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Transcript
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
18. HORMONES, OTHER ENDOCRINE DRUGS AND CONTRACEPTIVES
18.1 Adrenal hormones and synthetic substitutes
*dexamethasone
tablet 500 micrograms, 4 mg; injection 4 mg
dexamethasone phosphate (as disodium salt)
in 1-ml ampoule
Potent corticosteroid. Suppression of
inflammatory and allergic disorders,
shock and variety of other uses
hydrocortisone
powder for injection, 100 mg (as sodium
succinate) in vial
Corticosteroid For adrenocortical
insufficiency
*prednisolone
tablet 1 mg, 5 mg
Potent corticosteroid. Suppression of
inflammatory and allergic disorders
(C)
tablet, 100 micrograms (acetate)
For adrenocortical insufficiency
Cochrane Library: No reviews but
RCTs exist
(C) (2)
injection, 200 mg (enantate) in 1-ml ampoule
Replacement therapy
Cochrane Library: No reviews but
RCTs exist
*ethinylestradiol +
*levonorgestrel
tablet, 30 micrograms + 150 micrograms
Oral contraceptive
Cochrane Library: Several reviews on
oral contraceptives
*ethinylestradiol +
*levonorgestrel
tablet, 50 micrograms + 250 micrograms
(pack of four)
Emergency contraception
Cochrane Library: Several reviews on
oral contraceptives
*ethinylestradiol +
tablet, 35 micrograms + 1.0 mg
EDL2 Oral contraceptive
Cochrane Library: Several reviews on
Complementary drug
fludrocortisone
18.2 Androgens
Complementary drug
testosterone
18.3 Contraceptives
18.3.1 Hormonal contraceptives
Section 3 Page 1 of 14
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
*norethisterone
oral contraceptives
levonorgestrel
tablets, 750 micrograms (pack of two)
EDL11 added for emergency
contraception
Cochrane Library: Several reviews on
oral contraceptives
Complementary drugs
*levonorgestrel
(B)
tablets, 30 micrograms
EDL9 Replaces norethisterone, safer
for lactating mothers
Cochrane Library: Several reviews on
oral contraceptives
medroxyprogesterone
acetate
(B) (7, 8)
depot injection, 150 mg/ml in 1-ml vial
Provides contraception for 12 weeks.
Cochrane Library: Several reviews on
oral contraceptives
norethisterone enantate
(B) (7, 8)
oily solution, 200 mg/ml in 1-ml ampoule
Provides contraception for 8 weeks
Cochrane Library: Several reviews on
oral contraceptives
Contraceptive device
Cochrane Library: one review
18.3.2 Intrauterine devices
copper-containing device
18.3.3 Barrier methods
condoms with or without
spermicide (nonoxinol)
Contraceptive devices
diaphragms with spermicide
(nonoxinol)
Contraceptive devices
Cochrane Library: one review
18.4 Estrogens
*ethinylestradiol
tablet, 10 micrograms, 50 micrograms
Hormone replacement sometimetimes
used for menopausal symptoms
tablets, 2.5 mg, 5 mg
EDL10 Restored: recognised as more
suitable prototype drug than
18.5 Insulins and other antidiabetic agents
*glibenclamide
Section 3 Page 2 of 14
CE6 intensive treatment reduces
complications for Type 1 and type 2
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
tolbutamide. Sulphonylurea.
diabetes
insulin (soluble)
injection, 40 IU/ml in 10-ml vial, 100 IU/ml
in 10-ml vial
Replacement hormone for diabetes
See glibenclamide
intermediate-acting insulin
injection, 40 IU/ml in 10 ml vial; 100 IU/ml
in 10 ml vial (as compound insulin zinc
suspension or isophane insulin)
Replacement hormone for diabetes
See glibenclamide
metformin
tablet, 500 mg (hydrochloride)
EDL10 To complete the range of oral
antidiabetic drugs. Different mode of
action from sulphonylureas
See glibenclamide
tablet, 50 mg (citrate)
EDL2 Female infertility due to
oligomenorrhoea or secondary
amenorrhoea
CE6 One SR found clomiphene
increases likelihood of pregnancy in
women who ovulate infrequently. Little
evidence that prolonged use increases
risk of ovarian cancer
tablet, 5 mg
EDL2 Added as progesterone only
contraceptive
tablet, 5 mg
Mild to moderate endometriosis
CE6 SRs have shown that pain is
reduced but no evidence that fertility
was improved.
For hypothyroidism
Cochrane Library: No reviews but
RCTs exist
18.6 Ovulation inducers
*clomifene
(2, 8)
18.7 Progestogens
norethisterone
Complementary drug
medroxyprogesterone
acetate
(B)
18.8 Thyroid hormones and antithyroid drugs
levothyroxine
tablet, 50 micrograms, 100 micrograms
(sodium salt)
Section 3 Page 3 of 14
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
potassium iodide
tablet, 60 mg
Prophylaxis and treatment of iodine
deficiency and pre-operative
management of hyperthyroidism
*propylthiouracil
tablet, 50 mg
For hyperthyroidism
Cochrane Library: No reviews but
RCTs exist
19. IMMUNOLOGICALS
19.1 Diagnostic agents
All tuberculins should comply with the WHO Requirements for Tuberculins (Revised 1985). WHO Expert Committee on Biological Standardization Thirty sixth report, WHO
Technical Report Series, No. 745, 1987, Annex 1..
tuberculin, purified protein
derivative (PPD)
injection
Intra dermal injection as diagnostic test
for hypersensitivity to tubercular
protein. Used prior to BCG vaccination
Cochrane Library: One review
19.2 Sera and immunoglobulins
All plasma fractions should comply with the WHO Requirements for the Collection, Processing and Quality Control of Blood, Blood Components and Plasma Derivatives
(Revised 1992). WHO Expert Committee on Biological Standardization Forty-third report, WHO Technical Report Series, No. 840, 1994, Annex 2..
anti-D immunoglobulin
(human)
injection, 250 micrograms in single-dose vial
To prevent rhesus negative mother
from forming antibodies to fetal rhesus
positive cells.
Cochrane Library: No reviews or
RCTs found
*antitetanus
immunoglobulin (human)
injection, 500 IU in vial
For the management of tetanus prone
wounds and for established tetanus
alongside other interventions.
Cochrane Library: No reviews or
RCTs found
antivenom serum
injection
Range of specific sera for use following
snake bite
Cochrane Library: one review on
preventing reactions to antivenoms
diphtheria antitoxin
injection, 10,000 IU, 20,000 IU in vial
For active immunisation against
diphtheria or when an individual has
Cochrane Library: No reviews or
RCTs found
Section 3 Page 4 of 14
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
come into contact with the disease or is
travelling to an endemic area.
immunoglobulin, human
normal
(2)
intramuscular injection
For protection against Hepatitis A,
measles and to a lesser extent rubella.
Cochrane Library: No reviews or
RCTs found
immunoglobulin, human
normal
(2, 8)
intravenous injection
Used in a variety of conditions as
replacement therapy for patients who
are immune deficient
Cochrane Library: No reviews or
RCTs found
injection, 150 IU/ml
Used following exposure of a unimmunised victim in or from a high risk
country. Injected at the site of the bite
and intramuscularly.
Cochrane Library: No reviews or
RCTs found
BCG
For immunisation against tuberculosis
in those who have no natural immunity
Cochrane Library: a number of reviews
on immunisation
diphtheria
Routine childhood vaccine often
combined with pertussis and tetanus
hepatitis B
Vaccine for health care workers and
other groups at risk
measles
Routine childhood vaccine
pertussis
Routine childhood vaccine
poliomyelitis
Routine childhood vaccine
tetanus
Routine childhood vaccine or after
*rabies immunoglobulin
19.3 Vaccines
All vaccines should comply with the WHO Requirements for Biological Substances..
19.3.1 For universal immunization
Section 3 Page 5 of 14
CE6 Five doses probably confer life
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
injury
long immunity
19.3.2 For specific groups of individuals
influenza
For at risk individuals
meningitis
For travellers to endemic areas or on
the Hadj annual pilgrimage
rabies
For those at risk from rabid animals or
treating rabies patients
rubella
Routine childhood vaccine for girls
typhoid
For travellers to endemic areas
yellow fever
For travellers to endemic areas
20. MUSCLE RELAXANTS (PERIPHERALLY ACTING) AND CHOLINESTERASE INHIBITORS
*alcuronium chloride
(2)
*neostigmine
injection, 5 mg/ml in 2-ml ampoule
EDL8 Muscle relaxant for surgery.
Replaces gallamine.
Cochrane Library: No reviews but
RCTs exist
tablet, 15 mg (bromide); injection, 500
micrograms in 1-ml ampoule; 2.5 mg
(metilsulfate) in 1-ml ampoule
Reverses the effect of non depolarising
muscle relaxants Tablets used in
myasthenia gravis
Cochrane Library: No reviews but
RCTs exist
pyridostigmine bromide
(2, 8)
tablet, 60 mg; injection, 1 mg in 1-ml
ampoule
Reverses the effect of non depolarising
muscle relaxants Tablets used in
myasthenia gravis
Cochrane Library: No reviews but
RCTs exist
suxamethonium chloride
(2)
injection, 50 mg/ml in 2-ml ampoule; powder
for injection
Rapid onset short duration muscle
relaxant for surgery
Not heat stable
Complementary drug
Section 3 Page 6 of 14
Cochrane Library: No reviews but
RCTs exist
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
vecuronium bromide
(C)
powder for injection, 10 mg in vial
EDL7 Muscle relaxant for surgery
Short duration of action and lack of
vagolytic activity.
Cochrane Library: No reviews but
RCTs exist
Broad spectrum antibiotic
CE6 RCTs suggest that no significant
differences between different agents
21. OPHTHALMOLOGICAL PREPARATIONS
21.1 Anti-infective agents
*gentamicin
solution (eye drops), 0.3% (sulfate)
Has chloramphenicol been excluded ?
*idoxuridine
solution (eye drops), 0.1%; eye ointment,
0.2%
EDL5 Of value as a specific antiviral
agent in herpes keratitis
CE6 one small RCT shows significant
benefit
silver nitrate
solution (eye drops), 1%
Used as prophylaxis against neonatal
conjunctivitis (gonococcus)
*tetracycline
eye ointment, 1% (hydrochloride)
For eye infections due to sensitive
organisms
Cochrane Library: 2 reviews exist
eye drops, 0.5% (sodium phosphate)
Local treatment of inflammation
CE6 little evidence of effect
solution (eye drops), 0.5% (hydrochloride)
Local anaesthetic for minor surgery
Cochrane Library: No reviews but
RCTs exist
acetazolamide
tablet, 250 mg
Oral treatment to reduce intra-ocular
pressure. Not for prolonged use.
Cochrane Library: No reviews but
RCTs exist
*pilocarpine
solution (eye drops), 2%, 4% (hydrochloride
To reduce intra-ocular pressure
Cochrane Library: No reviews but
21.2 Anti-inflammatory agents
*prednisolone
21.3 Local anaesthetics
*tetracaine
21.4 Miotics and antiglaucoma drugs
Section 3 Page 7 of 14
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
or nitrate)
*timolol
RCTs exist
solution (eye drops), 0.25%, 0.5% (as
maleate)
EDL4 reduces intra-ocular pressure in
chronic simple glaucoma.
Cochrane Library: No reviews but
RCTs exist
Solution (eye drops), 0.1%; solution 0.5%,
1% (sulfate)
Used to dilate pupil in a variety of
conditions
Cochrane Library: No reviews but
RCTs exist
solution (eye drops), 2% (as hydrochloride)
To reduce intra-ocular pressure
Cochrane Library: No reviews or
RCTs found
21.5 Mydriatics
atropine
Complementary drug
epinephrine (adrenaline)
(A)
EDL11 committee asked for a systematic review of this section and on drugs for
menorrhagia
22. OXYTOCICS AND ANTIOXYTOCICS
22.1 Oxytocics
*ergometrine
tablet, 200 micrograms (hydrogen maleate);
injection, 200 micrograms (hydrogen
maleate) in 1-ml ampoule
For treatment of post partum
haemorrhage
Cochrane Library: Several reviews
exist.
oxytocin
injection, 10 IU in 1-ml ampoule
To induce or augment labour and
treatment of post partum haemorrhage
Cochrane Library: Several reviews
exist.
tablet, 4 mg (as sulfate); injection, 50
micrograms (as sulfate)/ml in 5-ml ampoule
EDL5 new subsection. To inhibit
uncomplicated premature labour
Cochrane Library: No reviews but
RCTs exist
To maintain fluid and electrolyte
balance in patients with acute or
chronic renal failure
Cochrane Library: No reviews but
RCTs exist
22.2 Antioxytocics
*salbutamol
(2)
23. PERITONEAL DIALYSIS SOLUTION
intraperitoneal dialysis
solution (of appropriate
composition)
parenteral solution
Section 3 Page 8 of 14
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
ED11 Committee asked for a review of drugs to treat mental illness
24. PSYCHOTHERAPEUTIC DRUGS
24.1 Drugs used in psychotic disorders
*chlorpromazine
*fluphenazine decanoate
(5)
*haloperidol
tablet, 100 mg (hydrochloride); syrup, 25 mg
(hydrochloride)/5ml; injection, 25 mg
(hydrochloride)/ml in 2-ml ampoule
For schizophrenia and other psychoses
injection, 25 mg (decanoate or enantate) in 1ml ampoule
For schizophrenia and other psychoses
tablet, 2 mg, 5 mg; injection, 5 mg in 1-ml
ampoule
For schizophrenia and other psychoses
tablet, 25 mg (hydrochloride)
Tricyclic antidepressant. Also used for
neuropathic pain
Cochrane Library: range of reviews in
schizophrenia
CE6 one SR shows global improvement
in short and medium term but AEs
make it unacceptable to many
24.2 Drugs used in mood disorders
24.2.1 Drugs used in depressive disorders
*amitriptyline
Cochrane Library: range of reviews in
depression
CE6 SRs show effective but frequent
AEs
24.2.2 Drugs used in bipolar disorders
carbamazepine
(10, 11)
scored tablet, 100 mg, 200 mg
EDL10 New section on drugs used in
bipolar disorders. Used in bipolar
(manic depressive) disorder in patients
unresponsive to lithium.
lithium carbonate
(2, 4)
capsule or tablet, 300 mg
EDL10 New section on drugs used in
bipolar disorders. Prophylaxis and
Section 3 Page 9 of 14
Serum levels need to be monitored
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
treatment of mania and bipolar disorder
valproic acid
(7, 11)
enteric coated tablet, 200 mg, 500 mg
(sodium salt)
For manic episodes associated with
bipolar disorder
24.3 Drugs used in generalized anxiety and sleep disorders
*diazepam
(1b)
scored tablet, 2 mg, 5 mg
Anxiolytic and hypnotic
Cochrane Library: No reviews but
RCTs exist
EDL8 For panic attacks and obsessivecompulsive disorders
CE6. SR evidence for effectiveness in
obsessive-compulsive disorders.
24.4 Drugs used for obsessive compulsive disorders and panic attacks
clomipramine
capsules, 10 mg, 25 mg (hydrochloride)
25. DRUGS ACTING ON THE RESPIRATORY TRACT
25.1 Antiasthmatic drugs
*aminophylline
(2)
injection, 25 mg/ml in 10 ml ampoule
For acute severe asthma. Plasma
concentration should be monitored
*beclometasone
inhalation (aerosol), 50 micrograms per dose
(dipropionate); 250 micrograms
(dipropionate) per dose
EDL2 For non systemic corticosteroid
prophylaxis for asthma
*epinephrine (adrenaline)
injection, 1 mg (as hydrochloride or hydrogen
tartrate) in 1-ml ampoule
For acute anaphylaxis
*ipratropium bromide
inhalation, 20 micrograms/metered dose
EDL10
CE6 conflicting evidence of effect in
children due to small studies
*salbutamol
tablet, 2 mg, 4 mg; inhalation (aerosol), 100
micrograms (as sulfate) per dose; syrup, 2
mg/5 ml; injection, 50 micrograms (as
sulfate)/ml in 5-ml ampoule; respirator
solution for use in nebulizers, 5 mg (as
For treatment and prophylaxis of mild
to moderate asthma
CE6 evidence of benefit in children in
early treatment but no increase in
benefit after 1 year
Section 3 Page 10 of 14
CE6 Inhaled steroids more effective
than theophylline, cromoglicate or long
acting beta agonists
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
sulfate)/ml
*theophylline
(10, 11)
tablet, 100 mg, 200 mg, 300 mg
EDL9 (300mg added EDL11 for
compliance) Bronchodilator for acute
airways obstruction and acute severe
asthma
(B)
inhalation (aerosol), 20 mg (sodium salt) per
dose
EDL2 Prophylaxis of asthma
(1a)
oral solution, 3.5 mg (bromide)/5 ml
EDL10 Replaces codeine more widely
available-less likely to lead to drug
abuse
CE6 evidence of increase of symptom
free days but insufficient evidence on
benefits vs. harm
Complementary drug
*cromoglicic acid
25.2 Antitussives
*dextromethorphan
26. SOLUTIONS CORRECTING WATER, ELECTROLYTE AND ACID-BASE DISTURBANCES
26.1 Oral
oral rehydration salts (for
glucose -electrolyte
solution)
see section 17.7.1
Replaces fluid and salts lost in acute
diarrhoea
potassium chloride
powder for solution
To prevent and treat potassium
depletion e.g. with diuretic use
glucose
injectable solution, 5% isotonic, 10%
isotonic; 50% hypertonic
Fluid replacement, glucose replacement
or as calorie source (50%)
glucose with sodium
chloride
injectable solution, 4% glucose, 0.18%
sodium chloride (equivalent to Na+ 30
EDL2 Fluid replacement
ED11 Committee asked for a revised
formula of rehydration fluid that
contains micronutrients to be
considered
26.2 Parenteral
Section 3 Page 11 of 14
Cochrane Library: One review on
crystalloids and colloids
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
mmol/l, Cl- 30 mmol/l)
potassium chloride
(2)
solution, 11.2% in 20-ml ampoule,
(equivalent to K+ 1.5 mmol/ml, Cl- 1.5
mmol/ml)
To prevent and treat potassium
depletion
sodium chloride
injectable solution, 0.9% isotonic (equivalent
to Na+ 154 mmol/l, Cl- 154 mmol/l);
injectable solution, 0.18% (Na+ 30 mmol/l,
Cl- 30 mmol/l) + glucose, 4%
Fluid replacement
sodium hydrogen carbonate
injectable solution, 1.4% isotonic (equivalent
to Na+ 167 mmol/l, HCO3- 167 mmol/l);
solution, 8.4% in 10-ml ampoule (equivalent
to NA+ 1000 mol/l, HCO3-1000 mol/l)
Used to control metabolic acidosis and
emergency treatment of hyperkalaemia
*sodium lactate, compound
solution
injectable solution
Used to control metabolic acidosis
2-ml, 5-ml, 10-ml ampoules
Sterile diluent
Must be diluted before administration
Is this now called Sodium Lactate
Solution ?
26.3 Miscellaneous
water for injection
ED11 Committee asked for a revised formula of rehydration fluid that contains
micronutrients to be considered
27. VITAMINS AND MINERALS
ascorbic acid
tablet, 50 mg
EDL2 Originally in hexavitamin EDL1
Vitamin C
*ergocalciferol
iodine
(8)
Cochrane Library: one review and
RCTs
capsule or tablet, 1.25 mg (50,000 IU); oral
solution, 250 micrograms/ml (10,000 IU/ml)
EDL2 Originally in hexavitamin EDL1
Cochrane Library: one review and
RCTs
iodized oil, 0.5 ml (240 mg of iodine/ml), 1
ml (480 mg iodine/1 ml) in ampoule (oral or
injectable); solution, 0.57 ml (308 mg iodine)
EDL6 For prophylaxis of goitre where
iodine deficiency is endemic
Cochrane Library: No review but
RCTs exist
Section 3 Page 12 of 14
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
in dispenser bottle; capsule, 200 mg.
*nicotinamide
tablet, 50 mg
EDL2 Originally in hexavitamin EDL1
Vitamin B group
Cochrane Library: one review on
nutritional supplements and RCTs
pyridoxine
tablet, 25 mg (hydrochloride)
Vitamin B6
Cochrane Library: one review on
nutritional supplements and RCTs
*retinol
sugar-coated tablet, 10,000 IU (as palmitate)
(5.5 mg); capsule, 200,000 IU (as palmitate)
(110 mg); oral oily solution 100,000 IU (as
palmitate)/ml in multidose dispenser; watermiscible injection 100,000 IU (as palmitate)
(55 mg) in 2-ml ampoule
EDL2 Originally in hexavitamin EDL1
Cochrane Library: 3 reviews on
vitamin A
tablet, 5 mg
EDL2 Originally in hexavitamin EDL1
riboflavin
Vitamin A High doses should be used
with caution
Vitamin B2
Cochrane Library: one review on
nutritional supplements and RCTs
*sodium fluoride
in any appropriate formulation
EDL2 Where water supplies are not
fluoridated-prophylaxis of dental caries
Cochrane Library: No review but
RCTs exist. 2 DARE reports
thiamine
tablet, 50 mg (hydrochloride)
EDL2 Originally in hexavitamin EDL1
Cochrane Library: one review on
nutritional supplements and RCTs
Vitamin B1
Complementary drug
calcium gluconate
(C), (2, 8)
injection, 100 mg/ml in 10-ml ampoule
For hypocalcaemia and hypocalcaemic
tetany
Phil Wiffen
Notes: +It can be assumed that drugs were on the original EDL (EDL1) unless there is a later reference to a subsequent EDL list
++ level of evidence used.
Section 3 Page 13 of 14
WHO Model List of Essential Drugs (EDL) with rational and evidence where available
11th edition (Nov. 1999)
By Therapeutic Group
CE6 refers to Clinical Evidence Issue 6 December 2001. SR - systematic review, RCT -randomised controlled trial,
Cochrane Library: 2002 Issue 1
DARE database of abstracts of reviews from NHS centre in York England published on their website (http://nhscrd.york.ac.uk/ ) and the Cochrane Library:
ADR- Adverse drug effect AE- adverse effects.
Comment. The review of evidence is minimal to give an indication of what is available. Some sections such as section 8 where drugs are used for a number of indications
need a thorough work up beyond the scope of this first trawl. Other areas need to be linked to WHO guidelines which are also being reviewed in the light of available
evidence.
Phil Wiffen email phil.wiffen @pru.ox.ac.uk
Feb2002
Section 3 Page 14 of 14