Assessment Survey of TB Drug Management in Cambodia Uchiyama Y, Chay S, Kousoum M, Leng C, Kien S, Nou C, Chhom C (CENAT/JICA National TB Control Project, Cambodia) Background  In 2003, the National Tuberculosis Programme of Cambodia (NTP) faced serious stock shortage of TB drugs for the first time in its history due to the occurrence of unpredictable events related to drug management (DM). Although the crisis was come through, it became the trigger for the NTP to recognize the significance of DM and to review the current practices. To that end, the National Center for Tuberculosis and Leprosy Control/Japan International Cooperation Agency (CENAT/JICA) National TB Control Project, in collaboration with the Ministry of Health (MOH), initiated and organized the National Workshop on TB Drug Management in September 2003 to identify weaknesses and the causes in TBDM.  As the next step, the Project implemented the assessment survey to: -verify the findings obtained from the Workshop -provide data on the availability & use practices of TB drugs, which will help develop action plans for the improvement of TBDM.

Drug supply management system in Cambodia Selection/Procurement  National Essential Drug List  Public procurement (centralized system) -Yearly drug requests from ODs/NHs to MOH -Quantity adjustment, pricing & open tender by MOH Distribution  Flow of drug delivery & requests -CMS ⇔ ODs/NHs: quarterly -ODs ⇔ RHs/HCs: monthly  Inventory & store management, following MOH guidelines Use  Management is various among national programmes OD: Operational district NH: National hospital CMS: Central Medical Stores RH: Referral hospital HC: Health center

NTP TBDM Selection  Criteria: National/WHO Model List & authorized TB guides Procurement (source other than national budget)  Donation of GDF-standard TB drugs from Japan through the JICA’s Grant Aid Program ( ) Distribution  Safety stocks (ODs/NHs: 3M, RHs/HCs: 1M) Use  8M treatment regimen (C1: 2RHZE/6EH, C2: 2RHZES/1RHZE/5RHE, C3: 2RHZ/6EH)  DOTS approach: hospitalization, ambulatory & home delivery  DOTS expansion to HCs: 780/942 HCs (March 2004)  Two TB staff in each health facility with TB service

Examples of findings from the National Workshop on TBDM Selection/Procurement  Quantity of TB drugs per bottle delivered ≠ quantity indicated on the label  Shelf life of TB drugs delivered is not long enough to use up Distribution  Stock records ≠ physical counts  Poor quality of loose tablets (color change, moisture)  No measure to verify the validity of TB drug consumption Use  Poor patients’ adherence to TB treatment  Poor knowledge of TB/TB treatment among TB staff Management support  DM has not been a priority for NTP supervision Policy and legal framework  Private practitioners do not follow the TB treatment guidelines  TB drugs are available in private pharmacies without prescription

Survey methods  Design/Setting -Treatment record review, structured interview & inventory check -107 public TB health facilities (cover 40% of all the TB cases) in 14 TB high-burden ODs (14 provinces) out of 75 ODs (24 provinces), including a problematic OD in TBDM reported, and 66 private pharmacies  Intervention (7 investigators) -Preparation (Oct-Nov 03), data collection (Nov 03- Feb 04) & data analysis (Feb-Mar 04)  Outcome measures -% of new ss+ TB patients who received correct TB drugs in correct dosage -% of TB staff/new ss+ TB outpatients who had correct knowledge of TB/TB treatment -% of drug stores where stock records corresponded with physical counts for TB drugs -% of expired stocks for TB drugs -% of drug stores where stock-out for TB drugs was observed -% of treatment cost per new ss+ TB patient (Design & outcome measures were referred to in the Drug Management for Tuberculosis Manual, MSH)

Survey results 1 % of new ss+ TB patients who received correct TB drugs in correct dosage TB facilities surveyed: 107 TB facilities with TB standard treatment regimen: 107 (100%) TB treatment records reviewed: 2,146 CENAT (141), RHs (328), HCs (1,677) Dosage of TB drugs given Correct1, % Incorrect % Unknown30.1% Breakdown of incorrect medication (n=232) <25 Kg20.9% % % 50 – % %

Survey results 2 % of TB service providers who had correct knowledge of TB/TB treatment Interviewees: 92 Q1-Q4Four definitions of a new ss+ TB case Q5-Q9Five types of TB drugs provided to a new ss+ case (50Kg), with dosage & duration of treatment Q10Experience in receiving DOTS training in the last 6M Answer correct All of Q1-Q % All of Q5-Q % All of Q1-Q % Q10 (answer “Yes”)1415.2%

Survey results 3 % of new ss+ TB outpatients who had correct knowledge of TB treatment Interviewees: 799IF: 339 (42.4%)CF: 460 (57.6%) Q1What TB drugs must you take? (name, color) Q2How many tablets of each drug must you swallow per day? Q3How many times a week/when must you swallow TB drugs? Q4How long does your treatment last? Q5What will happen if TB drugs are not taken properly? Q6When must you (CF) return to TB facility to take TB drugs? Q7Did the TB staff tell you to return to the health facility in case of ADR signs? Q8Does anybody look at you when you swallow TB drugs? Answer correct (Q1-Q7)535 (67.0%) Answer “Yes” (Q8)504 (63.1%)IF315 (92.9%) CF189 (41.1%)

Survey results 4 - % of drug stores where stock records corresponded with physical counts for TB drugs - % of expired stocks for TB drugs - % of drug stores where stock-out for TB drugs was observed * S 1000 vials were stored in 27 out of 51 facilities ** [Physical counts=expired stocks] is regarded as stock-out Drug stores surveyed: 51 (OD: 13, RH: 13, HC: 23, CENAT: 2) Drug stores (stock records=physical counts) All TB drugs5 (9.8%) Individual TB drug RH 150/100 Z 500E 400EH 400/150 S (25.5%) 23 (45.1% ) 16 (31.4% ) 15 (29.4% ) 21* (77.8% ) Exp. stock / total stock 8.2%13.8%0020.0% Drug stores (stock-out)** 2 (3.9%) 5 (9.8%) 1 (2.0%) 1 (2.0%) 3* (11.1% )

Survey results 5 Treatment cost per new ss+ TB patient (8M, 35-49Kg) * Quoted from the International Drug Price Indicator Guide, MSH. ** Added 15% for shipping and insurance costs to FOB prices Product/unit price (US$) of loose tablets Med. Pvt. pharmacy (03) Public procure. (MOH 03) Med. Intl. (02)* GDF (03) RH 150/ RH 150/ Z Z E EH 400/ Cost Adjusted cost** % GDF cost353.8%164.2%152.8%

Conclusions & recommendations  Further attention should be paid to treatment for TB patients weighing >50Kg.  Periodic training on DOTS is needed for peripheral TB staff.  TB patients’ answers are affected by interviewers’ position & character (central NTP staff in charge of IEC/supervision activities are eligible).  DOT rate among CF patients can be increased with expansion of community DOT.  Periodic training on stock management is needed for pharmacists & store keepers.  More pharmacists are needed to reduce workload, or incentives should be considered for them.

Conclusions & recommendations (contd.)  TB drugs procured should be of high quality & the cheapest price. GDF-standard TB drugs are preferable.  An indicator-based TBDM assessment survey can be utilized for: -identifying both strengths & weaknesses in TBDM -monitoring changes in TBDM practices & quality of DOTS -developing specific action plans for the improvement of TBDM -providing health education to TB patients  Close cooperation with the MOH is important to address DM issues that are beyond the NTP scope.