Rod Hughes : Consultant Rheumatologist, Ashford and St Peter’s NHS Trust

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

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.

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: • 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: • 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

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

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