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The Selection and Use of Essential Medicines - WHO Technical Report Series, No. 914 (2003; 132 pages)  Índice de contenido
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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