drug procurement 10-03-09

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    DRUG

    PROCUREMENT

    Deliveredby

    Mrs. Opanuga O. O.

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    CONTENTS

    INTRODUCTION

    OBJECTIVES OF NATIONAL DRUG POLICY

    COMPONENTS OF DRUG MANAGEMENT DRUG PROCUREMENT

    - PROCUREMENT CYCLE

    - PROCUREMENT METHODS- PROCUREMENT /PURCHASING

    MODELS

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    KEY PRINCIPLES OF GOODPROCUREMENT

    CONCLUSION

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    INTRODUCTION

    Definition of a drug

    A drug includes any substance or mixture ofsubstances manufactured, sold or advertised for

    use in the diagnosis, treatment, mitigation orprevention of any disease disorder, abnormalphysical state, or the symptoms thereof, in manor in animals; restoring, correcting or modifying

    organic functions in man or in animals;disinfection or control of vermin, insects orpests; or contraception(National Drug Policy,NDP)

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    INTRODUCTION

    GOALS OF NDP

    To make adequate supplies of effective,affordable, safe and good quality drugs

    available to the Nigerian populace at alltimes

    To ensure rational use of drugs and

    To stimulate increased local production ofessential drugs

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    INTRODUCTION

    OBJECTIVES OF NDP

    Ensure efficient and effective drugmanagement in both public and private sectors

    Ensure access to drugs available at all levels ofhealthcare on the basis of health needs

    Promote rational drug use by prescribers,dispensers and consumers

    Increase local drug production and promoteexport

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    INTRODUCTION

    OBJECTIVES OF NDP

    Promote pharmaceutical research and development

    of raw materials for the production, compounding

    and formulation of pharmaceutical product as wellas operational research for effective implementationof NDP

    Enlist government commitment at all levels for the

    achievement of the goals and objectives of NDP

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    COMPONENTS OF DRUGMANAGEMENT

    Drug management involves four basic components:

    Selection

    Procurement Distribution

    Use

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    DRUG MANAGEMENT CYCLE

    The drug management framework representsthe flow of activities that must becoordinated to ensure that appropriate, highquality medicines are available when

    patients need them. The framework emphasizes the relationships

    between selection, procurement, distribution,

    and use activities All of which are supported by a strong

    management support system.

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    POLICY, LAW & REGULATION

    A countrys policies, laws, and regulations define the general

    goals and parameters for effective drug management overall,therefore encircling the other elements in the framework.

    Drug policy includes such elements as allocating budgets,prioritizing research and development, promoting educationinitiatives, and defining the role of the public and privatesectors.

    By establishing pharmaceutical laws and regulations, countriescan set pharmaceutical quality standards and price limits,require registration of pharmaceutical products, and establish

    guidelines.

    Good governance in the form of transparency and account-ability prevents waste of scarce resources and increasespeoples trust in the government and the health care system.

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    SELECTION Establishing and using a list of carefully selected essential

    medicines is perhaps the single most cost-effective action that

    any health care system can take to promote a regular supply ofpharmaceuticals.

    Essential medicines are those best suited to treat the mostprevalent illnesses afflicting a population.

    If these medicines are made available, prescribers can be sure of

    a sufficient supply to treat the most common illnesses.

    Selecting the most useful medicines also helps prevent wastageof scarce resources on unnecessary, unsafe, or ineffectivemedicines.

    Evidence-based selection of the most appropriate medicinesrequires that health managers and policy makers have access tocurrent information on common illnesses, budgetary limits, andpharmaceutical advances, as well as input from doctors andpharmacists.

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    SELECTION

    Selection process begins with

    Defining/Reviewing the prevalent healthproblems (disease pattern) for each level of

    health care

    Identifying treatment of first choice for eachhealth problem (basis for EDL)

    Choosing individual drugs and dosage forms.

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    WHO SELECTION CRITERIA

    Essential drugs should be selected based on

    Relevance to pattern of prevalent disease)

    Proven Efficacy & Safety

    Adequate scientific data & evidence of

    performance in a variety of settings

    Adequate quality including bioavailability &

    Stability

    Favourable cost-benefit ration in terms of thetotal treatment cost

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    SELECTION

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    SELECTION

    List of common health problems

    Choice of standard drug & Non-drug treatments

    Drug List

    EDL Drug Supply (Procurement, Treatment Guidelines

    Donations, Distribution, Producton)

    Formulary Rational Drug Use (Training, Supervision, Monitoring)

    Drug Information

    Greater Availability & More Rational Use of Drugs

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    PROCUREMENT

    Procurement strategies vary widely, butmost models include the following criticalactivities:

    pharmaceutical needs quantification, bidmanagement, supplier selection, andmedicine quality assurance.

    Good procurement practices, supported by

    adequate information systems, can helpensure that the selected medicines are madeavailable for distribution.

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    PROCUREMENT

    Drug Quantification

    Selection of Procurement procedure

    Tender Management

    Establishing Contract terms Assuring drug quality

    Ensuring Adherence to Contract terms

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    DRUG PROCUREMENT

    Drug procurement is a process of acquiringdrugs from private or public supplier orthrough purchases from

    Manufacturers,

    Distributors or

    Agencies like UNICEF, WHO or Bilateral Aidprograms

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    DRUG PROCUREMENT

    The Drug procurement system is a majordeterminant of availability drugs and totalhealth costs.

    In developing countries, cost of drugsrepresents the single largest healthexpenditure, after personnel costs.

    Drugs also consume the major share ofhealth related foreign exchange.

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    DRUG PROCUREMENT

    Drug procurement is a very importantaspect in delivery of Health Care

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    DRUG PROCUREMENT

    An effective procurement process should

    Procure the right drugs in the right quantitiesand at the lowest possible price

    Ensure that all drugs procured meetrecognized standard of quality

    Arrange prompt and dependable delivery toavoid shortages and stock outs

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    OBJECTIVES OF PROCUREMENT

    To obtain high quality drugs at the lowest cost usingstandard & economical methods

    To ensure prompt & dependable delivery by careful

    supplier selection and monitoring of order status To establish re-order points & quantities which avoid

    stock outs,prevent overstocks and maintain theminimum inventory necessary for constant

    replenishment of stock to health facilities

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    OBJECTIVES OF PROCUREMENTCONTD

    Ensure supplier reliability with respect to service andquality

    Set the Purchasing schedule, Formula for Ordered

    Quantities, Safety Stock levels, to achieve thelowest total cost at each level of the system i.e. setRe-order level, Minimum level, Re-order Quantity,Maximum level in order to avoid stock outs

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    OBJECTIVES OF PROCUREMENTCONTD

    Maximize Use of Local Suppliers whileseeking Low Prices, High Quality andDependable Delivery

    These Objectives should be achieved in theMost Efficient Manner Possible.

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    Procurement Review

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    ProcurementCycle

    Review

    Drug

    Selections Determine

    Quantity

    Needed

    Reconcile

    Needs and

    Funds

    Choose

    Procurement

    Method

    Locate

    and Select

    SuppliersSpecify

    Contract

    Terms

    Monitor

    Order

    Status

    Receive

    andCheck Drugs

    Make

    Payment

    Distribute

    Drugs

    Collect

    Consumption

    Information

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    Procurement Cycle

    The Cycle involves the following steps:

    Review drug selection

    Determine quantities needed Reconcile needs and funds

    Choose procurement method

    Locate and select suppliers Specify contract terms

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    Procurement Cycle contd

    Monitor order status

    Receive and check drugs

    Make payment Distribute drugs

    Collect consumption information

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    PROCUREMENT METHODS

    Method chosen should

    Obtain the lowest possible purchase prices

    Obtain supply of good quality products fromreliable of the Supplier who will back it up withadequate services.

    Minimize Loss of Resources [e.g. funds andgoods resulting from adverse influences onprocurement decisions and practices]

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    PROCUREMENT METHODS

    Obtain Optimum Economy in Personnel, timeand other resources used in the procurementprocess

    The critical decision is to select the method,which will achieve these objectives for theparticular health care systems or institution atany particular time.

    All drugs needs not be purchased by thesame method and one particular methodneeds not to be used at all times

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    PROCUREMENT METHODSCONTD

    There are 4 major methods:

    Open Tender

    Restricted Tender Competitive Negotiation

    Direct Procurement

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    OPEN TENDER

    It is an unrestricted public bid by eligible suppliersor manufacturer based on the term and conditionspecified in the advertised tender invitation.

    It is a formal procedure by which quotations areinvited from any manufacturer or representative on alocal, international worldwide basis - ICB.(International Competitive Biddings) as specified by

    the World Bank (1993s) guideline

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    OPEN TENDER

    It is open to all interested internationalmanufacturers from World Bank membercountries.

    The best/Lowest prices may be obtained bythis method.

    It also promotes local production

    It is time consuming

    The workload is high.

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    Restricted Tender/CloseBidding/Selected Tender

    Interested suppliers must be approved andregistered in advance often through aFormal Pre-qualification Process by the

    buyer.

    Such process considers Adherence to GoodManufacture Practices (GMP), Past Supply

    Performance/Record, Financial viability andRelated factors.

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    Restricted Tender/CloseBidding/Selected Tender contd

    This pre-qualification process is open to anysupplier that wishes to apply

    Favorable/Moderate prices are obtainedhere.

    It is less burdensome.

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    COMPETITIVE NEGOTIATION

    Buyer may also bargain with these suppliersto achieve lower prices or servicearrangement.

    This method is most useful for selected itemsfor which best supply sources are wellknown.

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    DIRECT PROCUREMENT

    It is the simplest and quickest but usually themost expensive method

    It deals with purchasing from single suppliersat the quoted or negotiated prices.

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    PROCUREMENT METHODSCONTD

    Careful selection of reliable, compatible andappropriate suppliers is important forguaranteeing eventual quality and cost ofsupplies.

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    PROCUREMENT METHODSCONTD

    At the initial stage of developing drugprocurement system, it may be best to startwith a relatively simple purchasing method,

    e.g. a combination of negotiation with knownsuppliers or international procurement andlocal tendering

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    Purchasing models/ mechanisms

    The most commonly used inventory model are:

    Periodic Purchasing :-

    - Annual Purchasing

    - Scheduled Purchasing

    Perpetual Purchasing

    Modified Optional Replenishment a

    modification of the two mechanisms above

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    Purchasing models/ mechanismscontd

    Different combination of these models maybe used at different levels of the system or fordifferent drug.

    Inventory control should therefore considerchanges in the purchasing system asprogram develops.

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    Purchasing models/ mechanismscontd

    Whichever combination of supply system andmodels used, most public sector drugprocurement involves group purchasing

    whereby the procurement office negotiatescontracts for members of a group with similarneeds and interests.

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    Periodic Purchasing

    Annual purchasing

    It is the simplest model/mechanism

    But it entails Uneven Workload.i.e Workload is high in the early part of thefiscal/year when purchase & contracts areinitiated thereafter the procurement staff have

    little or nothing to do, this is a waste ofHuman Resources.

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    Annual purchasing contd

    It is most useful for small programs or newprogram

    It requires very high safety stock leading tohigh inventory costs.

    It is therefore very costly as a permanentsystem.

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    Periodic Purchasing contd

    Scheduled purchasing

    It is a modification of Annual Purchasing

    Intervals are cut down to three or six months Provides an even workload for procurement

    staff &

    This requires less inventory.

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    P h i d l / h i

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    Purchasing models/ mechanismscontd

    Government funding and accounting

    procedures or requirement may not allow

    the adoption of a superior model or allow the adoption of a less superior

    model

    e.g. perpetual purchasing is lesscompatible with government annualbudgeting but may be adopted whenthere is no available fund.

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    KEY PRINCIPLES OF GOOD DRUGPROCUREMENT

    Procurement by generic name [INN International Non-Proprietary Name: Specifyquality standard and not specific brands

    Limitation of procurement to the EDL: Selectsafe, effective and cost effect drug

    Procurement in bulk: makes for favourable

    prices

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    KEY PRINCIPLES OF GOOD DRUGPROCUREMENT CONTD

    Formal supplier qualification and

    monitoring

    All suppliers should be pre and post qualifiedthrough a process that consider Qualityservice, Reliability and Financial viability.

    Competitive procurement

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    KEY PRINCIPLES OF GOOD DRUGPROCUREMENT CONTD

    Sole-source commitment: grouppurchasing where all contracted drugs are

    from contracted suppliers. Separatedeals have to be entered with non-contracted suppliers.

    Order Quantities based on ReliableEstimate of Actual Needs

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    KEY PRINCIPLES OF GOOD DRUGPROCUREMENT CONTD

    Reliable Payment and Good FinancialManagement

    Transparency and Written procedures

    Separation of key functions: that requiredifferent expertise e.g. functions thatinvolve committees, units may includeaward of contract, selection andqualification approval of suppliers.

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    KEY PRINCIPLES OF GOOD DRUGPROCUREMENT CONTD

    Product Quality Assurance program :

    Establish and maintain a formal system forProduct Quality Assurance this includes

    - QA product certification,

    - Inspection,

    - Targeted laboratory test and

    - Report of suspected products.

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    KEY PRINCIPLES OF GOOD DRUGPROCUREMENT CONTD

    Annual audit with published results :

    Conduct annual audit to access compliancewith procedure

    Regular reporting of procurementperformance indicator

    - Report key procurement performance

    indicator against targets at least annually

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    DRUG PROCUREMENT

    Failure or Success of a drug procurement dependon:

    Procurement method chosen and how it fits into

    the prevailing circumstances The Adequacy of Specification of Contract

    Terms

    The Caliber and Performance of Suppliers

    selected

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    DRUG PROCUREMENT

    The Reliability of the supply

    Monitoring process &

    The Quality Assurance of drugs procured

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    CONSTRAINTS

    Lack of fund (including foreign exchange

    Absence of a Rational System ofProcurement with Good Selection &

    Quantification of Drug needs

    Lack of information on suppliers and prices,both finished and raw materials

    DISTRIBUTION

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    DISTRIBUTION

    A primary goal of drug distribution system is to

    deliver procured medicines and supplies to theclinics, hospitals, and centres that use them in atimely manner.

    Storage managers monitor expiration dates, inventory

    levels, and storage conditions such as light,temperature, and sanitation.

    When distribution systems function well and aresupported by good procurement practices, patientsare more likely to receive the medicines they need,on time, and in good condition.

    DISTRIBUTION

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    DISTRIBUTION

    Storage & distribution costs are a

    significant component of a healthbudget

    Transportation cost can represent

    several times the value of drugsdistributed to remote locations

    Effective drug distribution relies ongood system design & goodmanagement

    Well-designed & well managed

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    Well designed & well managedDistribution system

    Well-designed & well managed Distribution system is

    cost effective & should

    Maintain a constant supply of drugs

    Keep drugs in good condition throughout the distributionprocess

    Minimise drug losses due to spoilage & expiry

    Rationalise drug storage points

    Use available transportation resources efficiently Reduce theft & fraud

    Provide information for forcasting drug need

    DISTRIBUTION CYCLE

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    DISTRIBUTION CYCLE

    Port/Custom Clearing

    Receipt & Inspection Control

    Inventory Control

    Storage

    Requisition of supplies

    Drug Delivery to Depots and Health Facilities

    Dispensing to patients

    Reporting Consumption

    USE

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    USE RUD requires that the patient receive drugs appropriate to their

    clinical needs in Correct doses, dosage forms & frequency for

    adequate period of time at the lowest cost to them & theircommunity.

    The prescriber, the dispenser, and the patient must each

    understand their role in treating the illness.

    The RUD is also supported through the development and useof national and institution-specific treatment guidelines, drugutilization reviews, drug information services, and drug andtherapeutic committees.

    Irrational Use of drugs occurs with polypharmacy, use of wrongor ineffective drugs, underuse or incorrect use of effective drugs

    Rational Use of Drugs

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    Rational Use of Drugs

    RUD involves the following Criteria

    Correct Drug

    Appropriate indication

    Appropriate drug (efficacy, safety, suitability, cost)

    Appropriate dosage, administration, & duration

    Appropriate patient (No contraindication, minimal ADR)

    Correct dispensing with appropriate information

    Patient adherence to treatment

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    Management Support

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    Management Support

    Management support reinforces each component of

    drug management and unifies the framework. The entire drug management system depends on

    effective integration and management of financesand budgets, maintenance of accurate, useful, and

    up-to-date information systems, identification andmotivation of capable staff, and the institution ofmonitoring and evaluation systems.

    The expertise and organizational structure

    provided through management support is critical ateach stage of the pharmaceutical managementframework.

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    DRUG MANAGEMENT CYCLE

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    DRUG MANAGEMENT CYCLE

    Selection

    Use Procurement

    Distribution

    ManagementSupport

    OrganizationFinancing

    Information Management

    Human Resources

    Policy and Legal Framework

    COMPONENTS OF DRUG

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    COMPONENTS OF DRUGMANAGEMENT CONTD

    Each component of the framework depends on the success ofthe previous component

    and contributes to the viability of the next.

    Each component plays in a role in getting medicines to thepeople who need

    them

    These components are interwoven performing themindependently or disjointedly and not as part of a system may

    lead to

    A rise in costs, Inevitable drug shortages &

    Patients dissatisfaction

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    CONCLUSION

    Effective drug management is a collaborationprocess between the procurement office withregistered staff and appropriate managementsystem including technical and policycommittees, which make final decisions asto:

    Which drug to buyWhat quantities to buyHow do we buy

    When do we buyFrom which supplier

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    CONCLUSION CONTD

    Key consideration for FinancialSustainability is Essential and thisincludes:

    Access to funds for drug purchaseincluding foreign exchange forinternational procurement

    Support for procurement office Reliable payment mechanism

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    CONCLUSION CONTD

    Accessibility to health facilities,

    The presence of qualified staff and

    The availability of pharmaceutical products are

    important components of an effectivehealth care system.

    It is recognized that well trained human resource isvery valuable in any health services system with

    evidence showing a direct and positive causal linkbetween the health work-force and health outcomes.

    CONCLUSION CONTD

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    Inadequate human resources provide majorimpediments to many global health initiatives anddeveloping a strong workforce is vital in ensuringsuccessful implementation of health related initiatives

    Conducting trainings, workshops for health workers

    on Pharmaceutical supply management is thereforevery important. Perhaps this is one of the majorinterventions that can address the stock outs of

    medicines, expiries and other logistical problems.

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    THANK YOU