E-drug: Re: Fixed Dose Combinations: Information/Evidence (cont)
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Dear Warren,
The following might be helpful. Earlier this year (May 2001) I found
these two articles on Medline:
http://www.nlm.nih.gov/databases/freemedl.html
[The articles can be accessed in full text from the Bulletin on the WHO
website. KM]
1: Bull World Health Organ 2001;79(1):61-8
The rationale for recommending fixed-dose combination tablets for treatment
of tuberculosis.
Blomberg B, Spinaci S, Fourie B, Laing R.
Centre for International Health, University of Bergen, Bergen, Norway.
There is considerable exigency to take all necessary steps to cure
tuberculosis cases and prevent further emergence of drug-resistant
tuberculosis. The most important of these steps is to ensure that the
treatment, particularly of sputum smear-positive cases, is adequate and
that patients adhere to their treatment by supervised, direct observation
of drug-taking according to the standardized regimens. Use of fixed-dose
combinations (FDCs) of tablets against tuberculosis is now being
recommended by WHO and the International Union Against Tuberculosis and
Lung Disease (IUATLD) as an additional step to ensuring proper treatment.
FDCs simplify the prescription of drugs and the management of drug supply,
and may also limit the risk of drug-resistant tuberculosis arising as a
result of inappropriate drug selection and monotherapy. Only FDCs of proven
quality and proven rifampicin bioavailability should be purchased and used.
In most situations, blood levels of the drugs are inadequate because of
poor drug quality rather than poor absorption. This is true irrespective of
the human immunodeficiency virus (HIV) infection status of the tuberculosis
patients (other than those with overt acquired immunodeficiency syndrome,
with CD4 counts < 200 cells/mm3). Currently, WHO, IUATLD and their partners
are developing strategies for ensuring that only quality FDCs are used in
tuberculosis programmes. A simplified and effective protocol for assessment
of rifampicin bioavailability has been developed, and laboratories are
being recruited to form a supranational network for quality assurance of
FDCs. Standardization of FDC drug formulations has been proposed, which
limits rifampicin-containing preparations to nine (including a four-drug
FDC and three paediatric FDCs).
PMID: 11217670 [PubMed - indexed for MEDLINE]
1: Int J Tuberc Lung Dis 2000 Dec;4(12 Suppl 2):S194-207
Tuberculosis drug issues: prices, fixed-dose combination products and
second-line drugs.
Laing RO, McGoldrick KM.
Department of International Health, Boston University School of Public
Health, Massachusetts 02118, USA. richardl@bu.edu
Access to tuberculosis drugs depends on multiple factors. Selection of a
standard list of TB drugs to procure is the first step. This paper reviews
the advantages and disadvantages of procuring and using fixed-dose
combination (FDC) products for both the intensive and continuation phases
of treatment. The major advantages are to prevent the emergence of
resistance, to simplify logistic management and to reduce costs. The major
disadvantage is the need for the manufacturers to assure the quality of
these FDCs by bioavailability testing. The paper reports on the inclusion
of second-line TB drugs in the 1999 WHO Essential Drug List (EDL). The need
to ensure that these drugs are used within established DOTS-Plus programs
is stressed. The price of TB drugs is determined by many factors, including
producer prices, local taxes and duties as well as mark-ups and fees. TB
drug prices for both the public and private sectors from industrialized and
developing countries are reported. Price trends over time are also
reported. The key findings of this study are that TB drug prices have
generally declined in developing countries while they have increased in
developed countries, both for the public and private sectors. Prices vary
between countries, with the US paying as much as 95 times the price paid in
a specific developing country. The prices of public sector first-line TB
drugs vary little between countries, although differences do exist due to
the procurement methods used. The price of tuberculin, a diagnostic agent,
has increased dramatically in the US, with substantial inter-country
variations in price. The paper suggests that further research is necessary
to identify the reasons for the price disparities and changes over time,
and suggests methods which can be used by National Tuberculosis Programme
managers to ensure availability of quality assured TB drugs at low prices.
Rob Verhage
Consultant
PO Box 4002
Paramaribo
Suriname
(597)438966
rverhage@cq-link.sr
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