Three-month tapering and discontinuation of long- term, low-dose glucocorticoids in senior patients with rheumatoid arthritis is feasible and safe: placebo-controlled double blind tapering after the GLORIA trial.

OBJECTIVE: The randomised placebo-controlled GLORIA (Glucocorticoid LOw-dose in RheumatoId Arthritis) trial evaluated the benefits and harms of prednisolone 5 mg/day added to standard care for 2 years in patients aged 65+ years with rheumatoid arthritis (RA). Here, we studied disease activity, flares and possible adrenal insufficiency after blinded withdrawal of study medication. METHODS: Per protocol, patients successfully completing the 2-year trial period linearly tapered and stopped blinded study medication in 3 months. We compared changes in disease activity after taper between treatment groups (one-sided testing). Secondary outcomes (two-sided tests) comprised disease flares (DAS28 (Disease Activity Score 28 joints) increase >0.6, open-label glucocorticoids or disease-modifying antirheumatic drug (DMARD) increase/switch after week 4 of tapering) and symptoms/signs of adrenal insufficiency. In a subset of patients from 3 Dutch centres, cortisol and ACTH were measured in spot serum samples after tapering. RESULTS: 191 patients were eligible; 36 met treatment-related flare criteria and were only included in the flare analysis. Mean (SD) DAS28 change at follow-up: 0.2 (1.0) in the prednisolone group (n=76) vs 0.0 (1.2) in placebo (n=79). Adjusted for baseline, the between-group difference in DAS28 increase was 0.16 (95% confidence limit -0.06, p=0.12). Flares occurred in 45% of prednisolone patients compared with 33% in placebo, relative risk (RR) 1.37 (95% CI 0.95 to 1.98; p=0.12). We found no evidence for adrenal insufficiency. CONCLUSIONS: Tapering prednisolone moderately increases disease activity to the levels of the placebo group (mean still at low disease activity levels) and numerically increases the risk of flare without evidence for adrenal insufficiency. This suggests that withdrawal of low-dose prednisolone is feasible and safe after 2 years of administration.

Transforming pharmacy practice in Kuwait.

In the last few decades, pharmacy services have expanded to fulfil the need for more complex health needs from population worldwide. Moving from 'product-centred' to a 'patient-centred' profession, pharmacists are required to master more professional competencies to deliver high quality pharmaceutical services to their patients and community. In Kuwait pharmacy practice has long been identified as a sector yet to be developed. With the announcement of the 'new Kuwait vision 2035' planning for pharmacy practice and workforce development and improvement has become imperative. Academic, professional, and regulatory bodies have collaborated to shape the future of pharmacy profession in the country. The approach described here reflects the initial steps for transforming and advancing the pharmacy profession in Kuwait.

Stakeholder driven development of a multi-criteria decision analysis tool for purchasing off-patent pharmaceuticals in Kuwait.

BACKGROUND: In Kuwait, the government is planning to improve the specifications for purchase of medicine and to improve the tendering system intending to slow the growth of the expenditure for medicine and to improve the sustainability of the healthcare system. Multiple Criteria Decision Analysis (MCDA) is a method which can help to assess multiple and sometimes conflicting criteria in the evaluation of the available alternatives. The objective of this initiative was to develop collaboratively a MCDA tool which is locally relevant, and which could be used to improve the use of performance indicators in the purchasing of off-patent pharmaceuticals. METHODS: Nineteen leading experts representing a broad range of pharmaceutical policy stakeholders elaborated a locally adapted MCDA format by following a 7-step process for criteria selection, scoring, ranking and weighting. RESULTS: The most important criterion was the price measured as savings versus the originator product with a weight of 35% in the final decision and a full score with a 60% price reduction. In addition, eight criteria were considered important for assessing the product performance in the Kuwaiti healthcare system: 'equivalence with the reference product' (weight of 16.2%), 'stability and drug formulation' (13.5%), 'quality assurance' (11.2%), 'reliability of drug supply' (8.8%), 'macroeconomic benefit' (5.5%), 'real world outcomes (clinical and economic)' (4.2%), 'pharmacovigilance' (3.3%), and 'added value services related to the product' (2.3%). CONCLUSIONS: A MCDA model was successfully adapted to the Kuwait decision context by a group of Kuwaiti pharmacists from a broad range of institutions. The participants agreed with the approach and considered it suitable to improve the transparency and consistency of decision making for off-patent pharmaceuticals in Kuwait. A pilot implementation project was proposed.