Availability, prices and affordability of the World Health Organization’s essential medicines for children in Guatemala

Children in poorer countries are more likely to die from treatable conditions than those in higher resource settings because they do not receive appropriate or timely medications [1]. This is also true in Guatemala, where poverty contributes to the country’s high mortality rate for children under the age of five [2]. Millennium Development Goal 4 (MDG4) states that a two-thirds reduction in mortality from 1990 to 2015 in children younger than five years is essential for global development [3]. Compared to the rate of mortality in 1990, Guatemala will need to increase the rate of decline in childhood deaths from 75.8 to 25.3 deaths per 1000 to achieve the MDG goal by 2015 [4]. To assist member countries with achieving MDG4, the WHO constructed the first Essential Medicines List for Children (EMLc) and launched the “Make Medicines Child Size” effort in December of 2007. This initiative aims to improve the accessibility of safe, effective and quality medicines for children by promoting awareness and action through research, regulatory measures and changes in government policy.

A vital first step to improving medicine access for children is measuring the availability and prices of essential medicines present on pharmacy shelves and in national medicines lists. Data on medicine stock deficits and unaffordable prices creates an evidence base to inform the development of national and regional policies. A recent survey of essential medicines for children in Africa exposed the severe lack of medicines for children in central medicine stores, hospitals, pharmacies and national medicine lists in 14 different countries [5]. The objective of this study is to measure access to children’s medicines in Guatemala using validated methods, similar to those used in Africa [6, 7].

We conducted a survey of the availability, prices and affordability of children’s medicines in Guatemala using an adaption of the standardized methodology developed by the World Health Organization (WHO) and Health Action International (HAI) [7]. A validation study of the WHO/HAI survey methodology conducted in Peru in 2005 found that focusing on commonly used medicines yields sufficient and valid results [16]. We collected data on the availability and final patient prices of medicines in a subsector of public and private sector medicine outlets during April and May of 2010.

The availability of essential children’s medicines is low in both the public and private sectors in Guatemala. Availability is lowest in the public sector, but there is inconsistent pricing and poor affordability of medicines in the private sector. Furthermore, formulations of medications that are preferable for use in children were often hard to find. Of the 30 medicine formulations in the survey protocol, seven were not assessed because they are not registered in Guatemala [6]. These consisted of dispersible (3) and chewable (2) tablets, oral liquid (1) and intrarectal solution (1); all formulations preferred for use in children. It is unclear if the lack of registered medicines for children is related to low prescriber demand similar to the case with magnesium sulfate in Zambia, or exclusion from the contrato abierto, the central government purchasing mechanism, due to high purchasing prices [20]. Guatemala is subject to rules and regulations under Trade Related Aspects of Intellectual Property Rights (TRIPS). Essential medicines that have been reformulated to be better suited for children may be under patent and therefore more expensive in Guatemala for up to 5 to 15 years after becoming generic in the United States [11]. Another factor that may be responsible for a dearth of registered child friendly formulations may be difficultly obtaining the product if it is not manufactured in the country or nearby. As suggested in previous literature, studies of local prescribing practices and government purchasing are required to fully answer these questions [5]. Development of a national essential medicines list that includes children’s medicines could increase demand from providers and guide purchasing decisions [21].

Among the surveyed medicines, originator brands were almost never available in the PROAM sector as the government contracts with generic pharmaceutical companies to procure less expensive medications. In addition, the availability of generic medicines in the PROAM sector was exceptionally low with only about one quarter of index medicines stocked in each outlet. These findings are similar to a recent study on the accessibility of children’s medicines in 14 African countries, where essential children’s medicines were available at central medicine stores 15 to 75% of time with only 3 medicine outlets containing over 50% of medicines [5]. Our findings are also consistent with a number of pricing and availability surveys that have been conducted for adult medicines for both acute and chronic diseases [22‐25]. These studies show that availability of essential medicines is lower in the public than the private sector, varies by country, and that medicines for chronic conditions are less available than those for acute conditions.

Seven medications were not found at all in the private sector. One medication, chloramphenicol injection, was not stocked due to concerns about its toxicity. One would expect the remainder of these medicines to be found at the hospital level and therefore, not stocked in outpatient outlets. However, as the availability in hospitals is low, friends or family of hospitalized patients often go to alternate locations such as private retail pharmacies to purchase medications. Even the poorest patients in Guatemala seek medicines from the private sector [26].

Diarrheal disease is one of the major causes of mortality in children under five in Guatemala [8]. Although oral rehydration powders for reconstitution and premixed solutions for treatment of diarrhea were available in the PROAM and private sectors, oral zinc was unavailable in these sectors and the mean availability was only 25% in the hospital setting. Zinc is included on the EMLc due to its benefit in treating children with diarrhea [27].

Antibiotics for treating pneumonia and other respiratory infections in children should be available for use as empiric treatment, to decrease a major cause of morbidity in children [8]. While ceftriaxone was found quite frequently in the private and public sectors, it was only available in about half of the PROAM outlets. Amoxicillin and amoxicillin-clavulanic acid were available most frequently in 250mg/5ml concentration. When child appropriate concentrations are not available, pharmacy employees must calculate the dose. This could lead to adverse drug events as pharmacy employees in low income countries may need additional training [28].

In the PROAM sector, affordability of lowest price medicines was reasonable compared to the private sector where many of lowest priced treatments cost more than the daily wage of a lowest paid government employee. In the private sector, the most unaffordable treatments were for seizure disorder with carbamazepine (6.6 days wages) and infections with ceftriaxone (15 days wages). Carbamazepine is an ongoing treatment for a chronic condition, making it even less affordable. Given that 24% of the population in Guatemala is living below the international poverty line of less than $2/day, treatments which appear affordable may still be too costly [29]. In addition, treatment costs refer to medicines only and do not include the additional costs of consultation and diagnostic tests. Finally, families who need medications for more than one child may be confronted with insurmountable drug costs. These findings are consistent with other studies of affordability of adult medicines showing that chronic medicines, in particular, are unaffordable for many populations [22, 23, 25, 30].

A major strength of this study is the use of a previously validated methodology which allows for the measurement of medicine prices and availability in a reliable and standardized way [16]. Additional strengths include training and utilization of multiple check points to ensure quality data collection, data entry and interpretation.

Limitations of the WHO/HAI methodology are consistent with past surveys. Therapeutic alternatives or alternate dosage forms were not assessed. The availability data refers to the day of data collection at each particular facility in subsectors of the country and may not reflect average monthly or yearly availability of medicines at individual facilities or throughout the entire country. Also, the standard for determining the median price ratio is the median of supplier prices. However, if supplier prices are not available, buyer prices are substituted to determine the median international reference price for the different medications. This can lead to artificially high or low reference price that isn’t necessarily indicative of true median price paid internationally [25]. NGOs, private dispensing doctors and unregistered dispensaries were not surveyed and their importance as a source of medicines for those with low socioeconomic status is unknown. Further investigation is warranted into the amount that these sources contribute to accessibility to medications in Guatemala.

The findings of this study can be used to structure policies to improve the accessibility of children’s medicines in Guatemala and help the country meet MDG4 in 2015. Monitoring the availability and pricing of children’s essential medicines in Guatemala and other countries is crucial for improving transparency about global prices. Updated lists of all registered pharmacies are needed to facilitate these analyses. Inclusion of the WHO’s Essential Medicines List for children into national formularies and purchasing lists such as the PROAM and contrato abierto could improve the availability of essential children’s medicines. Data should be collected on prescribing practices of local pediatricians to detect deficiencies, if any, in rational prescribing and develop educational programs to improve prescribing of medicines from the EMLc [5]. The coordination of the WHO EMLc with national clinical practice guidelines could promote physician use of essential medicines. Further analysis of the procurement, supply and distribution of specific medicines is needed to determine reasons for lack of availability [20].

AA, BR, ARE and LB conceived of the study, and participated in its design and coordination and helped to draft the manuscript. All authors read and approved the final manuscript.

AA is a PharmD and a Pharmacy Practice Resident at University of San Francisco, California Medical Center. BR is a PharmD and a Health Sciences Assistant Clinical Professor at University of San Francisco, California and a Professor in the Departamento de Química-Farmacéutica at the Universidad del Valle de Guatemala. ARE is an MPH and a consultant at Cedar Associates. LB is a PhD and Professor of Clinical Pharmacy and Health Policy.