Overview of Ethiopia ARVs and other Medicines Supply Management Issues

WHO Meeting October 2005

MSH/RPM Plus in Ethiopia

• Started operation in September 2003• Funded by USAID/E under PEPFAR• Registered by Ministry of Justice as US-PVO in

June 2004• Set up a modest office in Addis • Current staff of 17 (all Ethiopian)

Qualitative and Quantitative Assessment

Human resources – staffing levels & training needs

Infrastructure – structural & equipmentSystem/Procedure – components of the

pharmaceutical management systemAvailability

LEVELS PRIVATE SECTORPUBLIC SECTOR PARTNERS

International EPI/TBLFP/PMTCTGF

National

PASS/MOH/MOD

Local Importers/Wholesalers

Distributors (70)

Regional Regional Stores (14)

Local

Community

DistrictStores

Target Population

Local Manufacturers

(12)

Multinational Suppliers

PrivatePharmacies, Druggist Shops, RDVs(2450)

NGOs, CBOs, FBOs, Special

Pharmacies

WBOther Donors (USAID, JICA, etc)

& ProcurementAgencies

HAPCO

The Pharmaceutical Supply System: ETHIOPIA

PHARMIDParastatal

PHARMID Branches (8)

Hospitals, Health Centers

Drug Import/Distribution: Public SectorMajor Players:

• Pharmacy Administration and Supply Service – PASS/MoH

• Pharmaceuticals and Medical Supplies Import and Wholesale Share Company - PHARMID

• Armed Forces and Ethiopian Red Cross

• NGOs, Donors including the UN

• Private Commercial Sector – There are 51 importers and wholesale distributors

Public & Private Sector Pharmacies

(i) Public/NGO Non-profit Pharmacies:• Special Pharmacies (USAID/Irish supported pharmacies

managed by public health facilities) - 260• KENEMA Pharmacies (City Council) - 35• Red Cross Pharmacies/Drug Shops/RDVs - 41• Hospital/HC Pharmacies (DRF/IPP/OPP)

(ii) Private for-profit Pharmacies:• Pharmacies/Drug Shops/Rural Drug Vendors

SECTOR

Ownership

Drug Outlets

PrivateRed Cross

PHARMIDPrivateDonation

Drug Outlets in Ethiopia

Public Health Facilities

PHARMIDRed Cross

PrivatePHARMID

PHARMIDPrivate

Public / Quasi-Private (Non-Profit) Private

Supply Source

City CouncilKENEMA

Pharmacy 304Drug Shop 270Rural Drug Vendor

Special Pharmacy 260Out -Patient PharmacyIn-Patient Pharmacy

Pharmacy 24Druggist Shop 7Rural drug Vendor 4

Pharmacy 25 Drug Shop/RDV 16

Service OTC, RxHosp Rx, otcOTC, Rx ARVs OTC, Rx

ARVs

RPM Plus/MSH 2003

Drug Supply Management Cycle Approach

Selection & Quantification

ManagementSupport

Distribution

ProcurementUse

Policy and Legal Framework

M&E

M&E

M&E

M&E

Main areas of investigation for site assessments

• Information management

~ What record keeping and reporting procedures are in place to build upon?

~ What transaction forms are used between facilities and suppliers (RHBs, PHARMID etc.)?

~ What methods of communication and information exchange are used?

~ What basic MIS system can be put in place to improve accountability and stock status and patient tracking?

Main areas of investigation for site assessments

• Human resources~ What is the current status of pharmacy and lab man power in the

target facilities?

~ How can the number of pharmaceutical personnel be increased to cope with increasing workload?

~ What other methods are there to tackle the manpower problem?

• Infrastructure~ How adequate and appropriate are the infrastructure and storage

conditions of pharmaceutical and laboratory facilities in the target sites?

~ What infrastructure improvements can be initiated and at which target facilities (working space, shelving, security, privacy, record keeping, etc)?

Findings - Staffing & Training

• Shortage and high attrition rate of professional staff (There are 26 pharmacists -46% in HF, 36 Druggists -75% in HF, 30 Pharm Technicians -83% in HF, 14 Pharmacy Assistants -100% in HF, and 4 clerks)

• Limited management capacity at regional, district and health facility levels

• Inadequate training on rational drug use and drug supply management

• Lack of standard operating procedures, current reference materials or manuals

0

1

2

Lid

eta

Ad

dis

ket

ema

Tek

le

Ha

yma

no

t

Bo

le

Mo

jo

Ax

um

Wu

kro

Ma

rai

Wo

reta

Ad

et

PMTCT/ART Program Assessment RPM Plus Nov/Dec 2003

Pharmacy Personnel in Health Centers

Druggist Pharm Tech Pharm Asst Clerk

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

PMTCT/ART Program Assessment RPM Plus Nov/Dec 2003

Pharmacist Druggist Pharm Tech Pharm Asst Clerk

012345678910111213141516171819202122232425

Zewditu T ikur Anbassa Adama Axum Felege Hiwot Karamara

PMTCT/ART Program Assessment RPM Plus Nov/Dec 2003

Pharmacy Personnel in Hospitals

Lab Technologist Lab Technician Lab Asst

M&E and Inventory Control

• Inventory control systems (bin cards, stock cards etc.) not adequate [only 64% of PMTCT facilities have bin/stock card]

• Weak monitoring and evaluation system • Limited quality assurance of drugs due to

shortage of human resources, weak information system, and lack of quality assurance management system.

Preliminary Findings from 15 ART SitesIndicator Percentage (n=15)

Pharmacist available and trained

Two pharm. personnel available (not pharmacists)

47%

87%

Monthly collection of ARV drugs feasible 53%

Stock record cards used

SOP available for ARV management

80%

0%

Stock status regularly recorded

Stock status regularly reported

53%

47%

Space for confidential patient counseling 7%

Lockable storage space (cabinets) available

Lockable filing cabinet suitable for ART

Sufficient cold storage space available

43%

29%

79%

Kardex filing

Computer

Patient registration book for out-patients

0%

22%

29%

Additional Findings from the Assessment of 15 ART Target Sites

• 80% of the sites receive supplies from PHARMID

• 80% of sites use stock cards but only 53% of sites regularly update and 47% report stock status

• Only 60% use bin cards but only 40% update them

• 33% of the facilities realized that there is loss due to damage, expiry and pilferage but only 1 facility had a system of recording such losses

• Only 67% reported some kind of supervisory visits

• 88% of the sites had stock of essential drugs on the day of the visit

• 67% use past consumption data for quantification

Appropriate Tools • Patient profile card• Daily drug dispensing register• Monthly activity reports• Periodic supervisory tools and feedback mechanism• Expiry date tracking chart• Adherence follow-up chart• Temperature monitoring chart for commodities• Facility supervisory checklists• Inventory management stock cards, bin cards, requisition

slips, ADR reporting formats etc.• Simple locally sustainable computer software where

applicable

Sample Monitoring Indicators

~ % patients who could correctly describe how the prescribed medication should be used

~ % ART sites that had ARV drug by type was out of stock for more than 5 days during the last quarter

~ % of ARV drugs expired during the last quarter

~ Cost of loss due to expiry of ARV drugs

~ % of defaulters of ART program

Demonstration of Computer System in the Making……

PHARMID / PASS LEVEL

PHARMID BRANCHES/RHB LEVEL

HEALTH FACILITY LEVEL

Drug supply management

Drug stock management, client care and dispensing

Collaborative Vision for HIV/AIDS Patient Monitoring System

Clinical System

Pharmacy System

Diagnostic System (Laboratory, Rad. etc.)

Care & Support System

Patient

Profile

HMIS

Management System

PASS / PHARMID HQ/ DACA / HMIS

ART Service Centers

ART Patients

Supply Chain of ARV Drugs

PASS/ PHARMID BRANCHES / DACA/

HMIS

Information Flow

•Consolidated information based on data from the health facilities

•Report on the supervisory visits and directives to the ART centers

•Information based on periodic surveys of ART centers or Patients•New patient enrollment (by gender and age) in different programs (ART, PEP, PMTCT), revisiting patients, defaulters, change in regimen, drug substitution, and total drug consumption, current stock position, drug requirements, patient satisfaction and quality of care information

•Information for International Community and National Publications

•Consolidated information for ARV quantification and scaling up

• Report on the supervisory visits and directives to the branches

•Information based on periodic surveys of ART centers or Patients

ARV Drug Inventory Management at the Facility Level

Drug Main Store

•Stock cards, Bin cards, Temperature recording chart, Expiry date tracking charts

Drug Dispensing Pharmacy

•Individual patients cards

•Drug dispensing register

•Bin cards

•Stock status and daily drug consumption report

•Temperature recording chart for commodities

•Expiry and adherence tracking charts

Requisition slips

Stock and consumption report

ARV drugs

PASS/ PHARMID HQ

HEALTH FACILITIES

ART Patients

Supply Chain of ARV Drugs

PHARMID BRANCHES/

RHBs

RPM Plus MIS Support Areas

Strengthen

•Procurement

•Storage, inventory and distribution system

•Simple MS Access based computer system* + training on the use of information + Supervisory tools and proceduresStrengthen

•Storage, inventory and distribution system

•Simple MS Access based computer system* + training on the use of information+ Supervisory tools and proceduresStrengthen

•Quantification, storage, Inventory ,expiry tracking, adherence tracking and follow-up system

•ADR monitoring and reporting system

•Individual patient counseling and drug history recording system (computerized or manual)**

Current Challenges

I. Difficulty in meeting minimum requirements by the new sites:

~ GF money earmarked for site renovation has not been put to use

~ Pharmacies at new sites have no confidential counseling rooms and/or booths

~ Many sites have no lockable cupboards, filing cabinets, shelves

Challenges (contd …)

II. “Integration” of ETAEP and GF ART drugs and services - the technical details of the integration need to be worked out urgently (eg. Distribution outlets, flow of information)

lll. Need to revise Regimen and Dosage Forms List of ARV drugs permitted for importation – list does not include:

> Tenofovir

> Triple combinations

> Pediatric solid and liquid formulations are limited

> 2nd line regimen is incomplete

Challenges (contd …)

IV. Unreliability of suppliers due to manufacturing constraints (e.g. Stavudine; new orders for GSK’s AZT-containing drugs now need > 5 months to be processed)

Good news: many generic manufacturers are coming on the market (partial shipment within 3 weeks!)

V. Significant difference in the pattern of ARV prescribing by clinicians (next slide)

Comparison of the use of Efavirenz & Neverapine at Zewditu Hospital

0

5000

10000

15000

20000

25000

March April May June

Nu

mb

er

of

Do

se

s D

isp

en

se

d

Efavirenz 600mg

Neverapine 200mg

Comparison of the Use of EFV & NVP at Black Lion Hospital

0

10

20

30

40

50

60

70

March April May

Nu

mb

er

of

do

se

s D

isp

en

se

d

EFV

NVP

Challenges (contd …)

VI. Acute Shortage of Pharmacy Staff – one pharmacist serving > 1200 patients at Zewditu

~ The need for training mid-level pharmacy personnel to handle ARVs and fully participate in ART

~ Unavailability of data clerks

There is a need for pharmacy data clerks to record drug movement, track expiry and monitor patient profile.

Computerized ARV Drug Use and Stock Management Tool at Zewditu Hospital – data is being maintained by RPM Plus staff, because the facility could not assign a data clerk. Data clerks are urgently required at all facilities!

Thank You !