Purpose: To explore the national survey of hospital medication safety practice during mass gathering (Hajj -2016) in Saudi Arabia, finding from ISMP (2011) self-assessment of medication safety at the hospital with emphasis on Patient education, quality process, and Risk Management. Methods: It is 15 days cross-sectional national survey of hospital medication safety at Makkah region. The survey modified from Institution of Safe Medication Practice (ISMP) self-assessment of hospital medication safety. It consisted of a demographic section and ten domains with 270 questions. The ten areas included patient information, drug information, communication of medication orders, drug preparation, medication distribution, medication devices, work environment, staff competency, patient education, quality process with risk management domain. The 5-points Likert response scale system used. The survey distributed to sixteen directors of hospital pharmacy during mass gathering Hajj-2016. The medications safety officer at Makkah region distributed the questionnaire and made follow up on a daily basis used physical visiting and through the telephone call. Results: The survey distributed to sixteen hospitals, the response rate, was eleven hospitals (68.75%). The total score of all ISMP-self assessment of medication safety was 3.39 +/- 0.51 (67.68 %) with CI (3.2-3.6) P< 0.05. The average rating of Patient Education domain at all hospital were 3.75 (63.6 %) while the mean score Quality Processes and risk management domain at all hospital were 3.18 (67.8%). The highest score of both domains was a Drug selection, preparation, and labeling errors identified during routine checking processes reported and collected 4.1 (82%). The lowest score of both domains was the Machine-readable coding used to verify all based solutions and additives 2 (40%). Conclusion: The patient education and quality process and risk management related to medication safety were acceptable at the hospital during mass gathering Hajj period. May be the correction of computerized physician order entry and using of new technology will minimize the patient risk and improve hospital pharmacy management of medication safety during a mass gathering in Makkah, Saudi Arabia.
Key words: Medication Safety, Hajj, Patient education, Quality Process, Risk Management, Ministry of Health, Saudi Arabia.