Table 5

International sources for individualisation of medication

Source	Summary of Product Characteristics (SPC).17	Databases. Micromedex Drug interactions18	Safety information from US FDA Medwatch19
1. Can we trust it?	Yes, approved by EMA/MPA	Yes	Yes, reputable government agency.
a. Is up to date?	Continuously updated but new data must be approved before added, can take time	Continuously updated	November 2012 updated. Frequently updated when new information becomes available.
b. Is the content based on best available evidences?	Clinical and or laboratory studies assessed by EMA/MPA	Based on 9 relevant studies included in the literature review.	Partly. Studies assessed by FDA.
c. Is the process for the preparation fully described and transparent?	Detailed policy for procedures for application and approval. SPC part of this. Scientific discussion published as a background for SPC.	Partly. The summaries of literature were included. Also included rating of the documentation for this interaction	Minimal. Included ‘data summary’ which stated the background information and the results from one study.
c. Are important experts, users and customers involved?	European expert group with national rapporteurs and experts from each EU county including user representatives.	In-house clinician editors. NICE (National Institute of Health and Care Excellence, UK) accredited.20 Details not stated.	FDA advisory committee on drugs includes specialists in each areas, and users. Not stated consumer involvement for ‘Medwatch’ programme.
d. Is COI declared and taken account of?	Detailed described policy on the handling of COI for its scientific experts, including committee members. It is proactive and based on risk levels for involvement in different activities.	Contents are ‘objectively validated, referenced and sourced.’20 Detailed code of conduct for Micromedex staff on handling conflict of interest.21	US government agency. Has transparency reports on websites.22
2. Can we use it?	Yes	Yes	Yes
a. Is it easy to read, understand and apply?	Yes. Section 4.5 Interaction: Proton Pump Inhibitors (PPI)	Yes. Interaction checker. Gives warning and clinical management.	Yes
b. Does it give us information to improve patient care?	Omeprazole 80 mg once daily given simultaneously or separated 12 h decreased the exposure of the active metabolite by 40–45% and a 21–39% reduction of inhibition of platelet aggregation. As a precaution, concomitant use of omeprazole or esomeprazole should be discouraged. Less pronounced reductions of metabolite exposure with pantoprazole or lansoprazole. 14–20% reduced with pantoprazole 80 mg and reduction of inhibition of platelet aggregation by 11–15% indicating that clopidogrel can be administered with pantoprazole.	Severity: Major. Concurrent use of cloprodigrel and omeprazole may result in reduction in clinical efficacy of clopidogrel and increased risk for thrombosis. Clinical Management: Concomitant use of clopidogrel and omeprazole should be avoided due to the potential of reduction in clopidogrel active metabolite concentrations and subsequent reduced platelet inhibition. For patients who require acid-lowering therapy during clopidogrel treatment, an alternative acid-reducing drug with less CYP2C19 inhibitory effect, such as pantoprazole More very detailed information from studies is available with references.	Avoid concomitant use of esomeprazole/omeprazole with clopidogrel. Concomitant use of clopidogrel with 40 mg esomeprazole/omeprazole reduces the pharmacological activity of clopidogrel. When using esomeprazole/omeprazole, consider alternative antiplatelet therapy.
What should we recommend based on the case?	To discuss the given information with the patient or contact the physician dependent on the situation or the patient	To inform the patient that there is need to confirm with prescriber. Contact physician to recommend avoiding the combination.	To inform the patient that there is need to confirm with prescriber. Contact physician to recommend considering alternative antiplatelet therapy.