Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon, USA.
Research Centre for Integrated Development, Kathmandu, Nepal.
Cochrane Database Syst Rev. 2021 Jun 11;6(6):CD013566. doi: 10.1002/14651858.CD013566.pub2.
Medical abortion is usually offered in a clinic or hospital, but could potentially be offered in other settings such as pharmacies. In many countries, pharmacies are a common first point of access for women seeking reproductive health information and services. Offering medical abortion through pharmacies is a potential strategy to improve access to abortion.
To compare the effectiveness and safety of medical abortion offered in pharmacy settings with clinic-based medical abortion.
We searched CENTRAL, MEDLINE, Embase, four other databases, two trials registries and grey literature websites in November 2020. We also handsearched key references and contacted authors to locate unpublished studies or studies not identified in the database searches.
We identified studies that compared women receiving the same regimen of medical abortion or post-abortion care in either a clinic or pharmacy setting. Studies published in any language employing the following designs were included: randomized trials and non-randomized studies including a comparative group.
Two review authors independently reviewed both retrieved abstracts and full-text publications. A third author was consulted in case of disagreement. We intended to use the Cochrane risk of bias tool, RoB 2, for randomized studies and used the ROBINS-I tool (Risk Of Bias In Non-randomized Studies of Interventions) to assess risk of bias in non-randomized studies. GRADE methodology was used to assess the certainty of the evidence. The primary outcomes were completion of abortion without additional intervention, need for blood transfusion, and presence of uterine or systemic infection within 30 days of medical abortion.
Our search yielded 2030 records. We assessed a total of 89 full-text articles for eligibility. One prospective cohort study met our inclusion criteria. The included study collected data on outcomes from 605 women who obtained a medical abortion in Nepal from either a clinic or pharmacy setting. Both sites of care were staffed by the same auxiliary nurse midwives. Over all domains, the risk of bias was judged to be low for our primary outcome. During the pre-intervention period, the study's investigators identified a priori appropriate confounders, which were clearly measured and adjusted for in the final analysis. For women who received medical abortion in a pharmacy setting, compared to a clinic setting, there may be little or no difference in complete abortion rates (adjusted risk difference (RD)) 1.5, 95% confidence interval (CI) -0.8 to 3.8; 1 study, 600 participants; low certainty evidence). The study reported no cases of blood transfusion, and a composite outcome, comprised mainly of infection complications, showed there may be little or no difference between settings (adjusted RD 0.8, 95% CI -1.0 to 2.8; 1 study, 600 participants; very low certainty evidence). The study reported no events for hospital admission for an abortion-related event or need for surgical intervention, and there may be no difference in women reporting being highly satisfied with the facility where they were seen (38% pharmacy versus 34% clinic, P = 0.87; 1 study, 600 participants; low certainty evidence).
AUTHORS' CONCLUSIONS: Conclusions about the effectiveness and safety of pharmacy provision of medical abortion are limited by the lack of comparative studies. One study, judged to provide low certainty evidence, suggests that the effectiveness of medical abortion may not be different between the pharmacy and clinic settings. However, evidence for safety is insufficient to draw any conclusions, and more research on factors contributing to potential differences in quality of care is needed. It is important to note that this study included a care model where a clinician provided services in a pharmacy, not direct provision of care by pharmacists or pharmacy staff. Three ongoing studies are potentially eligible for inclusion in review updates. More research is needed because pharmacy provision could expand timely access to medical abortion, especially in settings where clinic services may be more difficult to obtain. Evidence is particularly limited on the patient experience and how the care process and quality of services may differ across different types of settings.
药物流产通常在诊所或医院提供,但也可能在药店等其他场所提供。在许多国家,药店是妇女寻求生殖健康信息和服务的常见第一站。通过药店提供药物流产是改善堕胎服务可及性的一种潜在策略。
比较在药店环境中提供的药物流产与基于诊所的药物流产的有效性和安全性。
我们于 2020 年 11 月检索了 CENTRAL、MEDLINE、Embase、另外四个数据库、两个试验注册库和灰色文献网站。我们还手动检索了关键参考文献,并联系作者以确定未发表的研究或数据库检索中未识别的研究。
我们确定了将相同的药物流产方案或流产后护理在诊所或药店环境中提供给妇女的研究。包括以下设计的研究均被纳入:随机试验和非随机研究,包括对照组。
两名综述作者独立审查了检索到的摘要和全文出版物。如果存在分歧,将咨询第三名作者。我们打算使用 Cochrane 偏倚风险工具 RoB 2 评估随机研究的偏倚风险,并使用 ROBINS-I 工具(干预措施的非随机研究偏倚风险)评估非随机研究的偏倚风险。使用 GRADE 方法评估证据的确定性。主要结局是无需额外干预即可完成流产、需要输血以及药物流产后 30 天内存在子宫或全身感染。
我们的搜索产生了 2030 条记录。我们评估了总共 89 篇全文文章的纳入标准。一项前瞻性队列研究符合我们的纳入标准。该纳入研究收集了 605 名在尼泊尔从诊所或药店获得药物流产的妇女的结局数据。两个护理场所均由同一辅助护士助产士提供服务。在所有领域,我们对主要结局的偏倚风险判断为低。在干预前阶段,研究人员预先确定了合适的混杂因素,并在最终分析中明确测量和调整了这些因素。与诊所环境相比,在药店环境中接受药物流产的妇女的完全流产率可能没有差异或略有差异(调整后的风险差异(RD)1.5,95%置信区间(CI)-0.8 至 3.8;1 项研究,600 名参与者;低确定性证据)。该研究报告没有输血病例,由主要由感染并发症组成的复合结局表明,两种环境之间可能没有差异(调整后的 RD 0.8,95%CI-1.0 至 2.8;1 项研究,600 名参与者;非常低确定性证据)。该研究报告没有因流产相关事件或需要手术干预而住院的事件,也没有报告有多少妇女对她们就诊的设施非常满意(38%的药店与 34%的诊所,P=0.87;1 项研究,600 名参与者;低确定性证据)。
由于缺乏比较研究,关于在药店提供药物流产的有效性和安全性的结论受到限制。一项研究(被判定为提供低确定性证据)表明,药物流产的效果在药店和诊所环境之间可能没有差异。然而,关于安全性的证据不足,无法得出任何结论,并且需要更多的研究来了解可能影响护理质量的因素。需要注意的是,这项研究包括了一种由临床医生在药店提供服务的护理模式,而不是药剂师或药店工作人员直接提供护理。目前有三项正在进行的研究可能有资格纳入审查更新。由于药店提供服务可能会扩大药物流产的及时获得,特别是在诊所服务可能更难获得的环境中,因此需要进行更多的研究。关于患者体验以及护理过程和服务质量如何在不同类型的环境中可能存在差异的证据尤其有限。