Self-monitoring of blood glucose levels among pregnant individuals with gestational diabetes: a systematic review and meta-analysis.

Introduction: The World Health Organization (WHO) recommends treatment and management of gestational diabetes (GD) through lifestyle changes, including diet and exercise, and self-monitoring blood glucose (SMBG) to inform timely treatment decisions. To expand the evidence base of WHO's guideline on self-care interventions, we conducted a systematic review of SMBG among pregnant individuals with GD. Setting: Following PRISMA guidelines, we searched PubMed, CINAHL, LILACS, and EMBASE for publications through November 2020 comparing SMBG with clinic-based monitoring during antenatal care (ANC) globally. Primary and secondary outcome measures: We extracted data using standardized forms and summarized maternal and newborn findings using random effects meta-analysis in GRADE evidence tables. We also reviewed studies on values, preferences, and costs of SMBG. Results: We identified 6 studies examining SMBG compared to routine ANC care, 5 studies on values and preferences, and 1 study on costs. Nearly all were conducted in Europe and North America. Moderate-certainty evidence from 3 randomized controlled trials (RCTs) showed that SMBG as part of a package of interventions for GD treatment was associated with lower rates of preeclampsia, lower mean birthweight, fewer infants born large for gestational age, fewer infants with macrosomia, and lower rates of shoulder dystocia. There was no difference between groups in self-efficacy, preterm birth, C-section, mental health, stillbirth, or respiratory distress. No studies measured placenta previa, long-term complications, device-related issues, or social harms. Most end-users supported SMBG, motivated by health benefits, convenience, ease of use, and increased confidence. Health workers acknowledged SMBG's convenience but were wary of technical problems. One study found SMBG by pregnant individuals with insulin-dependent diabetes was associated with decreased costs for hospital admission and length of stay. Conclusion: SMBG during pregnancy is feasible and acceptable, and when combined in a package of GD interventions, is generally associated with improved maternal and neonatal health outcomes. However, research from resource-limited settings is needed. Systematic Review Registration: PROSPERO CRD42021233862.

Reclassifying contraceptives as over-the-counter medicines to improve access.

Self-care interventions include over-the-counter contraceptives, which enable individuals to make informed, autonomous decisions about fertility management. As there is a substantial unmet need for contraception in many countries, increasing access by establishing sound, affordable and effective regulation of over-the-counter contraceptives could help reduce unintended pregnancies and improve maternal health. We performed a review of 30 globally diverse countries: (i) to assess national regulatory procedures for changing oral contraceptives, emergency contraceptives and injectable contraceptives from prescription-only to over-the-counter products; and (ii) to determine whether national lists of over-the-counter medicines included contraceptives. Of the 30 countries, 13 (43%) had formal regulatory procedures in place for changing prescription-only medicines to over-the-counter medicines, 11 (36%) had national lists of over-the-counter medicines, and four (13%) included contraceptives on those lists. Changing from prescription-only to over-the-counter medicines presents challenges for national medicines regulatory authorities and manufacturers, involving, for example, reporting side-effects, quality control and the often poorly-defined process of switching to over-the-counter products. To facilitate the over-the-counter availability of contraceptives, countries should consider adopting a formal regulatory procedure for reclassifying prescription-only contraceptives as over-the-counter contraceptives. Although the availability of over-the-counter contraceptives can increase users' independence and anonymity and improve access, there may also be disadvantages, such as higher out-of-pocket costs and the need for accurate self-assessment. Basic remedial actions to improve, harmonize and standardize regulatory procedures for the reclassification of contraceptives are proposed with the aim of enabling national medicines regulatory authorities to manage the switch to over-the-counter contraceptives and to control their quality.

Les soins autoadministrés incluent les contraceptifs en vente libre, qui permettent aux individus de prendre des décisions réfléchies et autonomes concernant le contrôle de la fécondité. Vu le besoin criant de contraception dans de nombreux pays, faciliter l'accès en proposant des méthodes de régulation sûres, efficaces et abordables par le biais de contraceptifs en vente libre pourrait contribuer à diminuer le nombre de grossesses non désirées et à améliorer la santé maternelle. Nous avons passé en revue 30 pays aux profils variés: (i) pour évaluer les procédures réglementaires nationales visant à modifier le statut des contraceptifs oraux, d'urgence et injectables afin qu'ils soient en vente libre au lieu d'être considérés comme des médicaments sur ordonnance; et (ii) pour déterminer si les contraceptifs figuraient sur les listes nationales de médicaments en vente libre. Sur les 30 pays observés, 13 (43%) avaient mis en place des procédures réglementaires officielles en vue de modifier le statut des contraceptifs, 11 (36%) possédaient des listes nationales de médicaments en vente libre et quatre (13%) y avaient inscrit les contraceptifs. Le passage du statut de médicament sur ordonnance à celui de médicament en vente libre représente un défi pour les autorités nationales de réglementation pharmaceutique et les fabricants, notamment en matière de déclaration des effets secondaires, de contrôle de la qualité et en raison d'un processus souvent mal défini. S'ils souhaitent favoriser la disponibilité des contraceptifs en vente libre, les pays devraient envisager l'adoption d'une procédure réglementaire officielle destinée à reclassifier les contraceptifs sur ordonnance en contraceptifs en vente libre. Bien que cette disponibilité puisse accroître l'autonomie et l'anonymat des usagers et améliorer l'accès à la contraception, elle présente également des désavantages car elle entraîne une hausse des frais non remboursés et requiert une autoévaluation correcte. Le présent document formule des mesures correctrices élémentaires servant à améliorer, harmoniser et normaliser les procédures réglementaires de reclassification des contraceptifs. Objectif: permettre aux autorités nationales de réglementation pharmaceutique de superviser le passage au statut de médicament en vente libre et de contrôler la qualité.

Las intervenciones de cuidado personal incluyen los anticonceptivos de venta libre, que permiten a las personas tomar decisiones informadas y autónomas sobre la gestión de la fertilidad. Dado que en muchos países existe una importante necesidad insatisfecha de anticoncepción, aumentar el acceso mediante el establecimiento de una normativa sólida, asequible y eficaz de los anticonceptivos de venta libre podría ayudar a reducir los embarazos no deseados y mejorar la salud materna. Se realizó una revisión de 30 países de todo el mundo: (i) para evaluar los procedimientos normativos nacionales relativos al cambio de los anticonceptivos orales, los anticonceptivos de urgencia y los anticonceptivos inyectables de medicamentos de venta con receta a productos de venta libre; y (ii) para determinar si las listas nacionales de medicamentos de venta libre incluían los anticonceptivos. De los 30 países, 13 (43 %) contaban con procedimientos normativos formales para el cambio de medicamentos de venta con receta a medicamentos de venta libre, 11 (36 %) tenían listas nacionales de medicamentos de venta libre, y cuatro (13 %) incluían los anticonceptivos en esas listas. El cambio de los medicamentos de venta con receta a los de venta libre supone un desafío para las autoridades nacionales de regulación de medicamentos y para los fabricantes, ya que implica, por ejemplo, la notificación de los efectos secundarios, el control de calidad y el proceso, que suele estar mal definido, de pasar a los productos de venta libre. Para facilitar la disponibilidad de los anticonceptivos sin receta, los países deberían considerar la adopción de un procedimiento normativo formal para reclasificar los anticonceptivos de venta con receta como anticonceptivos de venta sin receta. Aunque la disponibilidad de los anticonceptivos de venta libre puede aumentar la independencia y el anonimato de los usuarios y mejorar el acceso, también puede haber desventajas, como los mayores costos de bolsillo y la necesidad de una autoevaluación precisa. Se proponen acciones correctivas básicas para mejorar, armonizar y estandarizar los procedimientos normativos para la reclasificación de los anticonceptivos, con el objetivo de que las autoridades nacionales de regulación de medicamentos puedan gestionar el cambio a los anticonceptivos sin receta y controlar su calidad.

Self-monitoring of blood pressure among women with hypertensive disorders of pregnancy: a systematic review.

BACKGROUND: The World Health Organization (WHO) recommends self-monitoring of blood pressure (SMBP) for hypertension management. In addition, during the COVID-19 response, WHO guidance also recommends SMBP supported by health workers although more evidence is needed on whether SMBP of pregnant individuals with hypertension (gestational hypertension, chronic hypertension, or pre-eclampsia) may assist in early detection of pre-eclampsia, increase end-user autonomy and empowerment, and reduce health system burden. To expand the evidence base for WHO guideline on self-care interventions, we conducted a systematic review of SMBP during pregnancy on maternal and neonatal outcomes. METHODS: We searched for publications that compared SMBP with clinic-based monitoring during antenatal care. We included studies measuring any of the following outcomes: maternal mortality, pre-eclampsia, long-term risk and complications, autonomy, HELLP syndrome, C-section, antenatal hospital admission, adverse pregnancy outcomes, device-related issues, follow-up care with appropriate management, mental health and well-being, social harms, stillbirth or perinatal death, birthweight/size for gestational age, and Apgar score. After abstract screening and full-text review, we extracted data using standardized forms and summarized findings. We also reviewed studies assessing values and preferences as well as costs of SMBP. RESULTS: We identified 6 studies meeting inclusion criteria for the effectiveness of SMBP, 6 studies on values and preferences, and 1 study on costs. All were from high-income countries. Overall, when comparing SMBP with clinic-monitoring, there was no difference in the risks for most of the outcomes for which data were available, though there was some evidence of increased risk of C-section among pregnant women with chronic hypertension. Most end-users and providers supported SMBP, motivated by ease of use, convenience, self-empowerment and reduced anxiety. One study found SMBP would lower health sector costs. CONCLUSION: Limited evidence suggests that SMBP during pregnancy is feasible and acceptable, and generally associated with maternal and neonatal health outcomes similar to clinic-based monitoring. However, more research is needed in resource-limited settings. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021233839 .

Regulatory standards and processes for over-the-counter availability of hormonal contraception and drugs for medical abortion in five countries in the Eastern Mediterranean Region.

The World Health Organization 2019 WHO consolidated guideline on self-care interventions for health: sexual and reproductive health and rights includes recommendations on self-administration of injectable contraception, over-the-counter (OTC) oral contraception and self-management of medical abortion. A review of the regulatory status of these two self-care interventions can highlight processes required to ensure that the quality of the medicines and safety of individuals are safeguarded in the introduction and scale-up in countries. This review outlines the legal regulatory status of prescription-only medicine (POM) and OTC contraceptives, including emergency contraception, and drugs for medical abortion in Egypt, Jordan, Lebanon, Morocco and Tunisia using information obtained from internet searches, regulatory information databases and personal contacts. In addition, the review examines whether the national medicines regulatory authorities have documented procedures available to allow for a change in status from a POM to OTC to allow for increased accessibility, availability and uptake of self-care interventions recommended by WHO. Egypt, Jordan and Lebanon have a documented national OTC list available. The only contraceptive product mentioned in the OTC lists across all five countries is ellaOne (ulipristal acetate for emergency contraception), which is publicly registered in Lebanon. None of the five countries has an official documented procedure to apply for the change of POM to OTC. Informal procedures exist, such as the ability to apply to the national medicines regulatory authority for OTC status if the product has OTC status in the original country of manufacture. However, many of these procedures are not officially documented, highlighting the need for establishing sound, affordable and effective regulation of medical products as an important part of health system strengthening. From a public health perspective, it would be advantageous for licensed products to be available OTC. This is particularly the case for settings where the health system is under-resourced or over-stretched due to health emergencies. Readiness of national regulatory guidelines and OTC procedures could lead to increased access, availability and usage of essential self-care interventions for sexual and reproductive health and rights.

An Innovative Network Approach to Coordinating a National Effort to Improve Cardiovascular Health: The Case of Million Hearts.

OBJECTIVE: To assess the structure, content, quality, and quantity of partnerships that developed in response to a national cardiovascular health initiative, Million Hearts. DESIGN: This study used a social network analysis (SNA) approach to assess the Million Hearts initiative network partnerships and identify potential implications for policy and practice. SETTING/PARTICIPANTS: The Million Hearts network comprised a core group of federal and private sector partners that participate in Million Hearts activities and align with initiative priorities. To bound the network for the SNA, we used a list of 58 organizations (74% response rate) from a previously completed qualitative analysis of Million Hearts partnerships. MAIN OUTCOME MEASURES: We used the online PARTNER (Program to Analyze Record and Track Networks to Enhance Relationships-www.partnertool.net) survey to collect data on individual organizational characteristics and relational questions that asked organizations to identify and describe their relationships with other partners in the network. Key SNA measures include network density, centralizations, value, and trust. RESULTS: Our analyses show a network that is decentralized, has strong perceptions of trust and value among its members, and strong agreement on intended outcomes. Interestingly, partners report a desire and ability to contribute resources to Million Hearts; however, the perceptions between partners are that resources are not being contributed at the level they potentially could be. The majority of partners reported that being in the network helped them achieve their goals related to cardiovascular disease prevention. The largest barrier to successful activities within the network was cited as lack of targeted funding and staff to support participation in the network. CONCLUSIONS: The Million Hearts network described in this article is unique in its membership at the national level, agreement on outcomes, its powerful information-sharing abilities that require few resources, and its decentralized structure. We identified strategies that could be implemented to strengthen the network and its activities. By examining a national-level public-private partnership formed to address a public health issue, we can identify ways to strengthen the network and provide a framework for developing other initiatives.