regarded as included under the Transtec risks of abuse and addiction. Important identified risk; Important identified risk; Section II.SVI.1 Potential for – Accidental overdose Overdose harm from overdose and II.SVII.3 – Details of important identified and potential risks from clinical development and experience (including newly identified) of the Transtec RMP summarise the data for Transtec. The Norspan risk of accidental overdose is included under the Transtec risk of overdose. Important potential risk; No corresponding risk identified Section II.SVI.4 of the Transtec Medication error for Transtec RMP Potential for medication errors summarises the data for Transtec. No important safety Important Potential Risk: Off label concern was identified based on use (cutting of the BTDS patch to the data provided. Cutting the achieve an intermediate dose) plaster into pieces was the most often observed medication error for Transtec. As no safety concern was identified in the cases related to the topic, this is not regarded to provide a basis for an important potential risk. Important potential risk: Important identified risk: The Transtec RMP covers the Psychological dependence Addiction important potential risk dependence’ under ‘psychological it important identified risk of ‘addiction’. Missing information: use in No corresponding missing As outlined in the Transtec RMP pregnant and breastfeeding information for Transtec Section II.SV.3- post authorisation patients use in populations not studied in clinical trials there is considerable experience with the use of Missing information: paediatric buprenorphine during pregnancy use derived from opioid maintenance therapy and there is data on the use of transdermal buprenorphine in paediatric patients. Summary of recommendations Outstanding issues Issues in relation to the RMP New recommendations The for medication errors or other risks if applicable’ section of the revised ASA is ‘Potential not satisfactory in that it does not consider risks of inadvertent exposure, including
regarded as included under the Transtec risks of abuse and addiction. Important identified risk; Accidental overdose Important identified risk; Overdose Section II.SVI.1 – Potential for harm from overdose and II.SVII.3 – Details of important identified and potential risks from clinical development and experience (including newly identified) of the Transtec RMP summarise the data for Transtec. The Norspan risk of accidental overdose is included under the Transtec risk of overdose. Important potential risk; Medication error No corresponding risk identified for Transtec Section II.SVI.4 of the Transtec RMP Potential for medication errors summarises the data for Transtec. No important safety concern was identified based on the data provided. Cutting the plaster into pieces was the most often observed medication error for Transtec. As no safety concern was identified in the cases related to the topic, this is not regarded to provide a basis for an important potential risk. Important Potential Risk: Off label use (cutting of the BTDS patch to achieve an intermediate dose) Important potential risk: Psychological dependence Important identified risk: Addiction The Transtec RMP covers the important potential risk ‘psychological dependence’ under it important identified risk of ‘addiction’. Missing information: use in pregnant and breastfeeding patients No corresponding missing information for Transtec As outlined in the Transtec RMP Section II.SV.3- post authorisation use in populations not studied in clinical trials there is considerable experience with the use of buprenorphine during pregnancy derived from opioid maintenance therapy and there is data on the use of transdermal buprenorphine in paediatric patients. Missing information: paediatric use Summary of recommendations Outstanding issues Issues in relation to the RMP New recommendations The ‘Potential for medication errors or other risks if applicable’ section of the revised ASA is not satisfactory in that it does not consider risks of inadvertent exposure, including
auspar-buprenorphine-161213.docx