The Selection and Use of Essential Medicines - WHO Technical Report Series, No. 920
(2003; 137 pages) Ver el documento en el formato PDF
Índice de contenido
Ver el documento1. Introduction
Ver el documento2. Open session
Abrir esta carpeta y ver su contenido3. Update on current activities
Abrir esta carpeta y ver su contenido4. Changes made in revising the Model List
Abrir esta carpeta y ver su contenido5. Reviews of sections of the Model List
Ver el documento6. Priorities for future reviews
Abrir esta carpeta y ver su contenido7. Recommendations
Ver el documentoReferences
Ver el documentoAnnex 1 The 13th WHO Model List of Essential Medicines
Ver el documentoAnnex 2 The Anatomical Therapeutic Chemical (ATC) classification system1
Ver el documentoAlphabetical list of essential medicines (with ATC classification code numbers)
Ver el documentoSelected WHO Publications of Related Interest
 

Annex 1 The 13th WHO Model List of Essential Medicines

Introduction

The concept of essential medicines

Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility. Experience has shown that careful selection of a limited range of essential medicines results in a higher quality of care, better management of medicines (including improved quality of prescribed medicines), and a more cost-effective use of available health resources (1, 2).

The WHO Model List of Essential Medicines

Most countries require that a pharmaceutical product be approved on the basis of efficacy, safety and quality before it can be prescribed. The majority of health care and insurance schemes will only cover the cost of medicines on a given list of approved medicines. Medicines on such lists are selected after careful study of the medicines used to treat particular conditions and a comparison of the value they provide in relation to their cost. The WHO Model List of Essential Medicines (the Model List) is an example of such a list.

The first WHO Model List was drawn up in 1977 (3) in response to a request from the World Health Assembly (resolution WHA28.66) to the Director-General of WHO to provide Member States with advice on the selection and procurement, at reasonable costs, of essential medicines of established quality corresponding to their national health needs (4). The Model List has since been revised and updated 11 times (excluding the present revision) at intervals of approximately 2 years (5-15). Over the past two decades, the regular updating of the Model List has not only been at the heart of WHO's revised drug strategy (16) but has also formed a key component of the information required by Member States in relation to their medicine procurement and supply programmes.

The Model List was originally intended as a guide for the development of national and institutional essential medicine lists. It was not designed as a global standard. Nevertheless, since its introduction 25 years ago, the Model List has led to a global acceptance of the concept of essential medicines as a powerful tool for promoting health equity. By the end of 1999, 156 Member States had official essential medicines lists, of which 127 had been updated in the previous 5 years. Most countries have national lists; some have provincial or state lists as well.

The concept of essential medicines has also been adopted by many international organizations, including the United Nations Children's Fund (UNICEF) and the Office of the United Nations High Commissioner for Refugees (UNHCR), as well as by nongovernmental organizations and international non-profit supply agencies. Many of these organizations base their medicine supply system on the Model List. Lists of essential medicines also guide the procurement and supply of medicines in the public sector, schemes that reimburse medicine costs, medicine donations and local medicine production, and, furthermore, are widely used as informational and educational tools by health professionals. Health insurance schemes too are increasingly using national lists of essential medicines for reference purposes.

The way in which national lists of essential medicines are developed and used has evolved over time. Initially, lists were drawn up primarily as a means to guide the procurement of medicines. More recently, however, greater emphasis has been placed on the development of treatment guidelines as the basis for medicine selection and supply, and on the evidence underlying the development of those treatment guidelines. Consequently, there has been an increasing demand for information on why a particular medicine is included in the Model List and also for references to the underlying evidence. Activities are now underway to strengthen the links between the Model List and the treatment guidelines developed by WHO.

In its present form, the Model List aims to identify cost-effective medicines for priority conditions, together with the reasons for their inclusion, linked to evidence-based clinical guidelines and with special emphasis on public health aspects and considerations of value for money. Information that supports the selection of essential medicines, such as summaries of relevant WHO clinical guidelines, systematic reviews, key references and indicative cost information is being made available via the WHO web site as the WHO Essential Medicines Library1. The latter provides links to other relevant sources of information, including the WHO model formulary and information on nomenclature and quality assurance standards. The Essential Medicines Library is under construction and will be expanded over time. Its primary function is to facilitate the work of national and institutional committees in developing national and institutional lists of essential medicines.

1 http://www.who.int/medicines.


Medicines on the Model List are classified as either "core" list or "complementary" list medicines. The core list presents a list of minimum medicine needs for a basic health care system, listing the most efficacious, safe and cost-effective medicines for priority conditions. Priority conditions are selected on the basis of current and estimated future public health relevance, and potential for safe and cost-effective treatment. The complementary list presents essential medicines for priority diseases, for which specialized diagnostic or monitoring facilities and/or specialist medical care and/or specialist training are needed. In case of doubt, medicines may also be listed as complementary on the basis of consistently higher costs or less attractive cost-effectiveness in a variety of settings.

A number of medicines are labelled with a square box symbol. This symbol is primarily intended to indicate similar clinical performance within a pharmacological class. The listed medicine should be the example of the class for which there is the best evidence for effectiveness and safety. In some cases, this may be the first medicine that is licensed for marketing; in others, subsequently licensed compounds may be safer or more effective. Where there is no difference in terms of the efficacy and safety data, the listed medicine should be the one that is generally available at the lowest price, based on international drug price information sources. Therapeutic equivalence is only indicated on the basis of reviews of efficacy and safety and when consistent with WHO clinical guidelines. National lists should not use a similar symbol and should be specific in their final selection, which would depend on local availability and price. Examples of alternatives for the medicines with a square box symbol are not included in the Model List, but such information is provided in the WHO model formulary and in the Essential Medicines Library.

Procedures for updating the Model List

The procedures for updating the Model List are in line with the WHO recommended process for developing clinical practice guidelines (17). The key components are a systematic approach to collecting and reviewing evidence and a transparent development process with several rounds of external review. The procedures are intended to serve as a model for developing or updating national and institutional clinical guidelines and lists of essential medicines. Further information on the procedures for updating the Model List, including descriptions of the applications and details of the review process, is available from the WHO web site1.

1 http://www.who.int/medicines.


Selection criteria

The choice of essential medicines depends on several factors, including public health relevance and the availability of data on the efficacy, safety and comparative cost-effectiveness of available treatments. Factors such as stability in various conditions, the need for special diagnostic or treatment facilities and pharmacokinetic properties are also considered if appropriate. In adapting the Model List to their own needs, countries often consider factors such as local demography and the pattern of prevalent diseases; treatment facilities; training and experience of available personnel; local availability of individual pharmaceutical products; financial resources; and environmental factors.

The selection of essential medicines must be based on valid scientific evidence; only medicines for which sound and adequate data on effi-cacy and safety are available should be selected. In the absence of adequate scientific evidence on current treatment of a priority disease, the WHO Expert Committee on the Selection and Use of Essential Medicines may either defer its decision regarding selection until more evidence becomes available, or choose to make recommendations based on expert opinion and experience.

Most essential medicines should be formulated as single compounds. Fixed-dose combination products are selected only when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety, adherence or in delaying the development of drug resistance in malaria, tuberculosis and HIV/AIDS.

When making cost comparisons between medicines, the cost of the total treatment, not just the unit cost of the medicine, is considered. Cost and cost-effectiveness comparisons may be made among alternative treatments within the same therapeutic group, but are generally not made across therapeutic categories (e.g. between the treatment of tuberculosis and the treatment of malaria). The absolute cost of the treatment does not constitute a reason to exclude a medicine from the Model List that otherwise meets the stated selected criteria. The patent status of a medicine is not considered when selecting medicines for the Model List.

Quality assurance

Priority should be given to ensuring that available medicines have been made according to good manufacturing practices (18) and are of assured quality. Factors that need to be considered include:

- knowledge of, and confidence in, the origin of the product;
- the pharmaceutical stability of the product, particularly in the environment that it will be used;
- where relevant, bioavailability and bioequivalence information.


It is recommended that all medicines be purchased from known manufacturers, their duly accredited agents, or recognized international agencies known to apply high standards in selecting their suppliers.

Promoting rational use of essential medicines

The selection of essential medicines is only one step towards the improvement of the quality of health care; selection needs to be followed by appropriate use. Each individual should receive the right medicine, in an adequate dose for an adequate duration, with appropriate information and follow-up treatment, and at an affordable cost. Within different countries and settings, this is influenced by a number of factors, such as regulatory decisions, procurement, information, training, and the context in which medicines are prescribed or recommended.

Training, education and the provision of medicines information

To ensure the safe, effective and prudent use of essential medicines, access to relevant, reliable and independent information on medicines is vital. Health care professionals should receive education about the use of medicines not only during their training but also throughout their careers. The more highly trained individuals should be encouraged to assume responsibility for educating those with less training. Health care providers and pharmacists who are responsible for dispensing medicines should take every opportunity to inform consumers about the rational use of products, including those for self-medication, at the time they are dispensed.

Governments, universities and professional associations have a critical role to play with regard to the improvement of undergraduate, postgraduate and continuing education in clinical pharmacology, therapeutics and medicines information issues. Problem-based phar-macotherapy teaching has been shown to be a particularly effective strategy in this area (19).

Well presented and appropriate information about medicines not only ensures that they are used properly but also decreases the inappropriate use of medicines. Health ministries have a responsibility to arrange for the provision of such information. Independent medicines information activities should also be properly funded and, if necessary, financed through health care budgets. Electronic, readily accessible sources of medicines information are becoming more widely available and can form the basis of reliable medicines information systems in many settings.

Standard clinical guidelines

Standard clinical guidelines are an effective tool for assisting health professionals to choose the most appropriate medicine for a given patient with a given condition. They should be developed at national and local levels and updated on a regular basis. In order to be effective, however, standard clinical guidelines require the support of appropriate education and training programmes aimed at encouraging their use.

Drugs and therapeutic committees

Drugs and therapeutic committees can play an important role in the development and implementation of effective essential medicines programmes. Such committees should be encouraged to select products for local use from a national essential medicines list, to measure and monitor the use of these products in their own environments and to undertake interventions to improve their rational use. There is good evidence to suggest that involving both drugs and therapeutic committees and prescribers in guideline development can contribute to improved prescribing behaviour (20).

Measuring and monitoring medicine use

The purpose of drug utilization studies is to examine the development, regulation, marketing, distribution, prescription, dispensing and use of medicines within a society, with special emphasis on the medical, social and economic consequences. Studies of this type consider all levels of the therapeutic chain, from the development of medicines to their use by consumers. Drug utilization studies can be medicine-oriented (i.e. focused on the use of a particular medicine or group of medicines) or problem-oriented (i.e. focused on the treatment of a particular condition or disease) and can provide consumption indicators for a given country, area or institution.

Consumption can be measured in terms of economic expenditure (either in absolute terms or as a percentage of the total health budget), the number of units, or as Defined Daily Doses (DDDs) (21). However, it is generally recommended that drug utilization studies be conducted using the Anatomical Therapeutic Chemical (ATC) classi-fication and the DDD as the measuring unit, especially when making international comparisons on the use of medicines.

The efficacy of a medicine is best assessed on the basis of randomized clinical trials, which, if well conducted, provide reliable estimates of the treatment effect of a new medicine. However, clinical trials cannot be conducted in all possible populations or settings and therefore their results must be translated into routine clinical practice with care. Given that drug utilization studies generally provide evidence on the use and the effects of medicines in routine conditions, they can provide additional evidence for the evaluation of the effectiveness of a medicine.

Drug utilization studies and clinical trials are important tools for identifying those factors or elements of the therapeutic chain in need of improvement or change. The results of such studies should be taken into consideration when taking regulatory action, selecting medicines, or designing information, training and teaching programmes.

Monitoring of medicine safety and pharmacovigilance

Safety monitoring is an important part of the overall surveillance of medicine use. The aims of the various forms of pharmacovigilance are to identify new, previously unrecognized adverse effects of medicines, to quantify their risks, and to communicate these to drug regulatory authorities, health professionals, and, when relevant, the public. Voluntary reporting of adverse effects of medicines, on which the International WHO Programme for Drug Monitoring is based, has been effective in identifying a number of previously undescribed effects. Voluntary reporting schemes, together with other methods for assembling case series, can identify certain local safety problems, and thus form the basis for specific regulatory or educational interventions. The magnitude of the risk of adverse effects is generally evaluated using observational epidemiological methods, such as case-control, cohort and case-population studies. Each country and institution should set up simple schemes aimed at identifying problems related to the safety of medicines.

Explanatory notes

The core list presents a list of minimum medicine needs for a basic health care system, listing the most efficacious, safe and cost-effective medicines for priority conditions. Priority conditions are selected on the basis of current and estimated future public health relevance, and potential for safe and cost-effective treatment.

The complementary list presents essential medicines for priority diseases, for which specialized diagnostic or monitoring facilities and/or specialist medical care and/or specialist training are needed. In case of doubt, medicines may also be listed as complementary on the basis of consistently higher costs or less attractive cost-effectiveness in a variety of settings. In the present Model List (the 13th), complementary list medicines are distinguished by italicized typeface.

When the strength of a medicine is specified in terms of a selected salt or ester, this is mentioned in brackets; when it refers to the active moiety, the name of the salt or ester in brackets is preceded by the word "as".

The square box symbol () is primarily intended to indicate similar clinical performance within a pharmacological class. The listed medicine should be the example of the class for which there is the best evidence for effectiveness and safety. In some cases, this may be the first medicine that is licensed for marketing; in others, subsequently licensed compounds may be safer or more effective. Where there is no difference in terms of the efficacy and safety data, the listed medicine should be the one that is generally available at the lowest price, based on international drug price information sources. Therapeutic equivalence is only indicated on the basis of reviews of efficacy and safety and when consistent with WHO clinical guidelines. National lists should not use a similar symbol and should be specific in their final selection, which would depend on local availability and price.

Medicines are grouped according to therapeutic categories. The numbers preceding the sections and subsections have, in general, been allocated in accordance with English alphabetical order; they have no formal significance. Within sections, medicines are listed in alphabetical order.

Certain pharmacological effects have many therapeutic uses. Medicines with multiple uses could be listed under several therapeutic categories in the Model List. However, the inclusion of such medicines in more than one therapeutic category has been limited to those circumstances that the Expert Committee wishes to emphasize. Medicines on the Model List are therefore not listed in all of the therapeutic categories in which they are of value. Detailed information on the therapeutic use of essential medicines is available in the WHO model formulary (22).

Medicine

Route of administration, dosage forms and strengths

   

1. Anaesthetics

   

1.1 General anaesthetics and oxygen

   

ether, anaesthetica

inhalation

   

halothane

inhalation

   

ketamine

injection, 50mg (as hydrochloride)/ml in

 

10-ml vial

   

nitrous oxide

inhalation

   

oxygen

inhalation (medicinal gas)

   

thiopental

powder for injection, 0.5g, 1.0g (sodium

 

salt) in ampoule

1.2 Local anaesthetics

   

bupivacaine

injection, 0.25%, 0.5% (hydrochloride) in

 

vial

   
 

injection for spinal anaesthesia, 0.5%

 

(hydrochloride) in 4-ml ampoule to be

 

mixed with 7.5% glucose solution

   

lidocaine

injection, 1%, 2% (hydrochloride) in vial

   
 

injection for spinal anaesthesia, 5%

 

(hydrochloride) in 2-ml ampoule to be

 

mixed with 7.5% glucose solution

   
 

topical forms, 2-4% (hydrochloride)

lidocaine + epinephrine

injection, 1%, 2% (hydrochloride) +

(adrenaline)

epinephrine 1:200000 in vial

 

dental cartridge, 2% (hydrochloride) +

 

epinephrine 1:80000

   

Complementary list medicine

 
   

ephedrineb

injection, 30mg (hydrochloride)/ml in 1-ml

 

ampoule

   

1.3 Preoperative medication and sedation for short-term procedures

   

atropine

injection, 1mg (sulfate) in 1-ml ampoule

   

diazepam

injection, 5mg/ml in 2-ml ampoule

   
 

tablet, 5mg

   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

b For use in spinal anaesthesia during delivery, to prevent hypotension.

   

Morphine

injection, 10mg (hydrochloride or sulfate)

 

in 1-ml ampoule

   

promethazine

elixir or syrup, 5mg (hydrochloride)/5ml

   

2. Analgesics, antipyretics, non-steroidal anti-inflammatory medicines, medicines used to treat gout and disease-modifying agents used in rheumatoid disorders

   

2.1 Non-opioid analgesics and antipyretics, and non-steroidal anti-inflammatory medicines

   

acetylsalicylic acid

tablet, 100-500mg

   
 

suppository, 50-150mg

   

ibuprofen

tablet, 200mg, 400mg

   

paracetamola

tablet, 100-500mg

   
 

suppository, 100mg

   
 

syrup, 125mg/5ml

   

2.2 Opioid analgesics

   

codeine

tablet, 30mg (phosphate)

   

morphine

injection, 10mg (hydrochloride or sulfate)

 

in 1-ml ampoule

   
 

oral solution, 10mg (hydrochloride or

 

sulfate)/5ml

   
 

tablet, 10mg (sulfate)

   

2.3 Medicines used to treat gout

   

allopurinol

tablet, 100mg

colchicineb

tablet, 500 mg

2.4 Disease-modifying agents used in rheumatoid disorders

   

chloroquine

tablet, 100mg, 150mg (as phosphate or

 

sulfate)

   

a Not recommended for anti-inflammatory use due to lack of proven benefit to that effect.

b The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

Complementary list medicines

 
   

azathioprine

tablet, 50mg

   

methotrexate

tablet, 2.5mg (as sodium salt)

   

penicillamine

capsule or tablet, 250mg

   

sulfasalazine

tablet, 500mg

   

3. Antiallergics and medicines used in anaphylaxis

   

chlorphenamine

tablet, 4mg (hydrogen maleate)

   
 

injection, 10mg (hydrogen maleate) in

 

1-ml ampoule

   

dexamethasone

injection, 4mg dexamethasone

 

phosphate (as disodium salt) in 1-ml

 

ampoule

   

epinephrine (adrenaline)

injection, 1mg (as hydrochloride or

 

hydrogen tartrate) in 1-ml ampoule

   

hydrocortisone

powder for injection, 100mg (as sodium

 

succinate) in vial

   

prednisolonea

tablet, 5mg, 25mg

   

4. Antidotes and other substances used in poisonings

   

4.1 Non-specific

   

charcoal, activated

powder

   

4.2 Specific

   

acetylcysteine

injection, 200mg/ml in 10-ml ampoule

   

atropine

injection, 1mg (sulfate) in 1-ml ampoule

   

calcium gluconate

injection, 100mg/ml in 10-ml ampoule

   

deferoxamine

powder for injection, 500mg (mesilate) in

 

vial

   

dimercaprol

injection in oil, 50mg/ml in 2-ml ampoule

   

DL-methionine

tablet, 250mg

   

a There is no evidence for complete clinical similarity between prednisolone and dexamethasone at high doses.

   

methylthioninium chloride

injection, 10mg/ml in 10-ml ampoule

(methylene blue)

 

naloxone

injection, 400 µg (hydrochloride) in 1-ml

 

ampoule

   

penicillamine

capsule or tablet, 250mg

   

potassium ferric hexacyano-

powder for oral administration

ferrate(II)·2H2O (Prussian blue)

 
   

sodium calcium edetate

injection, 200mg/ml in 5-ml ampoule

   

sodium nitrite

injection, 30mg/ml in 10-ml ampoule

   

sodium thiosulfate

injection, 250mg/ml in 50-ml ampoule

   

5. Anticonvulsants/antiepileptics

   

carbamazepine

scored tablet, 100mg, 200mg

   

diazepam

injection, 5mg/ml in 2-ml ampoule

 

(intravenous or rectal)

   

magnesium sulfatea

injection, 500mg/ml in 2-ml ampoule,

 

500mg/ml in 10-ml ampoule

   

phenobarbital

tablet, 15-100mg

   
 

elixir, 15mg/5ml

   

phenytoin

capsule or tablet, 25mg, 50mg, 100mg

 

(sodium salt)

   
 

injection, 50mg (sodium salt)/ml in 5-ml

 

vial

   

valproic acid

enteric coated tablet, 200mg, 500mg

 

(sodium salt)

   

Complementary list medicines

 

clonazepamb

scored tablet, 500µg

ethosuximide

capsule, 250mg

   
 

syrup, 250mg/5ml

a For use in eclampsia and severe pre-eclampsia and not for other convulsant disorders.

b The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

6. Anti-infective medicines

   

6.1 Anthelminthics

   

6.1.1 Intestinal anthelminthics

   

albendazole

chewable tablet, 400mg

   

levamisole

tablet, 50mg, 150mg (as hydrochloride)

   

mebendazole

chewable tablet, 100mg, 500mg

   

niclosamidea

chewable tablet, 500mg

   

praziquantel

tablet, 150mg, 600mg

   

pyrantela

chewable tablet, 250mg (as embonate)

   
 

oral suspension, 50mg (as embonate)/ml

   

6.1.2 Antifilarials

   

ivermectin

scored tablet, 3mg, 6mg

   

Complementary list medicines

 
   

diethylcarbamazine

tablet, 50mg, 100mg (dihydrogen citrate)

   

suramin sodium

powder for injection, 1g in vial

   

6.1.3 Antischistosomals and other antitrematode medicines

   

praziquantel

tablet, 600mg

   

triclabendazolea

tablet, 250mg

   

Complementary list medicine

 
   

oxamniquinea

capsule, 250mg

   
 

syrup, 250mg/5ml

   

6.2 Antibacterials

6.2.1 β-Lactam medicines

amoxicillin

capsule or tablet, 250mg, 500mg

 

(anhydrous)

   
 

powder for oral suspension, 125mg

 

(anhydrous)/5ml

   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

amoxicillin + clavulanic acida

tablet, 500mg + 125mg

ampicillin

powder for injection, 500mg, 1g (as

 

sodium salt) in vial

   

benzathine benzylpenicillin

powder for injection, 1.44g

 

benzylpenicillin (= 2.4 million IU) in

 

5-ml vial

benzylpenicillin

powder for injection, 600mg (= 1 million

 

IU), 3g (= 5 million IU) (sodium or

 

potassium salt) in vial

   

cloxacillin

capsule, 500mg, 1g (as sodium salt)

   
 

powder for oral solution, 125mg (as

 

sodium salt)/5ml

   
 

powder for injection, 500mg (as sodium

 

salt) in vial

   

phenoxymethylpenicillin

tablet, 250mg (as potassium salt)

   
 

powder for oral suspension, 250mg (as

 

potassium salt)/5ml

procaine benzylpenicillin

powder for injection, 1g (= 1 million IU),

 

3g (= 3 million IU) in vial

Complementary list medicines

 
   

ceftazidimea

powder for injection, 250mg (as

 

pentahydrate) in vial

   

ceftriaxonea

powder for injection, 250mg (as sodium

 

salt) in vial

imipenem + cilastatina,b

powder for injection, 250mg (as

 

monohydrate) + 250mg (as sodium

 

salt), 500mg (as monohydrate) +

 

500mg (as sodium salt) in vial

   

a Reserve antimicrobial for use only when there is significant resistance to other medicines on the Model List.

b The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

6.2.2 Other antibacterials

   

azithromycina

capsule, 250mg, 500mg

   
 

oral suspension, 200mg/5ml

   

chloramphenicol

capsule, 250mg

   
 

oral suspension, 150mg (as palmitate)/

 

5ml

   
 

powder for injection, 1g (sodium

 

succinate) in vial

   
 

oily suspension for injection, 0.5g (as

 

sodium succinate)/ml in 2-ml ampoule

   

ciprofloxacinb

tablet, 250mg (as hydrochloride)

   

doxycyclineb

capsule or tablet, 100mg (hydrochloride)

   

erythromycin

capsule or tablet, 250mg (as stearate or

 

ethyl succinate)

   
 

powder for oral suspension, 125mg (as

 

stearate or ethyl succinate)

   
 

powder for injection, 500mg (as

 

lactobionate) in vial

   

gentamicinb

injection, 10mg, 40mg (as sulfate)/ml in

 

2-ml vial

   

metronidazole

tablet, 200-500mg

   
 

injection, 500mg in 100-ml vial

   
 

suppository, 500mg, 1g

   
 

oral suspension, 200mg (as benzoate)/

 

5ml

   

nalidixic acidc

tablet 250mg, 500mg

   

nitrofurantoin

tablet, 100mg

   

a Only listed for single-dose treatment of genital Chlamydia trachomatis and of trachoma.

b Final selection depends on indication for use.

c The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

spectinomycina

powder for injection, 2g (as

 

hydrochloride) in vial

sulfamethoxazole + trimethoprim

tablet, 100mg + 20mg, 400mg + 80mg

 

oral suspension, 200mg + 40mg/5ml

 

injection, 80mg + 16mg/ml in 5-ml

 

ampoule, 80mg + 16mg/ml in 10-ml

 

ampoule

   

trimethoprim

tablet, 100mg, 200mg

   

Complementary list medicines

 
   

clindamycin

capsule, 150mg

   
 

injection, 150mg (as phosphate)/ml

   

sulfadiazine

tablet, 500mg

   
 

injection, 250mg (sodium salt) in 4-ml

 

ampoule

   

vancomycinb

powder for injection, 250mg (as

 

hydrochloride) in vial

   

6.2.3 Antileprosy medicines

 
   

Medicines used in the treatment of leprosy should never be used except in combination (i.e. as multidrug therapy (MDT)). Combination therapy is essential to prevent the emergence of drug resistance. Colour-coded blister packs (MDT blister packs) containing standard two-medicine (paucibacillary leprosy) or three-medicine (multibacillary leprosy) combinations for adult and childhood leprosy should be used. MDT blister packs can be supplied free of charge through WHO.

   

clofazimine

capsule, 50mg, 100mg

   

dapsone

tablet, 25mg, 50mg, 100mg

   

rifampicin

capsule or tablet, 150mg, 300mg

   

6.2.4 Antituberculosis medicines

   

ethambutol

tablet, 100-400mg (hydrochloride)

   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

b Reserve antimicrobial for use only when there is significant resistance to other medicines on the Model List.

   

isoniazid

tablet, 100-300mg

isoniazid + ethambutol

tablet, 150mg + 400mg

pyrazinamide

tablet, 400mg

   

rifampicin

capsule or tablet, 150mg, 300mg

rifampicin + isoniazid

tablet, 60mg + 30mg, 150mg + 75mg,

 

300mg + 150mg, 60mg + 60mga,

 

150mg + 150mga

rifampicin + isoniazid +

tablet, 60mg + 30mg + 150mg, 150mg +

pyrazinamide

75mg + 400mg, 150mg + 150mg +

 

500mga

rifampicin + isoniazid +

tablet, 150mg + 75mg + 400mg +

pyrazinamide + ethambutol

275mg

streptomycin

powder for injection, 1g (as sulfate) in

 

vial

   

Complementary list medicines

 
   

amikacinb

powder for injection, 1g in vial

   

p-aminosalicylic acidb

tablet, 500mg

   
 

granules, 4g in sachet

   

capreomycinb

powder for injection, 1g in vial

   

ciprofloxacinb

tablet, 250mg, 500mg

   

cycloserineb

capsule or tablet, 250mg

   

ethionamideb

tablet, 125mg, 250mg

   

kanamycinb

powder for injection, 1g in vial

   

levofloxacinb,c

tablet, 250mg, 500mg

   

ofloxacinb

tablet, 200mg, 400mg

a For intermittent use three times weekly.

b Reserve second-line medicine for the treatment of multidrug-resistant tuberculosis which should be used in specialized centres adhering to WHO standards for tuberculosis control.

c The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

thioacetazone +

tablet, 50mg + 100mg, 150mg + 300mg

isoniazida

 
   

6.3 Antifungal medicines

   

fluconazole

capsule, 50mg

   
 

injection, 2mg/ml in vial

   
 

oral suspension, 50mg/5ml

   

griseofulvin

capsule or tablet, 125mg, 250mg

   

nystatin

tablet, 100000IU, 500000IU

   
 

lozenge, 100000IU

   
 

pessary, 100000IU

   

Complementary list medicines

 
   

amphotericin B

powder for injection, 50mg in vial

   

flucytosine

capsule, 250mg

   
 

infusion, 2.5g in 250ml

   

potassium iodide

saturated solution

   

6.4 Antiviral medicines

   

6.4.1 Antiherpes medicines

   

aciclovir

tablet, 200mg

   
 

powder for injection, 250mg (as sodium

 

salt) in vial

   

6.4.2 Antiretroviral medicines

   

The antiretroviral medicines do not cure the HIV infection, they only temporarily suppress viral replication and improve symptoms. They have various adverse effects and patients receiving these medicines require careful monitoring by adequately trained health professionals. For these reasons, continued rigorous promotion of measures to prevent new infections is essential and the need for this has not been diminished in any way by the addition of antiretroviral medicines to the Model List. Adequate resources and trained health professionals are a prerequisite for the introduction of this class of medicines. Effective therapy requires commencement of three or four medicines simultaneously, and alternative regimens are necessary to meet specific requirements at start-up, to substitute for first-line regimens in the case of toxicity, or to replace failing regimens. The Committee strongly recommends the use of three- or four-medicine combinations as specifically recommended in the WHO treatment guidelines (23). The use of fixed-dose preparations for these combinations is also recommended, with assured pharmaceutical quality and interchangeability with the single products as approved by the relevant drug regulatory authority.

   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

(a) Nucleoside reverse transcriptase inhibitors

   

abacavir (ABC)

tablet, 300mg (as sulfate)

   
 

oral solution, 100mg (as sulfate)/5ml

   

didanosine (ddI)

buffered chewable dispersible tablet,

 

25mg, 50mg, 100mg, 150mg, 200mg

   
 

buffered powder for oral solution, 100mg,

 

167mg, 250mg packets

   
 

unbuffered enteric coated capsule,

 

125mg, 200mg, 250mg, 400mg

   

lamivudine (3TC)

tablet, 150mg

   
 

oral solution, 50mg/5ml

   

stavudine (d4T)

capsule, 15mg, 20mg, 30mg, 40mg

   
 

powder for oral solution, 5mg/5ml

   

zidovudine (ZDV or AZT)

tablet, 300mg

   
 

capsule, 100mg, 250mg

   
 

oral solution or syrup, 50mg/5ml

   
 

solution for IV infusion injection, 10mg/ml

 

in 20-ml vial

   

(b) Non-nucleoside reverse transcriptase inhibitors

   

efavirenz (EFV or EFZ)

capsule, 50mg, 100mg, 200mg

   
 

oral solution, 150mg/5ml

   

nevirapine (NVP)

tablet, 200mg

   
 

oral suspension, 50mg/5ml

   

(c) Protease inhibitors

   

Selection of two or three protease inhibitors from the Model List will need to be determined by each country after consideration of local clinical guidelines and experience, as well as the comparative costs of available products. Ritonavir is recommended for use in combination with indinavir, lopinavir and saquinavir as a booster, and not as a medicine in its own right.

   

indinavir (IDV)

capsule, 200mg, 333mg, 400mg (as

 

sulfate)

lopinavir + ritonavir (LPV/r)

capsule, 133.3mg + 33.3mg

 

oral solution, 400mg + 100mg/5ml

nelfinavir (NFV)

tablet, 250mg (as mesilate)

   
 

oral powder, 50mg/g

   

ritonavir (r)

capsule, 100mg

   
 

oral solution, 400mg/5ml

   

saquinavir (SQV)

capsule, 200mg

   

6.5 Antiprotozoal medicines

   

6.5.1 Antiamoebic and antigiardiasis medicines

   

diloxanide

tablet, 500mg (furoate)

   

metronidazole

tablet, 200-500mg

   
 

injection, 500mg in 100-ml vial

   
 

oral suspension, 200mg (as benzoate)/

 

5ml

   

6.5.2 Antileishmaniasis medicines

   

meglumine antimoniate

injection, 30%, equivalent to

 

approximately 8.1% antimony,

 

in 5-ml ampoule

   

Complementary list medicines

 
   

amphotericin B

powder for injection, 50mg in vial

   

pentamidine

powder for injection, 200mg, 300mg

 

(isetionate) in vial

   

6.5.3 Antimalarial medicines

   

(a) For curative treatment

   

Medicines for the treatment of P. falciparum malaria cases should be used in combination.

   

amodiaquinea

tablet, 153mg, 200mg (base)

   

a Amodiaquine should preferably be used as part of combination therapy.

   

artemether + lumefantrinea

tablet, 20mg + 120mg

chloroquine

tablet, 100mg, 150mg (as phosphate or

 

sulfate)

   
 

syrup, 50mg (as phosphate or sulfate)/

 

5ml

   
 

injection, 40mg (as hydrochloride,

 

phosphate or sulfate)/ml in 5-ml

 

ampoule

   

primaquine

tablet, 7.5mg, 15mg (as diphosphate)

   

quinine

tablet, 300mg (as bisulfate or sulfate)

   
 

injection, 300mg (as dihydrochloride)/ml

 

in 2-ml ampoule

   

Complementary list medicines

 
   

artemetherb

injection, 80mg/ml in 1-ml ampoule

   

artesunateb

tablet, 50mg

   

doxycyclinec

capsule or tablet, 100mg (hydrochloride)

   

mefloquine

tablet, 250mg (as hydrochloride)

sulfadoxine + pyrimethamine

tablet, 500mg + 25mg

(b) For prophylaxis

   

chloroquine

tablet, 150mg (as phosphate or sulfate)

   
 

syrup, 50mg (as phosphate or sulfate)/

 

5ml

   

doxycycline

capsule or tablet, 100mg (hydrochloride)

   

mefloquine

tablet, 250mg (as hydrochloride)

   

proguanild

tablet, 100mg (hydrochloride)

   

a Recommended for use in areas with significant drug resistance and not in pregnancy or in children below 10kg.

b Reserve antimicrobial for use only when there is significant resistance to other medicines on the Model List.

c For use only in combination with quinine.

d For use only in combination with chloroquine.

   

6.5.4 Antipneumocystosis and antitoxoplasmosis medicines

   

pyrimethamine

tablet, 25mg

sulfamethoxazole + trimethoprim

injection, 80mg + 16mg/ml in 5-ml

 

ampoule, 80mg + 16mg/ml in

 

10-ml ampoule

   

Complementary list medicine

 
   

pentamidine

tablet, 200mg, 300mg

   

6.5.5 Antitrypanosomal medicines

   

(a) African trypanosomiasis

   

melarsoprol

injection, 3.6% solution

   

suramin sodium

powder for injection, 1g in vial

   

Complementary list medicines

 
   

eflornithine

injection, 200mg (hydrochloride)/ml in

 

100-ml bottle

   

pentamidine

powder for injection, 200mg, 300mg

 

(isetionate) in vial

   

(b) American trypanosomiasis

   

benznidazole

tablet, 100mg

   

nifurtimox

tablet, 30mg, 120mg, 250mg

   

6.6 Insect repellents

   

diethyltoluamidea

topical solution, 50%, 75%

   

7. Antimigraine medicines

   

7.1 For treatment of acute attack

   

acetylsalicylic acid

tablet, 300-500mg

   

ergotaminea

tablet, 1mg (tartrate)

   

paracetamol

tablet, 300-500mg

   

a The public health relevance and/or efficacy and or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

7.2 For prophylaxis

   

propranolol

tablet, 20mg, 40mg (hydrochloride)

   

8. Antineoplastics, immunosuppressives and medicines used in palliative care

   

8.1 Immunosuppressive medicines

   

Complementary list medicines

 
   

azathioprine

tablet, 50mg

   
 

powder for injection, 100mg (as sodium

 

salt) in vial

   

ciclosporina

capsule, 25mg

   
 

concentrate for injection, 50mg/ml in

 

1-ml ampoule

   

8.2 Cytotoxic medicines

   

Complementary list medicines

 
   

asparaginase

powder for injection, 10000IU in vial

   

bleomycin

powder for injection, 15mg (as sulfate) in

 

vial

   

calcium folinate

tablet, 15mg

   
 

injection, 3mg/ml in 10-ml ampoule

   

chlorambucil

tablet, 2mg

   

chlormethine

powder for injection, 10mg

 

(hydrochloride) in vial

   

cisplatin

powder for injection, 10mg, 50mg in vial

   

cyclophosphamide

tablet, 25mg

   
 

powder for injection, 500mg in vial

   

cytarabine

powder for injection, 100mg in vial

   

dacarbazine

powder for injection, 100mg in vial

dactinomycin

powder for injection, 500µg in vial

daunorubicin

powder for injection, 50mg (as

 

hydrochloride)

   

a For organ transplantation.

   

doxorubicin

powder for injection, 10mg, 50mg

 

(hydrochloride) in vial

   

etoposide

capsule, 100mg

   
 

injection, 20mg/ml in 5-ml ampoule

   

fluorouracil

injection, 50mg/ml in 5-ml ampoule

   

levamisole

tablet, 50mg (as hydrochloride)

   

mercaptopurine

tablet, 50mg

   

methotrexate

tablet, 2.5mg (as sodium salt)

   
 

powder for injection, 50mg (as sodium

 

salt) in vial

   

procarbazine

capsule, 50mg (as hydrochloride)

   

vinblastine

powder for injection, 10mg (sulfate) in

 

vial

   

vincristine

powder for injection, 1mg, 5mg (sulfate)

 

in vial

   

8.3 Hormones and antihormones

   

Complementary list medicines

 
   

dexamethasone

injection, 4mg dexamethasone

 

phosphate (as disodium salt) in 1-ml

 

ampoule

   

hydrocortisone

powder for injection, 100mg (as sodium

 

succinate) in vial

   

prednisolonea

tablet, 5mg, 25mg

   

tamoxifen

tablet, 10mg, 20mg (as citrate)

   

8.4 Medicines used in palliative care

   

The Committee recommended that all the medicines mentioned in the WHO publication, Cancer pain relief: with a guide to opioid availability, 2nd ed., be considered essential (24). The medicines are included in the relevant sections of the Model List, according to their therapeutic use, e.g. as analgesics.

   

a There is no evidence for complete clinical similarity between prednisolone and dexamethasone at high doses.

   

9. Antiparkinsonism medicines

   

biperiden

tablet, 2mg (hydrochloride)

   
 

injection, 5mg (lactate) in 1-ml ampoule

levodopa + carbidopa

tablet, 100mg + 10mg, 250mg + 25mg

   

10. Medicines affecting the blood

   

10.1 Antianaemia medicines

   

ferrous salt

tablet, equivalent to 60mg iron

   
 

oral solution, equivalent to 25mg iron (as

 

sulfate)/ml

ferrous salt + folic acida

tablet, equivalent to 60mg iron + 400 mg

 

folic acid

   

folic acid

tablet, 1mg, 5mg

   

hydroxocobalamin

injection, 1mg in 1-ml ampoule

   

10.2 Medicines affecting coagulation

   

heparin sodium

injection, 1000IU/ml, 5000IU/ml,

 

20000IU/ml in 1-ml ampoule

   

phytomenadione

injection, 10mg/ml in 5-ml ampoule

   
 

tablet, 10mg

   

protamine sulfate

injection, 10mg/ml in 5-ml ampoule

   

warfarin

tablet, 1mg, 2mg, 5mg (sodium salt)

11. Blood products and plasma substitutes

   

11.1 Plasma substitutes

   

dextran 70

injectable solution, 6%

   

polygelineb

injectable solution, 3.5%

   

11.2 Plasma fractions for specific use

   

All plasma fractions should comply with the Requirements for the Collection, Processing and Quality Control of Blood, Blood Components, and Plasma Derivatives (Revised 1992) as published in the forty-third report of the WHO Expert Committee on Biological Standardization (25).

   

a Nutritional supplement for use during pregnancy.

b The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

Complementary list medicines

 
   

factor VIII concentratea

dried

   

factor IX complex (coagulation

dried

   

factors II, VII, IX, X) concentratea

 
   

12. Cardiovascular medicines

   

12.1 Antianginal medicines

   

atenolol

tablet, 50mg, 100mg

glyceryl trinitrate

tablet (sublingual), 500µg

isosorbide dinitrate

tablet (sublingual), 5mg

   

verapamil

tablet, 40mg, 80mg (hydrochloride)

   

12.2 Antiarrhythmic medicines

   

atenolol

tablet, 50mg, 100mg

digoxin

tablet, 62.5µg, 250 µg

 

oral solution, 50 µg/ml

 

injection, 250 µg/ml in 2-ml ampoule

epinephrine (adrenaline)

injection, 1mg (as hydrochloride)/ml in

 

ampoule

   

lidocaine

injection, 20mg (hydrochloride)/ml in 5-ml

 

ampoule

   

verapamil

tablet, 40mg, 80mg (hydrochloride)

   
 

injection, 2.5mg (hydrochloride)/ml in

 

2-ml ampoule

   

Complementary list medicines

 

isoprenalinea

injection, 20 µg (hydrochloride)/ml in

 

ampoule

   

procainamidea

injection, 100mg (hydrochloride)/ml in

 

10-ml ampoule

   

quinidinea

tablet, 200mg (sulfate)

   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

12.3 Antihypertensive medicines

   

atenolol

tablet, 50mg, 100mg

   

enalapril

tablet, 2.5mg

   

hydralazinea

tablet 25mg, 50mg (hydrochloride)

   
 

powder for injection, 20mg

 

(hydrochloride)

   
 

in ampoule

   

hydrochlorothiazide

scored tablet, 25mg

   

methyldopab

tablet, 250mg

   

nifedipinec

sustained-release formulations

   
 

tablet, 10mg

   

Complementary list medicine

 
   

sodium nitroprusside

powder for infusion, 50mg in ampoule

   

12.4 Medicines used in heart failure

   

digoxin

tablet, 62.5µg, 250 µg

 

oral solution, 50 µg/ml

 

injection, 250µg/ml in 2-ml ampoule

enalapril

tablet, 2.5mg

   

hydrochlorothiazide

scored tablet, 25mg

   

Complementary list medicine

 
   

dopamine

injection, 40mg (hydrochloride)/ml in 5-ml

 

vial

   

12.5 Antithrombotic medicines

   

acetylsalicylic acid

tablet, 100mg

   

Complementary list medicine

 
   

streptokinase

powder for injection, 1.5 million IU in vial

   

a Hydralazine is listed for use in the acute management of severe pregnancy-induced hypertension only. Its use in the treatment of essential hypertension is not recommended in view of availability of more evidence of efficacy and safety of other medicines.

b Methyldopa is listed for use in the management of pregnancy-induced hypertension only. Its use in the treatment of essential hypertension is not recommended in view of the availability of further evidence of the efficacy and safety of other medicines.

c The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

12.6 Lipid-lowering agents

   

The Committee recognizes the value of lipid-lowering medicines in treating patients with hyperlipidaemia. β-Hydroxy-β-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, often referred to as "statins", are a family of potent and effective lipid-lowering medicines with a good tolerability profile. Several of these medicines have been shown to reduce the incidence of fatal and non-fatal myocardial infarction, stroke and mortality (all causes), as well as the need for coronary by-pass surgery. All remain very costly but may be cost-effective for secondary prevention of cardiovascular disease as well as for primary prevention in some very high-risk patients. Since no single medicine has been shown to be significantly more effective or less expensive than others in the group, none is included in the Model List; the choice of medicine for use in patients at highest risk should be decided at the national level.

   

13. Dermatological medicines (topical)

   

13.1 Antifungal medicines

   

benzoic acid + salicylic acid

ointment or cream, 6% + 3%

miconazole

ointment or cream, 2% (nitrate)

   

sodium thiosulfate

solution, 15%

   

Complementary list medicine

 
   

selenium sulfide

detergent-based suspension, 2%

   

13.2 Anti-infective medicines

   

methylrosanilinium chloride

aqueous solution, 0.5%

(gentian violet)

 
 

tincture, 0.5%

neomycin + _bacitracin

ointment, 5mg neomycin sulfate + 500IU

 

bacitracin zinc/g

   

potassium permanganate

aqueous solution, 1:10000

   

silver sulfadiazine

cream, 1% in 500-g container

   

13.3 Anti-inflammatory and antipruritic medicines

   

betamethasone

ointment or cream, 0.1% (as valerate)

   

calamine lotion

lotion

   

hydrocortisone

ointment or cream, 1% (acetate)

   

13.4 Astringent medicines

   

aluminium diacetate

solution, 13% for dilution

   

13.5 Medicines affecting skin differentiation and proliferation

   

benzoyl peroxide

lotion or cream, 5%

   

coal tar

solution, 5%

   

dithranol

ointment, 0.1-2%

   

fluorouracil

ointment, 5%

   

podophyllum resin

solution, 10-25%

   

salicylic acid

solution, 5%

   

urea

ointment or cream, 10%

   

13.6 Scabicides and pediculicides

   

benzyl benzoate

lotion, 25%

   

permethrin

cream, 5%

   
 

lotion, 1%

   

13.7 Ultraviolet-blocking agents

   

Complementary list medicine

 
   

topical sun protection agent with

cream, lotion or gel

   

activity against ultraviolet A and

 
   

ultraviolet Ba

 
   

14. Diagnostic agents

   

14.1 Ophthalmic medicines

   

fluorescein

eye drops, 1% (sodium salt)

   

tropicamide

eye drops, 0.5%

   

14.2 Radiocontrast media

   

amidotrizoate

injection, 140-420mg iodine (as sodium

 

or meglumine salt)/ml in 20-ml ampoule

   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

barium sulfate

aqueous suspension

   

iohexol

injection, 140-350mg iodine/ml in 5-ml,

 

10-ml or 20-ml ampoule

   

iopanoic acid

tablet, 500mg

   

propyliodone

oily suspension, 500-600mg/ml in 20-ml

 

ampoulea

   

Complementary list medicine

 
   

meglumine iotroxate

solution, 5-8g iodine in 100-250ml

   

15. Disinfectants and antiseptics

   

15.1 Antiseptics

   

chlorhexidine

solution, 5% (digluconate) for dilution

   

ethanol

solution, 70% (denatured)

   

polyvidone iodine

solution, 10%

   

15.2 Disinfectants

   

chlorine base compound

powder (0.1% available chlorine) for

 

solution

   

chloroxylenol

solution, 4.8%

   

glutaral

solution, 2%

   

16. Diuretics

   

amiloride

tablet, 5mg (hydrochloride)

   

furosemide

tablet, 40mg

   
 

injection, 10mg/ml in 2-ml ampoule

   

hydrochlorothiazide

scored tablet, 25mg

   

mannitol

injectable solution, 10%, 20%

   

spironolactone

tablet, 25mg

   

a For administration only into the bronchial tree.

   

17. Gastrointestinal medicines

   

17.1 Antacids and other antiulcer medicines

   

aluminium hydroxide

tablet, 500mg

   
 

oral suspension, 320mg/5ml

   

magnesium hydroxide

oral suspension, equivalent to 550mg

 

magnesium oxide/10ml

   

ranitidine

tablet, 150mg (as hydrochloride)

   
 

oral solution, 75mg/5ml

   
 

injection, 25mg/ml in 2-ml ampoule

   

17.2 Antiemetic medicines

   

metoclopramide

tablet, 10mg (hydrochloride)

   
 

injection, 5mg (hydrochloride)/ml in 2-ml

 

ampoule

   

promethazine

tablet, 10mg, 25mg (hydrochloride)

   
 

elixir or syrup, 5mg (hydrochloride)/5ml

   
 

injection, 25mg (hydrochloride)/ml in 2-ml

 

ampoule

   

17.3 Antihaemorrhoidal medicines

   

local anaesthetic, astringent and

ointment or suppository

anti-inflammatory medicinea

 
   

17.4 Anti-inflammatory medicines

   

sulfasalazine

tablet, 500mg

   
 

suppository, 500mg

   
 

retention enema

   

Complementary list medicine

 
   

hydrocortisoneb

suppository, 25mg (acetate)

   
 

retention enema

   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

b The square box symbol () applies only to hydrocortisone, retention enema.

   

17.5 Antispasmodic medicines

 
   

atropinea

tablet, 1mg (sulfate)

   
 

injection, 1mg (sulfate) in 1-ml ampoule

   

17.6 Laxatives

   

senna

tablet, 7.5mg (sennosides) (or traditional

 

dosage forms)

   

17.7 Medicines used in diarrhoea

 
   

17.7.1 Oral hydration

     

oral rehydration salts (for

powder, 20.5g/l

glucose-electrolyte solution)

 
 

Components (for 1 litre of glucose-

 

electrolyte solution)b:

 

glucose

13.5g/l

 

sodium chloride

2.6g/l

 

potassium chloride

1.5g/l

 

trisodium citrate dihydratec

2.9g/l

     
 

These components provide a glucose-

 

elecrolyte solution with the

 

following molar concentrations:

 

glucose

75mEq

 

sodium

75mEq or mmol/l

 

chloride

65mEq or mmol/l

 

potassium

20mEq or mmol/l

 

citrate

10mmol/l

 

osmolarity

245mOsm/l

   

17.7.2 Antidiarrhoeal (symptomatic) medicines

   

codeinea

tablet, 30mg (phosphate)

   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

b In cases of cholera a higher concentration of sodium may be required.

c Trisodium citrate dihydrate may be replaced by sodium hydrogen carbonate (sodium bicarbonate) 2.5g/l. However, as the stability of this latter formulation is very poor under tropical conditions, it is only recommended when manufactured for immediate use.

   

18. Hormones, other endocrine medicines and contraceptives

   

18.1 Adrenal hormones and synthetic substitutes

   

Addison's disease is a rare condition; adrenal hormones for the treatment of this condition are already included in section 3.

   

18.2 Androgens

   

Complementary list medicine

 
   

testosterone

injection, 200mg (enantate) in 1-ml

 

ampoule

   

18.3 Contraceptives

   

18.3.1 Hormonal contraceptives

ethinylestradiol +

tablet, 30 µg + 150 µg

levonorgestrel

 

ethinylestradiol +

tablet, 35 µg + 1.0mg

norethisterone

 

levonorgestrel

tablet, 30 µg, 750 µg (pack of two),

 

1.5mg

   

norethisterone enantate

oily solution, 200mg/ml in 1-ml ampoule

   

Complementary list medicine

 
   

medroxyprogesterone acetatea

depot injection, 150mg/ml in 1-ml vial

   

18.3.2 Intrauterine devices

   

copper-containing device

 
   

18.3.3 Barrier methods

   

condoms

 
   

diaphragms

 
   

18.4 Estrogens

   

ethinylestradiol

tablet, 10µg, 50µg

 

18.5 Insulins and other antidiabetic agents

   

glibenclamide

tablet, 2.5mg, 5mg

   

insulin injection (soluble)

injection, 40IU/ml in 10-ml vial, 100IU/ml

 

in 10-ml vial

   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

intermediate-acting insulin

injection, 40IU/ml in 10-ml vial, 100IU/ml

 

in 10-ml vial (as compound insulin zinc

 

suspension or isophane insulin)

   

metformin

tablet, 500mg (hydrochloride)

   

18.6 Ovulation inducers

   

Complementary list medicine

 
   

clomifene

tablet, 50mg (citrate)

   

18.7 Progestogens

   

norethisterone

tablet, 5mg

   

Complementary list medicine

 
   

medroxyprogesterone acetatea

tablet, 5mg

   

18.8 Thyroid hormones and antithyroid medicines

   

levothyroxine

tablet, 50 µg, 100 µg (sodium salt)

potassium iodide

tablet, 60mg

   

propylthiouracil

tablet, 50mg

   

19. Immunologicals

   

19.1 Diagnostic agents

   

All tuberculins should comply with the Requirements for Tuberculins (Revised1985), as published in the thirty-sixth report of the WHO Expert Committee on Biological Standardization (26).

   

tuberculin, purified protein

injection

derivative (PPD)

 
   

19.2 Sera and immunoglobulins

   

All plasma fractions should comply with the Requirements for the Collection, Processing and Quality Control of Blood, Blood Components and Plasma Derivatives (Revised 1992) as published in the forty-third report of the WHO Expert Committee on Biological Standardization (25).

   

anti-D immunoglobulin

injection, 250 µg in single-dose vial

(human)

 
   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

antitetanus immunoglobulin

injection, 500IU in vial

(human)

 
   

antivenom seraa

injection

   

diphtheria antitoxin

injection, 10000IU, 20000IU in vial

   

rabies immunoglobulin

injection, 150IU/ml in vial

   

19.3 Vaccines

   

All vaccines should comply with the following requirements for biologicalsubstances, as published in the reports of the WHO Expert Committee on Biological Standardization. BCG vaccines should comply with the Requirementsfor Dried BCG Vaccine (Revised 1985), as published in the thirty-sixth report ofthe WHO Expert Committee on Biological Standardization (27) and subsequent Amendment 1987 as published in the thirty-eighth report of the WHO Expert Committee on Biological Standardization (28). Diphtheria, pertussis and tetanus vaccines should comply with the Requirements for Diphtheria, Tetanus, Pertussis and Combined Vaccines (Revised 1989), as published in the fortieth report of the WHO Expert Committee on Biological Standardization (29). Hepatitis B vaccines should comply with the Requirements for Hepatitis B Vaccine Prepared from Plasma (Revised 1994), as published in the forty-fifth report of the WHO Expert Committee on Biological Standardization (30). Measles, mumps and rubella vaccines should comply with the Requirements for Measles, Mumps and Rubella Vaccines and Combined Vaccine (Live) (Revised 1992), as published in the forty-third report of the WHO Expert Committee on Biological Standardization (31) and subsequent Note, as published in the forty-fourth report of the WHO Expert Committee on Biological Standardization (32). Poliomyelitis vaccines should comply with the Requirements for Poliomyelitis Vaccine (Oral) (Revised 1989), as published in the fortieth report of the WHO Expert Committee on Biological Standardization (33) or the Requirements for Poliomyelitis Vaccine (Inactivated) (Revised 1981), as published in the report ofthe WHO Expert Committee on Biological Standardization (34) and subsequent Addendum 1985, as published in the thirty-sixth report of the WHO Expert Committee on Biological Standardization (35). Influenza vaccines should comply with the Requirements for Influenza Vaccine (Inactivated) (Revised 1990), as published in the forty-first report of the WHO Expert Committee on Biological Standardization (36). Meningococcal meningitis vaccines should comply with the Requirements for Meningococcal Polysaccharide Vaccine, as published in the report of the WHO Expert Committee on Biological Standardization (37) and subsequent Addendum 1980, incorporating Addendum 1976 and Addendum 1977, as published in the thirty-first report of the WHO Expert Committee on Biological Standardization (38). Rabies vaccines should comply with the Requirements for Rabies Vaccine for Human Use (Revised 1980), as published in the thirty-first report of the WHO Expert Committee on Biological Standardization (39) and subsequent Amendment 1992, as published in the forty-third report of the WHO Expert Committee on Biological Standardization (40), or the Requirements for Rabies Vaccine (Inactivated) for Human Use Produced in Continuous Cell Lines (Revised 1986), as published in the thirty-seventh report of the WHO Expert Committee on Biological Standardization (41) and subsequent Amendment 1992, as published in the forty-third report of the WHO Expert Committee on Biological Standardization (42). Typhoid vaccines should comply with the Requirements for Typhoid Vaccine (Live, Attenuated, Ty 21a, Oral), as published in the report of the WHO Expert Committee on Biological Standardization (43) or the Requirements for Vi Polysaccharide Typhoid Vaccine, as published in the forty-third report of the WHO Expert Committee on Biological Standardization (44). Yellow fever vaccines should comply with Requirements for Yellow Fever Vaccine (Revised 1995), as published in the forty-sixth report of the WHO Expert Committee on Biological Standardization (45).

 

a Exact type to be defined locally.

   

19.3.1 For universal immunization

   

BCG vaccine

 
   

diphtheria vaccine

 
   

hepatitis B vaccine

 
   

measles vaccine

 
   

pertussis vaccine

 
   

poliomyelitis vaccine

 
   

tetanus vaccine

 
   

19.3.2 For specific groups of individuals

   

influenza vaccine

 
   

meningococcal meningitis

 

vaccine

 
   

mumps vaccine

 
   

rabies vaccine (inactivated)

 

(prepared in cell culture)

 
   

rubella vaccine

 
   

typhoid vaccine

 
   

yellow fever vaccine

 
   

20. Muscle relaxants (peripherally-acting) and cholinesterase inhibitors

   

alcuronium

injection, 5mg (chloride)/ml in 2-ml

 

ampoule

   

neostigmine

tablet, 15mg (bromide)

 

injection, 500mg, 2.5mg (metilsulfate) in

 

1-ml ampoule

   

suxamethonium

injection, 50mg (chloride)/ml in 2-ml

 

ampoule

   
 

powder for injection (chloride), in vial

   

Complementary list medicines

 
   

pyridostigmine

tablet, 60mg (bromide)

   
 

injection, 1mg in 1-ml ampoule

   

vecuronium

powder for injection, 10mg (bromide) in

 

vial

   

21. Ophthalmological preparations

   

21.1 Anti-infective agents

   

gentamicin

solution (eye drops), 0.3% (as sulfate)

   

idoxuridine

solution (eye drops), 0.1%

   
 

eye ointment, 0.2%

   

silver nitratea

solution (eye drops), 1%

   

tetracycline

eye ointment, 1% (hydrochloride)

   

21.2 Anti-inflammatory agents

   

prednisolone

solution (eye drops), 0.5% (sodium

 

phosphate)

   

21.3 Local anaesthetics

   

tetracaine

solution (eye drops), 0.5%

 

(hydrochloride)

   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

21.4 Miotics and antiglaucoma medicines

   

acetazolamide

tablet, 250mg

   

pilocarpine

solution (eye drops), 2%, 4%

 

(hydrochloride or nitrate)

   

timolol

solution (eye drops), 0.25%, 0.5% (as

 

maleate)

   

21.5 Mydriatics

   

atropine

solution (eye drops), 0.1%, 0.5%, 1%

 

(sulfate)

   

Complementary list medicine

 
   

epinephrine (adrenaline)

solution (eye drops), 2% (as

 

hydrochloride)

   

22. Oxytocics and antioxytocics

   

22.1 Oxytocics

ergometrinea

tablet, 200 µg (hydrogen maleate)

 

injection, 200 µg (hydrogen maleate) in

 

1-ml ampoule

   

oxytocin

injection, 10IU in 1-ml ampoule

   

22.2 Antioxytocics

   

salbutamola

tablet, 4mg (as sulfate)

 

injection, 50 µg (as sulfate)/ml in 5-ml

 

ampoule

   

23. Peritoneal dialysis solution

   

Complementary list medicine

 
   

intraperitoneal dialysis solution

parenteral solution

(of appropriate composition)

 
   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

24. Psychotherapeutic medicines

   

24.1 Medicines used in psychotic disorders

   

chlorpromazine

tablet, 100mg (hydrochloride)

   
 

syrup, 25mg (hydrochloride)/5ml

   
 

injection, 25mg (hydrochloride)/ml in 2-ml

 

ampoule

   

fluphenazine

injection, 25mg (decanoate or enantate)

 

in 1-ml ampoule

   

haloperidol

tablet, 2mg, 5mg

   
 

injection, 5mg in 1-ml ampoule

   

24.2 Medicines used in mood disorders

   

24.2.1 Medicines used in depressive disorders

   

amitriptyline

tablet, 25mg (hydrochloride)

   

24.2.2 Medicines used in bipolar disorders

   

carbamazepine

scored tablet, 100mg, 200mg

   

lithium carbonate

capsule or tablet, 300mg

   

valproic acid

enteric coated tablet, 200mg, 500mg

 

(sodium salt)

   

24.3 Medicines used in generalized anxiety and sleep disorders

   

diazepam

scored tablet, 2mg, 5mg

   

24.4 Medicines used in obsessive-compulsive disorders and panic attacks

   

clomipramine

capsule, 10mg, 25mg (hydrochloride)

   

25. Medicines acting on the respiratory tract

   

25.1 Antiasthmatics and medicines for chronic obstructive pulmonary disease

   

beclometasone

inhalation (aerosol), 50 mg, 250 mg

 

(dipropionate) per dose

   

epinephrine (adrenaline)

injection, 1mg (as hydrochloride or

 

hydrogen tartrate) in 1-ml ampoule

ipratropium bromide

inhalation (aerosol), 20mg/metered dose

   

salbutamol

tablet, 2mg, 4mg (as sulfate)

 

inhalation (aerosol), 100 mg (as sulfate)

 

per dose

   
 

syrup, 2mg (as sulfate)/5ml

 

injection, 50 mg (as sulfate)/ml in 5-ml

 

ampoule

   
 

respirator solution for use in nebulizers,

 

5mg (as sulfate)/ml

   

theophyllinea

tablet, 100mg, 200mg, 300mg

   

Complementary list medicines

 
   

aminophyllinea

injection, 25mg/ml in 10-ml ampoule

   

cromoglicic acida

inhalation (aerosol), 20mg (sodium salt)

 

per dose

   

26. Solutions correcting water, electrolyte and acid-base disturbances

   

26.1 Oral

   

oral rehydration salts (for

For composition, see section 17.7.1

glucose-electrolyte solution)

 
   

potassium chloride

powder for solution

   

26.2 Parenteral

   

glucose

injectable solution, 5%, 10% isotonic,

 

50% hypertonic

   

glucose with sodium chloride

injectable solution, 4% glucose, 0.18%

 

sodium chloride (equivalent to Na+

 

30mmol/l, Cl- 30mmol/l)

potassium chloride

solution, 11.2% in 20-ml ampoule

 

(equivalent to K+ 1.5mmol/ml,

 

Cl- 1.5mmol/ml)

sodium chloride

injectable solution, 0.9% isotonic

 

(equivalent to Na+ 154mmol/l,

 

Cl- 154mmol/l)

   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

   

sodium hydrogen carbonate

injectable solution, 1.4% isotonic

 

(equivalent to Na+ 167mmol/l, HCO3-

 

167mmol/l), 8.4% (equivalent to Na+

 

1000mmol/l) in

 

1000mmol/l, HCO3-

 

10-ml ampoule

   

sodium lactate, compound

injectable solution

   

solution

 
   

26.3 Miscellaneous

   

water for injection

2-ml, 5-ml, 10-ml ampoules

   

27. Vitamins and minerals

   

ascorbic acid

tablet, 50mg

   

ergocalciferol

capsule or tablet, 1.25mg (50000IU)

 

oral solution, 250µg/ml (10000IU/ml)

iodine

iodized oil, 1ml (480mg iodine), 0.5ml

 

(240mg iodine) in ampoule (oral or

 

injectable), 0.57ml (308mg iodine) in

 

dispenser bottle

   
 

capsule, 200mg

   

nicotinamide

tablet, 50mg

   

pyridoxine

tablet, 25mg (hydrochloride)

   

retinol

sugar-coated tablet, 10000IU (as

 

palmitate) (5.5mg)

   
 

capsule, 200000IU (as palmitate)

 

(110mg)

   
 

oral oily solution, 100000IU (as

 

palmitate)/ml in multidose dispenser

   
 

water-miscible injection, 100000IU (as

 

palmitate) (55mg) in 2-ml ampoule

   

riboflavin

tablet, 5mg

   

sodium fluoridea

in any appropriate formulation

   

thiamine

tablet, 50mg (hydrochloride)

   

Complementary list medicine

 
   

calcium gluconatea

injection, 100mg/ml in 10-ml ampoule

   

a The public health relevance and/or efficacy and/or safety of this item has been questioned and its continued inclusion in the Model List will be reviewed at the next meeting of the Expert Committee.

 

Recommended of example within a pharmaceutical class. See Explanatary notes on page 61.


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