ManageMent of Medication errors associated with the use of

Poster number: B133
Management of Medication Errors
associated with the use of
delivery devices for orally ingested
liquid drugs – The French Drug Agency
M. Dahani, D. Durand, F. Cardona, P. Maison, E. Falip
French National Agency for Medicines and Health Products Safety (ANSM)
AIM
To quantify and analyse medication errors due to the use of Delivery Devices (DD)
of orally ingested liquid drug products (not including homeopathic drugs) and
establish recommendations to reduce this risk.
INTRODUCTION
Within the framework of the objectives set by the Public Health Law to reduce
drug-related adverse events (adopted in 2004), the National Agency of Medicine
and Health Product Safety (ANSM) has set up in 2005 a dedicated unit to collect and
manage, in a single location, reports of medication errors (ME) or potential errors
related to the packaging, labelling or names of medicinal products, and perform the
follow up of those likely to present a risk to Public Health. The “Medication Errors
Guichet” enables healthcare professionals to report directly to the Agency, medication errors without adverse reaction or near misses in addition of reports collected from the Pharmacovigilance System. In 2011 and 2012, respectively 1,734
and 1,589 medication errors have been collected.
Figure 1: number of reports of ME collected by the dedicated unit of the French
Agency since 2005
Figure 4: ME attributable to the delivery Figure 5: ME attributable to the Human
device : causes
errors : causes
n=38
3%
4%
Difficulty of use or readabilty
of the DD
21%
16%
Difference between
prescription and DD units
26%
18%
n=92
Use of the wrong
Delivery Device
7%
Inappropriate mesure for low
dosages by the DD
5%
3%
Utilization habits
x pipettes administered instead
of the x mg ou mL prescribed
10%
73%
Lack of specialty or drug
name on the DD
1,734
1,800
1,600
1,400
1,124
1,200
Misunderstanding the double
graduation of the DD
Different calibration
of the DD availables
2. Analysis of the liquid oral multidosis products available
on the French Market (syrups, oral solution etc.)
1,589
1,168
1,000
800
600
245
2005
2006
2007
2008
2009
2010
2011
Pipette - Dropper
2012
Among medication errors reported, some were dosing errors related to the use of
delivery devices of orally ingested liquid drug products.
Oral syringe
(with vial adapter, “sheath” with syringe holder)
The variety of DD is
wide. They have
the status of medical devices, meaning they need to
meet the essential
requirements
of
the
93/42/CEE
Directive and be
CE marked if necessary.
Cup
Figure 7: characteristics of the 410 products available as liquid oral multidosis form
METHODS
Narcotic drugs 1%
• Retrospective analysis of medication errors (risk, near misses and patent)
reported in the ANSM medication error database for the period of May 2005 to
February 2013.
• A nalysis of liquid oral multidosis products authorised and available on the
French Market.
• Current recommendations on this topic (Non Urgent Information – NUI to
European member states, bibliography).
• French Agency medication errors working group (various experts).
No
15%
Adult
15%
Yes
85%
Availability of a Delivery Device
NAI
7%
OTC
31%
Pediatric
27%
Adult and pediatric
52%
Population
Available on
prescription
68%
Prescription and delivery conditions
3. Current recommendations on this topic (Non Urgent
Information to European member states, bibliography)
RESULTS
1. Medication reports received at the ANSM between 2005
and February 2013
Twenty six reports of risk of ME and 109 reports of proven errors resulting in patient administration associated with the use of DD for orally ingested liquid drug
products have been identified.
Of the 109 errors, 46% were without an AE, 37% with AE (half serious), 17% with no
available information (NAI). A high percentage of patients (94%) belong to the paediatric population, 4% were adults, age was unknown in 2%.
Figure 2: distribution of the
Figure 3: distribution of the patients’s
places of occurrence for the
population concerned by the ME reports
109 proven ME and of the persons
who gave the medication
Pediatric population
1%
2%
3%
2%
5%
Children
10%
Infants
5%
94%
Newborns
85%
32%
55%
Adolescents
Elderly
Adult
Home setting Parents
and close persons
Hospitals
Hospital staff
NAI
NAI
Adult population
4%
In order to have information on current recommendations at an European and
International level on this topic :
• a Non-Urgent Information (NUI) was sent on February 2013 to European Member
States : no specific recommendation have been made,
• a n international literature review was conducted in November 2012 : 2 major
Guidances have been identified, the FDA’s Guidance for Industry “Dosage Delivery
Devices for Orally Ingested OTC Liquid Drug Products” and the European
Medicines Agency’s “Guideline on pharmaceutical development of medicines for
paediatric use”.
4. Risk minimisation measures
The ANSM decided to set up risk minimisation measures in
accordance with the experience of healthcare professionals of
medication errors working group :
• 17 Practical recommendations to MAH for safer DD (adopted
after a step of public consultation on our website);
• Communication to healthcare professionals highlighting the
risk of ME related to DD;
• P oster to raise awareness concerning this issue for patients
and caregivers: “Don’t mix up the cups”.
N
m e
p éla vou
le as ng s
s
ez
pip
et
te
s
!
0
287
102
Spoon
(graduated or not,
with a cylinder or not)
Dosing pump
448
400
200
No exaplanation
DD available with
the medication not used
Lack of DD in the
medication box
13%
Figure 6: variety of different Delivery Devices available
2,000
Number of reports
Two major causes of errors were identified, 38 were directly attributable to DD and
92 attributable to human errors of utilization.
Some of these reports led in the past to corrective measures on a case by case basis
at the request of ANSM, e.g. adding a DD when none was available, adding table of
equivalence or warnings in the SPC, labelling and leaflet etc.
Les seringues orales, les pipettes, les cuillères-mesure et les compte-gouttes sont des dispositifs
d’administration que vous pouvez trouver dans les
boîtes de certains médicaments.
Un dispositif d’administration, s’il est mal utilisé, peut
délivrer une dose trop importante ou insuffisante du
médicament ; il peut alors devenir inefficace voire
dangereux.
Un dispositif
d’administration =
un médicament
Le dispositif d’administration est conçu uniquement pour le
médicament qui vous a été délivré.
Des règles simples vous permettront d’éviter les erreurs :
Gardez toujours le dispositif d’administration dans la
boite du médicament associé pour ne pas le mélanger
avec un autre.
En cas de perte du dispositif ou de doute sur son
utilisation, demandez conseil à un professionnel de
santé.
Lisez toujours attentivement la notice du médicament.
Cette dernière contient des informations importantes
pour l’utilisation des dispositifs d’administration.
CONCLUSION
This analysis highlights that given the number of products involved and the number
of reports, implementing general measures to minimize this kind of medication
errors is necessary.
It would be essential to measure the effectiveness of the modifications an the
impact to reduce medication errors.