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

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

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.

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

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

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

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

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%

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)

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!

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

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

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

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

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)

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