of the mystery clients were offered and/or advised to take misoprostol or other medicines for MR. Among 113 prompted situations, 34.1% were offered misoprostol and other drugs by pharmacy workers. Overall, 94% of the mystery clients were not taken to a separate counseling room by the pharmacy workers to discuss their inquiries. In total, 22.6% of the mystery clients were referred to other places (public and private hospitals, NGO clinics, doctors, traditional healers, and other pharmacies), and 85% of the referred mystery clients were asked to seek care at private clinics or hospitals (Table 1). Only 7.1% of the pharmacy workers, either unprompted or prompted, advised an effective regimen of misoprostol for MR (4 pills of 200 μg a day for 2 days). By contrast, 65% suggested administration of misoprostol by vaginal and oral routes together (Table 1). Overall, 17% of the mystery clients were cautioned about the adverse effects of misoprostol such as nausea and vomiting, 46% were counseled on excessive bleeding, and 4.2% were advised about infection. Approximately three-quarters (72.4%) of the mystery clients did not receive any advice regarding where to go in case of complications, whereas 27.6% were told to go to trained providers (i.e. doctors, nurses, and midwives) for complications (Table 1). Overall, 94% of the pharmacy workers did not provide post-MR family planning methods. In Gazipur, a significantly higher proportion of male mystery clients were offered misoprostol and other medicines for MR compared with their female counterparts (75.2% vs 24.7%, P ≤ 0.001). A similar distribution was observed when comparing Gazipur to the other 2 regions. The proportion of pharmacy workers who offered other medicines in addition to misoprostol was higher in Badda (58.1%) than in Mirpur (41.9%) or Gazipur (41.7%, P = 0.03). A higher percentage of pharmacy workers in Gazipur recommended both oral and vaginal routes together
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Table 1 Overall provision practices among pharmacy workers regarding medicines for MR (n = 331). Provision practices of pharmacy workers Response to mystery clients (n = 331) Mystery clients were offered misoprostol/other medicines (unprompted) Mystery clients were given misoprostol when they asked (prompted) No medicines offered Referred after giving information Mystery clients were referred to health facility (n = 331) Government hospital Private clinic/hospital NGO clinic General practitioners Homeopath/Kabiraja Another pharmacy Medicines offered to the mystery clients (overall) (n = 251) Misoprostol only Misoprostol in addition to other medicinesb Medicines other than misoprostol Misoprostol provided (n = 212) Effective dosage (4 pills/d for 2 d) Non-effective dosage Suggested route of administration of misoprostol (n = 212) Oral only Vaginal and oral Don’t know Counseling on adverse effects of misoprostolc (n = 212) Diarrhea Nausea/vomiting Fever/chills Counseling on danger signs of misoprostol usec (n = 212) Excessive bleeding Infection (fever N1 d) Where to go in case of complication (n = 212) Referral to trained providers No referral/counseling for advice or treatment
No. (%) of workers 138 (41.7) 113 (34.1) 5 (1.5) 75 (22.7) 2 (0.6) 64 (19.3) 2 (0.6) 4 (1.2) 1 (0.3) 2 (0.6) 97 (38.6) 115 (45.8) 39 (15.5) 15 (7.1) 197 (92.9) 67 (31.9) 137 (65.2) 8 (2.9) 3 (1.4) 36 (17.0) 11 (5.2) 98 (46.2) 9 (4.2) 58 (27.6) 154 (72.4)
Abbreviation: MR, menstrual regulation. a Kabiraj, traditional healer. b For example, combination of methylestrenolone and methylestradiol; emergency contraceptive pill; oral pills; herbal medicines; and hormonal preparations. c Multiple responses.
for misoprostol administration compared with Mirpur or Badda (90.1% vs 45.6% or 47.1%, respectively; P ≤ 0.001) (Table 2). The age and sex of mystery clients were significantly associated with the pharmacy worker’s provision of misoprostol and other medicines. In prompted situations, a higher percentage of young (b25 years) male mystery clients (60.4%) were offered misoprostol and other medicines compared with young female mystery clients (39.6%, P ≤ 0.001) (Table 3). On the other hand, pharmacy workers offered misoprostol and other medicines for MR to a higher portion of the older (≥25 years) males (52.2%) compared with older females (32.6%, P ≤ 0.001).
4. Discussion The present study found that misoprostol is widely available in pharmacies in Dhaka and Gazipur districts of Bangladesh, and that pharmacy workers are willing to provide it to mystery clients who seek it for selfinduction of MR. However, the pharmacy workers had considerable knowledge gaps in terms of the correct dosing regimen, route of administration, adverse effects, referral for complications, and provision of information about post-MR family planning. This is not unexpected because the pharmacy workers included in the present study did not receive any formal training on the off-label use of misoprostol and many of them had limited training in general. The findings are similar to studies in other countries that document variations in knowledge of protocols, drug combinations, dosage, routes of administration, and complications among pharmacy workers and other providers [15,20,21].
There were significant differences in misoprostol provision by study area. Gazipur was consistently different in provision practices in terms of the drug, regimen, route of administration, and adverse effects mentioned. Pharmacy workers in Gazipur were significantly more likely to offer misoprostol only, and to suggest simultaneous vaginal and oral routes of administration. Although there is no direct evidence from the study to explain these findings, we speculate that misoprostol may be more popular among women working in garment factories in this area owing to its relatively simpler regimen and low cost (10–15 Taka/US $0.13 per tablet). The dual route of administration may suggest that there is a perception among providers that using both routes together is quicker and more private, which might be more convenient for women. The study has some limitations. First, there was potential for recall bias or misreporting by the mystery clients during the debriefing process. Although the mystery clients were debriefed immediately via a standardized questionnaire, the possibility for recall bias, particularly on information such as dosage and route of administration, remains. Second, the pre-developed mystery client situations might not be representative of actual situations and might have raised the suspicions of the pharmacy workers, leading them to report incorrect information. To minimize this, mystery clients were rigorously trained, mystery client situations were pre-tested, and mystery clients with prior knowledge of MR were hired. Third, the findings might not be representative of pharmacy worker’s practices in rural areas. Last, the pharmacy workers in the study had no formal training on the misoprostol-only regimen for MR, which may explain their limited knowledge about effective dosage, adverse effects, and complications [15,16,22]. Pharmacy workers have an important role in health service provision for many women. Studies from Latin America demonstrate that
Table 2 Differences in provision practices among pharmacy workers regarding misoprostol for MR by study area (n = 331).a Characteristics
Gazipur
Mirpur
Badda
Mystery clients by age and sex Female aged b25 y Male aged b25 y Female aged ≥25 y Male aged ≥25 y Medicines offered Misoprostol only Misoprostol in addition to other medicinesb Medicines other than misoprostol Misoprostol provided Effective dosage (4 pills/d for 2 d) Non-effective dosage Suggested route of administration of misoprostol Oral only Vaginal and oral Don’t know Counseling on adverse effects of misoprostolc Diarrhea Nausea/vomiting Fever/chills Counseling on danger signs misoprostolc Excessive bleeding Infection (fever N1 d) Where to go in case of complication Referral to trained providers No referral/counseling for advice or treatment
110 14 (12.8) 36 (33.0) 14 (11.9) 46 (42.2) 103 49 (47.6) 43 (41.7)
111 26 (23.4) 32 (28.8) 26 (23.4) 27 (24.3) 86 32 (37.2) 36 (41.9)
110 33 (30.3) 24 (21.1) 28 (25.7) 25 (22.9) 62 16 (25.8) 36 (58.1)
P value
11 (10.7) 91 7 (7.7) 84 (92.3)
18 (20.9) 68 5 (7.4) 63 (92.6)
10 (16.1) 51 3 (5.9) 48 (94.1)
7 (7.7) 82 (90.1) 2 (2.2)
35 (51.5) 31 (45.6) 2 (2.9)
25 (49.0) 24 (47.1) 2 (3.9)
b0.001
1 (1.1) 15 (16.1) 7 (7.5)
2 (2.9) 16 (23.5) 2 (2.9)
0 (0.0) 5 (9.8) 2 (3.9)
0.40 0.14 0.40
51 (54.8) 3 (3.2)
27 (39.7) 6 (8.8)
20 (39.2) 0 (0.0)
0.08 0.05
31 (34.4) 60 (65.6)
19 (27.9) 49 (72.1)
8 (15.4) 43 (84.6)
0.11
b0.001
0.03
0.92
Abbreviation: MR, menstrual regulation. a Values are given as number (percentage) or number unless stated otherwise. b For example, combination of methylestrenolone and methylestradiol; emergency contraceptive pill; oral pills; herbal medicines; and hormonal preparations. c Multiple responses.
F.A. Huda et al. / International Journal of Gynecology and Obstetrics 124 (2014) 164–168 Table 3 Differences in provision practices among pharmacy workers regarding misoprostol for MR by prompted and unprompted provision (n = 251).a Characteristics
Unprompted for misoprostol
Prompted for misoprostol
P value
Medicines were offered by age and sex of the mystery clients Female aged b25 y Male aged b25 y Female aged ≥25 y Male aged ≥25 y Medicine offered to the mystery clients (overall) Misoprostol only Misoprostol along with other medicineb Medicines other than misoprostol Misoprostol provided Effective dosage (4 pills/d for 2 d) Non-effective dosage Suggested route of administration of misoprostol Oral only Vaginal and oral Don’t know Counseling on adverse effects of misoprostolc Diarrhea Nausea/vomiting Fever/chills Counseling on danger signs of misoprostol usec Excessive bleeding Infection (fever N1 d) Where to go in case of complication Referral to trained providers No referral/counseling for advice or treatment
138
113
10 (7.2) 11 (8.0) 45 (32.6) 72 (52.2)
44 (39.6) 69 (60.4) 0 (0.0) 0 (0.0)
b0.001
89 (64.5) 14 (10.1)
8 (7.1) 101 (89.4)
b0.001
35 (25.4) 103 6 (5.8) 97 (94.2)
4 (3.5) 109 9 (8.4) 100 (91.6)
33 (32.0) 67 (65.0) 3 (2.9)
34 (31.8) 70 (65.4) 5 (2.8)
0.99
2 (2.0) 23 (23.2) 6 (6.1)
1 (0.9) 13 (12.3) 5 (4.7)
0.52 0.04 0.70
47 (47.5) 4 (4.0)
50 (47.2) 5 (4.7)
0.97 0.81
28 (28.9) 75 (71.1)
30 (27.8) 79 (72.2)
0.95
0.50
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self-induction of MR are most in need of family planning to prevent future unintended pregnancies; therefore, contraceptive counseling must be a mandatory part of a comprehensive MR service package. Further assessments on the knowledge and provision practices of MR among pharmacy workers are needed in rural and urban settings. Future research should focus on the safety, effectiveness, and feasibility of training of pharmacy workers in the provision of a misoprostol-only regimen for MR. Research on the provision of mifepristone–misoprostol will also be necessary. Referral mechanisms for complications and intervention to improve post-MR family planning should be evaluated. Pharmacy workers have the potential to expand access to safe MR with medication in Bangladesh in the future, particularly with the recent approval of mifepristone–misoprostol. Training pharmacy workers and increasing their awareness of appropriate referral networks will help to ensure safe, effective, and quality MR services. Acknowledgments The present research study was funded by the Research, Monitoring and Evaluation Team within the Health System Department at Marie Stopes International (grant number GR #00834). Conflict of interest The authors have no conflicts of interest. References
Abbreviation: MR, menstrual regulation. a Pharmacy workers who offered any medication to the mystery clients for MR were considered as “unprompted;” those who were asked directly for misoprostol for MR by the mystery clients were considered as “prompted.” Values are given as number (percentage) or number unless stated otherwise. b For example, combination of methylestrenolone and methylestradiol; emergency contraceptive pill; oral pills; herbal medicines; and hormonal preparations. c Multiple responses.
an increase in both the availability of misoprostol in pharmacies and its use has resulted in a decrease in the rate and severity of complications associated with unsafe abortion [15]. A large proportion of Bangladeshi women still present at health facilities with complications from unsafely performed abortions [23,24]. Training of pharmacy workers to provide a safe and effective misoprostol-only regimen for MR in Bangladesh might be an effective strategy to prevent women from experiencing unnecessary harm to their health. Recently, the Directorate of Drug Administration approved the use of a mifepristone–misoprostol combination for MR in Bangladesh. This combination is being produced locally and will be available in pharmacies with a prescription. It is important to increase awareness of this policy among women and pharmacies, while bearing in mind that mifepristone is more costly than misoprostol and is not yet widely accessible in pharmacies. Misoprostol and other drugs are already being provided for MR in a large number of registered and unregistered pharmacies. Bangladesh should adopt the “harm reduction” approach [25] to train pharmacy workers to provide accurate information, highquality products, and referral mechanisms for women seeking MR through pharmacies. Because MR and post-MR services are provided free of charge by the government of Bangladesh, it is also important that pharmacy workers establish a referral mechanism to these facilities. Women presenting at pharmacies seeking medicines for
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