Antenatal care and maternal health

WHO News and activities Recommendations for the composition of influenza virus vaccines for the 1993-94 seasona During the 1992-93 season, influenza A (H3N2), A (HINI) and influenza B viruses all continued to circulate. Influenza B viruses were the most prevalent and were antigenically related to B/Panama/45/90. Vac- cines containing B/Yamagata/16/88-like or B/Pana- ma/45/90-like viruses induced antibodies with simi- lar frequencies and titres both to the vaccine viruses and to representative recent isolates. Vaccines containing influenza A/Singapore/6/86 (HlN1)-like viruses induced satisfactory antibody responses to representative recent isolates. The predominant influenza A (H3N2) viruses showed antigenic differences from the vaccine strain A/Beijing/353/89 and were antigenically similar to A/Beijing/32/92. Vaccines containing A/Beijing/353/ 89-like viruses induced antibody responses to A/ Beijing/32/92-like viruses at lower frequency and titre than to the vaccine virus. Consequently, it is recommended that trivalent vaccines be used in the 1993-94 season, and that they contain the following: * an A/Beijing/32/92(H3N2)-like strain; * an A/Singapore/6/86(HlN1)-like strain; and * a B/Panama/45/90-like strain; As in previous years the specific viruses used in each country should be approved by the national control authorities. Most of the population is likely to have been in- fected with influenza A (H3N2), influenza A (HINI) and influenza B viruses in recent years. As a con- sequence, one dose of inactivated vaccine should be immunogenic for individuals of all ages except young children. Previously unimmunized children should receive two doses of vaccine, with an interval between doses of at least 4 weeks. Reagents for use in laboratory standardization of inactivated vaccine may be obtained from the Divi- sion of Virology, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Herts EN6 3QG, England; or from the Division of Virology, Center for Biologics, Evalua- tion and Research, Food and Drug Administration, a Based on: Recommended composition of influenza virus vac- cines for use in the 1993-1994 season. Weekly epidemiological record, 68(9): 57-60 (1993). Reprint No. 5404 Building 29A, 8800 Rockville Pike, Bethesda, MD 20892, USA. Reference strains for antigenic analysis may be obtained from the WHO Collaborating Centres for Reference and Reseach on Influenza, Influenza Branch, Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA; and National Institute for Medical Research, The Ridgeway, Mill Hill, London NW7 IAA, England. * A review of the prevalence of influenza viruses in the world is scheduled for publication in the Weekly epidemiological record on the last Friday of Septem- ber 1993 for consideration by those making recom- mendations for the composition of influenza virus vaccines for use in the southern hemisphere. Antenatal care and maternal health Maternal mortality level is the health indicator that exhibits the greatest difference between developing and industrialized countries. For example, in Africa the lifetime risk of death for a woman as a result of pregnancy or childbirth has been estimated to be 1 in 23, compared with only about 1 in 10 000 in nor- thern Europe. Family planning methods and delivery services offer some scope for reducing this differ- ence. However, the potential of antenatal care to reduce maternal mortality or serious morbidity in developing countries has not been systematically as- sessed, despite widespread belief that such care could improve maternal health. As a first step in a proposed programme to explore this potential, a 74-page review of the effec- tiveness of antenatal interventions in relation to the poor maternal health in developing countries has been prepared on behalf of the WHO Maternal Health and Safe Motherhood Programme.b The report draws together available information on how antenatal care could be used to reduce maternal mortality and serious morbidity in areas where levels are currently high. Outlined in the report are various interventions that are effective in detecting, treating, or preventing conditions in pregnant women that may give rise to serious morbidity or mortality. These relate mainly to chronic conditions such as anaemia, hypertension, and infections in pregnancy rather than to acute conditions such as haemorrhage or obstructed labour, which occur close to the time of delivery. However, even for these chronic conditions the situation is not b Rooney, C. Antenatal care and maternal health: How effective is it? A review of evidence. Unpublished document WHO/MSM/ 92.4. Bulletin of the World Health Organization, 71 (3/4): 463-466 (1993) © World Health Organization 1993 463 WHO News and activities straightforward and further research needs to be undertaken into their etiology and interventions to promote and improve their management. A critical review is made of the scientific evi- dence from randomized controlled trials and other types of intervention or observations on the effec- tiveness of antenatal interventions. The sources and quality of available data and possible biases in their collection and interpretation are considered. As in other areas of maternal health, good quality information is scarce and many interventions in cur- rent practice have not been tested rigorously. Listed are those antenatal interventions whose effectiveness has been proven under conditions that can lead to maternal mortality or serious morbidity. Interventions for which there is some promising evi- dence of effectiveness are explored and the out- standing questions are formulated in a series of tables, with suggestions about the types of study that need to be carried out to answer them. The review includes an extensive bibliography of relevant literature. Requests for single copies of this review should be sent to Maternal Health and Safe Motherhood Programme, Division of Family Health, World Health Organization, 1211 Geneva 27, Switzerland. Counterfeit drugsc Over the last 10 years there has been a considerable increase in the number of reports of counterfeit drugs, i.e., drugs whose identity and/or source have been deliberately and fraudulently mislabelled. The scale of the problem is impossible to gauge accurate- ly; however, the Counterfeit Intelligence Bureau esti- mates that 5% of total world trade in 1991 was in counterfeit goods; for pharmaceuticals that are in high demand and are easily transported this propor- tion is likely to be higher. Counterfeiting of drugs occurs worldwide and changes in intemational trad- ing conditions could lead to a further rapid increase in this activity. A pharmaceutical product that is made with the same care that is assured within the legitimate manu- facturing facility may not present a hazard to public health. Counterfeit products, in contrast, escape all modalities of control, and no assurance can be given about their quality. Such products may contain the labelled active ingredients in an acceptably bioavail- able form that meets the relevant characteristics or contain too little of the therapeutically active sub- stance. This may result in patients not receiving the c Based on: Counterfeit drugs: report of a joint WHO/IFPMA Workshop, 1-3 April 1992. Unpublished document WHO/DMP/ CFD/92. right amount of active compound, and consequently, in their disease remaining untreated. Worst of all, the products may have been accidently adulterated or deliberately formulated using toxic industrial chemicals that have no place in pharmaceutical manu- facture. In 1988 the World Health Assembly adopted resolution WHA 41.16 in which governments and pharmaceutical manufacturers were requested to cooperate in the detection and prevention of the increasing incidence of the export or smuggling of falsely labelled, counterfeit or substandard pharma- ceutical preparations. Against this background, WHO and the International Federation of Pharma- ceutical Manufacturers Associations (IFPMA) convened a joint workshop on 1-3 April 1992 in Geneva to discuss the problem. The workshop was attended by representatives from the International Chamber of Commerce, Interpol, the Customs Cooperation Council, the International Narcotics Control Board, the International Organization of Consumers Unions, the European Association of Industries of Branded Products, and GATT. Below are summarized the recommendations made by the participants for action at various levels. International level * There is a need for a greater international aware- ness and acknowledgement of the hazards to health presented by counterfeit medicines. Political will is needed to mobilize resources for the implication of effective countermeasures. * A sound legal framework to deal with the problem is provided by the proposed anti-counterfeiting pro- visions in the draft GATT-TRIPS agreement, which is based on effective international trademark protec- tion and supported by enforceable sanctions and penalties, including imprisonment. * Governments should implement appropriate legis- lation that identifies as a customs offence the import, national transit and export of counterfeit goods into, across, and out of their customs territories and should confer upon their customs services legal powers to seize the goods with a view to forfeiture if they prove to be counterfeit. * A mechanism should be established through which organizations can exchange information about the nature and extent of counterfeiting, the move- ment of counterfeit products, and the results of investigations into counterfeit operations. * A databank of cases should be established. National level * A legal and administrative framework needs to be in place to define and control the legitimate drug 464 WHO Bulletin OMS. Vol 71 1993 Notes et activites OMS Recommandations pour la composition des vaccins antigrippaux pour la saison 19931 994a Au cours de la saison 1992-1993, les virus grippaux A (H3N2), A (H1NI) et B ont continue a circuler. Les virus B etaient les plus repandus et ils etaient antigeniquement apparentes a B/Pana- ma/45/90. Les vaccins contenant des virus analogues a B/Yamagata/16/88 ou B/Panama/45/90 ont suscite une reponse en anticorps de frequence et de titre ana- logues a ceux correspondant tant aux virus vaccinaux qu'aux isolements rdcents representatifs. Les vaccins contenant des virus analogues 'a A/Singapore/6/86 (HINI) ont suscite des reponses satisfaisantes en anticorps diriges contre les isole- ments recents representatifs. Les virus gripaux A (H3N2) predominants ont montre des differences antigeniques par rapport a la souche vaccinale A/Beijing/353/89 et dtaient ana- logues du point de vue antigenique a A/Bei- jing/32/92. Les vaccins contenant des virus ana- logues a A/Beijing/353/89 ont suscite des reponses en anticorps diriges contre les virus analogues a A/Beijing/32/92 de frequence et de titre inferieurs a ceux correspondant au virus vaccinal. En consequence, il est recommande d'utiliser pour la saison 1993-1994 des vaccins trivalents contenant les souches suivantes: * une souche analogue a A/Beijing/32/92 (H3N2); * une souche analogue a A/Singapore/6/86 (HINI); * une souche analogue a B/Panama/45/90. Comme les annees precedentes, les virus utilises dans chaque pays devront etre approuves par les autorites nationales de controle. La plus grande partie de la population a proba- blement ete infectee au cours de ces demieres annees par les virus A (H3N2), A (H1NI) et B. II s'ensuit qu'une dose de vaccin inactivd devrait etre immuno- gene quel que soit l'age des sujets, sauf chez le jeune enfant. Les enfants non encore vaccines auront besoin de 2 doses de vaccin, administrees a 4 semaines d'intervalle au moins. Les reactifs destinds a la standardisation en labo- ratoire du vaccin inactivd peuvent etre obtenus aux adresses suivantes: Division of Virology, National a D'apres: Composition recommandee des vaccins antigrippaux pour la saison 1993-1994. Relev6 6pidemiologique hebdomadaire, 68 (9): 57-60 (1993). Tire a part NO: 5405 Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Herts EN6 3QG, Angleterre, ou Division of Virology, Cen- ter for Biologics, Evaluation and Research, Food and Drug Administration, Building 29A, 8800 Rockville Pike, Bethesda, MD 20892, Etats-Unis d'Am6rique. Les souches de r6ference destinees 'a l'analyse antigenique peuvent etre obtenues aupres des Centres collaborateurs de reference et de recherche pour la grippe: Influenza Branch, Division of Viral and Ric- kettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Preven- tion, Atlanta, GA 30333, Etats-Unis d'Amerique, et National Institute for Medical Research, The Ridge- way, Mill Hill, Londres NW7 lAA, Angleterre. * Une mise au point sur la prevalence des virus grippaux dans le monde paraltra dans le Releve' e'pi- demiologique hebdomadaire du demier vendredi de septembre 1993 'a l'intention des autorit6s appelees a formuler des recommandations pour la composition des vaccins antigrippaux inactives utilises dans l'hemisphere Sud. Soins antenatals et sante maternelle La mortalite matemelle est l'indicateur de sant6 pour lequel la difference est la plus grande entre les pays en d6veloppement et les pays industrialises. Par exemple, chez les femmes africaines, le risque, cal- cule sur toute la duree de la vie, de mourir du fait d'une grossesse ou d'un accouchement a et6 estime a 1 sur 23, contre 1 sur 10 000 environ dans le nord de l'Europe. Les methodes de planification familiale et les services d'obstetrique peuvent dans une certaine mesure contribuer a r6duire cette diff6rence. Pour- tant, la possibilite de faire baisser la mortalite ou la morbidite matemelle grave dans les pays en develop- pement grace aux soins ant6natals n'a pas et6 syst6- matiquement evaluee, bien que le role de ces soins dans l'amelioration de la sante matemelle soit tres largement reconnu. Dans une premiere etape d'un programme pro- pose en vue d'explorer ce potentiel, un rapport de 74 pages sur l'efficacite des interventions antenatales en relation avec l'etat de sant6 matemel mediocre qui prevaut dans les pays en developpement a ete prepa- re au nom du Programme OMS de sante matemelle et matemit6 sans risqueb. Ce rapport rassemble les donn6es disponibles sur les moyens d'utiliser les soins antenatals pour r6duire la mortalite matemelle b Rooney, C. Antenatal care and maternal health: How effective is it? A review of evidence. Document non publie WHO/MSM/ 92.4 (anglais seulement). Bulletin de lOrganisation mondiale de la Sante, 71 (3/4): 467-471 (1993) © Organisation mondiale de la Sant6 1993 467 Notes et activites OMS et la morbidite matemelle grave dans les regions oiu ces taux sont encore eleves. Sont d6crites diverses interventions efficaces pour deceler, traiter ou prevenir des affections de la femme enceinte pouvant donner lieu a des maladies graves ou entrainer la mort. I1 s'agit principalement d'affections chroniques telles que l'anemie, l'hyper- tension et les infections survenant au cours de la grossesse, plutot que d'accidents survenant en fin de grossesse tels qu'hemorragie ou travail prolonge. Mais, meme pour ces affections chroniques, la situa- tion n'est pas reellement claire et il faudrait entre- prendre de nouvelles recherches sur leur etiologie et sur les interventions susceptibles de promouvoir et d'ameliorer leur prise en charge. Les donnees scientifiques issues d'essais contro- les randomises et d'autres types d'observations sur l'efficacite des interventions antenatales sont passes en revue, avec indication des sources et de la qualite des donnees disponibles ainsi que des facteurs d'erreur possibles au niveau de leur collecte et de leur interpretation. Comme dans les autres domaines de la sante matemelle, les informations de bonne qualite sont rares et nombre d'interventions deja mises en pratique n'ont fait l'objet d'aucune evalua- tion rigoureuse. Le rapport enumere les interventions antenatales dont l'efficacite a ete demontree dans les conditions susceptibles de conduire a une maladie ou au dec's de la mere. Les interventions pour lesquelles il existe des signes encourageants d'efficacite sont decrites et les principales questions sont presentees dans une serie de tableaux, avec des suggestions quant aux types d'etudes qui permettraient d'y repondre. Le rapport s'acheve sur une vaste bibliographie. Des exemplaires de ce rapport peuvent etre obte- nus sur demande adressee au Programme de Sante matemelle et Maternite sans Risque, Division de la Sante de la Famille, Organisation mondiale de la Sante, 1211 Geneve 27, Suisse. Contrefaqons de medicamentsc Ces dix demieres anndes, on a assiste 'a une augmen- tation considerable du nombre de rapports concer- nant des contrefa,ons de medicaments, c'est-a-dire des medicaments dont l'identite et/ou la source ont ete deliberement et frauduleusement falsifiees. I1 est impossible de se faire une idee exacte de l'ampleur du probleme, mais le Counterfeit Intelligence Bureau estime que les contrefacons en tous genres represen- c D'apres: Counterfeit drugs: report of a joint WHO/IFPMA Workshop, 1-3 April 1992. Document non publie WHO/DMP/ CFD/92 (anglais seulement). taient en 1991 5% des echanges commerciaux mon- diaux; pour les produits pharmaceutiques, ce pour- centage est probablement plus eleve en raison de la forte demande de ces produits et de leur facilitd de transport. La contrefa,on de me'dicaments sevit dans le monde entier et pourrait encore augmenter rapide- ment avec l'dvolution des conditions du commerce international. Un produit pharmaceutique qui est fabrique avec le meme soin que chez le fabricant l6gitime peut etre sans danger pour la sante publique. En revanche, comme les contrefa,ons echappent a tout controle, I'assurance de la qualite fait totalement defaut. Ces produits peuvent contenir les principes actifs figurant sur l'etiquette sous une forme qui corresponde de maniere acceptable aux normes de biodisponibilite de la pharmacopee; toutefois, plus souvent, ils ont des caracteristiques de liberation inacceptables ou ne contiennent qu'une quantite insuffisante du principe actif. Le patient risque ainsi d'etre insuffisamment traite. Pire encore, ces produits peuvent avoir ete acci- dentellement adulteres ou deliberement prepares avec des produits chimiques industriels toxiques qui n'ont aucune place dans la production pharmaceutique. En 1988, l'Assemblee mondiale de la Sante a adopte la resolution WHA41.16 selon laquelle les gouvemements et les fabricants de produits pharma- ceutiques etaient pries de cooperer en vue de detecter et prevenir les cas de plus en plus nombreux d'exportation ou de contrebande de preparations pharmaceutiques faussement etiquetees, falsifiees, contrefaites ou ne repondant pas aux normes. Dans ce contexte, l'OMS et la Federation intemationale de l'industrie du medicament (FIIM) ont organise un atelier conjoint du ler au 3 avril 1992 a Geneve pour faire le point sur cette question. L'atelier reunissait des representants de la Chambre de commerce inter- nationale, d'Interpol, du Conseil de cooperation douaniere, de l'Organe international de controle des stupefiants, de l'Organisation intemationale des Unions de consommateurs, de l'Association euro- peenne des industries de produits de marque, et du GATT. Les participants ont formule les recommanda- tions suivantes, applicables a differents niveaux. Au niveau international * Sur le plan international, une plus grande sensibi- lisation s'impose a l'egard des risques que les medi- caments contrefaits font courir a la sant6 ainsi qu'une meilleure appreciation du danger. Un engage- ment politique est indispensable a la mobilisation des ressources necessaires a l'application de contre- mesures efficaces. 468 WHO Bulletin OMS. 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