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Title: The Role of Evidence in the Decision-Making Process of Selecting Essential Medicines in Developing

Article Number: EC/2014/007

Authors: Henry Irunde, PhD Student

Topic: Public Health



Medicines are an integral part of health care. If available, affordable, of good quality and properly used, medicines can offer a simple, cost-effective answer to many health problems. In Tanzania medicine and medical devices costs account for a large share of the total health budget.  Despite the obvious health and economic importance of medicines, there are still widespread problems with lack of access, poor quality, irrational use and waste.  Careful selection of a limited range of priority medicines can result in better management of medicines, more cost effective use of health resources and help deliver higher quality health care. However, there is a need for standardised methods to guide the selection process.


This article review is aimed at analyzing an article titled The Role of Evidence in the Decision-Making Process of Selecting Essential Medicines in Developing Countries: The Case of Tanzania” published in PLoS ONE. This is an important study in assessment of the process of selection of national essential medicines lists in low income countries like Tanzania for the purpose of improvement.


The authors describe the process of updating the Standard Treatment Guidelines (STG) and National Essential Medicine List in Tanzania (NEML) and further examine the criteria and the underlying evidence used in decision-making. A qualitative method of data collection, in-depth interview, was employed, together with informal interviews. Authors could not interview key informants such as secretary or chairperson of National Therapeutics Committee whose views could enrich findings of this study. Similarly, a single qualitative method is inadequate to justify their conclusion. Lack of written consent by respondents make the results invalid as these could be ghost respondents.


The authors conclude that, decisions about the selection of essential medicines in Tanzania were made by committees of experts who largely used experience and discretionary judgement, leaving evidence with only a limited role in decision-making process. Authors have forgotten that experience constitutes evidence. Most of essential medicines selected in poor countries are generic ones hence do not need rigorous health technology assessment employed by developed countries where new drugs are included in their national essential lists. The method of medicines selections in Tanzania follows a model developed by the WHO where expert committee supported by a team of secretariat plays major role in final decision making. In Tanzania, most essential medicines are drawn from WHO model formulary of essential medicines, and from database of registered medicines of Tanzania Food and Drugs Authority (TFDA), a national drug regulatory authority which performs rigorous dossiers evaluation.


Key words:    national essential medicines list, standard treatment guidelines, expert committee, Tanzania.



    COMMENT - 1

  • SARAH OBIANUJU UKEMENAM (Viewer) 30th Jan 2015 - 5:03 PM
    As already noted, Essential medicines are medicines which satisfy the priority health care needs of societies and are considered as a basis for public procurement or reimbursement decisions and target 8e of the Millennium Development Goals acknowledges the need to improve the availability of affordable medicines for the worlds poor. Several countries have made substantial progress towards increasing access to essential medicines and treatments to fight HIV/AIDS, malaria and tuberculosis, but access to essential medicines in developing countries is not adequate. From the foregoing therefore, it is clear that essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost effectiveness. From your article, you said the authors used experience based information to compile the essential drug use instead of the recommended WHO evidence based method. Was the list then accepted since it did not pass this very critical prerequisite? While experience is not to be wished away, the world and indeed medicine is now leaning on evidence based techniques and methods.
    Also, within a country, the selection of essential medicines is usually a two-step process. The first involves regulatory approval, which is based on a review of efficacy, safety, and quality of medicines (without comparison between medicines). From these registered products, essential medicines within a therapeutic class are then selected on the basis of comparative efficacy, safety, and cost. To best ensure the widest acceptance of the list, the selection process for essential medicines needs the involvement of a number I think your research work is in depth and relevant because the practice of breastfeeding of stakeholders, including prescribers, dispensers, academics, health facilities, civil society, professional organizations, and others. The large number of people or stakeholders necessitates the use of different methods of data collection such as quantitative (use of questionnaires) and qualitative. You however mentioned only the use of only in-depth interviews. Does it qualify the article to be taken seriously not to mention reviewed?
    Since you contacted the Ministry of health and found out that they were unaware of this study, it makes it practically unbinding so I want to know why you still went ahead to review it and what were your objectives or the new knowledge you hoped to contribute from your review. Thank you.

  • COMMENT - 2

  • HENRY FILLEMON HAMIS IRUNDE (Author) 30th Jan 2015 - 10:02 PM
    Thank you Sarah for sending these comments. This was an article review of the published article. This review provides honest, critical assessment of the research by analyzing the strengths and weaknesses of the research, then providing suggestions for improvement. The authors were critical to the method of selection of essential medicines in Tanzania and the review has clarified the matter.

    The article was reviewed because it was already published and the reviewer has a strong feeling that this article was misleading readers, this is why he selected to review it. We are not guided to review Good articles only, we can review also bad articles provided they have been published. The goal is to protect readers from being misled.

    The purpose of review is to asses the scientific quality of work (methods appropriateness and adequate data to support conclusion). This is what has been done in this review.

    I have noted you have mixed issues raised by authors and comments from the reviewer. Try to thoroughly read the full article so that you can distinguish between authors' comments and reviewer's comments and suggestion.

    Thank you for your participation
    • EDET-UTAN OLUWAKEMI (Viewer) 2nd Feb 2015 - 1:33 PM
      I agree with the reviewer that we have to also review 'bad' or misleading articles which are already published.

  • COMMENT - 3

  • EDET-UTAN OLUWAKEMI (Viewer) 2nd Feb 2015 - 1:41 PM
    however, I would like to add that going through the main content of the reviewed article, the authours identified the basic criteria that must be met in selecting essential drug in Tanzania as recommended by WHO, which is a laudable part of the article.

  • COMMENT - 4

  • HENRY FILLEMON HAMIS IRUNDE (Author) 3rd Feb 2015 - 1:44 AM
    Thanks Oluwakemi for your comments. I agree 100% with your all of your comments.


  • COMMENT - 5

  • SAHILA PEERBHAI (Viewer) 3rd Feb 2015 - 6:30 PM
    The study is a good one. infact being in one of the similar African countries and through my experience I think the decision making process needs to be looked into and the committee who is in the decision making.moreover a lot of medicines in the essential medicines list need to be reviewed and updated and discontinued. With newer diseases and events emerging there has to be motivation of newer drugs and some should be stopped.May be the study should look into how other developed countries deal with issues of decision making so that it could be an eye opener to solve some of these issues.

  • COMMENT - 6

  • HENRY FILLEMON HAMIS IRUNDE (Author) 4th Feb 2015 - 2:08 AM
    Thanks Sahila for your comments. I agree that we need to continuously upgrade and improve our systems and procedures of selecting essential medicines. It's true that new diseases are emerging and new medications are increasing and our selection criteria should march with the current demands. However, new medicines also need approval by the medicines regulatory authority through rigorous dossier evaluation and registration systems. I also agree that collaboration with developed countries to learn and exchange ideas and science is important.

    Kind regards.

  • COMMENT - 7

  • CLEMENTINA OBBY EZENWUBA (Viewer) 4th Feb 2015 - 12:32 PM
    I think you went into a right thing to study. Yes when one uses evidence base, one is speaking or acting with authority. But your abstract looks like the work itself. It is too long and is equally written in paragraph which should not be.

  • COMMENT - 8

  • HENRY FILLEMON HAMIS IRUNDE (Author) 4th Feb 2015 - 9:27 PM
    Thanks Clementina for your constructive criticism. There are two types of abstracts, structured and unstructured one. Structured is made of subheadings such as 'Purpose', 'Method', 'Results', 'Conclusion', and many writers prefer this. Unstructured one is made up of paragraphs where information flows in a logic manner from one paragraph to another. Abstract is a summary of an article and should be complete. When you read an abstract, you may decide whether to read the whole article or not. I have no objection with your proposal of cutting some of the words without distorting the completeness of the abstract.

  • COMMENT - 9

  • AVI NAHAR (Viewer) 7th Feb 2015 - 6:54 PM
    Dear All,
    Very exciting discussion already been done here. Great article & excellent critical review of the same. Evidence based medicine is a dictum in clinical practice. However, issue of spurious results concluded in a study not well planned or which did not follow the standards as per the WHO laid guidelines is a threat to Clinical Research. It not only raises questions on authenticity of the study but also bring under suspicion, all the other studies which are conducted.with utmost sincerity.

  • COMMENT - 10

  • HENRY FILLEMON HAMIS IRUNDE (Author) 7th Feb 2015 - 10:13 PM
    Thanks Dr. Avi for your valuable contribution and for showing interest of Evidence Based Medicine. Your comments are well noted.