pharmaceutical Warehouse

PSF-CI PHARMACEUTICAL GUIDEHow better to manage pharmaceutical

warehouses

PSF-CI Pharmaceutical UNIT Reference: DIST/GS/SIE/001/G/REV00MARCH 2003

DIST/GS/SIE/001/G/REV00

ContentsINTRODUCTION ...................................................................................... 1

1 – A PHARMACEUTICAL WAREHOUSE: FOR WHAT? ..................... 2

2 –WHAT SHOULD CHARACTERISE A WAREHOUSE? ..................... 32.1 – A WAREHOUSE OUGHT TO BE WELL SITUATED ..................................................................32.2 – A WAREHOUSE OUGHT TO BE WELL LAID OUT ...................................................................32.3 – A WAREHOUSE OUGHT TO BE TIDY...................................................................................4

2.3.1 - Basic rules for storage................................................................................. 42.3.2 - Classification of products ............................................................................ 52.3.3 – Preservation of products............................................................................. 6

2.4 – A WAREHOUSE OUGHT TO BE CLEAN................................................................................92.5 – A WAREHOUSE OUGHT TO BE WELL-SECURED................................................................10

3 – STOCK MANAGEMENT .................................................................. 113.1 - OBJECTIVES AND PRINCIPLES.........................................................................................113.2 – RESTOCKING ................................................................................................................11

3.2.1 – Evolution of stock levels ............................................................................113.2.2 – Calculation of the quantity to order............................................................13

3.3 – STOCK CARD ................................................................................................................143.3.1 - Definition ....................................................................................................143.3.2 – Stock card characteristics..........................................................................143.3.3 –Instructions for use .....................................................................................15

3.4 - STOCK MANAGEMENT USING SPREADSHEETS..................................................................153.5 – REGISTER OF CONTROLLED PRODUCTS .........................................................................15

4 - INVENTORIES .................................................................................. 174.1 – WHY DO THEM? ............................................................................................................174.2 – HOW TO DO THEM? .......................................................................................................17

5 – RECEPTION OF GOODS ................................................................ 195.1 – INSPECTION OF AN ORDER.............................................................................................19

5.1.1 – First inspection ..........................................................................................195.1.2 – The second inspection...............................................................................20

5.2- RECORDING OF AN ORDER ..............................................................................................215.3 – UNPACKAGING AND LABELLING OF PRODUCTS................................................................21

6 – DISTRIBUTION OF PRODUCTS ..................................................... 236.1 – VALIDATION OF THE LIST OF NEEDS................................................................................236.2 – PREPARATION OF THE CONSIGNMENT ............................................................................246.3 – RELEASE OF PRODUCTS................................................................................................24

6.3.1 – Delivery note .............................................................................................246.3.2 – Invoice .......................................................................................................246.3.3 – Certificate of donation................................................................................256.3.4 – Credit note.................................................................................................256.3.5 - Waybill........................................................................................................25

6.4 – MONITORING OF CONSUMPTION IN THE BENEFICIARY FACILITIES .....................................256.5 – TRACEABILITY OF PRODUCTS ........................................................................................26


7 – THE WAREHOUSE STAFF: WHO DOES WHAT? ......................... 277.1 – THE RESPONSIBLE PHARMACIST ....................................................................................277.2 – THE WAREHOUSE KEEPER.............................................................................................287.3 – THE WAREHOUSE STAFF ...............................................................................................287.4 – THE SECURITY GUARD...................................................................................................297.5 – THE CLEANER ...............................................................................................................29

8 – QUALITY ASSURANCE .................................................................. 308.1 – STANDARD OPERATING PROCEDURES (SOPS) ...............................................................308.2 – PHARMACEUTICAL INFORMATION ...................................................................................318.3 - AUDITS 31

APPENDICES .................................................................................. XXXIIIAPPENDIX I: OUTLINE FLOW DIAGRAM OF PHARMACEUTICAL PRODUCTS AND ACTIVITIES OF PSFCI IAPPENDIX II: TYPICAL SCHEMATIC DIAGRAM FOR THE LAYOUT OF A PHARMACEUTICALWAREHOUSE ......................................................................................................................IIAPPENDIX III: STORE TEMPERATURE CONTROL CARD................................................................IIAPPENDIX III: STORE TEMPERATURE CONTROL CARD...............................................................IIIAPPENDIX IV: REFRIGERATOR MAINTENANCE AND TEMPERATURE CONTROL CARD ................... IVAPPENDIX V: STOCK CARD...................................................................................................... VAPPENDIX VI: INVENTORY LIST ............................................................................................... VIAPPENDIX VII: TEMPORARY RECEPTION CERTIFICATE (PHARMACEUTICAL PRODUCTS)............. VIIAPPENDIX VIII: DEFINITIVE RECEPTION CERTIFICATE (PHARMACEUTICAL PRODUCTS) ............. VIIIAPPENDIX IX: ESTIMATE ........................................................................................................ IXAPPENDIX X: EXAMPLE OF A DELIVERY PREPARATION VOUCHER............................................... XAPPENDIX XI: EXAMPLE OF A DELIVERY NOTE ........................................................................ XIIAPPENDIX XII: EXAMPLE OF AN INVOICE ............................................................................... XIIIAPPENDIX XIII: CERTIFICATE OF HUMANITARIAN DONATION ....................................................XVAPPENDIX XIV: EXAMPLE OF A CUSTOMER CREDIT NOTE.......................................................XVIAPPENDIX XV: SCHEMATIC DIAGRAMS DISPLAYING BASIC INSTRUCTIONS..............................XVIIBIBLIOGRAPHY ................................................................................................................XXI

Pharmaceutical Unit

DIST/GS/SIE/001/G/REV00 1

INTRODUCTIONPutting together this guide arose out of a desire to ensure quality insurance in the

different PSF-CI (Pharmaciens sans Frontières – Comité International) missions andto capitalize its actors’ knowledge in the medico-pharmaceutical field. Indeed, thefield volunteer pharmacists have felt for a long time that they reinvent the wheelevery mission by recreating already existing (but unavailable) management ortraining tools and procedures.

This guide is a compendium describing a set of rules and actions to go through toimprove the quality of PSF-CI intervention in the pharmaceutical stores whatevertheir geographical location is. These recommendations are a tool to adapt to thelocal context of every mission, every PSF-CI store having specific activityprocedures.

After the objectives of the pharmaceutical warehouses and their characteristicshave been explained, we will study the essential activity that falls to the Responsiblepharmacist: the management of stocks. The presentation of tools for stockmanagement will be complemented by guidelines on the receipt and distribution ofproducts managed by the warehouse. Finally, the tasks of every worker in thepharmaceutical stores will be explained along with notions of quality assurance.

The implementation of the different guidelines will enable:- The simplification of the tasks falling to the field volunteer pharmacist, as

paradoxical as it may seem;- The standardisation of PSF-CI operations, without necessarily normalizing

them;- Easy taking over between the volunteer pharmacists who follow one

another on the same mission thanks to the traceability of the operations;- The optimisation of the different aspects of PSF-CI programs.

In addition, although this compendium is based on field experience andinternational recommendations, the different guidelines will regularly bereviewed by the field teams to improve their pertinence.

Of course, this tool does not make the optimal use of judgement and ofpharmaceutical/biomedical knowledge of the pharmacist any the less necessary toimprove efficacy, safety, economy and precision according to which drugs shall beused “for the largest pharmacy in the world always to stay on duty”.

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1 – A pharmaceutical warehouse: for what?To enable the fastest and cheapest transport of drugs and medical

equipment from suppliers to beneficiaries (cf. Appendix I).This is only possible through rigorous management of stocks. There are three main stages:

! Purchase of pharmaceutical products: it consists in placing pertinent orders,either locally or via the Purchasing Service at the Headquarters, then takingdelivery of the goods and checking they are as described.

! Storage of ordered products: it consists in recording and storing theproducts received, then monitor their preservation and their consumption.

! Distribution of stocked products: it consists of the preparation, delivery, thenmonitoring of orders.

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2 –What should characterise a warehouse?A pharmaceutical warehouse should be well situated, well laid out, tidy, clean and

well secured. This enables:! Easy and efficient management;! Good preservation of drugs and medical equipment! Safety for staff and stocked goods.

2.1 – A warehouse ought to be well situatedFor this, one must take into account:

• The number and location of the health structures to be supplied

• The roads, railways, ports etc. situated between the suppliers and thehealth structures

• Seasonal factors (for example: cut off roads)

• Transhipment needs

• The number, the type and the capacity of the existing storage facilities

• The access, drainage, security, water and services (electricity,telephone) on the selected place.

2.2 – A warehouse ought to be well laid outThe size of the warehouse should be sufficient to allow a partition in different

areas. (cf. Appendix II):- An administrative area where the administrative and financial management of

the store will be done (computer recording of orders, monitoring of theconsumption of the beneficiary structures, assessment of the needs,archiving of invoices, of order forms, of delivery notes1; etc.);

- An area for the preparation of goods only;- An area for the storage of empty boxes and other packages- A store made up of a worktop and several storage areas:

• For the different forms of medicines

• For the medical equipment

• For products to be kept in a cool place (cold rooms or refrigerators)

• For narcotics and controlled products (locking cabinet or room)

• For products in quarantine

• For outdated products awaiting destruction- A stocking area: should be provided in the store if the volume of

pharmaceutical products is such that products cannot be shelved.

1 All documents must be kept for a period at least as long as the one imposed by the law in force in the countryand in accordance with the PSF-CI archiving charter.

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The size and layout of the store shall be such that each area can be clearlydelimited and that there can be no confusion between the products to bedistributed and the products to be destroyed.

2.3 – A warehouse ought to be tidy

2.3.1 - Basic rules for storageThese recommendations are meant to enable correct storage and to avoid

possible loss. ! Systematic storage of the delivered goods! Use of pallets (nothing should be stored on the floor!) for better air circulation

and for protection against rodents (rats) or against possible flooding.! Leave a space of at least 50 cm between the rows of pallets and between the

pallets and the warehouse’s walls. This enables the airing of the warehouse,the cleaning of the premises and the checking of the condition of the products.Also make provision of spaces to allow people and/or transpallets to circulate.

! Provision of solid, stable and adjustable shelves (to adjust the spacesbetween the shelves to the size of the goods to be stored), preferably metallicshelves in tropical countries where termites attack wood.

! On shelves as in stock, each product shall have one and only one specificplace.

! On shelves, this place is shown by a label bearing the characteristics of theproduct. Medicines are identified by their International Non-proprietary Name(INN), their proportion and form2.

! A sufficient space should be left for each pharmaceutical product to avoidmixings and possibly to incorporate new items that are not yet in stock.

! If a shelved product is also in stock, this shall be specified on the stock card ofthe product (colour sticker)

! For every shelved item, the products with the furthest expiration dates will bestore at the back of the shelves and the ones with nearest expiration dates willbe shelved in the front. This enables the reduction of the risk related to theexpiration of the product use-by date during storage3;

! Boxes should be perfectly piled up while limiting the height to preventcollapses.

! Boxes should be stored in such a manner so that their labels are easily visibleand readable.

! All boxes in stock should be closed (scotch).! For every shelved product, only one box should be opened for the distribution.

2 Examples of characteristics for different products: Amoxicillin - 500mg –capsules; Glucose 20% - injectable;Catheter IV - 16G - 20cm.3 “FEFO” principle: First Expired First Out.

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! Narcotics and other controlled products4 will be stored separately, in a lockingcabinet (or little room), which will be guarded by the Responsible pharmacist.

! Flammable products such as alcohol and ether shall be stored in specificpremises or, if when possible, in a separate well ventilated room.

! Remove infested, damaged or outdated goods immediately. Report on thestock card and draw up a written document (report or minutes) to justifyremoval from the stock.

! Put in quarantine any batch considered suspect by the responsible pharmacist(change in colour, abnormal precipitation) or declared suspect (by the supplieror by the Purchasing service at the headquarters). Suspect products shall bephysically separated from other products in stock. You will have to wait for theresults of the analysis of the suspect batch before destroying them (andrecording their removal from the stock) or before re-shelving them if the doubtis not established.

2.3.2 - Classification of productsFor an easier and more effective stock management, it is essential to:

! adopt a classification of pharmaceutical products that is simple and usableby non specialists.

! conform with this classification at each level of the management system.

2.3.2.1 - Classification of medicinesIt is better to store the medicines by pharmaceutical form (or by method of

ingestion) and in alphabetical order by their International Non-proprietary Namewithin each pharmaceutical form5.

The different forms are (cf. appendix II):- tablets and related products;- syrups;- medicines for external use (ointments, eye drops, solutions …);- medicines administered by injection (IV et IM);- perfusion solutions (located separately because of their bulk)- medicines to be kept in a refrigerator (vaccines, serums, insulin…);- narcotics to be kept in a locking cabinet- alcohols, ethers; etc.

4 Psychotropic substances (products of the benzodiazepine and the barbiturate family) and narcotic drugs (centralanalgesics) are poisonous substances acting upon the central nervous system. For this reason, misappropriationsfor drug trafficking are possible. The production, manufacturing, extraction, preparation, offer, putting on sale ,transport, import, export of these products are governed by the U.N. Convention (Vienna Convention) of 1988.5 The alphabetical classification by INN is often preferred to the Anatomical Therapeutical and Chemicalclassification (ATC), where medicines are classify according to their therapeutical action. The ATC classification ismore pedagogical and makes substitutions easier. However it requires qualified staff and rigorous monitoring, fora product can belong to several therapeutic classes and can therefore be stored in different places.

Pharmaceutical Unit


2.3.2.2 - Classification of medical equipmentGiven the diversity of items and the bulk of many of them, it is better not to use

alphabetical order and to group them by category: syringes, needles, sutures,bandages, catheters, surgical instruments, sterilization equipment, auscultationfeatures, etc.

The equipment will then be stored by size and by expiry date within each category,

2.3.3 – Preservation of productsMedicines are sensitive products. So, to protect the most sensitive ones,

manufacturers use different techniques and adjuvants (preservatives, desiccators,coloured or dark flasks). In addition, each product goes with its own preservationinstructions.

In the warehouse, it is essential to preserve the pharmaceutical products from thefactors of degradation (temperature, air/oxygen, humidity and light) to guarantee theirstability up to their expiration date.

2.3.3.1 – Preservation conditions

a) TemperatureThe room temperature in the warehouse must not exceed 25-30°C. It must be

controlled, measured and recorded on the appropriate sheet every day (cf. appendixIII).

The devices used to measure temperature must themselves be controlled, andpossibly tested. They shall be placed in areas where temperature fluctuations are thewidest, that is to say near openings. If you can, use a maxima minima thermometerwhich enables the recording of the lowest and the highest day temperature.

Here are the storage temperatures as defined by the European Pharmacopoeia:

Place TemperatureIn freezer - 15°C à 0°C

In refrigerator 0°C à + 8°CIn cool place + 8°C à + 15°C

At room temperature + 15°C à + 30°CParticular attention shall be given to drugs in solution. Indeed, they should

never be exposed to temperatures under 0°C, as freezing can cause theprecipitation of the active ingredient and the formation of crystals. These crystals willnot become soluble again even if the temperature rises again over 0°C.

As for products to be kept in the freezer or in the refrigerator (vaccines, serums,ergometrine, oxytocin, insulin, some laboratory tests), the cold chain6 must not beinterrupted. One must be sure that the cold equipment is always functional so thatthe products are always kept at the right temperature. To do that, put a functionalthermometer in the refrigerator or in the freezer to fill in the temperature control cardattached to the refrigerator or to the freezer every day and from which temperaturecurves can be drawn (cf. appendix IV). 6 The term refers to the whole process (from the manufacturing to the use) ensuring adequate preservation ofheat sensitive products. Cf. « PSF-CI Logistics Guide:The cold chain»

Pharmaceutical Unit


It is desirable that the cold equipment is combined with generators that start up(preferably automatically7) in case of disconnection of electricity supply.

In addition to the storage conditions, the distribution system shall make provisionfor using mobile devices such as cool-boxes, vaccine racks and ice-packs8 tomaintain an unbroken cold chain during transport.

Here are some advices to maintain cold equipment and to guarantee the coldchain:

! Control the daily temperature (morning and afternoon) and fill in thetemperature control card;

! If handling is necessary (unpacking…), remove the box of productsconcerned from the refrigerator and close the door before handling theproducts outside the refrigerator as quickly as possible;

! Defrost the refrigerator once a month, clean the inside, brush and vacuumthe tubes placed in the rear, clean the door joints, put talcum powder onthem and when you do this, write the date on the line “maintenance” of therefrigerator temperature and maintenance control card (cf. appendix IV);

! In warm countries, leave a space of about 50 cm between the back of therefrigerator and the wall to keep the refrigerator from overheating.

! Keep “cold accumulators” (ice-packs) in the freezer compartment and waterbottles in the lower part of the refrigerator;

! Never keep drinks or food in the refrigerator;! As for electrical refrigerators, make sure that they are always correctly

plugged in and that the electricity generator runs smoothly.! As for kerosene-powered refrigerators, fill in the tank every day and always

have kerosene reserves on hand.! As for propane gas refrigerators, check the level of the gas bottle every day

and have two gas cylinders on hand.! When changing the gas bottle, write the date of installation of the new bottle

on the appropriate card.

b) AirOxygen and humidity in the air are degradation factors of active ingredients of

medicines. So, in order to protect the products: - All containers shall be hermetically closed;- Avoid prolonged unpackaging;- Prefer original packaging to guarantee airtightness and opacity;- Make sure that the premises have good ventilation (window openings,

ventilators, air vents placed high with grilles to prevent rodents fromentering…).

7 This is however difficult to set up because of the cost of it. The generators are generally started manually. 8 They are cold accumulators which come in the form of plastic briquettes filled with a special liquid.

Pharmaceutical Unit


The level of humidity in the pharmaceutical warehouse shall be checked,measured and recorded regularly. The devices used to measure level of humiditymust be controlled and tested.

c) LightMany active ingredients are light-sensitive, especially solutions that shall be kept

in their packaging.No product shall be directly exposed to daylight.

2.3.3.2 – Outdating of products

a) Expiry dateMedicines expire. To determine the expiration date (or use-by date) of a medicine,

manufacturers perform accelerated degradation studies and real-time stabilitytesting. It is set by the manufacturing laboratory to ensure a stable therapeutic effectup to that date (90% of the active ingredient shall be present and there shall be nosubstantial increase in toxicity). The expiration date applies to a drug in its originalclosed and undamaged package or container. It must appear on the package and/oron the product.

When this date in expressed in month and year, it is a convention that the deadlinedate is the last day of the month of the indicated year.

If this date is preceeded by « use before », then the first day of the stated monthshall be set.

b) Outdated productsProducts shall not be used beyond the expiration date. Degradation of the drug

may indeed reduce the therapeutic efficacy and sometimes increase the toxicity byforming products inducing side effects or toxic effects.

" The loss of therapeutic efficacy due to under-dosage may have seriousconsequences for the patient’s health when the medicine requires precisedosage (digoxin, digitoxin, phenitoin…).

" Using an outdated antibiotic, that is therefore less active, may encourage theemergence of antibiotic-resistant organisms in addition to not curing theinfection.

" Over time, tetracyclines are degraded and become more toxic." As for penicillins and cephalosporins, an increase of the allergenic power can

be observed.

c) Measures to be taken to reduce the quantity of outdated productsin stock

Bad management (overstocking) causes important losses due to expiration as wellas unnecessary costs. It is imperative to reduce the risks of expiration of productsstored in the pharmaceutical warehouse and this is only possible through rigorousstock management.

This involves carrying out rigorous needs assessments prior to any order andappropriate stock rotation by complying with the FEFO principle.

Pharmaceutical Unit


To reduce the quantity of outdated products in stock, it is necessary to:

• List the products (or batches9) risking expiration;

• Check the time remaining before the expiration date against the timecovered by the quantities still in stock (the average monthly consumptionsof the products must be known).

• Make visible the products expiring within predefined time (for example in 6months or in 9 months) by marking them.

• Use the products marked first.

d) Management of outdated productsThe management of outdated products must be the subject of standardized

operational procedures in which the cost, the energy, the time and the humanresources necessary to destroy the outdated drugs must not be underestimated.Indeed, if you could not avoid expiry, expired drugs shall be destroyed because ofthe risks related to their use10.

• First, the expired products shall be removed from the stock of products,placed in a reserved area of the store that can be locked (risks of theft).

• Secondly, these products are sorted by form to be destroyed incompliance with the law and the regulation in force in the country and withthe guidelines for safe disposal of unwanted pharmaceuticals11. Accordingto these principles, their destruction is compulsory to guarantee theprotection of public health and the preservation of the environment.

2.4 – A warehouse ought to be cleanA large part of pharmaceuticals being ingested by patients or in contact with sick

persons, hygiene and good sense are essential at all levels of handling of products.One must therefore make sure that the inside of the warehouse and the area aroundit are clean.

Here are some recommendations:! Clean the premises regularly with disinfectant solutions (sodium or calcium

hypochlorite…)12;! When you have legal permission to unpackage products, take care to avoid

handling medicines with hands by using non-reusable gloves, countingtrays and spatulas;

9 A batch is a quantity made up of all the units of the same medicine with the same expiration date.10 The destruction of pharmaceuticals in the framework of a humanitarian program is intolerable if it is aconsequence of management neglect in a PSF-CI warehouse.

11 Please refer to the document « Interagency Guidelines For Safe Disposal of Unwanted Pharmaceuticals in andafter emergencies » or « Principes directeurs pour l’élimination sans risques des produits pharmaceutiques nonutilisés pendant et après les situations d’urgence ». WHO/EDM/PAR/99.2. written in collaboration withPharmaciens Sans Frontières-Comité International.12 All the information relating to the cleaning of the warehouse (cleaning frequency, products used, methodused…) should be included in standardized procedures.

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! Staff shall wash their hands with an antiseptic solution (chlorhexidine,chlorhexidine + cetrimid) or, failing that, with ordinary soap prior to handlingmedicines.

! Smoking and eating must be forbidden in the premises and a separateroom shall be provided for that purpose.

2.5 – A warehouse ought to be well-securedWhat is the point of well-stocked, tidy and clean premises if they are not protected

and safe?To protect staff and products from risks, it is necessary:

! To have locking doors and sufficiently solid locks;! To keep all the keys in one place;! To have protected windows;! To be sure that visitors only have access to the administrative area.! That staff is appropriately dressed and suitably equipped to be sure they

are protected whilst carrying out their assigned duties.! Adapted and functional lighting, as well as generators ready to work to

ensure good working conditions.! To clean the ground surface regularly! To forbid smoking in the warehouse! To provide extinguishers to fight fires.! To fight against insect pest by spraying insecticide periodically13;! To clear the undergrowth from around the warehouse regularly.

13 Clear guidelines on the use of pesticides without risks to staff and to pharmaceuticals, as well as emergencyaction to take in the event of contamination must be available.

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3 – Stock management

3.1 - Objectives and principlesThe objective of stock management is twofold:

" to ensure continuity of supplies (a stock shortage always has a negativeimpact on health program progress);

" to avoid over-stocking meaning frozen money, additional storage costs,warehouse clutter, increasing risks of deterioration or theft of products.

The key to good stock management is foresight. The person in charge of thepharmaceutical warehouse should be able to answer at any time such questions as:

• Which pharmaceutical products are necessary for the good running of aPSF-CI program with storage activities?

• Where is stored what product and in which quantity?

• What is the approximate consumption for every product in a given period(week, month, etc.)?

• Where and how are the different products purchased?

• What is the delivery time?

• Until when can the products be used?Stock management will set out to:

- monitor stock levels;- monitor consumption;- Anticipate delivery-time for order activation.

3.2 – Restocking

3.2.1 – Evolution of stock levelsIt can be analysed by a mathematical technique using the different parameters

defined below:A = consumption indicator: is the quantity of product going out of the

warehouse (and considered as being consumed) over a given period (week,month, year). To determine this value, you have to use management tools such asstock cards or statistics about the past consumption of the project.

(AMC) for instance, is calculated from the outgoing products recorded on stockcards: all you have to do is add the sum of products issued over a period of severalmonths (3, 6 or 12) and divide the total by the number of months to obtain an AMC.

Remarks: The quantity of consumed products must best correspond to the realmedical needs of the population going to the health structures supported by PSF-CI.So, to assess the needs for pharmaceuticals, the responsible pharmacist must takeinto account the epidemiological data and the morbidity statistics as well as thenational therapeutic protocols14.

14 Refer to the PSF-CI Pharmaceutical Technical Document: "How to assess needs?"

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Furthermore, we can optimise the orders by training the prescriberson the rational use of drugs.

d = delivery time: is the estimated time between the order and the delivery tothe warehouse (estimation expressed in months or days).p = frequency of order: is the number of months between two orders; it equalsthe period of time that should be covered by the content of an order. This frequencyis defined by the person in charge of the supply taking into account the financialresources available, prospects for the duration of the project, product specifications(use-by date, size, supply difficulties…).

As regards pharmaceutical products purchased via the Procurement Departmentat the HQ, orders are usually placed quarterly.Z = safety stock (or buffer stock): is a certain quantity that should be keptpermanently in stock in the warehouse. This quantity of products is only kept tosafeguard against unforeseen shortages (delivery delays, sudden increase inemergency consumption, thefts, etc.). The quantity is arbitrarily defined by the personin charge of the supply, according to the specifications of each product.X = maximum value of stock: stock ranges between the minimum value (safetystock Z), and the maximum value X.

X = Z + (p x A)M = order threshold: you must determine when it becomes necessary to place anorder. This moment corresponds to a certain value of the stock m which will ensurecontinuity of supply during delivery time. When the stock reaches this value (M), thestorekeeper tells the person in charge of the supply that an order must be placed.

In theory, one should not let the stock go below the value M. In certain cases (eg,supply of pharmaceutical products via the HQ), the frequency of order (p) takesprecedence over the order threshold. Indeed, orders are generally placed quarterlyand all the products are restocked at that time according to the needs.

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Those parameters being defined, we can graphically represent the evolution of thestock level of a product:

(stock) S

(maximum stock) X

(order threshold) M

(safety stock) Z

t (time)

order delivery

3.2.2 – Calculation of the quantity to orderIn practise, you cannot always place an order at the exact moment when the stock

reaches the value M (order threshold). So, you need a formula to define the quantityto order at any time, depending on the stock level, and to help you reach themaximum value of stock X.

Let us define beforehand the cycle stock: it is the quantity of each drugconsumed between two supplies (p x A).

For instance, if the order placed quarterly, the cycle stock will be three times theAverage Monthly Consumption.

That is to say:S(t) = stock level at time t: quantity that is physically present in the warehouse at a

given time (t). This value corresponds to the last balance on the stock card.L(t) = pipeline at time t: expected quantity (order in progress, donation prospects,

expected reimbursements, etc.). It is judicious to have an « Ordered » column on thestock card to write down the L(t) value.

Then:C(t) = quantity to order at time T = (cycle stock + safety stock + probable

consumption during delivery time) – (stock level on the day of the order +quantity already ordered if need be).

C(t) = ( (p x A) + Z + (d x A) ) – S(t) – L(t)

d p

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Remark: The values obtained from this calculation must be rounded off andadapted to the classical packaging of pharmaceutical products. This helps avoidsupplier errors in the preparation of a shipment and at the time of inspection upondelivery.

Product type Unit sizeTablets 1000Injectables 100Syrup 10Bandages 10Sutures 12Non sterile

compresses 100

For example, you order 2,100 phials instead of 2,128.

3.3 – Stock card

3.3.1 - DefinitionIt is a simple and efficient tool that enables the management of a warehouse (cf.

appendix V). A stock card should be created for each pharmaceutical product andregularly updated. Depending on the stock’s volume, stock cards will either be put onthe shelves in front of each corresponding product or centralised in a single place inthe administrative area. In all cases, they must be easily accessible.

Stock cards make it possible to:

• Identify stock movements: incoming and outgoing products;

• Know the theoretical stock level at any point in time;

• Monitor the consumption of the different users;

• Monitor expiry dates;

• Assess losses by comparing the theoretical and real stocks;

• Have data to plan subsequent orders.

3.3.2 – Stock card characteristicsEach stock card contains:

• The exact description of the product (for drugs: INN, dosage);

• Expiry date of the product;

• Products movements: date; incoming quantities15 and origin; outgoingquantities and destination; losses due to damaged products, brokenflasks, outdated products, lost products (…);

• Stock level after every movement (balance).The above defined stock management parameters (A, d, p, Z, M) can appear on

the stock card of each product. 15 Quantities are always in units (tablets, phials…), and never in a number of boxes.

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To make the use of stock cards practical, it is preferable to use cardboard cardswith a distinctive colour according to the classification adopted for the storage ofproducts in the warehouse (tablets and related products, syrups, drugs for externaluse, etc.).

A new stock card is created for each type of packaging of a same product, (eg,box of 100 or box of 500). This helps avoid management mistakes.

3.3.3 –Instructions for use! Upon receipt of shipment once the products are stored on shelves, the

quantity received should be recorded on the stock card of the correspondingproduct in the « incoming » column, along with the date, supplier’s name andexpiry date, and should be added to the previous stock in order to obtain anew stock level;

! Upon release of an order, once the products are withdrawn from theshelves, the outgoing quantity should be recorded on the stock card of thecorresponding product in the « outgoing » column, along with the date andaddressee’s name and the balance will be calculated immediately;

! At the end of the month, the total quantity of each product delivered to thedifferent beneficiaries will be calculated;

! After inventory, the real quantities of each product will be recorded in avisible way (red ink…) on the stock cards. This helps adjust possiblediscrepancies between the physical and theoretical stocks.

3.4 - Stock management using spreadsheetsIt is also desirable to have a computer toll for data processing (spreadsheet,

database, specific software…) as a supplement to stock cards. Product movementswill be recorded and, as a precaution, all computer data will be saved in severaldifferent ways (hard disk, CD-ROM, etc.).

Below is an example of stock management of drugs whose frequency of order (p)is 6 months and delivery time (d) 2 months:

Item

Aver.Mthly.Cons.A

Safety.Stock Z

Max. stock Z+(6xA)

OrderthresholdM =Z+(2xA)

PresentStock S

PeriodcoveredS/A

PipelineL

Qty to orderZ+(6xA)-S-L

Ibuprofen200 mg tab 40 20 260 100 120 3 - 220

Paracetamol500 mg cap 150 40 940 340 300 2 40 900

3.5 – Register of controlled productsControlled products (narcotics, psychotropic drugs) should be managed

independently on the basis of management tools specific to these products andunder the responsibility of a pharmacist.

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Just like the stock card, the register records every in and out movement of eachbatch of products in stock in real time and gives the balance. The register may havethe following layout:

DateandTime

Item(INN, dosage)

BatchN°

IncomingQuantity

OutgoingQuantity

Deliveredor

Receivedfrom

Formref. Remarks

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4 - Inventories4.1 – Why do them?As stock cards give a theoretical level of the stock, it is essential to make an

inventory of the quantities that really are in stock (physical stock). Mistakes,omissions, or thefts can explain the differences between the theoretical and realstock. Those differences should of course be cleared up.

Furthermore, an inventory makes it possible to check the expiry dates of all thepharmaceutical products.

4.2 – How to do them? ! Inventories should be made on a regular basis, with a frequency defined by

a procedure specific to each warehouse. The more frequent and of goodquantity the inventories, the more accurate the theoretical stock and thebest the stock management.

" Inventory frequency will depend on the size of the warehouse, theduration of the program, the frequency of orders and receipts.Generally, it is preferable to make an inventory at the beginning ofeach new program, then to conduct one monthly and before everydelivery of large quantities. Finally, an inventory should be done atthe end of the program.

" In addition, one should:- Take into account the foreseeable dates of goods receipts, the

delivery schedule and delivery commitments to set inventorydates;

- Choose a fixed date each month if the inventory is mademonthly;

- Set the inventory date at least a month in advance if it is avery large warehouse where a physical inventory can only becarried out twice or three times a year;

- Communicate as soon as possible the date set to all the staffas well as to all the people concerned;

! On the day of the inventory, all activities should be stopped except thecounting of stocks: NO IN OR OUT MOVEMENT OF PRODUCTS on thatday;

! The inventory should be conducted in a minimum time and the resultsshould immediately be recorded to enable normal working to resume;

! All the staff should take part in it and items should be counted one by one:" There will be teams of two people (one to handle the boxes and

count the items and one to add up and write down the results on theinventory listing);

" Determine the size of storage areas that can be inventoried in oneday by a team of two people. This helps know how many teams areneeded;

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" Prepare inventory lists and respect the classification order used inthe warehouse, but do not show the theoretical quantities in stock (cf.VI appendix);

" Form teams, assign them a section of the area to be inventoried andprovide them with equipment (inventory lists on stiff paper,calculators, pencils, marker pens, Stanley knives, tape, etc...);

" Remind them that everything must be counted;" When certain products are stored simultaneously in the forward area

and in the reserve area, they must be distinctly counted (quantity inthe forward area, quantity in the reserve area), then add up the twonumbers to determine the total quantity of the products in stock;

" Ask the teams to place labels with the date to mark the areas wherestock taking has been done (to avoid to count twice);

! At the end of the inventory, each team should hand the inventory sheets into the warehouse manager who make a general inspection to ensure thatno area has been forgotten;

! On the day following the day of inventory at the latest, record inventory dataon the stock cards and on the computer before you resume entering the inand out movements of goods:

" Compare the inventory results and the theoretical stock from thecomputer to the information on the stock cards;

" In case of major differences, carry out checks (checks shouldpreferably be carried out by a team different to the one that firstcounted the products);

" Make a list of the discrepancies that will be annexed to the inventory;" Enter clearly (in red ink…) on the different stock cards the quantity of

products obtained after counting is complete;! A complete physical inventory should be followed by selective checks as

often as possible during the year.

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5 – Reception of goodsTo carry out supply operations for health facilities, regional pharmaceutical stores

and/or NGOs, the responsible pharmacist shall regularly order pharmaceuticalproducts16.

As for imported products, the national regulations relating to imports ofpharmaceutical products must be complied with, in particular the regulations relatingto narcotics. Customs clearance formalities must be carried out before collecting thegoods17.

For certain orders, the Headquarters will carry out quality audits (i.e. take a sampleof products and get it analysed by a certified quality controlled laboratory). In thesecases, the responsible pharmacist should be informed of the method of internal auditby the Medical Purchasing Manager of the Headquarters.

The reception of pharmaceutical products can mobilise the different actors of thePSFCI team, but it is the pharmacist who is responsible for activities relating to thepharmaceutical store.

An order should always be accompanied by:- A copy of the packing list;- The delivery note;

An order may be accompanied by an invoice.All consignments must be checked and registered upon delivery before they may

be stored. For this reason, a goods reception area should be provided in thewarehouse.

5.1 – Inspection of an orderThere are two types of inspections that can be performed with the help of the

packing list.

5.1.1 – First inspectionEach consignment must first undergo an initial inspection:

! Collect and check all the documents required for these transports18;! List pallets: the number on each pallet must be the same as the one on the

packing list. Mark the pallets whose number matches the number on thepacking list with a sticker. The total number of pallets must be identical tothe number mentioned on the packing list.

! Count the number of boxes on each pallet and check that it conforms to thenumber given by the supplier on the packing list.

! Check the condition of boxes: do some of them look to have beendamaged, opened (or else …)? If the boxes are opened, it is useful tospecify which ones and to identify the probable cause of the opening

16 Cf. « PSFCI Pharmaceutical guide: Supply of pharmaceutical products». (currently under way).17 Cf. «Logistical Guide: Transport -Customs».18 Cf. « Logistical Guide: Transport -Customs ».

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(slip/fall of boxes, theft, sample taken by customs…). This information isessential for insurance claims in some particular cases19;

! Check the special preservation conditions: cold chain, etc.! As for products carried by truck, ask the driver about transport conditions

(road hazards, contacts with authorities, etc.);! If the merchandise is the result of an order placed by the Medical

Purchasing Department at the headquarters, you should, after the firstinspection, acknowledge receipt of the order by filling out a TemporaryReception Certificate (cf. appendix VII) and by sending it to the MedicalPurchasing Manager at the Headquarters. This is generally done by thelogistician who collects the consignments in accordance with proceduresrelating to the mode of transport used (by truck, etc.).

5.1.2 – The second inspectionSecondly, the consignment must be checked in full by the medical team. To make

the inspection easier, you can, as the pallets and boxes are inspected, mark the oneswhich you have checked with an ‘X‘ or stick a green label on it with the mention‘CHECKED’ (…).

The medical team should:! Check that the goods delivered do correspond to the invoice;! Check that the quantities received match the quantities shown on the

packing list;! Check the conformity of each product: designation, quantity per packing

unit, packaging, labelling, expiry date and product appearance (colourchange, precipitation…).

19 Cases of theft. Obvious burglary (opened tarpaulin…) should be notified on the Temporary Reception

Certificate and all notification of theft (for example, statement of the driver on the border…) should be attachedto it.

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- If the merchandise is the result of an order placed by the Purchasing Department atthe Headquarters, you should, after the second inspection, fill out the DefinitiveReception Certificate and send it to the Purchasing Manager at the Headquarters (cf.appendix VIII)20.Depending on the remarks mentioned in the Definitive Reception Certificate, thePurchasing Manager at the Headquarters will be able to pay the suppliers thebalance of orders and notify them of errors encountered during delivery, and, if needbe, try to solve the problems. The Purchasing Manager may make use of insurancein case of theft or assess the “profits and losses” after sample taking by customs. Inaddition, if certain products are found suspicious on the Definitive ReceptionCertificate, the Purchasing Manager may initiate quality control of these products.Whatever the case, the pharmacist in charge of the warehouse should receivefeedback of information from the headquarters on the progress of the order21.- If the merchandise is the result of a local order, please refer to the PSFCIPharmaceutical Guide “Supply of pharmaceutical products” or ask for the assistanceof the Purchasing Manager or the Technical Pharmacist at the headquarters.

Once the second inspection is completed (all the consignment has been checked),the products may be moved and incorporated in the general stock of the warehouseat their assigned storage place. Products to be kept in a cool place and controlledproducts should be stored as quickly as possible.

5.2- Recording of an orderFor each commodity, the quantities received should be recorded on the

corresponding stock card at the time of storage. The quantities received may also beentered in a stock management program or in an Excel spreadsheet called“suppliers”.

Delivery notes, invoices and packing lists should be filed with order forms in a filecalled “orders” and kept for a period of time at least equal to the period of timerequired by the regulations in force in the country and in compliance with the PSFCIArchiving Charter.

5.3 – Unpackaging and labelling of productsLegal authorization is required to unpackage pharmaceutical products (for

example, making bags of tablets from a hospital pack) or to change the labelling ofpackages (for example, sticking labels giving the characteristics of the product in alocal language). This authorization is only granted to ”pharmaceuticalestablishments” and PSFCI is not one. So, PSFCI staff may not unpackagepharmaceutical products nor change the labelling of packages.

If packaging or labelling of products are required, PSFCI should subcontract theseactivities to a certified pharmaceutical establishment (suppliers of pharmaceuticalproducts, manufacturers of pharmaceutical products, local private pharmaceutical 20 Examples of comments that should be provided because they are very useful:¤ Box #213 : received opened; contains 12,000 tab of folic acid 5mg instead of 16,000. Theft? Sample taken bycustoms for analysis? (…)¤ Box #152 :received closed; contains 900 vials of oily chloramphenicol 500mg (250mg/ml, 2ml) instead of 1000.Supplier’s error.21 Cf. « Pharmaceutical Guide: supply of pharmaceutical products » (currently under way).

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establishments…). One should therefore find information about the legislation inforce in the country, be sure that the establishment has an approval certificate, andconclude a contract in due form, in which the responsibility of the PSFCI mission andof the certified pharmaceutical establishment are clearly defined.

If need be, the pharmacist in charge of the warehouse should notify beforehandthe Desk Officer and the Purchasing Manager at the headquarters who will then beable to assist him.

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6 – Distribution of productsIn general, PSFCI pharmaceutical stores issue pharmaceutical products to health

facilities and/or NGOs. It is preferable that a Memorandum of Understanding bindingthe PSFCI mission and the beneficiaries of the activities of the pharmaceutical storeis written by the PSFCI mission representatives and then signed by the two parties.

For the distribution of pharmaceutical products to be effective, you will have toestablish an operational process and state the documents that relate to each stage ofthe distribution process.

There are the following stages:! Validation of the list of needs;! Preparation of the consignment;! Release of products;! Monitoring of consumption.

Each document issued during the distribution process should bear the logo ofPSFCI, the name of the person who is responsible for this step of the distributionprocess and elements of identification of the requisitioner. All documents should bephotocopied and filed to guarantee the traceability and transparency of operations.

6.1 – Validation of the list of needsThe health facilities and/or NGOs benefiting from the services of the PSFCI

pharmaceutical store should assess their needs and send a list of needs to thepharmaceutical store. The pharmacist in charge of the store may offer his technicalassistance to health facilities having difficulties in assessing their needs22. This willbe part of the monitoring activity (cf. paragraph 4.4).

To be validated, the list of needs should then be analysed (quantitatively andqualitatively) by the responsible pharmacist, who should make sure that:

• The products ordered belong to the national list of Essential Drugs23;

• The products ordered are compatible with the sanitary level of thefacility which orders them;

• The drugs are used rationally.To make this step easier, the pharmaceutical store may provide health facilities

and/or NGOs with a pre-established list of products that may be handled by thepharmaceutical store. This limitative list will take into account the product designationand classification method adopted by the store. The pre-printed list may include afew blank lines so that the person who is responsible for the stock management of ahealth facility or of an NGO may add “other products” that do not belong to the pre-established list.

In certain cases, the health facility or NGO can ask the responsible pharmacist toassess the estimated amount of needs by writing up an estimate (cf. appendix IX).

22 Cf PSFCI Pharmaceutical Technical Document “How to assess needs?” (currently under way).23 If there is no National List, please refer to the PSFCI Pharmaceutical Technical Document “PSFCI List ofEssential Drugs and Medical Equipment” (currently under way).

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6.2 – Preparation of the consignmentOnce the request of the health facility or NGO is validated, the delivery can be

prepared in the order preparation area of the warehouse.For this purpose, a delivery preparation voucher (cf. appendix X) will be handed to

the person designated to prepare the deliveries. The document shall include for eachproduct: the code, designation, dosage, quantity per package unit, quantity to bedelivered, batch number and expiry date. The name of the person who prepared theconsignment and the name of the person who checked the consignment must bespecified.

The regulations relating to the receipt and issue of products will have to berespected (updating of the stock card…). Particular attention will be given to thebatch number of each product distributed in order to guarantee the traceability ofpharmaceutical products and to facilitate the possible withdrawal of the batch.

The regulations relating to the packing of products for delivery (packaging ofcertain products, recycling of cardboard boxes, use of ice-packs …) will have to bedefined for each store according to the nature and quantity of products handled in thewarehouse.

6.3 – Release of productsIf the transportation of products to the medical facilities and/or NGOs is paid by the

pharmaceutical store, then standard operating procedures will have to be drafted toensure compliance with the preservation conditions of products and with safetymeasures during transportation.

Dans tous les cas, la remise des produits s’accompagne de la remise desdocuments suivants:

6.3.1 – Delivery noteIt is always compulsory (cf. appendix XI). It should include for each product: the

code, designation, dosage, quantity per packing unit, quantity delivered, batchnumber and expiry date. The estimated weight and volume of the consignment arespecified when it is possible. The name of the beneficiary should always appear.

The document may be accompanied by another bearing the name and thesignature of the driver in charge of the delivery, the vehicle used, the date and time ofdeparture from the warehouse, the date and time of arrival in the health facility orNGO, as well as the name and signature of the person who received the products atthe health facility or NGO.

6.3.2 – InvoiceIt is compulsory when the health facility or NGO has to pay for the ordered

products (cf. appendix XII). It should include for each product: the code, designation,dosage, quantity per packing unit, the quantity delivered, the unit price and the totalprice.

The payment of an invoice is made after the pharmaceutical products aredelivered. As a result, if at the time of the preparation of an order certain products aremissing (supply delays, stock shortages in the warehouse…), these products will notbe invoiced. The pharmacist in charge of the warehouse will then have to inform the

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beneficiaries of the services of the store that the delivery of those products ispostponed or impossible.

6.3.3 – Certificate of donationIt is compulsory if the products are given by PSFCI to the health facility or NGO

receiving the delivery (humanitarian donation). It should include the same items asthe invoice (cf. appendix XIII).

6.3.4 – Credit noteIn some cases (error made when placing or preparing an order, change in

needs…), the health facilities or NGOs benefiting from the services of the PSFCIpharmaceutical store can return certain products to the warehouse24. In these cases,a credit note must be issued, for the returned products have already been invoiced.This document should include the same items as the invoice (cf. appendix XIV).

6.3.5 - WaybillThis document is only provided on rare occasions when a border or particular

check points must be crossed to deliver the products.

6.4 – Monitoring of consumption in the beneficiary facilitiesThe consumption of medicines and medical equipment should meet a real,

rational, clearly defined and quantified need. For this purpose, the responsiblepharmacist is in charge of the monitoring of consumption in the health facilities and/orNGOs which benefit from the activities of the store.

The monitoring of consumption also makes it possible to adjust the orders of thewarehouse and to limit the number of outdated products both in the health facilitiesand/or NGOs and in the PSFCI pharmaceutical warehouse. The destruction ofoutdated products has a cost and the monitoring of consumption should notably helpreduce it.

To encourage the rational use of pharmaceutical products, the pharmacistshould:

• Choose the products to be purchased in accordance to the local needs andthe international recommendations about the use of essential drugs andessential biological reagents;

• promote the use of these products among prescribers (doctors, nurses andauxiliaries, mid-wives, etc.) and among the managers of peripheral stores byorganising training sessions for example;

• offer his technical assistance to the beneficiary facilities wanting to improvetheir needs assessment and their stock management;

• collect consumption data to draw up statistics which reveal the activity of thewarehouse and the consumption of products (consumption by beneficiary, bygeographical area, by therapeutic category…);

24 To guarantee the quality assurance of pharmaceutical products distributed by PSFCI, all precautions must betaken to avoid the return of products. PSFCI may reserve the right to accept or not a return of products. Thereturn conditions must be stated beforehand in the Memorandum of Understanding binding PSFCI and thebeneficiaries of its services.

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• collect epidemiological data to determine whether the objectives of providinghealthcare cover have been reached.

6.5 – Traceability of productsBecause of the sensitivity of pharmaceutical products and the possible risks linked

to their use, the pharmacist must be able to guarantee at all times the identificationand integrity of the products he is responsible for. This way, the vigilance of thepharmacist helps preserve the quality of pharmaceutical products for which he isresponsible and the safety of users.

The measures taken to guarantee the traceability of products distributed by PSFCIare, among others, the identification of the batch number of the distributed productsfor each beneficiary facility. The fact of having a written “history of batches” of thedifferent products helps for example to localize the batches found suspicious by thesupplier (or seen as suspicious by the team in the warehouse) to put them inquarantine or to rapidly and efficiently recall batches from NGOs or health facilitiesbenefiting from the activities of the store. Standard operating procedures shall bewritten for that purpose.

In addition, the restocking of merchandise returned to the warehouse by the healthfacility or NGO benefiting from the activities of the warehouse may be permitted bythe responsible pharmacist only if the products are not a threat for the health ofpotential users. The responsible pharmacist will particularly have to beuncompromising as soon as there is a doubt about the traceability of products. Fromthe time that he is not certain about how the returned products have beentransported and stored, he must order their destruction.

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7 – The warehouse staff: who does what?People working in a warehouse should form a team following the principles of

motivation, honesty and respect of work. Tasks should be well defined for eachperson and should be clear to everyone.

In addition, each person should be trained on the tasks he/she will have to carryout. Simple diagrams displaying work instructions may be posted on the walls of thewarehouse (cf. appendix XV).

Communication is a key element of the efficiency of the pharmaceuticalwarehouse:

! Notice board for the attention of the staff, where is displayed all theinformation likely to improve the coordination of the team and the quality ofthe services provided by the warehouse (internal rules and regulations,review notes of procedures, absent persons and reasons for absence …);

! Working meetings are regularly organised to assess the development ofactivities and to focus on the difficulties encountered or anticipated.

7.1 – The responsible pharmacistHe is responsible for the quality assurance of the activities of the warehouse and

sometimes for the administrative and financial management of the warehouse.His duties include:

- Good management of the stock of the warehouse;- Good preservation of drugs and equipment; - Safety of the staff and of the stored goods;

To achieve this, he must in particular:" Establish and review procedures25, make them clear to all the staff, be sure

that they are correctly applied including by himself;" Ensure that the protocol of understanding signed with the beneficiaries of the

warehouse is respected;" Set up work goals and distribute tasks;" Organise work so as to avoid periods of inactivity and periods of over activity;" supervise and manage the staff;" place orders according to the frequency adopted;" know the international conventions relating to psychotropic substances and

narcotics (he is the only person authorized to deal with controlled productsand should keep the key of the cabinet or of the room where these productsare stored);

" be present when certain critical activities are carried out (such as thereception of an order or inventories) to validate them;

25 Cf. Procedure for PSFCI Pharmaceutical Technical Documents

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" ensure the tracking of the pharmaceutical products handled in thewarehouse;

" order the withdrawal of a batch and the quarantine of the suspectedproducts;

" order the destruction of unusable products;" validate the lists of needs before deliveries are prepared and products are

distributed;" select products to be purchased according to local needs;" monitor the beneficiaries or customers of the warehouse to adapt the list of

products in stock;" promote the rational use of pharmaceutical products and possibly to train

prescribers.All the decisions taken should be written and signed by the pharmacist who,

through this act, becomes in charge.

7.2 – The warehouse keeperUnder the supervision of the responsible pharmacist, the warehouse keeper has

the role of a stock manager. His duties include:- the reception of supplies;- the storage of stocks of goods;- the recording of every in and out movement of products on stock cards;- the issue of products during the preparation of orders.

He should respect the standards of warehousing and notify the pharmacist whenthe order threshold (M) of a product has been reached.

In addition, the warehouse keeper assists in the inventory of the stocks.He also has under his responsibility:

" the monitoring of the refrigerators and warehouse temperature twice a day;" the maintenance of the equipment of the warehouse (eg, refrigerators).

7.3 – The warehouse staffHandling operations include the carrying and moving of goods which are intended

for storage, shipment and sale. The warehouse staff receives, issues goods and maintains inventory.The handling instructions should be pre-established for bad handling of products

can cause damage fraught with consequences:! Do not step on boxes (provide a ladder);! Handle boxes with care and in the correct way;! Pay particular attention to liquid products and injectables;

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! Systematically report the damages occurred during handling operations(broken, opened, destroyed products …).

7.4 – The security guardIs responsible for ensuring supervision and security of the warehouse and

immediate vicinity.

7.5 – The cleanerEnsures cleanliness of premises and equipment. These must be cleaned regularly

with a predefined frequency and procedure.

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8 – Quality assuranceAs much as PSF-CI requires quality assurance from its suppliers, its

pharmaceutical stores must guarantee certain quality standards. So, differentmeasures must be known and respected.

8.1 – Standard operating procedures (SOPs)Each warehouse will have to establish standard operating procedures26, that is to

say clear and compulsory instructions of which the application guarantees resultsthat comply with quality standards.

The instructions apply to the organisation and the management of the warehouse.They must be clearly defined for each stage of each activity of the warehouse:

- Direct purchase from missions;- Purchase via the Headquarters;- Reception of local orders;- Reception of imported products;- Unpackaging of products;- Labelling of products;- Storage of products;- Computerized stock management;- respect of cold chain;- management of narcotic drugs;- preparation of an order for delivery;- repackaging of drugs;- return of products;- Management of outdated drugs;- Withdrawal of batches;- safety of premises;- cleanness of premises;- inventories;- human resources management;- etc.

SOPs are the reference tools of the warehouse. They shall be clear andaccessible to the warehouse staff. They will be used in particular during trainingsessions for the team.

They shall be written in compliance with the general instructions contained in thisguide. Particular attention should be given to the traceability of the products and to

26 Standard Operating Procedure (SOP) for PSFCI Pharmaceutical Technical Documents can be consulted toprovide tips to help write procedures.

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the responsibility of each member of the team (name, position, signature of thepersons having completed such and such task).

Field standard operating procedures, like any Pharmaceutical TechnicalDocuments, should include the logo of PSFCI and an endpaper identical to that ofthe Guidelines for PSFCI Pharmaceutical Technical Documents. The assistance ofthe responsible pharmacist (technical) may be required for the writing or the review ofthe procedures.

All standard operating procedures must be regularly reviewed as qualityassurance is a dynamic process: everything can always be improved by taking intoaccount the suggestions of the members of the team and the recommendationscontained in an external or internal audit report.

In all cases, a copy of all SOPs should be sent to the Headquarters.

8.2 – Pharmaceutical informationEach warehouse should have its own operational library in order to have, for each

product stored in the warehouse, clear, objective and updated information on theirindications, use, storage and their directions for use.

This information is kept in different standard guidelines such as NationalTherapeutic Formularies, the WHO Model Formulary, the Vidal dictionary, etc. Whenpossible, you should systematically subscribe to independent pharmaceuticaljournals.

8.3 - AuditsAudits aim at assessing the activities and the organisation of the warehouse.

They aim at answering key questions such as:! Have initially set activity and quality objectives been reached?! Are procedures correctly written, respected, reviewed?! Does the warehouse guarantee safety standards?! etc.

To assess the activities of the warehouse, the auditor shall use different activityindicators as well as pre-defined results that are objectively verifiable. For example:

- number of days where the temperature of the warehouse was over30°C;

- number of days where the temperature of the refrigerators was between0 and 8°C;

- number of deteriorated products handled;- number of days of stock outs;- number of products that are out of stock;- quantity of expired drugs;- quantity of destroyed drugs;

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- number of discrepancies between the physical and the theoretical stockafter inventory;

- number of stock cards that are not filled out correctly;- number of days where the team is complete;- number of complaints from beneficiary structures and/or NGOs;- etc.

The aim of these audits is to detect potential malfunctionings and, above all, tosuggest corrective measures to guarantee quality assurance in the PSFCIwarehouses.

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APPENDICES

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DIST/GS/SIE/001/G/REV00 I

Appendix I: OUTLINE FLOW DIAGRAM OF PHARMACEUTICAL PRODUCTS ANDACTIVITIES OF PSFCI

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DIST/GS/SIE/00

Appendix II: Typical schematic diagram for the layout of a pharmaceuticalwarehouse

GOODS RECEIPT

AREA

AREA FOR

PREPARATION OF

GOODS

ADMINISTRATIVEAREA

STORE

StorageOf

Emptyboxes

SYRUPS

INJECTABLES

PERFUSIONSOLUTIONS

REFRIGERATOR

NARCOTICS AND

CONTROLLEDPRODUCTS

Q

OR

MO

Worktop

FLAMMABLESPRODUCTS

TABLETS ANDRELATED

MATERIALS

1/G/REV00 II

MEDICAL EQUIPMENT

EXTERNAL USEUARANTINE

AREA RETURNED

PRODUCTS

ANAGEMENTF EXPIRED

MEDICINES

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DIST/GS/SIE/001/G/REV00 III

Appendix III: Store temperature control card

T°C(afternoon)DATE T°C

(morning) SIGNATUREMIN MAX

SIGNATURE

12345678910111213141516171819202122232425262728293031

MISSION :

THERMOMETER :

MONTH / YEAR :

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DIST/GS/SIE/001/G/REV00 IV

Appendix IV: Refrigerator maintenance and temperature control card

DATE T°C (morning) SIGNATURE T°C (afternoon) SIGNATURE

12345678910111213141516171819202122232425262728293031

MAINTENANCE DATE: NAME, POSITION, SIGNATURE :

MISSION :

REFRIGERATOR :

MONTH /YEAR :

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DIST/GS/SIE/001/G/REV00 V

Appendix V: Stock card

STOCK CARD

DESIGNATION (INN): STRENGTH: FORM :

Order threshold (M):

BATCH NB: EXPIRATION DATE:

QUANTITY PER PACKING UNIT:

DateTime

Issued to orReceived from

Ref of thenote

Input(quantities)

Output(quantities)

Balance(quantities) Remarks

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DIST/GS/SIE/001/G/REV00 VI

Appendix VI: Inventory list

INVENTORY LIST

DATE: TEAM :

NAMES:

INN Strength Form BATCHNB

EXP.DATE

Physicalstock(qties)

RemarksTheoretical

stock (qties)

Total number of mistakes: Signatures :

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DIST/GS/SIE/001/G/REV00 VII

Appendix VII: Temporary reception certificate (pharmaceutical products)

PHARMACIENS SANS FRONTIERES COMITE INTERNATIONAL

MISSION............................................

DATE : .…./…./2003 Temporary Reception Certificate

Page : …/… # PSFCI Clermont-FerrandCHRISTINE GODEFROY

Medical Purchasing Manager

SUPPLIER’S name :

DATE OF DELIVERY ……./…..…./2003

PACKING LIST Nb

INVOICE Nb

Transport : By Air $ By Sea $ By Road $ By Rail $

Company’s or Carrier’s name:

RECEPTION CONDITIONS :

Refrigerated items?: Yes$ No$ If yes : Conform ? Yes$ No$ Number of Pallets :Number of Boxes on the packing lists: ……….Number of Boxes received: …………….REMARKS (indicate if there is any damaged, missing or opened box, etc.). Do not forget toindicate the number of missing/damaged boxes and the cause of the problem :

Ex : damage due to the poor quality of the packaging, due to bad stowage, box opened bycustoms for inspection, by a robber….) :

Name :Position :Signature :

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DIST/GS/SIE/001/G/REV00 VIII

Appendix VIII: Definitive reception certificate (pharmaceutical products)

PHARMACIENS SANS FRONTIERES COMITE INTERNATIONAL

MISSION............................................

Definitive Reception CertificateDATE …./…./2003

# PSFCI Clermont-FerrandCHRISTINE GODEFROYMedical Purchase Manager

Page /

SUPPLIER

DATE OF DELIVERY

PACKING LIST Nb

INVOICE NbREMARKS (in case of any problem with an item, do not forget to indicate the number of thebox in which the item was, and the cause of the problem). Ex : missing, broken, stolen,expiry date too short…) :

Name :Position :Signature :

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DIST/GS/SIE/001/G/REV00 IX

Appendix IX: Estimate

ESTIMATEMission Zimbabwe Number : PO Box 12345 Date :

Tel : 00 23 56789 Ref of request : Type of structure :Fax : 00 23 69824 NGO : Facility : Town : Area :

Code Designation Pack. Quantity UnitPrice Amount

1TASA300 Aspirine 300mg cpr 1000 5 2.1 10.51TASA301 Aspirine 300mg cpr 500 1 0.8 0.81TPara500 Paracétamol 500mg cpr 1000 3 1.6 4.81IAMOX250 Amoxicilline 250mg inj powder 1 200 0.5 1001Scotri200 Cotrimoxazole 200mg/5ml syrup (5L) 1 2 5 102Cons aig21 Needle 21G 100 3 0.3 0.9

Weight/Vol. estimated: Kg / m3

Prices are in (currency) TOTAL AMOUNT :

Pharmaceutical Unit

DIST/GS/SIE/001/G/REV00 X

Appendix X: Example of a delivery preparation voucher

Delivery preparation voucherMission Zimbabwe Number : PO Box 12345 Date :

Tel : 00 23 56789 Ref. of request : Fax : 00 23 69824 NGO : Facility : Town : Area :

Estimate number:

Code Designation Pack. Qty UnitPrice Amount Batch

nb Exp. date.

1TASA300 Aspirine 300mg cpr 1000 5 2.1 10.5 8945M

02/05/06

1TASA300 Aspirine 300mg cpr 500 1 0.8 0.8 4557H

06/04/03

1TPara500 Paracétamol 500mg cpr 1000 3 1.6 4.8 5665Y 05/12/03

1IAMOX250

Amoxicilline 250mg injpowder 1 200 0.5 100 5387E 29/01/06

1Scotri200 Cotrimoxazole200mg/5ml syrup (5L) 1 2 5 10 5627P 25/11/05

2Consaig21 Needle 21G 100 3 0.3 0.9 2424

C22/06/04

Weight/Vol. estimated :Kg / m3

Prepared by: Controlled by :

Pharmaceutical Unit

DIST/GS/SIE/001/G/REV00 XI

Signature: Signature :

Pharmaceutical Unit

DIST/GS/SIE/001/G/REV00 XII

Appendix XI: Example of a delivery note

Delivery NoteMission Zimbabwe Number : PO Box 12345 Date :

Tel : 00 23 56789 Réf. Of request : Fax : 00 23 69824 NGO : Type of facility : Facility : Town : Area :

Estimate number:Delivery preparation voucher number:

Code Designation Pack. Qty Batchnb Exp. date

1TASA300 Aspirine 300mg cpr 1000 5 53745P 02/05/061TASA300 Aspirine 300mg cpr 500 1 45574Y 06/04/031TPara500 Paracétamol 500mg cpr 1000 3 65478I 05/12/031IAMOX250 Amoxicilline 250mg inj powder 1 200 63887I 29/01/06

1Scotri200 Cotrimoxazole 200mg/5mlsyrup (5L) 1 2 63787T 25/11/05

2Cons aig21 Needle 21G 100 3 24247I 22/06/04

Weight/Vol. estimated : Kg/ m3

Pharmaceutical Unit

DIST/GS/SIE/001/G/REV00 XIII

Appendix XII: Example of an invoice

INVOICEMission Zimbabwe Number : PO Box 12345 Date :

Tel : 00 23 56789 Ref. of request : Fax : 00 23 69824 NGO : Type of facility : Facility : Town : Area :

Estimate number: Delivery preparation voucher number:Delivery note number:

Code Designation Pack. Qty UnitPrice

Amount(autom.)

Batchnb

Exp.date

1TASA300 Aspirine 300mg cpr 1000 5 2.1 10.5 2457M

02/05/06

1TASA300 Aspirine 300mg cpr 500 1 0.8 0.8 7874T 06/04/03

1TPara500 Paracétamol 500mg cpr 1000 3 1.6 4.8 7879M

05/12/03

1IAMOX250 Amoxicilline 250mg injpowder 1 200 0.5 100 78979

E29/01/06

1Scotri200 Cotrimoxazole200mg/5ml syrup (5L) 1 2 5 10 25688

A25/11/05

2Cons aig21 Needle 21G 100 3 0.3 0.9 24247A

22/06/04

Pharmaceutical Unit

DIST/GS/SIE/001/G/REV00 XIV


Pharmaceutical Unit

DIST/GS/SIE/001/G/REV00 XV

Appendix XIII: Certificate of humanitarian donation

ATTESTATION DE DON HUMANITAIRECERTIFICATE OF HUMANITARIAN DONATION

Je, soussignée Christine GODEFROY, Responsabledes Achats de Pharmaciens Sans Frontières Comité

International (PSFCI), ONG (Organisation NonGouvernementale) humanitaire française, certifie

que les biens, objets de la présente attestation, sontdu don humanitaire en faveur de notre base située

à:

I, the undersigned, Christine GODEFROY, PurchasingManager of Pharmaciens Sans Frontières Comité

International (PSFCI), a French humanitarian NGO (NonGovernmental Organization), certify that the goods

concerned by this certificate are a humanitarian donationto our office located at:

Pharmaciens Sans Frontières C.I.Mission Tadjikistan 9

122 Proletarsky StDUSHAMBE(Tadjikistan)

Pharmaciens Sans Frontières C.I.Mission Tajikistan 9122 Proletarsky St

DUSHAMBE(Tajikistan)

Important: Ces biens sont destinés exclusivement àun usage humanitaire, et ne peuvent en aucun cas

être l'objet d’une vente, d’un échange ou d’unchangement de destination. Il n’y a eu aucune

transaction financière concernant ce don entre leTadjikistan et la France.

Important: These goods are exclusively for humanitarianuse, and on no account the products can be sold,

exchanged or sent to other destinations that the a/m one.There has been no financial transaction regarding this

donation between Tajikistan and France.A faire valoir ce que de droit. To Whom It May Concern.

Clermont-Ferrand, 13 February 2002

Christine GODEFROYResponsable des AchatsPurchasing Manager

Valeur marchande douanière / Value (EUR)13'314.24

N° Factures / Invoice Nb.3912

Poids / Weight (kg)4035.30

Volume / Volume (m3)12.496

Nbre de Colis / Nb. of Boxes255

Nbre de Palettes / Nb. of Pallets

Nature des Biens / Nature of GoodsMédicaments / Drugs

Fournisseur /SupplierMISSION PHARMA

Pharmaceutical Unit

DIST/GS/SIE/001/G/REV00 XVI

Appendix XIV: Example of a customer credit note

CUSTOMER CREDIT NOTEMission Zimbabwe Number : PO Box 12345 Date :

Tel : 00 23 56789 Invoice number: Fax : 00 23 69824 NGO : Structure :

Code Designation Pack. Qty UnitPrice Amount Batch

nbExpirydate

1TASA300 Aspirine 300mg cpr 1000 5 2.1 10.5 15647D

02/05/06

1TASA300 Aspirine 300mg cpr 500 1 0.8 0.8 57555H

06/04/03

1TPara500 Paracétamol 500mg cpr 1000 3 1.6 4.8 55888R

05/12/03

1IAMOX250

Amoxicilline 250mg injpowder 1 200 0.5 100 88785

E29/01/06

1Scotri200 Cotrimoxazole200mg/5ml syrup (5L) 1 2 5 10 47225

B25/11/05

2Consaig21 Needle 21G 100 3 0.3 0.9 24245

B22/06/04

Pharmaceutical Unit

DIST/GS/SIE/001/G/REV00 XVII


Appendix XV: Schematic diagrams displaying basic instructions

INVENTORY

Paracéta mol

500mg cpé

Acide ACETYLSALICILIQUE AMINOPHILINË

Stock card

Paracetamol 500mg Tab..

Stock: 4000Tab..

WHY?

• Deteriorated products

• Disappearance

• Mistakes

• Oversights

• Expired products

On the shelf:

3000 tablets = 3 boxes

Pharmaceutical Unit


Bon de Commande

Visé par le MIP ou le PIP

ou le MCZ

Order form

Signed by MIP or PIP

or MCZ

PSYCHOTROPICS

BCZ

MANAGEMENT OF PSYCHOTROPIC PRODUCTS

ORDER FORM SPECIFIC TO PSYCHOTROPICS

REGISTER OF PSYCHOTROPIC PRODUCTS

Pharmaceutical Unit


PSYCHOTROPICS

STORAGE OF PSYCHOTROPIC PRODUCTS

LOCKING CABINET

Pharmaceutical Unit


AminophyllineCp

Acetylsalicillic acid Amoxiycilline

STORAGE OF MEDICINES BYMETHOD OF INGESTION

AND IN ALPHABETICAL ORDER

Aminopphyllin

Adrenalin ACETYLSALICILIQUE

Ampicillin

ORAL DRUGS INJECTABLE DRUGS

Benzylpenicillin 1MUIAmoxycillinSyrup 125mg

Put the medicines in alphabetical order in each productfamily.

Place in front of each medicine a position card (label), givethe generic name (INN), dosage form and strength.

Store the medicines with the nearest expiration date first(FEFO)

CimetidinTab. 200mg

Pharmaceutical Unit


BIBLIOGRAPHY

- AEDES, Approvisionnement en médicaments; 2ème édition; novembre1993.

- MASSIS, Gérard (sous le direction de), Aide à l’organisation d’unemission : Situation-Intervention, Volume II, 2ème édition, 1994.

- PSF-CI, Final Report Tadjikistan 9 Echo/TJK/210/2001/0100601, PSF-CIMission Tadjikistan, 2002.

- PSF-CI, Procédures de gestion des stocks pharmaceutiques, PSF-CIMission Afghanistan; Mai 1997.

- MSFF, Médicaments essentiels, guide pratique d’utilisation; 3ème éditionrévisée

- MSH, Bien gérer les médicaments : la sélection, l’acquisition, la distributionet l’utilisation des produits pharmaceutiques dans les soins de santéprimaires; Management Sciences for Health, Institut Universitaire d’Etudesdu Développement.

- RUE-FENOUCHE, Cécile, Guide pratique : pré-requis à la gestion de stockdes pharmacies hospitalières; PSF-CI Mission Albanie, 2001.

- SCHELL, Jérôme, Guide de Gestion Logistique : Stock et Matériel PSF-CI;Service Missions; version 2.1, 2002.


PHARMACEUTICAL TECHNICAL DOCUMENT

REFERENCE : DIST/GS/ SIE/001/G/REV00

TITLE :« PSF-CI PHARMACEUTICAL GUIDE : HOW BETTER TO MANAGEPHARMACEUTICAL WAREHOUSES ? »

AUTHOR : Assalama ALFIDJA-CISSE POSITION: Responsible Pharmacist (Technical)

CIRCULATION DATE: 24 March 2003 IMPLEMENTATION: 31 March 2003

Approvals

Name Position Date SignatureM. BENEDIK Operations ManagerA. ALFIDJA-CISSE Responsible Pharmacist (technical)

1- CREATION UPDATING cancels and replaces PTD ref :…………………………………………

2 – OBJECT Recommandations relating to the management of PSFCI warehouses.

3 –APPLICATION FIELD: All PSFCI pharmaceutical warehouses.

4 – APPENDICES Appendix 1: Outline flow diagram of pharmaceutical products and activities of

PSFCIAppendix 2: Typical schematic diagram for the layout of a pharmaceutical

warehouseAppendix 3: Store temperature control cardAppendix 4: Refrigerators maintenance and temperature control cardAppendix 5: Stock cardAppendix 6: Inventory listAppendix 7: Temporary reception certificateAppendix 8: Definitive reception certificate Appendix 9: EstimateAppendix 10: Delivery preparation voucherAppendix 11: Delivery noteAppendix 12: InvoiceAppendix 13: Donation certificateAppendix 14: Customer credit noteAppendix 15: Schematic diagrams giving basic instructions


5 – CROSS REFERENCES AND CIRCULATION LIST

References:

- Interagency Guidelines for Safe Disposal of Unwanted Pharmaceuticals in and afteremergencies WHO/EDM/PAR/99.2.

- Guide Logistique : « La chaîne du froid ».- Guide Logistique : « Transport - Douanes ».- Procédure schéma directeur des Documents Techniques Pharmaceutiques de PSF-

CI.- Document Technique Pharmaceutique PSF-CI: « Comment évaluer les besoins ? »

(under way). - Guide PSF-CI « L’approvisionnement en produits pharmaceutiques » (under way).- Document Technique Pharmaceutiques PSF-CI « Liste des MEDESS et des

MATMED de PSF-CI » (under way).

Circulation list:

Operations ManagerDesk OfficerMedical Purchasing managerResponsible pharmacist (technical)Information officerMedical expatriates at the time of their briefing