Comparison of Pregnancy and Lactation Labeling for Attention-Deficit Hyperactivity Disorder Drugs Marketed in Australia, the USA, Denmark, and the UK

Warrer, Pernille; Aagaard, Lise; Hansen, Ebba Holme

doi:10.1007/s40264-014-0215-2

Cited by 13 publications

(10 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Incorrect information can potentially lead to inappropriate prescribing, or physicians avoid prescribing due to lack of sufficient information. [23] Hence, many medicines are prescribed without license (unlicensed) or in disagreement with the PI (off-label). Off-label prescription includes prescribing outside the recommended dosage, indication, route of administration, or age of the patient.…”

Section: Introductionmentioning

confidence: 99%

Off-Label Prescribing of Antipsychotics in a Danish Child and Adolescent Mental Health Center

Korno¹,

Aagaard

2018

Journal of Research in Pharmacy Practice

Self Cite

View full text Add to dashboard Cite

Objective:We analyzed prescribing patterns of antipsychotics for children and adolescent affiliated with a Danish Child and Adolescent Mental Health Center) with respect to age, sex, medicine, diagnoses, off-label status, and time.Methods:We included all patients below 19 years of age prescribed antipsychotics during 2007–2008 and as of November 1, 2014. Prescription data included all antipsychotic prescriptions and prescriptions of concomitant psychotropic medications. We defined an antipsychotic user as a patient receiving at least one prescription during the study period, irrespective of any previous history of antipsychotic use. We defined off-label prescribing as prescriptions outside the licensed age group and approved indication.Findings:We analyzed 404 antipsychotic prescriptions that were located for 150 patients. The patients were between 7 and 18 years of age. Two-thirds of the prescriptions were for girls and two-thirds of prescriptions for olanzapine and quetiapine. Totally, 92% of all prescribed antipsychotics were used off-label. For typical antipsychotics, this share was 96% and for atypical antipsychotics 90%. As of November 1, 2014, the total share of off-label antipsychotic prescriptions was 96%, and 63% of these were for medications prescribed outside the approved age group, and 26% for nonlicensed indication(s).Conclusion:This study demonstrated a high level of off-label prescribing over time with respect to age and indication. The prescribing patterns underpin the need for further economic incentives for pharmaceutical companies to register pediatric indications, particular for off-patent products.

show abstract

Section: Introductionmentioning

confidence: 99%

Off-Label Prescribing of Antipsychotics in a Danish Child and Adolescent Mental Health Center

Korno¹,

Aagaard

2018

Journal of Research in Pharmacy Practice

Self Cite

View full text Add to dashboard Cite

show abstract

“…Failure to treat some maternal conditions may also lead to increased foetal risks, including foetal abnormalities, intrauterine growth restrictions and stillbirth [4]. For a physician to make an informed decision about prescribing a medicine during pregnancy or lactation, relevant evidence-based information is required to help decide whether a treatment is appropriate during pregnancy or lactation, as well as to identify the risks of inadvertent exposure of a pregnant woman or a breastfeeding neonate to the particular treatment [5,6]. One of the main concerns of researchers and healthcare professionals who work in antenatal care is the lack of information regarding the use of many medicines during pregnancy [7].…”

Section: Introductionmentioning

confidence: 99%

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Arguello

Salgado

Fernández-Llimós

2015

Brit J Clinical Pharma

View full text Add to dashboard Cite

AIMSTo assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). METHODSSmPCs available on the EMA website in April 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre-clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child-bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPCs were classified as containing 'conclusive' or 'ambiguous' information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. RESULTSOf the 534 SmPCs, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. CONCLUSIONSImportant information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Reliable information regarding the use of many medicines during pregnancy is critical for researchers and healthcare professionals who work in antenatal care, but this information has been found to differ across different sources.• The Summary of Product Characteristics (SmPCs) is the European official medicines information source for professionals and contains a specific section to include information on medicines use during pregnancy and lactation to guide decision making.• Future electronic versions of SmPCs to be included in clinical decision support systems will require intelligible and logical electronic information. WHAT THIS STUDY ADDS• Important information deficits on the use of medicines during pregnancy and lactation were found in European SmPCs, and the time elapsed since a SmPC's marketing authorization was not associated with an increase in information quality.• Post-authorization data on the exposure to medicinal products during pregnancy and lactation should be actively collected and included in official information sources to keep them updated and to assist decision making.

show abstract

“…With this in mind, it should be stressed that ADRs that are not labeled in Europe may be labeled in other parts of the world (e.g., the US and Australia). [ 36 37 38 39 40 ] All ADRs identified in this study and classified as unlabeled were checked against US labeling information (accessed via the FDA website in December 2013) and no discrepancies were found. Hypotheses or cases of unlabeled ADRs may also be present in scientific publications that are not easily available to the prescribing physician.…”

Section: Discussionmentioning

confidence: 99%

Identification of possible adverse drug reactions in clinical notes: The case of glucose-lowering medicines

et al. 2015

Self Cite

View full text Add to dashboard Cite

Objective:Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions (ADRs) associated with three classes of glucose-lowering medicines: “Combinations of oral blood-glucose lowering medicines” (A10BD), “dipeptidyl peptidase-4 (DDP-4) inhibitors” (A10BH), and “other blood glucose lowering medicines” (A10BX). Specifically, we aimed to describe the potential of clinical notes to identify new ADRs and to evaluate if sufficient information can be obtained for causality assessment.Methods:For observed adverse events (AEs) we extracted time to onset, outcome, and suspected medicine(s). AEs were assessed according to World Health Organization-Uppsala Monitoring Centre causality criteria and analyzed with respect to suspected medicines, type of ADR (system organ class), seriousness and labeling status.Findings:A total of 207 patients were included in the study leading to the identification of 163 AEs. 14% were categorized as certain, 60% as probable/likely, and 26% as possible. 15 (9%) ADRs were unlabeled of which two were serious: peripheral edema associated with sitagliptin and stomach ulcer associated with liraglutide. Of the unlabeled ADRs, 13 (87%) were associated with “other blood glucose lowering medications,” the remaining 2 (13%) with “DDP-4 inhibitors.”Conclusion:Clinical notes could potentially reveal unlabeled ADRs associated with prescribed medicines and sufficient information is generally available for causality assessment. However, manual review of clinical notes is too time-consuming for routine use and hence there is a need for developing information technology (IT) tools for automatic screening of patient records with the purpose to detect information about potentially serious and unlabeled ADRs.

show abstract

Comparison of Pregnancy and Lactation Labeling for Attention-Deficit Hyperactivity Disorder Drugs Marketed in Australia, the USA, Denmark, and the UK

Cited by 13 publications

References 15 publications

Off-Label Prescribing of Antipsychotics in a Danish Child and Adolescent Mental Health Center

Off-Label Prescribing of Antipsychotics in a Danish Child and Adolescent Mental Health Center

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Identification of possible adverse drug reactions in clinical notes: The case of glucose-lowering medicines

Contact Info

Product

Resources

About