italy drug information: strategies and efficacy

1
1043 retarded children born into families with pre-existing troubles. The development of services for the newborn, and the associated technology, has generated several ethical dilemmas. Not least is the question of how hard we should be trying to keep very-low-birthweight babies alive. Disabilities are common in babies born very small and none of the follow-up surveys cited found low-birthweight infants as a group to be the equal of their normal-weight peers. Mothers of low-birthweight infants more often come from a background of socioeconomic disadvantage, smoke more, and are more often unmarried, very young, or above average age-factors important also for the postnatal environment of the child. Should we be spending more on neonatal care? In another part of the book, and about another subspecialty, a contributor comments, "the paediatric nephrologist is serving the children and families well but what an extraordinarily high input of trained staff for so few children...". This is an outstanding and challenging book. Perhaps not surprisingly the central theme is that the practice of paediatrics and the promotion of child health are of critical importance for the nation. Yet the dilemma remains. The worst UK figures for child health even now are in those parts of the country with a high level of unemployment and poverty, so children might be better served by the provision of work and a higher standard of living for their parents than by an increase in the amount spent on health care. But a wealthy country like the United Kingdom has little option but to do both. If the book has emphasised the social milieu of the child it has also clarified the key role of the paediatrician. Many of our present dilemmas are a direct consequence of the astonishing success of paediatricians in providing hope for children who a generation ago would have had no chance of survival. Will paediatricians 60 years hence be able to record similar achievements? If so it will be because we have understood the failures, successes, and dilemmas of the past so ably recorded here. Camberwell Health Authority, King’s College Hospital, London SE5 9RS ANTHONY GOLDING Round the World From our Correspondents Italy DRUG INFORMATION: STRATEGIES AND EFFICACY EARLY in April an international meeting on strategies and efficacy of drug information took place in Reggio Emilia, a small town between Milan and Bologna. Few tourists have heard of Reggio Emilia, and it rarely sees an international meeting, but it is the home of the oldest municipally owned group of pharmacies there, the Farmacie Comunali Riunite (FCR), founded in 1903.1 It has also become an important regional wholesale organisation, and a major centre for drug information in Italy. In the past 10 years FCR has produced a great deal of information on medicines for prescribers and the public, including a drug bulletin, Informazioni sui Farmaci. The meeting was organised jointly by FCR and the Italian Drug Utilisation Research Group (DURG-I) in association with the International Society of Drug Bulletins (ISDB); the dairy and the computer industry gave financial support. It is a paradox that in Italy drug information has been developed much further than drug regulation and the rational use of drugs. Italy must implement the EEC directives on medicines by 1992, and the need for change has become urgent. Two striking features of the Italian medicines market are the wide prescription of nonsense preparations and the exuberant use of the newest active drugs. Dr Nicola Montanaro, professor of pharmacology in Bologna, had found that of the top 50 prescription drugs about a third were not described in standard textbooks-presumably because they were considered scientifically irrelevant. Examples are ’Cronassial’, a preparation of gangliosides suggested for all kinds of peripheral neuropathy, and acetyl-camitine, which is supposed to benefit brain metabolism. Active drugs that are grossly overused include ranitidine, enalapril, and aztreonam. Pharmaceutical promotion is powerful and appears to be highly effective. The chairman of Farmindustria, the Italian industry association, said the industry believed that patients were entitled to potential benefit of drugs even if these had not been tested by conventional scientific methods. The Ministry of Health appears to take the same view. The officially approved data sheet for carnitine, for instance, states as indications "acute and chronic myocardial ischaemia; latent and overt cardiac 1. Festanti M, Rombaldi O. Le Farmacie Comunali di Reggio Emilia stona di un’idea, Reggio Emilia; Farmacie Comunali Riunite, 1986 failure; myopathies". Placental extract is indicated in "all those cases in which the organism required biological stimulation"; dihydroergotoxin in "senile cerebral insufficiency".2 But camitine is not marketed solely in Italy, and vasodilators are extensively used in France, Germany, and Spain. At present the only non-commercial drug information all doctors receive is in the Ministry’s Bolletino d’informazione sui Farmaci, which is potentially useful but was criticised for its lack of clear editorial policy and priorities, its unpunctuality, and its indifferent quality. A variety of regional and local publications are distributed free to doctors and pharmacists in a region, or sold by subscription. They include lnformazioni sui Farmaci, Ricerca e Pratica, and the Italian editions of The Medical Letter and Drug and Therapeutics Bulletin. A question that concerned the meeting was not only how to measure the effect of such information, but also how to identify what information prescribers need most urgently. The discussion, led by members of DURG-I, emphasised that the two processes go together: each leads to the other. What policies should now be developed in Italy? How can drug information, continuing education of doctors and pharmacists, and drug utilisation research, including adverse reaction monitoring, be integrated? Speakers from other countries, predominantly members of ISDB, described some of their national experiences. While the Nordic countries and the United Kingdom had made most progress in providing comprehensive and good quality information for prescribers, they had started with a better regulated medicines market. From this point of view, the experience in Germany, Spain, and France seemed more relevant to that of Italy. In Germany, the actors on the medicines stage are far from getting their act together. The regulatory authority is showing only limited initiative and does not seem ready to take real responsibility for the provision of effective drug information to doctors. The industry remains mostly intransigent and pugnacious, the medical profession is still rather ambivalent and indecisive, and the sick funds are worrying about money but not yet very interested in what it is spent on. An unhappy result is that drug information is often contested and made controversial. In Spain, drug regulation is much stronger, and makes good use of experienced and active people outside government. Firm regulation is gradually becoming accepted by the industry, a Spanish national formulary is now in its third edition, and adverse drug reaction monitoring is spreading from Catalonia, the region where it was first effectively implemented. The meeting was a satisfying example of European mutual help. The 150 or so participants gained not only food for thought but also courage for action. 2. Repertorio Farmaceutico Italiano (REFI), Farmindustria, 2nd ed Milan: CEDOF, December, 1987.

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Page 1: Italy DRUG INFORMATION: STRATEGIES AND EFFICACY

1043

retarded children born into families with pre-existingtroubles. The development of services for the newborn, andthe associated technology, has generated several ethical

dilemmas. Not least is the question of how hard we shouldbe trying to keep very-low-birthweight babies alive.

Disabilities are common in babies born very small and noneof the follow-up surveys cited found low-birthweightinfants as a group to be the equal of their normal-weightpeers. Mothers of low-birthweight infants more often comefrom a background of socioeconomic disadvantage, smokemore, and are more often unmarried, very young, or aboveaverage age-factors important also for the postnatalenvironment of the child. Should we be spending more onneonatal care? In another part of the book, and aboutanother subspecialty, a contributor comments, "the

paediatric nephrologist is serving the children and familieswell but what an extraordinarily high input of trained stafffor so few children...".

This is an outstanding and challenging book. Perhaps notsurprisingly the central theme is that the practice of

paediatrics and the promotion of child health are of criticalimportance for the nation. Yet the dilemma remains. Theworst UK figures for child health even now are in those partsof the country with a high level of unemployment andpoverty, so children might be better served by the provisionof work and a higher standard of living for their parents thanby an increase in the amount spent on health care. But awealthy country like the United Kingdom has little optionbut to do both. If the book has emphasised the social milieuof the child it has also clarified the key role of the

paediatrician. Many of our present dilemmas are a directconsequence of the astonishing success of paediatricians inproviding hope for children who a generation ago wouldhave had no chance of survival. Will paediatricians 60 yearshence be able to record similar achievements? If so it will bebecause we have understood the failures, successes, anddilemmas of the past so ably recorded here.

Camberwell Health Authority,King’s College Hospital,London SE5 9RS ANTHONY GOLDING

Round the World

From our Correspondents

Italy

DRUG INFORMATION: STRATEGIES AND EFFICACY

EARLY in April an international meeting on strategies and efficacyof drug information took place in Reggio Emilia, a small townbetween Milan and Bologna. Few tourists have heard of ReggioEmilia, and it rarely sees an international meeting, but it is the homeof the oldest municipally owned group of pharmacies there, theFarmacie Comunali Riunite (FCR), founded in 1903.1 It has alsobecome an important regional wholesale organisation, and a majorcentre for drug information in Italy. In the past 10 years FCR hasproduced a great deal of information on medicines for prescribersand the public, including a drug bulletin, Informazioni sui Farmaci.The meeting was organised jointly by FCR and the Italian DrugUtilisation Research Group (DURG-I) in association with theInternational Society of Drug Bulletins (ISDB); the dairy and thecomputer industry gave financial support.

It is a paradox that in Italy drug information has been developedmuch further than drug regulation and the rational use of drugs.Italy must implement the EEC directives on medicines by 1992,and the need for change has become urgent. Two striking features ofthe Italian medicines market are the wide prescription of nonsensepreparations and the exuberant use of the newest active drugs. DrNicola Montanaro, professor of pharmacology in Bologna, hadfound that of the top 50 prescription drugs about a third were notdescribed in standard textbooks-presumably because they wereconsidered scientifically irrelevant. Examples are ’Cronassial’, apreparation of gangliosides suggested for all kinds of peripheralneuropathy, and acetyl-camitine, which is supposed to benefit brainmetabolism. Active drugs that are grossly overused include

ranitidine, enalapril, and aztreonam. Pharmaceutical promotion ispowerful and appears to be highly effective. The chairman ofFarmindustria, the Italian industry association, said the industrybelieved that patients were entitled to potential benefit of drugs evenif these had not been tested by conventional scientific methods. TheMinistry of Health appears to take the same view. The officiallyapproved data sheet for carnitine, for instance, states as indications"acute and chronic myocardial ischaemia; latent and overt cardiac

1. Festanti M, Rombaldi O. Le Farmacie Comunali di Reggio Emilia stona di un’idea,Reggio Emilia; Farmacie Comunali Riunite, 1986

failure; myopathies". Placental extract is indicated in "all thosecases in which the organism required biological stimulation";dihydroergotoxin in "senile cerebral insufficiency".2 But camitineis not marketed solely in Italy, and vasodilators are extensively usedin France, Germany, and Spain.

At present the only non-commercial drug information all doctorsreceive is in the Ministry’s Bolletino d’informazione sui Farmaci,which is potentially useful but was criticised for its lack of cleareditorial policy and priorities, its unpunctuality, and its indifferentquality. A variety of regional and local publications are distributedfree to doctors and pharmacists in a region, or sold by subscription.They include lnformazioni sui Farmaci, Ricerca e Pratica, and theItalian editions of The Medical Letter and Drug and TherapeuticsBulletin. A question that concerned the meeting was not only how tomeasure the effect of such information, but also how to identifywhat information prescribers need most urgently. The discussion,led by members of DURG-I, emphasised that the two processes gotogether: each leads to the other.What policies should now be developed in Italy? How can drug

information, continuing education of doctors and pharmacists, anddrug utilisation research, including adverse reaction monitoring, beintegrated? Speakers from other countries, predominantlymembers of ISDB, described some of their national experiences.While the Nordic countries and the United Kingdom had mademost progress in providing comprehensive and good qualityinformation for prescribers, they had started with a better regulatedmedicines market. From this point of view, the experience inGermany, Spain, and France seemed more relevant to that of Italy.In Germany, the actors on the medicines stage are far from gettingtheir act together. The regulatory authority is showing only limitedinitiative and does not seem ready to take real responsibility for theprovision of effective drug information to doctors. The industryremains mostly intransigent and pugnacious, the medical professionis still rather ambivalent and indecisive, and the sick funds areworrying about money but not yet very interested in what it is spenton. An unhappy result is that drug information is often contestedand made controversial. In Spain, drug regulation is much stronger,and makes good use of experienced and active people outsidegovernment. Firm regulation is gradually becoming accepted by theindustry, a Spanish national formulary is now in its third edition,and adverse drug reaction monitoring is spreading from Catalonia,the region where it was first effectively implemented.The meeting was a satisfying example of European mutual help.

The 150 or so participants gained not only food for thought but alsocourage for action.

2. Repertorio Farmaceutico Italiano (REFI), Farmindustria, 2nd ed Milan: CEDOF,December, 1987.