National Survey of Medication Safety Practice: Patient Education, Quality Process and Risk Management at Primary Healthcare Centers/Community Pharmacies in Riyadh, Saudi Arabia

Yousef Ahmed Alomi*, The Past General Manager of General Administration of Pharmaceutical Care, Head, National Clinical Pharmacy and Pharmacy Practice, Head, Pharmacy R & D Administration, Ministry of Health, Riyadh11392, SAUDI ARABIA. Zainab Abdulmunem Almuallem, Saudi Food and Drug Authority, Riyadh, SAUDI ARABIA. Manar Mohammed Alslim, Staff Pharmacist, Prince Sultan Military Medical City, Riyadh, SAUDI ARABIA. Khulud Abdulrahman Alamoudi, Narcotic in-charge, Alhammadi Hospital, Riyadh, SAUDI ARABIA. Adel Mehmas H. Alragas, Medical City-king Saud University, Riyadh, SAUDI ARABIA. Rana Mohammed Alslim, Staff Pharmacist, Ministry of Health, Riyadh, SAUDI ARABIA. Correspondence: Dr. Yousef Ahmed Alomi, Bsc. Pharm, MSc. Clin Pharm, BCPS, BCNSP, DiBA, The Past General Manager of General Administration of Pharmaceutical Care, Head, National Clinical Pharmacy and Pharmacy Practice, Head, Pharmacy R & D Administration, Ministry of Health, Riyadh11392, SAUDI ARABIA.


INTRODUCTION
GAPC started the implementation of pharmacy strategic plan in 2012. 1 The plan covers all healthcare institutions including hospitals and PHCs. Part of this initiative was to implement national quality management standards in the pharmacy practice. During the period 2012-2015, there was a collaboration between pharmacy and quality management administration at the MOH. The partnership was developed to implement the Saudi standards of quality management to cover all healthcare centers and hospital. The Saudi Center for Healthcare Accreditation released the first edition of the standard, which was updated in 2016. 2 The updated version had necessary elements of medication safety. If the healthcare institutions, particularly hospitals implement all elements of medications safety, then they can obtain the accreditation. Several studies have shown the impact of missing quality management implementation. [3][4][5][6] Medication safety practice at CPs have not been included in the updated CBAHI standards. In 2016, the first author of this article published a new initiative project of Saudi-Managed Care Pharmacy System. 7 He suggested implementing new measures for CPs including medication safety-related issues. The community pharmacies had been missed several the practice standard. The initiation of medication safety practice as the assessment tool of prevention of errors in the PHCs and CPs. Few studies have published the finding of self-assessment tools for hospitals. 8,9 According to these articles, the score of patient education and quality management factors were 48-68% and 51-72%, respectively. Another local study conducted during Hajj period showed that the score was 75% for patient education key element and 63.6% for quality management. 10 All previous investigations have been conducted at the hospital pharmacy. However, to the best of our knowledge, there is no study about the selfassessment of medications safety practices with the emphasis of quality factors and risk management. Therefore, in this study, we aimed to ex-Alomi, et al.: Patient Education, Quality Process and Risk Management at Primary Healthcare Centers/Community Pharmacies in Saudi Arabia plore the self-assessment of medications safety: quality and risk management at PHCs and CPs in Riyadh city, Saudi Arabia.

METHODS
This is a four-month cross-sectional medication safety practice survey conducted at PHCs and CPs in Riyadh city. The survey consisted of the modified version of the Medication Safety Self-Assessment ® for Community/Ambulatory Pharmacy from the ISMP. 11 It consisted of a demographic section and 10 domains with 198 questions. The domains included patient information; drug information; communication of drug orders and other drug information; drug labeling, packaging and nomenclature; use of devices; environmental factors; staff competency and education; patient education; quality processes; and risk management domain. The survey was conducted at PHC pharmacies of MOH and CPs located in Riyadh city. The responses were collected using 5-point Likert response scale system. The scoring key identified as number (1) was equal to (A): No activity to implement, (2) was equal to (B): Considered, but not implemented, (3) was equal to (C): Partially implemented in some or all areas, (4) was equal to (D): Fully implemented in some areas and (5) was equal to (E): Fully implemented throughout. The survey was distributed to the directors of PHC pharmacies and CPs. The authors distributed the questionnaire and followed-up on a daily basis by physically visiting and by making a telephonic call. The study questionnaire was prepared in an electronic format and it analyzed through survey monkey system and Microsoft Excel version 10. Based on GAPC and CBAHI standards, we suggested some solutions to improve the scores of the medication safety practice and the results of the ISMP self-assessment. 1,2 The 10 domains were divided into several parts for the sake of analysis, discussion and solution. Part one consisted of patient information and part two consisted of drug information. Part three consisted of medication preparation and dispensing (communication of drug orders and other drug information, drug labeling and packaging and nomenclature) and part four consisted of medication administration (drug standardization, storage and distribution, medication devices acquisition, use and monitoring). Part five consisted of environmental factors, workflow, staffing and staff competency and part six consisted of patient education, quality processes and risk management. In this study, we emphasized on part one; it is the finding from medication safety selfassessment for community/ambulatory pharmacy in Riyadh city.

RESULTS
The survey was distributed to 13 PHC pharmacies and 23 CPs. Most of the PHCs were types M1 and M3 (4 (30.8%) and 3 (23.1%), respectively). Most of the CPs were large (8 (33.3%)) and medium type (8 (33.3%)). The majority of PHCs and CPs had obtained accreditation from the Saudi Commission of Health Specialties (7 (70%) and 20 (87%), respectively). Most of PHCs dispensed more than 100 prescriptions daily (7 (53.9%)), whereas most of the CPs dispensed less than 20 prescriptions daily (11 (45.8%)). Most of the responders in PHCs were female (9 (69.2%)) (4 (30.8%) were males) and in CPs all were males (25 (100%)). Majority of the responders in PHCs were Saudi professionals (12 (92.3%)), whereas all were non-Saudi professionals in CPs (25 (100%)). Most of the responders belonged to the age group of 30-44 years (9 (69.2%)) and most of them in CPs belonged to the age group of 18-29 years (15 (62.5%)). Most of the responders in PHCs had obtained a diploma or BSc degree in Pharmacy or a Master of Science degree in Clinical Pharmacy (2 (22.2%), 3 (33.3%) and 2 (22.2%), respectively). In CPs, majority of them had obtained a BSc degree in Pharmacy (22 (88%)). Most of the pharmacy staff had not obtained accreditation from the Board of Pharmaceutical Specialties (8 (88.9%) and 21 (91.3%) working in the PHCs and CPs, respectively) ( Tables 1 and 2 Table 3). The highest score of the patient education with Core #16 was obtained for the statement "Pharmacists fully investigate all patient/caregiver concerns and questions about a medication prior to dispensing" (3.6 (72%)) at PHCs, whereas at CPs, the highest score was obtained for the statement "Pharmacists design drug administration schedules that consider the patient's lifestyle and minimize the number of times per day that medications must be taken for patients at high risk for nonadherence with prescribed medications" (4.22 (84.4%)). The lowest score at PHCs was obtained for the statement "When counseling is provided, the patient's drug container is opened in front of the patient/caregiver to verify the appearance of the medication" (2.00 (40%)), whereas at CPs, the lowest score was obtained for the statement "In as confidential a manner as possible, pharmacists inquire about the patient's understanding of the purpose of new medications and refilled prescriptions" (3.33 (66.6%)) ( Table 4). At PHCs and CPs, the highest score of the patient education with Core #17 was obtained for the statement "Pharmacists participate in clinical disease management programs for conditions such as asthma, hypertension, diabetes or hypercholesterolemia" (3.33 (66.6%) and 3.67 (73.4%), respectively). The lowest score at PHCs it was obtained for the statement "In the past year, pharmacists have participated in at least one screening clinic locally to promote early detection of disease" (3.09 (61.8%)) and at CPs, it was obtained for the statement "Pharmacists have participated in promoting, facilitating and providing immunizations to the local community to improve public health" (3.24 (64.8%)) ( Table 5). The highest score of quality processes and risk management with Core #18 was obtained for the statement "Error prevention strategies in the pharmacy target the system, not individual practitioners" (3.00 (60%)) at PHCs, whereas at CPs, it was obtained for the statement "Pharmacists and technicians are trained in the clinical and administrative procedures for responding to a serious medication error" (3.63 (72.6%)). The lowest score at PHCs was obtained for the statement "In the individual pharmacy or for chains of pharmacies, error rates are not determined or calculated from practitioner error reports and are not used for internal comparisons" (2.09 (41.8%)), whereas at CPs, it was obtained for the statement "Error prevention strategies in the pharmacy target the system, not individual practitioners involved)" (2.68 (53.6%)) ( Table 6). The highest score of quality processes and risk management with Core #19 was obtained for the statement "Management and staff pharmacists/ technicians routinely read and use published error experiences from other organizations" (3.18 (63.6%)) at PHCs, whereas at CPs, it was obtained for the statement "A clear definition and examples of medication errors and hazardous situations that should be reported has been established and disseminated to staff (3.79 (75.8%)). The lowest score at PHCs was obtained for the statement "One pharmacist in the individual pharmacy has responsibility for enhancing detection of medication errors, overseeing analysis of their causes and coordinating an effective error reduction plan" (2.33 (46.6%)), whereas at CPs, it was obtained for the statement "Pharmacy management supports practitioner reporting to external reporting programs such as the USP-ISMP Medication Errors Reporting Program and the CDC Vaccine Adverse Reaction Reporting System" (2.58 (51.6%)) ( Table 7). The highest score of quality processes and risk management with Core #20 was obtained for the statement "A pharmacist verifies all over-the-counter insulin with the patient/caregiver before the product is dispensed" (3.5 (70%) at PHCs and 3.89 (77.8%) at CPs).   The highest scores items of Primary care center pharmacy 152 Pharmacists fully investigate all patient/caregiver concerns (e.g., affordability, inability to swallow, difficulty adhering to directions, etc.) and questions about a medication prior to dispensing. The highest scores items of community pharmacy 161 Pharmacists design drug administration schedules (in cooperation with the patient's physician as necessary) that consider the patient's lifestyle and minimize the number of times per day that medications must be taken for patients at high risk for nonadherence with prescribed medications. The lowest scores items of Primary care center pharmacy 149 When counseling is provided, the patient's drug container is opened in front of the patient/caregiver to verify the appearance of the medication.  3.33 66.6 Table 6: The highest and lowest scores items of domain quality processes and risk management core # 18.

Key elements
Core #18: A non-punitive, system-based approach to error reduction is in place and supported by pharmacy owners or senior management. Error prevention strategies in the pharmacy target the system, not individual practitioners (e.g., in addressing problems, a change in the pharmacy's process or practice is sought, rather than focusing on the role of the specific individual(s) involved). If the pharmacy discovers that an error has led to improper medication dispensing, regardless of the level of harm that results, the error is honestly disclosed to the patient/caregiver/family in a timely manner. If the pharmacy discovers that an error has led to improper medication dispensing and selfadministration, regardless of the level of harm that results, the error is honestly disclosed to the prescriber in a timely manner. If the pharmacy discovers that an error has led to improper medication dispensing, regardless of the level of harm that results, the error is honestly disclosed to the patient/caregiver/family in a timely manner. The lowest scores items of Primary care center pharmacy 174 In the individual pharmacy or for chains of pharmacies, error rates are not determined or calculated from practitioner error reports and are not used for internal (pharmacist-to-pharmacist) or external (pharmacy-to-pharmacy) comparisons. The lowest scores items of community pharmacy 166 Error prevention strategies in the pharmacy target the system, not individual practitioners (e.g., in addressing problems, a change in the pharmacy's process or practice is sought, rather than focusing on the role of the specific individual(s) involved).  The lowest score at PHCs was obtained for the statement "Where electronic prescribing is available and used, a pharmacist reviews the order in the computer before generating a label from which the drug order is filled" (2.18 (43.6%)), whereas at CPs, it was obtained for the statement "Both the medication base product and the mixing solution/diluents used for reconstituted products are checked and documented with initials on the prescription by at least a pharmacist and one other person" (2.47 (49.4%)) ( Table 8).

Key elements
Core #20: Simple redundancies that support a system of independent double checks or an automated verification process are used for vulnerable parts of the dispensing system to detect and correct serious errors before they reach patients. The highest scores items of Primary care center pharmacy 196 A pharmacist verifies all over-the-counter insulin with the patient/caregiver before the product is dispensed. The highest scores items of community pharmacy 196 A pharmacist verifies all over-the-counter insulin with the patient/caregiver before the product is dispensed. 0 4 3 2 9 3.89 77.8 18 The lowest scores items of Primary care center pharmacy

192B
Where electronic prescribing (e.g., prescription sent electronically via computer/hand held device) is available and used, a pharmacist reviews the order in the computer before generating a label from which the drug order is filled. The lowest scores items of community pharmacy

195
Both the medication base product and the mixing solution/diluents used for reconstituted products are checked and documented with initials on the prescription by at least a pharmacist and one other person

DISCUSSION
The patient education and quality management programs were goals of the strategic pharmacy at the MOH in the KSA. 1 There were separated committees for each project. The committee consisted of representatives from each region to follow the program's implementation at hospitals and PHCs. CPs were not included in both programs. However, the patient education and quality management programs were implemented through self-improvement for all primary care center and community pharmacy. We explored both programs as related to medication safety. The results of this study showed that the patient education scores of CPs was better than that of PHCs. This is related to more effort for competition in the pharmacy market. The results regarding CPs were similar to the results of previous international and local studies, whereas the results related to PHCs were lower than that of previous international and regional studies. [8][9][10] Because it was newly established. The results of both PHCs and CPs in quality management are almost the same. However, both results were found to be lower than that of previous international and local studies. [8][9][10] This is because it was newly established at PHCs and not well developed at CPs. The lowest score related to patient education at PHCs and CPs were related to some skills in patient counseling. Both demand for education and training courses improve their skills. Moreover, some services need to be added to both types of pharmacies. This includes the clinic for screening the disease and immunization services. Both services are not allowed in the pharmacy law. The law should be updated. The findings of cores # 18 and # 19 of the medication safety demand prevention measures and documentation of adverse drug reactions at PHCs and CPs. The national system of medication errors education and training is mandated. The lowest safety score with an emphasis on the quality management at PHCs; that's related to the missing of an electronic prescribing. Most of primary care center pharmacy not started the computerized physician order enter. In the CPs the lowest safety scores was the standardized of extemporaneous preparation; that's excepted because the unified extemporaneous preparations not excised. The PHCs and CPs need more efforts to implement the medication safety assessment tools with emphasis on the patient counseling and quality management system and risk management in the KSA.