ART Set-up and Procurement

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ART Set-up and Procurement

• Unit 3
• HIV Care and ART
• A Course for Healthcare Providers

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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

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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

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Practice Care Model
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ART Practice

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

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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

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ART Care Model

• Multidisciplinary (Team) Effort
• Minimum Team Members MD, RN, RP, CHCW

Physician
Social Worker
Nurse
Patient
Community HC Worker
Pharmacist
TGK/ITECH/9.03
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Maximizing the Minimum
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Patients with chronic illness care provider needs
SP
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MD
Non-MD PA/ HO, MSW, RPh Nut, RN
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Workload could safely and legally be delegated
to the appropriate level. TGK/PSHCS,
Primary Care
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ART Patient Flow
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Think About the Patient Experience

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

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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?

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The Patients Route

• Registration
• Record room
• OPD
• HIV/ART clinic
• Lab
• Pharmacy

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Ideal Patient Flow

• Arrival area
• RN triage
• the emergent
• patients with cough x gt 2 weeks
• FU visits scheduled, unscheduled

• Coughers Exam room
• RN further evaluation based on protocol
• order sputum, x-ray
• call in MD to examine

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

• Emergent Exam room
• RN evaluate
• call in MD after patient prepared for MD
  evaluation

• Registration desk/window
• New
• capture pertinent data
• issue HIV care patient pocket book/passport
• New enrolled
• issue visit
• prepare medical chart
• direct to the waiting area

• RN evaluation room
• Hx (standard New/FU doc form)
• VS, wt
• intro to HIV care

• General exam room
• RN briefly summarizes ,patients
  issues
• MD takes over

• RN counseling/disposition room
• Review MD instructions and go over them with
  patient
• schedule patient
• ART counseling
• . Needs assessment, nutrition, etc

• Pharmacy
• ART counseling visit 1
• ART counseling visit 2
• ART adherence safety review FU

clinical services

Home Case manager Health Center
Community Resources
TGK 5/05
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ART Patient Flow
ID, age, gender, married, children, Support
(family, friend), Dx date, ART date
Intake Desk
First visit
Awareness score, mental status, Karnofsky's
Score, Wt. HIV related Sx. Nutritional status

Introduction to ARV
Life style, habits, family or friend support
Income, job
ABC/prevention, disclosure
RN visit
MD visit
Complete HP, baseline labs, CXR, R/O or TX TB
(Reminder)
HP, review past Tx, labs, CXR, R/O or TX TB,
order missing
MC referred
Self or VCT referred

• Support Services
• . Emotional support
• . Counseling regarding ARVs adherence,
  transmission risk reduction, general health
  maintenance, status disclosure
• . Home-based Care
• . PMTCT
• . Family planning
• . Other services

Eligible ?
NO
YES
TX OI, TmSx, FU
ART protocol, TmSx
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

MD Review lab, X-ray Determine regimen
Discuss critical adverse effects
Emphasize adherence Issue Rx
Schedule 4-week FU
2nd visit
TGK/ITECH/12/03
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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

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ART Patient Visits
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ART Practice Setup
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ART Practice Setup Minimum Needs

• Structure
• Staff
• Space
• Tools
• Process
• Clinic stop interventions
• Follow up
• Monitoring System
• Clinical
• Safety
• Efficacy
• Operations/management
• Outcome
• Performance

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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

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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

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HIV/AIDS Committee

• Coordinator
• Review ART DATA waiting list status
• Report to Committee
• Update list
• Prepare action-plan
• Take action
• Report to management

Members Director/Chair ART MD ART RN ART
pharmacists ART Lab technician Coordinator staffs
the meeting
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Pediatrics Priorities

• Age cut off lt10 years (because children older
  than 10 can swallow pills, therefore are grouped
  with adults)
• The sickest children must go first
• Children lt5 years tend to perish rapidly with
  HIV/AIDS

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Clinical Tools Resources

• Provider resources
• 3x5 cards WHO staging, Karnofskys performance
  scale, etc
• Ring Pocket books Pathophysiology, medicine
  dosages, interactions, side-effects, OIs
• Wall Posters Flow charts algorithms, etc
• Patient resources
• Brochures
• Patient instructions
• Forms
• Provider documentation
• Communication forms
• Data capture and collection

In major local languages
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Communication Forms

• Inter-facility referral forms
• Hospital Hospital
• Hospital Health Center
• Hospital Community
• Intra-facility referral forms
• ART Clinic Clinic
• ART Clinic Lab
• ART Clinic Pharmacy

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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

 
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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

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Clinical Documentation Forms
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Customer Requirements
Quality
Value

• Patients
• Providers
• Managers
• Facility
• Regional
• National
• Donors

• Capture all essential data elements
• Legible
• Simple
• User friendly
• Time saver
• Comprehensive
• Facilitates/reminds/prompts/ promotes practice
  model

Customer Satisfaction
Service
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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

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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

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Data Flow Chart
Date Wt ARV 1 ARV 2 ARV 3 Reason For chg Hgb wbc CD4 WHO ALT AST CR Amyl Note
Date 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
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Patient Medication Record
Date Time 1 A M P 2 A M P 3 A M P 4 A 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
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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

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Systems Issues

• ME
• Pharmacy MIS
• Quota management system
• Follow-up system

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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

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

• Develop required infrastructure
• Establish process
• Assure an uninterrupted supply of standard drugs
• Install information system

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Selection, Quantification, Procurement,Distributi
on and Use of ARV Drugs
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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

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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

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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

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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

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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)

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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

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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 and on back order
• Lead time (time it take from ordering to
  delivery)
• Expected consumptions during the lead time

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Quantification of ARV Drugs (7)

• Expected consumption is influenced by
• Number of current patients and their regimen
• Anticipated 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

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Quantification of ARV Drugs (8)

• Procurement Cycle without scale up

Lead time
Lead time
Lead time
Lead time
Working Stock
Working Stock
Working Stock
Buffer Stock
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Quantification of ARV Drugs (9)

• Procurement cycle during scale up

Lead time
Lead time
Working Stock
Working Stock
Lead time
Lead time
Working Stock
Buffer Stock
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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

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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

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ARV Drugs Procurement (2)

• Essential factors for calculating order quantity
• Average monthly consumption
• Supplier lead time
• Safety stock
• Stock on order
• Stock in inventory

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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

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Quality Assurance (2)

• Drug quality is affected by
• The manufacturing process
• Packaging
• Transportation
• Storage conditions

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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

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Quality Assurance (4)

• Defining and assessing drug quality
• Identity
• Purity
• Potency
• Uniformity of dosage forms
• Bioavailability
• Stability

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Quality Assurance (5)

• Maintaining drug quality
• Appropriate storage and transport
• Appropriate dispensing and use
• Monitoring drug quality
• Product problem reporting system
• Product recalls

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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 for forecasting drug needs

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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

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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)

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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

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Supply Chain and Information Tracking
At Supplier Level
MIS (Info Tracking) Formats
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Supply Chain and Information Tracking (2)

• At Facility Level

MIS (Info Tracking) Formats
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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

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ARV Drugs Management Information System (DMIS)
(2)

• Following are examples of key information
  tracking formats currently in use

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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 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

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Lab Supply Management Information System (LSMIS)

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

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Group Discussion Barriers and Solutions

• Discuss
• What are structural barriers to implementing ART
  in Ethiopia?
• What are strategies for overcoming these barriers?

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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

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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

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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

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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