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The Selection and Use of Essential Medicines - WHO Technical Report Series, No. 914
(2003; 132 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on the Selection and Use of Essential Medicines
View the document1. Introduction
View the document2. Open session
Open this folder and view contents3. The new procedures for updating and disseminating the Model List
Open this folder and view contents4. Other outstanding technical issues
Open this folder and view contents5. Format and presentation of the 12th Model List
Open this folder and view contents6. Changes made in revising the Model List
Open this folder and view contents7. Future reviews of sections of the Model List
Open this folder and view contents8. Recommendations
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 The 12th WHO Model List of Essential Medicines
View the documentAnnex 2 Additional notes on the medicines recommended for inclusion in the 12th WHO Model List of Essential Medicines
View the documentAnnex 3 The Anatomical Therapeutic Chemical (ATC) classification system1
View the documentAlphabetical list of essential medicinces (with ATC classification codes)
 

Annex 1 The 12th 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. 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 10 times (excluding the present revision) at intervals of approximately 2 years (5-14). 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 (15) 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 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 Library.1 The web site 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.mednet3.who.int/mf/.


The current version of the Model List (the 12th) is divided into two lists, a list of “core” medicines and a list of “complementary” 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 which are efficacious, safe and cost-effective but not necessarily affordable, or for which specialized health care facilities or services may be needed.

A number of medicines in the lists are labelled with a square box symbol. This symbol indicates that a listed medicine should be seen as a representative example from a group of clinically equivalent medicines with wide experience of use, within a pharmacological class. The medicine listed on the Model List would generally be the least costly therapeutic equivalent within the group. National lists should not use a similar symbol and should be specific in their final selection, which would depend on local availability and price.

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 (16). 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 (see Appendix 1). 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 site.2

2 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 selection 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 (17) 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 (18).

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 (19).

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) (20). However, it is generally recommended that utilization studies be conducted using the Anatomical Therapeutic Chemical (ATC) classification 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 provide data 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.

The WHO Model List of Essential Medicines: core list

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.

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”.

Many medicines included in the Model List are preceded by a square box symbol () to indicate that they represent an example of a therapeutic group and that various medicines could serve as alternatives. It is imperative that this is understood when medicines are selected at national level, since choice is then influenced by the comparative cost and availability of equivalent products. Examples of acceptable substitutions include:

- hydrochlorothiazide: any other thiazide-type diuretic currently in broad clinical use;
- hydralazine: any other peripheral vasodilator having an antihyper-tensive effect;
- senna: any mild stimulant laxative (either synthetic or of plant origin).


Numbers in parentheses following the medicine names indicate:

(1) Medicines subject to international control under: (a) the Single Convention on Narcotic Drugs, 1961 (21); (b) the Convention on Psychotropic Substances, 1971 (22); or (c) the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (23).

(2) Specific expertise, diagnostic precision, individualization of dosage or special equipment required for proper use.

(3) Greater potency or efficacy.

(4) In renal insufficiency, contraindicated or dosage adjustments necessary.

(5) To improve compliance.

(6) Special pharmacokinetic properties.

(7) Adverse effects diminish benefit/risk ratio.

(8) Limited indications or narrow spectrum of activity.

(9) For epidural anaesthesia.

(10) Sustained-release preparations are available. A proposal to include such a product in a national list of essential medicines should be supported by adequate documentation.

(11) Monitoring of therapeutic concentrations in plasma can improve safety and efficacy.


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 in 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 (24).

Medicine

Route of administration, dosage forms and strengths

   

1. Anaesthetics

   

1.1 General anaesthetics and oxygen

ether, anaesthetic (1c, 2)

inhalation

halothane (2)

inhalation

ketamine (2)

injection, 50mg (as hydrochloride)/ml in

 

10-ml vial

nitrous oxide (2)

inhalation

oxygen

inhalation (medicinal gas)

thiopental (2)

powder for injection, 0.5g, 1.0g (sodium

 

salt) in ampoule

1.2 Local anaesthetics

bupivacaine (2, 9)

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

lidocaine + epinephrine

injection, 1%, 2% (hydrochloride) +

(adrenaline)

epinephrine 1:200000 in vial

 

dental cartridge, 2% (hydrochloride) +

 

epinephrine 1:80000

1.3 Preoperative medication and sedation for short-term procedures

atropine

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

chloral hydrate

syrup, 200mg/5ml

diazepam (1b)

injection, 5mg/ml in 2-ml ampoule

 

tablet, 5mg

morphine (1a)

injection, 10mg (hydrochloride or sulfate)

 

in 1-ml ampoule

promethazine

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

   

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

   

2.1 Non-opioid analgesics and antipyretics and nonsteroidal anti-inflammatory medicines

acetylsalicylic acid

tablet, 100 500mg

 

suppository, 50 150mg

ibuprofen

tablet, 200mg, 400mg

paracetamol

tablet, 100 500mg

 

suppository, 100mg

 

syrup, 125mg/5ml

2.2 Opioid analgesics

codeine (1a)

tablet, 30mg (phosphate)

morphine (1a)

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 (4)

tablet, 100mg

colchicine (7)

tablet, 500 mg

2.4 Disease-modifying agents used in rheumatoid disorders

azathioprine (2)

tablet, 50mg

chloroquine (2)

tablet, 100mg, 150mg (as phosphate or sulfate)

cyclophosphamide (2)

tablet, 25mg

methotrexate (2)

tablet, 2.5mg (as sodium salt)

penicillamine (2)

capsule or tablet, 250mg

sulfasalazine (2)

tablet, 500mg

   

3. Antiallergics and medicines used in anaphylaxis

   

chlorphenamine

tablet, 4mg (hydrogen maleate)

 

injection, 10mg (hydrogen maleate) in1-ml ampoule

dexamethasone

tablet, 500 µg, 4mg

 

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

prednisolone

tablet, 5mg

   

4. Antidotes and other substances used in poisonings

   

4.1 Nonspecific

charcoal, activated

powder

ipecacuanha

syrup, containing 0.14% ipecacuanha

 

alkaloids calculated as emetine

4.2 Specific

acetylcysteine

injection, 200mg/ml in 10-ml ampoule

atropine

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

calcium gluconate (2, 8)

injection, 100mg/ml in 10-ml ampoule

deferoxamine

powder for injection, 500mg (mesilate) in

 

vial

dimercaprol (2)

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

DL-methionine

tablet, 250mg

methylthioninium chloride

injection, 10mg/ml in 10-ml ampoule

(methylene blue)

 

naloxone

injection, 400 µg (hydrochloride) in 1-ml

 

ampoule

penicillamine (2)

capsule or tablet, 250mg

potassium ferric

powder for oral administration

hexacyanoferrate (II)· 2H2O

 

(Prussian blue)

 

sodium calcium edetate (2)

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 (10, 11)

scored tablet, 100mg, 200mg

diazepam (1b)

injection, 5mg/ml in 2-ml ampoule

 

(intravenous or rectal)

ethosuximide

capsule, 250mg

 

syrup, 250mg/5ml

magnesium sulfate

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

 

500mg/ml in 10-ml ampoule

phenobarbital (1b, 11)

tablet, 15 100mg

 

elixir, 15mg/5ml

phenytoin (7, 11)

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

 

(sodium salt)

 

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

 

vial

valproic acid (7, 11)

enteric coated tablet, 200mg, 500mg

 

(sodium salt)

   

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

niclosamide

chewable tablet, 500mg

praziquantel

tablet, 150mg, 600mg

pyrantel

chewable tablet, 250mg (as embonate)

 

oral suspension, 50mg (as embonate)/ml

6.1.2 Antifilarials

diethylcarbamazine

tablet, 50mg, 100mg (dihydrogen citrate)

ivermectin

scored tablet, 3mg, 6mg

6.1.3 Antischistosomals and other antitrematode medicines

praziquantel

tablet, 600mg

triclabendazole

tablet, 250mg

6.2 Antibacterials

6.2.1 β-Lactam medicines

amoxicillin

capsule or tablet, 250mg, 500mg

 

(anhydrous)

 

powder for oral suspension, 125mg

 

(anhydrous)/5ml

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

6.2.2 Other antibacterials

chloramphenicol (7)

capsule, 250mg

 

oral suspension, 150mg (as palmitate)/5ml

 

powder for injection, 1g (as sodium

 

succinate) in vial

ciprofloxacin

tablet, 250mg (as hydrochloride)

doxycycline (5, 6)

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

gentamicin (2, 4, 7, 11)

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 acid (8)

tablet, 250mg, 500mg

nitrofurantoin (4, 8)

tablet, 100mg

spectinomycin (8)

powder for injection, 2g (as hydrochloride)

 

in vial

sulfadiazine (4)

tablet, 500mg

 

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

 

ampoule

sulfamethoxazole +

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

trimethoprim (4)

 
 

oral suspension, 200mg + 40mg/5ml

 

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

 

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

 

ampoule

trimethoprim (8)

tablet, 100mg, 200mg

 

injection, 20mg/ml in 5-ml ampoule

6.2.3 Antileprosy medicines

clofazimine

capsule, 50mg, 100mg

dapsone

tablet, 25mg, 50mg, 100mg

rifampicin

capsule or tablet, 150mg, 300mg

6.2.4 Antituberculosis medicines

ethambutol (4)

tablet, 100 400mg (hydrochloride)

isoniazid

tablet, 100 300mg

isoniazid + ethambutol (5)

tablet, 150mg + 400mg

pyrazinamide

tablet, 400mg

rifampicin

capsule or tablet, 150mg, 300mg

rifampicin + isoniazid (5)

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

 

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

 

150mg + 150mga

rifampicin + isoniazid +

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

pyrazinamide (5)

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

 

500mga

   

a For intermittent use three times weekly.

   

rifampicin + isoniazid +

tablet, 150mg + 75mg + 400mg + 275mg

pyrazinamide + ethambutol

 

streptomycin (4)

powder for injection, 1g (as sulfate) in vial

6.3 Antifungal medicines

amphotericin B (4)

powder for injection, 50mg in vial

fluconazole

capsule, 50mg

 

injection, 2mg/ml in vial

 

oral suspension, 50mg/5ml

griseofulvin (7)

capsule or tablet, 125mg, 250mg

nystatin

tablet, 100000IU, 500000IU

 

lozenge, 100000IU

 

pessary, 100000IU

6.4 Antiviral medicines

6.4.1 Antiherpes medicines

aciclovir (8)

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 (25). 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) 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 packet

 

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

capsule, 133.3mg + 33.3mg

(LPV/r)

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

pentamidine (5)

powder for injection, 200mg, 300mg

 

(isetionate) in vial

6.5.3 Antimalarial medicines

(a) For curative treatment

artemether + lumefantrinea

tablet, 20mg + 120mg

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

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 (dihydrochloride)/ml in

 

2-ml ampoule

(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)

proguanila

tablet, 100mg (hydrochloride)

6.5.4 Antipneumocystosis and antitoxoplasmosis medicines

pentamidine (2)

tablet, 200mg, 300mg

pyrimethamine

tablet, 25mg

sulfamethoxazole +

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

trimethoprim

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

 

ampoule

6.5.5 Antitrypanosomal medicines

(a) African trypanosomiasis

melarsoprol (2)

injection, 3.6% solution

pentamidine (2)

powder for injection, 200mg, 300mg

 

(isetionate) in vial

suramin sodium

powder for injection, 1g in vial

a For use only in combination with chloroquine.

(b) American trypanosomiasis

benznidazole (7)

tablet, 100mg

nifurtimox (2, 8)

tablet, 30mg, 120mg, 250mg

6.6 Insect repellents

diethyltoluamide

topical solution, 50%, 75%

   

7. Antimigraine medicines

   

7.1 For treatment of acute attack

acetylsalicylic acid

tablet, 300 500mg

ergotamine (7)

tablet, 1mg (tartrate)

paracetamol

tablet, 300 500mg

7.2 For prophylaxis

 

propranolol

tablet, 20mg, 40mg (hydrochloride)

   

8. Antineoplastics, immunosuppressives and medicines used in palliative care

   

8.1 Immunosuppressive medicines (please see complementary list)

   

8.2 Cytotoxic medicines (please see complementary list)

   

8.3 Hormones and antihormones (please see complementary list)

   

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. (26), be considered essential. These medicines are included in the relevant sections of the Model List, according to their therapeutic use,e.g. as analgesics.

   

9. Antiparkinsonism medicines

   

biperiden

tablet, 2mg (hydrochloride)

 

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

levodopa + carbidopa (5, 6)

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 (2)

tablet, 1mg, 5mg

 

injection, 1mg (as sodium salt) in 1-ml

 

ampoule

hydroxocobalamin (2)

injection, 1mg in 1-ml ampoule

10.2 Medicines affecting coagulation

desmopressin (8)

injection, 4 µg (acetate)/ml in 1-ml ampoule

 

nasal spray, 10 µg (acetate)/metered dose

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 (2, 6)

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

   

11. Blood products and plasma substitutes

   

11.1 Plasma substitutes

dextran 70

injectable solution, 6%

polygeline

injectable solution, 3.5%

11.2 Plasma fractions for specific uses (please see complementary list)

   

12. Cardiovascular medicines

   

12.1 Antianginal medicines

atenolol

tablet, 50mg, 100mg

glyceryl trinitrate

tablet (sublingual), 500 µg

a Nutritional supplement for use during pregnancy.

isosorbide dinitrate

tablet (sublingual), 5mg

verapamil (10)

tablet, 40mg, 80mg (hydrochloride)

12.2 Antiarrhythmic medicines

atenolol

tablet, 50mg, 100mg

digoxin (4, 11)

tablet, 62.5 µg, 250 µg

 

oral solution, 50 µg/ml

 

injection, 250 µg/ml in 2-ml ampoule

lidocaine

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

 

ampoule

verapamil (8, 10)

tablet, 40mg, 80mg (hydrochloride)

 

injection, 2.5mg (hydrochloride)/ml in 2-ml

 

ampoule

12.3 Antihypertensive medicines

atenolol

tablet, 50mg, 100mg

captopril

scored tablet, 25mg

hydralazine

tablet, 25mg, 50mg (hydrochloride)

 

powder for injection, 20mg (hydrochloride)

 

in ampoule

hydrochlorothiazide

scored tablet, 25mg

methyldopa (7)

tablet, 250mg

nifedipine (10)

sustained-release formulations

 

tablet, 10mg

reserpine

tablet, 100 µg, 250 µg

 

injection, 1mg in 1-ml ampoule

12.4 Medicines used in heart failure

 

captopril

scored tablet, 25mg

digoxin (4, 11)

tablet, 62.5 µg, 250 µg

 

oral solution, 50 µg/ml

 

injection, 250 µg/ml in 2-ml ampoule

dopamine

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

 

vial

hydrochlorothiazide

tablet, 25mg, 50mg

12.5 Antithrombotic medicines

acetylsalicylic acid

tablet, 100mg

12.6 Lipid-lowering agents

The Committee recognizes the value of lipid-lowering medicines in treating patients with hyperlipidaemia. b-Hydroxy-b-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%

13.2 Anti-infective medicines

methylrosanilinium

aqueous solution, 0.5%

chloride (gentian violet)

 
 

tincture, 0.5%

neomycin + bacitracin (7)

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 (3)

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 (7)

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 (please see complementary list)

   

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

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

   

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 (4, 7, 8)

tablet, 5mg (hydrochloride)

furosemide

tablet, 40mg

 

injection, 10mg/ml in 2-ml ampoule

hydrochlorothiazide

tablet, 25mg, 50mg

spironolactone (8)

tablet, 25mg

   

17. Gastrointestinal medicines

   

17.1 Antacids and other antiulcer medicines

aluminium hydroxide

tablet, 500mg

 

oral suspension, 320mg/5ml

cimetidine

tablet, 200mg

 

injection, 100mg/ml in 2-ml ampoule

magnesium hydroxide

oral suspension, equivalent to 550mg

 

magnesium oxide/10ml

a For administration only into the bronchial tree.

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

ointment or suppository

and anti-inflammatory

 

medicine

 

17.4 Anti-inflammatory medicines

hydrocortisonea

suppository, 25mg (acetate)

 

retention enema

sulfasalazine (2)

tablet, 500mg

 

suppository, 500mg

 

retention enema

17.5 Antispasmodic medicines

atropine

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, 27.9g/l

glucose- electrolyte

 

solution)

 

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

 

Components (for 1 litre of

 
 

glucose electrolyte solution):

 
 

sodium chloride

3.5g/l

 

trisodium citrate dihydratea

2.9g/l

 

potassium chloride

1.5g/l

 

glucose

20.0g/l

17.7.2 Antidiarrhoeal (symptomatic) medicines

codeine (1a)

tablet, 30mg (phosphate)

   

18. Hormones, other endocrine medicines and contraceptives

   

18.1 Adrenal hormones and synthetic substitutes

dexamethasone

tablet, 500 µg, 4mg

 

injection, 4mg dexamethasone phosphate

 

(as disodium salt) in 1-ml ampoule

hydrocortisone

powder for injection, 100mg (as sodium

 

succinate) in vial

prednisolone

tablet, 1mg, 5mg

18.2 Androgens (please see complementary list)

18.3 Contraceptives

18.3.1 Hormonal contraceptives

ethinylestradiol + levonorgestrel

tablet, 30 µg + 150 µg

 

tablet, 50 µg + 250 µg (pack of four)

ethinylestradiol + norethisterone

tablet, 35 µg + 1.0 mg

levonorgestrel

tablet, 0.75mg (pack of two)

18.3.2 Intrauterine devices

copper-containing device

 

a 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.

18.3.3 Barrier methods

condoms with or without spermicide (nonoxinol)

 

diaphragms with spermicide (nonoxinol)

 

18.4 Estrogens

ethinylestradiol

tablet, 10 µg, 50 µg

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

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

clomifene (2, 8)

tablet, 50mg (citrate)

18.7 Progestogens

norethisterone

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 (27).

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 (28).

anti-D immunoglobulin

injection, 250 µg in single-dose vial

(human)

 

antitetanus

injection, 500IU in vial

immunoglobulin (human)

 

antivenom sera

injection

diphtheria antitoxin

injection, 10000IU, 20000IU in vial

immunoglobulin, human

injection (intramuscular)

normal (2)

 

immunoglobulin, human

injection (intravenous)

normal (2, 8)

 

rabies immunoglobulin

injection, 150IU/ml in vial

19.3 Vaccines

All vaccines should comply with the following requirements for biological substances, as published in the reports of the WHO Expert Committee on Biological Standardization. BCG vaccines should comply with the Requirements for Dried BCG Vaccine (Revised 1985), as published in the thirty-sixth report of the WHO Expert Committee on Biological Standardization (29) and subsequent Amendment 1987 as published in the thirty-eighth report of the WHO Expert Committee on Biological Standardization (30). 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 (31). 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 (32). Measles, mumps and rubella vaccines should comply with the Requirements for Measles, Mumps and Rubella Vaccines and Combined Vaccine (Live) (Revised1992), as published in the forty-third report of the WHO Expert Committee on Biological Standardization (33) and subsequent Note, as published in the forty- fourth report of the WHO Expert Committee on Biological Standardization (34). 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 (35) or the Requirements for Poliomyelitis Vaccine (Inactivated) (Revised 1981), as published in the report of the WHO Expert Committee on Biological Standardization (36) and subsequent Addendum 1985, as published in the thirty-sixth report of the WHO Expert Committee on Biological Standardization (37). 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 (38). 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 (39) and subsequent Addendum 1980, incorporating Addendum 1976 and Addendum1977, as published in the thirty-first report of the WHO Expert Committee on Biological Standardization (40). 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 (41) and subsequent Amendment 1992, as published in the forty-third report of the WHO Expert Committee on Biological Standardization(42) 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 (43) and subsequent Amendment 1992, as published in the forty-third report of the WHO Expert Committee on Biological Standardization (44). Typhoid vaccines should comply with the Requirements for Typhoid Vaccine (Live, Attenuated, Ty21a, Oral), as published in the report of the WHO Expert Committee on Biological Standardization (45) or the Requirements for Vi Polysaccharide Typhoid Vaccine, as published in the forty-third report of the WHO Expert Committee on Biological Standardization (46). 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 (47).

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 (2)

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

 

ampoule

neostigmine

tablet, 15mg (bromide)

 

injection, 500 µg, 2.5mg (metilsulfate) in

 

1-ml ampoule

pyridostigmine (2, 8)

tablet, 60mg (bromide)

 

injection, 1mg in 1-ml ampoule

suxamethonium (2)

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

 

ampoule

 

powder for injection (chloride), 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 nitrate

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)

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)

   

22. Oxytocics and antioxytocics

   

22.1 Oxytocics

ergometrine

tablet, 200 µg (hydrogen maleate)

 

injection, 200 µg (hydrogen maleate) in 1-ml ampoule

oxytocin

injection, 10IU in 1-ml ampoule

22.2 Antioxytocics

salbutamol (2)

tablet, 4mg (as sulfate)

 

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

   

23. Peritoneal dialysis solution

   

intraperitoneal dialysis

parenteral solution

solution (of appropriate

 

composition)

 
   

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 (5)

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 (10, 11)

scored tablet, 100mg, 200mg

lithium carbonate (2, 4)

capsule or tablet, 300mg

valproic acid (7, 11)

enteric coated tablet, 200mg, 500mg

 

(sodium salt)

24.3 Medicines used in generalized anxiety and sleep disorders

diazepam (1b)

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 Antiasthmatic medicines

aminophylline (2)

injection, 25mg/ml in 10-ml ampoule

beclometasone

inhalation (aerosol), 50 µg, 250 µg

 

(dipropionate) per dose

epinephrine (adrenaline)

injection, 1mg (as hydrochloride or

 

hydrogen tartrate) in 1-ml ampoule

ipratropium bromide

inhalation (aerosol), 20 µg/metered dose

salbutamol

tablet, 2mg, 4mg (as sulfate)

 

inhalation (aerosol), 100 µg (as sulfate) per

 

dose

 

syrup, 2mg (as sulfate)/5ml

 

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

 

ampoule

 

respirator solution for use in nebulizers,

 

5mg (as sulfate)/ml

theophylline (10, 11)

tablet, 100mg, 200mg, 300mg

25.2 Antitussive medicines

dextromethorphan

oral solution, 3.5mg (bromide)/5ml

   

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

injectable solution, 4% glucose, 0.18%

chloride

sodium chloride (equivalent to Na+

 

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

potassium chloride (2)

11.2% solution 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

sodium hydrogen carbonate

injectable solution, 1.4% isotonic

 

(equivalent to Na+ 167mmol/l,

 

HCO3- 167mmol/l), 8.4% solution in

 

10-ml ampoule (equivalent to Na+

 

1000mmol/l, HCO3- 1000mmol/l)

compound solution of

injectable solution

sodium lactate

 

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, 250 µg/ml (10000IU/ml)

iodine (8)

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 fluoride

in any appropriate formulation

thiamine

tablet, 50mg (hydrochloride)

 

Example of a therapeutic group.


The WHO Model List of Essential Medicines: complementary list

Explanatory notes

The complementary list presents essential medicines for priority diseases which are efficacious, safe and cost-effective but not necessarily affordable, or for which specialized health care facilities or services may be needed.

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”.

Many medicines included in the Model List are preceded by a square box symbol () to indicate that they represent an example of a therapeutic group and that various medicines could serve as alternatives. It is imperative that this is understood when medicines are selected at national level, since choice is then influenced by the comparative cost and availability of equivalent products. Examples of acceptable substitutions include:

- hydrochlorothiazide: any other thiazide-type diuretic currently in broad clinical use;
- hydralazine: any other peripheral vasodilator having an antihyper-tensive effect;
- senna: any mild stimulant laxative (either synthetic or of plant origin).


Numbers in parentheses following the medicine names indicate:

(1) Medicines subject to international control under: (a) the Single Convention on Narcotic Drugs, 1961 (21); (b) the Convention on Psychotropic Substances, 1971 (22); or (c) the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (23).

(2) Specific expertise, diagnostic precision, individualization of dosage or special equipment required for proper use.

(3) Greater potency or efficacy.

(4) In renal insufficiency, contraindicated or dosage adjustments necessary.

(5) To improve compliance.

(6) Special pharmacokinetic properties.

(7) Adverse effects diminish benefit/risk ratio.

(8) Limited indications or narrow spectrum of activity.

(9) For epidural anaesthesia.

(10) Sustained-release preparations are available. A proposal to include such a product in a national list of essential medicines should be supported by adequate documentation.

(11) Monitoring of therapeutic concentrations in plasma can improve safety and efficacy.


The letters in parentheses following the medicine names indicate the reasons for the inclusion of the medicine in the complementary list:

(A) When medicines in the core list cannot be made available.

(B) When medicines in the core list are known to be ineffective or inappropriate for a given individual.

(C) For use in rare disorders or in exceptional circumstances.

(D) Reserve antimicrobials to be used only when there is significant resistance to other medicines on the list.


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 in 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 (24).

Medicine

Route of administration, dosage forms and strengths

   

1. Anaesthetics

   

1.2 Local anaesthetics

ephedrinea (C)

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

 

ampoule

   

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

   

2.2 Opioid analgesics

pethidine (A) (1a, 4)

injection, 50mg (hydrochloride) in 1-ml

 

ampoule

 

tablet, 50mg, 100mg (hydrochloride)

   

5. Anticonvulsants/antiepileptics

   

clonazepam (B) (1b)

scored tablet, 500 mg

   

6. Anti-infective medicines

   

6.1 Anthelminthics

6.1.2 Antifilarials

suramin sodium (B) (2, 7)

powder for injection, 1g in vial

6.1.3 Antischistosomals and other antitrematode medicines

oxamniquine (C) (8)

capsule, 250mg

 

syrup, 250mg/5ml

6.2 Antibacterials

6.2.1 β-Lactam medicines

amoxicillin + clavulanic acidb (D)

tablet, 500mg + 125mg

ceftazidimeb (D)

powder for injection, 250mg (as

 

pentahydrate) in vial

ceftriaxoneb (D)

powder for injection, 250mg (as sodium

 

salt) in vial

imipenem + cilastatinb (D)

powder for injection, 250mg (as

 

monohydrate) + 250mg (as sodium salt),

 

500mg (as monohydrate) + 500mg (as

 

sodium salt) in vial

   

a For use in spinal anaesthesia during delivery, to prevent hypotension.
b Reserve antimicrobial for use only when there is significant resistance to other medicines on the Model List.

6.2.2 Other antibacterials

chloramphenicol (C)

oily suspension for injection, 0.5g (as

 

sodium succinate)/ml in 2-ml ampoule

clindamycin (B) (8)

capsule, 150mg

 

injection, 150mg (as phosphate)/ml

vancomycina (D)

powder for injection, 250mg (as

 

hydrochloride) in vial

6.2.4 Antituberculosis medicines

amikacinb (D)

powder for injection, 1g in vial

p-aminosalicylic acidb (D)

tablet, 500mg

 

granules, 4g in sachet

capreomycinb (D)

powder for injection, 1g in vial

ciprofloxacinb (D)

tablet, 250mg, 500mg

cycloserineb (D)

capsule or tablet, 250mg

ethionamideb (D)

tablet, 125mg, 250mg

kanamycinb (D)

powder for injection, 1g in vial

levofloxacinb (D)

tablet, 250mg, 500mg

ofloxacinb (D)

tablet, 200mg, 400mg

thioacetazone + isoniazid (A) (5, 7)

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

6.3 Antifungal medicines

flucytosine (B) (4, 8)

capsule, 250mg

 

infusion, 2.5g in 250ml

potassium iodide (A)

saturated solution

6.5 Antiprotozoal medicines

6.5.2 Antileishmaniasis medicines

 

amphotericin B (B) (4)

powder for injection, 50mg in vial

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

6.5.3 Antimalarial medicines

(a) For curative treatment

doxycyclinea (B)

capsule or tablet, 100mg (hydrochloride)

mefloquine (B)

tablet, 250mg (as hydrochloride)

sulfadoxine +

tablet, 500mg + 25mg

pyrimethamine (B)

 

artemetherb (D)

injection, 80mg/ml in 1-ml ampoule

artesunateb (D)

tablet, 50mg

6.5.5 Antitrypanosomal medicines

(a) African trypanosomiasis

eflornithine (C)

injection, 200mg (hydrochloride)/ml in

 

100-ml bottle

   

8. Antineoplastics, immunosuppressives and medicines used in palliative care

   

8.1 Immunosuppressive medicines

Adequate resources and specialist oversight are a prerequisite for this class of medicines.

azathioprine (2)

tablet, 50mg

 

powder for injection, 100mg (as sodium salt) in vial

ciclosporinc (2)

capsule, 25mg

 

concentrate for injection, 50mg/ml in 1-ml

 

ampoule

8.2 Cytotoxic medicines

Adequate resources and specialist oversight are a prerequisite for this class of medicines.

asparaginase (2)

powder for injection, 10000IU in vial

a For use only in combination with quinine.
b Reserve antimicrobial for use only when there is significant resistance to other medicines on the Model List.
c For organ transplantation.

bleomycin (2)

powder for injection, 15mg (as sulfate) in

 

vial

calcium folinate (2)

tablet, 15mg

 

injection, 3mg/ml in 10-ml ampoule

chlorambucil (2)

tablet, 2mg

chlormethine (2)

powder for injection, 10mg (hydrochloride)

 

in vial

cisplatin (2)

powder for injection, 10mg, 50mg in vial

cyclophosphamide (2)

tablet, 25mg

 

powder for injection, 500mg in vial

cytarabine (2)

powder for injection, 100mg in vial

dacarbazine (2)

powder for injection, 100mg in vial

dactinomycin (2)

powder for injection, 500 µg in vial

daunorubicin (2)

powder for injection, 50mg (as

 

hydrochloride)

doxorubicin (2)

powder for injection, 10mg, 50mg

 

(hydrochloride) in vial

etoposide (2)

capsule, 100mg

 

injection, 20mg/ml in 5-ml ampoule

fluorouracil (2)

injection, 50mg/ml in 5-ml ampoule

levamisole (2)

tablet, 50mg (as hydrochloride)

mercaptopurine (2)

tablet, 50mg

methotrexate (2)

tablet, 2.5mg (as sodium salt)

 

powder for injection, 50mg (as sodium

 

salt) in vial

procarbazine

capsule, 50mg (as hydrochloride)

vinblastine (2)

powder for injection, 10mg (sulfate) in vial

vincristine (2)

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

 

vial

8.3 Hormones and antihormones

prednisolone

tablet, 5mg

 

powder for injection, 20mg, 25mg (as

 

sodium phosphate or sodium succinate)

 

in vial

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. (26), be considered essential. These medicines are included in the relevant sections of the Model List, according to their therapeutic use,e.g. as analgesics.

   

10. Medicines affecting the blood

   

10.1 Antianaemia medicines

iron dextran (B) (5)

injection, equivalent to 50mg iron/ml in

 

2-ml ampoule

   

11. Blood products and plasma substitutes

   

11.2 Plasma fractions for specific uses

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 (28).

factor VIII concentrate (C) (2, 8)

dried

factor IX complex

dried

(coagulation factors II, VII,

 

IX, X) concentrate (C) (2, 8)

 
   

12. Cardiovascular medicines

   

12.2 Antiarrhythmic medicines

epinephrine (adrenaline) (C)

injection, 1mg (as hydrochloride)/ml in ampoule

isoprenaline (C)

injection, 20 µg (hydrochloride)/ml in ampoule

procainamide (B)

injection, 100mg (hydrochloride)/ml in10-ml ampoule

quinidine (A) (7)

tablet, 200mg (sulfate)

12.3 Antihypertensive medicines

prazosin (B)

tablet, 500 µg, 1mg

sodium nitroprusside (C) (2, 8)

powder for infusion, 50mg in ampoule

12.5 Antithrombotic medicines

streptokinase (C)

powder for injection, 100000IU, 750000IU

 

in vial

   

13. Dermatological medicines (topical)

   

13.1 Antifungal medicines

selenium sulfide (C)

detergent-based suspension, 2%

13.7 Ultraviolet-blocking agents

topical sun protection agent

cream, lotion or gel

with activity against

 

ultraviolet A and

 

ultraviolet B (C)

 
   

14. Diagnostic agents

   

14.2 Radiocontrast media

meglumine iotroxate (C)

solution, 5 8g iodine in 100 250ml

   

16. Diuretics

   

mannitol (C)

injectable solution, 10%, 20%

   

18. Hormones, other endocrine medicines and contraceptives

   

18.1 Adrenal hormones and synthetic substitutes

fludrocortisone (C)

tablet, 100 µg (acetate)

18.2 Androgens

testosterone (C) (2)

injection, 200mg (enantate) in 1-ml

 

ampoule

18.3 Contraceptives

18.3.1 Hormonal contraceptives

 

levonorgestrel (B)

tablet, 30 µg

medroxyprogesterone acetate (B) (7, 8)

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

norethisterone enantate (B) (7, 8)

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

18.7 Progestogens

medroxyprogesterone acetate (B)

tablet, 5mg

   

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

vecuronium (C)

powder for injection, 10mg (bromide) in

 

vial

   

21. Ophthalmological preparations

   

21.5 Mydriatics

epinephrine (adrenaline) (A)

solution (eye drops), 2% (as

 

hydrochloride)

   

25. Medicines acting on the respiratory tract

   

25.1 Antiasthmatic medicines

cromoglicic acid (B)

inhalation (aerosol), 20mg (sodium salt)

 

per dose

   

27. Vitamins and minerals

   

calcium gluconate (C) (2, 8)

injection, 100mg/ml in 10-ml ampoule

 

Example of a therapeutic group.


References

1. Hogerzeil HV et al. Impact of an essential drugs programme on availability and rational use of drugs. Lancet, 1989, i(8630):141 142.

2. Quick JD et al., eds. Managing drug supply, 2nd ed. West Hartford, CT, Kumarian Press, 1997:122- 123.

3. The selection of essential drugs. Report of a WHO Expert Committee. Geneva, World Health Organization, 1977 (WHO Technical Report Series, No. 615).

4. WHA28.66. Prophylactic and therapeutic substances. In: Handbook of resolutions and decisions of the World Health Assembly and Executive Board. Volume II, 1973- 1984. Geneva, World Health Organization, 1985:129.

5. The selection of essential drugs. Second report of a WHO Expert Committee. Geneva, World Health Organization, 1979 (WHO Technical Report Series, No. 641).

6. The use of essential drugs. Report of a WHO Expert Committee. Geneva, World Health Organization, 1983 (WHO Technical Report Series, No. 685).

7. The use of essential drugs. Model list of essential drugs (fourth revision). Second report of the WHO Expert Committee. Geneva, World Health Organization, 1985 (WHO Technical Report Series, No. 722).

8. The use of essential drugs. Model list of essential drugs (fifth list). Third report of the WHO Expert Committee. Geneva, World Health Organization, 1988 (WHO Technical Report Series, No. 770).

9. The use of essential drugs. Model list of essential drugs (sixth list). Fourth report of the WHO Expert Committee. Geneva, World Health Organization, 1990 (WHO Technical Report Series, No. 796).

10. The use of essential drugs. Model list of essential drugs (seventh list). Fifth report of the WHO Expert Committee. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 825).

11. The use of essential drugs. Sixth report of the WHO Expert Committee. Geneva, World Health Organization, 1995 (WHO Technical Report Series, No. 850).

12. The use of essential drugs. Seventh report of the WHO Expert Committee. Geneva, World Health Organization, 1997 (WHO Technical Report Series, No. 867).

13. The use of essential drugs. Eighth report of the WHO Expert Committee. Geneva, World Health Organization, 1997 (WHO Technical Report Series, No. 882).

14. The use of essential drugs. Ninth report of the WHO Expert Committee (including the revised Model List of Essential Drugs). Geneva, World Health Organization, 2000 (WHO Technical Report Series, No. 895).

15. WHO’ s revised drug strategy. In: Thirty-ninth World Health Assembly, Geneva, 5- 16 May 1986. Volume 1. Resolutions and decisions, and list of participants. Geneva, World Health Organization, 1986, Annex 5:93 101 (document WHA39/1986/REC/1).

16. Development of WHO treatment guidelines: recommended process. Geneva, World Health Organization, 2001 (in preparation).

17. Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 823).

18. Guide to good prescribing. Geneva, World Health Organization, 1994 (document WHO/DAP/94.11).

19. Laing RO, Hogerzeil HV, Ross-Degnan D. Ten recommendations to improve use of medicies in developing countries. Health Policy and Planning, 2001, 16(1):13- 20.

20. Guidelines for ATC classification and DDD assignment, 5th ed. Oslo, WHO Collaborating Centre for Drug Statistics Methodology, 2001.

21. Single Convention on Narcotic Drugs, 1961 with amendments 1972. New York, NY, United Nations, 1972.

22. Convention on Psychotropic Substances, 1971. New York, NY, United Nations, 1977.

23. United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988. New York, NY, United Nations, 1991.

24. WHO model formulary. Geneva, World Health Organization, 2002.

25. Scaling up antiretroviral therapy in resource-limited settings: guidelines for a public health approach. Geneva, World Health Organization, 2002 (available from the Internet at http://www.who.int/hiv/topics/arv/ISBN 9241545674.pdf).

26. Cancer pain relief: with a guide to opioid availability, 2nd ed. Geneva, World Health Organization, 1996.

27. Requirements for Tuberculins (Revised 1985). In: WHO Expert Committee on Biological Standardization. Thirty-sixth report. Geneva, World Health Organization, 1987, Annex 1 (WHO Technical Report Series, No. 745).

28. Requirements for the Collection, Processing and Quality Control of Blood, Blood Components, and Plasma Derivatives (Revised 1992). In: WHO Expert Committee on Biological Standardization. Forty-third report. Geneva, World Health Organization, 1994, Annex 2 (WHO Technical Report Series, No. 840).

29. Requirements for Dried BCG Vaccine (Revised 1985). In: WHO Expert Committee on Biological Standardization. Thirty-sixth report. Geneva, World Health Organization, 1987, Annex 2 (WHO Technical Report Series, No. 745).

30. Requirements for Dried BCG Vaccine (Amendment 1987). In: WHO Expert Committee on Biological Standardization. Thirty-eight report. Geneva, World Health Organization, 1988, Annex 12 (WHO Technical Report Series, No. 771).

31. Requirements for Diphtheria, Tetanus, Pertussis and Combined Vaccines (Revised 1989). In: WHO Expert Committee on Biological Standardization. Fortieth report. Geneva, World Health Organization, 1990, Annex 2 (WHO Technical Report Series, No. 800).

32. Requirements for Hepatitis B Vaccine Prepared from Plasma (Revised 1994). In: WHO Expert Committee on Biological Standardization. Forty-fifth report. Geneva, World Health Organization, 1995, Annex 3 (WHO Technical Report Series, No. 858).

33. Requirements for Measles, Mumps and Rubella Vaccines and Combined Vaccine (Live) (Revised 1992). In: WHO Expert Committee on Biological Standardization. Forty-third report. Geneva, World Health Organization, 1994, Annex 3 (WHO Technical Report Series, No. 840).

34. Requirements for Measles, Mumps and Rubella Vaccines and Combined Vaccine (Live). In: WHO Expert Committee on Biological Standardization. Forty-fourth report. Geneva, World Health Organization, 1994, Note (WHO Technical Report Series, No. 848).

35. Requirements for Poliomyelitis Vaccine (Oral) (Revised 1989). In: WHO Expert Committee on Biological Standardization. Fortieth report. Geneva, World Health Organization, 1990, Annex 1 (WHO Technical Report Series, No. 800).

36. Requirements for Poliomyelitis Vaccine (Inactivated) (Revised 1981). In: WHO Expert Committee on Biological Standardization. Geneva, World Health Organization, 1982, Annex 2 (WHO Technical Report Series, No. 673).

37. Requirements for Poliomyelitis Vaccine (Inactivated) (Addendum 1985). In: WHO Expert Committee on Biological Standardization. Thirty-sixth report. Geneva, World Health Organization, 1987, Annex 4 (WHO Technical Report Series, No. 745).

38. Requirements for Influenza Vaccine (Inactivated) (Revised 1990). In: WHO Expert Committee on Biological Standardization. Forty-first report. Geneva, World Health Organization, 1991, Annex 2 (WHO Technical Report Series, No. 814).

39. Requirements for Meningococcal Polysaccharide Vaccine. In: WHO Expert Committee on Biological Standardization. Geneva, World Health Organization, 1976, Annex 2 (WHO Technical Report Series, No. 594).

40. Requirements for Meningococcal Polysaccharide Vaccine (Addendum 1980, incorporating Addendum 1976 and Addendum 1977). In: WHO Expert Committee on Biological Standardization. Thirty-first report. Geneva, World Health Organization, 1981, Annex 6 (WHO Technical Report Series, No. 658).

41. Requirements for Rabies Vaccine for Human Use (Revised 1980). In: WHO Expert Committee on Biological Standardization. Thirty-first report. Geneva, World Health Organization, 1981, Annex 2 (WHO Technical Report Series, No. 658).

42. Requirements for Rabies Vaccine for Human Use (Amendment 1992). In: WHO Expert Committee on Biological Standardization. Forty-third report. Geneva, World Health Organization, 1994, Annex 4 (WHO Technical Report Series, No. 840).

43. Requirements for Rabies Vaccine (Inactivated) for Human Use Produced in Continuous Cell Lines (Revised 1986). In: WHO Expert Committee on Biological Standardization. Thirty-seventh report. Geneva, World Health Organization, 1987, Annex 9 (WHO Technical Report Series, No. 760).

44. Requirements for Rabies Vaccine (Inactivated) for Human Use Produced in Continuous Cell Lines (Amendment 1992). In: WHO Expert Committee on Biological Standardization. Forty-third report. Geneva, World Health Organization, 1994, Annex 5 (WHO Technical Report Series, No. 840).

45. Requirements for Typhoid Vaccine (Live, Attenuated, Ty 21a, Oral). In: WHO Expert Committee on Biological Standardization. Geneva, World Health Organization, 1984, Annex 3 (WHO Technical Report Series, No. 700).

46. Requirements for Vi Polysaccharide Typhoid Vaccine. In: WHO Expert Committee on Biological Standardization. Forty-third report. Geneva, World Health Organization, 1994, Annex 1 (WHO Technical Report Series, No. 840).

47. Requirements for Yellow Fever Vaccine (Revised 1995). In: WHO Expert Committee on Biological Standardization. Forty-sixth report. Geneva, World Health Organization, 1998, Annex 2 (WHO Technical Report Series, No. 872).

Appendix 1: Information to be included with an application for the inclusion, change or deletion of a medicine in the WHO Model List of Essential Medicines

1. Summary statement of the proposal for inclusion, change or deletion.

2. Name of the focal point within WHO submitting or supporting the application.

3. Name of the organization(s) consulted and/or supporting the application.

4. International Nonproprietary Name (INN, generic name) of the medicine.

5. Whether listing is requested as an individual medicine or as an example of a therapeutic group.

6. Information supporting the public health relevance (e.g. epide-miological information on disease burden, assessment of current use, target population).

7. Treatment details (i.e. dosage regimen and duration; reference to existing WHO and other clinical guidelines; need for special diagnostic or treatment facilities and skills).

8. Summary of comparative effectiveness in a variety of clinical settings, including:

- identification of clinical evidence (i.e. search strategy, systematic reviews identified, reasons for selection/exclusion of particular data);

- summary of available data (i.e. appraisal of quality, outcome measures, summary of results);

- summary of available estimates of comparative effectiveness.


9. Summary of comparative evidence on safety, including:

- estimate of total patient exposure to date;
- description of adverse effects/reactions;
- identification of variation in safety due to health systems and patient factors;
- summary of comparative safety against comparators.


10. Summary of available data on comparative cost1 and cost-effectiveness within the pharmacological class or therapeutic group, including:

- range of costs of the proposed medicine;

- comparative cost-effectiveness presented as range of cost per routine outcome (e.g. cost per case, cost per cure, cost per month of treatment, cost per case prevented, cost per clinical event prevented, or, if possible and relevant, cost per quality-adjusted life year gained).

1 Information on cost and cost-effectiveness should preferably refer to average generic world market prices as listed in the International Drug Price Indicator Guide, an essential medicines pricing service provided by WHO and maintained by Management Sciences for Health. If this information is not available, other international sources, such as the WHO, UNICEF and Médecins sans Frontières price information service, can be used. All cost analyses should specify the source of the price information.


11. Summary of regulatory status of the medicine (in country of origin, and preferably in other countries as well).

12. Availability of pharmacopoeial standards (British pharmacopoeia, The international pharmacopoeia, United States pharmacopoeia).

13. Proposed (new/adapted) text for the WHO model formulary.

Applications for additions and changes to, or deletions from, the Model List of Essential Medicines should be sent to: The Secretary of the Expert Committee on the Selection and Use of Essential Medicines, Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland.

 

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