pharmacoepidemiology and drug safety 2014; 23: 1107–1109
Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/pds.3693
LETTER TO THE EDITOR
Medicine use in pregnancy and public cord blood bank databases To the Editor Charlton et al. recently showed that combining the systematic use of electronic healthcare databases with data collected in population-based registries for the epidemiological surveillance of congenital anomalies (the EUROCAT network) can lead to a reliable European system for the evaluation of medicine use in pregnancy in relation to the risk of congenital anomalies.1 Actually, most cited databases (Danish National Birth Registry, Danish National Patient Registry, Medical Birth Registry of Norway, EFEMERIS database in France, National Community Child Health Database and the Patient Episode Database for Wales, Emilia Romagna and Tuscany CeDAP databases in Italy) capture information relative to abortions and stillbirths, provide figures on gestational age and birth weight and record maternal co-morbidities or family history of congenital anomalies.1 However, potential confounders like alcohol consumption or smoking, as well as the last menstrual period date, necessary to calculate the actual exposure time, are irregularly reported.1 In addition, healthcare databases trace the drug prescription, more than the actual drug consumption, because non-compliance information are usually not available and underreport the use of over the counter (OTC) drugs. For example, in the study of Charlton et al., all registries were able to capture data on high-dose folic acid (5 mg) prescription, whereas information on standard-dose folic acid (0.4 mg) consumption were very scarce.1 Indeed, the analysis of data recruited directly through maternal interviews, even though investigating significantly smaller pregnant population, can help to highlight the extent and the type of drug use not captured by databases. Currently, public cord blood banks gather a great deal of various information in a sizeable sample of pregnant women. Donating cord blood to the purpose of allogeneic hematopoietic stem cell transplantation of patients with hematological diseases is a worldwide acknowledged practice. In 2010, 3.6% of the whole Italian pregnant population addressed public cord blood banks to donate their cord blood; these figures have further increased in the last years.2 The donor eligibility is established after week 32 of gestation by healthcare Copyright © 2014 John Wiley & Sons, Ltd.
personnel ascertaining the healthy status of the women and of her partner: in particular, infectious diseases and hereditary diseases are carefully investigated and excluded. To this purpose, maternal and paternal medical history, family medical history and donor habits (including alcohol and drug consuming and medicines taken during pregnancy) are collected. In addition, data relative to pregnancy course are acquired. After the delivery, when cord blood is collected, the health status of the newborn, including birth weight and Apgar score, is recorded. In this study, we show the data on drug exposure, including OTC medications, micronutrients and vitamins, registered in a sample of 2135 pregnant women in two public Italian cord blood banks (Unicatt Cord Blood Bank; “A. Gemelli” Hospital, Rome and Banca del Lazio, “Umberto I” Hospital, Rome) in the 2011–2013 period. The study was approved by the local Ethic Committees. Drugs were classified according to the World Health Organization’s (WHO) Anatomical Therapeutic Chemical (ATC) code, and the data were analyzed using the IBM SPSS Statistics 21.0 software. Age, gestational age at the time of the interview, parity, pregnancy course and concomitant diseases, as well as the commercial names or active substances of drugs used during pregnancy were recorded in all the 2135 investigated women. The reason of the treatment and therapy duration was detailed in 97.7% of cases. The mean gestational age at the time of the interview was 36 + 3 weeks. The mean maternal age at delivery was 33.8 ± 4.6 years: this figure is slightly higher than that of 32.0 reported in our country in 2011.3 The expected miscarriage rate for people of similar age is 20%, very close to the figure of 19.8% that we reported.4 Moreover, in our study population, about 2% of women underwent assisted fertilization, a proportion tightly similar to the value of 1.4% reported in 2009 in Italian population.5 On the whole, 22.4% of women reported a disease pre-existing to pregnancy, while 28.1% developed a pregnancy-related illness, with genitourinary infections, thyroid diseases and iron deficiency anemia being the most frequent reported (17.8%, 13.9% and 10.3%, respectively). The prevalence of diabetes (0.9%) or congenital thrombophilia (3.7%), as well as the incidence of gestational diabetes (3.7%),
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gestational hypertension (1.7%) or intrahepatic cholestasis (2.1%), were similar to those reported in general pregnant population.6–10 These findings suggest that cord blood donors may be considered sufficiently representative of the entire pregnant population. Overall, excluding vitamins and dietary supplements, 64.8% of women received at least one drug, 28.8% more than one drug and 10.7% more than two medications. These figures suggest that a progressive increase of drug exposure among pregnant women over time.11,12 In general, women with higher age, concomitant diseases or those subjected to amniocentesis received a higher number of drugs (p = 0.004, p
Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/pds.3693
LETTER TO THE EDITOR
Medicine use in pregnancy and public cord blood bank databases To the Editor Charlton et al. recently showed that combining the systematic use of electronic healthcare databases with data collected in population-based registries for the epidemiological surveillance of congenital anomalies (the EUROCAT network) can lead to a reliable European system for the evaluation of medicine use in pregnancy in relation to the risk of congenital anomalies.1 Actually, most cited databases (Danish National Birth Registry, Danish National Patient Registry, Medical Birth Registry of Norway, EFEMERIS database in France, National Community Child Health Database and the Patient Episode Database for Wales, Emilia Romagna and Tuscany CeDAP databases in Italy) capture information relative to abortions and stillbirths, provide figures on gestational age and birth weight and record maternal co-morbidities or family history of congenital anomalies.1 However, potential confounders like alcohol consumption or smoking, as well as the last menstrual period date, necessary to calculate the actual exposure time, are irregularly reported.1 In addition, healthcare databases trace the drug prescription, more than the actual drug consumption, because non-compliance information are usually not available and underreport the use of over the counter (OTC) drugs. For example, in the study of Charlton et al., all registries were able to capture data on high-dose folic acid (5 mg) prescription, whereas information on standard-dose folic acid (0.4 mg) consumption were very scarce.1 Indeed, the analysis of data recruited directly through maternal interviews, even though investigating significantly smaller pregnant population, can help to highlight the extent and the type of drug use not captured by databases. Currently, public cord blood banks gather a great deal of various information in a sizeable sample of pregnant women. Donating cord blood to the purpose of allogeneic hematopoietic stem cell transplantation of patients with hematological diseases is a worldwide acknowledged practice. In 2010, 3.6% of the whole Italian pregnant population addressed public cord blood banks to donate their cord blood; these figures have further increased in the last years.2 The donor eligibility is established after week 32 of gestation by healthcare Copyright © 2014 John Wiley & Sons, Ltd.
personnel ascertaining the healthy status of the women and of her partner: in particular, infectious diseases and hereditary diseases are carefully investigated and excluded. To this purpose, maternal and paternal medical history, family medical history and donor habits (including alcohol and drug consuming and medicines taken during pregnancy) are collected. In addition, data relative to pregnancy course are acquired. After the delivery, when cord blood is collected, the health status of the newborn, including birth weight and Apgar score, is recorded. In this study, we show the data on drug exposure, including OTC medications, micronutrients and vitamins, registered in a sample of 2135 pregnant women in two public Italian cord blood banks (Unicatt Cord Blood Bank; “A. Gemelli” Hospital, Rome and Banca del Lazio, “Umberto I” Hospital, Rome) in the 2011–2013 period. The study was approved by the local Ethic Committees. Drugs were classified according to the World Health Organization’s (WHO) Anatomical Therapeutic Chemical (ATC) code, and the data were analyzed using the IBM SPSS Statistics 21.0 software. Age, gestational age at the time of the interview, parity, pregnancy course and concomitant diseases, as well as the commercial names or active substances of drugs used during pregnancy were recorded in all the 2135 investigated women. The reason of the treatment and therapy duration was detailed in 97.7% of cases. The mean gestational age at the time of the interview was 36 + 3 weeks. The mean maternal age at delivery was 33.8 ± 4.6 years: this figure is slightly higher than that of 32.0 reported in our country in 2011.3 The expected miscarriage rate for people of similar age is 20%, very close to the figure of 19.8% that we reported.4 Moreover, in our study population, about 2% of women underwent assisted fertilization, a proportion tightly similar to the value of 1.4% reported in 2009 in Italian population.5 On the whole, 22.4% of women reported a disease pre-existing to pregnancy, while 28.1% developed a pregnancy-related illness, with genitourinary infections, thyroid diseases and iron deficiency anemia being the most frequent reported (17.8%, 13.9% and 10.3%, respectively). The prevalence of diabetes (0.9%) or congenital thrombophilia (3.7%), as well as the incidence of gestational diabetes (3.7%),
1108
s. spartano et al.
gestational hypertension (1.7%) or intrahepatic cholestasis (2.1%), were similar to those reported in general pregnant population.6–10 These findings suggest that cord blood donors may be considered sufficiently representative of the entire pregnant population. Overall, excluding vitamins and dietary supplements, 64.8% of women received at least one drug, 28.8% more than one drug and 10.7% more than two medications. These figures suggest that a progressive increase of drug exposure among pregnant women over time.11,12 In general, women with higher age, concomitant diseases or those subjected to amniocentesis received a higher number of drugs (p = 0.004, p
