PMID- 21144238
OWN - NLM
STAT- MEDLINE
DCOM- 20110406
LR  - 20110415
IS  - 1815-7920 (Electronic)
IS  - 1027-3719 (Linking)
VI  - 14
IP  - 12
DP  - 2010 Dec
TI  - Tuberculosis regimen change in high-burden countries.
PG  - 1538-47
AB  - BACKGROUND: Experience with past tuberculosis (TB) regimen changes can guide 
      future regimen changes. METHODS: To explore the process, major players and 
      procedural success factors for recent public sector TB regimen changes, we 
      conducted 166 interviews of country stakeholders in 21 of the 22 TB high-burden 
      countries (HBCs). RESULTS: Stakeholders described 40 distinct regimen changes for 
      drug-susceptible TB. Once countries committed to considering a change, the 
      average timing was  approximately 1 year for decision-making and  approximately 2 years for roll-out. 
      Stakeholders more often cited concerns that were program-based (e.g., logistics 
      and cost) rather than patient-focused (e.g., side effects), and patient 
      representatives were seldom part of decision making. Decision-making bodies in 
      higher-income HBCs had more formalized procedures and fewer international 
      participants. Pilot studies focused on logistics were more common than 
      effectiveness studies, and the evidence base was often felt to be insufficient. 
      Once implementation started, weaknesses in drug management were often exposed, 
      with additional complications if local manufacturing was required. Best practices 
      for regimen change included early engagement of budgeting staff, procurement 
      staff, regulators and manufacturers. CONCLUSIONS: Future decision makers will 
      benefit from strengthened decision-making bodies, patient input, early and 
      comprehensive planning, and regimens and evidence that address local, practical 
      implementation issues.
FAU - Wells, W A
AU  - Wells WA
AD  - Global Alliance for TB Drug Development, New York, New York 10005, USA. 
      william.wells@tballiance.org
FAU - Konduri, N
AU  - Konduri N
FAU - Chen, C
AU  - Chen C
FAU - Lee, D
AU  - Lee D
FAU - Ignatius, H R
AU  - Ignatius HR
FAU - Gardiner, E
AU  - Gardiner E
FAU - Schwalbe, N R
AU  - Schwalbe NR
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - France
TA  - Int J Tuberc Lung Dis
JT  - The international journal of tuberculosis and lung disease : the official journal 
      of the International Union against Tuberculosis and Lung Disease
JID - 9706389
RN  - 0 (Antitubercular Agents)
SB  - IM
EIN - Int J Tuberc Lung Dis. 2011 Mar;15(3):425
MH  - Antitubercular Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Data Collection
MH  - *Decision Making
MH  - Humans
MH  - Patient Participation/statistics & numerical data
MH  - Research Design
MH  - Time Factors
MH  - Tuberculosis/*drug therapy/prevention & control
EDAT- 2010/12/15 06:00
MHDA- 2011/04/07 06:00
CRDT- 2010/12/15 06:00
PHST- 2010/12/15 06:00 [entrez]
PHST- 2010/12/15 06:00 [pubmed]
PHST- 2011/04/07 06:00 [medline]
PST - ppublish
SO  - Int J Tuberc Lung Dis. 2010 Dec;14(12):1538-47.