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Bibliographic review of research publications on access to and use of medicines in low-income and middle-income countries in the Eastern Mediterranean Region: identifying the research gaps

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Bibliographic review of research publications on access to and use of medicines in low-income and middle-income countries in the Eastern Mediterranean Region: identifying the research gaps
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  Bibliographic review of researchpublications on access to and useof medicines in low-incomeand middle-income countries inthe Eastern Mediterranean Region:identifying the research gaps Arash Rashidian, 1,2,3 Nader Jahanmehr, 1,3 Samer Jabbour, 4 Shehla Zaidi, 5 Fatemeh Soleymani, 6 Maryam Bigdeli 7 To cite:  Rashidian A,Jahanmehr N, Jabbour S, et al  . Bibliographic review ofresearch publications onaccess to and useof medicines in low-incomeand middle-income countriesin the Eastern MediterraneanRegion: identifying theresearch gaps.  BMJ Open  2013; 3 :e003332.doi:10.1136/bmjopen-2013-003332 ▸  Prepublication history forthis paper is available online.To view these files pleasevisit the journal online(http://dx.doi.org/10.1136/ bmjopen-2013-003332).Received 3 June 2013Revised 26 August 2013Accepted 27 August 2013For numbered affiliations seeend of article. Correspondence to Dr Arash Rashidian;arashidian@tums.ac.ir ABSTRACTObjectives:  We assessed the situation of academicpublications on access to and use of medicines (ATM) inlow-income and middle-income countries (LMICs) of theEastern Mediterranean Region (EMR). We aimed toinform priority setting for research on ATM in the region. Design:  Bibliographic review of published studies. Setting:  LMICs in EMR. Inclusion criteria:  Publications on ATM issuessrcinating from or focusing on EMR LMICs covering theperiod 2000 – 2011. Publications involving multinationalstudies were included if at least one eligible country hadbeen included in the study. Information sources and data extraction:  Weconducted comprehensive searches of the PubMed,Social Science Citation Index and Science CitationIndex. We used the WHO ATM framework for dataextraction and synthesis. We analysed the dataaccording to the ATM issues, health system levels, yearof publication and the countries of srcin or focus of thestudies. Results:  151 articles met the inclusion criteria. Mostarticles (77%) srcinated from LMICs in EMR,suggesting that the majority of evidence on ATM in theregion is home-grown. Over 60% of articles were fromIran, Pakistan, Jordan and Lebanon (in order ofvolume), while we found no studies assessing ATM inSomalia, Djibouti and South Sudan, all low-incomecountries. Most studies focused on the rational use ofmedicines, while affordability and financing receivedlimited attention. There was a steady growth over timein the number of ATM publications in the region(r=0.87). Conclusions:  There is a growing trend, over the years,of more studies from the region appearing ininternational journals. There is a need for furtherresearch on the financing and affordability aspects ofATM in the region. Cross-border issues and the roles ofnon-health sectors in access to medicines in the regionhave not been explored widely. INTRODUCTION The provision of reliable access to affordable,appropriate and high-quality medicines is a key component of a functioning health system. 1  According to the WHO Framework for AccessTo and appropriate use of Medicines (ATM),access has been de 󿬁 ned as having four para-meters: that the available medicines are effect-ive, of consistently good quality and are usedrationally (rational use), that there is no  󿬁 nan-cial obstacle to a patient receiving it (afford-ability), that the  󿬁 nancing mechanisms aresustainable to ensure that access to quality medicines and affordability are ensured overtime (sustainable  󿬁 nancing), and that thehealth system provides the required infrastruc-ture, knowledge and guidance for proper useof medicines (health system and availability).The Framework stipulates that any isolatedefforts on one ATM aspect would not result inadequate and lasting improvement in the ATMsituation. 2 ARTICLE SUMMARYStrengths and limitations of this study ▪  This is the first study conducted in this regionthat has collated Access To and appropriate useof Medicines (ATM)-related published literatureto identify research priorities. ▪  We conducted systematic searches of the maininternational databases for identifying ATMarticles. ▪  Although we followed rigorous methods, the searchshould not be considered exhaustive. Further studiesmight have been published in locally indexed ornon-indexed journals, which might not have beencaptured by our methods. Rashidian A, Jahanmehr N, Jabbour S,  et al  .  BMJ Open   2013; 3 :e003332. doi:10.1136/bmjopen-2013-003332  1 Open Access Research  Unfortunately, ATM is often poor in low-income andmiddle-income countries (LMICs). WHO estimated that about one-third of the world ’ s population had limitedaccess to the medicines they needed. Many factors deter-mine access. They include, for example, tax and tariff pol-icies, pricing and affordability of medicines, price mark-uppolicies, cost-sharing and copayment for medicines, andhealthcare regulation policies and  󿬁 nancial protectionsystems for healthcare users. WHO estimates that, onaverage, the availability of essential drugs in LMICs is 35%in the public sector facilities and 66% in the privatesector. 3 The quality of pharmaceutical products and therational use of medicines (RUMs) also affect the effective-ness of the medicines and health outcomes. 4 In many LMICs, there is limited access to information that might help clinical decision-making on the use of medicines. 5 6 Medicines account for a high proportion of healthspending in LMICs, between 20% and 60% (compared with an average of around 18% in high-income countries). 7 Moreover, more than half of the expenditure on medicinesin most LMICs is out of the pocket. 8 This inequitable 󿬁 nan-cing situation, whether due to a lack of effective generalrevenue  󿬁 nancing or social insurance  󿬁 nancing or othermechanisms, creates signi 󿬁 cant access barriers for the poorand may lead to catastrophic household expenditures. Thepoor and other population groups often rely on the privateinformal sector for medicines, particularly in rural areas.Overprescribing and inappropriate prescribing and dis-pensing of medicines are prevalent. 9 Despite some progress in some areas — such as price andavailability  7 — data on ATM are often weak. Even wheredata are available, there is often limited systematic researchthat enables the interpretation of the data and using it inidentifying priorities and developing policy options toimprove access to medicines in LMICs. The application of health systems research tools and methods in the  󿬁 eld of access to medicines will help in understanding the weak-nesses and barriers of access to medicines and generating useful evidence to formulate policies. 10 This study was part of the ATM Policy Researchproject, funded by the WHO Alliance for Health Policy and Systems Research with the ultimate goal of   “ increas-ing access to and improve the use of medicines in low and middle income countries, particularly for the poor(Millennium Development Goal no. 8) ” . We aimed to assess the situation of academic publica-tions on ATM in LIMCs in the Eastern MediterraneanRegion (EMR), and the distribution of such publicationsin terms of geographical coverage and issues of interest.The ultimate objective of the study was to inform prior-ity setting for research in the area of access to medicinesin the region and globally. METHODSStudy design  We conducted a bibliographic review of research in EMR,involving comprehensive searches of the literature.The study involved an extensive search of the national,regional and international literature in the EMR  ’ sLMICs in 2000 – 2011 and mapping of research to iden-tify the geographical and research gaps that may not have been covered in previous research. Literature searches EMR included 16 LMICs according to the World Bank categories which comprised the geographical focus of the study. The country-speci 󿬁 c searches were conductedboth in relation to author af  󿬁 liations as well as the titlesand abstracts of the articles. A set of speci 󿬁 c ATM terms were developed in twobrainstorming meetings and used to devise the searchstrategy. The initial search strategy was tested in a numberof limited searches and was compared with a list of previ-ously known publications. The results of the assessment  were used to  󿬁 nalise the search strategy (box 1). The Box 1  Search strategy for regional literature PubMed example :#1- ((((((((((((((((Iran[Affiliation]) OR Pakistan[Affiliation]) ORLebanon[Affiliation]) OR Egypt[Affiliation]) OR Afghanistan[Affiliation]) OR Sudan[Affiliation]) OR Yemen[Affiliation]) ORJordan[Affiliation]) OR Tunisia[Affiliation]) OR Morocco[Affiliation]) OR Syria[Affiliation]) OR Palestine[Affiliation]) ORIraq [Affiliation]) OR Djibouti[Affiliation]) OR Libya$[Affiliation])OR Somalia[Affiliation])#2- (((((((((((((((((((middle east[Title/Abstract]) OR Iran[Title/ Abstract]) OR low income countries[Title/Abstract]) OR middleincome countries[Title/Abstract]) OR Pakistan[Title/Abstract])OR Lebanon[Title/Abstract]) OR Egypt[Title/Abstract]) ORAfghanistan[Title/Abstract]) OR Sudan[Title/Abstract]) ORYemen[Title/Abstract]) OR Jordan[Title/Abstract]) OR Tunisia[Title/Abstract]) OR Morocco[Title/Abstract]) OR EMRO[Title/ Abstract]) OR Syria[Title/Abstract]) OR Palestine[Title/Abstract])OR eastern Mediterranean[Title/Abstract]) OR Iraq [Title/ Abstract]) OR Djibouti[Title/Abstract]) OR Libya$[Title/ Abstract]) OR Somalia[Title/Abstract])#3- (#1) OR (#2)#4- ((((drug$[Title/Abstract]) OR medicines[Title/Abstract]) ORmedication$[Title/Abstract]) OR pharmac$[Title/Abstract])#5- ((((((((((((((((((use[Title/Abstract]) OR access[Title/Abstract])OR available[Title/Abstract]) OR availability[Title/Abstract]) ORaffordable[Title/Abstract]) OR affordability[Title/Abstract]) ORutilisation[Title/Abstract]) OR utilization[Title/Abstract]) ORessential [Title/Abstract]) OR counterfeit$[Title/Abstract]) ORprice[Title/Abstract]) OR pricing[Title/Abstract]) OR licensing[Title/Abstract]) OR licencing[Title/Abstract]) OR labeling[Title/ Abstract]) OR labelling[Title/Abstract]) OR formularies[Title/ Abstract]) OR generic[Title/Abstract])#6- ((((((((prescription$ [Title/Abstract]) OR prescrib$ [Title/ Abstract]) OR "drug policy"[Title/Abstract]) OR "pharmaceuticalpolicy"[Title/Abstract]) OR formulary[Title/Abstract]) OR phar-macy[Title/Abstract]) OR pharmacies[Title/Abstract]) ORpharmacist$[Title/Abstract])#7- (#3) AND (#6)#8- (#3) AND (#4) AND (#5)#9- (#7) OR (#8) 2  Rashidian A, Jahanmehr N, Jabbour S,  et al  .  BMJ Open   2013; 3 :e003332. doi:10.1136/bmjopen-2013-003332 Open Access  main terms selected for this study included drugs, medi-cines, medications and pharmaceuticals and their varia-tions. These were suitably linked with ATM-related terms. We conducted comprehensive searches of three majorelectronic databases (PubMed, Social Science CitationIndex and Science Citation Index). Initial searches wereconducted in January 2011 and all the searches wereupdated in June 2011 ( 󿬁 gure 1). Additionally, wesearched the WHO websites and contacted a few topicexperts for additional publications. Inclusion process and criteria  Articles published from 2000 onwards were considered.To ensure accuracy, two separate samples of 100 titles were reviewed by two researchers and disagreements werediscussed and clari 󿬁 ed. All the remaining titles and theabstracts of the identi 󿬁 ed articles via the search were ini-tially reviewed by one author. After the initial screenings,the abstracts (and subsequently the full text articles) wereread by two authors. We used the following criteria for the inclusion andexclusion of the articles ▸  No research design limit was used. However, letters tothe editors and abstract-only publications wereexcluded; ▸  Studies that were directly relevant to ATM issues wereincluded. For example, for RUM studies, we consid-ered studies that assessed RUM in a certain setting orstudies that sought to improve the use of medicinesspeci 󿬁 cally. However, broader studies of improving thequality of clinical care (which might have involved pre-scribing issues) were not included. (eg, a clinical Figure 1  Flow chart of search strategies in electronic databases for access to and appropriate use of medicines. Rashidian A, Jahanmehr N, Jabbour S,  et al  .  BMJ Open   2013; 3 :e003332. doi:10.1136/bmjopen-2013-003332  3 Open Access  practice guideline development project may not beincluded). Although prescribing is a part of the majority of the guidelines, if the purpose of the guideline is not prescribing per se; then the article may not be includedin here. This criterion was required to ensure that weremained focused on ATM issues. The same logic wasapplied to other aspects of ATM; ▸  Studies of drug resistance that did not elaborate onthe health system or ATM implications, studies of herbal medicines alone, studies of drug misuse,studies of use of contraceptive medicines that focusedon family planning issues only and studies focusing only on education methods and curriculum develop-ment for pharmacy courses were not included. Data extraction and analysis  After agreeing on the inclusion of a study, the full texts of the studies were retrieved. We developed a data extrac-tion tool based on the study conceptual framework. Weextracted data on the title, authors, year of publication,corresponding author ’ s country of srcin, countries of focus, research design and sample, summary of the main 󿬁 ndings, ATM issues considered in the study,  ‘ levels ’  of barrier studied and the research topics recommended by the authors. If a publication discussed more than one ATM issue, we noted as many issues as applied to that publication. We categorised the  ‘ levels ’  of the health system barriers to ATM as:  ‘ household and community  ’ ,  ‘ health service provi-ders ’ ,  ‘ health sector as a whole ’ ,  ‘ other related sectors ’  and ‘ cross border issues ’ . 11 12  We de 󿬁 ned ATM issues based onthe WHO Framework for ATM, which included fouraspects: affordability, sustainability of   󿬁 nancing, rationaluse, and health systems and availability of medicines. 13 One author extracted data from all the included studies,and another author assessed all the data extractions foraccuracy and completeness. Then we used not only descriptive methods and presentational graphs and dia-grams pertaining to the study questions, but also Pearson restimates to assess the publication trends over time. RESULTS In total, 4755 titles were retrieved as a result of thesearches and were reviewed ( 󿬁 gure 1). In total, 151articles were identi 󿬁 ed ( 󿬁 gure 1) that focused entirely or partially on ATM issues in one or more of EMR  ’ sLMICs. As the search strategy was sensitive to identify studiesthat were conducted in LMICs, we also identi 󿬁 ed anadditional 12 international studies that had important implications about ATM in LMICs of the region. 1 14 – 24  Among these 12 studies, 8 had been published in 2011alone. We used these studies to discuss and highlight some of the identi 󿬁 ed issues but did not include themin the analyses.Six articles were published in languages other thanEnglish: French (two each from Tunisia and Moroccoand one from Lebanon) and Czech (on Yemen). Countries of srcins of the studies Most of these articles (117 articles, 77%) originated(based on the corresponding author ’ s address) from theLMICs in EMR, while eight (5%) srcinated from high-income countries of the region and 26 (17%) fromother countries ( 󿬁 gure 2 A). There was a wide variationin the number of publications per country ( 󿬁 gure 2 A).The countries that produced at least 10 articles in the journals indexed in international databases were Iran(41, 27%), Pakistan (15, 10%), Jordan (13, 9%) andLebanon (10, 7%). These were followed by Sudan (9),Palestine Occupied Territories (8), Egypt (6), the USA (5) and Kuwait (5). Figure 2  Distribution of the country of srcin (A) and the country of focus* (B) for publications on access to and appropriate useof medicines issues in the Eastern Mediterranean Region ’ s low-income and middle-income countries. 4  Rashidian A, Jahanmehr N, Jabbour S,  et al  .  BMJ Open   2013; 3 :e003332. doi:10.1136/bmjopen-2013-003332 Open Access   We found several comparative international studiesthat used data from EMR or discussed issues relevant to EMR countries. In total, 17% of the identi 󿬁 ed lit-erature originated from countries outside EMR.Eleven (out of 26) of these studies were multicountry studies that included one or more EMR countriesalongside others. Countries of focus of the studies In total, 14 EMR LMICs have been the focus of at least one ATM research article in the past decade. The coun-tries that were the focus of at least 10 articles were Iran(46, 30%), Pakistan (28, 19%), Sudan (20, 13%), Jordan(18, 12%) and Lebanon (16, 11%).Two countries (Iraq, Libya) were discussed in only twoarticles each ( 󿬁 gure 2B). We found no studies onSomalia and Djibouti. There were also no studies onSouth Sudan, that is, none of the publications discussing Sudan had speci 󿬁 c attention or data from South Sudan, which is now an independent country. Research designs The majority of the included studies involved cross-sectional studies of various designs. Questionnairesurveys — of facilities, providers and students (38 arti-cles), patients and users (16 articles) and households (7articles) —  were the most common research designs and were used in 41% of the articles. This was followed by prescription audits and medicines utilisation reviews that  were observed in 35 articles (23%). Qualitative studies(mainly as case studies) were observed in 10 articles.Similarly, 15 articles (10%) focused on policy-relatedissues in review articles, policy briefs or advocacy articles,although pinpointing the research designs in thesestudies was not straightforward and some studies did not employ a formal research approach. We also identi 󿬁 ed 13 interventional studies (including 2 randomised controlled trials), 2 economic studies and2 consensus development studies. These articles, except for one, were all published since 2008. We includednine secondary data analyses (mostly involving multi-national data analyses), one systematic review, one biblio-metric study, one cohort and one case – control study.The studies had substantial variations in their designs,from well-designed trials or large-sample national andmultinational studies to small-scale studies of convenient samples or with unclear research designs. Growth in ATM publications  We observed a relatively steady growth in the number of publications per year on ATM in EMR within the last decade (Pearson r=0.87; see  󿬁 gure 3). While in the  󿬁 rst 3 years of this period there were only about 10 publica-tions from the region, 80 studies had been published inthe last 3 years of the study period. We also observed amodest increase in the proportion of studies srcinatedfrom outside EMR during the 2006 – 2010 period (20%)compared with the 2000 – 2004 period (13%). ATM issues of focus To understand the ATM issues on which the publishedarticle focused, we assigned each article to one or moreof the four large components in the WHO ATM frame- work. We noted the ATM issues of focus for the articles:affordability (25, 17%),  󿬁 nancing (18, 12%), rationaluse (106, 70%), and health system and availability (63,42%; table 1). RUM studies were the main bulk of thestudies conducted in the region, while very limited atten-tion had been devoted to the  󿬁 nancing aspects of accessto medicines.Similarly, the articles were assigned to one or more ‘ health system levels ’  that were the focus of attention forthe study (the total adds up to more than 151): house-hold and community (44, 29%), health service (108,72%), national health sector (79, 52%), national beyondhealth sector (7, 5%) and cross border issues (9, 6%; Figure 3  The increasingnumber of access to andappropriate use of medicinespublications per year and EasternMediterranean Region. Note:2011 publications cover only thefirst half of this year. Rashidian A, Jahanmehr N, Jabbour S,  et al  .  BMJ Open   2013; 3 :e003332. doi:10.1136/bmjopen-2013-003332  5 Open Access
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