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CLOSE THIS BOOKEssential Drugs -Practical Guidelines (MSF, 1993, 286 p.)
Part two
VIEW THE DOCUMENTOrganization and management of a pharmacy
VIEW THE DOCUMENTPreservation and quality of the drugs
VIEW THE DOCUMENTPrescription, cost, compliance
VIEW THE DOCUMENTUse of antibiotics in precarious situations
VIEW THE DOCUMENTAntiseptics and disinfectants

Essential Drugs -Practical Guidelines (MSF, 1993, 286 p.)

Part two

Organization and management of a pharmacy

Preliminary stage
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 supplies;
- 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).

Preliminary stage

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,
· injectables,
· infusions,
· 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

The premises

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.

Shelving

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,

BACTRIM (R)

see Cotrimoxazole

FLAGYL (R)

see Metronidazole

VALIUM (R)

see Diazepam

TOTAPEN (R)

see Ampicillin

- 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.

Stock-control

STOCK CARDS

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 tablets]).
- 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 months,
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 made,
· 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
Date: 29.04.92
Signature: XXX


ORAL ADMINISTRATION

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.

INVENTORY

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.

DISTRIBUTION

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 drugs,
· 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.

Remarks

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.

QUALITY

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.

COST

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.

Preservation and quality of the drugs

General remarks
Quality
Identification
Stability - Storage
Expiry period
Deterioration

To guarantee effective treatment, it is vital to maintain the quality of the drugs, which means that their identity, dosage and condition have to be assured.

General remarks

Storage conditions and climatic conditions such as temperature, humidity and light are often very different in tropical countries than in those countries in which the drug was tested. This raises the question whether the drug is still reliable and effective upon arrival.

First, we ought to bear in mind that drugs do not lose their efficacy suddenly at the expiry date. The deterioration process is very slow and varies widely.

There are not only many different products but any given product may also come in various forms and the process of deterioration may vary accordingly.

The determination of the conventional expiry date is based upon the average rate of deterioration that is supposed to occur under normal conditions of light, temperature and humidity. When the expiry date has been calculated on the basis of such conditions, drugs will keep their original therapeutic effect up to the very date of expiry (at least 90% of the active ingredients should be still present and there should not be any substantial increase in toxicity).

Quality

In order to obtain good quality drugs, we should try to acquire them in the best possible manner, which means dealing with reliable suppliers and being able to assure quality maintenance through optimum transport and storage conditions.

The quality of generic drugs is equal to that of specialized pharmaceutical products, provided that they are manufactured and controlled properly. When no laboratory is available to test the quality of these generics, we have to rely on the manufacturers and wholesalers for proof of that quality. The choice of a supplier should never depend exclusively upon price.

Identification

All drugs should be easily identifiable, both by the medical staff and the patient. In whatever form the drug is packed (bottle, bag or box), it must bear not only the name of the product inside, but also its dose and expiry date. This is particularly important for generic drugs which are sometimes hard to recognize. Different products often look alike or, on the other hand, the same product may exist in different colours and/or forms (e.g. tablets or capsules).

Stability—Storage

Environmental conditions, such as temperature, air and light, are all factors that influence the storage of drugs.

TEMPERATURE

Standard storage conditions are normally defined as the following temperatures:

deep freeze

-15 to 0°C

refrigerator

0 to + 6°C

cooled

+6 to +15°C

room temperature

+ 15 to + 30°C

However, temperatures during transit and transport may reach 5°C to 60°C in vehicles, wagons or on loading platforms. This means that very often the original expiry dates cannot be guaranteed.

Freezing can be particularly damaging to solutions, causing precipitation of the active ingredients or breaking the ampoules.

AIR

Drugs may also be damaged by the influence of humidity and oxygen. Therefore all drug containers must remain closed. Special medical packing, often opaque and waterproof, offers protection against the influences of air and light. Avoid repackaging, until first distribution.

LIGHT

Excessive light may also harm drugs. Solutions are particularly sensitive to light. Injectable preparations have to be kept in the dark in their original packing. Certain types of coloured glass give the misleading impression that they protect drugs from light.

Remark

Laboratory equipment, such as chemical substances or rubber and sometimes plastic materials, require protective measures that are comparable to those for drugs.

Expiry date

In most countries, manufacturers art bound by law to have the stability of their products tested under standard conditions. They have to be able to ensure a minimum period of preservation. This is usually between 3 and 5 years, although certain sophisticated products have only a 1 to 2 year period before they expire.

Packaging should bear the expiry date and any specifications as to storage conditions.

When there is no such expiry date, the manufacturing date can be used as a basis for calculating the expiry period. Common antibiotics, hormone preparations, vitamins and liquid drugs in general will last 3 years from the date of manufacture. Other preparations usually have a 5-year period before expiry. This is only a very general rule and there are many exceptions. For instance, it does not apply to products that have to be stored under special conditions (refrigerated.).

Disposable material in sterilized packs may be used as long as the packaging remains intact.

Deterioration

Being well acquainted with the normal characteristics of every drug (colour, smell, solubility, appearance) is essential. It will enable you to detect any changes as soon as they occur. Certain processes may however occur without any detectable change in the appearance of the products.

Active agents that lose their power may have consequences varying in severity both for the individual patient or for a larger group of users.

Antibiotics that have expired, and become less active, may encourage resistant strains.

Any loss in effectiveness should not be compensated for by administering higher doses, since this may lead to serious risks of overdosage of toxic drugs.

Some drugs may even undergo changes that bring about the formation of substances which are far more dangerous and lead to an increase in toxicity. A classic example is tetracycline: when this pale-yellow powder has become brownish and viscous, it must not be used; tetracycline would then be dangerous to use, even if the expiry date has not yet been reached.

Other drugs which lose their effectiveness may produce an increase of allergic reactions. This is the case with penicillin and cephalosporin.

Do not use suppository, ovules, creams or ointments that have melted because of the heat. The active substance will no longer be homogeneously mixed.

Oral rehydration salts can be used as long as they maintain their typical white powdery aspect. Humidity will turn them into a compact mass, more or less brownish and insoluble. Whatever their expiry date, they are then no longer fit for consumption.

DRUGS THAT HAVE EXPIRED

When the only drug available has passed its expiry date, the doctor may in certain cases decide to use it anyway.

It is better to use such drug than to leave a seriously ill patient without treatment. Although a particular drug will not suddenly become unfit for consumption from one day to the next, the following factors should be considered before using any drug after its expiry date. Storage conditions should have been consistently acceptable, i.e. packaging undamaged, stored at an average temperature and protected against humidity and light. It should also be remembered that its physical appearance may not reveal some problems such as insolubility.

The drug sheets give information on the stability of a individual drugs. Unfortunately, research does not yet offer enough readily available information.

Expiry dates on drugs that require a precise dosage need to be strictly respected because of the risk of under-dosage. This is especially the case for cardiotonic drugs or anti-epileptics, and for drugs that may become toxic such as tetracyclines.

THROWING AWAY EXPIRED OR USELESS DRUGS AND MATERIALS

Do not throw away or bury any expired products without taking special precautions. It is advisable to incinerate them. If any tablets, capsules or liquid drugs are enclosed in incombustible packing, that packing should first be removed before incinerating the drugs. Keep a special spot for this operation and bury residual material at a great depth, far away from any well or water reservoir.

Prescription, cost, compliance

SOME SUGGESTIONS FOR

Reducing costs - Facilitating control - Reducing risks

Limiting the use of injectable drugs

Limiting the use of syrups and other drinkable solutions

Looking at other regimens of treatment

Considering the prescription of non-essential drugs and placebos

Using the traditional pharmacopoeia as a supplement to essential drugs

A more effective, safe and economical use of drugs can result from carefully choosing treatment protocols and the corresponding list of drugs.

Limiting the use of injectable drugs

Many patients ask to be treated by means of injection because they imagine it to be more effective. There are also prescribers who attach greater value and effectiveness to injections and transfusions.

Treatment by injection is always more costly than oral treatment. The price of the drug is higher for an equal dose of effective, active substance. More over, treatment by injection requires the strict sterilization of injection material or even the use of expensive disposable material. It may also expose the patient to complications due to poorly tolerated products (e.g. abscess, gangrene as a result of quinine injections, transfused antibiotics). Complications may arise when the injection technique is performed badly (overdose symptoms following an IV injection administered too quickly, paralysis of the sciatic nerve). If sterilization does not meet optimum standards, there may also be a risk of bacterial or viral contamination (tetanus, hepatitis, AIDS.).

If the drug required also exists in the form of tablets or capsules, injections should not be administered except in emergency cases when the patient's digestive system would not tolerate any other treatment or when he or she is incapable of taking the drug orally.

In such a case, treatment by means of oral drugs should replace treatment by injection as soon as possible (antimalarials, antibiotics, diuretics.).

Limiting the use of syrups and other drinkable solutions

It is often easier to take drugs in liquid form, especially for children who like the nice-smelling sweetened solutions. There are however numerous reasons to avoid the use of such syrups:

- Risk of incorrect usage

Away from controlled hospital conditions, people with little medical understanding may often take a dangerous dose of the drug. Spoons are never of a standard size (there are spoons used for soup, coffee, tea.). Solutions have to be prepared in advance, using an exact measure of clean boiled water and should be shaken before use. There is therefore a high chance of an under- or overdose.

Solutions can only be stored for a few days and carry the risk of contamination or fermentation.
In many countries, syrups are thought of as cough mixtures. This may account for much confusion between such cough mixtures and antibiotic syrups or solutions.

- Economic considerations

Compared with the price of tablets or capsules, the price of syrups and drinkable solutions is substantially higher. Even if used in the form of a powder for subsequent preparation, costs may be between 2 and 7 times higher than for an equivalent active dose. This is because of the drug bottle itself and the higher transportation costs caused by weight and volume.

Looking at other regimens of treatment

The initial choice of a particular treatment will often determine compliance and its medium-term cost. It is preferable to choose those treatments that are as short as possible and require fewest doses (once or twice a day). Obviously, treatment with a single dose daily is the ideal. In this respect, the following cases are good examples:

- An "instant" treatment using a single dose is often preferable, even if such a treatment is sometimes less effective from a pharmacological point of view. For instance, the treatment of amoebiasis with a single dose of 8 tablets of 250 mg metronidazole may be preferred to a dassic 7-day treatment.

- The combination of pyrimethamine-sulfadoxine for treating malaria should not be given as a first choice treatment in those zones where chloroquine is effective. But a single dose which may be taken immediately may be preferable for those patients who may not be very disciplined.

- A short-course anti-tuberculosis chemotherapy including rifampicin may seem a costly treatment. Those costs might be even higher if poorly monitored treatment is interrupted, followed by relapse or reinfection.

Considering the prescription of non-essential drugs and placebos

Psychosomatic illnesses occur frequently in developing countries, just as they do in industrialised ones. It is not always possible to prescribe a specific therapy in order to overcome these complaints. Is it really possible and desirable to send those patients home without giving them a symptomatic drug or a placebo? And what kind of placebo should be used?

When local medication rules are quite strict and do not allow the use of any placebo or non-essential symptomatic medication, we often see an abuse of other products (chloroquine, acetyl salicylic acid, diazepam and even antibiotics).

On the other hand, you may sometimes run the risk of using a placebo when genuinely effective and necessary medication should be prescribed. This happens, but not very frequently. Therefore, the introduction of a placebo on the drug list may be justified. Multivitamins may, for example, act as a harmless and relatively cheap placebo. Their composition is generally that necessary to prevent vitamin deficiencies and they have no contra-indications.

Many specialized pharmaceutical products (tonics, liver treatments presented as drinkable ampoules) have no real therapeutic justification and, as they cost more, they should not be used as placebos.

Using the traditional pharmacopoeia as a supplement to essential drugs

Effective traditional medication, usually intended for the treatment of symptoms, still exists nearly everywhere in the world. Prepared from local plants and used for generations, these remedies often have all the advantages and half the cost of industrially-prepared drugs for the same indications.

This may be the case for laxatives, cough mixtures, anti-diarrhoea, cholagogue and dermatological preparations. They may be administered in the form of infusions, decoctions or various other mixtures and they can be prepared at health care facilities.

Medical personnel should of course be aware of the existence of these treatments and suggest their use to patients as a complement to the therapeutic treatment that has already been chosen.
Nevertheless, the patient must understand the limits of traditional remedies when it comes to serious illnesses such as tuberculosis,meningitis. In these cases, there is no effective treatment other than "modern" drugs.

Use of antibiotics in precarious situations

ANTIBACTERLAL = ANTIBIOTICS + SULPHAMIDES.

Possible causes for failure of antibiotic treatment
Choice of antibiotic therapy
Combination of antibiotics
Principal antibiotic groups

Knowing which antibiotic to prescribe is difficult in precarious situations.

The diagnosis of an infection is essentially based on clinical criteria. It is practically impossible to rely on bacteriology (culture, isolation and identification of the bacteria). At best, a Gram stain can give an idea of the nature of the bacteria involved.

The choice of treatment protocol depends on the context in which the patient is seen:

- Dispensary: many patients examined rapidly and therefore difficult to follow up for treatment. Standard protocols should be drawn up for diagnosis and treatment of the most frequently encountered diseases. The number of available antibiotics will be restricted.

- Health centre and hospital: prescriptions can be more versatile. In case treatment fails or the patient tolerates the initial treatment badly, altematives are available. More antibiotics are available.

Possible causes for failure of antibiotic treatment

- Poor diagnosis: clinical signs of infection may be caused by diseases that are not of bacterial origin: viral, parasitic.
- The dosage or the length of treatment has been inadequate.
- The treatment has not been followed properly.
- Vomiting occurs after the drug has been taken orally.
- The interaction between different types of drugs taken by the patient decreases their absorption (e.g. tetracyclines with ferrous salts or antacids).
- The antibiotic does not diffuse well into the infected tissue (abscess, cerebro-spinal fluid).
- The antibiotic becomes inactive after several products have been mixed in the same infusion bag.
- The antibiotic has passed its expiry date or has lost its efficacy due to poor storage conditions (most antibiotics simply lose their effectiveness; tetracyclines, however, become toxic for the kidneys and they must be avoided).
- Bacterial resistance to the chosen antibiotic.

Choice of antibiotic therapy

The following table gives, for each type of infection, the bacteria most often responsible for such an infection and the antibiotics most suited both to these bacteria and diffusion into the infected tissue.

Explanatory notes:

- Medication preceded by an asterisk (*) is contra-indicated during pregnancy.
- Figures between brackets give an idea of the average price per treatment in French Francs (standard treatment being 5 days, except for typhoid fever: 3 weeks, and for trachoma: 1 month).
It is interesting to compare prices of different treatments. The cost would affect the choice of a particular treatment, along with other criteria such as effectiveness, tolerance and expected results.
- Antibiotics under the heading "alternative" should be prescribed if the initial choice of antibiotic fails, is not tolerated or is contra-indicated.


FIGURE


FIGURE

PPF = Procaine Penicillin Forte (3 MIU procaine penicillin + 1 MIU penicillin G)
Metro. = Metronidazole
Genta. = Gentamicine

Combination of antibiotics

A combined treatment using several antibiotics can only be justified in cases of severe infections.

Certain combinations are to be avoided because the effect of one antibiotic may neutralize the effect of the second when administered at the same time.

At any rate, the decision to use antibiotics in combination must be made by a doctor for each case and such a decision must never be made as a matter of course.

Penicillin and its derivatives should not be used in combination with tetracycline, chloramphenicol, erythromycin or rifampicin.

Principal antibiotic groups

PENICILLIN AND ITS DERIVATIVES

· Ampicillin and amoxycillin
· Benzathine penicillin
· Benzyl penicillin (Penicillin G)
· Cloxacillin
· Phenoxymethyl penicillin (Penicillin V)
· Procaine penicillin with or without benzyl penicillin

Fast-acting types

- Penicillin V or phenoxymethyl penicillin taken orally is the first treatment for tonsillitis. However, its effect on pulmonary infections is variable.
- Penicillin G or benzylpenicillin should be reserved for acute infections only. Because of its rapid elimination, injections every six hours are vital. This is difficult to manage outside a hospital environment.

Long-acting types

- Procaine penicillin has the advantage that it can be injected in one single dose once a day. It reacts quickly (45 to 60 minutes) and can only be injected IM.

For the treatment of gonorrhoea, it must be combined with probenecid.

- Procaine penicillin forte (PPF) is a combination of procaine penicillin and benzylpenicillin. It acts 15 to 30 minutes after injection, more rapidly than the procaine penicillin on its OWll, because of the penicillin G. For the treatment of gonorrhoea, it must be combined with probenecid.
- The concentration of the benzathine penicillin builds up progressively in the 24 hours following injection. It remains active for 15 to 20 days. Because of the delayed action and the low concentrations in the blood, it is only used for infections susceptible to penicillin which evolve slowly. Its use is contra-indicated in cases of acute infections.

Derivatives of penicillin

- Ampicillin is a broad-spectrum antibiotic. It is only to be used for the treatment of respiratory infections in children under 5 years of age: it is active against Hmophilus influenz, frequently the cause of these infections. Its use is also recommended for pregnant women, for whom other antibiotics are frequently contra-indicated. Apart from these examples, the use of cheaper antibiotics is preferred. The injectable forms should only be used in cases of severe infections.
- Amoxycillin has the same spectrum as ampicillin and has the advantage of a better intestinal absorption rate which allows lower doses to be given.
If orally administered, use amoxycillin rather than ampicillin if the cost is more or less the same.
- Cloxacillin is a small spectrum antibiotic, limited to the treatment of staphylococcus infections, as most of these have become resistant to penicillin.

MACROLIDES

- Erythromycin

Erythromycin should only be used in cases of penicillin allergy because it is expensive.
It is the only macrolide available in generic form. The others have the same indications.

PHENICOLS

- Chloramphenicol

Chloramphenicol is a broad spectrum antibiotic, effective against many types of infections. It should be the antibiotic of first choice in cases of typhoid fever.

Because of its efficacy and low cost, it is still widely used, but because of the risks of haematological toxicity, its use should be strictly limited to specific indications: typhoid fever, meningitis and broncho-pneumonia.

The injectable form of chloramphenicol in oil should be reserved for meningitis epidemics.

SULPHONAMIDES

· Sulfadimidine
· Sulfadoxine
· Cotrimoxazole (sulfamethoxazole + trimethoprim)

Simple sulphonamides

- The use of sulphonamides in the form of sulphadimidine is limited to lower urinary infections without complications (without lumbar pain or fever).
- Sulfadoxine is a long-acting antibiotic (about one week). Despite the existence of resistant strains and significant side-effects, it is still incorrectly used for meningitis or cholera epidemics.
- The use of non-absorbing sulphonamides (sulfaguanidine, phtalysulfathiazole) is not recommended because they rarely work in cases of intestinal infections of bacterial origin.

Combined sulphonamides
- The use of a sulphonamide in combination with trimethoprim (e.g. cotrimoxazole) benefits from the synergic effect of the two products. Indications are more numerous than for simple sulphonamides: urinary infections with fever, pneumonia's..

CYCLINES

· Tetracycline and oxytetracycline
· Doxycycline

- Because of the multiplication of organisms resistant to cyclines, they should be kept for specific infections: brucellosis, cholera, borreliosis, typhus, gonorrhoea resistant to penicillin and certain chronic pneumopathies. They must not be used as a matter of course and must always be prescribed under medical supervision.
- Doxycycline has the advantage of being able to be administered in a single dose for the treatment and prevention of cholera or typhus. It is still less widespread and better tolerated than tetracycline, even in case of renal disease.

AMINOSIDES

- Gentamicin

The specific indications for gentamicin are such that they should always be prescribed under medical supervision because of its toxicity, cost and frequent appearance of resistance.

ANTIBACTERIAL (ANTISEPTIC) OF THE URINARY TRACT

- Nitrofurantoin

It acts over a sufficiently wide spectrum to cover the majority of lower urinary tract infections in young women. In that case, it can be prescribed as first choice except late in pregnancy. Its cost is low.

Antiseptics and disinfectants

Definition
Selection
Table for the use of antiseptics and disinfectants
Preparation and storage of antiseptic solutions
Preparation and use of disinfectant solutions for floors and surfaces
Preparation and use of disinfectant solutions for medical material

Definition

Antiseptics are products used for the disinfection (asepsis) of living tissues (skin, wounds, mucosa.).

Disinfectants are products used for the disinfection of objects and surfaces (floors, tables.).

Certain products can be used both as antiseptic and as disinfectant (e.g. polyvidone iodine, chloramine T), but, unfortunately, the perfect product, which is cheap, effective for all bacteria, stable, easy to transport and suitable for use both on living tissue and objects, does not exist - at least not yet.

Selection

We can nevertheless suggest a restricted list of products that meet all the demands of medical facilities:

- normal soap,
- tosylchloramide sodium (= chloramine T),
- chlorhexidine (or preferably chlorhexidine + cetrimide),
- polyvidone iodine,
- gentian violet,
and for floors and surfaces:
- a soapy solution of cresol (= Lysol) or preferably a product that generates chlorine like calcium hypochlorite (HTH), bleach, sodium dichloro-isocyanurate (= NaDCC) or even chloramine T.

In the chapter "Drugs for external use and disinfectants", the descriptions for each product give details on the use of these products. Other widely-used products are also described.

Finally, some notes on particular products:

- Alcohols (ethanol and isopropanol)

Good disinfectants at 60-70° (60-70%) for objects or intact skin (more effective at 60-70° than at 90-95°), but:

They are not good for wounds because they are painful and slow the healing process.

They are expensive both to buy and to transport (they require special packing for air transport). Moreover, the purchase, transport and importation of ethanol often require complicated administrative procedures.

They can be advantageously replaced by polyvidone iodine.

- Chloroxylenol (Dettol (R))

An efficient but expensive product which can be used as an antiseptic (0.25% chloroxylenol solution) and disinfectant (see "soapy solution of cresol").

Can be of interest if locally available.

- Eosin

Antiseptic with limited effectiveness, but useful as a drying agent. Its aqueous solutions are easily contaminated by pathogenic bacteria.

Can be replaced by gentian violet.

- Hydrogen peroxide (hydroperoxide)

Very useful for certain indications (e.g. dirty wounds), but very hard to preserve in diluted and ready-to-use form. Concentrated hydrogen peroxide is dangerous to transport and handle.

- Hexachlorophene

Antiseptic with limited effectiveness and toxic for the central nervous system. Usage not advised.

- Mercury derivatives: e.g. Phenylmercury (Merfen (R)), Mercuresceine (Merbromine, Mercurochrome (R), Mercurobutol (Mercryl (R)), Thiomersal (Merthiolate (R), Timerosal (R))
Antiseptics with limited effectiveness in aqueous solutions (mercurosceine has very little effect).

Toxic for the kidneys and the central nervous system, often cause allergies and pollute the environment.

Forbid their use.

- Ether

Often wrongly used as an antiseptic. It has no disinfecting properties, but degreases the skin and removes sticky residues of elastoplast and similar dressings.


Table for the use of antiseptics and disinfectants

Preparation and storage

Although it may seem paradoxical, the aqueous solutions of antiseptics can become contaminated when handled and turn into bacterial cultures, especially Pseudomonas aeruginosa (pyocyanic).

To avoid this, the following precautions must be taken:

- Make all aqueous dilutions with either:

· drinking water,
· water filtered by a well-maintained candle type filter,
· boiled water (previously filtered through cotton if it is turbid).

- RENEW ALL AQUEOUS SOLUTIONS AT THE LAST ONCE A WEEK.
- Only prepare small amounts at a time to avoid wastage and the temptation to keep and use expired solutions.
- Never mix the fresh solution with the expired one (wash and dry the bottle before each refill).
- Do not use a cork.

On the bottles, mark the name and concentration of products.

Preparation and use of disinfectant solutions for floors and surfaces

- The dilutions of Lysol (or similar) and the dilutions of chlorinated disinfectants must be prepared just before use. Make the dilutions with clear water.
- The chlorinated disinfectants are only fully effective on clean surfaces. The area must be cleaned before they are applied. Nevertheless, they have the advantage of clearly proven antiviral activity and are relatively cheap.

Preparation and use of disinfectant solutions for medical material

Soaking clean material for 15 minutes in the disinfectant solutions indicated in the table below gives a very effective disinfection for bacteria in vegetative forms and for viruses (including the AIDS and hepatitis B virus). However, the bacterial spores are generally not destroyed (e.g. tetanus spores).

Sterilization (elimination of all bacteria, including the spores) can only be obtained with an autoclave or a good electric hot air sterilizer. Sterilization is obligatory for all materials that come in contact with sterile parts of the body (equipment for punctures, injections and surgery.)

Soaking in strong disinfectant solutions can sometimes be an alternative to sterilization when the latter is impossible. However, in that case, boiling is still the best approach. The effectiveness of chemical disinfection can be impaired by an error in the dilution or the degradation of the disinfectant resulting from poor storage conditions.

Chemical disinfection is never recommended for sterilizing syringes and needles.


Powerful disinfectants suitablefor use on medical material

CLEANING OF DIRTY EQUIPEMENT

Reusable equipment must be carefully cleaned before sterilization or disinfection.

The cleaning is carried out with water and soap (or another detergent).

To facilitate cleaning, the material should be soaked in water immediately after use, so soiled parts will not dry. Half an hour before cleaning the equipment, a disinfectant can be added to this water for an initial decontamination (e.g. chloramine 20 g/litre, Lysol 50 g/litre). Soaking for too long or with too high a concentration of disinfectant can cause corrosion of metal instruments.

After cleaning, the equipment must be carefully rinsed with clean water and then dried.

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