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3.
Value Health ; 26(10): 1549-1557, 2023 10.
Article in English | MEDLINE | ID: mdl-37285917

ABSTRACT

OBJECTIVES: Health technology assessment (HTA) is an established mechanism for explicit priority setting to support universal health coverage. However, full HTA requires significant time, data, and capacity for each intervention, which limits the number of decisions it can inform. Another approach systematically adapts full HTA methods by leveraging HTA evidence from other settings. We call this "adaptive" HTA (aHTA), although in settings where time is the main constraint, it is also called "rapid HTA." METHODS: The objectives of this scoping review were to identify and map existing aHTA methods, and to assess their triggers, strengths, and weaknesses. This was done by searching HTA agencies' and networks' websites, and the published literature. Findings have been narratively synthesized. RESULTS: This review identified 20 countries and 1 HTA network with aHTA methods in the Americas, Europe, Africa, and South-East Asia. These methods have been characterized into 5 types: rapid reviews, rapid cost-effectiveness analyses, rapid manufacturer submissions, transfers, and de facto HTA. Three characteristics "trigger" the use of aHTA instead of full HTA: urgency, certainty, and low budget impact. Sometimes, an iterative approach to selecting methods guides whether to do aHTA or full HTA. aHTA was found to be faster and more efficient, useful for decision makers, and to reduce duplication. Nevertheless, there is limited standardization, transparency, and measurement of uncertainty. CONCLUSIONS: aHTA is used in many settings. It has potential to improve the efficiency of any priority-setting system, but needs to be better formalized to improve uptake, particularly for nascent HTA systems.


Subject(s)
Biomedical Technology , Technology Assessment, Biomedical , Humans , Europe , Africa
4.
Int J Health Policy Manag ; 12: 7502, 2023.
Article in English | MEDLINE | ID: mdl-36086853

ABSTRACT

As countries around the world seek to deliver universal health coverage, they must prioritize which services to pay for with public funds, to whom, and at what cost. Countries are increasingly using health technology assessment (HTA) to identify which interventions provide the best value for money and merit inclusion in their health benefit packages (HBPs)-the explicit lists of health services provided using public funds. Oortwijn et al understand the importance of providing practical guidance on the foundation of HBP design, and their article, "Evidence-Informed Deliberative Processes for Health Benefit Package Design - Part II: A Practical Guide," provides recommendations for HTA bodies to improve the legitimacy of their decision-making by incorporating four elements in their HBP procedures: stakeholder involvement, evidence-informed evaluation, transparency, and appeal. This article proposes three approaches to enhance the value of the guide: moving from structure to compliance and performance, prioritizing key issues of legitimacy within HBP processes, and acknowledging potential the costs and risks associated with the use of this framework.


Subject(s)
Technology Assessment, Biomedical , Universal Health Insurance , Humans
5.
School Ment Health ; 15(1): 165-176, 2023.
Article in English | MEDLINE | ID: mdl-36160322

ABSTRACT

Background: Chile's national school-based mental health program, Skills for Life (SFL), has demonstrated effectiveness in improving behavioral and academic outcomes in first- through third-grade students. The current study assessed the feasibility and outcomes of SFL's program for sixth- through eighth-grade students. Methods: We assessed the percentage of students who participated in the program and longitudinal changes on teacher-reported Teacher Observation of Classroom Adaptation Re-Revised (TOCA-RR) scores, youth-reported Pediatric Symptom Checklist-Chile (PSC-Y-CL) scores, grade-point average, and school attendance from sixth to eighth grade (2016-2018) for SFL's workshop intervention. Linear mixed effects models analyzed the association between outcome variables and workshop attendance. Results: Of the 30,649 sixth graders who attended the 754 participating schools in 2016, 28,204 (92.0%) were screened with the TOCA-RR. Of the 1829 students who screened at risk, 1344 had available workshop data for seventh grade, with 86.9% of them participating in most (≥ 7) workshop sessions. Workshop attendance was significantly associated with improvements in school attendance and peer relationships (a TOCA-RR subscale) in eighth grade. Conclusions: With high rates of behavioral health screening and workshop attendance, this study demonstrated the feasibility of implementing SFL's middle school program on a national scale. Higher workshop attendance by at-risk students was associated with better school attendance and peer relationships in eighth grade, as well as better but not significantly different outcomes on other measures (e.g., teacher-rated school performance and aggressive behavior in the classroom). Overall, these findings provide preliminary evidence of the feasibility and benefits of SFL's middle school program.

6.
Healthcare (Basel) ; 10(10)2022 Oct 01.
Article in English | MEDLINE | ID: mdl-36292377

ABSTRACT

Background: Due to the health restrictions put in place to face the pandemic, a decrease in the levels of physical activity and an alteration in the quality of sleep have been observed. One group susceptible to these changes is represented by students of physical education pedagogy, who, under normal conditions, present high levels of physical activity. However, the correlation between these variables has not been studied in the context of a pandemic lockdown. Objective: The aim of this study was to determine the prevalence of the quality of sleep and physical activity level as a function of gender and evaluate the association between quality of sleep and physical activity level in physical education pedagogy students during the COVID-19 pandemic considering sociodemographic and health characteristics. Methods: This was a cross-sectional study. An online questionnaire was applied to 280 Chilean university students of physical education pedagogy. The survey considered sociodemographic information, healthy habits, and self-reported health and included the International Physical Activity Questionnaire (IPAQ) for physical activity levels and the Pittsburgh Sleep Quality Index (PSQI) for sleep quality. Results: The prevalence of good sleep quality was 20.4%. Furthermore, 52.9% of students had a high level of physical activity. Regression analysis between PSQI global score and age-adjusted physical activity levels indicated that being male and presenting a high level of physical activity favored a better PSQI global score. Conclusions: The prevalence of good sleep quality was low in general and significantly lower in women. Being male and having a high level of physical activity during quarantine benefits good sleep quality, regardless of age.

7.
Foot Ankle Orthop ; 7(3): 24730114221119731, 2022 Jul.
Article in English | MEDLINE | ID: mdl-36046552

ABSTRACT

Background: Open hindfoot surgery is associated with a relatively high rate of complications, including neurovascular injuries and wound healing problems compared with percutaneous techniques. However, there is a scarcity of literature describing the outcomes of these percutaneous techniques given their relatively recent adoption. The present study aims to assess the rate of postoperative complications for 3 commonly performed percutaneous calcaneal osteotomies. Methods: One hundred eighteen patients (unilateral feet) were treated with one of 3 common percutaneous calcaneal osteotomies. Sixty-five patients (55.1%) were treated with a medializing calcaneal osteotomy for hindfoot valgus, 32 patients with a Zadek osteotomy (27.1%) for insertional Achilles tendinopathy, and 21 patients (17.8%) with a modified Dwyer osteotomy for hindfoot varus. Fisher exact test was used to assess for associations between categorical variables. Results: The mean age was 46.2 years and there was a mean follow-up of 16.1 months. The overall rate of postoperative complications was 3.4% (n = 4), and no significant differences were found between the different osteotomy types. Complications included 2 cases (1.7%) of transient neuritis, 1 case of prolonged wound drainage (0.8%), and 1 nonunion (0.8%). None of the complications were associated with any recorded preoperative comorbidity. Discussion: In this series, we found that percutaneous calcaneal osteotomies are a safe alternative method for the treatment of conditions involving the hindfoot. The rate of postoperative complications may be less when compared to the reported rates of open hindfoot correction and should be considered in patients with a traditionally high risk of developing a postoperative complication. Level of Evidence: Level IV, retrospective analysis.

8.
Case Rep Orthop ; 2022: 1843367, 2022.
Article in English | MEDLINE | ID: mdl-35496947

ABSTRACT

Case: A fifteen-year-old male patient sustained a posteriorly dislocated right capital femoral Delbet type Ib epiphyseal fracture-separation and a right acetabular posterior column fracture after a low-energy trip and fall. The capital femoral epiphysis was closed reduced and fixed with cannulated screws on an urgent basis. He underwent acetabular osteosynthesis via a Kocher-Langenbeck approach two days thereafter. Twenty-two months after injury, he was weight-bearing on the right lower extremity without radiologic evidence of avascular necrosis or clinical evidence of pain or functional deficit. Conclusion: Fracture-separation of the capital femoral epiphysis comprises only 8% of skeletally immature femoral neck fractures in the Delbet and Colonna classification. Prognosis is worse with ipsilateral hip dislocation due to the risk of avascular necrosis from disruption of the medial femoral circumflex artery. Urgent referral to a trauma center and treatment by appropriate specialists enables good long-term results after this uncommon traumatic injury pattern.

9.
Health Policy Technol ; 11(2): 100621, 2022 Jun.
Article in English | MEDLINE | ID: mdl-35340774

ABSTRACT

Introduction: Colombia has been hit particularly hard by the COVID-19 pandemic, being ranked 22nd among 187 countries in deaths per 100,000 people by February 2022. The country has also experienced the worst economic recession in its history, with real GDP contracting 7% in 2020. This paper describes Colombia's pre-pandemic context and the overall effect of the pandemic on health and economic indicators and examines the government's response to COVID-19. Methods: Descriptive chronologic policy analysis on the COVID-19 pandemic in Colombia and the measures and interventions implemented, using publicly available secondary data from Colombia's official agencies and international sources published from March 2020 to February 2022. Results: The Colombian healthcare system increased its capacity in terms of infrastructure and human resources (from 8.6 ICU beds per 100,000 pre-pandemic to 21.9 in 2020, from 1.7 to 1.3 per 1000 doctors and nurses, respectively in 2019 to 1.8 and 1.5 per 1000 in 2020). The government commenced the National Vaccination Strategy on February 17, 2021, despite a slow start it managed to fully vaccinate 65.1% of its population, including Venezuelan immigrants, by February 2022. Conclusions: Colombia's response to the pandemic combines hits and misses. The country organized an early and robust response; increased its healthcare system capacity; designed a risk-based, equitable, and inclusive national vaccination strategy; and introduced a flexible and responsive vaccine rollout. However, the government chose the wrong timing for reform, implemented a long and unpredictable lockdown, was late to procure COVID-19 vaccines and has not appropriately tackled vaccine hesitancy. Public interest summary: Colombia has been hit particularly hard by the COVID-19 pandemic, with over 138,000 COVID-19 deaths and over 6 million cases by the end of February 2022. According to number of deaths per 100,000 people, Colombia ranks 22nd in the world, among 187 countries. The country has also experienced the worst economic recession in its history. The Colombian healthcare system has been able to cope with a high number of COVID-19 cases without collapsing, but some public health indicators deteriorated. Colombia's response to the pandemic combines hits and misses. The country organized an early and robust response; increased its healthcare system capacity; designed a risk-based, equitable, and inclusive national vaccination strategy; and introduced a flexible and responsive vaccine rollout. As of February 2022, Colombia has fully vaccinated 65.1% of its population. However, the government chose the wrong timing for a tax reform, implemented a long and unpredictable lockdown, was late to procure COVID-19 vaccines and has not appropriately tackled vaccine hesitancy, which certainly contributed to its undesirable position in the mortality world raking.

10.
J Trauma Stress ; 35(4): 1177-1188, 2022 08.
Article in English | MEDLINE | ID: mdl-35355336

ABSTRACT

The impact of an 8.8 magnitude Chilean earthquake on elementary school students' psychosocial functioning was assessed along with exposure to adverse childhood experiences (ACEs). Skills for Life, a national school-based mental health program in Chile, routinely assesses first- and third-grade students' psychosocial functioning and classroom adaptation. Students (N = 19,627) were screened before (2009) and after (2011) the 2010 earthquake with parent- and teacher-report measures and with a parent-report of four ACEs (family psychopathology, child chronic illness, family social isolation, father absence). Earthquake exposure was categorized as mild, moderate, or severe for Chile's 15 regions. Multilevel models analyzed the unadjusted and adjusted impacts of earthquake exposure and ACEs on functioning while clustering for school- and district-level effects. In covariate-adjusted models, earthquake exposure and three ACEs were significantly associated with worsened psychosocial functioning; earthquake exposure and all four ACEs were significantly associated with worsened classroom adaptation. New family psychopathology, B = 1.90, p < .001; chronic illness, B = 2.25, p < .001; and severe earthquake impact, B = 1.29, p < .001, held the strongest negative effects on psychosocial well-being. Moderate, B = 3.04, p = .011, and severe earthquake exposure, B = 2.53, p = .047, and new family psychopathology, B = 1.99, p < .001, were associated with the worst classroom functioning 1-year postdisaster. Findings suggest that both exogenous and home-based stressors can have significant consequences for children's psychosocial functioning and classroom adaptation, and routine screening helps quantify how individual students are affected by chronic versus acute stressors.


Subject(s)
Adverse Childhood Experiences , Earthquakes , Stress Disorders, Post-Traumatic , Child , Chile/epidemiology , Chronic Disease , Humans , Longitudinal Studies , Psychosocial Functioning , Stress Disorders, Post-Traumatic/epidemiology , Stress Disorders, Post-Traumatic/psychology
11.
Orthop Traumatol Surg Res ; 108(7): 103133, 2022 11.
Article in English | MEDLINE | ID: mdl-34706289

ABSTRACT

BACKGROUND: The demand for total ankle arthroplasty (TAA) and ankle arthrodesis surgery is increasing. Findings from other orthopaedic populations suggest an increasing comorbidity burden among those planned for surgery, however, data on TAA and ankle arthrodesis is limited. The goal of this study is to study the comorbidity burden for TAA and ankle arthrodesis. HYPOTHESIS: Comorbidity burden is associated with higher resource utilization for both TAA and ankle arthrodesis. PATIENTS AND METHODS: This retrospective cohort study utilized data from the nationwide Premier Healthcare Database (2006-2016) which contains inpatient claims on n=10,085 ankle arthrodesis and n=4,977 TAA procedures. Patients were categorized into Deyo-Charlson comorbidity index (DCCI) groups. Outcomes were cost of hospitalization, length of stay (LOS), total opioid utilization, discharge to a skilled nursing facility (SNF), and 30-day readmission. Mixed-effects models estimated associations between DCCI and outcomes. We report odds ratios (OR, or % change for continuous outcomes) and 95% confidence intervals (CI). RESULTS: In the TAA group, 67.9% of patients were in DCCI category 0 while 22.4%, 6.6%, and 3.1% were in the 1, 2, and >2 DCCI categories, respectively. This was 61.3%, 18.1%, 9.8% and 10.9% in the ankle arthrodesis group. The most common comorbidities were obesity, diabetes mellitus, and chronic pulmonary disease. Particularly in the ankle arthrodesis group, the proportion of patients with comorbidities has increased over time. After adjustment for relevant covariates, patients in the DCCI group >2 (compared to '0') were associated with stepwise effects of up to 77.1% (CI 70.9%; 83.6%) longer length of stay and up to 48.5% (CI 44.0%; 53.2%) higher cost of hospitalization. DISCUSSIONS: Comorbidity burden is increasing among patients undergoing ankle arthrodesis where it is associated with significantly increased resource utilization. Our data demonstrate the potential impact of patient selection, which may be crucial in optimizing preoperative status. LEVEL OF EVIDENCE: III.


Subject(s)
Ankle , Arthroplasty, Replacement, Ankle , Humans , Retrospective Studies , Ankle Joint/surgery , Postoperative Complications/epidemiology , Postoperative Complications/surgery , Arthrodesis/methods , Comorbidity
12.
Foot Ankle Int ; 43(1): 32-41, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34293943

ABSTRACT

BACKGROUND: Hallux valgus is a common cause of pain and dysfunction of the foot, sometimes requiring surgical correction when conservative measures fail. Although there are many methods of correction, one of the newer techniques is minimally invasive chevron-Akin (MICA). The aim of the current study is to evaluate clinical and radiographic effectiveness of MICA and narcotic use in a large patient cohort. METHODS: All patients in this retrospective study were treated by a single fellowship-trained foot and ankle orthopaedic surgeon. Patient demographics were collected for all cases. Preoperative and postoperative intermetatarsal angle (IMA) and hallux valgus angle (HVA) were measured in all patients on weightbearing 3-views radiographs. The Foot Function Index (FFI) was obtained pre- and postoperatively at each visit. All patients were prescribed regular use of ibuprofen for 3 days with acetaminophen and oxycodone reserved for breakthrough pain. Use of narcotic pain medication was recorded. RESULTS: A total of 274 feet in 248 patients were included in the study. Overall, 87.9% were female and 12.1% were male. The mean preoperative IMA and HVA were 13.4 and 29.1 degrees, respectively. The postoperative IMA and HVA were 4.9 and 8.9 degrees, respectively. The mean FFI score part A was 92 preoperatively and 43 postoperatively. Patient satisfaction was 91.6%. The mean postoperative 5 mg oxycodone pill consumption was 2.2. CONCLUSION: MICA is good method to correct hallux valgus deformity with low postoperative narcotic use. LEVEL OF EVIDENCE: Level III, restrospective cohort study of a single surgeon practice.


Subject(s)
Bunion , Hallux Valgus , Metatarsal Bones , Cohort Studies , Female , Hallux Valgus/diagnostic imaging , Hallux Valgus/surgery , Humans , Male , Osteotomy , Retrospective Studies , Treatment Outcome
13.
J Eat Disord ; 9(1): 135, 2021 Oct 20.
Article in English | MEDLINE | ID: mdl-34670625

ABSTRACT

OBJECTIVE: To describe the characteristics of the patients, as well as the treatment outcomes for the people treated in an Endocrinology and Nutrition unit with a diagnosis of SE-ED (> 7 years evolution despite evidence-based conventional treatment). METHODS: A descriptive observational study was conducted. Patients with a diagnosis of SE-ED (anorexia nervosa and bulimia nervosa) treated in the Endocrinology and Nutrition service of the Virgen del Rocío University Hospital between 2014 and 2019 were included. RESULTS: 67 patients were contacted and accepted to participate in the study. 95.5% were women. 67.2% were diagnosed with AN (anorexia nervosa) and 32.8% with BN (bulimia nervosa). Their median ages (years) at the onset of symptoms, beginning of follow-up and at present were 17, 32 and 42.5 respectively. Their median time of follow-up was 9 years. 73.1% had mental comorbitidy and AN patients had more osteoporosis (48.9% vs 22.7%, p = 0.04) and hypogonadotropic hypogonadism (31.1% vs. 4.5%, p = 0.014). DISCUSSION: The SE-ED patients in our sample began treatment years after the onset of symptoms, which may have led to their chronification. This emphasizes the importance of an early diagnosis in eating disorders. They presented with a high rate of physical complications and mental comorbidity. In the current sample, it was determined that patients with AN presented with higher rates of osteoporosis and hypogonadotropic hypogonadism than patients with BN. LEVEL OF EVIDENCE: Level III: Evidence obtained from well-designed cohort or case-control analytic studies. At present, the criteria for severe and enduring eating disorders (SE-ED) are not sufficiently clearly defined. It has been calculated that approximately 20% of patients with anorexia nervosa (AN) and 10% of patients with bulimia nervosa (BN) suffer a chronification. We evaluated the characteristics of the patients, as well as the treatment outcomes for the people treated in an Endocrinology and Nutrition unit with a diagnosis of SE-ED (which was made based on an evolution greater than 7 years despite conventional treatment). The SE-ED patients in our sample began treatment years after the onset of symptoms, which may have led to their chronification. They presented with a high rate of physical complications and mental comorbidity. In the current sample, it was determined that patients with AN presented with higher rates of osteoporosis (health condition that weakens bones, making them fragile and more likely to break) and hypogonadotropic hypogonadism (illness in which testes or ovaries produce little or no sex hormones due to a problem in the pituitary gland) than patients with BN.

16.
J Pharm Policy Pract ; 14(1): 27, 2021 Feb 28.
Article in English | MEDLINE | ID: mdl-33648589

ABSTRACT

BACKGROUND: Increasingly, there has been recognition that siloed approaches focusing mainly on human health are ineffective for global antimicrobial resistance (AMR) containment efforts. The inherent complexities of AMR containment warrant a coordinated multisectoral approach. However, how to institutionalize a country's multisectoral coordination across sectors and between departments used to working in silos is an ongoing challenge. This paper describes the technical approach used by a donor-funded program to strengthen multisectoral coordination on AMR in 11 countries as part of their efforts to advance the objectives of the Global Health Security Agenda and discusses some of the challenges and lessons learned. METHODS: The program conducted a rapid situational analysis of the Global Health Security Agenda and AMR landscape in each country and worked with the governments to identify the gaps, priorities, and potential activities in multisectoral coordination on AMR. Using the World Health Organization (WHO) Joint External Evaluation tool and the WHO Benchmarks for International Health Regulations (2005) Capacities as principal guidance, we worked with countries to achieve key milestones in enhancing effective multisectoral coordination on AMR. RESULTS: The program's interventions led to the achievement of key benchmarks recommended actions, including the finalization of national action plans on AMR and tools to guide their implementation; strengthening the leadership, governance, and oversight capabilities of multisectoral governance structures; establishing and improving the functions of technical working groups on infection prevention and control and antimicrobial stewardship; and coordinating AMR activities within and across sectors. CONCLUSION: A lot of learning still needs to be done to identify best practices for building mutual trust and adequately balancing the priorities of individual ministries with cross-cutting issues. Nevertheless, this paper provides some practical ideas for countries and implementing partners seeking to improve multisectoral coordination on AMR. It also demonstrates that the WHO benchmark actions, although not intended as an exhaustive list of recommendations, provide adequate guidance for increasing countries' capacity for effective multisectoral coordination on AMR in a standardized manner.

17.
J Pharm Policy Pract ; 14(1): 16, 2021 Jan 21.
Article in English | MEDLINE | ID: mdl-33478590

ABSTRACT

Well-functioning national regulatory authorities (NRAs) ensure access to safe, effective, quality-assured, and affordable medical products. However, the benefits of their work are often unseen and difficult to attribute, thereby making NRAs undervalued and under-resourced, particularly in low- and middle-income countries. This paper offers three key arguments NRAs and other stakeholders can use to advocate for greater investment in regulatory systems strengthening-medical products regulation effectively safeguards public health; effective regulation improves health system's efficiency by increasing access to affordable medical products, contributing to universal health coverage; and robust regulation strengthens local pharmaceutical manufacturing and bolsters pharmaceutical trade. NRAs' critical role in health systems is indisputable, yet they need to better promote their value to receive the requisite resources to function effectively.

18.
Orthopedics ; 44(1): e148-e150, 2021 Jan 01.
Article in English | MEDLINE | ID: mdl-33002173

ABSTRACT

A 73-year-old woman with significant medical comorbidities presented with a grade I open left ankle fracture dislocation. Distraction arthroplasty was used as a definitive treatment for this injury. The patient tolerated the procedure and had no postoperative complications. The external fixator was removed at 6 months. The patient maintained good ankle function at the 1-year postoperative visit. Distraction arthroplasty is a viable acute and definitive treatment option for ankle fracture in patients with significant medical comorbidities. [Orthopedics. 2021;44(1):e148-e150.].


Subject(s)
Ankle Fractures/surgery , Arthroplasty/methods , Fracture Dislocation/surgery , Fractures, Open/surgery , Aged , Ankle Joint/physiopathology , Ankle Joint/surgery , Arthroplasty/instrumentation , External Fixators , Female , Humans
19.
Clin Sports Med ; 39(4): 877-891, 2020 Oct.
Article in English | MEDLINE | ID: mdl-32892973

ABSTRACT

Recreational athletes are susceptible to experiencing pain in the Achilles tendon, affecting their ability to complete daily activities. Achilles tendinosis is a degenerative process of the tendon without histologic or clinical signs of intratendinous inflammation, which can be categorized by location into insertional and noninsertional tendinosis. This condition is one that can be treated conservatively with great success or surgically for refractory cases. Currently, there is a lack of consensus regarding the best treatment options. This review aims to explore both conservative and operative treatment options for Achilles tendinopathy and Achilles tendon rupture.


Subject(s)
Achilles Tendon/injuries , Ankle Injuries/therapy , Athletic Injuries/therapy , Orthopedic Procedures/methods , Return to Sport , Rupture/therapy , Tendinopathy/therapy , Achilles Tendon/surgery , Ankle Injuries/diagnosis , Ankle Injuries/etiology , Ankle Injuries/physiopathology , Athletic Injuries/diagnosis , Athletic Injuries/etiology , Athletic Injuries/physiopathology , Conservative Treatment/methods , Humans , Rupture/diagnosis , Rupture/etiology , Rupture/physiopathology , Tendinopathy/diagnosis , Tendinopathy/etiology , Tendinopathy/physiopathology , Treatment Outcome
20.
BMJ Glob Health ; 5(8)2020 08.
Article in English | MEDLINE | ID: mdl-32784212

ABSTRACT

Many low-income and middle-income countries lack the capacity to effectively and efficiently regulate medical products in their countries. To support countries in strengthening their capacity, WHO has developed the Global Benchmarking Tool (GBT) as the global standard for objectively assessing regulatory capacity for medicines and vaccines. The GBT is a game changer because it is the first globally accepted tool for assessing and strengthening national regulatory authorities. The inclusion of an institutional development plan in the GBT methodology provides context-specific actionable steps countries can take to advance their system's functionality and maturity. The GBT facilitates coordination and improves the effectiveness of regulatory strengthening efforts. The tool also facilitates regulatory reliance and harmonisation, which helps to improve timely access to quality-assured medicines, and creates incentives for trade, particularly in countries and regions with a strong pharmaceutical manufacturing base. The GBT is a necessary tool for creating strong and effective regulatory systems, which are critical for ensuring the efficacy, safety and quality assurance of medicines and populations' timely access to these medicines. In outlining the benefits of the GBT, this paper also offers some specific ideas for strengthening the GBT framework and process.


Subject(s)
Benchmarking , Vaccines , Humans , Income , World Health Organization
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