1. Prevalence of potentially inappropriate prescribing in a sub-population of older European clinical trial participants
O’ Riordan, D 1; Walsh , K1; Sinnott, C 2; Byrne, S 1; Galvin, R 3; Kearney, PM 4.
1 Clinical Research Practice Group, School of Pharmacy, 2 Department of General Practice, 4Department of Epidemiology & Public Health, University College Cork, Ireland.
3 Department of Clinical Therapies, Health Research Institute, University of Limerick, Ireland.
BACKGROUND
TRUST (Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial) is a five year EU funded randomised placebo controlled clinical trial across four European countries (Ireland, Scotland, Switzerland, Netherlands) comparing thyroxine to placebo among people ≥65 years with a mildly underactive thyroid gland. Community dwelling older adults (≥65 years) with subclinical hypothyroidism (SCH) were included 1.
To date, no studies have estimated the prevalence of potentially inappropriate prescribing (PIP) and potentially prescribing omissions (PPOs) in those enrolled to randomised controlled trials using the STOPP/START version 2 (V2) criteria.
The aim of this study is to estimate the prevalence of PIP/PPOs using a subset of the STOPP/START V2 criteria based on community dwelling older people randomised to the TRUST trial across three European sites.
METHODS
Study population
Medication information was only available for three sites: Ireland, Switzerland, the Netherlands.
STOPP/START criteria
51 PIP indicators and 22 PPO indicators from version 2 were applied as information relating to drug strength, dose and duration was not available.
Statistical analysis
The association among any PIP/PPO (versus none) and gender, age, comorbidity, polypharmacy and country was assessed using logistic regression.
RESULTS
Population demographics
A total of 532 people over 65 years were included in the study.
The most common examples of PIP in each country
Ireland: Prescribing of hypnotic Z-drugs (zopiclone, zolpidem), 3.5%, n=4.
Switzerland and the Netherlands: Prescribing of benzodiazepines, 4.3%, n=7,
7.1%, n=18 respectively.
The most common examples of PPOs in each country
Ireland: Vitamin D and calcium supplements in patients with osteoporosis
3.5%, n=4.
Switzerland and the Netherlands: Bone anti-resorptive therapy or anabolic therapy (bisphosphonate, strontium ranelate, teriparatide) in patients with osteoporosis, 9.9%, n=16, 8.6%, n=22 respectively.
Factors associated with PIP and PPOs
The association between PIP and polypharmacy remained significant after adjusting for country, gender, age and comorbidities (aOR 3.61, p<0.01, 95% CI ).
The association between PPOs and polypharmacy remained significant after adjusting for country, gender, age and comorbidities (aOR 0.34, p<0.01, 95% CI ).
Figure 1: Overall prevalence of PIP and PPOs in each country
CONCLUSIONS
These study findings highlight that PIP and PPOs are prevalent among community dwelling older people at three European sites using a subset of the STOPP/START V2 criteria.
Further research should consider the potential role for medication reviews to be carried out for patients recruited to clinical trials to optimise prescribing appropriateness.
Acknowledgements
This research was funded by the Health Research Board SPHeRE/2013/1.
We would like to acknowledge the participants of the FP7 – Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism TRUST trial and to acknowledge financial support from this trial also (EU Project grant agreement number ).
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