Introduction: Ethical issues limit pregnant women enrolment in clinical trials [1]. Observational studies may highlight neonates risk following drug exposure in pregnancy [2-4]. However, complicated studies design and related methodological shortcomings may limit results reliability. Consequently, great uncertainty surrounds the use of drugs during pregnancy. Aim: To provide information to clinicians and women in Tuscany on drug exposure during pregnancy; to identify the most concerning drugs for pregnancy; and to evaluate the occurrence of adverse drug events in neonates. Methods: The Stork project, carried out from 2012 to 2016, provided counselling to Tuscan clinicians and citizens, with the activation of the Teratologic Counselling Centre at Pisa University. Phone requests were recorded in data collection forms (demographic details, background information, call motivations) and answers were provided based on a priority flow-chart. The counselling provided a detailed report. When customers accepted to enter into the monitoring, an informed consent was requested for telephonic follow-up. Results: Overall, 94 informal and 1 formal counselling were recorded and over-the-counter medications, for seasonal or pregnancy complications, were mostly involved. Inadequate information (62.11%), second opinion (18.95%), conflicting information (13.68%), worrying symptoms (4.21%) and information overload (1.05%) were the calling motivations. Metoclopramide, amoxicillin, acyclovir, ibuprofen, paracetamol, dexchlorpheniramine, loratadine, dextromethorphan and antacids were the most enquired drugs. For the first trimester gestation, 43 calls, concerning inadequate information, were recorded on the following anatomical therapeutic chemical classifications: NO2B (other analgesics and antipyretics), R06A (systemic antihistamines), R05D (cough suppressants), M01A (antiinflammatories and anti-rheumatics), A02A (antacids). For the second trimester, 37 informal counselling, for inadequate information and second opinion, were recorded on: NO2B, R06A, J01C (penicillins), J05A (antivirals). For the third trimester, 14 calls, for inadequate and conflicting information, involved: R06A, A02A, N02B. In 71 cases the drug intake occurred actually. The 12% of these (n = 9) did not consent follow up, while the 87% (n = 62) accepted, but only 14% (n = 10) answered questionnaire. All 10 followed-up women delivered healthy neonates. One formal counselling was requested by a clinician at Pisa University Hospital, about the possible role of drugs taken by the mother (acyclovir, beclomethasone, ambroxol, miconazole, betamethasone, rubella vaccine) and the new-born death, occurred after delivery for respiratory distress. In the final report, no correlation was identified. Discussion: This real-world analysis point to need for information on drug use during pregnancy. Conclusion: Routine consultations could address physicians and patients to a safer and more aware approach of drug use during pregnancy.
IntenSive Monitoring Program of TeratOgen and Non-Teratogen Risk of Drugs During Pregnancy: the STORK Project
Tuccori, M;Convertino, I;Galiulo, M;Mantarro, S;Corona, T;Blandizzi, C
2017-01-01
Abstract
Introduction: Ethical issues limit pregnant women enrolment in clinical trials [1]. Observational studies may highlight neonates risk following drug exposure in pregnancy [2-4]. However, complicated studies design and related methodological shortcomings may limit results reliability. Consequently, great uncertainty surrounds the use of drugs during pregnancy. Aim: To provide information to clinicians and women in Tuscany on drug exposure during pregnancy; to identify the most concerning drugs for pregnancy; and to evaluate the occurrence of adverse drug events in neonates. Methods: The Stork project, carried out from 2012 to 2016, provided counselling to Tuscan clinicians and citizens, with the activation of the Teratologic Counselling Centre at Pisa University. Phone requests were recorded in data collection forms (demographic details, background information, call motivations) and answers were provided based on a priority flow-chart. The counselling provided a detailed report. When customers accepted to enter into the monitoring, an informed consent was requested for telephonic follow-up. Results: Overall, 94 informal and 1 formal counselling were recorded and over-the-counter medications, for seasonal or pregnancy complications, were mostly involved. Inadequate information (62.11%), second opinion (18.95%), conflicting information (13.68%), worrying symptoms (4.21%) and information overload (1.05%) were the calling motivations. Metoclopramide, amoxicillin, acyclovir, ibuprofen, paracetamol, dexchlorpheniramine, loratadine, dextromethorphan and antacids were the most enquired drugs. For the first trimester gestation, 43 calls, concerning inadequate information, were recorded on the following anatomical therapeutic chemical classifications: NO2B (other analgesics and antipyretics), R06A (systemic antihistamines), R05D (cough suppressants), M01A (antiinflammatories and anti-rheumatics), A02A (antacids). For the second trimester, 37 informal counselling, for inadequate information and second opinion, were recorded on: NO2B, R06A, J01C (penicillins), J05A (antivirals). For the third trimester, 14 calls, for inadequate and conflicting information, involved: R06A, A02A, N02B. In 71 cases the drug intake occurred actually. The 12% of these (n = 9) did not consent follow up, while the 87% (n = 62) accepted, but only 14% (n = 10) answered questionnaire. All 10 followed-up women delivered healthy neonates. One formal counselling was requested by a clinician at Pisa University Hospital, about the possible role of drugs taken by the mother (acyclovir, beclomethasone, ambroxol, miconazole, betamethasone, rubella vaccine) and the new-born death, occurred after delivery for respiratory distress. In the final report, no correlation was identified. Discussion: This real-world analysis point to need for information on drug use during pregnancy. Conclusion: Routine consultations could address physicians and patients to a safer and more aware approach of drug use during pregnancy.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
