ART Set-up and Procurement

Unit 3

HIV Care and ART:

A Course for Healthcare Providers

2

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

3

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

Practice Care Model

5

ART Practice

Family-centered without the exclusion of the individual

MD-led RN-coordinated Multidisciplinary (MD, RN, RP, Lab, CHCW)

team practice

6

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 careCommunity careHealth facility based care

7

Multidisciplinary (Team) Effort:

Minimum Team Members: MD, RN, RP, CHCW

ART Care Model

TGK/ITECH/9.03

Patient

Physician

Nurse

Community HC WorkerPharmacist

Social Worker

8

SP

MD

Non-MD

PA/ HO, MSW, RPh

Nut, RN

5%

35%

60%

“Workload could safely and legally be delegated to the appropriate level.” TGK/PSHCS, Primary Care

Maximizing the Minimum

Patients with chronic illness’ care provider needs

ART Patient Flow

10

Think About the Patient Experience

Safety: Communicable diseases, emergency Comfort: Seats, shelter Wait time Distance between services Unnecessary travel between stops

11

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?

12

The Patient’s Route

Registration Record room OPD HIV/ART clinic Lab Pharmacy

13

Ideal Patient Flow Arrival area:RN triage:1 the emergent2 patients with cough x > 2 weeks3 FU visits: scheduled, unscheduled

Registration desk/window:New1 capture pertinent data2 issue HIV care patient pocket book/passportNew & enrolled3 issue visit #4 prepare medical chart5 direct to the waiting area

RN evaluation room1 Hx (standard New/FU doc form)2 VS, wt3 intro to HIV care

Coughers: Exam room1 RN further evaluation based

on protocol2 order sputum, x-ray3 call in MD to examine

Emergent: Exam room1 RN evaluate2 call in MD after patient prepared for MD evaluation

General exam room:1 RN briefly summarizes ,patients issues2 MD takes over

RN counseling/disposition room:1 Review MD instructions and go over them with patient2 schedule patient3 ART counseling4. Needs assessment, nutrition, etc

Pharmacy:1 ART counseling visit 12 ART counseling visit 23 ART adherence & safety review FU

clinical services Home

Case manager

Health Center Community Resources

Waiting area:1 Patient ed: videos on nutrition, healthy living, etc2 Patient ed live to answer patient questions on HIV care (dispel myths, etc)

TGK 5/05

14

ART Patient FlowIntake Desk

RN visit

MD visit

MC referred Self or VCT referred

Eligible ?

YES NO

TX OI, TmSx, FUART protocol, TmSx

First visit

MD : Review lab, X-ray Determine regimen Discuss critical adverse effects Emphasize adherence Issue Rx Schedule 4-week FU

RP : Regimen property Key side effects & measures Adherence counseling Invite & answer questions Hand out written instructions Hand out medications schedule 2-week FU

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 Schedule 4-week FU

2nd visit

ID, age, gender, married, # children,

Support (family, friend), Dx date, ART date

H&P, review past Tx, labs, CXR,R/O or TX TB, order missing

Complete H&P, baseline labs, CXR,

R/O or TX TB (Reminder)

Support Services 1. Emotional support2. Counseling regarding ARVs & adherence, transmission risk reduction, general health maintenance, status disclosure3. Home-based Care4. PMTCT5. Family planning 6. Other services

Introduction to ARV Life style, habits, family or friend support Income, job ABC/prevention, disclosure

Awareness score, mental status, Karnofsky's Score, Wt.

HIV related Sx.

Nutritional status

TGK/ITECH/12/03

15

ARV Visits

Medical Evaluation - H & P

1.

Screening visit - Eligibility

ARV Evaluation visit - Lab, counsel

2.

ARV initiation visit - Initiate, counsel

ARV FU visit - 2, 4, 6, 8 weeks

16

Visits Week Month Year Staff Lab

Eval 1 0     MD, RN, RP HIV’ CBC, LFT, BUN, CR, UA, pregnancy, WHO stage

LFT if NVP

2 0     MD, RN, RP  

FU: 1 2     RP  

2 4     MD, RN, RP CBC, LFT3 6     RP  

4   3   MD, RN, RP CBC, LFT5   6   RN  

6   9 MD, RN, RPCBC, LFT, BUN, CR7   12  1 RN  

8   18   MD, RN, RP  

9   21 RN  

    24  2 MD Whatever is indicated    27   RN  

    30   MD  

    33   RN  

    36 3 MD Indicated    39   RN  

    42   MD  

    45   RN  

    48 4 MD Indicated           

ART Patient Visits

ART Practice Setup

18

ART Practice Setup Minimum Needs

Structure Staff Space Tools

Process Clinic stop interventions Follow up

Monitoring System Clinical

Safety Efficacy

Operations/management Outcome Performance

19

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

20

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= 1st come 1st served

21

Coordinator

Review ART DATA + waiting list status

Report to Committee

Update listPrepare action-plan

Take actionReport to management

Members:

Director/Chair

ART MD

ART RN

ART pharmacists

ART Lab technician

Coordinator staffs the meeting

HIV/AIDS Committee

22

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

23

Clinical Tools & Resources

Provider resources:3x5 cards: WHO staging, Karnofsky’s performance scale, etcRing Pocket books: Pathophysiology, medicine dosages,

interactions, side-effects, OIs Wall Posters: Flow charts & algorithms, etc

Patient resources: BrochuresPatient instructions

Forms: Provider documentationCommunication formsData capture and collection

In major local languages

24

Communication Forms

Inter-facility referral formsHospital HospitalHospital Health CenterHospital Community

Intra-facility referral formsART Clinic ClinicART Clinic LabART Clinic Pharmacy

25

 

Primary Care Provider

Previous antiretrovirals: None  Proposed regimen (discussed Y/N): AZT + 3TC

+ 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

26

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

Clinical Documentation Forms

28

Customer Requirements

Customer Satisfaction

Quality Value

Service

-Capture all essential data elements

-Legible

-Simple

-User friendly

-Time saver

-Comprehensive

-Facilitates/reminds/prompts/ promotes practice model

-Patients

-Providers

-Managers

-Facility

-Regional

-National

-Donors

29

30

31

32

Current Follow-up Form

Follow-up FormCaptures:

• 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

33

Proposed Form Data Flow Sheet

Data flow sheetCaptures chronologically:

• Dates

• ARVs (1, 2, 3)

• TB Status, OI Tx, OIP

• Labs

• ReferralsDesigned to benefit MD, RN, Data manager

• Simplifies continuity & record review

34

Date Wt ARV

1

ARV

2

ARV

3

Reason

For chg

Hgb

wbc

CD4

WHO

ALT

AST

CR

Amyl

Note

1/1/04 68 d4T 3TC NVP 14.2

7

164 46

56

ART started

FU 29/1/04

29/1/04

68 14.2

6.2

304

110

FU 29/2/04

29/2/04

69 EFV

LFT

FU 2/4/04

2/4/04 70 60

65

FU 5/5/04

17/4/04

69 14.2

7.8

198 47

50

Acute rash

FU as schdld

Data Flow Chart

35

Date

Time1

A M P

2A M P

3 A M P

4A M P

AZT

3TC

EFV

. .

In the past three days, how many days have you had missed doses?[ ] None[ ] One day[ ] Two days[ ]Three days

Since last visit how has the patient taken his/her ARVs?[ ] About as prescribed[ ] Less often than prescribed[ ] More often than prescribed[ ] Not at all

Patient Medication Record

36

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

37

Systems Issues

M&E Pharmacy MIS Quota management system Follow-up system

38

Follow-up System

StructureAppointment bookPatient passportClinic schedulesConfidential patient directoryFollow up coordinators

ProcessTest your system to see if it worksHave 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

39

Follow up System

No Show

Tele # of patient or support

Yes

No

Call until contact established

Case manager (CHCW)

Visit

Drug Management System

41

Drug Supply Management

Develop required infrastructure Establish process Assure an uninterrupted supply of standard

drugs Install information system

Selection, Quantification, Procurement,

Distribution and Use of ARV Drugs

43

ARV Drugs Selection

The selection of ARV drugs is based on:The purpose of use

• ART (Adult, pediatrics)

• PEP

• PMTCTThe level of available health institution (hospitals,

drug retail outlets)Availability of authorized prescribers and dispensersGuidelines for the use of ARV drugs in EthiopiaNational drug lists

44

Quantification of ARV Drugs

Quantification of ARV drugs is impacted by a complex web of factors related to:ARV productARTDemand (continuation and scaling up/rollout)Supply

45

Quantification of ARV Drugs (2)

Issues related to ARV Product:Shelf Life

• Short expiry dateCost

• ExpensiveHandling Requirements

• Require secure storage

• Require refrigeration/temperature control

46

Quantification of ARV Drugs (3)

Issues related to ART:Rapidly evolving scientific fieldImpact of stock outTaken for lifeARVs used for prevention and treatmentMultiple drug therapy (3 or more and all must be

available) Multiple regimensResistance evolves quickly and is inevitable

47

Quantification of ARV Drugs (4)

Issues related to demand:Availability of historical consumption dataEfficient patient tracking (Up-to-date patient information):

• Deaths

• Lost for follow-up

• Transfer out, transfer in

• Treatment interruptions

Unpredictable scale upCapacity to deliver servicesChanges in regimen (Wt., pregnancy, Tx failure, ADR)Pediatrics (change in regiment/dose, wastage of liquids)

48

Quantification of ARV Drugs (5)

Issues related to supply:Facility capacity to overcome handling costs of large

stockDelays in disbursement of funds by donors Level of available fundingVery few suppliersRapidly changing marketPrequalification/regulatory approvalSpecial pricing/donationUnpredictable and long lead time

49

Quantification of ARV Drugs (6)

Issues to consider when quantifying ARV drug requirements:Consumption data at each health facilitiesWorking and buffer stock kept at different levelsQuantity of stock on hand and on back orderLead time (time it take from ordering to delivery) Expected consumptions during the lead time

50

Quantification of ARV Drugs (7)

Expected consumption is influenced by:Number of current patients and their regimenAnticipated scaling-up pattern

• New patients on 1st line, 2nd 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

51

Quantification of ARV Drugs (8)

Procurement Cycle without scale up

Working Stock Working Stock Working Stock

Buffer Stock

Lead time Lead timeLead time Lead time

52

Quantification of ARV Drugs (9)

Procurement cycle during scale up

Working Stock

Working Stock

Working Stock

Buffer Stock

Lead time Lead time

Lead time

Lead time

53

Quantification of ARV Drugs (10)

Other quantification issuesReduced NVP requirements due to initial phase is not

usually accounted forARV 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

54

ARV Drugs Procurement

The procurement cycle involve the following steps:Review drug selectionDetermine quantities neededReconcile needs and fundsChoose procurement methodLocate and select suppliersSpecify contract termsMonitor order statusReceive and check drugsMake paymentDistribute drugs Collect consumption information

55

ARV Drugs Procurement (2)

Essential factors for calculating order quantityAverage monthly consumptionSupplier lead timeSafety stockStock on orderStock in inventory

56

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

57

Quality Assurance (2)

Drug quality is affected by:The manufacturing processPackagingTransportationStorage conditions

58

Quality Assurance (3)

Possible consequences of poor quality drugs:Lack of therapeutic effect leading to death or

prolonged illnessToxic and adverse reactionsWastage of limited financial resourcesLoss of credibility of the health care delivery system

59

Quality Assurance (4)

Defining and assessing drug quality:IdentityPurityPotencyUniformity of dosage formsBioavailabilityStability

60

Quality Assurance (5)

Maintaining drug qualityAppropriate storage and transportAppropriate dispensing and use

Monitoring drug qualityProduct problem reporting systemProduct recalls

61

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 drugsKeep drugs in good condition throughout the distribution processMinimize drug losses due to spoilage and expiryMaintain accurate inventory recordsRationalize drug storage pointsUse available transport as efficiently as possibleReduce theft and fraudProvide information for forecasting drug needs

62

Distribution and Use of ARV Drugs (2)

The distribution cycle include the following steps:Port clearingReceipt and inspectionInventory controlStorageRequisition of suppliesDelivery (push or pull)Dispensing to patientsReporting consumption

63

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)

64

Distribution and Use of ARV Drugs (4)

Intensive recording and stock monitoringStock cards, bin cards, stock movement cardsExpiry date tracking chartTemperature monitoring chartOrdering and receiving forms, models

Regular reporting of stock statusAt least monthly

65

Supply Chain and Information Tracking

At Supplier Level

PHARMID Central Store

PHARMID Branches

FACILITYMain Stores

Distribution Formats, Stock/Bin Cards, Expiry Date Tracking Charts, and To Recording Charts

Distribution Formats, Ordering and Receiving Form, Stock/Bin Cards, Expiry Date Tracking Charts and To Recording Charts

Ordering and Receiving Form, Receiving Voucher (Model 19), Receiving Discrepancy Reporting Form, Stock/Bin Cards, Expiry Date Tracking Charts and To Recording Charts

MIS (Info Tracking) Formats

66

Supply Chain and Information Tracking (2)

At Facility Level

FACILITYMain Stores

Dispensaries

Patients

Ordering and Receiving Form, Issuing Voucher (Model 22), Stock/Bin Cards, Expiry Date TrackingCharts, 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 DrugsDispensing and Consumption Summary Sheet,Patient Tracking Charts and To Recording Charts

ARV Drugs and Patient Information Sheets,Patient Tracking Charts

MIS (Info Tracking) Formats

67

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 systemsData reporting formsFeedback reports

68

ARV Drugs Management Information System (DMIS) (2)

Following are examples of key information tracking formats currently in use

69

70

71

72

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 and 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

73

Lab Supply Management Information System (LSMIS)

Lab supply should be managed likewise 3 month buffer stock Similar MIS

74

Group Discussion: Barriers and Solutions

Discuss:What are structural barriers to implementing ART in

Ethiopia?What are strategies for overcoming these barriers?

75

Key Points

HIV care should be comprehensive and include a spectrum of care activities

A multidisciplinary approach to ART care is recommended for:Improved adherenceOptimizing capacityAssuring continuityOverall improved outcome

76

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, 3x5 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

77

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

78

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