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This is the second of two papers reporting the development of a spiritual care competency framework for pre-registration nurses and midwives as part of a PhD study using an embedded sequential mixed methods eclectic research design. The first paper outlines how 116 competency items were generated from an in-depth review of international literature, and offers a theoretical model to underpin development of the Framework. This paper reports how the Framework was developed. Method/Results: Five focus groups were held with stakeholders in Malta (chaplains/spiritual leaders, undergraduate nursing/midwifery educators, qualified nurses/midwives, parents/carers, patients/clients) to ensure that aspects of spirituality/spiritual care important to them, but not identified in the literature review, were included in the Framework. The resulting 55 competencies in seven domains formed the Delphi Questionnaire which was validated using a two round modified Delphi method involving experts from Malta. The final seven domain 54 item Framework demonstrated good to strong internal consistency, stability and a good fit with a six factor model. The Framework's greatest immediate contribution is in its ability to inform undergraduate nursing/midwifery spiritual care curriculum design and delivery. Further development of the Framework could assist in student selection ensuring that the 'art' of nursing/midwifery has parity with the 'science'. • This is the first pre-registration Spiritual Care Competency Framework for nurses/midwives. • It was developed using a rigorous embedded sequential mixed methods eclectic research design. • The Framework is informing design/delivery of spiritula care education programmes across Europe [ABSTRACT FROM AUTHOR]

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Background: In Malta, off-label prescribing of medicines in children stands at 45%, mainly because of failure by prescribers to follow the dosing recommendations in the product literature. In addition, registration procedures of pharmaceuticals may inadvertently contribute to this high incidence of off-label prescribing. Methods: A literature review was conducted to identify regulatory provisions relating to the registration of medicines in Malta that could give rise to off-label use. Furthermore, the product literature of the 2 classes of medicines most commonly prescribed in children, antibiotics and respiratory medicines, were reviewed. This was done in order to gauge whether the different registration routes implemented in Malta to market these medicines could give rise to off-label use. Results: The national registration procedure relating to Article 126a of Directive 2001/83/EC and, to a lesser extent, line extensions, parallel importation, and the provision detailed in Article 11 of Directive 2001/83/EC were found to lead to discrepancies and potentially misleading inclusions in the product literature. These, in turn, may well contribute to off-label use of medicines in children. Conclusions: Off-label prescribing does not necessarily mean that efficacy and safety data are unavailable. Variances in the product literature of medicines having the same active ingredients but imported from different countries may cause divergent prescribing practices, leading to inadvertent off-label use. The various stakeholders, including member states such as Malta, should devise strategies to harmonize the most recent labeling information in order to support the safe and effective use of pediatric medicines, thereby decreasing off-label use. [ABSTRACT FROM AUTHOR]