# \[e-drug\] Moving towards a new definition of essential medicines? **URL:** \ **Category:** e-drug\ **Created:** [August 5, 2015, 4:51am UTC](https://talk.edrugplus.org/t/e-drug-moving-towards-a-new-definition-of-essential-medicines/41958 "2015-08-05T04:51:10Z")\ **Posts on this page:** 9\ **Page:** 1
**Author:** ![drsmanikandan001](https://avatars.discourse-cdn.com/v4/letter/d/46a35a/32.png) [@drsmanikandan001](https://talk.edrugplus.org/u/drsmanikandan001)\ **Post date:** [August 5, 2015, 4:51am UTC](https://talk.edrugplus.org/t/e-drug-moving-towards-a-new-definition-of-essential-medicines/41958/1 "2015-08-05T04:51:10Z")
E-DRUG: Moving towards a new definition of essential medicines? ------------------------------------------------ Dear All, WHO has recently released the 19th Model list of Essential Medicines and 5th Model List of Essential Medicines for Children. The Model List is considered a guiding beacon for all countries but the current list has characteristic differences from the previous lists. Many investigational agents, drugs for off-label indications, drugs not registered by stringent drug regulatory authorities have been included in the list. These are against the principles of selection of essential medicines. There are some more serious concerns addressed in the recently published editorial - "Are we moving towards a new definition of essential medicines?". Please follow the link to read the editorial [http://www.jpharmacol.com/article.asp?issn=0976-500X;year=2015;volume=6;issue=3;spage=123;epage=125;aulast=Manikandan](http://www.jpharmacol.com/article.asp?issn=0976-500X;year=2015;volume=6;issue=3;spage=123;epage=125;aulast=Manikandan) I thought of sharing this editorial in this forum and invite your comments. Best Wishes, Dr. S. Manikandan MD, DNB, MNAMS, Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and research (JIPMER), Pondicherry, INDIA drsmanikandan001@gmail.com ---
**Author:** ![Dr\_Leo\_Offerhaus](https://avatars.discourse-cdn.com/v4/letter/d/57b2e6/32.png) [@Dr\_Leo\_Offerhaus](https://talk.edrugplus.org/u/Dr_Leo_Offerhaus)\ **Post date:** [August 5, 2015, 7:44am UTC](https://talk.edrugplus.org/t/e-drug-moving-towards-a-new-definition-of-essential-medicines/41958/2 "2015-08-05T07:44:44Z")
E-DRUG: Moving towards a new definition of essential medicines? (2) -------------------------------------------- Dear colleague,      I fully agree with your suggestion - it is certainly a matter of principle which should be discussed in Geneva. When I was a temporary member of the advisory council of the Essential Medicines project I felt quite uneasy when powerful pressure groups forced the program to add scores of expensive anti-HIV drugs to the list, in a way indirectly forcing countries where HIV-AIDS was a minor problem to purchase drugs for which there was not a immediate need. The same is now happening with the list of 12 new anticancer drugs which now have been added. Many countries have no funds to buy them, and, in addition they lack the facilities for their safe and effective use. The list was originally meant to facilitate the acquisition of a restricted number of life-saving drugs in circumstances and in countries with limited facilities. WHO Europe did the same in Russia after the downfall of communism, and it was a huge success. Outside pressure on the scientific decisions may in the long run wreck the whole programme. Your remarks are timely and to the point, though they may fall on deaf ears in some circles. Good luck! Dr.Leo Offerhaus, Former acting head medicines division, WHO Europe 1991-1993. offerhausl@euronet.nl ---
**Author:** ![Willem\_Scholten1](https://avatars.discourse-cdn.com/v4/letter/w/898d66/32.png) [@Willem\_Scholten1](https://talk.edrugplus.org/u/Willem_Scholten1)\ **Post date:** [August 5, 2015, 10:02am UTC](https://talk.edrugplus.org/t/e-drug-moving-towards-a-new-definition-of-essential-medicines/41958/3 "2015-08-05T10:02:05Z")
E-DRUG: Moving towards a new definition of essential medicines? (3) --------------------------------------------    Dear all,    I share concerns with Dr Manikandan on the developments around the WHO    Essential Medicines List. The examples in his editorial are clear, but    I want to draw your attention to another aspect.    When I worked in WHO, we developed the WHO Guidelines for the    Pharmacological Treatment of Persisting Pain in Children (2012). These    evidence-based guidelines concluded that the evidence for all strong    opioid analgesics is relatively low (as for so many more medicines that    old); that the strongest evidence is for morphine; and that there is    no evidence to prefer one opioid full-agonist analgesic over another    when it comes to the need for alternatives. However, two alternatives    should be available at all times, because many patients do not well on    one opioid and in such a case pain can often be managed with another    opioid.    Based on these paediatric guidelines, I submitted an application in    2012 to add child-friendly morphine preparations to the list for    children. Furthermore, I submitted an application that at least two    alternative opioids should be available in addition to morphine.    Because there is no evidence for preferring one opioid over another, I    suggested that the square box should be used indicating that is an    example of a class and that a footnote explains that at least two    alternatives, e.g. hydromorphone and oxycodone, should be available. As    this aspect is not age-related, the application extended to the EML for    adults as well.    When the 18th Model List and the 4th Model List for Children were    published in 2013, I was amazed to find that their wording limit the    alternatives to two opioids only by saying "alternatives limited to    hydromorphone and oxycodone", in spite that there is not any scientific    reason for such a limitation or to prefer these two alternatives over    several other alternative opioids, like methadone or fentanyl.    This limitation is a novelty in the EML and it works out as a    suggestion to governments not to allow other opioid analgesics accepted    for pain management world-wide. The chosen wording is prohibitive for    having an optimal number of alternatives available for difficult cases    and therefore it is very unfortunate. It is also a violation of the WHO    policy guidelines for access to controlled medicines that rules should    not be applied any stricter on controlled medicines than on    non-controlled medicines unless good justification available.    Not having been able to find any explanation on what happened in the    expert meeting preceding the publication of the lists in 2013, I    assumed that this all was a misunderstanding. Therefore, for the 2015    meeting, I submitted an application to correct this, but it was    rejected again. The Secretary explained this to me with "As you recall,    the EML generally does not list ALL possible options in a class,    especially when there are large differences in price amongst the    alternatives - which is the case for the opioids. The Committee found    that there was no reason to move from this position." However, to    everybody who looks at other medicines with a square box indicating    that they are listed as an example of a class, it will be clear that    this is a specious argument.    I feel that the Committee put its bias against controlled medicines in    the EML without any reasonable justification. While the entire world,    including the World Health Assembly in its palliative care Resolution    67.19 of May 2014, is moving away from drug control policies that leave    over 80% of the world untreated for moderate and severe pain, the    Expert Committee on the Selection and Use of Essential Medicines seems    now having been recruited as an squadron in the War on Drugs at the    eleventh hour.    Best regards,    Willem Scholten Consultancy    Willem Scholten PharmD MPA    Consultant - Medicines and Controlled Substances    Wielsekade 64    3411 AD Lopik, the Netherlands    T: +31 348 769 029    M: +31 6 4847 3368    E: [1]wk.scholten@xs4all.nl    Skype: wimscholten    Twitter: @WKScholten    Chamber of Commerce number: 59656832    VAT Identification number: NL067732380B01 ---
**Author:** ![Mohga\_Kamal-Yanni](https://avatars.discourse-cdn.com/v4/letter/m/898d66/32.png) [@Mohga\_Kamal-Yanni](https://talk.edrugplus.org/u/Mohga_Kamal-Yanni)\ **Post date:** [August 5, 2015, 12:58pm UTC](https://talk.edrugplus.org/t/e-drug-moving-towards-a-new-definition-of-essential-medicines/41958/4 "2015-08-05T12:58:40Z")
E-DRUG: Moving towards a new definition of essential medicines? (4) -------------------------------------- [Response to Offerhaus' posting. Moderator] Actually some countries lack funding for antibiotics. Does that mean antibiotics should be off the essential medicines list? Best wishes ---
**Author:** ![Dr\_Leo\_Offerhaus](https://avatars.discourse-cdn.com/v4/letter/d/57b2e6/32.png) [@Dr\_Leo\_Offerhaus](https://talk.edrugplus.org/u/Dr_Leo_Offerhaus)\ **Post date:** [August 5, 2015, 3:26pm UTC](https://talk.edrugplus.org/t/e-drug-moving-towards-a-new-definition-of-essential-medicines/41958/5 "2015-08-05T15:26:16Z")
E-DRUG: Moving towards a new definition of essential medicines? (6) ------------------------------------ Dear Mr. Scholten, The problem you mentioned is quite a different one because you are asking for a safe medium-strength analgesic because there is a void between paracetamol/NSAIDs on the one hand, and opiods on the other. (Semi-) synthetic opioids do not form the solution, because at equal analgesic effect secondary effects and adverse reactions are the same as those of morphine. Recently some people, particularly from Eastern Europe, have advocated the use of the old drug metamizol, but that again is "between the devil and the deep blue sea". So far industry has not managed to produce a suitable alternative, the last failure being the COX inhibitors. That is not a problem that WHO can solve, though they should put additional pressure on the pharma industry to accelerate development of suitable safe pain killers. Let's focus on Dr.Manikandan's remarks instead. Best regards, Leo Offerhaus. offerhausl@euronet.nl ---
**Author:** ![Willem\_Scholten1](https://avatars.discourse-cdn.com/v4/letter/w/898d66/32.png) [@Willem\_Scholten1](https://talk.edrugplus.org/u/Willem_Scholten1)\ **Post date:** [August 5, 2015, 5:28pm UTC](https://talk.edrugplus.org/t/e-drug-moving-towards-a-new-definition-of-essential-medicines/41958/6 "2015-08-05T17:28:11Z")
E-DRUG: Moving towards a new definition of essential medicines? (7) -------------------------------------------- Dear Dr Offerhaus    This is not my point. I am discussing full-agonist opioid analgesics,    not non-opioid analgesics. The guidelines advisory group for the WHO    pediatric treatment guidelines recommended that morphine should be    available, plus at least two such strong opioid analgesics as an    alternative for patients who do not react well to morphine.     On the EML, it was then introduced that the alternatives should be    limited to hydrocodon and oxycodone, in this way excluding methadone    and fentanyl with the argument that some substances are expensive. This    is pure nonsense, as methadone is the cheapest opioid analgesic of all,    and in some countries (e.g. Greece), fentanyl is cheaper than morphine.    In most countries (together having 80% of the world population) access    to opioids is very low and often absent. In many of these countries    only one or two full-agonist opioid analgesics are on the market - out    of the five full-agonist opioids that are commonly in use in    industrialized countries nowadays. The EML excludes now two of them,    increasing the global crisis in pain management, in particular in    countries where fentanyl or methadone is among the alternatives for    morphine. The mechanism is novel and it is my view that it is not by    hazard that this is applied for the first time on controlled    substances: the Expert Committee for the Selection of Essential    Medicines shows an unjustified fear for the use of opioid analgesics    that does not find any justification in the scientific literature, and    it comes up with false justifications for its measure.     In this way the Expert Committee counteracts many WHO policies like the    WHO pediatric pain guidelines, the WHO policy guidelines on access to    controlled medicines and the WHA resolution on palliative care.    I hope I made myself more clear now,    Best regards,    Willem Scholten    Willem Scholten Consultancy    Willem Scholten PharmD MPA    Consultant - Medicines and Controlled Substances    Wielsekade 64    3411 AD Lopik, the Netherlands    T: +31 348 769 029    M: +31 6 4847 3368    E: [1]wk.scholten@xs4all.nl    Skype: wimscholten    Twitter: @WKScholten    Chamber of Commerce number: 59656832    VAT Identification number: NL067732380B01 ---
**Author:** ![BONFACE\_FUNDAFUNDA](https://avatars.discourse-cdn.com/v4/letter/b/7bcc69/32.png) [@BONFACE\_FUNDAFUNDA](https://talk.edrugplus.org/u/BONFACE_FUNDAFUNDA)\ **Post date:** [August 6, 2015, 1:06pm UTC](https://talk.edrugplus.org/t/e-drug-moving-towards-a-new-definition-of-essential-medicines/41958/7 "2015-08-06T13:06:16Z")
E-DRUG: Moving towards a new definition of essential medicines? (10) --------------------------------------------- Dear colleagues, The term 'essential drugs' appears to be subjective? It reminds me of the use of the term 'Basic Package of Care'. In some circles, the term 'Basic Package of Care' refers to the provision of basic, primary- type of health services. Tertiary care, the sort of high end, high cost health care services such as cancer screening and treatment, would be considered not part of the 'Basic Package of Care'. If that line of thought is stretched, it would imply that the basic package of care will not attend to the more complex diseases (cancer? dialysis? NCDs?) that require high cost diagnosis, care and treatment. What then, to do about these, new emerging diseases, for example, that now have become common? Not so long ago, I came across this opinion / position from some healthcare planners and health professionals: 'if we cannot afford the treatment, then the disease does not exist'. The idea of an Essential Drugs List certainly helps to concentrate the mind of governments, so that there is control on what products to use, procure and use in the health care system for the diseases prevailing. I do not believe the EDL strategy aims to prevent or restrict the inclusion of any other products, event when those products are expensive. In that regard, ARVs, anti- cancer drugs, for example, would immediately fit the term, Essential Drug, in spite of their cost. So, if WHO recommends new and expensive drugs, I guess it is from a recognition that the primary purpose of organizing the list of essential requirements, is indeed about affordability, reducing wastage, reducing cost, creating control, prioritizing, etc, particularly in resource- limited settings. But it is also about ensuring that we are able to treat all diseases that we are faced with (not suggesting that we'd ignore any disease). Furthermore, the disease profiling and the health programming activities in many countries are mature enough to recognize the need to attend to the more sophisticated diseases that require the more expensive products, that are now, also essential. So, I think that the above consideration is what the new List of recommendations from WHO is suggesting. Regards, Bonnie Bonface Fundafunda PhD., MBA., B.Pharm Managing Director, Medical Stores Limited P.O. Box 30207 Mukwa Road, Plot 6446 Lusaka, Zambia Tel (Dir): +260 211 246510 (Dir)Tel (General): + 242768/ 244105 / 242346 Fax: +260 211 246288 Mobile: + 260 979 25 29 00 Email: bonface.fundafunda@medstore.co.zm Web: www.medstore.co.zm ---
**Author:** ![Mohga\_Kamal-Yanni](https://avatars.discourse-cdn.com/v4/letter/m/898d66/32.png) [@Mohga\_Kamal-Yanni](https://talk.edrugplus.org/u/Mohga_Kamal-Yanni)\ **Post date:** [August 7, 2015, 3:42pm UTC](https://talk.edrugplus.org/t/e-drug-moving-towards-a-new-definition-of-essential-medicines/41958/8 "2015-08-07T15:42:42Z")
E-DRUG: Moving towards a new definition of essential medicines? (11) ------------------------------------------ In addition to what Boneface is saying: high priced medicines need governments' actions to cut their prices. When WHO launched 3x5, donors and others thought the organisation had gone mad. And yes, at $10,000/person/year -as the price of ARVs used to be-it would have been mad to imagine treating 3 million. But at $360 /person/year it has been possible to mobilise global efforts to treat 10 million people now. Best wishes Mohga ---
**Author:** ![Murtada\_SESAY](https://avatars.discourse-cdn.com/v4/letter/m/8baadc/32.png) [@Murtada\_SESAY](https://talk.edrugplus.org/u/Murtada_SESAY)\ **Post date:** [August 8, 2015, 12:30am UTC](https://talk.edrugplus.org/t/e-drug-moving-towards-a-new-definition-of-essential-medicines/41958/9 "2015-08-08T00:30:30Z")
E-DRUG: Moving towards a new definition of essential medicines? (12) --------------------------------------------- Dear Colleagues, I hope our current debate will deliver the relevant clarity and way forward on this important subject. In the early 90s, I had the opportunity to represent the Commonwealth Pharmaceutical Association on a couple of biennial meetings of the Expert Committee and, I recall that whatever the product inclusion/exclusion proposal before the committee, was very robustly and professionally debated by the very best folks in the field, and resolved with the best available options at any one time. At that time, the engagement of the general professional public prior to the meeting was not so extensive, but I noticed that by late 90s into the 2000s, the public was extensively invited to contribute towards the work of the committee, regarding proposals that would be tabled for the forthcoming committee deliberations. If this process is currently the case, then the question on my mind is 'why are the important issues raised by Dr. S. Manikandan and follow-up postings only coming up now?, or were they raised but ignored? Allowing for the possibility that procedures and principles of reviewing and updating the EML may have changed, I have quickly checked the WHO website and I encourage colleagues who have not done so to review the short preamble write-up to the upload of the current list headed: Criteria for Selection of Essential Medicines, Essential Medicines Lists, and Global Concept The text which attracts my attention, and which could probably explain some of the apparent discrepancies now being discussed, is the one headed 'A global concept' and I reproduce this below for ease of reference: The concept of essential medicines is forward-looking. It incorporates the need to regularly update medicines selections to reflect new therapeutic options and changing therapeutic needs; the need to ensure drug quality; and the need for continued development of better medicines, medicines for emerging diseases, and medicines to meet changing resistance patterns. I must confess I find some of these objectives/principles, e.g. 'forward looking', 'development of better medicines', rather unclear in as far as my previous experience goes, and further clarification would be helpful. Having worked for over two decades across multiple UN Agencies involved in improving access to medicines in countries, especially those with fragile and/or highly compromised health infrastructures, my concern is not so much what gets listed in the EML( WHO or National), but rather what actions countries specifically take to ensure their citizenry benefit from the intended purpose of the list. I will like to use the issue of Folic Acid which has been raised as a typical example with which I have extensive experience. It may be recalled that the WHO Expert Committee on Essential Drugs agreed during its 11th meeting in Geneva, Switzerland in November 1999, to recommend to countries to change from the old formulation of 60 mg elemental iron with 0.20mg Folic Acid to 60 mg elemental iron with 0.4 mg Folic acid. I see that to this day there appears to be ongoing debate on the position of Folic Acid; and I suspect there are countries which may still not have taken any informed view on this matter. The result is that benefit optimization is delayed. Usually, it is only when a public procurement tender is floated for this item that all the available options on the national market begin to show up in bids and complicate evaluations! My point, in summary, is that I think countries must honestly and professionally use The WHO EML to take care of their specific needs, expressed in National EMLs and, even more, use the list in their routine health supply chain work. I appreciate the numerous 'other factors' at play, but this is the only way we can avoid being distracted into the global whirlwind of possible product options, present as well as future!