I write this based on information available as on 4 th
October 2009. H1N1 scenario, as also the management guidelines, is rapidly
changing. Please keep track of the changes from time to time from official
websites.
Dr Fadnis has raised a pertinent point in her letter;
the point concerning the H1N1 guidelines to be followed while managing a
case of suspected novel H1N1 infection. She has observed that many
children with cough, cold, sore throat and fever with or without loose
stools or vomiting [Influenza like illness (ILI)] are being treated with
oseltamivir, (besides the other management modalities as are appropriate
for the child’s condition), and that many of these cases ultimately turn
out to be negative for novel H1N1 infection on nasopharyngeal swab PCR
making it seem unnecessary to treat every such patient with oseltamivir.
However this situation is now even more intense in Maharashtra due to the
revised guidelines followed in Maharashtra while managing suspected novel
H1N1 infection which now recommends treating each and every person
(including children and adults) with even mild ILI with oseltamivir within
48 hours of onset of illness(1). While one can understand starting
oseltamivir in severe, hospitalized cases with ILI (classified as category
A in revised Maharashtra guidelines), one kind of feels it too much to
treat everyone (including children and adults) with even mild ILI with
oseltamivir (classified as category B in revised Maharashtra guidelines).
Theoretically this will ensure that every person with potential H1N1 is
started on oseltamivir within the critical 48 hours of onset of symptoms
(with maximum benefit in potentially reducing morbidity and mortality)(2).
However this approach also throws open a Pandora’s Box!
(1) The revised Maharashtra guidelines are in
contrast to the guidelines from other reputed international bodies like
WHO or CDC(2,3). For severe hospitalized patients, even revised WHO and
CDC guidelines suggest treating all such patients with oseltamivir as
soon as possible. However for mild ILI, WHO and CDC suggest starting
oseltamivir only for those who are at high risk for complications and
all children < 5 years (WHO) or < 2 years (CDC). Besides, the revised
Maharashtra guidelines are entirely different from national guidelines
dated 14 th June 2009 available on
the website of ministry of health and family welfare, Govt. of India(4).
The available national guideline classifies suspected H1N1 in different
A, B or C categories (in reverse order as compared to revised
Maharashtra guidelines) and do not recommend oseltamivir in mild disease
or severe non-hospitalized patients without the high risk factors (as is
recommended by revised Maharashtra guidelines)(4). As such, the revised
Maharashtra guidelines are not available on any governmental website.
(2) There are various developed countries that are
liberal in starting oseltamivir at "a drop of a hat" as is suggested in
the revised Maharashtra guidelines. However these countries are small
with limited population, are prepared with pre-conceived stock piling
based on the population strength and have effective public distribution
system to disperse the drug (at times delivered at home almost on a
phone call request). In India none of these situations exist. We are
populous country (1 billion plus), are ill-prepared in general and with
the stocks of oseltamivir in particular and most important we do not
have effective distribution system.
(3) Oseltamivir syrup is generally available with
great difficulty. Capsules are difficult to give in a child < 5 years
(the age group maximally affected with ILI). It is estimated that up to
50% of the population is ultimately likely to be affected by the
pandemic influenza virus(5). It would mean 500 million people getting
the virus and the ILI in India in the next 2-6 months or so. If we have
to treat all of them as per the revised Maharashtra guidelines, we would
need that much number of courses of oseltamivir (even WHO website states
that it has stock piled only 5 million courses of oseltamivir!)(6). Many
or most children get recurrent cough, cold and fever and as per the
revised Maharashtra guidelines have to be treated with oseltamivir every
time! This will further add to the number of courses of oseltamivir
required in coming time. All this when most (and read MOST) will recover
even without oseltamivir!
(4) Such indiscriminate use of oseltamivir as per the
revised Maharashtra guidelines is likely to lead to shortage of the drug
in near future and may deprive the serious or hospitalized patients from
getting the much required oseltamivir which will jeopardize their
survival chances. WHO/UNICEF suggest that 44 million episodes of
clinical pneumonia (which would all would qualify to be classified as
severe ILI) occur in children in India every year(7). At least all these
children will certainly need oseltamivir when they would develop these
episodes of pneumonia. Do we have enough stocks of drugs (especially
syrups form)? If not, why waste the little precious stocks that we have
in treating every ‘cough-cold-fever’ (ILI)?
(5) Oseltamivir till late was distributed only though
H1N1 centers identified by the public health authority which in any case
are far few and distant making it difficult if not impossible for
patients to access them to procure oseltamivir once prescribed,
especially in private setup. Now the drug is made available though
chemists with "schedule X" license, which are even fewer. The cost of
the drug is exorbitant in open market making it difficult for many of
the patients to afford (not all patients who visit practitioners outside
the public health are affording). Hence without effective distribution
system, it is making life difficult at least for the private
practitioners and their patients!
(6) Widespread use of oseltamivir has been known to
lead to resistance and such 25 oseltamivir resistant strains of H1N1 are
reported world over(8). Revised Maharashtra guidelines are likely to
expose a large population to oseltamivir which is most likely to lead to
development of drug resistance soon. Whereas restricted use of drug in
those who require it most is likely to delay development of such drug
resistance.
(7) Last but not the least is the problem of how to
dissipate the often changing H1N1 guidelines to the entire medical
fraternity? It is next to impossible to train the entire medical
fraternity (including consultants and family physicians) in this revised
H1N1 guidelines, especially in the given short time and in face of
rapidly changing scenario as also the guidelines. It is practically not
possible to expect the entire medical fraternity to access and follow
these guidelines online. There is no communication to the medical
fraternity in this regards from health authorities at local or national
level like official infomercials in any form of media. The revised
Maharashtra guidelines are not even available on any official government
website! All this is making the entire medical fraternity highly
vulnerable to health authorities on one side and media on the other
side.
References
1. Guidelines for management of Pediatric patients of
H1N1 influenza A. Available at http://www.kem.edu/swineflu_screening.htm.
Accessed on October 4, 2009.
2. WHO Guidelines for Pharmacological Management of
Pandemic (H1N1) 2009 Influenza and other Influenza Viruses. Available at
http://www.who.int/entity/csr/resources/publications/swineflu/h1n1_guidelines_pharmaceutical_mngt.pdfWho
Accessed on October 4, 2009.
3. CDC. Updated Interim Recommendations for the Use of
Antiviral Medications in the Treatment and Prevention of Influenza for the
2009-2010 Season. Available at http://www.cdc.gov/H1N1flu/recommendations.htm.
Accessed on October 4, 2009.
4. MOHFW GOI. Guidelines on categorization of influenza
a H1N1 cases during screening for home isolation, testing, treatment and
hospitalization. Available at http://mohfw-h1n1.nic.in. Accessed on
October 4, 2009.
5. WHO. Pandemic influenza prevention and mitigation in
low resource communities. Available at http://www.who.int/csr/resources/publications/swineflu/low_resource_measures/en/index.html.
Accessed on October 4, 2009.
6. WHO. Use of antiviral drugs against influenza
A(H1N1). Available at http://www.who.int/csr/disease/swineflu/frequently_asked_questions/swineflu_faq_antivirals/en/index.html.
Accessed on October 4, 2009.
7. UNICEF/WHO. Pneumonia: The Forgotten Killer of
Children. http://www.unicef.org/publications/files/Pneumonia_The_Forgotten_Killer_of_Children.pdf.
Accessed on October 4, 2009.
8. WHO. Antiviral use and the risk of drug resistance.
Available at http://www.who. int/csr/disease/swineflu/notes/h1n1_antiviral_use_20090925/en/index.html.
Accessed on October 4, 2009.
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