Clinical trial NCT03218189: Differences Between Essential Medicines Lists in 135 Countries and Model List of Essential Medicines
Official title: Differences Between Essential Medicines Lists in 135 Countries and the World Health Organization's Model List of Essential Medicines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Formularies
Keywords: Essential medicines lists
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 137
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Countries that have an essential medicines list are included in the study

Brief summary: The World Health Organization (WHO) has developed a model list of more than 400 medicines and recommends that each country adapt the list to its own circumstances. More than 100 countries have developed essential medicines lists.

Some countries have essential medicines lists that are very similar to the WHO's model list and other countries have lists that are very different from the WHO's model list. Differences between the WHO list and country lists could be explained by features of the country including population demographics, disease prevalence, Gross Domestic Product (GDP), and healthcare system organization. Other factors such as the influence of particular individuals or organizations may also explain differences between countries.

The purpose of this project is to compare the essential medicines lists developed by countries with the WHO's model list and to identify attributes of countries that are associated with differences from the WHO list. Predictors such as region, population, life expectancy, infant mortality rate, GDP per capita, health expenditure per capita, inequality, and the corruption perception index will be considered.

Detailed description: Statistical analysis plan for objective 3 (relationship between the total number of differences and country features)

Plots will be generated to show the relationships between variables. Correlation coefficients will be calculated where appropriate. Two separate multivariate models will be fit to the data for outcomes 2a and 2b \[continuous, between 1 and 500\]. A similar model will be fit the total number of differences. The analytical method will be determined by the data and may be liner regression.

Predictors:

Region-Categorical (6)

Population-Continuous

Life expectancy-Continuous

Infant mortality rate-Continuous

GDP per capita-Continuous

Health expenditure per capita

Inequality-Continuous

Corruption Perception Index-Continuous

Eligibility criteria: Inclusion Criteria:

* Countries that have an essential medicines list, and Canada

Exclusion Criteria:

* countries that do not have an essential medicines list that is available online

Primary outcomes:
measure: Total number of differences between the WHO model list of essential medicines and the essential medicines list in each country
timeFrame: 1 year
Secondary outcomes:
measure: Medications that are on the WHO list but not on the country list
timeFrame: 1 year
measure: Medications that are on the country list but not on the WHO list
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
Study officials:
References: