Logez S, Hutin Y, Somda P, Thualt J, Holloway K Impact of a national medicine policy on Injection Safetty and Rational Use of Injections, Burkina Faso 1995-2000 Logez S, Hutin Y, Somda P, Thualt J, Holloway K

Abstract Problem Statement: In 1995, the Ministry of Health of Burkina Faso reformed the national essential medicines policy to improve access to medicines and basic supplies, including disposable injection devices, in all health care facilities with a pharmaceutical depot. While two studies indicated that injection safety improved dramatically between 1995 and 2000, the impact on the use of injectable medicines was unknown. Objectives: We conducted a study in 2001 to determine to what extent the improvement of injection safety observed between 1995 and 2000 was related to the increased access to injection devices, and to determine whether an increased access to injection devices and essential drugs could have led to irrational use of injections. Design: Retrospective, cross sectional programme review. Setting and Population: This review assessed retrospectively the situation between 1992 and 2001. In 2001, we visited 52 public primary health care facilities where injections had been already observed during an injection safety assessment in 2000. In addition, we visited adjacent 50 public pharmaceutical depots. We collected data on (1) injection devices available (structured observation); (2) the percentage of prescriptions including at least one injection; and (3) the number of medicines per prescription. Outcome Measures: Percentage of health care facilities equipped with a pharmaceutical depot between 1992 to 2000; availability of injection devices in the depots in 2001; percentage of prescriptions including at least one injection; and average number of medicines per prescription over the period 1995 to 2000. Results: Of the 52 facilities visited, the number of facilities equipped with a pharmaceutical depot selling injection devices rose from 13 (26%) to 50 (96%) between 1995 and 2000. Of 50 depots, 96% had disposable 5ml syringes available in 2001. At all facilities, patients were buying injection devices out of the depot for their injections. While injection devices were available in more facilities, the proportion of prescriptions including at least one injection remained stable at 26% to 24% between 1995 and 2000. In contrast, the average number of medicines per prescription increased from 1.8 to 2.7. Conclusions: Establishing pharmaceutical depots next to health care facilities through the national policy of essential medicines increased access to safe injection devices and led to safer injection practices, while no increase in injection prescriptions was observed. However, the increased average number of medicines per prescription suggests more irrational use in general, but the study design did not allow for any firm conclusion in this regard.

Background In 1995, an injection safety assessment in Burkina Faso indicated that sterile injection devices were used for each injection in 80% of the urban health care facilities, 60% of provincial facilities and 11% of the rural facilities. In 2000, a second assessment suggested improvement of practices. In 96% of the health care facilities visited, a new syringe and needle were used for each patient. (Fitzner et al) Key change that could have explained this improvement had occurred in the area of essential medicines

Objectives of the Study Evaluate the impact of the new national essential medicines policy on improvement of injection safety between 1992 and 2001, by: Identifying the features of the national essential medicines policy that may have influenced injection practices Quantifying the improved access to injection devices between 1992 and 2000 Determining whether an increased access to injection devices could have led to irrational use of injections The main objective of this two phases study was to evaluate the impact of BF national drug policy on injection safety between 1992 and 2001. Particulary to: _

Methodology Retrospective cross-sectional programme review between 1992 and 2001 Visits to 52 public health care facilities where injection practices had been observed in 2000 and to 50 adjacent public pharmaceutical depots Data Collection Procedure Interviews with key stakeholders (Central level) Interviews with district wholesalers (District level) Review of registers, structured observation of injection devices available in facility, structured interviews with health care workers, pharmacy staff (Health care centre level) The medodology applied was a cross sectionnal study, organised in two phases: - phase 1 in June 2000, to assess injection practices by using the tool C of the SIGN toolbox - phase 2 in April 2001, to evaluate the impact of National Drug Policy on injection safety. A two-stage cluster sample methodology was used. Firstly, 8 Health Districts were selected with probability of selection proportional to population size. Then 10 health centres were randomly selected from a list of all health care facilities in each district. Data collection proceeded in interviews with stakeholders, district wholesalers, health care workers, pharmacy staff and population, and finally review of prescription registers.

Key Elements of the National Essential Medicines Policy Central level National essential medicines policy formulation with regulatory framework Central bulk procurement by public-private consortium Injection devices in National Essential Medicines List, with set prices District level Wholesalers and supervisory team Health care centre level Community pharmacies in each health care centre Cost recovery according to the Bamako initiative here are the key elements of the NDP it is organised in 3 levels At the central level A NDP with regulatory framework is implemented the public health system is provided by a central bulk procurement Injection equipement has been included in the national essential drug list, in that way, it has been exempted from taxes Set price are fixed by the ministry of Health every year At the district level intermediair wholesalers have been implemented as well as a supervisory team AT the HC centre level Each HC Centre should be equiped with a Community pharmacy functionning according the cost recovery system

Improved Geographical Access to Pharmaceutical depots and injection devices 96% of 50 depots visited had 5ml syringes available 5 ml syringe sales for public health care 1996: 884 000 2000: 1 840 000 Proportion of health care facilities with pharmaceutical depot, Burkina Faso, 1990 -2000

Increased Access to Injection Devices : Price of Injection Devices Official price of syringes and needles remained stable from 1997 to 2001 Price of devices judged affordable by: 88% of pharmacy managers 50% of healthcare workers Retail price of 2 ml, 5 ml and 10 ml syringe and needle sets

Rational Drug Use Indicators during Months of June, 1992-2000

Impact of the National Medicines Policy on Injection Practices in Burkina Faso: Strengths Increased access to safe injection devices No major adverse effects related to injection overuse National medicines policy may have contributed to: Decrease in the reuse of devices in the absence of sterilization Consumer demand for safe devices Weaknesses Unsafe practices in the area of sharps waste management Limited implementation of recommended prices Cost recovery as per Bamako initiative is the keystone of the whole system Coming to the results of the study We have observed the following:

Summary Improved injection practices are likely to be a consequence of an improved geographical access rather than a consequence of improved financial access, since the retail prices of injection devices remained unchanged Use of injections did not increase substantially during the same period as a result of the increased availability of injection devices Use of antibiotics did increase with increased availability of medicines. This difference suggests that increased availability of injection devices did not lead to irrational overuse of injections.

Conclusion 1995: reform of the national essential medicines policy to establish pharmaceutical depots for the delivery of essential medicines, medical consumables and injection devices 1998: decision of the government to systematically set up a depot for all new health care facilities The strong political commitment to improve access to essential medicines and consumables for the population increased access to injection devices and subsequently improved injection safety

Recommendations Ensure injection device security, by: bundling auto-disable injection devices and sharps boxes with vaccines combining curative injection devices orders with sharps boxes Financing sharps boxes with cost recovery using syringes and needles sales Include sharps boxes in the list of essential medicines Address price control and profit margin issue Implement policies and plans for safe health care waste management As recommendations, the accessibility could be improve by enforcing current national price control and by supervising profit margin at all level but mostly at the central level without affecting the cost recovery system. The accessility to sharps boxes need to be address The suggestion is to