|Essential Drugs -Practical Guidelines (MSF, 1993, 286 p.)|
Layout of the pharmacy
Management of the pharmacy
Organisation and rigorous management of the pharmacy are vital in all health structures, particularly when the resources are limited. These activities are often entrusted to doctors and nurses with little preparation and no experience in this area. The principles set out concisely in this guide concern the organisation and the management of a pharmacy in a health centre or health post; they are directed towards the following objectives:
- to maintain a permanent stock of drugs and appropriate medical
- to reduce the costs: purchase - management - wastage;
- to save time and optimise the work of the staff;
- to make it easier to check the management and continuously evaluate consumption.
During an emergency programme or in a precarious situation, the first objective is to ensure that the health structures are supplied. Pharmacy management (supply storage, distribution) should be both simple and precise enough to:
- set up the system quickly;
- integrate non-specialised, even non-qualified staff;
- replace the person in charge of the pharmacy if necessary, without adversely affecting medical activity;
- facilitate the later evolution towards a more complex management system.
In any case, it is essential to bear in mind the national pharmaceutical strategy and regulations, within which any pharmaceutical activities must be fitted.
To organise a regional or national programme, refer to the specialist works (see bibliography), especially "Managing drug supplies" (18) and "Approvisionnement en medicaments" (21).
Choice of drugs - Therapeutic regimens
Drawing up a list of basic drugs and standard therapeutic regimens offer two major advantages:
- better therapeutic treatment due to more rational and safer
use of a restricted number of essential drugs;
- economic and administrative improvements at the level of purchase, storage, distribution and control.
If a recently adapted national essential drug list exists, it should be respected. Otherwise the list proposed by the WHO (Technical reports series 796,1990) is adapted to suit the needs and priorities of each programme, based on the recommended selection procedures.
The use of such a list, which has generally proved its worth in practice, has several advantages:
- it makes it easier to coordinate international aid and obtain
the approval of the organisations which subsidise the projects (United Nations,
European Economic Community...);
- it simplifies and reduces the costs of supply: most drugs on the WHO list are available in generic form, at a price far more affordable than the corresponding patent drugs.
It is advisable to conform to certain treatment habits. For example, the doses of certain common drugs: in francophone Africa, tablets of 100 mg (base) of chloroquine are used, and 500 mg tablets of aspirin; in anglophone Africa, it is 150 mg (base) tablets of chloroquine and 300 mg aspirin tablets that are commonly used.
It will usually be necessary to avoid including the same drug under several dosages, which risks causing confusion in prescription and complicates management: paediatric doses can be obtained by dividing adult doses, made easier if the tablets are divisable.
The choice can also be affected by availability on the local market, if quality products are available at competitive prices.
Medical items (material for sterilisation, injection, suture.) should also be limited to the essentials and a standard list prepared.
Designation of drugs
Each active ingredient has an International Nonproprietary Name (INN) given by the WHO: drugs are designated by their INN in all standard lists. This name should be use in therapeutic protocols and management, so that everyone speaks the same language and there is no confusion. Common drugs are sold under a wide variety of brand names, depending on the manufacturer and distributor; same laboratory product may even have different names in different countries. For example, ampicillin can be Totapen (R), Penbritin (R), Pentrexil (R), Binotal (R).
Generic drugs are copies of drugs whose patents have expired. They can therefore be made by any pharmaceutical laboratory and are most often sold under their INN or occasionally under a new brand name.
Classification of drugs
Drugs can be classified in several ways.
- Pharmaco-therapeutic classification
In the WHO list, drugs are grouped according to their therapeutic action. In some cases, a drug can appear in several groups, sometimes in a different form (atropine, diazepam.). With this classification (and its peadagological advantage), it is easier to insert supplies from different origins as well as find a substitute for a missing product.
- Alphabetic classification according to administration
The drugs are divided into four groups and listed in alphabetical order within each group:
· oral drugs,
· drugs for external use.
This classification is used throughout this document since it satisfies the criteria of simplicity and standardization needed for the whole management system. Nonspecialised personnel can work with it.
Whichever classification is adopted, it should be used at every level of the management system (ordering, storage, distribution, dispensing) in order to facilitate all these procedures.
Levels of use
More limited lists should be drawn up depending on the capacities of the health facilities and the competence of the prescribers.
- "Health Post"
For the viIlage health workers.
- "Health Clinic"
For clinics with nurses or health auxiliaries.
- "District Hospital"
For health centres with doctors and physician's assistants.
- "Special Department"
To deal with the major endemic diseases and specialised hospital services: surgery, anaesthesia, obstetrics.
These restricted lists and the designation of the different levels must be adapted to the terminology and context of each country.
Quantitative evaluation of the needs
To define or reorganise a supply system, it is necessary to determine the quantities of drugs and materials needed. Once the list and therapeutic regimens have been established, it is possible to calculate the respective quantities of each drug from the expected number of patients and the diseases seen.
Several methods have been suggested: see "Estimating drug requirements" (41). The figures obtained can differ from those corresponding to the true needs or demand: this is the case when the improvement of a health centre increases its use, or when the prescribers do not follow the proposed lists and therapeutics regimens. It may be possible to refer to the consumption of drugs in other situations that are comparable in terms of population and pathology.
When the system is well organised, the management aids will easily supply the necessary figures.
In all precarious situations, the "Emergency Health Kit" provides a rapid response to the medical needs, both qualitative and quantitative. Each kit is intended to supply the drugs and material needed to cater to the health needs of a population of 10,000 people for 3 months. Afterwards, the specific local needs must be quickly evaluated to establish a suitable supply.
The systematic evaluation of the needs also makes it possible to check how well the prescription schemes are respected.
Layout of the pharmacy
It is necessary to design working premises sufficient to enable:
- the safekeeping of stocks,
- the preservation of the drugs and material,
- rational and straightforward management.
Whether it is a question of building from scratch or converting an existing building, a regional warehouse or a clinic pharmacy, the objectives are the same, only the means of reaching these objectives differ. The proposals in this chapter apply to a district pharmacy, responsible for supplying the district health centre as well as the clinics and village health posts that refer to it.
In this case, two separate areas, which may or may not be adjacent, are needed: one for the daily dispensing to the patients of the centre, the other a warehouse where the drugs and medical material intended for all of the health facilities of the district can be stored, managed and distributed.
Characteristics of the warehouse
The dimensions of the warehouse will be determined by the storage needs which depend on:
- the number of drugs and kinds of material held,
- the number and activities of the facilities supplied,
- the timespan between distributions of supplies and deliveries received: the further apart these are, the bulkier the stocks are and the bigger the space needed.
It is better to have something too big than too small: a cramped warehouse is difficult to work in and keep tidy, and any necessary increases in stock or activity are awkward.
The security of the goods stored necessitate that the doors, locks, windows and even ceilings are solidly built.
Whether the drugs are well preserved or not depends on the ambient temperature and humidity, factors that are often hard to control in a tropical environment.
- It should be well-aired, with fans if possible, or even air
conditioning which reduces the heat and humidity, but is very costly.
- Isolating construction materials can be used.
- The floors will be sloped so that water can run away, which makes maintenance far easier.
In colder countries, it should not be forgotten that frost can cause ampoules and bottles to break.
Layout of the interior of the warehouse
The layout should be logical and correspond to the circuit: reception, storage, distribution.
Solid and stable shelving is vital. In tropical countries where termites attack wood, metal structures are preferred; if they can be taken apart, it is easy to adjust the distances between the shelves to suit the goods to be stored.
The arrangement of the shelves, tables. varies according to the arrangement of the premises.
Space between the shelves and the walls will improve ventilation. No products or package, even large-sized, should be stored on the floor, but on pallets which permit air circulation and protect against flooding.
Examples of layout of a peripheral pharmacy (Health Center). For more larger stock or for a central pharmacy, use several rooms and apply the same principles by adapting the layout to the needs: administration, cold room or refrigerators.
Inside the room, or if this is not possible in an adjoining room, it is necessary to prepare the following storage areas:
- Incoming storage area
For the storage of packages, unpacking and checking of goods before they are placed on the shelves.
- Outgoing storage area
For the storage of peripheral orders before they are distributed. Every destination should have its assigned area where it is possible to store the packages until their distribution.
Those two storage areas will be situated close to the entrance to facilitate handling.
It is also recommended to plan a storage area for empty boxes which will be used to prepare the orders from peripheral pharmacies.
A working area has to be included to check the orders or to prepare the orders.
A desk, close to a light source if possible, will be used by the person in charge of the pharmacy for administration.
Arrangement of medicines and materials
The stock will be arranged according to the classification adopted:
- oral drugs,
- injectable drugs; infusion solutions will be stored separately due to their bulk
- drugs for external use and disinfectants,
- smaller medical materials classified in sub-categories: dressing, injection, suture
In every category (oral, injectable, infusions, external usage), the product will be classified alphabetically.
Every product needs its own well defined place, shown by a large label giving the name of the product in INN, its form and dose; for example:
Ampicillin caps 250 mg
Every box and bottle will be correctly labelled, a new label being put on if necessary (old one illegible, in a foreign language). A label should clearly show:
- the name of the product in INN,
- the dose,
- the form,
- the expiry date.
Narcotic drugs should be kept in a locked cupboard: fentanyl, pethidine, morphine (as well as ketamine. pentazocine and codeine in certain countries).
Clearly indicate on the boxes (chalk, large marker) the expiry date. Arrange the products with the latest expiry date at the back of the shelves and those that should be used first in the front. This arrangement is essential to avoid products passing their expiry date and becoming unusable.
- Storing bulky materials
Put a few boxes in their normal place and, on the label, state where the rest of the stock is kept. Do not separate the rest of the stock in several places.
- Storing medical materials
Given the diversity of the articles to be stored, it is preferable not to use a strict alphabetical ordering, but to group the articles by category: injection material, dressing, sutures.
Using the same order for the arrangement in the pharmacy, for the inventory lists and for orders makes the work far easier.
Further, to enable a person who is not familiar with the INN system to find their way around in times of emergency or in case of sudden replacement, or in order to train the auxiliary staff, a list of the commercial names and the corresponding INN can be put up,
- Allow enough space for each drug.
- The arrangement should make it possible to work "by sight".
It should be possible to pick out the number of boxes of each product. In a few minutes, it should be possible to work out how many weeks or months stock of a given product remains.
- An empty space behind a label immediately shows that that product is out of stock.
This way of arranging the supplies is essential to a simple and effective management. A few hours should be enough to do a complete stock inventory.
Management of the pharmacy
Organisation of activities
The management of a district pharmacy should be entrusted to a single person with adequate training. He will be responsible for both the health centre pharmacy and the warehouse; he will be helped by one or more assistants, depending on the workload anticipated.
The job of each worker must be defined exactly: one of them should be able to replace the person in charge if necessary.
The timetable and calendar of work (orders, distributions, stock-control activities) will be planned to spread the workload as evenly as possible.
The stock-card is the main instrument for stock-control. For each item (drug and material), a stock-card is made out and regularly updated, always by the same person. These cards allow:
- the identification of all movements of stock, in or out;
- the theoretical stock level to be available at any time;
- the consumption of the different users to be monitored;
- the orders to be correctly foreseen;
- an assessment of what and how much has been lost (difference between the theoretical stock and the actual stock after inventory).
On this stock-card, the following will be noted:
- The name of the product in INN, the form and the dose.
- All the movements (entries, exits, origin, destination) and the date.
- Orders made and the date.
- Inventories and the date. If the cards are well kept, and there are no thefts, the stock column corresponds to a permanent inventory.
- The following can also be included:
· safety stock,
· maximum stock,
· other storage areas for this product,
· unit price.
- The amounts are always recorded in units (5,000 tablets, 80
ampoules.) and never by box (10 boxes of ampicillin tablets could correspond to
200 tablets [10 boxes of 20 tablets] or 10,000 tablets [10 boxes of 1,000
- Write only one movement on each line, even if several operations take place the same day.
When an order is made, the date, supplier, and amount ordered are recorded. The stock column is not changed. When the order arrives, the amount received is included in the "incoming" column, and the "stock" column is then modified.
Example of a stock card
CALCULATION OF QUANTITIES TO RETAIN IN STOCK AND TO ORDER(STOCK LEVELS)
- Monthly consumption
This is calculated from the exits recorded on the stock cards: add the quantities in the outgoing column from several months (3, 6 or 12) and divide the total by the number of months.
- Working stock
Working stock corresponds to the amount of each drug consumed
between supply of the pharmacy. For example, if the supplies arrive every three
working stock = monthly consumption x 3.
- Safety stock (or reserve stock)
This stock is planned to compensate for any delays in delivery, increases in consumption or possible losses. It depends on the delivery time of the orders.
This is the quantity below which the stock should never fall, at the risk of running out of stock.
The quantity to be kept as a safety stock is generally calculated as half of the consumption during the time between two deliveries. It depends on the risks that the programme is able to take: running out of stock and having drugs pass their expiry date, in its particular context (resources, seasonal supply problems.).
- Quantity to order
The amount to order is based, for each item, on the information on the stock cards:
· stock according to the inventory when the order is
· safety stock,
· working stock.
Order = (working stock + safety stock) - remaining stock on the day the order was made.
ORDER AND DELIVERY FORMS
Pre-printed order forms make it easier to prepare orders and inventories, and to avoid transcription errors.
Order forms are drawn up according to the classification of the stock; the drugs are recorded using their INN names and the form (tablet, gel, bottle, ampoule.), dosage, amount ordered. The following can also be included:
- The unit price, so that the person in charge of the health
facility can calculate the cost of his order.
- The packaging generally supplied (box of 1,000 tabs, 100 ampoules).
- The level of distribution: each product is allocated to a level of health facility (the same order form is used for all facilities).
- The stocks: it is best to make an inventory before every order.
- The monthly consumption.
Three copies of the order should be made, dated and countersigned by the person in charge of the health facility. Two copies will be sent to the supplier: one of which will be used as a delivery note and can also be used for invoicing, the second one rests at suppliers. The third copy will be kept for the facility itself.
Example: health centre order form, supplied every 3 months, with a reserve stock of 4 months
Name of the facility: Beboro
Person responsible: Dr A. Bernard
RECEPTION OF THE ORDER
The order should be accompanied by a delivery note or an invoice showing the number of packages and their contents.
On reception, the number of packages should be checked immediately. Then, their contents can be checked:
- Ensure that the items delivered correspond to the items
ordered, and that the quantities conform to those on the delivery note.
- The packaging of each drug is checked, its labelling, its expiry date and the appearance of the product if possible.
The dispatcher will be informed immediately of any discrepancy.
The drugs and materials will be arranged, as soon as possible, in the place assigned to them. The quantities received are recorded on the stock-cards.
The delivery notes and invoices are filed with the order forms in an "orders" file to be kept for three years or more depending on the regulations in force.
At least once a year, but if possible before every order, an inventory of the quantities actually in stock and their expiry dates should be made.
The stock cards give a theoretical figure for the stock, but the quantities actually available should be checked, product by product. Differences can arise through theft or errors in the record-keeping. These differences should be thoroughly investigated.
An inventory can be made easily in a correctly arranged pharmacy. It is a vital job.
During the inventory, the pharmacy or warehouse should arrange that there is no movement of stock.
The warehouse supplies the pharmacies in the district following a timetable agreed between the warehouse manager and the persons in charge of the district health facilities. Each pharmacy will send the warehouse two copies of an order form (as described earlier):
- the quantities actually supplied by the warehouse in
completing the order will be filled in on both copies;
- one copy will be sent along with the delivery;
- the other will be placed in a file that has been created for each pharmacy in the district, after checking that each item sent has been correctly recorded on its stock card; the date of this recording will be on the order form as proof.
The orders and deliveries to the pharmacy of the district health centre will proceed in the same manner.
Each pharmacy in the district will have its own file intended for its own internal management. The entries in this file will keep an account of all that has come in from the order forms and all that has gone out from the consultation and (for the structures that have this facility) hospitalisation registers.
- Re-packaging drugs in view of their distribution
The drugs are delivered in large boxes (or containers) holding, for example, 1,000 tablets or 100 ampoules. It is necessary to divide the boxes of certain little-used or expensive drugs (e.g. ampoules of adrenaline - praziquantel) to distribute them to the pharmacies of small clinics.
To dispense the drugs to patients, it is better to pre-packe.
To do this:
· make a list of the most commonly prescribed
· note the usual treatment regimens for each of these drugs, for adults and for children in each age range;
· obtain small plastic bags (rather than paper);
· prepare labels for each drug, showing clearly:
- the name of the centre,
- the name of the drug (INN) and its dose,
- the dosage written out in full (and in symbols for the illiterate);
· put the number of tablets corresponding to a single
treatment and add the corresponding label into the bag;
· seal the bags: there are bags that can be resealed by pressure; if not it is possible to staple them closed or, preferably, to use a small heat-sealing machine which welds both sides.
Prepacking has many advantages:
· easier and quicker distribution;
· the drugs keep better;
· easier and more rigorous control over drugs going out;
· a more acceptable presentation to the patient; at the same time, the drug is easier to identify and the way to use it clearly indicated.
Drugs should be pre-packed according to precise procedures and checked to ensure hygiene norms are respected (cleanliness of hands, tables, containers before they are opened, bags.), to avoid the risk of making mistakes in the drugs dispensed or in counting, as well as to avoid drugs being lost while this work is being done. It is necessary for all health structures which have more than 20 consultations per day.
To get 100, 200 or 500 tablets from a container of 1000, it is possible to weigh them, rather than counting, if a sufficiently accurate balance is available.
To repackage large quantities of tablets (health centres of large districts) tablet-counters exist, either for manual counting or for automatic counting through a simple electrical device.
- Dispensing drugs to the pahent
For the patient to correctly follow his treatment, adequate explanation should be given to ensure that they understand:
· how to take the medicine;
· how often a for how long;
· why the entire course of an antibiotic treatment must be taken, whilst treatment with an analgesic should be stopped when the pain stops;
· possible side-effects: for example, drowsiness caused by anti-histamines, the need to avoid alcohol with metronidazole.
The person dispensing the drugs should be able to give the patient the information that he needs.
The packaging of the drug should be presentable; its label sufficiently legible and complete to remind the patient how to use the drug.
In busy centres, it is better to have two people responsible for dispensing to double check the delivery of prescriptions; the first assembles the drugs prescribed, the second checks that they are correct and gives them to the patient giving him all necessary explanations, a little apart from the other users.
Interpreters are needed if several languages or dialects exist in the same region.
Gifts of recuperated medicines and medical samples
It is recommended that you do not seek or accept supplies coming from collections of medicines retrieved from consumers in industrialised countries, or the samples that the manufacturers give freely to doctors.
Very often, they are proprietary drugs that are unknown to the prescribers and unsuitable for the local pathologies. The many brand drugs that are supplied in this way interfere with the implementation of standardised therapeutic regimens and makes any form of management impossible.
In certain individual cases, this support can be valuable, provided the drugs have been rigorously sorted and reply to the precise needs of competent prescribers. However, for most health centres and for the clinics, it is far better to use an autonomous supply system, based on a limited number of drugs at an acceptable cost, that can be used and managed correctly.
The choice of suppliers
To buy or to import? A choice has to be made whenever there is the possibility of obtaining supplies locally (manufacturers and/or wholesalers) and that, at the same time, individual importation procedures are permitted. Other than in emergencies, the decision depends on two factors, quality and cost.
There are poor quality drugs on the market that have not passed the necessary controls: some of them do not contain enough of the active ingredients, or even no active ingredients at all, while others are poorly made and deteriorate quickly.
To identify the dubious suppliers, those in charge of supply centres can seek advice from the local health authorities and hospital pharmacists who know the local pharmaceutical market that they must use.
You should compare the local price of supplies against the cost price of importing the same items, including freight charges (by sea of by air), transit costs and, sometimes, the payment of various duties.
Local supplies can have an advantage, even if the prices are slightly higher than the cost price of importation: they make it possible to reduce the level of stocks, since more frequent resupplies are possible, and therefore to reduce the risks of losses (expiry, misappropriations.) and the volume of storage needed.
For infusion solutions, which are very bulky and cost a lot in freight charges, it is recommended to buy locally if they are available and of good quality.
For rarely used drugs, which represent a negligible percentage of the total cost of supplies, it is not worth the effort of importing them if they are available on the spot and of good quality.