Amendments to the individual entries in the list are detailed below.

Section 3. Antiallergics and drugs used in anaphylaxis

For epinephrine, the Committee recommended the addition of the name adrenaline, on the basis of its worldwide usage.

Section 4. Antidotes and other substances used in poisonings

4.2 Specific

Acetylcysteine injection, 200mg/ml in 10-ml ampoule, is added to this section for the treatment of paracetamol poisoning because it shows greater efficacy when given intravenously than DL,-methionine given orally (52).

Section 5. Anticonvulsants/antiepileptics

Magnesium sulfate is transferred to the main list, since eclampsia is not considered a rare disorder.

Section 6. Anti-infective drugs

6.2.4 Antituberculosis drugs

Rifampicin + isoniazid (tablet, 60 mg + 30 mg, 60 mg + 60 mg), rifampi-cin + isoniazid + pyrazinamide (tablet, 60 mg + 30 mg + 150 mg) and rifampicin + isoniazid + pyrazinamide + ethambutol (tablet, 150mg + 75 mg + 400 mg + 275 mg) are added to facilitate treatment of tuberculosis in paediatric patients and to improve compliance among adult patients (53).

6.3 Antifungal drugs

Fluconazole replaces ketoconazole as the prototype drug since it is more cost-effective and is associated with fewer adverse effects.

6.4.2 Antiviral drugs

Nevirapine tablet, 200 mg and oral solution, 50 mg/5 ml, are added to this section for the prevention of mother-to-child transmission of HIV, based on the results of a study sponsored by WHO and the recommendations of the WHO/UNAIDS Technical Working Group (54). The Committee discussed the limited safety information available on this drug, particularly for this use, but considered that its demonstrated value in reducing mother-to-child transmission of HIV outweighed the risk.

6.5.3 Antimalarial drugs

Artesunate tablet, 50 mg, is added for the treatment of malaria resistant to older drugs. Since this drug has variable bioavailability, special attention to the quality of the product is required.

The Committee discussed the combination product artemether + lumefantrine and is awaiting additional information on operational use in adults before making a decision.

Doxycycline capsule or tablet, 100mg (hydrochloride) is added for prophylaxis against malaria, as an alternative to mefloquine.

6.5.5 Antitrypanosomal drugs

The Committee was informed that eflornithine and suramin sodium are no longer being produced. These drugs continue to be essential for treating African trypanosomiasis, especially in view of the resistance developing to melarsoprol. The Committee urged that production of these drugs be resumed.

Section 8. Antineoplastic and immunosuppressive drugs and drugs used in palliative care

8.1 Immunosuppressive drugs

A square symbol is added to ciclosporin to indicate that tacrolimus could serve as an alternative.

8.2 Cytotoxic drugs

The Committee acknowledged the review of cancer therapy and anti-neoplastic drugs conducted by the International Agency for Research on Cancer (IARC) and accepted its recommendation to add daunorubicin powder for injection, 50 mg (as hydrochloride) and chlorambucil tablet, 2mg, to the list, for the reasons summarized in a WHO Consultation (55). Asparaginase, chlormethine, dacarbazine and levamisole are retained on the list, as the evidence in support of their deletion was unclear. The Committee hopes that WHO will continue its evidence-based reviews in this area and inform the Committee of the results.

Section 11. Blood products and plasma substitutes

11.2 Plasma fractions for specific uses

Albumin is deleted from the list since the results of the review by the Cochrane Collaboration suggest the likelihood of previously unrecognized hazards and a lack of evidence of better efficacy of albumin compared with alternatives.

Section 12. Cardiovascular drugs

12.3 Antihypertensive drugs

Prazosin tablet, 500µg and I mg, replaces doxazosin in the complementary list as the representative of the a-adrenoreceptor antagonist class of drugs since it is now less expensive than doxazosin.

12.6 Lipid-lowering agents

The paragraph on lipid-lowering agents has been revised to focus only on drug issues. The Committee recommended that management of risk factors for atherosclerotic disease should be addressed in treatment guidelines.

Section 13. Dermatological drugs (topical)

13.2 Anti-infective agents

The Committee reviewed the safety of methylrosanilinium chloride (gentian violet), but concluded that the overall benefits (including its very low cost) outweighed the risks and that it should be maintained on the list.

Section 14. Diagnostic agents

14.2 Radiocontrast media

lohexol injection, 140-350 mg iodine/ml in 5-ml, 10-ml or 20-ml ampoule is added since it is safer than ionized contrast media. The Committee discussed whether propyliodone is essential and asked that a formal recommendation be made at its next meeting.

Section 15. Disinfectants and antiseptics

The Committee discussed section 15 and requested that it be formally reviewed at its next meeting.

15.1 Antiseptics

Ethanol, 70% solution is added, owing to its widespread use. The Committee recommended that the solution be denatured to preclude its use as a beverage. The square symbol is to indicate that propanol may be used as an alternative.

Section 17. Gastrointestinal drugs

17.1 Antacids and other antiulcer drugs

The Committee recognized that other H2 blockers may be slightly safer than cimetidine but cimetidine continues to be listed as representative of the H 2 blocker class of drugs. Detailed review of all drugs for treatment of peptic ulcer is requested for the future.

17.4 Anti-inflammatory drugs

Hydrocortisone, retention enema, is now recognized as representative of this class of drugs, which includes prednisolone, retention enema.

17.6 Laxatives

The Committee recommended that the antidiarrhoeal class of drugs be reviewed and its revision be considered at the next meeting.

17.7 Drugs used in diarrhoea

The Committee recommended that the antidiarrhoeal class of drugs be reviewed and its revision be considered at the next meeting.

Section 18. Hormones, other endocrine drugs and contraceptives

18.3 Contraceptives

Levonorgestrel tablet, 0.75 mg (pack of two) is added for emergency contraception on the basis of the published comparative clinical trials. The Committee recognizes that this regimen is superior to ethinylestradiol + levonorgestrel tablet, 50 µg + 250µg (pack of four), which is retained on the list for the time being. These drugs are included on the main list in recognition of their need.

Section 19. Immunologicals

19.2 Sera and immunoglobulins

Antiscorpion sera are deleted because of a lack of efficacy of these products (56).

19.3 Vaccines

The Committee accepted the recommendation of the WHO Department of Vaccines and Biologicals to modify the list of essential vaccines to list the antigens but not the specific vaccine mixtures. The reason is that there are various combination products intended for different groups of people and that listing all of the recommended vaccines would unduly complicate the list. Specific therapeutic recommendations for vaccines containing single antigens or mixtures of antigens are found in the policy statements of the WHO Department of Vaccines and Biologicals (57).

Section 22. Oxytocics and antioxytocics

The Committee urges a systematic review of haemostatic agents for the next meeting rather than considering single agents at this time. The Committee also urges that a systematic review of agents for the treatment of menorrhagia be carried out in the future.

Section 24. Psychotherapeutic drugs

Suggestions to change the title of this section, explain the meaning of the square symbol, and add the selective serotonin re-uptake inhibitors to the list initiated a general discussion of the drugs in section 24 and the subclassifications in this section. The Committee decided that there was insufficient urgency to include the selective serotonin re-uptake inhibitors at this time and requested that this section be reviewed in total and that a recommendation for the essential drugs to treat mental illness be presented at the next meeting.

Data from the Cochrane Collaboration indicate that nicotine replacement therapy aids in smoking cessation, especially when provided as part of a comprehensive smoking cessation programme. The public health consequences of smoking have been demonstrated repeatedly. The specific usefulness of nicotine replacement therapy in a smoking cessation programme must be decided at the national or more local level. Because the cost-effectiveness of such therapy varies in different localities, no individual product was listed as essential at this time. Additional information on the cost-effectiveness of nicotine replacement therapy in a variety of countries and settings and in various smoking cessation programmes would be helpful in any future consideration of this subject. The Committee discussed micronutrient supplementation of oral rehydration fluid, and requested that a formal proposal of a specific formula be made available at a future meeting.

Section 25. Drugs acting on the respiratory tract

25.1 Antiasthmatic drugs

For theophylline, a 300-mg tablet is added to improve compliance.

Section 27. Vitamins and minerals