Central Medication incidents RegistrationCMR

Dutch Portal for Patient Safety/CMR

Arianne van RhijnJacqueline Santen- Reestman

History

• 2005 Start pilot initiated bij hospital pharmacists

• 2006 CMR is available for all Dutch hospitals (n=93)

• 2009 Expansion to community pharmacies and mental health care institutions

• 2011 Pilot with general practitioners• 2012 Pilot for primary care

Facts - reports

* Extrapolated data** The error reached the patient, approx. 30% are near-incidentsCP = Community pharmacies

No of reports

Patientinvolved?**

Reports withharm

Reports withserious harm

Hospitals – 2012 9512 6368 (67%) 2101 (22%) 366 (3,8%)

Hospitals – 2013* 12434 6131 (66%) 1846 (20%) 323 (3,5%)

CP – 2012 3274 2003 (61%) 420 (13%) 65 (2,0%)

CP – 2013* 2340 1077 (61%) 203 (12%) 39 (2,2%)

Situation in the Netherlands

• Dutch Pharmacovigilance Centre –collects and analyses reports of adverse reactions of medicines– Product-related

• CMR focusses on errors in the medication-process– Process-related

Medication report vs adverse drug event Drug Safety 2006; 29:1011-22

Latest developments

• Focus on better and more reports• Focus on better analysis (using RCA)• Registration system for all incidents in

health care (medical care)?:VIM-DIGITAAL

• Start with primary care: GP’s, dentists, midwives, home care services

• Patient reports?

CMR Alerts

• Since 2006 19 alerts• Dosing errors with MTX,

chemotherapeutics• Confusion between different formulations

of one active substance (Ambisome/ Fungizone)

• Confusion between different strengths• Different software-related issues

Cabazitaxel incident

August 2013 hospital report:8 patients (total of 30 doses) were given over several months a 15.6% higher dose of cabazitaxel than prescribed. Two patients died while taking this drug.Main cause:Incomplete information in the SmPC about the overfill of the diluent on the moment the drug was introduced in the hospital (mid-2012)

Revised SmPC:

6.5 Nature and contents of containerOne pack contains one vial of concentrate and one vial of solvent:• Concentrate: 1.5 ml of concentrate in a 15 ml clear glass vial (type I) closed

with a grey chlorobutyl rubber closure sealed by an aluminium cap covered with a light green plastic flip-off cap. Each vial contains 60 mg cabazitaxel per 1.5 ml nominal volume (fill volume: 73.2 mg of cabazitaxel/1.83 ml). This fill volume has been established during the development of JEVTANA to compensate for liquid loss during preparation of the premix. This overfill ensures that after dilution with the entire content of the accompanying solvent for JEVTANA, there is a minimal extractable premix volume of 6 ml containing 10 mg/ml JEVTANA which corresponds to the labelled amount of 60 mg per vial.

• Solvent: 4.5 ml of solvent in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap covered with a colourless plastic flip-off cap. Each vial contains 4.5 ml nominal volume (fill volume: 5.67 ml). This fill volume has been established during the development and the overfill ensures, after the addition of the entire content of the solvent vial to the content of JEVTANA 60 mg concentrate vial, a concentration of the premix solution of 10 mg/ml JEVTANA.

Cabazitaxel incidents

First action: warning for hospital pharmacists to check the preparation specification for cabazitaxel.

Outcome: another 12 hospitals reported that they made the same mistakes in the preparation!

What went wrong?- In first SmPC no information about overfill- In 2012 EMA requested an update of the SmPC

following incidents in Finland- End of 2012 the update was approved, february

2013 the updated SmPC was available in NL- Health care professionals were not informed

ISMP-Spain mentioned the same incident on a workshop in London in febr 2013.

What do we learn?

• Healthcare professionals should be informed about important additions or changes in the SmPC

• Important alerts should be shared internationally

• Role Eudravigilance database / EMA is not yet clear

Role IMSN

IMSN-members can share:

• Alerts• List of Drug-name confusions

“De CMR houdt u Alert”

Email: cmr@medicatieveiligheid.info

www.medicatieveiligheid.info