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					Rational Drugs
An Update on Rational Drug Use                                                                            Issue 21
                                                                                               July-September 2005

                                                  REVIEW TOPIC

            Treating Common Childhood
CHILDREN’S MEDICATION                     generally based on body weight (in        stools can become hard and cause

         s far as possible, medicines     kilograms) or various age ranges.         pain, making the child reluctant to
         for children should be used      Antibiotics etc. should be prescribed     pass stools. If this continues the
         as described in their product    at regular intervals throughout the       rectum may become enormously
licence. However, many medicines          day. However, some flexibility            enlarged, rectal sensation is de-
are not licensed for use in children      should be allowed to avoid waking         creased and further retention of
and the formulation may need to be        the child during the night.               stools occurs. Overflow of watery
changed with tablets being crushed                                                  faecal material around these hard,
or liquids licensed for injection being   SOME COMMON CHILDHOOD                     bulky stools may occur.
given orally. Prescribers for children    DISEASES                                  Treatment: For the young infant,
therefore, need to keep up-to-date                                                  drinks of boiled water or diluted
with what is the current evidence-        Colic
                                                                                    fresh orange juice can be offered
based best practice.                      Colic is a common problem effecting       between feeds, and formula feed
                                          both breast-fed and bottle-fed            should not be over-concentrated. For
  ADVERSE DRUG REACTIONS IN               babies. Typically this occurs during      toddlers reducing the intake of cow’s
          CHILDREN                        the first four months of life, often in   milk may help. After a certain age, a
 The identification and reporting of      the evening. The baby is inconsol-        balanced diet containing fruit and
 adverse reactions to drugs in            able, with repetitive bouts occurring
                                                                                    vegetables should be encouraged.
 children is particularly important       over several hours before suddenly
                                                                                    An osmotic laxative, such as
 because:                                 ceasing. It usually resolves sponta-
                                                                                    lactulose, may be given to soften the
                                          neously by five months of age. For
 1.The action of the drug and its                                                   stool. If these measures are unsuc-
                                          those on cow’s milk for some reason
 pharmacokinetics may differ in                                                     cessful, a stimulant laxative such as
                                          or the other (e.g.. no adequate breast
 children                                                                           biscacodyl can be given each night.
                                          milk, mother going to work). If there
 2.Drugs are not extensively tested                                                 Toileting after meals (making use of
                                          is colic, then replacing with
 in children during clinical trials                                                 the gastro-colic reflex) may help.
                                          hypoallergenic hydrolysed protein
 3. Many medicines for children are       formula feed may help.                    Fever
 used outside their product licence          Dicyclomine is effective, but has      Most infective agents can cause fever
 4.Suitable formulations may not          serious side effects. Simethicone         and it is this fever which often
 be available to allow precise            shows uncertain benefit. Reduced          makes the child appear unwell and
 dosing in children                       stimulation of the child appears to       causes distress to both child and
 5.Adverse drug reactions may             be beneficial whilst increased            carer. To help reduce the fever the
 differ between adults and chil-          carrying and holding does not seem        child’s clothes should be removed
 dren.                                    to reduce crying.                         and he or she should be covered
                                                                                    with just a sheet. Paracetamol 10-
                                          Constipation                              15mg/kg every 4-6 hours upto 4
DOSAGE IN CHILDREN                        Constipation involves the passage of      doses in 24 hours is the preferred
For children, doses should always be      hard stools at a reduced frequency.       antipyretic and adequate fluid
calculated with care. They are            If fluid intake is inadequate the         should be given. Ibuprofen 5mg/kg
                                                                                   often results from bacteria from the
                  RECOGNISING THE SERIOUSLY ILL CHILD                              upper respiratory tract making their
                                                                                   way into the lungs, following a viral
    The warning signs are:                and toes in spite of a fever             URTI, rather than direct person-to-
     Unconsciousness or excessive         suggests septicaemic shock               person infection. The commonest
     drowsiness                           A rapidly progressing dark               organisms are Haemophilus
     In babies and toddlers, floppi-      purple, blotchy rash anywhere            influenzae in younger children, and
     ness and indifference to sur-        on the body, that does not disap-        Streptococcus pneumoniae in older
     roundings                            pear when a glass is pressed up          children. Diagnosis is from charac-
                                          against it, suggests meningococ-         teristic chest sounds and by chest X-
     In older children, confusion,
                                          cal septicaemia                          ray. Often the causative organism
     delirium or disorientation with
                                          In children with breathing               cannot be identified so antibiotic
                                          difficulties (croup, asthma,             treatment is empirical. Broad-
     Severe headache, and/or                                                       spectrum penicillins, cephalosporins
                                          bronchiolitis, etc), severe reces-
     inability to bend the neck, with                                              and macrolides are equally effective.
                                          sion (“tugging-in” beneath and
     fever                                                                         Sicker children and those with an
                                          between the ribs with each
     Skin that is cold to the touch       inspiration), inability to talk,         underlying condition may require
     and mottled in appearance or         distress and exhaustion .                intravenous antibiotics. Atypical
     poor circulation to the fingers                                               pneumonia caused by mycoplasma
                                                                                   organisms requires macrolide
every 6-8 hours can be given if the      misery, deafness and rubbing of the
fever does not resolve with Paraceta-    ears. A discharge from the ear only       Asthma and recurrent infant
mol.                                     occurs if the eardrum perforates.         wheezing
   About one in 20 children, be-         Viruses cause over half the cases of      Many children are wrongly diag-
tween the ages of 6 months and five      Otitis media but it is difficult to       nosed as having recurrent chest
years, will be prone to developing       distinguish viral from bacterial          infections when they suffer from
febrile convulsions. These are brief     infection. The most common bacteria       asthma. The difficulty arises because
(less than 20 minutes), generalised      are Haemophilus influenzae, pneu-         asthma attacks are often triggered
fits that usually occur at the begin-    mococci and M. catarrhalis. It has        by a viral URTI. So the symptoms
ning of a febrile illness while the      been suggested that if there is no        and signs may be similar. In asthma,
temperature is rising rapidly. They      fever or systemic illness, antibiotics    however, the characteristic wheeze
are benign and do not develop into       should be withheld for 48 hours. If       is heard. The distinction is important
epilepsy, but can be frightening and     there is then no improvement, antibi-     because, in asthma, there is normally
distressing. Parents should be           otics such as amoxycillin or              no bacterial infection and antibiotics
advised to treat episodes of fever as    cephalexin should be prescribed.          are useless, while specific asthma
above, to avoid them in the future.      With an intact eardrum, eardrops are      treatment (inhaled bronchodilators
                                         not thought to be helpful.                or steroids) may be of great benefit.
Common Cold
The main symptoms are sneezing,          Croup (laryngitis, laryngo-tracheo-
nasal discharge, and mild fever.         bronchitis)
Most viral illnesses are self-limiting                                             1.   British National Formulary. No 49.
                                         This is nearly always viral, and can           London: BMA/RPharms GB March
and Paracetamol for fever may be         occur during an URTI. It is character-         2005. P 12-13
the only medication needed. Antibi-      ised by inspiratory and expiratory
otics should not be given unless the                                               2.   Puntis JWL. Childhood diseases 1:
                                         stridor, a “barking” cough and                 Gastrointestinal Problems PJ 265
child is sick and bacterial infection
                                         hoarseness that can come on quite              N7104 p52-56 July 8, 2000
cannot be ruled out. A normal
                                         suddenly, and cause great alarm.          3.   Royal College of Paediatrics and
healthy child between the ages of
                                         Most children improve considerably             Child Health. Medicines for
one and five years will have about
                                         after inhaling steam but sometimes             children. London: RCPCH publish-
six colds a year. The commonest
                                         hospital admission is required. Oral           ing, 1999.
complication is acute otitis media
but secondary bacterial infections       or inhaled steroids are effective in      4.   Scott-Jupp R. Childhood diseases 2:
                                         severe cases.                                  Infections PJ 265 N7105 p91-96 July
of the lower respiratory tract may
                                                                                        15, 2000
also occur.                              Pneumonia, bronchopneumonia,              5.   Valman HB. The ABC of one to
Otitis media                             lower respiratory tract infection              seven. 4th ed. London: BMJ pub-
The middle ear chamber is linked to      (LRTI)                                         lishing, 2000
the upper respiratory tract via the      Symptoms may include fever, cough
Eustachian tube. Infection therefore     with or without sputum, chest or                              Catherine Truman
frequently follows a cold. Typical       abdominal pain and respiratory                                       Pharmacist
symptoms are fever, pain and             distress in severe cases. The infection

2                                                                                                        Rational Drugs Issue 21
        Rational Prescription in Children –
              Ethics and Economics
                                                                                    Remains Vital to
   t is well understood that the vast      lack of time of both parents and
   majority of childhood diseases          doctors
   are self limiting and benign and     c) Doctors’ lack of experience and
                                                                                     Child survival
do not require much more than              training contributing to lack of
supportive care and simple sympto-         conviction in rational prescribing      A Report Card on Immunisation
matic relief.                              even if arrives at right diagnosis      Number 3
TONICS AND COUGH SYRUPS                 d) Doctors’ lack of peer support           UNICEF September 2005
According to Health Action Interna-     e) Lack of treatment protocols   
tional, “More than four out of every    f) Lack of audit systems by the doc-       progressforchildren/2005n3/
five vitamin preparations cannot be        tors community and professional
                                                                                   With vaccine-preventable dis-
recommended; nearly three out of           associations
                                                                                   eases killing some 1.4 million
every five is indicated for unproven    g) Wrong or incomplete information         children under five annually, the
indications; more than two out of          to doctors by drug companies            United Nations Children’s Fund
every five contain non-essential or
                                        h) Paucity of independent, non             warned today that an estimated
ineffective ingredients; more than
                                           partisan research where drugs are       27 million children and 40 million
one out of every two is irrationally
                                           concerned                               pregnant women are not being
formulated; and nearly one out of
                                        i) Increasing litigations with inad-       immunised each year and 41
every two contains excessive dos-
                                           equate structures for handling          countries are protecting fewer
age.” Over 80 per cent of cough and
                                           them                                    youngsters than a decade ago -
cold remedies on the market are
                                                                                   UN REPORT New York, Sept. 29,
irrational, most with ineffective and   j) Lack of understanding of ill
some with dangerous ingredients.           effects of over-prescription
                                           amongst doctors and carers                 Immunisation is currently
VACCINES                                k) Self prescription and OTC avail-
                                                                                   preventing some 2 million deaths
Even vaccines like anti pneumococ-                                                 among children under five every
cal vaccine and influenza vaccine                                                  year and the study shows that 103
                                        2. Reasons related to monetary             countries are already protecting
are being used routinely by some
                                        benefits to prescriber:                    90 per cent of their children
though this has no current justifica-
tion.                                   a) Doctor’s unwillingness to ‘lose a       against vaccine-preventable
                                           patient’ by defying the trend or        diseases while another 16 are
ANTIBIOTICS                                not providing a quick fix. (‘Aren’t     making steady progress. But in 74
There is a great tendency to shift to      you going to give any medicine at       countries programmes have not
newer and more expensive antibiot-         all doctor?’ ‘Do I still pay a fee if   kept up, or progress is too slow,
ics that do not necessarily provide        you haven’t prescribed any-             particularly in West and Central
an advantage.                              thing?’                                 Africa.
                                        b) Doctors unwillingness to lose a           The major killers are measles,
ANALGESICS                                 patient by suggesting a stigmatis-      haemophilus influenzae type b
The medical community’s response           ing or chronic problem like             (Hib), whooping cough (pertussis)
to drugs like Nimesulide has di-           asthma, epilepsy or cerebral            and neonatal tetanus, all of which
vided the medical profession with          palsy, leading to both inadequate       are preventable with vaccines that
many professional organisations            and unnecessary treatment.              are currently available at low
declaring it safe and others claiming   c) Desire to please drug companies         cost.
to have seen children die as a result      and ‘earn’, conference sponsor -
of liver failure from its use.                                                        In the near future, an addi-
                                           ships, corporate gifts, CME
                                                                                   tional 1.1 million deaths could be
                                           sponsorships etc.
ROOT CAUSES OF IRRATIONAL                                                          prevented with vaccines against
                                        d) The overall experience or opinion       pneumococcus and rotavirus,
                                           that investments in quality             important causes of severe pneu-
CHILDREN                                   relationships and a non compro-
1. Reasons not related to monetary                                                 monia and diarrhoea in develop-
                                           mising ethical practice are not         ing countries. In total, immunisa-
benefits to prescriber:                    seen to allow the making of a           tion programmes could reduce.
a) Parental demand and anxiety             ‘decent ‘ living in the short term.
   (built upon by drug companies,
   media etc.)                                              Vandana Prasad
b) Need for quick fixes because of            Paediatrician and member JSA

Rational Drugs Issue 21                                                                                                 3
                      INVITATION FOR A DIALOGUE
                                                                                   The focus theme for the next
          ON NATIONAL PULSE-POLIO PROGRAMME ( FOR POLIO                            issue will be on “Drugs &
                          ERADICATION)                                             Women’s Health.” We welcome
 The National Pulse-Polio programme was started by the Government of               readers to contribute for ‘Read-
 India in 1995 with the objective of eradication of the Wild Polio-Virus           ers Forum’ and Adverse Drug
 (WPV) transmission in the country. The immediate concern for some of              Reaction (ADR).
 us, now is the rising number of Acute Flaccid Paralyses Cases in the year
 2004 and 2005. As compared to the year 2003, when 8505 cases of AFP
 were reported in the country, the figures were 13,274 for the year 2004
 and 15,735 for the year 2005 till the end of month of August 2005.                We look forward to the
 Majority of such cases are being detected in the States of UP and Bihar           readers for contributions to
 where repeated rounds of pulse-polio are being conducted. There appears           our future Issues on, Drugs
 to be direct correlation between the increasing rounds of pulse-polio in          & women’s health, Quality
 these two states and the increasing number of AFP cases. The Oral Polio
 Vaccine is a live virus vaccine and repeated doses of any live virus can
                                                                                   issues, Diagnostics & de-
 cause unforeseen damages. An effective surveillance for any possible side         vices, Drugs used in medical
 effects of the vaccine is needed.                                                 emergency, Drugs used in
 Is there a theoretical possibility that the wild attenuated virus can form        accidents and trauma, and
 new recombinant strains with other enteric viruses? Any other cause?              ADR & Pharmacovigilence.
 Reader’s interest in this dialogue will be helpful. Data can be accessed
 from NPSP’s website
                                                              Dr Onkar Mittal
                                                  Rational Drugs
                                                                                   A health education publication
      REGULATORY MATTERS                               CAUTION                     from the Policy Advocacy Group
                                                                                   of CMAI.
          GMP for Quality                         Protect your children                             Christian
                                          Children see adults taking pills and,                     Medical
The Union Ministry of Health and
Family Welfare has amended the            given the opportunity, may take                           Association of
Good Manufacturing Practices              those pills themselves. Safety sug-                       India
(GMP) outlined in Schedule M of the       gestions include:                        Published by
Drugs and Cosmetics Rules vide            1.Store medicines in childproof          The General Secretary, CMAI
Gazette Notification GSR 431 (E)          containers, if possible.                 All correspondence to:
                                                                                   Policy Advocacy Group
dated 30.06.2005 and is applicable to     2.Keep medicines locked in cup-          Christian Medical Association of India
all the manufacturers from 01.07.         boards out of children’s reach.          Plot No 2, A-3 Local Shopping Centre
2005.                                                                              Janakpuri, New Delhi 110 058
                                          3.If your handbag contains medi-         Phone: 2559 9991/2/3 or 2552 1502
                                          cines, make sure to keep your bag,
          READERS FORUM                   out of children’s reach.       
Thanks for your literature “Rational      4.Try to avoid taking tablets in front
                                                                                   CMAI Bangalore Office
Drugs”, which is really quite in-         of your children, as they may want       HVS Court, 3rd Floor, 21 Cunningham
formative. The literature has been        to imitate you.                          Road, Bangalore 560 052
properly displayed. A lot of people                                                Tel: (080) 2220 5464, 2220 5837
are going through it and showing                  ANNOUNCEMENT
great interest.                                                                    Editorial Committee
                           R K Gupta                                               Dr Alice Kuruvilla
                                          CMAI’s quarterly Newsletter              Dr Sujith Chandy
                 Surya Research Centre    ‘Rational Drugs’ is now available        Dr Santanu K Tripathi
                       Dalhousie Road     online in the following web link.        Sr   Jessie Saldanha
                     Pathankot-145001           Dr Ashish Maseeh
    E-Mail:                                              Dr Vijay Aruldas
                                          article view/
                                                                                   Ms Reena Mathai Luke
                                                                                   Dr Joe Varghese
    “Immunisation is one of the safest and most cost-effective interventions we
                                                                                   Dr R Sweety Prem Kumar
    know. We need to protect the gains we have made in many countries and          Design & Production
    expand our efforts in others,” UNICEF Executive Director Ann M. Veneman,       Ms Susamma Mathew
    Progress for Children.                                                         Printed at: Impulsive Creations

4                                                                                                        Rational Drugs Issue 21

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