Improving medication safety and prescribing of higher-risk medications in individuals with chronic kidney disease: A validation study

Background: Chronic kidney disease (CKD) affects 1 in 10 Canadians. Medications cleared by the kidneys can be harmful if dosed improperly. Community pharmacists are well-positioned to optimize prescribing, but inconsistencies between medication resources can complicate dosing. This study developed and validated higher-risk medication toolkits, including decision support algorithms for community pharmacists managing people with CKD. Methods: Fifty-one toolkits and algorithms were developed by team experts using Lynn’s method (domain identification, item generation per domain, and instrument formation). Team experts followed by community pharmacists rated toolkit content and algorithm face validity using a 2-part questionnaire with Likert scales. Each toolkit was validated by 5 to 6 participants over 2 rounds. Content validity was computed using an item-level content validity index (I-CVI) and scale-level content validity index (S-CVI/Ave) per round. Face validity calculated percentages for level of agreement to 5 statements. Community pharmacist interviews were conducted after each round, data analyzed, and toolkit revisions were made between rounds. Results: Twenty-two team experts validated 51 toolkits in 2 rounds between August and September 2024. Toolkit I-CVI, S-CVI/Ave, and face validity per algorithm ranged from 0.5 to 1, 0.87 to 1, and 49% to 100%, respectively. Thirteen toolkits were excluded from the community pharmacist validation. In 2 additional rounds, 23 community pharmacists, with 13.7 ± 9.1 years of experience, validated 38 medication toolkits between October and December 2024. Toolkit I-CVI and S-CVI/Ave and face validity per algorithm ranged from 0.83 to 1 and from 0.87 to 1, which met the content validity threshold of 0.83 to 1 ( P < 0.05) for at least 5 to 6 participants per round. Participants’ overall agreement for the face validity statements ranged from 75% to 100%, which was above the prespecified threshold of 70% for face validity consensus. Conclusions: Thirty-eight toolkits achieved high content and face validity. Future research will integrate them into a digital tool and assess their effectiveness and safety in community pharmacy practice in people with CKD.