ART Set-up and Procurement HIV Care and

* ART Set-up and Procurement HIV Care and ART: A Course for Healthcare Providers

Learning Objectives · Explain the continuum of HIV Care · Recognize the multidisciplinary (MD, RN, RP, CHCW) team approach to the chronic illness care model · Explain why the ART practice model requires patient flow and interventional definition at every clinic stop · Describe the clinical communication tools and forms required for effective multidisciplinary team practice 2

Learning Objectives (2) · Describe ART practice setup · Identify the minimum requirements for ART practice · Describe the art of maximizing minimum resources · Identify the components of drug management 3

Practice Care Model

ART Practice · Family-centered without the exclusion of the individual · MD-led · RN-coordinated · Multidisciplinary (MD, RN, RP, Lab, CHCW) team practice 5

Continuum of Care Model · Continuity of care provided at home to care or evaluation performed in any health care setting by specialists, generalists and primary care providers: Home based care Community care Health facility based care 6

ART Care Model · Multidisciplinary (Team) Effort: Physician Social Worker Nurse Patient Pharmacis t Community HC Worker · Minimum Team Members: MD, RN, RP, CHCW TGK/ITECH/9. 03 7

Maximizing the Minimum Patients with chronic illness’ care provider needs SP 5% 35% MD Non-MD 60% PA/ HO, MSW, RPh Nut, RN “Workload could safely and legally be delegated to the appropriate level. ” TGK/PSHCS, Primary Care 8

ART Patient Flow

Think About the Patient Experience · · · Safety: Communicable diseases, emergency Comfort: Seats, shelter Wait time Distance between services Unnecessary travel between stops 10

Justify the Stops · Is it essential? · What would the patient lose if it was not there? · What would the organization lose if it were not there? · Is more than one stop necessary on the same visit? 11

The Patient’s Route · · · Registration Record room OPD HIV/ART clinic Lab Pharmacy 12

Ideal Patient Flow Arrival area: RN triage: 1 the emergent 2 patients with cough x > 2 weeks 3 FU visits: scheduled, unscheduled Registration desk/window: New 1 capture pertinent data 2 issue HIV care patient pocket book/passport New & enrolled 3 issue visit # 4 prepare medical chart 5 direct to the waiting area Coughers: Exam room Waiting area: 1 Patient ed: videos on nutrition, healthy living, etc 2 Patient ed live to answer patient questions on HIV care (dispel myths, etc) 1 RN further evaluation based on protocol 2 order sputum, x-ray 3 call in MD to examine Emergent: Exam room 1 RN evaluate 2 call in MD after patient prepared for MD evaluation RN evaluation room 1 Hx (standard New/FU doc form) 2 VS, wt 3 intro to HIV care General exam room: 1 RN briefly summarizes , patients issues 2 MD takes over RN counseling/disposition room: 1 Review MD instructions and go over Pharmacy: 1 ART counseling visit 1 2 ART counseling visit 2 3 ART adherence & safety review FU them with patient 2 schedule patient 3 ART counseling 4. Needs assessment, nutrition, etc clinical services Home Case manager TGK 5/05 Health Center Community Resources 13

ART Patient Flow Intake Desk First visit Introduction to ARV Life style, habits, family or friend support Income, job ABC/prevention, disclosure H&P, review past Tx, labs, CXR, R/O or TX TB, order missing RN visit ID, age, gender, married, # children, Support (family, friend), Dx date, Awareness score, date ART mental status, Karnofsky's Score, Wt. HIV related Sx. MD visit Nutritional status Complete H&P, baseline labs, CXR, MC referred Self or VCT referred Eligible ? YES ART protocol, Tm. Sx 2 nd visit TGK/ITECH/12/03 MD : Review lab, X-ray Determine regimen Discuss critical adverse effects Emphasize adherence Issue Rx Schedule 4 -week FU NO TX OI, Tm. Sx, FU RP : Regimen property Key side effects & measures Adherence counseling Invite & answer questions Hand out written instructions Hand out medications schedule 2 - R/O or TX TB (Reminder) Support Services 1. Emotional support 2. Counseling regarding ARVs & adherence, transmission risk reduction, general health maintenance, status disclosure 3. Home-based Care 4. PMTCT 5. Family planning 6. Other services RN : Adherence; review life style & counsel. Explain access to emergent FU. Discuss nutrition & healthy living. Check mental competence & level of understanding Hand out FU schedule Refer to support services if indicated 14 Schedule 4 -week FU

ARV Visits Medical Evaluation - H & P 1. Screening visit ARV Evaluation visit - Eligibility - Lab, counsel 2. ARV initiation visit - Initiate, counsel ARV FU visit - 2, 4, 6, 8 weeks 15

ART Patient Visits Week Year 0 Mont h 0 FU: 1 2 2 4 3 6 4 3 5 6 6 9 7 12 1 8 18 9 21 24 2 27 30 33 36 3 39 42 45 48 4 Visits Eval 1 2 Staff Lab MD, RN, RP RP MD, RN, RP RN MD RN MD HIV’ CBC, LFT, BUN, CR, UA, pregnancy, WHO stage LFT if NVP CBC, LFT CBC, LFT, BUN, CR Whatever is indicated Indicated 16

ART Practice Setup

ART Practice Setup Minimum Needs · Structure Staff Space Tools · Process Clinic stop interventions Follow up · Monitoring System · Clinical Safety Efficacy · Operations/management Outcome Performance 18

ART Practice · Multidisciplinary, generalist or specialist led · Family-centered primary care • Comprehensive • Continuous • Accountable (quality, cost) • To patients • To management · Teaching institutions should consider a stand alone HIV care clinic 19

Management of Waiting List: · · · · · Establish HIV/AIDS committee Committee will have to meet weekly Set up an open access HIV clinic Grandfather those on Tx Mothers first priority Gender equity Prioritize anyone under 18 years old Take family size and family earner into account Priority of last resort= 1 st come 1 st served 20

HIV/AIDS Committee Members: Director/Chair Coordinator Review ART DATA + waiting list status ART MD ART RN ART pharmacists ART Lab technician Coordinator staffs the meeting Report to Committee §Update list §Prepare action-plan §Take action §Report to management 21

Pediatrics Priorities: · Age cut off <10 years (because children older than 10 can swallow pills, therefore are grouped with adults) · The sickest children must go first · Children <5 years tend to perish rapidly with HIV/AIDS 22

Clinical Tools & Resources · Provider resources: 3 x 5 cards: WHO staging, Karnofsky’s performance scale, etc Ring Pocket books: Pathophysiology, medicine dosages, interactions, side-effects, OIs Wall Posters: Flow charts & algorithms, etc · Patient resources: Brochures Patient instructions In major local languages · Forms: Provider documentation Communication forms Data capture and collection 23

Communication Forms · Inter-facility referral forms Hospital Health Center Community · Intra-facility referral forms ART Clinic Lab Pharmacy 24

Primary Care Provider · Previous antiretrovirals: None · Proposed regimen (discussed Y/N): AZT + 3 TC + EFV · Concerns/problems anticipated: Not sure whether he has told me or RN all about his life style · Signature: GKMD Date: 07/25/05 · Provider: please give form to nursing staff, so appointments can be scheduled 25

Pharmacy · Education Conducted: Introduction to HAART. Adherence & consequences of non-adherence. Introduction to healthy living. Need for drug Tx · Problems Identified: Binge drinker and intermittent drug user, gambler, marginal financial support · Comments/follow-up: Referred to MSW & ATP. Review for referral to adherence protocol group · __ Suggest HAART · X Suggest delay · Signature: JB Date: 07/25/05 26

Clinical Documentation Forms

Customer Requirements Quality Value -Patients -Providers -Managers Customer Satisfaction -Facility -Legible -Simple -Regional -User friendly -National -Donors -Capture all essential data elements Service -Time saver -Comprehensive -Facilitates/reminds/prompts/ promotes practice model 28

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Current Follow-up Form · Follow-up Form Captures: • • FU status Sx: potential ARV complications + IRS VS, weight, functional score ARVs and labs OIs, including TB and their status Assessment, including adherence Reasons for deferral of ART Disposition 32

Proposed Form Data Flow Sheet · Data flow sheet Captures chronologically: • • • Dates ARVs (1, 2, 3) TB Status, OI Tx, OIP Labs Referrals Designed to benefit MD, RN, Data manager • Simplifies continuity & record review 33

Data Flow Chart Date 68 ARV 1 d 4 T ARV 2 3 TC ARV 3 Reason For chg CD 4 ALT CR WHO AST Amyl 14. 2 NVP Hgb wbc 1/1/04 Wt 164 46 7 29/1/04 68 304 6. 2 29/2/04 69 ART started 56 14. 2 Note FU 29/1/04 FU 29/2/04 110 EFV FU 2/4/04 LFT 2/4/04 70 60 FU 5/5/04 65 17/4/04 69 14. 2 7. 8 198 47 Acute rash FU as schdld 50 34

Patient Medication Record Date Time AZT 1 A M P. 2 3 4 A M P A M P. 3 TC EFV In the past three days, how many days have you had missed doses? Since last visit how has the patient taken his/her ARVs? [ ] None [ ] One day [ ] Two days [ ]Three days [ ] About as prescribed [ ] Less often than prescribed [ ] More often than prescribed [ ] Not at all 35

Clinical Tools · · · Standardize documentation Save time Facilitate continuity of care Help during record review Foundation for clinical research Help in the delegation of clinical workload 36

Systems Issues · · M&E Pharmacy MIS Quota management system Follow-up system 37

Follow-up System · Structure Appointment book Patient passport Clinic schedules Confidential patient directory Follow up coordinators · Process Test your system to see if it works Have patient repeat follow up schedules Show patient that it is in his/her passport Instruct patient to call you if he/she wants to reschedule or for any other question 38

Follow up System No Show Tele # of patient or support No Yes Case manager (CHCW) Call until contact established Visit 39

Drug Management System

Drug Supply Management · Develop required infrastructure · Establish process · Assure an uninterrupted supply of standard drugs · Install information system 41

Selection, Quantification, Procurement, Distribution and Use of ARV Drugs

ARV Drugs Selection · The selection of ARV drugs is based on: The purpose of use • ART (Adult, pediatrics) • PEP • PMTCT The level of available health institution (hospitals, drug retail outlets) Availability of authorized prescribers and dispensers Guidelines for the use of ARV drugs in Ethiopia National drug lists 43

Quantification of ARV Drugs · Quantification of ARV drugs is impacted by a complex web of factors related to: ARV product ART Demand (continuation and scaling up/rollout) Supply 44

Quantification of ARV Drugs (2) · Issues related to ARV Product: Shelf Life • Short expiry date Cost • Expensive Handling Requirements • Require secure storage • Require refrigeration/temperature control 45

Quantification of ARV Drugs (3) · Issues related to ART: Rapidly evolving scientific field Impact of stock out Taken for life ARVs used for prevention and treatment Multiple drug therapy (3 or more and all must be available) Multiple regimens Resistance evolves quickly and is inevitable 46

Quantification of ARV Drugs (4) · Issues related to demand: Availability of historical consumption data Efficient patient tracking (Up-to-date patient information): • • Deaths Lost for follow-up Transfer out, transfer in Treatment interruptions Unpredictable scale up Capacity to deliver services Changes in regimen (Wt. , pregnancy, Tx failure, ADR) Pediatrics (change in regiment/dose, wastage of liquids) 47

Quantification of ARV Drugs (5) · Issues related to supply: Facility capacity to overcome handling costs of large stock Delays in disbursement of funds by donors Level of available funding Very few suppliers Rapidly changing market Prequalification/regulatory approval Special pricing/donation Unpredictable and long lead time 48

Quantification of ARV Drugs (6) · Issues to consider when quantifying ARV drug requirements: Consumption data at each health facilities Working and buffer stock kept at different levels Quantity of stock on hand on back order Lead time (time it take from ordering to delivery) Expected consumptions during the lead time 49

Quantification of ARV Drugs (7) · Expected consumption is influenced by: Number of current patients and their regimen Anticipated scaling-up pattern • New patients on 1 st line, 2 nd line (adult and pediatrics) Likely changes in prescribing patterns due to: • Revised STG, changes in registration status of ARV drugs, procurement constraints, varying composition of patient groups, non-naïve patients with non-standard regimen 50

Quantification of ARV Drugs (8) · Procurement Cycle without scale up Lead time Working Stock Buffer Stock 51

Quantification of ARV Drugs (9) · Procurement cycle during scale up Lead time Working Stock Buffer Stock 52

Quantification of ARV Drugs (10) · Other quantification issues Reduced NVP requirements due to initial phase is not usually accounted for ARV drugs for PMTCT when guidelines change • Affect the stock for ART patients (e. g. if NVP HAART) • Over stock of the old PMTC product (e. g. NVP) Quantification for PEP requirements 53

ARV Drugs Procurement · The procurement cycle involve the following steps: Review drug selection Determine quantities needed Reconcile needs and funds Choose procurement method Locate and select suppliers Specify contract terms Monitor order status Receive and check drugs Make payment Distribute drugs Collect consumption information 54

ARV Drugs Procurement (2) · Essential factors for calculating order quantity Average monthly consumption Supplier lead time Safety stock Stock on order Stock in inventory 55

Quality Assurance · No ARV drugs shall be marketed or made available for use unless their safety, efficacy and quality, including packaging materials, is approved by DACA, prior to importation · Only ARV drugs on the List of Drugs for Ethiopia (LIDE) shall be imported or locally manufactured, except for DACA-authorized research 56

Quality Assurance (2) · Drug quality is affected by: The manufacturing process Packaging Transportation Storage conditions 57

Quality Assurance (3) · Possible consequences of poor quality drugs: Lack of therapeutic effect leading to death or prolonged illness Toxic and adverse reactions Wastage of limited financial resources Loss of credibility of the health care delivery system 58

Quality Assurance (4) · Defining and assessing drug quality: Identity Purity Potency Uniformity of dosage forms Bioavailability Stability 59

Quality Assurance (5) · Maintaining drug quality Appropriate storage and transport Appropriate dispensing and use · Monitoring drug quality Product problem reporting system Product recalls 60

Distribution and Use of ARV Drugs · Effective drug distribution relies on good system design and good management · A well run distribution system should: Maintain a constant supply of ARV drugs Keep drugs in good condition throughout the distribution process Minimize drug losses due to spoilage and expiry Maintain accurate inventory records Rationalize drug storage points Use available transport as efficiently as possible Reduce theft and fraud Provide information forecasting drug needs 61

Distribution and Use of ARV Drugs (2) · The distribution cycle include the following steps: Port clearing Receipt and inspection Inventory control Storage Requisition of supplies Delivery (push or pull) Dispensing to patients Reporting consumption 62

Distribution and Use of ARV Drugs (3) · After being received at health facilities, ARV drugs require special handling: Appropriate storage warehouses • Adequate space/size • Clean • Shelves or pallets • Ventilated • Secured Availability of equipment/facilities • Refrigerators • Lockable cupboards • AC (hot regions) 63

Distribution and Use of ARV Drugs (4) · Intensive recording and stock monitoring Stock cards, bin cards, stock movement cards Expiry date tracking chart Temperature monitoring chart Ordering and receiving forms, models · Regular reporting of stock status At least monthly 64

Supply Chain and Information Tracking At Supplier Level PHARMID Central Store MIS (Info Tracking) Formats Distribution Formats, Stock/Bin Cards, Expiry Date Tracking Charts, and To Recording Charts PHARMID Branches Distribution Formats, Ordering and Receiving Form, Stock/Bin Cards, Expiry Date Tracking Charts and To Recording Charts FACILITY Main Stores Ordering and Receiving Form, Receiving Voucher (Model 19), Receiving Discrepancy Reporting Form, Stock/Bin Cards, Expiry Date Tracking Charts and To Recording Charts 65

Supply Chain and Information Tracking (2) At Facility Level FACILITY Main Stores Dispensaries Patients MIS (Info Tracking) Formats Ordering and Receiving Form, Issuing Voucher (Model 22), Stock/Bin Cards, Expiry Date Tracking Charts, Expiry and Damage Inventory Sheet and To Recording Charts Ordering and Receiving Form, ARV Drugs and Patient Information Sheets, Dispensing Registers, Stock Movement Cards, Monthly ARV Drugs Dispensing and Consumption Summary Sheet, Patient Tracking Charts and To Recording Charts ARV Drugs and Patient Information Sheets, Patient Tracking Charts 66

ARV Drugs Management Information System (DMIS) · Coordinating the elements of a drug supply system requires accurate and timely information · DMIS is an organized system for collecting, processing, reporting and using information for decision-making · Such information is collected by means of Record-keeping documents, a combination of registers, ledgers and filing systems Data reporting forms Feedback reports 67

ARV Drugs Management Information System (DMIS) (2) · Following are examples of key information tracking formats currently in use 68

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ARV Drugs Management Information System (DMIS) (3) · Information/data generated from such sources is the basis for quantification and procurement · Errors made at any step (during recording or reporting) will add up and bring about an impact on the national volumes of procurement • Destroys the balance between demand supply • Shortage of ARV Drugs • National Crisis · Every one involved in ART should try his/her level best in generating and reporting reliable data/information 72

Lab Supply Management Information System (LSMIS) · Lab supply should be managed likewise · 3 month buffer stock · Similar MIS 73

Group Discussion: Barriers and Solutions · Discuss: What are structural barriers to implementing ART in Ethiopia? What are strategies for overcoming these barriers? 74

Key Points · HIV care should be comprehensive and include a spectrum of care activities · A multidisciplinary approach to ART care is recommended for: Improved adherence Optimizing capacity Assuring continuity Overall improved outcome 75

Key Points (2) · Minimally, a multidisciplinary team should include: MD, RN, RP, Lab, (CHCW for case management) · An algorithm for HIV patient flow should be adapted and followed · Clinical tools such as pocket books, wall posters, 3 x 5 cards should be issued to providers. Patient education materials and medication instructions should be in the local language · Standardized communication forms are essential with a multidisciplinary approach to care 76

Key Points (3) · Launching a national ARV drug program requires coordinated efforts of government, private investors, and local and international organizations · The guidelines for the procurement, storage, inventory control, distribution, recording and reporting of ARV drugs should be properly followed · The quantification and hence procurement of ARV drugs is impacted by a complex web of factors that require special considerations 77

Key Points (4) · The handling and use of ARV drugs involves quite expensive procedures that need the commitment of health professionals and facility managers · Reporting on a regular basis (monthly) is expected from each health facility · The quality of the data/information obtained from health facilities is as important as the ARV drugs itself 78