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PubMed2006

[Epidemiologic surveillance of measles and rubella in Campinas (SP), Brazil: the reliability of the data].

OBJECTIVE: To evaluate and validate the information concerning measles and rubella from the Brazilian National Disease Notification System (BNDNS) (Sistema Nacional de Informação de Agravos de Notificação, or SINAN) for Campinas, a large city in the state of São Paulo, Brazil, using as a reference the data from a control system, the Syndromic Surveillance System for Fever and Exanthem (SSSFE) (Sistema de Vigilância Sindrômica de Febre e Exantema, or VigiFEx), which operated from May 2003 through June 2004. METHOD: In our study we compared: (1) annual data from BNDNS for the years 1999 through 2003 and (2) data from BNDNS and data from SSSFE for the period of June 2003 through May 2004. We analyzed the rate of completion for key fields (record number, date of notification, and city of notification) as well as for name of disease, date of first symptoms, name of patient, birth date and age, sex, city of residence, date of investigation, immunization history, presence of exanthem, date at start of exanthem, presence of fever, suspected cases among pregnant women, signs and symptoms, date of collection of first sample, results with the sample, virus isolation, final classification, criteria for confirmation/exclusion of cases, diagnosis of excluded patients, development of the case, and date of closure. The level of agreement between the recorded cases in the two data banks was also analyzed. RESULTS: From June 2003 through May 2004, 211 suspected cases of measles or rubella were identified in SSSFE and 275 in BNDNS. All the records had complete information concerning the three key fields. The rate of completion was also 100% for patient name, disease, and city of residence. The completion rate was higher than 95% for date of investigation, measles vaccine, measles and rubella vaccine, and rubella vaccine. A lower completion rate was found for other vaccination variables (number of doses and date of last dose) and for exanthem, fever, and date of start of exanthem. The two information systems were not completely consistent, particularly in terms of variables related to epidemiologic background, clinical data, and case closure. The quality of the SSSFE data was higher. CONCLUSIONS: Epidemiologic surveillance, immunization, and laboratory information systems need to undergo routine evaluation to ensure that the data are reliable and can support the planning of public health efforts.

Adult↗
PubMed2004

The pharmacovigilance of psychoactive medications in Brazil.

OBJECTIVE: The present study aimed to analyze 219 notifications of suspected adverse reactions (AR) produced by psychoactive medicaments (ARPM), notified by Brazilian psychiatrists, during a 3-month period (April 1999 up to September 2001). METHOD: A notifying card for adverse reactions possibly produced by psychoactive medications was quarterly sent to all psychiatrists affiliated to the Brazilian Association of Psychiatry. Once each notification, dully filled in, was received, the possible adverse reaction was analyzed in order to verify the causality. RESULTS: The psychiatrists classified as severe 50 of the ARPMs; 150 others were not considered as severe. Among the severe ones there were 3 deaths, 12 life-threatening reactions, 26 ARPMs required or prolonged hospitalization and 9 notifications described temporary disability of the patients. Among the medications, antidepressants ranked first with 122 ARPMs being notified, followed by neuroleptics (46 ARPMs) and antiepiletic medicaments (25 ARPMs). The three main organs and systems affected by the ARs were the Central Nervous System with 102 ARs, skin and mucosa with 44 and gastrointestinal with 21 ARPMs. CONCLUSION: Considering causality, i.e., the association between the medication and the described AR, 24 cases were considered as Definite (with positive dechallenge and rechallenge, i.e., withdrawal and reintroduction of the medication) and 134 other ARPMs were classified as Probable (only dechallenge positive; only with medication withdrawal; rechallenge was not performed).

Adult↗
PubMed1995

Psychological impact of islet cell antibody screening for IDDM on children, adults, and their family members.

OBJECTIVE: To describe the psychological impact of positive islet cell antibody (ICA) screening results in children and adults, as well as their parents and spouses. RESEARCH DESIGN AND METHODS: The psychological impact of ICA screening results was assessed subsequent to subjects' being informed of ICA-positive (ICA+) status and was re-evaluated 4 months later. Impact was measured using the state subscale of the State-Trait Anxiety Inventory (STAI) for adults or the State-Trait Anxiety Inventory for Children (STAIC), as well as structured interviews. A total of 34 ICA+ children, 34 ICA+ adults, 33 parents, and 25 spouses were evaluated. RESULTS: At initial notification of ICA+ status, clinically and statistically significant anxiety was observed in ICA+ children and adults and their family members (P < 0.001). Parents of ICA+ children were more anxious than spouses of ICA+ adults (P < 0.05). Child and parent anxiety were significantly correlated (P < 0.05); more-anxious children lived with more-anxious parents. No significant association was found between ICA+ adults' initial anxiety and their spouses' anxiety. For ICA+ participants and their family members, anxiety dissipated to normal levels in 4 months (P < 0.02). ICA+ children were less likely than parents to believe they would ever develop insulin-dependent diabetes mellitus (IDDM). Nevertheless, 52% of ICA+ children and 24% of ICA+ adults endorsed lifestyle or behavior changes as a result of their IGA+ status. Behavior change was associated with greater initial anxiety in both children and adults (P < 0.05 for both). CONCLUSIONS: These data suggest that notification of ICA+ status has both emotional and behavioral impact. Initial notification of ICA+ status is associated with considerable anxiety in both ICA+ individuals and their family members. In most cases, this initial anxiety appears to dissipate to normal levels over time. However, many ICA+ individuals report initiating lifestyle or health behavior changes in an effort to delay or prevent IDDM onset.

Adolescent↗
PubMed2004

Maternal anxiety associated with newborn genetic screening for type 1 diabetes.

OBJECTIVE: To describe maternal anxiety associated with newborn genetic screening for type 1 diabetes during the first year after risk notification. RESEARCH DESIGN AND METHODS: Mothers of at-risk infants (n = 435), identified through newborn genetic screening as part of the Prospective Assessment of Newborn for Diabetes Autoimmunity (PANDA) study, were administered a short form of the State Trait Anxiety Inventory (STAI) during telephone interviews approximately 3.5 weeks, 4 months, and 1 year after risk notification. Statistical analyses were conducted to examine predictors of maternal anxiety at each interview as well as changes in anxiety over time. RESULTS: For the total sample, initial state STAI scores were not elevated and declined further over time. However, Hispanic mothers, those with low levels of education, those who overestimated the child's risk for diabetes, and mothers of infants in the highest risk group exhibited significantly elevated initial state STAI scores. At 4 months, higher state STAI scores were associated with higher initial state STAI scores, single parent status, having an infant with a first-degree relative with diabetes, and overestimation of the child's actual risk. Initial and 4-month STAI scores remained predictive of STAI scores at 1 year. In addition, single mothers and mothers of female children reported higher STAI state scores 1 year after risk notification. CONCLUSIONS: For most mothers, newborn genetic screening to identify infants at increased risk for type 1 diabetes is not associated with significantly elevated maternal anxiety; anxiety further dissipates over time. However, anxiety levels vary considerably as a function of maternal ethnic status, education, marital status, maternal estimation of infant risk, and sex of the child and may be significantly elevated in some women.

Adult↗
PubMed1995

The impact on behavior of notifying methadone patients of their HIV serostatus.

Questions have arisen about the implications of notifying drug abusers of their HIV serostatus. One major concern is that awareness of HIV infection would have a negative impact on abstinence from drug abuse. In order to ascertain the effects of serostatus notification, the authors reviewed the clinical records of 73 methadone patients who learned of their serostatus within 20 weeks after enrolling in the clinic and thereafter remained in treatment for at least 1 year. They found that, at serostatus notification, seropositive patients were more likely to be socially disadvantaged and were younger than the seronegatives at first opiate use. After serostatus notification, seropositives had more "fair hearings" for noncompliance with program norms and used more cocaine. Although the patients notified of HIV infection may have more behavioral problems, further research is needed to determine whether or not this reflects antecedent behavior patterns and drug use.

Adult↗
PubMed2005

Reported foodborne illness and gastroenteritis in Australia: annual report of the OzfoodNet network, 2004.

In 2004, OzFoodNet sites recorded 24,313 notifications of eight potentially foodborne diseases, along with 118 outbreaks of foodborne disease. Overall, reports of both notifications and outbreaks were higher than previous years. The most common sporadic diseases were campylobacteriosis (15,640 cases) and salmonellosis (7842 cases). Reports of sporadic cases of Shiga toxin-producing Escherichia coli were rare with only 46 cases, but there were two small clusters due to serotypes O157/O111 and 086. The 118 foodborne disease outbreaks affected 2,076 persons, of whom 5.6 per cent (116/2,076) were hospitalised and two people died. Foods prepared in restaurants and catering settings caused the most outbreaks and the most common agent was Salmonella Typhimurium. Outbreak investigations during 2004 implicated chicken, foods containing eggs, imported oysters and food handlers infected with norovirus. In addition to foodborne outbreaks, OzFoodNet sites reported 874 outbreaks that were spread from person-to-person affecting 25,363 people. Sites conducted 54 investigations into clusters of Salmonella and other pathogens where a source could not be identified. Surveillance of foodborne diseases continued to improve during 2004, with all jurisdictions contributing to national cluster reports and using analytical studies to investigate outbreaks. Ninety-eight per cent of Salmonella notifications on state and territory surveillance databases recorded complete information about serotype and phage type. Foodborne disease may cost Australia as much as 1.2 billion dollars annually making it vital to intervene to prevent disease.

Australia↗
PubMed1988

The acquired immunodeficiency syndrome: a tuberculosis threat?

In the United States there has been an increase in mycobacterial infections that is attributable to the acquired immunodeficiency syndrome (AIDS). Since 1983, when the first case of AIDS was reported in Australia, there have been 523 patients (to June 30, 1987) notified with group-IV AIDS and, of these, 361 (69%) cases have been in New South Wales. Of these 361 notifications, 59 (16%) patients have had concurrent mycobacterial infection. Seven of these patients had Mycobacterium tuberculosis infection and five of these infections occurred in 1986. This means that, in 1986, patients with group-IV AIDS had a rate of infection with Myco. tuberculosis of 3000 per 100,000 population, compared with 5.2 cases per 100,000 population for New South Wales. We sought to determine whether or not there was any unexplained increase in notifications which might be attributable to AIDS. This paper reports cases that were notified to the AIDS and tuberculosis registers, finds that atypical mycobacterial infections are underreported by at least 19.5%, and examines trends in notifications for mycobacterial disease since the onset of the AIDS epidemic. It also raises the importance of appropriate measures to protect health workers from tuberculosis.

Acquired Immunodeficiency Syndrome↗
PubMed1990

Tuberculosis surveillance in the South Australian aboriginal community.

Tuberculosis (TB) is still a significant problem in Aboriginal people. There are higher rates of active TB and evidence of continuing transmission among this group. We sought to define the specific epidemiological risks and best methods of surveillance for TB in Aboriginal people in South Australia. We compared the incidence of active TB in Aboriginal people in South Australia with that of the total number of cases in non-Aboriginal people from 1978 to 1988, and studied the prevalence of infection in four Aboriginal communities in South Australia. Incidence rates of active TB were four times higher in South Australian Aboriginal people than the total South Australian rates. Specific age analysis revealed higher active disease notification rates in Aboriginal people aged 45-54 years and 55-64 years. The notification rate for Aboriginal men was almost three times the rate for women. Standardized incidence ratios of active TB cases for Aboriginal communities were higher in rural and traditional communities than in urban Aboriginal people. Infection prevalence, measured by tuberculin skin testing, varied from 7.7% to 30.8% in the different communities but did not correlate with the standardized incidence ratios. We conclude that (i) South Australian Aboriginal people are suffering a higher rate of active TB disease than the total South Australian community, and (ii) that the disease and infection rates vary between communities and between age and sex groups. The discrepancy between disease notifications rates, as measured by standardized incidence ratios, and infection prevalence requires further investigation. To improve TB control in Aboriginal people, programmes need to be altered to be more appropriate for this group.

Adolescent↗
PubMed1991

Can infant death from child abuse be prevented?

OBJECTIVE: To assess the effectiveness of a child abuse surveillance and intervention program in protecting infants at risk. DESIGN AND SETTING: A retrospective review of all children discussed by the Suspected Child Abuse and Neglect Team of the Mater Misericordiae Children's Hospital, South Brisbane, over the five year period January 1986 to December 1990. PATIENTS: A total of 2126 children were discussed by the team; 375 were infants (less than 12 months of age) at the time of the initial discussion. Nine infants died suddenly and these nine deaths were examined in detail. RESULTS: All deaths were considered initially to be due to sudden infant death syndrome (SIDS), but autopsy findings in six suggested death was not accidental and in the other three significant doubt was raised by the history. Identifying risk factors for non-accidental injury were clearly present in all cases; however, there were major problems with notification to the appropriate authorities. Even in cases where appropriate identification and notification occurred planned interventions by multiple agencies failed to prevent death of these infants. CONCLUSIONS: There is a growing awareness of child abuse as a significant cause of morbidity and mortality in developed countries, but intervention is fraught with multiple difficulties and prevention programs are few. Recommendations are offered for improvement in recognition and notification of incipient child abuse as well as appropriate interventions to prevent infant deaths. Inappropriate death recording procedures may result in some sudden deaths being recorded as SIDS when in fact they are caused by child abuse.

Cause of Death↗
PubMed2005

Estimating Australia's abortion rates 1985-2003.

AIM: To estimate national rates of induced abortion in Australia from 1985 to 2003, using Medicare claim statistics for private patients and hospital morbidity statistics for public patients. DESIGN AND SETTING: Estimates were based on Australian and South Australian data collections relating to abortions. SA hospital morbidity statistics were compared with SA statutory notifications of abortions to estimate the accuracy of these collections. Medicare statistics on abortion procedures performed on private patients in South Australia were then compared with hospital morbidity statistics for private patients. National statistics on abortion derived from Medicare and hospital morbidity statistics were adjusted for inaccuracies found in these sources. MAIN OUTCOME MEASURES: Numbers of induced abortions in Australia for each year from 1985 to 2003; abortion rates per 1000 women aged 15-44 years. RESULTS: Abortion numbers based on Medicare claims by private patients overestimated by 18.7% the number of abortions derived from statutory notifications in South Australia during the period 1988-89 to 1999-00. Hospital morbidity data using principal diagnosis codes relating to medical abortion overestimated statutory notifications by 2.3% (mainly because of readmissions). National statistics were adjusted for these overestimations and for the estimated 14.1% of private patients who would not have submitted Medicare claims (based on surveys of private-clinic patients in New South Wales and Victoria). The estimated Australian abortion rate increased from 17.9 per 1000 women aged 15-44 in 1985 to a peak of 21.9/1000 in 1995, then declined to 19.7/1000 in 2003 (estimated number of abortions, 84,460). CONCLUSION: There are no data currently available for deriving accurate numbers of induced abortions in Australia. Suggestions are made for collection of national statistics.

Abortion, Induced↗
PubMed2005

Epidemic syphilis among homosexually active men in Sydney.

OBJECTIVES: To describe trends in the notification of infectious syphilis in New South Wales, the characteristics of homosexually active men recently notified with early syphilis, and the seroprevalence and incidence of syphilis, as well as associated risk factors, in a Sydney cohort of HIV-negative homosexually active men. DESIGN, SETTING AND PARTICIPANTS: Secondary analysis of New South Wales infectious syphilis surveillance data from 1998 to 2003; a case series of 57 homosexually active men diagnosed with early syphilis in inner Sydney from December 2002 to January 2004; and a prospective cohort study of syphilis among 1333 HIV-negative homosexually active men in Sydney recruited from June 2001 to December 2003. MAIN OUTCOME MEASURES: Rates of notification of infectious syphilis in New South Wales and in areas of inner Sydney; behavioural and clinical features of men with syphilis in the case series; and incidence of syphilis and hazard ratios (HRs) associated with sexual behaviours in the cohort study. RESULTS: Infectious syphilis notifications in inner Sydney rose more than 10-fold (from 6 in 1999 to 162 in 2003), and the increase was confined to men. Of 57 men with early syphilis in the case series, 54% were HIV-positive and 32% reported no symptoms of syphilis. These 57 men were highly sexually active and likely to report recreational drug use. In the cohort study, 1292 men (97% of participants) consented to syphilis testing; the incidence of syphilis was 0.78 per 100 person-years, and risk factors included reporting unprotected anal intercourse with HIV-positive partners (HR, 5.31; 95% CI, 2.00-184.93) and insertive oral sex (HR, 4.55; 95% CI, 1.14-18.18). CONCLUSION: Syphilis has been re-established among homosexually active men in Sydney, and HIV-positive men are over-represented. Frequent screening is needed in this population to curb the transmission of both syphilis and HIV.

Adolescent↗
PubMed2007

Assessment monitoring of laboratory critical values: a College of American Pathologists Q-Tracks study of 180 institutions.

CONTEXT: Critical laboratory value reporting is a highly visible and essential key activity for clinical laboratories. OBJECTIVE: To measure critical laboratory value reporting in multiple institutions over time and to examine the practice patterns and demographic factors associated with sustained improvement in critical value reporting. DESIGN: A longitudinal cohort study of 180 clinical laboratories that provided quarterly critical values reporting data for 2 to 16 quarters was conducted using a uniform definition of successful caregiver notification. Mixed linear model analysis of the 2001 through 2004 dataset was performed. RESULTS: A decrease in total and inpatient rates of undocumented critical values per 1000 results was associated with (1) the American Association of Blood Banks inspection within the past 2 years (P = .01, for both total and inpatient rates); (2) unit secretary/clerical staff not authorized to accept inpatient critical value notification (P = .004 [total] and .001 [inpatient]); and (3) the mandatory practice of requiring notification of health care providers when handling inpatients known to have results repeatedly in the critical range (P = .01, for both total and inpatient rates). Continued participation in the Q-Tracks monitoring program was associated with significant and progressive improvement in total, inpatient, and outpatient critical value reporting (P = .02, .01, and .003, respectively). CONCLUSIONS: Critical value reporting improved as the duration of participation in the Q-Tracks monitoring program increased. Improved total and inpatient critical value reporting was associated with factors that may be markers for institutions with priorities of quality management and enhanced communication with responsible caregivers.

Benchmarking↗
PubMed2005

Responding to the rofecoxib withdrawal crisis: a new model for notifying patients at risk and their health care providers.

BACKGROUND: We decided to inform our patients of the withdrawal of rofecoxib, one of the largest drug withdrawals in United States history, and instruct them to contact their providers for guidance. OBJECTIVE: To identify and inform patients and providers affected by the rofecoxib withdrawal. DESIGN: Descriptive observational study. SETTING: Tertiary care center with an electronic medical record (EMR) system. PATIENTS: Patients with an active rofecoxib prescription within the EMR. INTERVENTION: Existing information technology and traditional communication resources were used to automate the identifying and notifying of patients and providers and to deactivate rofecoxib prescriptions in the EMR. MEASUREMENTS: Characteristics of patients receiving rofecoxib at our institution, details of their prescription and provider, number of EMR alerts, and medication discontinuations. RESULTS: The 11,699 patients with a rofecoxib prescription in our practice were sent notifications within 24 hours of the withdrawal. LIMITATIONS: We did not directly measure the effect of our notification on patients or providers. CONCLUSIONS: Information technology enabled our institution to rapidly identify and notify individual patients and their providers about an important drug withdrawal. The methods modeled a feasible way for health care organizations with EMRs to participate in notification processes that may be applicable in a variety of situations.

Adult↗
PubMed1976

[Reports of clinical cases of taeniasis and consumption of taeniacides in the GDR district of Leipzig from 1967 to 1970].

Ascertainments on notifications of cases of taeniarhynchosis and of the consumption of taenial therapeutics in the regions of the district of Leipzig during the period 1967-1970. The factors are discussed which have influence on notifications or on the consumption of taenial therapeutics. From these examinations resulted, that consumption of taenial therapeutics come near to genuine extensity of the population, but it is not equal to this. The causes, at present, for bad notifications must be found and changes must be introduced. The statistics of numbers on consumption of taenial therapeutics must be improved and the sector of veterinarian science must be excluded.

Anticestodal Agents↗
PubMed1994

Medical devices; substantial equivalence; 510(K) summaries and 510(K) statements; class III summaries; confidentiality of information--FDA. Final rule.

The Food and Drug Administration (FDA) is issuing this final rule to implement the provisions of the Safe Medical Devices Act of 1990 (the SMDA) that require all persons who submit a premarket notification (510(k)) to provide to FDA, as part of the submission, an adequate summary (510(k) summary) of any information respecting safety and effectiveness or a statement (510(k) statement) that such information will be made available upon request by any person. This rule also implements the requirement of the SMDA that 510(k) submitters claiming substantial equivalence to a class III preamendments device for which FDA has not yet called for premarket approval submit a class III summary and certify that they have conducted a search of safety and effectiveness data. In addition, this rule amends the device regulations governing the confidentiality of certain premarket notification submissions to conform to the SMDA. This rule also provides that persons who submit a premarket notification must certify that, to the best of their knowledge, all information is truthful and accurate and that no material fact has been omitted.

Confidentiality↗
PubMed1999

[Fetal and neonatal mortality from 22 weeks of amenorrhea in the Loire area].

BACKGROUND: The Pays de Loire has a low perinatal mortality indicators among French regions but this could be due to under-notification. OBJECTS: To explore this hypothesis we undertook a survey in order to identify all fetal and neonatal deaths occurring at a gestionnal age of 22 weeks or more. We also tried to examine and analyze the causes of death. METHODS: All maternity (26) and neonatal wards (5) in the region took part in the survey in 1995. Clinicians were asked to fill out a questionnaire for all deaths occurring from gestational age (GA) 22 weeks and/or concerning a birthweight of a least 500 g. Only perinatal deaths related to parents living in the Pays de Loire were included in the study. RESULTS: Two hundred and sixty seven perinatal deaths were identified out of a total 29,440 births (9.1 /1000). Eighty three (2.8 /1000) were termination of pregnancy for medical reasons, of which 82% were motivated by chromosomic illness. Ninety-nine stillbirths fell (3.4 /1000) into two GA periods: 24 to 27 weeks (20%) and 38 to 41 weeks (2%). The cause of stillbirths remained unknown in 50% of cases despite a post-mortem examination rate of 87%. There were 29 deaths (1 /1000) in the immediate per and post-partum, 40% of which occurred at GA 22 to 25 weeks. Another 38% occurred at GA 36 to 40 weeks and these were related to undectected malformations or infections. Neonatal and intensive care units reported 56 neonatal deaths (1.9 /1000). GA was under 33 weeks for 44% of them. Deaths were caused by usual complications of severe prematurity, neurologic diseases and malformations. Thirty-two percent of total deaths were not notified to the French Authority: 25% of deaths for termination of pregnancy for medical reasons and 7% for stillbirths and per and post partum deaths. CONCLUSION: This survey suggests that the Pays de Loire perinatal mortality indicators remained low compared with other French regions, even after adjustment for this under notification. This casts doubts on the validity of perinatal mortality monitoring based on official notifications. The cause may lie in the inadequacy of legislation of the particular circumstances of perinatal deaths.

Abortion, Induced↗
PubMed1999

Tuberculosis control and surveillance in changing health reform in the Czech Republic.

In the Czech Republic a centralized, governmentally budgeted and vertically structured health system has been reformed to a liberalized health system with fragmentation of organisation, responsibilities and funding after 1989. Tuberculosis (TB) control and TB surveillance followed the general health system reform and implementation of liberalized health insurance system. In the liberalized health system the feasibility and accessibility of methods of TB control rather improved. In contrary to that TB surveillance in the liberalized system suffered bu absence of vertical mechanisms ensuring the completeness and validity of data collected in a centralised notification system (recording and reporting system). The rate of control notification dropped up to 50%. TB surveillance was therefore supplemented in 1996 by vertically oriented mechanisms of the hygienic (public health) service. TB consultants were appointed at regional and mostly also on district level as part-time jobs of the hygienic service and entitled to supervise all notifications from the given region (district), particularly what regards completeness of bacteriological data. As a consequence complete and reliable reports on epidemiological situation are issued and an assessment of antituberculous chemotherapy of new TB cases is made by a regional cohort analysis starting 1st quarter 1998. TB situation in the Czech republic is regarded as stable, being under control, with a decreasing trend of bacteriologically confirmed TB cases and increasing trend of bacteriologically not confirmed pulmonary TB. The TB is slowly shifting to high risk groups of population.

Czech Republic↗
PubMedDate not supplied

[Misuse and or overdose of BCG vaccine: evaluation over a 4-year period].

The inappropriate use of BCG vaccine could be followed by adverse events (AE). In order to know their frequency and type, we evaluated the spontaneous reports of misuses (MS) and overdosages (OV) over a 4-year period. One hundred and twenty-six notifications were collected; 109 concerned MS, 13 OV, and 4 concerned both MS and OV. We recorded a high number (97) of MS related to the injection of a BCG vaccine instead of a tuberculin test (TT). Among the 126 initial notifications, 122 cases of AE were reported, 107 after an MS, 11 after an OV and 4 after both MS and OV. The most common AE were related to injection-site reactions which were in fact expected reactions when BCG is used under correct conditions. In half of the cases systemic signs were associated. The most common were asthenia, fever and lymphadenopathy. Seven cases related to MS were considered as serious according to the ICH definition. Six of them recovered, for one the outcome was unknown. It appeared that perhaps the presentation of the products BCG vaccine and TT could play a role in contributing to this inappropriate use. Both presentations contain 10 doses but there are significant differences in colours used and in specific instructions. Despite the fact that the AE reported after an MS and/or an OV represented the one-third of the total notifications recorded with the BCG vaccine over the 4-year period under review, they have to be considered in light of the 170 million doses distributed in 150 countries. We have to consider the possibility of under reporting because of the delicacy of incorrect administration and differences in pharmacovigilance structures worldwide. Even if the number of AE is low, MS and OV should be reported and documented for good pharmacovigilance surveillance.

Adjuvants, Immunologic↗