The Problem with Amphotericin
Patient harm from inadvertent administration of amphotericin B (Fungizone™) instead of liposomal amphotericin (AmBisome ® ) has been described in the literature and has been the subject of patient safety alerts in the UK. Safe use of intravenous amphotericin depends on the knowledge and awareness of...
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Published in | Clinical drug investigation Vol. 40; no. 8; pp. 687 - 693 |
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Main Author | |
Format | Journal Article |
Language | English |
Published |
Cham
Springer International Publishing
01.08.2020
Springer Nature B.V |
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Abstract | Patient harm from inadvertent administration of amphotericin B (Fungizone™) instead of liposomal amphotericin (AmBisome
®
) has been described in the literature and has been the subject of patient safety alerts in the UK. Safe use of intravenous amphotericin depends on the knowledge and awareness of practitioners of the availability and differences between the different presentations of intravenous amphotericin. Knowledge is a weak barrier to error. Recommendations to reduce the risk of error following adverse drug events in the UK, USA and The Netherlands have largely focused on actions to be taken at an organisational level, such as drug supply, storage, dose checking and specifying brand and generic names on prescriptions. None have considered or addressed the contributory factors relating to the products themselves, namely the similarity between the presentations of AmBisome and Fungizone, both of which are manufactured as 50 mg vials despite their different dose recommendations. The need to use multiple vials of Ambisome to prepare infusions for adult patients is contrary to the usual practice of using only one or two vials to prepare doses of injectable medicines for adult patients, increasing the risk of error not only with injectable amphotericin formulations but potentially also with the preparation of other injectable medicines. Whilst the development of robust local risk reduction strategies are important, external factors, such as the design of medicines, should also be identified and highlighted to manufacturers and regulatory authorities as potential contributors to error and harm. |
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AbstractList | Patient harm from inadvertent administration of amphotericin B (Fungizone™) instead of liposomal amphotericin (AmBisome®) has been described in the literature and has been the subject of patient safety alerts in the UK. Safe use of intravenous amphotericin depends on the knowledge and awareness of practitioners of the availability and differences between the different presentations of intravenous amphotericin. Knowledge is a weak barrier to error. Recommendations to reduce the risk of error following adverse drug events in the UK, USA and The Netherlands have largely focused on actions to be taken at an organisational level, such as drug supply, storage, dose checking and specifying brand and generic names on prescriptions. None have considered or addressed the contributory factors relating to the products themselves, namely the similarity between the presentations of AmBisome and Fungizone, both of which are manufactured as 50 mg vials despite their different dose recommendations. The need to use multiple vials of Ambisome to prepare infusions for adult patients is contrary to the usual practice of using only one or two vials to prepare doses of injectable medicines for adult patients, increasing the risk of error not only with injectable amphotericin formulations but potentially also with the preparation of other injectable medicines. Whilst the development of robust local risk reduction strategies are important, external factors, such as the design of medicines, should also be identified and highlighted to manufacturers and regulatory authorities as potential contributors to error and harm. Patient harm from inadvertent administration of amphotericin B (Fungizone™) instead of liposomal amphotericin (AmBisome ® ) has been described in the literature and has been the subject of patient safety alerts in the UK. Safe use of intravenous amphotericin depends on the knowledge and awareness of practitioners of the availability and differences between the different presentations of intravenous amphotericin. Knowledge is a weak barrier to error. Recommendations to reduce the risk of error following adverse drug events in the UK, USA and The Netherlands have largely focused on actions to be taken at an organisational level, such as drug supply, storage, dose checking and specifying brand and generic names on prescriptions. None have considered or addressed the contributory factors relating to the products themselves, namely the similarity between the presentations of AmBisome and Fungizone, both of which are manufactured as 50 mg vials despite their different dose recommendations. The need to use multiple vials of Ambisome to prepare infusions for adult patients is contrary to the usual practice of using only one or two vials to prepare doses of injectable medicines for adult patients, increasing the risk of error not only with injectable amphotericin formulations but potentially also with the preparation of other injectable medicines. Whilst the development of robust local risk reduction strategies are important, external factors, such as the design of medicines, should also be identified and highlighted to manufacturers and regulatory authorities as potential contributors to error and harm. Patient harm from inadvertent administration of amphotericin B (Fungizone™) instead of liposomal amphotericin (AmBisome®) has been described in the literature and has been the subject of patient safety alerts in the UK. Safe use of intravenous amphotericin depends on the knowledge and awareness of practitioners of the availability and differences between the different presentations of intravenous amphotericin. Knowledge is a weak barrier to error. Recommendations to reduce the risk of error following adverse drug events in the UK, USA and The Netherlands have largely focused on actions to be taken at an organisational level, such as drug supply, storage, dose checking and specifying brand and generic names on prescriptions. None have considered or addressed the contributory factors relating to the products themselves, namely the similarity between the presentations of AmBisome and Fungizone, both of which are manufactured as 50 mg vials despite their different dose recommendations. The need to use multiple vials of Ambisome to prepare infusions for adult patients is contrary to the usual practice of using only one or two vials to prepare doses of injectable medicines for adult patients, increasing the risk of error not only with injectable amphotericin formulations but potentially also with the preparation of other injectable medicines. Whilst the development of robust local risk reduction strategies are important, external factors, such as the design of medicines, should also be identified and highlighted to manufacturers and regulatory authorities as potential contributors to error and harm.Patient harm from inadvertent administration of amphotericin B (Fungizone™) instead of liposomal amphotericin (AmBisome®) has been described in the literature and has been the subject of patient safety alerts in the UK. Safe use of intravenous amphotericin depends on the knowledge and awareness of practitioners of the availability and differences between the different presentations of intravenous amphotericin. Knowledge is a weak barrier to error. Recommendations to reduce the risk of error following adverse drug events in the UK, USA and The Netherlands have largely focused on actions to be taken at an organisational level, such as drug supply, storage, dose checking and specifying brand and generic names on prescriptions. None have considered or addressed the contributory factors relating to the products themselves, namely the similarity between the presentations of AmBisome and Fungizone, both of which are manufactured as 50 mg vials despite their different dose recommendations. The need to use multiple vials of Ambisome to prepare infusions for adult patients is contrary to the usual practice of using only one or two vials to prepare doses of injectable medicines for adult patients, increasing the risk of error not only with injectable amphotericin formulations but potentially also with the preparation of other injectable medicines. Whilst the development of robust local risk reduction strategies are important, external factors, such as the design of medicines, should also be identified and highlighted to manufacturers and regulatory authorities as potential contributors to error and harm. |
Author | Cavell, Gillian |
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References | DyerCHospital pays out six figure sum to widow for error over antifungal drugBMJ2010341c646710.1136/bmj.c646721075816 Drug Safety Update. Volume 11, Issue 12. 2018. https://www.gov.uk/drug-safety-update/parenteral-amphotericin-b-reminder-of-risk-of-potentially-fatal-adverse-reaction-if-formulations-confused. GroeneveldSVerweijPVan’t HekLBokkerinkJWarrisAAmphotericin B deoxycholate overdose due to administration error in paediatric patientsMed Mycol2008461851871:CAS:528:DC%2BD1cXivVeitrw%3D10.1080/1369378070165828018324499 Gilead Sciences Ltd. Summary of product characteristics. AmBisome liposomal 50mg powder for dispersion for infusion. 2019. https://www.medicines.org.uk/emc/product/1022/smpc. Accessed 14 Jan 2020. BurkeDLalRFinkelKSamuelsJForingerJAcute amphotericin B overdoseAnn Pharmacother200640225422591:CAS:528:DC%2BD2sXmtlyjsw%3D%3D10.1345/aph.1H15717090724 UKMi. In use product safety assessment report for methylprednisolone and medroxyprogesterone. 2014. https://www.sps.nhs.uk/wp-content/uploads/2016/03/methylprednisolone_medroxyprogesteroneJun2014.pdf. Accessed 14 Jan 2020. KoczmaraCRichardsonHHylandSLeeCSYHillebrandNALERT: Mix-ups between conventional and lipid formulations of amphotericin can be extremely dangerousDynamics2011221242621469498 FleuryMFonzo-ChristeCNormandCBonnabryPConfusion between two amphotericin B formulations leading to a paediatric rehospitalisationDrug Saf Case Rep20163410.1007/s40800-016-0028-6277476845005581 National Injectable Medicines Guide-Medusa. https://medusa.wales.nhs.uk/IVGuideDisplay.asp. Accessed 14 Jan 2020. Institute for Safe Medication Practices (ISMP) Medication error prevention “Toolbox”. 1999. https://www.ismp.org/resources/medication-error-prevention-toolbox. MohrJHallAEricssonCOstrosky-ZeichnerLFatal amphotericin B overdose due to administration of nonlipid formulation instead of lipid formulationPharmacotherapy200525342642810.1592/phco.25.3.426.61603 WangGBanerjiSRoussilTHeardKSurvival after amphotericin B overdose treated with plasmapheresisAnn Pharmacother201347e910.1345/aph.1R52723362040 Pharmacy Department. King’s College Hospital. Sure-MED Alert; 1994 (unpublished). LesarTPrescribing errors involving medication dosage formsJ Gen Intern Med20021757958710.1046/j.1525-1497.2002.11056.x Institute of Safe Medication Practices Canada. Ontario critical incident learning. Errors continue with Amphotericin B. 2015. Issue 14. https://www.ismp-canada.org/download/ocil/ISMPCONCIL2015-14_AmphotericinB.pdf. National Patient Safety Agency. Rapid Response Report. Risk of confusion between lipid and non-lipid formulations of injectable amphotericin. 2007. https://www.sps.nhs.uk/articles/npsa-alert-non-lipid-and-lipid-formulations-of-injectable-amphotericin-2007/. British National Formulary 76. Amphotericin. https://bnf.nice.org.uk.. Accessed 28th Oct 2019. 924_CR1 924_CR2 J Mohr (924_CR5) 2005; 25 S Groeneveld (924_CR7) 2008; 46 924_CR11 924_CR13 924_CR14 924_CR15 924_CR17 M Fleury (924_CR10) 2016; 3 C Dyer (924_CR9) 2010; 341 D Burke (924_CR6) 2006; 40 G Wang (924_CR8) 2013; 47 T Lesar (924_CR12) 2002; 17 C Koczmara (924_CR16) 2011; 22 924_CR3 924_CR4 |
References_xml | – reference: Institute for Safe Medication Practices (ISMP) Medication error prevention “Toolbox”. 1999. https://www.ismp.org/resources/medication-error-prevention-toolbox. – reference: MohrJHallAEricssonCOstrosky-ZeichnerLFatal amphotericin B overdose due to administration of nonlipid formulation instead of lipid formulationPharmacotherapy200525342642810.1592/phco.25.3.426.61603 – reference: LesarTPrescribing errors involving medication dosage formsJ Gen Intern Med20021757958710.1046/j.1525-1497.2002.11056.x – reference: National Injectable Medicines Guide-Medusa. https://medusa.wales.nhs.uk/IVGuideDisplay.asp. Accessed 14 Jan 2020. – reference: Gilead Sciences Ltd. Summary of product characteristics. AmBisome liposomal 50mg powder for dispersion for infusion. 2019. https://www.medicines.org.uk/emc/product/1022/smpc. Accessed 14 Jan 2020. – reference: FleuryMFonzo-ChristeCNormandCBonnabryPConfusion between two amphotericin B formulations leading to a paediatric rehospitalisationDrug Saf Case Rep20163410.1007/s40800-016-0028-6277476845005581 – reference: Drug Safety Update. Volume 11, Issue 12. 2018. https://www.gov.uk/drug-safety-update/parenteral-amphotericin-b-reminder-of-risk-of-potentially-fatal-adverse-reaction-if-formulations-confused. – reference: Pharmacy Department. King’s College Hospital. Sure-MED Alert; 1994 (unpublished). – reference: KoczmaraCRichardsonHHylandSLeeCSYHillebrandNALERT: Mix-ups between conventional and lipid formulations of amphotericin can be extremely dangerousDynamics2011221242621469498 – reference: DyerCHospital pays out six figure sum to widow for error over antifungal drugBMJ2010341c646710.1136/bmj.c646721075816 – reference: GroeneveldSVerweijPVan’t HekLBokkerinkJWarrisAAmphotericin B deoxycholate overdose due to administration error in paediatric patientsMed Mycol2008461851871:CAS:528:DC%2BD1cXivVeitrw%3D10.1080/1369378070165828018324499 – reference: Institute of Safe Medication Practices Canada. Ontario critical incident learning. Errors continue with Amphotericin B. 2015. Issue 14. https://www.ismp-canada.org/download/ocil/ISMPCONCIL2015-14_AmphotericinB.pdf. – reference: UKMi. In use product safety assessment report for methylprednisolone and medroxyprogesterone. 2014. https://www.sps.nhs.uk/wp-content/uploads/2016/03/methylprednisolone_medroxyprogesteroneJun2014.pdf. Accessed 14 Jan 2020. – reference: WangGBanerjiSRoussilTHeardKSurvival after amphotericin B overdose treated with plasmapheresisAnn Pharmacother201347e910.1345/aph.1R52723362040 – reference: BurkeDLalRFinkelKSamuelsJForingerJAcute amphotericin B overdoseAnn Pharmacother200640225422591:CAS:528:DC%2BD2sXmtlyjsw%3D%3D10.1345/aph.1H15717090724 – reference: British National Formulary 76. Amphotericin. https://bnf.nice.org.uk.. Accessed 28th Oct 2019. – reference: National Patient Safety Agency. Rapid Response Report. Risk of confusion between lipid and non-lipid formulations of injectable amphotericin. 2007. https://www.sps.nhs.uk/articles/npsa-alert-non-lipid-and-lipid-formulations-of-injectable-amphotericin-2007/. – volume: 17 start-page: 579 year: 2002 ident: 924_CR12 publication-title: J Gen Intern Med doi: 10.1046/j.1525-1497.2002.11056.x – volume: 22 start-page: 24 issue: 1 year: 2011 ident: 924_CR16 publication-title: Dynamics – ident: 924_CR13 – ident: 924_CR11 – ident: 924_CR15 – volume: 341 start-page: c6467 year: 2010 ident: 924_CR9 publication-title: BMJ doi: 10.1136/bmj.c6467 – ident: 924_CR14 – volume: 47 start-page: e9 year: 2013 ident: 924_CR8 publication-title: Ann Pharmacother doi: 10.1345/aph.1R527 – ident: 924_CR17 – volume: 3 start-page: 4 year: 2016 ident: 924_CR10 publication-title: Drug Saf Case Rep doi: 10.1007/s40800-016-0028-6 – ident: 924_CR1 – ident: 924_CR4 – ident: 924_CR2 – ident: 924_CR3 – volume: 25 start-page: 426 issue: 3 year: 2005 ident: 924_CR5 publication-title: Pharmacotherapy doi: 10.1592/phco.25.3.426.61603 – volume: 40 start-page: 2254 year: 2006 ident: 924_CR6 publication-title: Ann Pharmacother doi: 10.1345/aph.1H157 – volume: 46 start-page: 185 year: 2008 ident: 924_CR7 publication-title: Med Mycol doi: 10.1080/13693780701658280 |
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Snippet | Patient harm from inadvertent administration of amphotericin B (Fungizone™) instead of liposomal amphotericin (AmBisome
®
) has been described in the... Patient harm from inadvertent administration of amphotericin B (Fungizone™) instead of liposomal amphotericin (AmBisome®) has been described in the literature... |
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SubjectTerms | Anaphylaxis Antifungal agents Cardiac arrhythmia Computerized physician order entry Current Opinion Drug dosages Health risk assessment Internal Medicine Medical errors Medicine Medicine & Public Health Morphine Patient safety Pharmacology/Toxicology Pharmacotherapy Systems design |
Title | The Problem with Amphotericin |
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