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In settings where drug quality is an issue (there are many counterfeits, for example), how do health care workers address patients' low perceptions of drug quality for ARVs?
Hi Alexander, All,Here’s a stab at providing you with some feedback on this critical issue but I would like to call on members of the adherence community of GHDonline who have dealt with drug quality issues with patients in the field to share their experience. Much could be and should be said about drug quality issues in resource limited countries. Recent reports indicate that the availability of substandard and counterfeit drugs has reached a disturbing proportion in many low-income countries which puts many patients’ lives at risk in addition to delaying, if not making impossible, their treatment. Patients in these settings can understandably have doubts about the quality of ARVs provided to them as part of their regimen. Unfortunately not all patients are equal. The quality of drugs provided to them by health care workers under community-based delivery models vary widely depending on the quality assurance system put in place by the organization in charge of providing them with care in the first place and secondly by the procuring agency they use. Another critical factor is poor storage conditions. I asked your question to several people among our partners and most underlined that though it can be a huge problem for some organizations, it isn’t to them because they “always procure medications from good sources.”That aside, they are several articles and resources of reference. In “Substandard medicines in resource-poor settings: a problem that can no longer be ignored” published in August 2008 in Tropical Medicine and International Health (Volume 13 no 8 pp 1062–1072 – full text available on MSF Field Research website: http://fieldresearch.msf.org/msf/handle/10144/37334), Caudron et al, insist that:"[...] drug purchasers (NGOs, international organizations, charities, and national purchase centres in resource-limited countries) should assume their responsibility towards protecting patients’ health and insist that producers and distributors supply drugs that meet WHO standards. Quality assurance is a mandatory preliminary to drug purchases in the West, and there is no rationale for this procedure to be any different when drugs are exported to poor populations. Governments could act now to reduce this problem by granting export authorization only to pharmaceutical products that comply with the WHO standards for quality, efficacy and safety.Developing country governments can make important improvements with minor investments, particularly by making more use of technical resources that are already available from WHO and other organizations. This would be further enhanced through regional collaboration. The reality today is that health care providers in resource poor settings are finding it increasingly difficult to find sustainable and affordable sources of essential quality drugs. Confronted with situations where no quality assured product is available, they must make the impossible calculation of weighing the risk of not treating against that of using a drug whose quality and safety is unknown. This unacceptable situation will continue and in all likelihood worsen unless those responsible assume their responsibilities. Acknowledging the problem would be a good place to start.”Creating a good relationship with an open communication from the start is key for health care workers in addressing their patients’ concerns. Here for instance, Partners In Health has a list of “Dos and Don’ts” for their Accompagnateurs. This list notably underlines the importance of creating trust by respecting confidentiality, and calls for Accompagnateurs to “support the patient in taking medications every day by handing the medications directly to the patient”, “identify another accompagnateur in the area or another trusted and respected person to deliver medications on the occasions when he/she is unable to do so, and notify the patient”, “talk with the patient each day about the patient’s life, activities, and concerns” and “identify any health, socioeconomic, or other problems that the patient is having and notify the doctor or nurse immediately” (http://model.pih.org/files/DOs_and_DON%27Ts_for_Accompagnateurs_at_Inshuti_Mu...).Another example is the training manual “Adherence to Antiretroviral Therapy in Adults: A Guide for Trainers” (http://digitallibraries.macrointernational.com/gsdl/collect/officerlib/index/...), developed for the ART Program in Mombasa, Kenya by the Horizons Program of the Population Council, the International Centre for Reproductive Health, and the Coast Province General Hospital, Mombasa. In it, treatment providers are asked to “establish trust” (page 51) and to learn about patients’ attitudes and beliefs (page 56), and to discuss storage of medications (page 57) and other treatment barriers.Of course, the WHO Quality Assurance section of their website (http://www.who.int/medicines/areas/quality_safety/quality_assurance/en/) and mainly the Annex 6: A model quality assurance system for procurement agencies (Recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products) of the WHO Technical Report Series, No. 937, 2006, available in PDF:http://healthtech.who.int/pq/info_general/documents/TRS937/WHO_TRS_937__annex....Another great source of up-to-date information is the “Matrix of Drug Quality Reports Affecting USAID-assisted Countries” by the U.S. Pharmacopeia Drug Quality and Information Program developed to help monitor trends in poor drug quality in over 40 countries and is published quarterly. The most recent version is dated October 1, 2008, and is available in PDF: http://www.usp.org/pdf/EN/dqi/ghcDrugQualityMatrix.pdf.I hope more contributions will follow.Sincerely, Sophie
Can I draw your attention to a WHO document which should reassure your patients about the quality of ARVs in Africa. This is Survey of the quality of antiretroviral medicines circulating in selected African countries available at http://www.who.int/medicinedocs/index/assoc/s14230e/s14230e.pdfHere is the summary:Background:Provision of antiretroviral therapy has expanded in Sub-Saharan Africa and quality assurance ofantiretrovirals is of crucial importance for the success of treatment programmes. ThereforeWHO, in co-operation with national authorities, organized a quality survey of antiretrovirals inselected African countries.Methods:The survey was performed in Cameroon, the Democratic Republic of Congo, Kenya, Nigeria,United Republic of Tanzania, Uganda and Zambia. Country teams made up of WHO countryofficers and national authority representatives collected samples at public and private sectorantiretroviral procurement organizations and treatment centres around the capital cities. Samplesincluded monocomponent products of didanosine, efavirenz, lamivudine, nevirapine, stavudineand zidovudine, and fixed-dose combinations of lamivudine/zidovudine, stavudine/lamivudine,stavudine/lamivudine/nevirapine. All samples were tested by the Official Medicines ControlLaboratory of Switzerland, Swissmedic, for appearance, labelling, identity, related substances,and content of each active ingredient. In addition, capsules and tablets were tested foruniformity of mass and either dissolution or disintegration; oral solutions were tested for pH ifappropriate. Methods of the International Pharmacopoeia, United States Pharmacopoeia, IndianPharmacopoeia or manufacturers’ methods with method transfer were used as appropriate.Sampling and testing were carried out over a period of six months from 13 June to 15 December2005.Findings:None of the antiretrovirals sampled had any critical quality deficiencies which would pose aserious risk to patients.In 394 samples collected, the overall failure rate was 1.8%. One sample contained a brokentablet and tablets with chipped coating. Two samples were insufficiently labelled on theimmediate packaging. The content of active ingredient of one sample exceeded the upper limit.One of 163 samples tested for disintegration failed to disintegrate completely within 30 minutes,and two of 153 samples tested for dissolution showed lower results than required.Fifty-three percent of sampled products were WHO-prequalified. Information on registration byNational Drug Regulatory Authorities was available for 285 products; of these, 84% wereregistered. Products not registered at the time of sampling were found in three countries, mostlyat private sector facilities, and constituted 12% of the total of 394 sampled products.Conclusions:The generally good quality and safety of products sampled indicate the positive effect ofcommon efforts of National Drug Regulatory Authorities, WHO and other organizationsinvolved in prequalification and purchase policies. Market control was still incomplete in atleast three countries.Since the survey was limited to official distribution points and treatment centres around thecapital cities, these results cannot be generalized to the entire territories of the countriessurveyed.The take home message from this study is that sub standard or counterfeit ARVs do not appear to be a problem at this time.If you need a hard copy of the report please contacr Claude Da Re at RegardsRichard LaingWHO Geneva