1. Improving Patient Safety: reducing medication errors through acceptable, accessible medication packaging
Rod Hughes: Consultant Rheumatologist, Ashford and St Peter’s NHS Trust
Alison Carr: Special Lecturer in Musculoskeletal Epidemiology, University of Nottingham

2. Background
Inaccessibility of packaging implicated in some medication errors associated with methotrexate
Cambridge study commissioned by NPSA identified that patients with impaired hand function may experience real problems accessing medication in dispensed packages
This study was undertaken to identify a packaging design that is acceptable to patients with inflammatory arthritis and to establish a preference for different packaging designs
Inaccessibility linked to patient safety because of instances where patients had decanted their methotrexate into bottles with other labels (for other drugs) and when admitted to hospital, the ward staff had dispensed as per directions on the bottle which resulted in wrong dose of MTX

3. Study Objectives
To test different medication packaging designs with patients with inflammatory arthritis (RA, PsA and JIA) for:
Time to open, retrieve and close (British Standard EN ISO 8317:2004)
Ease of: opening, retrieval medication, closing
Patient preference for different designs
Probability of decanting medication for different designs
To establish whether there was a single design acceptable and preferred by all patients or whether preference differed by pain, hand function, hand deformity.
We tested each packaging design to the British Standard for adult testing of medication packaging (bearing in mind that the British Standards for testing packaging specifically EXCLUDE people with any sort of hand impairment – which would cover a significant proportion of the population who are prescribed medication. We also specifically asked for each design whether patients would leave medication in that packaging or whether they would have to decant it into some other container.

4. Methods Subjects: Adult patients with:
RA, PsA, JIA
Range of hand function (good-poor)
Range of hand pain
With and without hand deformity
Recruited through the Rheumatology Department at SPH

5. Study Procedures Single visit Clinical assessment: Demographics:
Hand function
Pain
Grip strength
Deformities
Current medication (packaging and help required to open it)
Duration arthritis
Relevant co-morbidity (neurological, cognitive)
Demographics:
Age, gender

6. Packaging Evaluation
7 packaging designs including blister pack and child resistant bottle
Designs evaluated in random order
Evaluation: Timed evaluation of:
Open, retrieve medication and reclose package
Repeat exercise as quickly as possible
For each packaging design rate ease of opening, retrieval and closure on 10 point graphic rating scale
Whether medication would be decanted from the packaging
50% video recorded opening packages

9. Study Flow Clinical assessment Pain assessment Packaging evaluation:
7 packages
Pain assessment
Consent
1 Hour

10. Results: The sample 103 patients: 76% female
87% RA
10% PsA
3% JIA
76% female
Mean age 62 years (SD 10.97, min-max 41-92)
Mean disease duration 17 years (SD 10.60, min-max 1-53)
Current DMARD methotrexate: 50%

11. Results: Current packaging
Current medication dispensed in:
Child resistant bottles 70%
Blister packs 29%
45% of patients had needed to decant medication into alternative containers because they had been unable to open them!
Only 48% are able to open medication packaging without any help (once factory seals have been broken by someone else)

12. Results: Packaging evaluation – worst designs
Child resistant bottle and blister pack performed significantly worse than any of the other designs:
Longer time to open and retrieve medication (some patients completely unable to open)
Worst ratings from patients (80% rated child resistant package as the worst design)
15% would decant medication from this design because unable to open
32% would decant because they would prefer an easier design
23% of patients would decant from blister packs
Things people did to get around the problem of child resistant packaging besides decanting:
Got someone else to open bottle initially and then never fully reclosed it – making it no longer child resistant!

13. Results: Packaging evaluation – best designs
All other designs performed well in terms of BS (times to open, retrieve and close)
Clear patient preference for one particular design:
41% preferred packaging design B because bottle size easy to hold
Design preferred by all subgroups:
Diagnosis
Gender
Age
Hand function
Pain
Hand deformity – preferred by people with hand deformity. Those without rated designs B and A highly

14. Results: Time taken to open packaging
Packaging design
Mean time to open packaging (seconds) A 8 B 9 C D 13 E F 29 G 35

15. Results: preference for designs
Highest rank B A C D E F G
Lowest rank

16. Summary
Child resistant (and to lesser extent blister packs) can be difficult for people with inflammatory arthritis to open
Presents a potential hazard:
47% of patients would decant medication from child resistant bottles into other containers
Alternative forms of packaging that conform to British Standards for medication packaging were acceptable to and preferred by patients

17. Implications/ Next steps
Present results at BSR annual meeting 2009
Manuscript accepted and published in Pharmaceutical Journal
Results fed back to manufacturers
Presentation of results to MHRA
Results shared with Scandinavian Packaging project (government initiative)

18. Acknowledgements
This study was funded by an unrestricted educational grant from Pfizer Inc. Pfizer had no access or input to the running of the study, the raw data, data analysis or interpretation of the results