Co-trimoxazole prophylaxis is safe, inexpensive and highly effective in reducing morbidity and mortality among HIV-infected infants and children. WHO recommends that all HIV-exposed infants be started on co-trimoxazole prophylaxis at four to six weeks of age to provide adequate prevention against early opportunistic infections. This is particularly critical for HIV-infected infants. However, despite the fact that countries have developed and put in place policies to support the scale up and implementation of co-trimoxazole prophylaxis for infants and children, and that it is inexpensive, life-saving, safe, and theoretically simple to deliver, UNICEF, WHO and partners estimate that in 2008, only 8% of children exposed to HIV were initiated on co-trimoxazole prophylaxis by two months of age.
This guide was developed to assist national programme managers and implementing partners to effectively implement and rapidly scale up the uptake of co-trimoxazole prophylaxis within the context of existing HIV and MNCH programmes. Developing reliable national- and district-level procurement and supply management mechanisms that ensure a consistent supply of co-trimoxazole for paediatric prophylaxis needs is identified as one of the six key strategies for scaling up national responses. The actions required at the national and district levels to establish procurement and supply systems that can support national programme scale up efforts are outlined in the document.
This document was developed by WHO and UNICEF on behalf of the Expanded Inter-Agency Task Team (IATT) on Prevention of HIV Infection in Pregnant Women, Mothers and their Children and with the collaboration of multiple organizations working to improve pediatric HIV prevention, care and treatment.
The document is available in English. The publication can be downloaded at
www.unicef.org/aids/files/CotrimoxazoleGuide_2009.pdf
www.who.int/hiv/pub/paediatric/co-trimoxazole/en/index.html
The Guide provides a spectrum of prices from 25 sources, including pharmaceutical suppliers, international development organizations, and government agencies. The Guide assists supply officers to determine the probable cost of pharmaceutical products for their programs, allows users to compare current prices paid to prices available on the international market or assess the potential financial impact of changes to a medicines list, and helps to support rational medicine use education.
For more details about the tool, click on this link: www.psmtoolbox.org/en/tool-details%7CPricing%7CInternational-Drug-Price-Indicator-Guide%7C40
The first ever WHO Model Formulary for Children released by the WHO provides information on how to use over 240 essential medicines for treating illness and disease in children from 0 to 12 years of age. This means that for the first time medical practitioners worldwide have access to standardized information on the recommended use, dosage, adverse effects, and contraindications of these medicines for use in children. A number of individual countries have developed their own formularies over the years, but until now there was no single comprehensive guide to using medicines in children for all countries.
You can find more details about this tool at: www.psmtoolbox.org/en/tool-details%7CSelection%7CWHO-Model-Formulary-for-Children%7C269
This practical manual guides the selection and procurement of safe and effective artemisinin-based antimalarial medicines meeting international quality standards through a concise 16-steps comprising checklist. It is based on the latest internationally agreed stringent quality standards. For more information, go to: www.psmtoolbox.org/en/tool-details%7CCapacity-building%7CGood-procurement-practices-for-artemisinin-based-antimalarial-medicines%7C259
This tool can be used before, during or after procurement to identify vulnerability of the system to corruption and/or unethical practices. It provides a solid basis for the formulation of a national framework on good governance for medicines. To find out more, go to : www.psmtoolbox.org/en/tool-details%7CPolicy%7CMeasuring-Transparency-in-the-Public-Pharmaceutical-Sector%7C257
The second edition introduces a new 5th ACT to the four already recommended for the treatment of uncomplicated malaria. Furthermore, the Guidelines recommend a parasitological confirmation of diagnosis in all patients suspected of having malaria before treating. You can find more info about the document at: www.psmtoolbox.org/en/tool-details%7CPolicy%7CWHO-Guidelines-for-the-Treatment-of-Malaria%7C202
The feature article in this final issue for 2009 describes how development of recombinant biotechnology products created a need for adaptation of the International Nonproprietary Name system and presents WHO’s response to the challenges of this evolution.
Despite technological advances, controlling the quality, safety and efficacy of biologicals remains difficult and highly specialized and strengthening biological standardization and its implementation remains a fundamental function for WHO through its Expert Committees and Expert Advisory Panels. Conclusions and recommendations from the latest meeting of the Expert Committee on Biological Standardization are presentted under Biomedicines and Vaccines.
The section Pharmacovigilance Focus describes the A/H1N1 vaccination safety surveillance tool, PaniFlow®, which was launched as a result of collaboration between WHO and The Swiss Agency for Therapeutic Products, Swissmedic.
In collaboration with UNAIDS, UNICEF, UNFPA, the Global Fund, UNITAID, with support from the World Bank, WHO has set up a process to prequalify quality control laboratories that meet recommended international norms and standards for the analysis of medicines prequalified or being considered for prequalification by WHO. This article describes the assessment process for quality control laboratories and follows with a brief summary of inspection and monitoring results to date.
International Harmonization provides updated information on the latest developments and recommendations from the ICH quality working groups and pharmacopoeial group discussions.
The section on Safety and Efficacy highlights information on signals and reports of adverse drug reactions, with other news from around the world, including labelling changes. This section is complemented by Regulatory Action and News which provides the most recent developments from regulatory authorities, and particularly those having an impact on decision-taking.
The International Pharmacopoeia Consultation Documents section covering artesunate and artesunate tablets is followed by Recent Publications, Information and Events.
The journal concludes with Proposed List number 102 of International Nonproprietary Names (INN).
To access the document, please visit: www.who.int/medicines/publications/druginformation/issues/DrugInformation2009Vol23_4/en/index.html
To illustrate the issue of high medicine prices, Health Action International (HAI) undertook a one day global ‘snapshot’ of the price of ciprofloxacin, a commonly-used off-patent antibiotic. The ‘snapshots’ indicate the full retail price a patient pays at a pharmacy on that day. Data were collected from 93 countries. Individuals from HAI’s extended network collected the prices for both the originator brand product manufactured by Bayer and the lowest priced generic equivalent in the pharmacy. An interactive map is on HAI’s website www.haiweb.org/medicineprices, indicating the price variations between the Bayer originator product and the generic product, for a 7 day treatment course (14 tablets) in US$ using the exchange rate of 30 November 2009.
In South East Asia, on average both the originator brand price (US$17.46) and the price of the lowest priced generic (US$1.19) were substantially less than prices in other regions. For example the originator brand was 16 times the price of the lowest priced generic (as found in Africa). A course of the originator brand varied in price from about US$57 in Malaysia to about US$2 in Nepal and India. Generic prices ranged from about US$32 in Australia to less than US$1 in Myanmar (US$0.42), Sri Lanka (US$0.57), Indonesia (US$0.66), Viet Nam (US$0.66) and Lao PDR (US$0.59). Indonesia had the largest brand premium with the originator brand priced at over 47 times the price of the lowest priced generic. By contrast, in India the originator brand was only 30% more than the generic.
The variation in price across countries within each income level was greater for the originator brand compared to the generics. For example, in lower middle-income countries the originator brand price varied from US$2 to US$131 whereas generics ranged from less than US$1 to US$27. Generic ciprofloxacin is available at much lower prices than the originator brand product. In many countries, the price of the generic versions could be much lower and more affordable.
To improve treatment affordability, interventions are needed to *increase the use of low priced generics*. Governments need to ensure only good quality medicines are on the market and mandate generic substitution and create incentives for the dispensing of low priced generics. Sickness cure should not cost the sky.
For the complete report, visit: www.haiweb.org/medicineprices/
UNICEF and WHO initiated a process to develop a programming framework designed to assist national health managers and implementing partners in resource constrained settings with a high HIV burden to scale up HIV prevention, diagnosis, care and treatment for children who are exposed to or who have HIV within the context of broader child survival and HIV programmes. Developing reliable procurement and supply management mechanisms that ensure a consistent supply of medicines and commodities that meet the needs of infants and children is identified as one of the seven key strategies for scaling up national responses. The actions required at the national level to establish procurement and supply systems that can support national programme scale up efforts are outlined in the document.
This framework was developed following an international consultation held in New York in 2006 that included more than 100 participants from the global paediatric HIV and child survival community. The document has been endorsed by 15 major organizations working in the area of paediatric HIV care and treatment.
The publication can be downloaded at:
English: www.unicef.org/aids/files/OMS_PAEDS_Programming_Frameworks_WEB.pdf
Français: www.unicef.org/aids/files/OMS_PAEDS_Prog._Frameworks_F.pdf
Management Sciences for Health has announced the availability of the 2008 edition of the International Drug Price Indicator Guide. The 2008 edition of the Guide includes nearly 50 new items (for a total of more than 1,200 items). The therapeutic classes with the most new entries this year are anti-infectives (especially antiretroviral and antimalarial medicines) and diagnostics.
The guide can be found in the Pricing category of the PSM Toolbox for more information. To download the English version, go to: erc.msh.org/dmpguide/pdf/DrugPriceGuide_2008_en.pdf