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2p19pos.gif (53399 bytes)Analysis of information to the attention of prescribers and patients concerning the treatment of diarrhoea in children in France

Bruneton C., Maritoux J., Topuz B.

 

Problem Statement: In spite of a large consensus on the treatment of diarrhoea in children by oral rehydratation therapy, antidiarrhoeals are still widely used in France as well as in developing countries, where diarrhoea is a major cause of death in children. Due to many links between France and French-speaking countries of Africa, the practices concerning promotion of these drugs and their use are similar, and any modification in France will have an effect in these countries.

Objectives: This study aims at analyzing the quality of information submitted to prescribers and consumers concerning the treatment of diarrhoea in children.

Design and setting: This study is based on research and analysis of information concerning the treatment of diarrhoea in children and use of antidiarrhoeals, as published in the medical, pharmaceutical and lay press in France. The sections of data sheet compendium, Dictionnaire Vidal, which is the main official source of information for French practitioners, have also been analyzed in the light of scientific data of reference and WHO recommendations.

Results: The information published in the main medical journals in 1993, 1994 and 1995 differ according to the quality of the quoted studies: some of them lacking some rigor, seem to be essentially designed for the promotion of some specialties. In the pharmaceutical press, aimed principally at the community pharmacists, a number of specialties are recommended, but oral rehydratation therapy is rarely quoted. The same heterogeneity exists among the information aimed at parents in the lay press and the books for general public.

The antidiarrhoeal specialties licensed on the French market are numerous: 36 are listed in the Vidal 1995, under 50 different formulations, 14 of which are for pediatric use, and the oral rehydratation salts which are considered in this book as dietary products. The data sheets for antidiarrhoeals in the Dictionnaire Vidal show some discordance in the mention of indications, contraindications, dosage or adverse effects, as well as ambiguity about the definition of efficacy level, especially the active principles not recommended by WHO.

Conclusions: There is an important gap between the recommendations concerning the treatment of diarrhoea in children and the information published in this field, among which the promotion of "antidiarrhoeals" by the industry has an important place. As no official directive exists, prescribers’ attention is derived from the necessity of modifying an irrational and obsolete therapeutic strategy.

 

Introduction

In 1994-1995, the association PIMED carried out a study aiming to assess the current practices in the treatment of diarrhoeal diseases in children in France.

This study was motivated by the following factors: in spite of a large consensus on the treatment of diarrhoea in children, which is essentially oral rehydration therapy, a few surveys have shown that antidiarrhoeal drugs were still widely used. Nonetheless, this situation had not been surveyed in France on a systematic basis.

The association PIMED has therefore decided to analyse this public health problem to inform the French health professionals and patients and even contribute to modify their practices.

This could also indirectly have a positive impact in French-speaking African countries, due to the fact that these countries are linked with France in many ways, especially in the field of pharmaceutical imports and promotion of drugs.

PIMED: Pour une Information Médicale Ethique et le Développement, 24 quai de la Loire,

75 019 PARIS, France.

Diarrhoea in children

The purpose of this study is the first line treatment of acute diarrhoea in children not in risk situations:

"child under 5 years, having a diarrhoea (emission of more than 3 stools per day, taking the form of the container), non-bloody, for less than 5 days, with weight loss under 10%, without dehydration signs or with benign dehydration signs and not presenting other illness; this definition not excluding other associated symptoms (fever, vomiting ...)".

The treatment of diarrhoea from bacterial, HIV+ or parasitic origin has not been tackled. The antibiotics used in the bacillary dysentery and other infections identified by laboratory tests, and the antiparasitic drugs used in amoebiasis and giardiasis, are not presented.

Antidiarrhoeal drugs use in France

* drugs for symptomatic treatment of diarrhoea:

anti-motility drugs or morphinic antipéristaltic

drugs: loperamide, diphenoxylate, codeine...

adsorbents and drugs modifying the consistency of stools: kaolin, pectin, attapulgite, activated charcoal

* antimicrobial agents: streptomycin, neomycin, colistin, sulfonamides, drugs derived from hydroxyquinolines and nitrofuran

* products of vegetable or microbial origin

* oral rehydration salts

 

Studied items

What is the incidence of diarrhoea in children in France?
Is there a vast market for pediatric antidiarrhoeals in France?
How are antidiarrhoeals used in France?
What kind of information is available in France on the treatment of diarrhoea in children:
in official documents?
in the professional press?
in the lay press?

 

Objectives

To inform the varied French actors (paediatricians, pharmacologists, pharmaceutical industry members, journalists of the professional press, health authorities, consumers associations)
To elaborate together recommendations aiming at a better management of diarrhoea in children in France
To improve the quality of information disseminated in France
To improve indirectly the information disseminated in the French-speaking countries of Africa.

 

Methodology

The panorama of the situation in France concerning the management of diarrhoea in children is studied under three aspects:

1. Epidemiological data available on diarrhoea in children

An analysis of the main surveys carried on in France is reported.

2. Data on the use of antidiarrhoeals

The results of available information concerning the world and French markets is presented as well as a review of the main surveys of consumption and prescription of antidiarrhoeals in children.

Within the framework of this study, a survey has been realised among 172 paediatricians on the Rhone Alpes region in France, in September-October 1995, with a questionnaire to fill in concerning their therapeutic decision for the first two cases of diarrhoea they had to manage.

3. Analysis of available information in France concerning the management of diarrhoea in children

The antidiarrhoeal proprietary drugs which are available on the French market and can be administered in adults and children are numerous; 36 of them appear in the Dictionnaire Vidal 1995 (French sheet comprendium), under 50 formulations, which 14 are for paediatric use, not including the oral rehydration salts which are considered in this book as diet products.

Table 2: antidiarrhoeal drugs commercialised in France

therapeutic class n° of proprietary drugs on the French market n° of paediatrician

formulations

recommendations of WHO in the treatment

of acute diarrhoea in children

antisecretory drugs

8

1

not recommended
intestinal antibacterials

26

10

not recommended *
adsorbents

7

1

not recommended
products of bacterial origin

17

1

not studied by WHO

no proved action

miscellaneous

3

1

not studied by WHO

no proved action

total

61

14

 

* concerning those that have been under study by WHO

According WHO, the use of antidiarrhoeals in children is not justified ; nevertheless the large number of preparations commercialised in France shows the large scale of this market.

Survey realised by P. Goyot and PIMED, September 1995:

58 of the 172 paediatricians of a regional association answered the survey.
113 prescriptions were analysed for children under 5 years whom 78% were aged or under 2 years.

Abuse of antidiarrhoeal drugs

They have been prescribed to 82% of children including:

adsorbents 45%

bacterial substances 34.5%

intestinal antibiotics 12%

loperamide 5%

(2 cases in children under 2 years, which is contraindicated).

Abuse prescription of several antidiarrhoeals to a sick child:

4 antidiarrhoeals have been prescribed to 1 child

3 antidiarrhoeals have been prescribed to 7 children

2 antidiarrhoeals have been prescribed to 29 children

Solutions of rehydration salts have been prescribed too rarely:

7 children have received only ORS

36 children have received ORS in association with antidiarrhoeals or antiemetics

Unjustified diet advice:

Coca-cola has been recommended in 3 cases.

The prescription of antidiarrhoeals by the French paediatricians is important among children under 2 years.

 

Results

1. Epidemiological data on diarrhoea in children

In France, diarrhoea in children represents an important health problem.

According a survey carried out in 19921:

-Mean number of acute diarrhoea cases = 1.16 case/practitioner/week

-incidence of 5,000 cases for 100,000 inhabitants

-3.1 millions of cases

-18% of cases concern children under 5 years

2. Use of antidiarrhoeal drugs

Consumption of antidiarrhoeals in children under 6 years during the survey INSEE/CREDES in 1991/1992

age class nb of children studied nb of children treated with antidiarrhoeals nb of boxes having been bought expense per box

in FF

under 30 months

718

91

160

26,69

30 months to 6 years2

1099

92

202

21,00

total

1817

183

362

23,52

Prospective survey from Collet J.P. in 1988: on 794 infants suffering from acute rotavirus diarrhoea, antimicrobials have been prescribed as a first line treatment in 50% of cases by general practitioners.

1Chauvin P.: Réseau national téléinformatique de surveillance et d’information sur les maladies transmissibles: bilan de la surveillance épidémiologique des médecins sentinelles en 1992, BEH 1993; (21): 93-98.

26 years of age not included

3Collet J.P., Danzon A., Renaux Ph., Liberas-Lacroix S., Roy P., Lachaux A., Hermier M., Duru G.,

«Modalités de la prise en charge de la diarrhée aiguë non grave du nourrisson en fonction des filières de soin: Etude prospective au cours d’une épidémie hivernale» Arch Fr Pediatr. 1988;45:369-72.

3. Information transmitted in the official documents, in the medical press and many publications aimed at the general public.

In the framework of this study, we have analysed the French source of information used by:

- prescribers

* Dictionnaire Vidal, Vidal GNP

* «fiches de transparence» of the Agence Française du Médicament

* Guide Pratique des Médicaments de Ph Dorosz

* articles and advertisements in the medical press (1993-94-95).

- pharmacists

* pharmaceutical press

* technical leaflets aimed at pharmacists

* promotional inserts

* Théra, Dictionnaire des médicaments conseil grand public.

- patients

* pharmaceutical advertisements

* Dictionnaire Vidal du particulier

* Guide des médicaments vendus sans ordonnance

* press aimed at the general public.

This information was analysed and compared with the information distributed by reference sources given by:

* WHO «Rational use of drugs in the management of acute diarrhoea in children»,

* Martindale, The Extra Pharmacopoeia,

* British National Formulary

* La revue Prescrire.

The monographs of antidiarrhoeals in the Dictionnaire Vidal, which is the main source of official information for French practitioners, were analysed with regard to scientific reference information and the recommendations of the World Health Organization (WHO). Some discrepancies were observed in the indications, contraindications, dosage or mention of adverse effects, and also some ambiguity on the definition of efficacy level, especially concerning the active principles not recommended by WHO.

The information disseminated in the main medical journals in 1993, 1994 and 1995 is very unequal. It differs according the quality of quoted studies, some of them being not rigorous and aimed essentially at the promotion of the involved preparations.

In the pharmaceutical press, which mainly focuses on counselling in community pharmacy, numerous preparations are recommended, but oral rehydration is not often quoted. The same heterogeneity exists among the information aimed at parents in the literature and the press aimed at the general public.

 

Conclusions

The data gathered during this study show that diarrhoea in children is frequent and leads to many consultations and hospitalisation. They reveal an important gap between the recommendations of therapeutic management and real practice: inefficient and sometimes dangerous drugs are prescribed repeatedly. These gaps are probably due to the quality of information disseminated on this subject, where promotion of "antidiarrhoeals" takes an important place. In the absence of official directives, the attention of prescribers is not drawn on the necessity of modifying an outdated and irrational therapeutic strategy.

In African countries where diarrhoeal diseases in children represent an important public health problem, promotion of antidiarrhoeals diverts from the use of rehydration salts, which are more essential in these countries, because of the climate and malnutrition. Beyond sanitary risks linked to the prescription of morphinic drugs or antiinfective agents, this useless consumption represents an important economical loss in countries where resources devoted to health are very limited. This is all the more why a consistent strategy in the management of acute diarrhoea in infants and children should be implemented at the French and international levels.