Professional Documents
Culture Documents
Drug Supply
Drug Supply
Drug Supply
Learning Objectives
• After completing this unit students are expected
to:
Define drug and medical supplies management
Identify the reasons why drugs need management
Identify common problems in drug supply
management
Identify the importance of drug and medical supplies
management
Introduction
Psycho therapy
Physiotherapy
Radiation
3
Intro….
4
Intro….
Most leading causes of death and disability (mortality and
morbidity) in developing and developed countries can be
prevented, treated or at least alleviated with cost effective
essential drugs.
6
Definition cont…
• MEDICAL SUPPLY
– Any article that may be used on the inner or outer
part of the body for diagnosis or treatment of a
disease in man or animal.
• Examples
– suturing materials, syringes & needles, bandages,
gauze, cotton & other similar articles, artificial
teeth, chemicals and x-ray films.
7
Definition cont…
• MEDICAL INSTRUMENT
15
The problem results
The problems enumerated above have resulted in:
Availability of unwanted drug products
Chronic and wide-speared shortage of highly needed
drugs.
Over-stock of unwanted as well as needed drugs
Irrational budgetary constraints.
Occurrence of drug related hazards such as
developing of bacterial resistance,
serious adverse effects.
Poor forecasting of drug budget for the coming year and
poor utilization and control of drug budget over year. 16
Importance Of Drug And Medical Supplies
Management
• It helps to:
– Achieve financial sustainability that increases
availability while ensuring equity.
– Improve efficiency in public drug supply.
– Change the behavior of providers, patients and
the public to promote rational use of drugs.
– Improve the availability, affordability and rational
use of drugs in the private sector.
– Regulate safety, efficiency and quality through
legislation and regulations.
17
Concept of
Essential Medicines
Definition
“Essential medicines are those that satisfy
the priority health care needs of the
population.”(WHO 1999)
• Should be available at all times, in adequate
amounts, in appropriate dosage forms and
at a price the individual and the community
can afford.
19
Importance of the EMs concept
Central to a NDP
– Promotes equity and helps to set priorities for the
health care system.
20
Principles of the EMs concept
21
Principles of the EMs concept…
22
Advantages of a limited list of EMs
Supply
Easy procurement, storage and distribution
Lower stocks
Easier dispensing
23
Advantage… cont’d
Cost
Lower prices
More competition
24
Advantage… cont’d
Prescribing
Training more focused and therefore easier
More experience with fewer medicines
No irrational treatment alternatives
available
Focused drug information
Better recognition of adverse drug
reactions
25
Advantage… cont’d
Patient use
26
Objectives of EM program
28
The formulary list (EML)
A list of drugs approved for use in specific
health care setting.
It is good if it is localized
29
Formulary manual
Drug centered
30
Standard treatment guidelines/STGs
Disease centered
– Common disease and complaints, treatment
alternatives.
31
Development and Implementation of
EML
32
Criteria for the Selection of Essential Drugs:
Benefit/risk ratio 33
Criteria…
Single CPDs
• Fixed ratio combinations are only acceptable if:
34
Criteria…
When two or more drugs are therapeutically
equivalent, preference should be given to drugs:
35
Approaches to Developing EMLs
37
3. Develop policies and guidelines for
implementation
Should include:
39
How EML, formularies, and STGs are Developed?
Treatment choice
Prevention
and care
40
Maintaining a formulary list
41
National Drug Policy
Definition
NDP is a commitment to a goal and a guide
for action.
43
Why is NDP needed?
45
Objectives of NDP
The general health related objectives are to ensure:
– Access/equitable availability & affordability of
EMs
– Quality/ the quality, safety & efficacy of all
medicines
– Rational use/ the promotion of therapeutically
sound and cost-effective use of drugs.
46
National drug policy
Other Goals of NDP include:
– Economic related goals
• Reduce foreign exchange for p’cal import
• Provide jobs (dispensing, production...)
– National development goal
• Develop national p’cal production
• Take a stand on intellectual property rights
47
Key components of a national drug policy
48
Key components ...cont’d
49
Key components ...cont’d
• Affordability
– Reduction of drug taxes, tariffs and
distribution margins; pricing policy;
– For multi-source products:
• Promotion of competition through
generic policies, generic substitution and
good procurement practices;
– For single-source products:
• Price negotiations
• Therapeutic substitution
50
Key components ...cont’d
• Drug financing
– Commitment to measures to improve efficiency and
reduce waste;
– Increased government funding for priority diseases,
and the poor and disadvantaged;
– Use of and limits of development loans for drug
financing;
– Guidelines for drug donations.
51
Key components ...cont’d
Supply systems
– Public–private mix in drug supply and distribution
systems;
– commitment to good pharmaceutical
procurement practices in the public sector
– Publication of price information on raw materials
and finished products;
– Inventory control, and prevention of theft and
waste;
– Disposal of unwanted or expired drugs.
52
Key components ...cont’d
53
Key components ...cont’d
54
Key components ...cont’d
• Rational use
– Development of evidence-based clinical
guidelines, as the basis for:
Training
Prescribing
Drug utilization review
Drug supply and
Drug reimbursement
55
Key components ...cont’d
56
Key components ...cont’d
• Research
– Operational research in:
Drug access, quality and rational use
57
Key components ...cont’d
59
Drug management
cycle
Learning objectives
• After completing this topic students are
expected to:
– Define Drug selection, quantification,
procurement, distribution and use
– Describe the basic steps and criteria in drug
selection
– Describe the methods of quantification
Introduction
• Drug management functions are undertaken in four
principal phases.
– Drug selection and quantification
– Procurement
– Storage and distribution
– Drug use
• Which are interlinked and are reinforced by
appropriate management support systems.
• A whole range of management capacities are
required and necessitate using the appropriate tools
within a given legal and policy framework.
The drug mgt cycle
Flow of supply activity
Selection
Drug
Distribution
• It is a process of
determining the amount
of drug products required.
I.e. Quantification
involves estimating the
quantities of specific
drugs needed for
procurement
Drug Quantification…
Advantages of drug quantification
Proper drug quantification avoids
over stock and
stock out of drugs
Promotes
Safe
effective and
economic use of drugs and increase drug
coverage.
Quantifying Drug Requirements
85
1. Consumption method
– Uses records of past consumption of
individual drugs to project future needs.
Preferred when:
Accurate consumption data are available
Drug supplies are adequate
Stock mgt is reasonably good, and wastage
and losses are not excessive.
86
Advantages
87
Disadvantages
88
2. Morbidity method
89
More appropriate when:
90
Advantages
91
3. Adjusted consumption method
93
Symptoms of Poor Quantification
94
Poor Quantification..
by prescribers or by patients 95
Poor Quantification..
96
Poor Quantification..
97
Steps in the
quantification
98
Consumption Method
1. Prepare a list of drugs to be quantified
2. Determine the period of time to be reviewed for
consumption
3. Enter consumption data for each drug
99
Calculate the consumption of each drug
100
2. Calculation from stock records, using one of the
following methods:
101
Example 1
• Lidocaine (Injectable) 1% 50 ml vials. If the
stock at 1st January was 20 vials, drugs
received during the year were 60 and 70 vials
and the stock at 31 December 30 vials, then
the consumption is calculated as follows:
• Consumption = 20 + (60 + 70) - 30 = 120 vials
102
Adjust consumption for stock-outs if necessary
103
Example 2:
• If recorded consumption is 80,000 tablets for
paracetamol and 1 month effectively out of stock,
with Calculation period of 12 months.
104
4. Calculate the average monthly consumption
Calculated as follows:
CA= CT ÷ [RM - (Dos ÷30.5)]
105
Example 3
• Consider the entry for Antihistamine
decongestant any strength of tablet. The total
consumption for a six-month review period
was 50,000 tablets. The drug was out of stock
for thirty-four days in the six-month period.
Therefore the average monthly consumption
is:
107
Example 4
SS=CA x LT
108
6. Calculate the quantity of each drug
required in the next procurement period
QO = CA x (LT+PP) + SS - (Si+SO)
= 10,235 x (3+6) + 30,705 – (345 + 62,500)
= 122,820 – 62,845 = 59,975
110
7. Adjust for expected changes in consumption
111
8. Adjust for losses
Quantification estimates should be adjusted to
allow for losses, in order to avoid stock outs.
9. Compile decentralized quantification
In a decentralized quantification, staff at each facility
or storage point enters their own consumption
quantities and stock out information
– Estimates of the individual facilities are totaled
and compiled on the master quantification list.
112
10. Estimating the cost of the Drug
Quantities Required
113
11. Compare total costs with budget and
make adjustment
114
Exercise
• The following information is taken from bin card of
Paracetamole 500mg tab.
• If the average lead time for paracitamol is 2months,
procurement period is 6 month and there is no stock
now on order .
Calculate:
• Average monthly consumption
• Safety stock
• Calculate the quantity of paracitamol required in the
next procurement period
Date Received Receive Qty Issued Qty Balance Remark
from/Issued to
30/03/11E.C Dispensary 50 0
30/06/11E.C Dispensary 50 50
Morbidity Method
Requires:
A list of common health problems
List of drugs for the problems and
A set of standard treatment
117
Steps of Quantification using morbidity
method
– Prepare Average Standard Treatment Schedules
(ASTS)
– Estimate number of Treatment Episodes for each
Health Problem
– Calculate total quantity of each drug(s) required
– Estimate the cost of the drug quantities required
– Prepare Annual Drug Budget
– Reconcile drug quantities to budget/fund
– Estimate the cost of drug quantities required
Steps
QE = DCU X ND X LD = 100ml
120
4. Estimate number of treatment Episodes for each health problem
122
5. Calculate total quantity of each drug(s)
QT=ET X QE X PT
QT= Total quantity of each drug, ET = The projected
number of t/t episodes, QE = Quantity of drugs for
each treatment episode and PT = the percentage of
cases that are expected to be treated
123
Example 3: If 90 % of patients under 5 with otitis
media are expected to be treated with
cotrimoxazole suspension. Calculate the
quantity of cotrimoxazole suspension needed
to treat otitis media.
347,634 x 100mL x 0.9= 31,287,060
124
6. Combine the estimates for each drug from the various
health problems into a master procurement list
125
7. Adjust Quantities to cover other health
problems
127
9. Adjust quantities for expected losses
129
Example
Metronidazole Amoebiasis
250mg capsule
- Adults 600 45 27,000
capsules caps.
- Children 400 6 capsules 2,400
caps.
Giardiasis 1000 15 15,000
capsules caps.
Trichomoniasis 1000 8 capsules 8,000
caps.
Total Metronidazole 250 mg capsule 52,400cap
s.
Adjusted consumption method
135
• This method is used when:
137
2. Develop the drug list
Same as the consumption method.
138
4. Review records from the standard system
139
5. Establish the Denominator for Extrapolation
140
6. Determine the consumption rate in the standard system
142
7. Extrapolate the standard system’s consumption rate to the target system
143
Example 2: If there is 80,000 inhabitants in example 1
above and unknown outpatient contacts in the target
system, then calculate the projected requirement in
the target system.
2.38 x 80,000 inhabitants
=190,400 capsules
144
8. Adjust for expected losses
145
9. Estimate costs for each drug and total costs and make adjustments
146
Service level projection of budget
requirements
Used to estimate financial requirements based on
costs
Information needed
147
Steps
1. Establish the categories of facilities and
determine the number in each
category .
149
Managing Procurement
02/20/2024
Introduction
• The pharmaceutical procurement system is a
major determinate of pharmaceutical
availability and total pharmaceutical costs.
• In most developing countries, pharmaceutical
purchase represent the single largest health
expenditure after personnel cost.
• Pharmaceuticals also consume the major share
of health related foreign currency exchange.
151
Introduction…
• Therefore, pharmaceutical procurement is a
complex process which involves many steps,
agencies, ministries and manufacturers.
152
An effective procurement process should
• Bid
– A written offer for a quantity of goods, works, or
services, at a stated price; based on technical
specifications and other terms and conditions.
02/20/2024
Terms ….
• Procurement
– The process of acquiring supplies from private or public
supplier or through purchasing from manufacturer or
agencies or bilateral aids program.
– The decision making process you follow when you
buy products or services; you usually have many options.
• Purchasing
– Subset of procurement
– Refers to buying goods or services, receiving and making
payments.
02/20/2024
Procurement ….cont’d
• Product selection and quantification
– Submit to the procurement unit to obtain the correct
quantities of the correct products from international,
regional, or local marketplaces.
• Specifications
– Mechanism of protecting populations against counterfeit
or substandard products;
– Ensure proper labeling, protection or storage, and
shipment.
02/20/2024
Assessment and Selection of
Procurement Options
• Pharmaceutical procurement methods ,at any
level of a health system, generally fall in to a
few basic categories ; open tender, restricted
tender, competitive negotiation and direct
procurement.
• Each of theses methods can be used with any of
the standard reorder frequency models-
annual, scheduled, or perpetual review- given
the right sort of procurement contact.
02/20/2024
Assessment and Selection of
Procurement Options
• Open tender
– Is a formal procedure by which quotations are invited
from any suppliers on a local or worldwide basis,
subjects to the terms and conditions specified in the
tender invitation
– The preferred procedure of procurement.
– A method other than open bidding is used only
where conditions for use of other method are
satisfied.
02/20/2024
Procurement methods
• Restricted tendering
– Interested suppliers must be approved in
advance (prequalification process)
– e.g Adhering to GMP, past supply
performance, financial viability and related
factor
– The pre qualification process is often open
for any supplier that wishes to apply
02/20/2024
Procurement methods
02/20/2024
Procurement methods
• Direct Procurement
– is when the purchaser establishes direct
contact with suppliers or their representatives.
– Simplest, most expensive method of
procurement
– For single source drugs
• negotiated or direct procurement
• selection of alternative drugs
02/20/2024
Procurement methods…
• Conditions for Direct Procurement
– In absence of competitions
• provided only by one candidate
– For additional deliveries of goods by the original
supplier
• Replacement , or as the extension of existing
supplies,
– Additional works, which have been not included in the
initial contract
– During emergency
02/20/2024
Procurement Methods
tendering
02/20/2024
• Reverse auction
02/20/2024
Factors influencing pharmaceutical prices
and total costs
1. Unit price
– Competition among supplier
• number of products and generic version
– The ‘’Rule of five’’ in pharmaceutical pricing says that in
general the lowest competitive prices are available when five
or more generic alternatives for a particular product are
available or when, in a tender ,there are at least five bids per
item ( WHO1999).
• Gov’t policy
– registration, licensing, prescribing, dispensing
• Procurement method
02/20/2024
Factors …
2. Reorder frequency and the total
cost of pharmaceutical purchasing
– Total cost = Drug acquisition price + inventory
holding cost + purchase operating cost + shortage
cost( extra costs incurred when stock outs occur)
02/20/2024
Factors …
– For each country's situation, total purchasing
costs can be minimized by choosing the
optimal reorder frequency model.
02/20/2024
Factors …
3. Visible and hidden costs
• The total procurement cost has four component;
– Drug acquisition price
– Inventory holding cost
– Purchase operating cost and
– shortage cost
• Some of these costs are visible to managers- the
total expenditure for pharmaceutical acquisition or
the salaries of procurement staff.
02/20/2024
Factors …
• However the cost associated with shortages and poor
supplier performance are not so obvious; hidden costs
associated with poor performance by the supplier or the
procurement office include-
• Increased acquisition cost due to emergency procurement
• Replacement cost
• Storage ,port charges and administrative expenses
• Health and economic costs of stock outs resulting from
delay or default on delivery
• Total cost= Hidden cost + visible cost
02/20/2024
02/20/2024
International Commercial Terms, Payment
Modalities and Documents used
• INCOTERMS
Transport:
• FAS - Free Alongside Ship
20/02/2024
INCOTERMS…cont’d
20/02/2024
INCOTERMS…cont’d
Transportation:
• EXW - Ex Works
– Seller delivers (without loading) the goods at disposal
export violations.
INCOTERMS…cont’d
02/20/2024
INCOTERMS…cont’d
02/20/2024
INCOTERMS…cont’d
seller.
02/20/2024
• The only difference between Incoterms
DDP and DAP is that in DDP all costs and taxes
of import clearance are paid by the seller
while inDAP are paid by the buyer.
INCOTERMS 2000 – Risk Snapshot
196
Role of Banks (Commercial /National)
Buyer 1. Contract 1. Am I going to get the goods? (in good condition / in time)
Wants fulfillment. 2. Does the settlement method safeguard these risks?
2. Convenience. 3. Before we pay—how to check the goods are exactly those
3. Credit. ordered?
4. Advice and 4. Any credit terms available Prefers to delay paying for the
assistance goods until they are sold.
5. From where can I get information on the exporter’s
creditability
198
Role of Banks (Commercial / National)
Basic agreement (International Trade – Sale Contract)
1. Preliminary Quotation & Commitment (Invoicing / order etc)
2. The Merchandise (goods to be imported / exported)
3. Packing (instructions regarding packing of imported /
exported merchandise)
4. Method of Settlement (Immediate or Credit /
Advance / LC Collection???)
5. Shipping Instructions (trans shipment – partial shipment etc)
6. Price and its components (INCOTERMS 2010)
7. Delivery Mode ,Period, Place (Sea, Air, Road – place of
shipment and last date of shipment)
8. Documents (Invoice, packing list, inspection report,
certificate of origin, etc)
199
Making and Receiving Payment Internationally :
International Payment Instruments
Importer
Clean Payments
How does a Payment in Advance transaction work?
PAYMENT IN ADVANCE:
The Importer sends Exporter
payment directly to the
Exporter and waits for the
Exporter to send the
GOODS PAYMENT
goods and documents. 2 1
Importer
Documentary Collections
What is a Documentary Collection?
» Flow of Goods
» Flow of Documents
» Flow of Payment
Documentary Collections:
Flow of Documents
• After the goods are shipped, documents originating with the
Exporter (e.g. commercial invoice) and the transport company
(e.g. bill of lading) are delivered to a bank, called the Remitting
Bank in the Collection process.
• The role of the Remitting Bank is to send these documents
accompanied by a Collection Instruction giving complete and
precise instructions to a bank in the Importer’s country, referred
to as the Collecting/ Presenting Bank in the Collection process.
• The Collecting/ Presenting Bank acts in accordance with the
instructions given in the Collection Instruction and releases the
documents to the Importer against payment or acceptance,
according to the Remitting Bank’s Collection instructions.
Documentary Collections:
Flow of Documents
2
Documents
Exporter/
Remitting
Drawer
Bank
1
Documents
3
GOODS
Documents
4
Importer/ Collecting/
Drawee Presenting Bank
Documentary Collections:
Flow of Payment
4
Payment is forwarded
Exporter/ Remitting
to the Remitting Bank Drawer Bank
for the Exporter’s
account. And the
3
Importer can now
present the transport GOODS
document* to the 1
carrier in exchange for
the goods.
Documents
Importer/ Presenting/
Drawee 2 Collecting Bank
• A letter of Credit
• Is a written undertaking by the Importer’s
bank, known as the Issuing Bank, on behalf of
its customer, the Importer (Applicant),
promising to effect payment in favor of the
Exporter (Beneficiary) up to a stated sum of
money, within a prescribed time limit and
against stipulated documents.
• A key principle underlying Letters of Credit is
that banks deal only in documents and
not in goods.
02/20/2024
A letter of Credit…
02/20/2024
Letters of Credit
How does a Letter of Credit work?
The mechanics of a Letter of Credit are easily
understood when separated into the following
three steps:
» Issuance
» Flow of Goods
» Flow of Documents & Payment
Letters of Credit:
Issuance
After the trading parties agree on a sale 4
of goods where payment is made by
Advice
Letter of Credit, the Importer requests
/Confirmation
that its bank (the Issuing Bank) issue a Exporter/ of the Letter of Advising/
Letter of Credit in favour of the Beneficiary Credit. Confirming Bank
Exporter (Beneficiary).
The Issuing Bank then sends the Letter
of Credit to the Advising Bank. A
Request to advise
request may be included for the Contract
& possibly
Advising Bank to add its confirmation. Negotiations confirm the
The Advising Bank is usually located in 1 Letter of Credit
3
the country where the Exporter does
business and may be the Exporter’s
Importer applies for
bank, but does not have to be. Letter of Credit.
Next, the Advising/Confirming Bank
verifies the Letter of Credit for
Importer/ 2
authenticity and sends it to the Issuing Bank
Exporter.
Applicant
Note: For the purpose of the Crash Course, the Advising Bank is
also acting as the Confirming Bank. However, the roles of
advising and confirmingthe Letter of Credit may be performed
by two separate banks.
Letters of Credit:
Flow of Goods
Importer/Applicant
Letters of Credit:
Flow of Documents & Payment
3
After the goods are shipped, the
Exporter presents the
documents specified in the Documents
Letter of Credit to the Advising/ Exporter/ 2 Advising/
Beneficiary Confirming Bank
Confirming Bank.
Once the documents are 4
checked and found to comply
Documents
5
with the Letter of Credit (i.e.
without discrepancies), the GOODS
Advising/ Confirming Bank 1
forwards these documents to
the Issuing Bank. The drawing is
negotiated, paid or accepted as
the case may be.
Importer/
Issuing Bank
Applicant
Letters of Credit:
Flow of Documents & Payment
3
In turn, the Issuing Bank
examines the documents to
ensure they comply with the Exporter/ Documents
Advising/
Letter of Credit. If the 2
Beneficiary Confirming Bank
documents are in order, the
Issuing Bank will obtain 4
payment from the Importer for
Documents
5
payment already made to the
GOODS
Confirming Bank.
1
Documents are delivered to the
Importer to allow it to take 7
Documents
possession of the goods.
Importer/
6 Issuing Bank
Applicant
Quality Assurance for Drug
Procurement
• Drug quality
• Quality of the final drug product is determined
– Raw material (ingredient)
– Equipment
– Technical knowhow
– Packaging
– storage
• Defining assessing drug quality
– Establish quality standards:
• e.g. BP, USP, EP,IP
– Identity, Purity:, Uniformity of dosage form,
Bioavailability: Bioequivalent, Stability etc
02/20/2024 219
Quality Assurance for Drug Procurement
02/20/2024 220
Quality Assurance …
• Practical approaches to quality assurance
– Careful product selection
• Powders for reconstitution instead of
injectable liquids
• Powders for reconstitution instead of oral
suspensions
• Tablets instead of capsules
– Careful supplier selection
• Certification, supplier reliability, product quality
• inspecting product sample
02/20/2024 221
Quality Assurance …
– Certification of good manufacturing practice
• GMP certificate
– Batch certification
– Inclusion of detailed specification in the contract
• Name of the pharmacopeia reference standard
to assess drug quality
• Language for the product label
• Minimum information required on the label
• Additional information such as product
registration
• Standard for packaging
– Withstand storage and transport conditions
02/20/2024 222
Quality Assurance …
02/20/2024 223
Quality Assurance …
• Procedures to monitor and maintain the quality of drug
– Proper storage and distribution procedures
– Appropriate dispensing
– Instructions to the patient on proper use of
medications
– Product defect reporting programs
02/20/2024 224
Drug Donation
• Disaster and suffering
– Donation of medicines
– The drugs are often not registered for use in the recipient country
02/20/2024 225
Drug Donation
– The drugs that arrive are frequently unsorted,
administrative procedures.
02/20/2024
unannounced. 229
TERMS AND CONDITIONS OF AGREEMENT
DONATION IN ETHIOPIA
1) Products should have minimum 50% of its
shelf life on arrival at Addis Ababa/port of
entry.
2) No drugs should be donated:
– That have been issued to patents and then
returned to a pharmacy or elsewhere.
– That were given to health professionals as free
samples.
– That were collected from any where, repacked
and relabeled
230
AGREEMENT DONATION IN ETHIOPIA…..
231
5) The label of the immediate container should at
least include:-
– The name of the product, brand and Generic/INN
– Pharmaceutical dosage form and route of
administration
– Composition of active ingredient(s)
– Quantity in container, Technical directions for use
– Handling and storage requirements
– Batch number, manufacturing and expiry dates
– Name and address of the manufacturer
232
6) Accompanying invoice should be as per the purchase
order including Batch number, manufacturing and
expiry date of each item.
7) Every product should be accompanied by a leaflet in its
immediate container, a leaflet must bear adequate
information for use and it should at least include:
– The name of the product; brand and generic /INN
– Description appearance, pharmaceutical dosage form and
route of administration
– Qualitative and quantitative composition of active
ingredients
– Clinical Pharmacology, indication(s), warnings, precautions,
contraindications, adverse reactions/side effects
– Dosage and administration (directions for use)
– Over dosage, storage instruction, package quantity, Name
233
and address of manufacturer
Good Procurement Practice
• Good Procurement Practice
– Generic name
– Limited to EML list or formulary list
– Bulk purchases
– Formal supplier qualification and monitoring
– Competitive bidding process
– Commitment to a sole source
– Order quantities based on reliable estimate of actual need
– Reliable payment and good financial management
– Transparency and written procedures
– Separation of key functions
– Product quality assurance program
– Annual audit with published results
– Regular reporting on performance
02/20/2024 234
Storage and distribution
02/20/2024 235
Medical Stores Management
02/20/2024 236
The Objectives of Good Medical Stores
Management
• To guarantee a continuous supply
distribution process.
02/20/2024 237
Key storage activities
• Material receiving and incoming inspection
– visual inspection
• Damaged, quantities
• Put away
– move products from the unloading dock to their
designated storage area.
02/20/2024 238
Key storage activities…….cont’d
• Picking and packing
– Products must be located, pulled from inventory,
and prepared for shipment.
• Shipping
– Check the list of products and their quantities
– Appropriate vehicle
02/20/2024 239
Key storage activities…….cont’d
02/20/2024 240
Good storage practices
02/20/2024 241
Good storage practices
• Clean and disinfect storeroom regularly
– Rodents and insects
– Avoid food and drink
• Store supplies in a dry, well-lit, well-
ventilated storeroom out of direct sunlight.
– extreme heat and exposure
– E.g Latex condom (> 40 Co )
– air conditioning
– ceiling fans and forced ventilation.
– Avoid direct sunlight( dark colored or opaque
bottle
02/20/2024 242
Vaccines vial monitoring
02/20/2024 243
Storage Guidelines……….cont’d
• Secure storeroom from water penetration.
– Destroy supplies and packaging
– Repair leaky roofs and windows
– Use dehumidifiers
– Stack supplies off the floor on pallets
• 10 cm high and 30 cm away from walls
02/20/2024 244
Storage Guidelines……….cont’d
02/20/2024 245
Storage Guidelines……….cont’d
• Ensure that fire safety equipment is available and
accessible and personnel are trained to use it.
02/20/2024 246
Storage Guidelines……….cont’d
– fire extinguishers
– water douses wood and paper fires
– use buckets of sand
– Train staff in the use of the available fire safety
equipment
– Flammables
• Must be stored in special buildings or rooms.
• well ventilated and fireproof.
02/20/2024 247
How to use fire extinguisher???
02/20/2024 248
Storage Guidelines……….cont’d
• Maintain cold storage, including a cold
chain, for commodities that require it.
– Ex. Insulin, Oxytocin, vaccines
– Damage if the cold chain is broken
– Refrigeration (electric or kerosene powered)
– Cold boxes or insulated coolers
02/20/2024 249
Storage Guidelines……….cont’d
• Keep narcotics and other controlled substances in a
locked place.
– Dangerous when misused
– Stolen for sale on the black market
– Limit access to the storeroom
– Track the movement of products.
– Physical inventories
02/20/2024 250
Storage Guidelines……….cont’d
• Store flammable products separately from other
products.
– bottled gas or kerosene powers
– Refrigerators
– Alcohol
– Bunsen burner
– Fire extinguisher.
02/20/2024 251
Storage Guidelines……….cont’d
• Stack cartons at least 10 cm off the floor, 30 cm
away from the walls and other stacks, and not more
than 2.5 m high.
02/20/2024 253
Block-Stacked Pallets
02/20/2024 254
Pallet racking
02/20/2024 255
Shelves
02/20/2024 256
Storage Guidelines……….cont’d
– Reduce space
• Security
02/20/2024 259
Zoning Stocks within the Stores
02/20/2024 260
• If no specific storage instructions are given,
“normal storage conditions” apply.
02/20/2024 261
• Cold Storage
• Secure Storage
– Narcotics and other controlled substances
– Ideally a red warning light or warning bell that will
activate when the door is unlocked should be fixed
close to the store.
02/20/2024 262
• Flammables
02/20/2024 263
Storage of vaccines
• All vaccines and diluents must be stored in the
refrigerator for short term between 2°C and 8°C in a
pharmacy that issues to the end- user or clinics.
• For long terms storage -20°C is preferred only for
BCG, OPV and measles.
• Do not freeze other vaccines.
• Domestic refrigerator, ice lined refrigerator are used
for short term storage and deep freezer for long term
storage.
264
Potency & temperature for storage vaccines
265
266
• Always have enough frozen icepacks to
transport items requiring cold storage in cold
boxes and /or vaccine carries.
• Use only icepacks filled with water.
267
• If there is enough space, place a few plastic
bottles of water in the refrigerator.
– Help to maintain the temperature for a longer
period of time if the power is cut off.
269
• National and regional vaccine stores should be
equipped with standby generators; ideally,
district vaccine stores should have them as
well.
270
Stock Location within a Zone
– fluid or
– semi-fluid locations
02/20/2024 271
Fixed location
02/20/2024 272
Fluid Location
02/20/2024 273
Semi-fluid Location
02/20/2024 274
Stock Classification
02/20/2024 275
Therapeutic or pharmacological category
02/20/2024 276
Clinical indication
02/20/2024 277
Alphabetical order
02/20/2024 278
Level of use
02/20/2024 279
Dosage form
02/20/2024 280
Random bin
02/20/2024 281
Commodity code
• Based on a unique article code combined with a
unique location code.
• Offers maximum flexibility
• Can be used equally well in small and large stores
• Can be used in any kind of stock location system
• The first 4 methods may become inappropriate…
02/20/2024 282
PHARMACEUTICAL
DISTRIBUTION
Managing distribution
Importation and port clearing
Medical store mgt
02/20/2024 283
Managing distribution
02/20/2024 3
Objective
02/20/2024 4
A well run PD system can help to:
– Maintain a constant supply of drugs
Consumpti Inventor
on y
Reporting Control
Dispensin
Storag
g to
e
patients
Deliver
Requisition
y of Supplies
02/20/2024 5
1. Drug procurement
– process of acquiring supplies from public or
private suppliers.
2. Port Clearing
– involves:
• processing shipments as soon as they arrive in port
• storing drugs properly until they leave the port
• surveying the shipment for losses & signs of damage and
• collecting the drugs as soon as they have been cleared
02/20/2024 6
3. Receipt and inspection
02/20/2024 7
4. Inventory control
02/20/2024 8
5. Storage
02/20/2024 291
6.Requisition of supplies
02/20/2024 9
7. Dispensing to patients
– The distribution process achieves its purpose
when drugs reach hospital wards, outpatient
clinics, health centers or community health
workers and are appropriately prescribed and
dispensed to patients
02/20/2024 293
8. Consumption Reporting
– The closing link in the distribution cycle
02/20/2024 10
Pharmaceutical Distribution system Design
CMS Key
S suppier
RS RS CMS central medical stores
RS regional store
DS HOSP DS HOSP DS Distric store
HOSP hospital
HC health center
HC HC
HC HC
02/20/2024 296
Push system Vs. Pull system
Push system
– Also known as an allocation or ration system
Pull system
– Also called an independent demand or a
requisition system
02/20/2024 297
Conditions favoring a push system
– Lower level staff are not competent in inventory
control
02/20/2024 299
Resupply intervals
02/20/2024 301
Delivery schedules
Good planning is needed to ensure that each facility
receives supplies regularly and on time.
Points to be considered:
Storage capacity of primary, intermediate and health
facility stores,
Increased transport costs per units supplied for
deliveries to small, remote facilities
Efficient vehicle usage,
climatic factors.
02/20/2024 302
Inventory Management
02/20/2024 303
Inventory Management
• Purpose of an Inventory Control System
– To determine when stock should be ordered/issued
system
– prevents shortages, oversupply, and expiry of
pharmaceuticals
02/20/2024 304
Issues to be considered…….cont’d
Selection of items to be stocked as
standard items
Reason to hold a stock
– To ensure availability
– To maintain confidence in the system
– To reduce the unit cost of medicine
– To avoid shortage cost
– To minimize ordering cost
– To minimize transport cost
– To allow fluctuation in demand
02/20/2024 305
Issues to be considered…….cont’d
02/20/2024 306
Issues to be considered…….cont’d
02/20/2024 307
Issues to be considered…….cont’d
Every
other 0.5
HC and
month 4 months 2 months months (=
Hospitals
2 wks)
0.25
Health
Monthly 2 months 1 months months
Posts
02/20/2024 310
(= 1 wk)
Types of Max-Min inventory Control
Systems
• Determining How Much to Order or Issue
• Stock Status
– Purpose of assessing stock status is to determine
how long supplies will last.
How much we have of a certain product = How long that product will last(in # of periods
How much we use during a given period
02/20/2024 311
Types of Max-Min………….cont’d
02/20/2024 312
Types of Max-Min………….cont’d
02/20/2024 313
Types of Max-Min………….cont’d
January 12 846
February 12 630
March 12 578
April 12 812
May 12 508
Balance of Chloroquine on hand February 30, 2015 is 756 tablets
02/20/2024 314
Types of Max-Min………….cont’d
02/20/2024 315
Types of Max-Min ICS
– Standard system
• end of the review period for the commodities that
02/20/2024 are at the minimum level. 316
Forced-ordering max-min system
02/20/2024 317
Forced-ordering max-min system
02/20/2024 318
Types of Max-Min ….
• Advantages of forced-ordering max-min
system
– rule for resupply is simple
• order/issue every item at the end of the period.
– easier to ensure the availability of transport
resources
• b/c orders are placed at regular intervals
– Every facility orders or is resupplied at the end
of every review period
– No need of storekeepers constantly assess
stock status, unless they think a potential
stockout is possible
02/20/2024 319
Types of Max-Min ….
02/20/2024 320
Types of Max-Min Inventory Control
Systems
• Forced –ordering variation: delivery truck
system
– also called a topping up or bread truck system
or Vendor Managed Inventory (VMI) system.
– difference b/n regular vs delivery truck forced-
ordering system
• the way the deliveries are made
• a truck is loaded with supplies at the end of the review
period.
• The truck and a delivery team travel to each facility
• assess the stock & leave (top up) an amount of
each product
02/20/2024 321
Types of Max-Min …
• Advantages of the forced-ordering
delivery truck system
– The order is filled on the spot
• the lead time is zero → lead time stock to
zero
• lowers the min and the max stock levels.
– Damaged or expired products can be put
back on the truck for disposal
02/20/2024 322
Advantages of the forced-ordering delivery truck
system
02/20/2024 326
Types of Max-Min Inventory Control
Systems
• Advantages of continuous review
max-min system
– rule for resupply is simple: reaching
minimum
– The system is more responsive and
flexible
• orders can be placed at any time.
– Small orders are eliminated
• stock levels are at the min when an order is
placed.
02/20/2024 327
Types of Max-Min Inventory Control
Systems
• Disadvantages of a continuous review
system
– Transportation resources are harder to schedule.
– Overload storekeepers in large facilities with a
large number of products
02/20/2024 328
Types of Max-Min ….
• Continuous review
system variation: two
bin
– Resupply rule is the same
– The difference
• the way of determining
when the min has been
reached.
– two equal-sized bins of
each individual product
– When the first bin is
empty, the min has been
reached.
02/20/2024 329
Types of Max-Min …
• Advantages continuous review system
variation: two bin.
– Require less training than a normal pull systems
• empty bin
– No calculations are required and paperwork is
minimal.
• Disadvantages:
– bin size must be continually reviewed
• If consumption for products is not stable
02/20/2024 330
Types of Max-Min …
• Standard max-min system
– Resupply (when to and how much to order) is
based on
• Reviewing all stock levels at the end of each
review period.
• Falling below the min
02/20/2024 331
Types of Max-Min …
• In a standard system—
– Ordering/issuing new stock is based on the min
stock level and the review period.
– The storekeeper must know the min, max, and
review period.
– An emergency order point is needed
• to ensure that a stock out does not occur
between review periods.
– The stock status must be assessed at the end
02/20/2024
of each review period 332
Types of Max-Min …
• Advantages of standard max-min
system
– Eliminate small orders
– Avoid the need to assess stock status
continually
– Reduce the number of calculations
– Transportation can be scheduled for specific
times
02/20/2024 333
Types of Max-Min …
• Disadvantages:
– Higher min stock level
• Increase the likelihood of expiry
• Increased costs.
02/20/2024 334
Distribution….cont’d
• Collection vs Delivery
• Transport
– Using private sector alternatives
– Evaluating fleet capacity
– Planning transport system improvements
– Acquiring and disposing vehicles
– Managing vehicle use
– Maintaining vehicles
– Maintaining medicines quality during transport
– Season or weather
02/20/2024 335
Health Care Waste Management
• Health care waste (HCW) products
02/20/2024 338
HCW transportation and disposal
02/20/2024 339
HCW transportation and disposal cont’d
– Encapsulation
– Incineration
02/20/2024 340
Rational Drug Use
02/20/2024 341
Drug Use- is a process of prescribing, Dispensing and
patient use of drugs.
02/20/2024 342
Rational drug use requires that patients
receive medications appropriate to their
clinical needs, in doses that meet their
individual requirements, for an adequate
period of time, and at the lowest possible cost
to them and their community (WHO).
02/20/2024 343
Components of RDU
02/20/2024 344
Irrational use of Drugs
– Inaccurate labeling
– Unsanitary procedures
– Improper packaging
02/20/2024 346
Irrational…cont’d
02/20/2024 347
Factors influencing the use of medicines
Prescriber,
Policy, legal and
dispenser and
regulatory
their
framework
workplaces
Client/patient Pharmaceutical
and community supply system
Rational
use of
medicines
02/20/2024 348
Client/patient and community
Patient-centred factors
– Demographic
– Psychosocial
– Patient-provider relationship
– Health literacy
– Patient knowledge
– Physical difficulties
– Forgetfulness
02/20/2024 349
Client/patient...cont’d
Therapy-related factors
• Route of administration
• Treatment complexity
• Duration of the treatment period
• Medication side effects
• Degree of behavioral change required
• Taste of the medication
• Requirements for drug storage
02/20/2024 350
Client/patient...cont’d
• Accessibility
• Long waiting time
• Difficulty in getting prescriptions filled
• Supplies
• Unhappy clinic visits
02/20/2024 351
Social and economic factors
• Inability to take time off work
• Cost and Income
• Social support
Disease factors
• Disease symptoms
• Severity of the disease
02/20/2024 352
Prescriber and dispenser
Training issues:
– Inappropriate role models
– Limited experience/training
02/20/2024 353
Prescriber and …cont’d
System flaws:
– Lack of unbiased, updated medicine information
or guidelines
– Lack of skill or conscientiousness by practitioners
– Unlicensed practitioners
– Lack of reporting or monitoring for ADRs
– Poor record-keeping
– Financial incentives
02/20/2024 354
Prescriber and …cont’d
02/20/2024 355
Workplaces
System flaws:
– Lack of a DTC
– Lack of SOPs
– No ADR monitoring and reporting system
– Pressure to prescribe and dispense
02/20/2024 356
Workplaces…cont’d
– Insufficient staffing
02/20/2024 358
Pharmaceutical supply system
– Medicine quality problems
– Unreliable suppliers
– Poor forecasting and poor
quantifications
– Inadequate inventory management
– Inadequate distribution system
02/20/2024 359
Pharmaceutical regulation
– Non formal prescribers/dispensers
– Lack of regulation enforcement
– Out-of-date or nonexistent STGs and
EDLs
– No DTC
– No pharmacovigilance program
02/20/2024 360
Strategies to improve use of medicines
02/20/2024 361
Tools to investigate
the use of
Medicicines
02/20/2024 362
• 4 main methods of measuring use of
medicines:
a. Aggregate data methods
02/20/2024 363
Stepwise approach to investigate the use of
medicines
02/20/2024 365
• Sources of aggregate data on drug use
Procurement records
Warehouse drug records
Pharmacy stock and dispensing records
Medication error records and
Adverse drug reaction (ADR) records.
02/20/2024 366
• Aggregate data sources can be used to obtain a
variety of information, for example:
– Cost of drugs used – individual drugs and drug
categories
– Which are the most expensive drugs? (ABC)
02/20/2024 368
Indicator study methods
• Use data which are collected at the
individual patient level
• Examples...
02/20/2024 369
STEP 2: In-depth investigation of specific
problems
02/20/2024 371
II. Qualitative methods
• Used to determine the causes of a drug use
problem
• Examples: focus group discussion, in-depth
interview, structured observation and structured
questionnaires are useful for identifying why
drug use problems occur.
02/20/2024 372
iii. Drug utilization review
• Is a system of ongoing criteria-based evaluation of
drug use.
• Involves the detailed analysis of individual patient
data
• Help to ensure appropriate use at the individual
patient level.
• Provide detail about the exact nature of the
irrational use.
02/20/2024 373
• Such details may concern incorrect medicine
choices, incorrect dose, prescribing drugs that
cause ADRs or drug interactions, and the use
of expensive drugs when cheaper ones would
do.
02/20/2024 374
STEP 3: Develop, implement and evaluate
strategies to correct the problem
02/20/2024 375
WHO/INRUD drug use indicators for health
facilities
02/20/2024 376
• Used to:
describe current treatment practices to determine
whether there are problems in medicine use, and
which facilities or prescribers have problems.
02/20/2024 377
Motivate health-care providers and DTC
members to improve and follow established
health-care standards.
Evaluate the impact of interventions
designed to change prescribing behaviour by
measuring indicators in control and
intervention facilities before and after the
intervention
02/20/2024 378
Core drug use indicators
02/20/2024 379
Prescribing indicators
02/20/2024 380
Patient care indicators
02/20/2024 381
Facility indicators
02/20/2024 382
Qualitative methods to investigate causes
of problems of medicine use
02/20/2024 383
Types
02/20/2024 384
DRUG MANAGEMENT
INFORMATION SYSTEMS
Definition
Tena M. 386
Importance
• Logistics Management Information System
(LMIS):
To improve accountability
– Much of the recording and reporting in a DMIS is
intended to create a paper audit trail for products
as they enter or leave a drug supply system.
– Every item that moves in and out of inventory
must be tracked, and decisions must be made
about how much to bill.
Tena M. 389
LMIS helps managers’ answers questions such
as:
Tena M. 390
Components of DMIS
Selection
Procurement
Distribution and
Use
Tena M. 391
• Information is necessary with in each of
these subsystems to manage:
Finances
Drug stocks and
Personnel efficiently
Tena M. 392
Information for each subsystem is
collected by:
– Record keeping documents
– Feedback reports
Tena M. 393
Steps in designing or revising DMIS
–Identify users
– Identify information needs
– Review the existing information system
– Match the existing information system with needs
–Draft record-keeping and reporting procedures to
fill the gaps
–Develop procedures for users to analyze data and
present findings.
Tena M. 394
Steps …cont’d
Tena M. 395
Steps …cont’d
Tena M. 396
Steps in Transforming Data into Action
Information
Processed Interpreted for
In to
Raw Data
Decision making
Feedback
Tena M. 397
Accounting principles
Tena M. 398
INTRODUCTION
• In business activity a lot of “give & take” exist
which is known as transaction.
• The exchange of money, goods & services
between the parties is known to have resulted
in a transaction.
• It is necessary to record all these transactions
very systematically & scientifically.
• The procedure to record all these transactions
is known as “Book-keeping”.
Tena M. 399
• Book keeping is the recording phase of
accounting.
• Accounting is based on an efficient
system of book keeping.
• Accounting is the analysis &
interpretation of book keeping records.
Tena M. 400
• Accounting is the process of recording,
summarizing, analyzing, and interpreting
financial (money related) activities to permit
individuals and organizations to make
informed judgments and decisions.
• By law all businesses must keep accounting
records.
• Decisions are based on accounting
information for profit and non-profit
companies alike.
Tena M. 401
THE ELEMENTS OF ACCOUNTING
• Assets: are items with money value that are
owned by a business or anything of use in
the future operations of the enterprise &
belonging to the enterprise. E.g., land,
building, machinery, cash etc.
• Equity: In broader sense, the term equity
refers to total claims against the enterprise. It
is further divided into two categories.
• i. Owner Claim or - Capital
• ii. Outsider’s Claim – Liability
Tena M. 402
Elements…
Tena M. 403
Elements…
Tena M. 404
Elements…
• Revenue: It is a monetary value of the products or
services sold to the customers during the period. It
results from sales, services & sources like interest,
commission.
• Expense/Cost: Expenditure incurred by the
enterprise to earn revenue is termed as expense or
cost.
• Withdrawal (Drawing) is the removal of business
assets for personal use by the owner. This transaction
decreases the asset taken and the value of the
business.
Tena M. 405
BUSINESS TRANSACTIONS AND THE ACCOUNTING
EQUATION
Tena M. 408
FINANCIAL STATEMENTS…
Tena M. 409
FINANCIAL STATEMENTS…
Tena M. 411
The Accounting Cycle
Tena M. 412
Accounting Cycle….
Tena M. 414
Contents of a journal
• 1. Journal pages numbered
• 2. Date
• 3. Account Title
• 4. Posting reference column
• 5. Debit and Credit columns
Tena M. 415
PRINCIPAL BOOK: LEDGER
Tena M. 416
LEDGER….
• Every ledger has two sides namely debit and
credit.
Tena M. 417
• In the particulars column of the debit side the
name of the account from which benefit is
received is recorded and
Tena M. 419
Ledger Posting….
• However, the following points must be
noted while posting the ledger.
For the same person or expense only one
account should be opened.
Cash and credit sales should be posted to
Sales Account and cash and credit
purchases to Purchase Account.
The word Debit as Dr. and Credit as Cr.
should not be omitted.
Tena M. 420
TRIAL BALANCE
Tena M. 421
TRIAL BALANCE
• ASSET = DEBIT
• LIABILITY = CREDIT
• OWNER’S EQUITY = CREDIT
• Drawing – Debit
• Expenses – Debit
• Revenue – Credit
Tena M. 423
Example how to Journalize
Tena M. 424
Cont…
• 17th January, 1997 Cash received from B
Rs.4,000/-
• 23rd January, 1997 Paid wages Rs.100/-
• 25th January, 1997 Furniture purchased from
R Rs.400/-
• 28th January, 1997 Paid for interest Rs.200/-
• 31st January, 1997 Paid salaries Rs.200/
Tena M. 425
Tena M. 426
Tena M. 427
How to Post to lager account
Tena M. 428
Tena M. 429
Tena M. 430
Tena M. 431
Tena M. 432
Tena M. 433
Tena M. 434
Tena M. 435
Pharmaceutical marketing and promotion
• DEFINITION OF ADVERTISISNG
• The word advertising originates from a Latin
word advertise, which means to turn to. The
dictionary meaning of the term is “to give
public notice or to announce publicly”.
Tena M. 436
Concept of Sales Promotion
Tena M. 437
Pharmaceutical marketing and promotion
Tena M. 439
• If promotion leads to better prescribing, more
rational use of medications or improved cost‐
effectiveness then there would be no concern.
• While the evidence is not conclusive, what there is all
points in the direction of a strong association
between reliance on promotion and less appropriate
overall use of prescription drugs.
• Heavy promotion of new drugs leads to widespread
prescribing and use before the safety profile of these
products is fully understood.
• Newer, more expensive medicines displace older, less
costly ones without any evidence of an improvement
in therapeutic outcomes .
Tena M. 440
Now your turn
Tena M. 441