Quantification in Resource-limited settings

Laila Akhlaghi

February 28, 2007

Pharmaceutical Supply Management System

What Is Quantification?

A process that involves estimating— Quantities of a specific item needed for a procurement Financial requirements needed to purchase the items

Estimating needs within a given context— Finances Human resources capacity Storage capacity Capacity to deliver services

Objectives of Good Commodity Quantification Consistent availability

Adequate supplies for projected scale-up/rollout

Minimal wastage

No overstocking

Cost-effectiveness

Rational adjustments

Easy management

Meeting demand

Satisfied clients

Applications of Quantification Methods (1) Calculate needs for—

Procurement (for example, central bulk purchases) Forecasting (for example, for manufacturers) Global Fund for AIDS, Tuberculosis, and Malaria (GFATM)

Procurement and Supply Management (PSM) plan and other donors

Plan for new or expanding programs

Prepare and justify a drug budget

Optimize medicines budgets based on priority health problems to be treated and the most cost-effective treatment approaches

Applications of Quantification Methods (2)

Estimate storage needs

Calculate emergency needs for disaster relief and epidemics

Resupply an existing supply network that has become depleted of products

Compare current medicines consumption with public health priorities and usage in other health systems

Quantification Methods

Consumption method

Morbidity method

Adjusted-consumption method

Service-level projection

Consumption Method

Uses data on medicines consumption

Predicts future needs most accurately when current usage patterns will continue

Requires reliable consumption data

Consumption data may or may not reflect rational prescribing or rational use of medicines

Comparison with morbidity-based method allows an estimate of the extent to which current consumption— Addresses priority health needs Reflects rational use of medicines

Morbidity Method

Used for new programs or for programs where consumption data are not available

Forecasts the quantity of medicines needed for prevention/treatment of specific diseases based on projections of disease incidence

Requires accurate information on the population, morbidity, and clinic attendance, and uses standard treatment guidelines (STGs) to project needs

Most complex and time-consuming of all four methods

Calculations can be complex

Adjusted-Consumption Method

Used for new sites or new programs

Can be population-based or service-based

Uses data from an existing system to extrapolate requirements for a new system based on population coverage or the service level to be provided

Can be difficult to match/adjust for all variables—for example, prescribing practices

Service-Level Projection

Used for estimating budget needs

Does not estimate quantities of medicines needed

Uses the average medical supply procurement cost per attendance or bed-day in different types of health facilities in one system to project needs for similar types of facilities in another system

Limitations: variations in facility use, attendance, treatment patterns, supply system efficiency

Forecasting Challenges in Resource-Limited Settings

Lack of knowledge or tools

Lack of data collection mechanisms

Lack of coordination

Complicated forecasts Antiretrovirals for HIV Antimalarials for malaria

Typical Practices

Lack of data collection mechanism and/or analysis

Based on previous orders/requests, plus a percentage Stock-outs not reviewed/included Buffer/safety stock is not included Consideration for filling the supply pipeline is not included

Data Collection and Reporting: Lessons Learned (1)

Inaccurate or lack of data is universally identified as a major constraint to successful quantification

Aggregating patient data to report can be problematic, especially as programs scale up/roll-out

Can be difficult to extract and aggregate data needed from manual tools, especially for pediatrics

Sites can lose motivation to report if supplier is not responsive or products and quantities supplied are inappropriate to needs

Data Collection and Reporting: Lessons Learned (2)

A concerted and coordinated team effort is needed to: Develop and sustain a system for data collection Harmonize tools and reporting systems Develop, print and disseminate tools to sites Provide standard operating procedures for, and advise and train

sites on data collection and aggregation Support efficient reporting by sites Give consistent and responsive feedback to sites

Consider and plan for computerized tools

Involve users in tool development and provide responsive feedback

Coordination Mechanism for Procurement and Quantification (1)

Mechanism to inform decision making at the central level for effective procurement and quantification

Should be inclusive of all stakeholders— CMS National committees (malaria, AIDS, TB, etc…) MOH Donors Facility staff Public and private sectors

Monitors and coordinates implementation of activities

Coordination Mechanism for Procurement and Quantification (2)

Challenges Building consensus among MOH, donors, facility staff,

CMS, and other stakeholders Lack of accurate data Quantifying for children Delayed implementation of recommendations

Complicated Quantification: ARV and ACT Products

Often have a short shelf life

Are expensive

Require secure storage

Require refrigeration or temperature control

Pediatric formulations Inappropriate pack sizes Limited options on formulations

New product; little experience with use

Proliferation of substandard quality medicines (ACTs)

Complicated Quantification: Treatment of HIV Scientific field is rapidly evolving

Effect of stock-outs is serious

ART is for life

ARVs are used for prevention and treatment

Multiple drug therapy is required Three or more medicines, and all must be available Can be fixed-dose combinations, patient packs, and/or single

products

Multiple regimens are used

Resistance evolves quickly and is inevitable

Complicated Quantification: Treatment of Malaria Standard treatment guidelines changes due to

resistance and new products (ACTs)

Failure of first-line medicines does not always mean patient will be transitioned to second-line treatment

Multiple regimens are used Simple malaria (uncomplicated)

First line Second line

Severe malaria Intermittent preventive therapy (IPT)

Bednets impregnated with insecticide

Complicated Quantification: HIV Programmatic Issues (1)

Lack of data: Historical data (consumption) Deaths Loss to follow-up Transfers out Changes in regimen

Weight; pregnancy; treatment failure; adverse drug reactions (ADRs); co-morbidities

Pediatrics Changes in dose; wastage of liquids

Complicated Quantification: HIV Programmatic Issues (2) Unpredictability in Scaling Up Rate

Political push for rapid and enormous scale-up Limited capacity to deliver services Limited capacity of supply systems Availability and demand for HIV testing Client demand for ART Level of funding available by government or delays in disbursement of

donor funds

Unpredictability in Product Use Profile of enrolling clients compared with continuing clients Prescribing practices Client characteristics (weight; pregnancy; co-morbidities; treatment-

naïve; treatment failure; ADRs; resistance; high-risk or low-risk HIV exposure; pediatric issues)

Complicated Quantification: Malaria Programmatic Issues Lack of data on:

Population/conditions to treat Dose dependent on patient weight/age group Population data does not match with treatment guideline

recommendations

Endemic areas/epidemics/refugee populations Quantity of second-line therapies

Depend on treatment failure of first-line therapy Previous consumption

Incidence of malaria not readily available Need to use incidence of fevers

Sharing of bednets

Complicated Quantification: Supply Issues (1)

New and imperfect market Supply and demand forces are influenced by factors not usual in

a “perfect” competitive environment

Oligopoly

Rapidly changing market

Prequalification or regulatory approval

Special pricing and donations

Unpredictable and long lead times, shortages

Lengthy public sector procurement process

Complicated Quantification: Supply Issues (2)

Suppliers’ preference for long-term forecasts and assurances of procurement

Capacity of manufacturers to meet demand (2) Problems in meeting demand for active ingredients Inaccurate forecasting leading to insufficient production Lack of flexibility to increase production to meet short-term

needs Lack of incentives to manufacture with limited guaranteed

markets

Complicated Quantification: Supply Issues (3) Demand

Characterized by extreme uncertainty Financing

Major purchasers mainly using donor funding Public and not-for-profit sector demand are increasing

relative to private sector demand

Variable user “demand” for, prescribing and use of, and response to ACTs

Summary (1)

Quantification requires a multitude of data from various sources.

Several different tools can be used to manage data collection and reporting.

A concerted and coordinated team effort is needed to inform stakeholders on data needs and to support sites in data collection and reporting for quantification.

Summary (2)

The success of quantification can be improved by—

A team approach to making assumptions and decisions and share information on— Potential changes in demand and prescribing practices Potential changes in rate of scale-up or roll-out Market intelligence—availability of product Epidemiological data sets and consumption data sets New science Successful problem-solving approaches (and failures)

Cross-checking data, information, and projected needs

Using ongoing monitoring of projected vs. actual needs to adjust assumptions