Outils de Quantification des Produits VIH/SIDA Welcome participants to this session. Séminaire Technique de Préparation des Consultants pour les Programmes VIH, TB et Paludisme Dakar 6-9 Mars 2006 Aoua Diarra

Quantification La quantification comporte les étapes de prévision de la consommation, l’estimation des besoins, le calcul des coûts et si nécessaire l’ajustement des quantités finales à commander sur la base de la capacité de service et des financements disponibles. Aoua,

Utilisation des Résultats de la Quantification Les résultats de la quantification peuvent être utilisés pour: Aider à la planification de programme à moyen et long terme (1 – 3 ans) et à l’effort de mobilisation des ressources Calculer les quantités spécifiques à commander et planifier les approvisionnements pour le court terme Aoua,

Outils de Quantification pour ARVs et tests VIH ProQ (tests) Tableurs (ARV et tests) PipeLine (ARV) Peuvent être utilisés ensemble, i.e., ProQ (ou tableurs) pour les prévisions basées sur la consommation attendue ajustée pour les pertes et la capacité de service + Pipeline pour l’estimation finale des besoins et la planification de l’approvisionnement Aoua,

Outils de Prévisions et Estimation des Besoins en ARVs et tests VIH PipeLine prend en compte Le stock disponible Les quantités en commande Le stock de sécurité Le délai de livraison Calcule les quantités à commander pour ramener les stocks à un niveau désiré Aoua,

Aperçu des outils de prévision Guide pour la quantification des ARV (caractéristiques, considérations, processus, méthodologie) Guide pour la quantification des tests VIH (id) Guide pour la quantification des produits de laboratoire (en cours de rédaction) ProQ Pipeline Tell participants that you will be briefly presenting on four forecasting tools. Two of these tools are paper-based, manual tools. The other two are software programs.

Qu’est-ce ProQ? Un logiciel utilisé pour la quantification des tests VIH sur la base d’une prévision réaliste de la demande ajustée pour la capacité existante des services, l’état du circuit d’approvisionnement et les ressources disponibles Just read the slide!

Eléments Essentiels du Logiciel ProQ pour les Tests VIH Fournit des informations sur les marques de tests VIH Quantifie pour les usages multiples des tests VIH et pour différents protocoles de tests Documente les hypothèses et assumptions Ajuste les prévisions par rapport à la capacité de service, au contrôle de qualité et au taux de pertes Sert d’outil de plaidoyer pour la mobilisation et l’allocation des resources Brands: product information, shelf life, # tests per kit, kit volume dimensions, storage requirements, additional supplies required Configuration: Blood Safety, VCT, PMTCT, Testing VIH-exposed Babies, Clinical Diagnosis, Sentinel Surveillance, Other (training, military) Protocols: serial, parallel [what would it cost to change testing protocol? To change brand of VIH test?] Methodologies: standard using logistics, service statistics, demo/morbidity or program target data. Can compare and select any or all methods or an average to arrive at forecast One of big challenges we’ve experienced have been quantification often budget-based, short term and unrelated to needs or program targets not founded on any of the other three methodologies. We have this much money therefore can buy this many VIH tests. Or quantification based on program targets e.g. we want to expand VCT by 50%. Use of questionnaires built into the software that can be printed from the software for data collection for each method to forecast demand. Because data is scarce, incomplete, poor quality even for morbidity and service statistics methodologies, Quantifications are heavily assumptions-based therefore need to carefully document assumptions. ProQ has a function for this in notes fields. . Adjusts forecasted need for service capacity, quality control and wastage rate. Software automatically chooses the lowest forecast (usually SC) but this can be overridden. END OF FORECAST More than a forecasting tool; it considers service capacity, the status of the supply chain and helps determine the quantity to procure to fill the pipeline. ProQ prompts the user for data using a matrix of specific questions for each methodology and use. The questionnaire can be printed for specific quantifications and used as a data collection tool.

ProQ Quantifie ….. Par usage Par programme Sécurité transfusionnelle Test et conseil volontaire Prévention de la transmission mère-enfant Test des Bébés à risque de VIH Diagnosis Clinique Surveillance Sentinelle Autre Par programme Ministère de la Santé ONG Financement de partenaire Other e.g. training, VIH testing in military, mobile units/outreach.

Méthodes de prévisions ProQ utilise les méthodes suivantes pour estimer la demande: Logistique Demographique/Morbidité Statistiques de service Population-cible L’utilisateur peut quantifier avec une ou toutes les méthodes ProQ presents a process for quantifying VIH test requirements in developing country settings using a variety of forecasting methodologies. It is intended to help program managers and logistics advisors select recognized methodologies and apply them based on specific country circumstances. These circumstances may include:   ·         epidemiological profile/disease prevalence ·         capacity of the logistics system, service provision system, and human resources ·         program maturity ·         political will ·         financial resource constraints. ProQ does not cover the quantification of the supplies and disposable items that are required for some VIH test kits. These items are very specific to the type and brand of kit chosen. An increasing number of newly developed VIH rapid test kits are self-contained, and do not require additional supplies.

Here is another screen shot of ProQ. On the left, you can see the tree menu, which is always visible no matter what part of the software you may be in, so that you can navigate easily between the different parts. This is a sample quantification where one of the methodologies chosen was demographic/morbidity. This was one of the methodologies chosen for quantifying the needs for PMTCT requirements. The other uses that are included in this quantification are blood safety and clinical diagnosis. Within PMTCT, this user has chosen to forecast by demographic/morbidity, service statistics, and target. For each methodology, the software walks the user through a series of questions. For example, in this example, the user has answered these questions regarding the population, the pregnancy rate, ANC visits, etc. After quantifying for each purpose of use, using different methodologies, the total forecast consumption is then adjusted for service capacity, quality control, and wastage rate. Finally, the total quantity required is used to prepare a cost estimate, which is then compared to available funding. (point out on the tree view where this is located). The information here can be used as an advocacy tool for resource mobilization and funding allocations.

This is a basic screen shot of ProQ, which shows the types of information on VIH test kits that comes pre-loaded onto the software. The type of information includes: supplier type – Rapid, Long ELISA, or Western Blot Shelf life in months Whether or not the test requires cold storage. The storage temperature. The materials that are required to run the test which are not included in the test kit. The number of tests per kit, the cost per kit, the dimensions, and the weight. Information in each of these fields can be changed. If a particular test is offered in more than one type of kit, that information can also be entered. For example, some tests can be offered in kits of 100 tests or kits of 20 tests. Both options can be entered.

Suivi du Pipeline et Planification de l’Approvisionnement ver 3

Rôle de PipeLine dans la Gestion de la Chaîne d’Approvisionnement Système Central des Partenaires PipeLine is a tool primarily used for procurement planning and shipment scheduling, and does have a function to forecast consumption, and estimate product requirements. Prévision, Estimation des Besoins et planification de l’approvisionnement (PipeLine) Système du Programme des Prestataires de Service (SIGL)

PipeLine Flot d’Information Entrant et Sortant Intrants Profil: Programme Produits (coûts, cartons, min, max) Categories Fournisseurs (délai de livraison) Transactions: Stock Livraisons Consommation Ajustements Extrants Graphiques: Etat des Stocks Prévision Impact Rapports: Livraisons Coûts Annuels Approvisionnement Alerte (suivi et planification de l’approvisionnemenst) Walk through the slide going over the inputs and outputs.

PipeLine Schéma du Flot d’Information Sortant This is an example of one of the outputs from PipeLine, the Stock Status Report. This is a report for condoms, reporting by quarter from Jan 2002 to December 2006. PipeLine gives a picture of the total number of stock in months. This is calculated by starting with the beginning balance, adding in the shipments that have been received, shipped, ordered, or planned, and subtracting the consumption and either subtracting or adding stock adjustments. The consumption entered into PipeLine can be either forecast or actual. This is indicated by a check mark in the box if it is actual consumption. The stock in months is calculated on a rolling basis, using the current months’ consumption and the following two month’s of forecast consumption.

This is another output from PipeLine, the Trend Analysis Graph This is another output from PipeLine, the Trend Analysis Graph. The actual consumption is shown with the blue bars, and the forecast consumption is shown by the red bars. The yellow line is the trend analysis. The trend analysis can be produced by using either linear regression on semi-averages. The trend analysis shows what forecast consumption should be given the actual consumption of the previous quarters. These figures produced by the trend analysis can then be entered into PipeLine as forecast consumption.

Finally, here is another example of an output from PipeLine, the consumption graph, which shows the actual consumption of the product in the blue bars, and the forecast consumption in the red bars.

Quantification des ARV Etapes: Prévoir la quantité de médicaments nécessaires pour les besoins du programme Calculer les quantité à commander (capacité de services et financement Estimer le coût pour l’achat et la livraison Information de base pour l’estimation: No. de patients sous traitement pendant l’année en cours No. de nouveaux patients à mettre sous traitement (sites existants and nouveaux sites) Nombre total de patients sous traitement pour l’année en cours et par année future % distribution selon les protocoles de traitement par année DELIVER was asked to quantify the Adult and pediatric ARV drugs needed to support expansion of the Ghana ART program for two years 2005-2006 This included: forecast the quantity of each drug needed for each of the forecast years to meet expected increase in demand (patients and drugs) calculate the quantity to order based on status of supply pipeline (MOS), max/min levels estimate the cost for procurement and delivery based on current supplier prices & shipping costs, cost of storage & distribution may or may not be included The forecasting and quantification exercise helps to determine which products to buy, how much to buy, when to buy, and how much it will cost. This information is crucial to supporting program expansion, sustainability and ensuring quality of care. General purpose of quantification is : (role of DELIVER) 1. To help link data on actual service delivery and drug consumption to program plans and policies 2. To inform financing and procurement decisions to be able to ensure an uninterrupted supply of quality products in the country.

Patients  Traitements NO. ADULT PAR TRAITEMENT Annee Actuelle   Année Future 1 A ADULT (traitement 1ere int) % No. Patients TotalPatients 100% 1,960 5,337 A1 AZT/3TC+NVP 31% 608 1,655 A2 AZT/3TC+EFV 35% 686 1,868 A3 d4T(30)+3TC+NVP 17% 333 15% 801 A4 d4T(40)+3TC+NVP 0% 2% 107 A5 d4T(30)+3TC+EFV A6 d4T(40)+3TC+EFV

Traitment  Médicaments Traitement Adultes - Quantités de médicaments par traitement Année de prévision A ADULT (traitement 1ere intention) No. Patients Patient-Jours (x 365) Dose/ Patient per jour No. Unités par an A1 AZT/3TC 300mg/150mg 1,655 603,909 2 1,207,819   NVP 200mg 1,184,655 A2 1,868 681,833 1,363,666 EFV 600mg 1 A3 d4T(30)mg < 60Kg 801 292,214 584,428 3TC 150mg 573,220 A4 d4T(40)mg > 60Kg 107 38,962 77,924 76,429 A5 d4T(30)mg < 60Kg A6

Quantification des Tests VIH (Ex de Zambie)

Défis Rencontrés dans les Prévisions des ARV Cible: à discuter avec le gouvernement et faire accepter par tous, basé sur la capacité de service Plans et calendrier d’expansion Disponibilíté de l’information Adhérence aux guides de traitement standards Quantification des ARV pédiatriques: les GTS pour le TAR pédiatrique n’est pas toujours assez détaillé pour fournir des instructions utiles pour la quantification Challenges for ARV Quantifications: Patients Targets: This always needs to be discussed with the government and agreed upon. Although most of the times the program has its pre defined targets, these targets are usually unrealistic taking into consideration, service capacity and availability of funds for the procurement of ARVs. Solutions: A compromise is usually reached with program managers on how realistic the targets should be taking into account the service capacity and funding. Scale up plans and timelines for scale up: For a valid quantification to be done, the program plans should be taking into consideration. This includes program scale up plans and more importantly the timeline for this scale up. Most programs usually have a general scale up plan without specifics on the implementation timeline of the plan. This makes phasing in of new patients into the program a difficult task requiring many more assumptions. A realistic timeline for the scale up is usually agreed upon with the program managers and then used for the quantification. Information availability: The availability of information is a huge determinant on the outcome of the quantification. The presence of an LMIS dramatically improves information availability and eases the quantification process as the essential logistics data (consumption, losses/adjustments, and stock on hand) become available. A system design is usually proposed. The availability or lack of data usually determines the methodology of the quantification. Adherence to standard treatment guidelines: Despite the fact that standard treatment guidelines exist in all the countries we work in, Prescribers still put patients on regimens not found on these standard treatment guidelines. This usually complicates the quantification because the breakdown of patients amongst the regimens in the standard treatment guidelines becomes less predictable. Program monitoring is usually advised to ensure compliance with the standard treatment guideline but in the meantime, the non standard regimens are included in the quantification since the patients are expected to be on these regimens for the long term unless a switch becomes unavoidable. Quantification for pediatric ARVs: The standard treatment guidelines for pediatric ART isn’t always detailed enough to provide useful guidance for a quantification. This usually necessitates extensive meetings with prescribers to agree on the weight bands for patients vs. the dosage they will administered. Thus the assumptions made are usually subjective based on the prescriber who provides the information being sought. Solutions Pediatric ART guidelines should provide detail breakdown of weights vs doses in the various regimens recommended

Défis Rencontrés dans les Prévisions des tests VIH (1) Manque ou insuffisance de données (en particulier pour les diagnostiques cliniques et la sécurité transfusionnelle Données non fiables Quantification pour de multiple programmes Multiples secteurs au sein de chaque programme (publique, privé, ONG), niveaux de soins multiples (lab nat, hôp, CS) Manque de coordination entre programmes et secteurs All of these points go together: there is usually little data on test kit use: usually no consumption data. Service data can serve as a proxy – where it exists – but this does not capture QC, controls, wastage, losses and often may be unreliable. There may be reasonable data for PMTCT and VCT (and sentinel surveillance) but rarely for blood safety (especially if significant amounts of blood screening is done in lower facilities like district hospitals) and clinical diagnosis Each program may have different testing protocol: e.g. blood safety uses screening only, VCT screening and confirmatory Apart from multitude of programs there may be different sectors involved, e.g., VCT in NGO, public and private facilites. Some sectors may have better data than others. Some may be using different tests. Or using alternative sources Manque de données fiables En général il n’existe pas de données de SIGL Les données de services sont très rudimentaires (en particulier pour les diagnostiques cliniques et la sécurité transfusionnelle Quantification pour de multiple programmes CVT PME Sécurité Transfusionnelle Surveillance Sentinelle Diagnostique Clinique CT pour TB et IST Multiples secteurs au sein de chaque programme (publique, privé, ONG), niveaux de soins multiples Manque de coordination entre programmes et secteurs

Défis Rencontrés dans les Prévisions des tests VIH (2) Objectifs d’expansion des programmes ambitieux entraînant des surstockages et des gaspillages. Multiples tests VIH: Pas de protocoles standards, protocoles non disséminés ou non acceptés par les prestataires Sources multiple de tests (systèmes parallèles) Ruptures de stocks rendent difficile l’évaluation de la demande réelle Aucun modèle pouvant prédire de l’impact de l’expansion du TAR sur les tests Absence de données historiques et objectifs d’expansion des programmes ambitieux entraînant des surstockages et des gaspillages. Dans certains cas, utilisations de multiples tests VIH Pas de protocoles standards Protocoles non disséminés Protocoles non acceptés par les prestataires Sources multiple de tests (chaînes d’approvisionnement parallèles), et ruptures de stocks rendent difficile l’évaluation de la demande réelle Aucun modèle pouvant prédire de l’impact de l’expansion du TAR sur les tests In the absence of real data, countries may rely on over-ambitious and unrealistic scale-up targets based on numbers of people to test. Becomes less of a problem as M&E systems improve but still a significant problem especially in countries that are rapidly scaling up (Note: due to short shelf lives or limited cold storage this is an even bigger problem for tests kits than many other drugs Absence of a national protocol – or at least one that is widely known, disseminated and that is adhered to is a challenge ofr forecasting Countries that are rapidly scaling up ART are seeing reduced stigma and increasing demand for testing, not just for clinical diagnosis but also VCT, PMTCT, etc. Hard to quantify this especially since data is poor

Défis Rencontrés dans les Prévisions des Produits de Laboratoire En plus des défis listés pour les test VIH s’ajoutent: L’étendue et le but de la quantification (diagnostique, évaluation de base et suivi pour VIH, et IO) Liste des produits à quantifier: Différents tests, différentes techniques chacune avec les produits y afférents Standardisation des pratiques et politiques de laboratoire (menus et techniques par niveau, normes et procedures) Considérations pour les prévisions pour les trois catégories de produits de laboratoire (réactifs, consommables et matériel/équipment) Test kits are often historically managed by national public health lab system. This can pose challenges: Often labs have weak logistics systems: no forecasting, little inventory control, e.g. no stock card. Usually systems are weaker than those of national drug supply sytem that is managed by pharmacy section Made more sense for labs to manage supplies when testing was carried out in labs but now tertiary facilities and point-of-care are carrying out tests (esp. PMTCT, VCT). Many tests require cold chain May be asked to forecast for tests but rarely for all the other supplies needed – syringes, lancet, swabs, tubes, droppers, vacutainers, etc. Most tests have 12-24 month shelf lives. Determine requires a bottle of Chase buffer which has shorter shelf live than test Technologies are changing rapidly – new better tests are being made, new technologies, tests are discontinued, prices are changing – hard for countries to keep up. Decision to change test in a national protocol is a big decision – retraining etc.

Exemples de Travail Récemment Effectué sur les test VIH et ARV Zambie: Prévisions, approvisionnement Malawi: Evaluation, integration des tests au SIGL national Ghana: Evaluation dy système, conception du SIGL et formation du personnel à son utilisation, prévisions Nepal: Prévisions Nigeria: Evaluation et conception du système logistique, formation du personnel en cours Tanzanie: Prévisions, approvisionnement In Zambia we prepared the first national forecast in 2005, and organized USG funded procurement (currently main source of funding for test kits in Zambia). Over 2004 country was experiencing major stock outs of test kits due to lack of planning and little data on demand. Situation improved significantly in 2005. DELIVER is also coordinating other funders/suppliers, and monitoring the national pipeline (PipeLine) Malawi : assessment, currently integrating test kits into national LMIS and inventory control system (designed by DELIVER) Ghana: forecast in 2006, designed LMIS system in 2004 (?) Nepal? Nigeria?