After extensive consultations at the country, regional and global levels, WHO published in 2011 a set of harmonized monitoring and evaluation indicators for procurement and supply management systems (75). It contains 12 key indicators to monitor the performance of supply chain management systems, six of which are considered as early-warning indicators to prevent stock-outs and overstocking of antiretroviral, antituberculosis and antimalarial medicines. In order to identify best practices to support the implementation of monitoring and evaluation systems for procurement and supply management, pilot tests were conducted in Burkina Faso, Burundi, Cameroon, Côte d’Ivoire, Guinea, Mozambique, Uganda, United Republic of Tanzania and Zimbabwe.
In the Ministry of Health and Child Welfare (MOHCW) in Zimbabwe, after a period of fi eld-testing, a monitoring plan was adopted and relevant data sources were identifi ed. To leverage and strengthen existing systems, procurement and supply management indicators were integrated into the routine mechanisms for collecting and analysing data on the country’s antiretroviral management programme.
From the beginning of January 2010, indicator results were reviewed at monthly stakeholder meetings which guided the design of strategies to address identifi ed shortcomings, including:
• implementing specifi c training workshops to address data quality issues and to ensure that at least two managers at every facility had been trained in procurement and supply management;
• pre-emptively adjusting buffer stock levels and placing orders before reaching critically low levels, which exposed them to higher stock-outs risks;
• piloting mobile phone solutions to minimize delays in transferring data from peripheral levels in the Ministry of Health and Child Welfare to central-level for aggregation;
• putting plans in place to introduce computerized dispensing software in high-volume facilities to ensure adequate logistic infrastructure;
and
• restructuring central warehouses through decentralisation of warehousing of antiretrovirals to ensure timely order processing and reduce lead time.
As a result of corrective actions, the rate of stock-outs for adult fi rst-line antiretroviral medicines fell consistently, resulting in no facilities reporting any stock-out of fi rst-line regimens between February and December 2010.
The roll-out of procurement and supply management indicators highlighted areas with high system performance (such as 100% of products ordered by all partners meeting national standard treatment guidelines and 100% of product batches meeting quality control tests), areas in which even lower targets could be pursued (such as lowering the target for the rate of product loss from 2% to 1%), and areas were continued effort was necessary (such as antiretroviral drugs for children, antiretroviral drug use, etc.). Coordination of all stakeholders and leadership by the Ministry of Health and Child Welfare in the procurement and supply management system also contributed to this success in Zimbabwe.
The experience in Zimbabwe demonstrates that procurement and supply management indicators can be implemented and can help governments to increase the performance of national supply systems and ultimately result in insignifi cant stockouts and losses of critical medicines in the public health system. However, although indicators are useful to aggregate logistic information and identify emerging bottlenecks, they will not per se improve national supply management systems unless corrective action is implemented with the full involvement of all relevant stakeholders and partners.
Participating countries Group A Group A
Number of countries 45 21
% of the total number of people receiving antiretroviral therapy by December 2010 83% (n = 5 467 000) 5% (n = 344 100) Regional distribution:
Sub-Saharan Africa 22
Latin America and the Caribbean 24
East, South and South-East Asia 8
Europe and Central Asia 3
North Africa and the Middle East 8
Western Pacifi c 4
People and regimens Adults 93% (n = 4 974 000) Adults 97% (n = 332 000)
First-line regimens 97.1% (n = 4 830 000) 69.1% (n = 230 000)
Second-line regimens 2.9% (n = 142 000) 27.8% (n = 92 000)
Third-line regimens 0.05% (n = 2000) 3.1% (n = 10 000)
Compliance with 2010 WHO recommendations (preferred and alternative) (1) First line: 99.9%
Second line: 95.7%
First line: 98.1%
Second line: 60.3%
Children 7% (n = 383 020) Children 3% (n = 11 100)
First-line regimens 96.8% (n = 371 000) 72.1% (n = 8000)
Second-line regimens 3.2% (n = 12 000) 24.9% (n = 2800)
Third-line regimens 0.01% (n = 20) 3.0% (n = 300)
Compliance with 2010 WHO recommendations (preferred and alternative) First line: 99.9%
Second line: 88.8%
First line: 84.2%
Second line: 80.9%
Table 5.12 Characteristics of responding countries, people and regimens in groups A (45 low- and middle-income countries
excluding the Region of the Americas) and B (21 low- and middle-income countries from the Region of the Americas)
Fig. 5.6 Composition and frequency of fi rst-line
antiretroviral therapy regimens used among adults in group A (45 low- and middle-income countries, excluding countries from the Region of the Americas), December 2010
d4T: stavudine; 3TC: lamivudine; AZT: zidovudine; NVP: nevirapine; EFV: efavirenz;
TDF: tenofovir; FTC: emtricitabine.
Fig. 5.7 Composition and frequency of second-line
antiretroviral therapy regimens used among adults in group A (45 low- and middle-income countries, excluding countries from the Region of the Americas), December 2010
d4T: stavudine; 3TC: lamivudine; AZT: zidovudine; NVP: nevirapine; EFV: efavirenz;
TDF: tenofovir; FTC: emtricitabine; LPV/r: lopinavir with a ritonavir boost; ddI:
didanosine; ABC: abacavir.
AZT+3TC+LPV/r
12.7
0
therapy in low- and middle-income countries as of December 2010.1
Similar to previous surveys, an initial analysis revealed that the 21 reporting countries from the Region of the Americas (comprising 344 100 people, with 332 000 adults and 11 100 children) presented a pattern of use of antiretroviral drugs notably different from the one observed in the remaining 45 low- and middle-income countries (comprising 5 467 020 people, with 4 974 000 adults and 383 020 children) that responded to the survey. To account for such differences, the results are presented separately between the two groups: group A includes 45 low- and middle-income countries but excludes countries from the Region of the Americas, and group B includes the 21 countries from the Region of the Americas (Table 5.12).
Adults
In group A, a large majority of the adults (97%) were receiving fi rst-line regimens as of December 2010. Of these, 58% received either zidovudine- or tenofovir-based regimens (39% and 19%, respectively), and the remaining (42%) received a stavudine-containing combination (Fig. 5.6).
Only 3% of adults (n = 142 000) were receiving a second-line regimen in group A, with most using a zidovudine-based (48%) or tenofovir-based (47%) regimen. Ritonavir-boosted lopinavir remained the predominant protease inhibitor, used by 95% of the people receiving a second-line regimen (Fig. 5.7).
In group B, comprising 21 reporting countries from the Region of the Americas, 69% of adults were receiving fi rst-line regimens as well, although this proportion was considerably lower than in group A. Of these, 82%
received a zidovudine-containing regimen. Similar to previous surveys, an important proportion of the adults receiving fi rst-line treatment reported the use of a protease inhibitor (27%), and only a small proportion (4%) received stavudine. Countries in the Americas reported a higher rate of second-line (28%) regimens among adults.
Children
In group A, most children (97%) were on fi rst-line regimens as of December 2010 (Fig. 5.8). Of the
1 Five more countries responded with information on distribution among fi rst- second- and third-line regimens and information on national guidelines (but no data on the composition of the regimens).
children receiving a first-line regimen, 56% used stavudine, 29% zidovudine and 15% abacavir. Uptake of ritonavir-boosted lopinavir in fi rst-line regimens was low (12%).2 As in adults, stavudine-containing regimens are no longer considered as preferred treatment options for children in accordance with WHO’s 2010 antiretroviral therapy guidelines (1) but remain in use in many countries. The development and uptake of user-friendly, affordable and less toxic fixed-dose combinations for children need to be promoted to increase the use of WHO-recommended preferred combinations. In group B, a large majority of children receiving fi rst-line regimens were receiving a zidovudine-containing combination (88%).
Trends
Fifteen countries from group A participated in all fi ve consecutive surveys on the use of antiretroviral drugs between 2006 and 2010.3 They provided detailed information on the regimens used by 3 100 000 people, representing 47% of the 6 650 000 people receiving antiretroviral therapy in low- and middle-income
2 WHO’s 2010 guidelines on antiretroviral therapy (1) recommend ritronavir-boosted lopinavir in fi rst-line regimens for infants and children younger than 24 months of age who have been exposed to nevirapine or other non-nucleoside reverse-transcriptase inhibitors.
3 Burkina Faso, Burundi, Cambodia, Cameroon, Ethiopia, India, Kenya, Lesotho, Namibia, Nigeria, Swaziland, Uganda, United Republic of Tanzania, Zambia and Zimbabwe.
Fig. 5.8 First-line regimens used for children in
antiretroviral therapy programmes in group A (45 low- and middle-income countries, excluding countries from the Region of the Americas), December 2010
40
d4T: stavudine; 3TC: lamivudine; AZT: zidovudine; NVP: nevirapine; EFV: efavirenz;
LPV/r: lopinavir with a ritonavir boost; ABC: abacavir.
countries by December 2010. In this subset of countries, the use of stavudine in fi rst-line regimens decreased from 67% in 2006 to 43% in 2010, whereas the use of zidovudine and tenofovir increased concomitantly from 29% and less than 0.1%, respectively, in 2006, to, 42%
and 15% of fi rst-line combinations in 2010 (Fig. 5.9).
Data from 2009 and 2010 surveys show that a large majority of low- and middle-income countries
have already incorporated or are in the process of adopting into their national treatment guidelines WHO’s revised recommendations on eligibility criteria and regimen choice for adults and adolescents (1).
Most (88 of 93) reporting countries now recommend initiating antiretroviral therapy for everyone with CD4 counts of or below 350 cells per mm3. Two countries apply the same initiation criteria for pregnant women only. Moreover, almost all (84 of 87) reporting countries also recommend shifting away from stavudine-based to zidovudine- or tenofovir-containing regimens as of late 2010 (Fig. 5.10).
5.3.7.2 Progress in phasing out the use of stavudine in low- and middle-income countries
In 2010, WHO published revised guidelines on antiretroviral therapy for adults and adolescents recommending that countries phase out the use of stavudine due to its long-term toxicity and side effects. As actual implementation practices often lag behind changes in normative guidelines, a qualitative survey of 24 low- and lower-middle-income countries representing all regions was undertaken in March 2011 to gather data on actual programmatic practices and Fig. 5.9 Proportions of people receiving stavudine,