MTCT Plus Durban site logistics baseline assessment Supply Chain and Pharmaceutical System Program at Assessment PHARMACY STAFF The plan to hire a part time pharmacy assistant has been set aside for now as it is felt that the position is not necessary at the early stage of the program. The senior professional nurse will manage the drugs. She is experienced in ICU work situations in which medications were closely accounted for, and in which daily stock inventories were taken. The ethekwini (Durban) Municipal Health Department (EMHD) has temporarily withdrawn from its planned partner role in MTCT Plus because of issues related to the national government s lack of a policy in favor of HAART. One implication of this move is that issues related to commodity procurement and pharmacy management which were to have been handled by the EMHD Pharmacy Manager will now be shouldered by the MTCT plus Cato Manor principal investigator. This arrangement will continue until such time as the national policy issue is resolved and EMHD once again takes up it s partner role in MTCT plus. FORECASTING DRUG REQUIREMENTS Dr. Hoos has calculated the quantities of first line ARVs required for the first year of operations for 250 patients based on assumptions regarding the percentage of HIV positive mothers, children and partners who will meet the clinical criteria for ART. For second line ARVs the quantities are based on assumptions regarding percentage of clients who will be resistant to the first line regimen, will experience toxicity, etc. DRUG PROCUREMENT, RECEIPT AND INSPECTION The ARV drugs are being procured by UNICEF Copenhagen. The ARVs for this site will be branded, and the respective manufacturers local distributors will deliver the drugs to the ithemba Lethu offices. At the time of this visit, the site had received the UNICEF purchase order documents for one second line drug. As the site has a number of patients lined up, they are keen to receive the first line regimens, enroll patients, and begin ART for qualified patients. The OI drugs for MTCT plus clients are either provided under other research grants or are supplied by the EHMD. A committee comprising the MTCT plus principal investigator, the senior professional nurse and the project training and community manager (who is also the ithemba Lethu medical officer) will inspect each shipment of ARVs upon arrival for conformance to invoice quantities and for any visual defects in product, labeling or packaging. The senior professional nurse will enter all receipts into the Stock Registers for each ARV which will be maintained at the ithemba Lethu office. The ithemba Lethu medical officer will check to ensure that all ARV receipts are correctly entered into the respective Stock Registers at ithemba Lethu. 1
DRUG STORAGE AND SECURITY Because of the ethekwini Municipal Health Department s temporary withdrawal from the program, the main ARV drug supply which was to have been stored at the the EMHD Newlands West Clinic will now be stored at the offices of ithemba Lethu, the NGO supporting MTCT plus in Durban. The ithemba Lethu office and training room is located in a quiet, middle class residential neighborhood called Manor Gardens, in a compound with the NGO s residence for AIDS orphans. It is about a five minute drive from the Cato Manor clinic. All windows of the office have security bars, and there is a burglar alarm system. The site is having a 0.31 cubic meter metal cabinet for storage of the ARVs equipped with two hasp and staple locks in addition to the normal lock on the cabinet. This metal cabinet will be placed inside a built in wooden storage closet inside the training room, and will be bolted to the floor. Because the metal cabinet will be inside one of the main closets, it will not be immediately obvious that there are goods being held under lock and key. ARVs received from the distributors will be placed in this cabinet. Because the dimensions of the ARVs being procured by UNICEF are not known, it is not possible to determine whether the cabinet intended for their storage is large enough. The ARV drugs for immediate use which were to have been stored at the EMHD s Cato Manor clinic dispensary will not be stored there until the policy issues are resolved. The MTCT plus staff will now bring the ARVs to the Cato Manor clinic from ithemba Lethu as a convenience to the patients who would be hard pressed to travel to the ithemba Lethu office to pick up their medicines. The Cato Manor clinic building has an electric alarm system monitored by a security company. In the four years the University of Natal research group has been operating in the building, they have had no thefts of drugs, computers or any of the other items stored at the site. Each week the senior professional nurse will withdraw a quantity of stock sufficient for 1-4 weeks use at Cato Manor clinic from the ithemba Lethu stock. These withdrawals will be entered on the appropriate Stock Registers at ithemba Lethu and the Registers will be double signed by the senior professional nurse and by ithemba Lethu medical officer. The medical officer will count the stock being withdrawn and the stock remaining in the cabinet prior to counter signing the Registers. At the clinic the MTCT plus staff plan to store these immediate use ARVs in a metal supply cabinet used for other drugs. Available space in this cabinet is approximately 0.25 cubic meter. As the patient load at the clinic grows, the senior professional nurse will draw ARVs from the main ithemba Lethu store at more frequent intervals, daily if necessary, in order to keep the quantities of stocks being held at the clinic at a minimum level. Upon bringing the immediate use ARVs to the Cato Manor clinic, the senior professional nurse will enter the quantities as receipts on the respective Stock Register for each ARV being kept in stock at Cato Manor clinic. The project coordinator/clinical manager will count the stock being received at the clinic, and initial the entries on the Stock Registers. There is no requirement for cold storage at the Cato Manor clinic MTCT plus rooms because none of the ARVs used by the site will require cold storage. 2
STOCK MANAGEMENT (Dispensing, Packaging and Labeling, Stock Taking, and Stockeeping Records and Reports) The senior professional nurse will dispense the ARVs to patients based on the prescription written by the clinician in the patient s clinical record. For each drug dispensed the senior professional nurse will enter the date, time, patient s name, and patient number in the respective Stock Register and calculate the remaining balance. The clinician or second nurse will confirm the counts and sign the Stock Register in the Checked of drug and administration by column of the Register. The project training and community manager will at the end of each week on each ARV Stock Register kept at Cato Manor clinic enter the date, write physical inventory under the Name of Patient column, conduct a physical count of each ARV, enter the count in the Stock Balance column, and sign the Register. The MTCT plus management team will investigate any discrepancies between the Stock Balance as calculated by the senior professional nurse and the physical count of stock as entered by the project director. The principal investigator will at the end of each month on each ARV Stock Register kept at the ithemba Lethu office enter the date, write physical inventory under the Name of Patient column, conduct a physical count of each ARV, enter the count in the Stock Balance column, and sign the Register. The MTCT plus management team will investigate any discrepancies between the Stock Balance as calculated by the senior professional nurse and the physical count of stock as entered by the principal investigator. A designated staff person will use the information on the ARV Stock Registers at the clinic and ithemba Lethu to report ARV monthly consumption and stock balances to the MTCT plus Secretariat. The principal investigator and project training and community manager should pick a random selection of entries from the ARV Stock Registers at Cato Manor clinic at least once a month and compare these to the relevant patient clinic records to ensure that the ARVs are reaching the intended clients and that there is no leakage of ARVs from the system. The site staff and assessment team discussed the type of packaging for the one week patient ARV supply. The site staff are interested in knowing more about packaging options (pill boxes, blister packs or bottles), packaging costs (reusable pill box versus throw away blister pack), and likely impact of packaging on facilitating patient adherence. The site staff expressed interest in conducting a simple operations research in which patients are randomly given ARV drugs in one of two or three different types of packaging, and assessing whether which type, if any, better facilitates patient adherence. Given that the Cato Manor site will receive branded ARVs, it might be that these will already be packed in blister packs when supplied. If this is the case it might preclude packing the ARVs in pill boxes for a study. INVENTORY CONTROL SYSTEM The estimated annual quantities of ARVs required for the Cato Manor site have been divided by four and one fourth of the total requirements are programmed for procurement by UNICEF and distribution to the site each quarter. If followed strictly, this system could result in stock outs of ARVs. 3
Issues to Consider 1. Because of EMHD s temporary withdrawal from the MTCT plus activity, the JSI team did not assess the EMHD drug supply management system, storage facilities, security measures, etc. If and when EMHD rejoins the MTCT plus activity and begins to manage the ARV drug supply, it will be necessary to assess the EMHD system. 2. As the site gains experience in patient care it will accumulate data on actual ARV and other drug consumption. After 6-9 months of operation, the site should analyze the accumulated data and develop new site-specific assumptions on percentages of enrolled clients which will require ART, will be resistant to first line regimens, experience toxicity, require treatment for various OIs, etc. based on site specific experience. These assumptions should then be used to forecast future requirements for ARVs and OI drugs. 3. If the UNICEF procured first line regimen ARVs do not arrive very soon, the site would like to make an emergency purchase of ARVs and be reimbursed by the Secretariat. The site staff believe it would take 24-48 hours to purchase the necessary ARVs If the Cato Manor site were authorized to make an emergency purchase of ARVs, it would be beneficial to monitor prices and lead times and compare these to the prices and lead times experienced under the UNICEF global ARV procurement. If the price differentials were not great and if the lead times were shorter under local procurement arrangements, this option for procurement could be studied further. Because of the uncertainty in predicting both resistance to first line ART regimens and toxicity among users, the flexibility and agility of a procurement mechanism which does not require a long term commitment to fixed quantities of specific drugs and can deliver the required drugs on very short notice could be advantageous. 4. It is important to obtain package dimensions for the various ARV drugs in order to be able to state definitively whether the Cato Manor clinic site and the ithemba Lethu office have sufficient secure storage space, and to plan for alternate secure storage arrangements if the space is not adequate. 5. Physical security for the drugs at the Cato Manor clinic is not adequate at present. The site staff do not think it is appropriate to put a barred door on the room where the ARVs will be held or to put steel bands and extra locks on the supplies cabinet where the ARVs will be stored. They believe it is better for the room and cabinet to remain inconspicuous. If it were known that very valuable drugs were being held in the cabinet, a problem of theft could possibly arise. 6. A decision has not yet been made on the packaging for the ARV supply to be given to patients at Cato Manor. It may be that the branded ARVs being procured will already be packed in monthly blister packs. However, if the ARVs are provided in bulk bottles, more information will be needed regarding on-site packaging options and costs in order to make this decision. 4
7. Once the initial UNICEF ARV drug procurement contracts for the Cato Manor site are completed and the first deliveries are made to the site, one would expect the lead time for subsequent deliveries to be short given that the manufacturers already hold ARVs in stock in South Africa. Nonetheless, some allowance should be made for lead time and safety stock in setting the maximum stock level for first line drugs for the Cato Manor site. Next Steps 1. The site should advise the Secretariat and JSI if there is a change in policy regarding HAART and the EMHD is to begin to handle ARVs. 2. Secretariat to keep the Cato Manor site updated on the status of UNICEF procurement, and if necessary authorize the site to make an emergency purchase of first line ARVs. 3. The Secretariat will obtain package dimensions for the various ARVs being procured for the Cato Manor site by UNICEF Copenhagen and pass this information on to JSI. 4. The site will have a lockable ARV storage steel box fabricated to fit inside the metal supplies cabinet at the Cato Manor clinic to restrict access to the ARVs without calling undue attention to the fact that the ARVs are being stored at the clinic. 5. The JSI IQA group will research available packaging and costs and advise the site of its findings. The site can then make a decision on the packaging to be used for the patient supply of ARVs. 6. The Secretariat, JSI, and UNICEF Copenhagen will discuss the merits of slightly increasing the first line ARV maximum stock level for the Cato Manor program. 5