Medication Safety Part 2

1. Medication SafetyPart 2

2. Outline • Recommendations to prevent medication errors • Actions upon error detection • Definition and assessment of ADRs • Role of pharmacist in medication safety • Role of Saudi FDA in medication safety

3. Recommendations for Preventing Medication Errors • Suitable work environments should exist for the preparation of drug products • Pharmacists responsible for processing drug orders should have routine access to appropriate clinical information about patients (allergies, diagnoses, lab values) • Storage of nonemergency floor stock medications on the nursing units or in patient-care areas should be minimized

4. Recommendations for Preventing Medication Errors • Use of a patient’s own or “home” medications should be avoided to the fullest extent possible • Computerized pharmacy systems that enable automated checking for doses, duplicate therapies, allergies, drug interactions • Use of technological innovations such as bar coding is recommended to help identify patients, products, and care providers

5. Recommendations for Preventing Medication Errors • The P&T committee should develop a list of standard abbreviations approved for use in medication ordering • Drug orders should be complete (patient name, generic drug name, route and site of administration, dosage form, dose, strength, quantity, frequency of administration, prescriber’s name) • Prescribers with poor handwriting should print or type medication or prescription orders if direct order entry capabilities for computerized systems are unavailable

6. Recommendations for Preventing Medication Errors • Verbal drug prescription orders should be reserved only for situations in which it is impossible or impractical for prescriber to write the order or enter it in computer • Pharmacists should make themselves available to prescribers and nurses to offer information and advice • Pharmacists should never assume or guess the intent of confusing medication orders. If there are any questions, the prescriber should be contacted prior to dispensing

7. Recommendations for Preventing Medication Errors • For high risk drug products, when possible, all work should be checked by a second individual (preferably, another pharmacist) • Pharmacists should dispense medications in ready to- administer dosage forms whenever possible. The unit dose system is strongly recommended as the preferred method of drug distribution • Pharmacists should ensure that medications are delivered to the patient-care area in a timely fashion

8. Recommendations for Preventing Medication Errors • When dispensing medications to ambulatory patients (e.g. at discharge), pharmacists should counsel patients or caregivers and verify that they understand why a medication was prescribed and dispensed • Separate storage areas, color differentiation,and change products • Use Tall Man Lettering: Chlorpromazine …ChlorproMAZINE Chlorpropamide ... ChlorproPAMIDE

9. Monitoring Medication Errors • Ongoing quality improvement programs for monitoring medication errors are needed • Medication errors should be identified and documented and their causes studied in order to develop systems that minimize recurrence • Several error monitoring techniques exist (e.g. anonymous self-reports, incident reports, and disguised observation technique)

10. Actions Upon Error Detection 1. Any necessary corrective and supportive therapy should be provided to the patient 2. The error should be documented and reported immediately after discovery, in accordance with written procedures 3. For clinically significant errors, fact gathering and investigation should be initiated immediately 4. Reports of clinically significant errors and the associated corrective activities should be reviewed by the supervisor and department head of the area(s) involved

11. Actions Upon Error Detection 5. When appropriate, the supervisor and staff members who were involved in the error should confer on how the error occurred and how its recurrence can be prevented 6. Appropriate committees should periodically review error reports & develop actions to prevent their recurrence (e.g. conduct organizational staff education, alter staff levels, revise policies and procedures, or change facilities, equipment, or supplies) 7. Medication errors should be reported to a national monitoring program

12. Barriers to Reporting Medication Errors • Failure to create a culture to report medication errors • The level of patient education and literacy • Educational support deficit for the staff • Lack of interdisciplinary collaboration and communication • Absence of front-line staff in sharing decision-making and system design • Failure to use an effective system and technology (poorly designed report forms)

13. To Encourage Medication Error Reporting • Accept that errors will occur; slips, lapses and mistakes will happen • Focus on ‘’how did it happen’’ not ‘’who did it’’ • Focus on the system, not the people • Everyone is involved in safety (individual, practitioners & organizational leadership) • Anonymous reports can increase reporting rate

14. Adverse Drug Reactions (ADRs)

15. Definition • Any unexpected, unintended, undesired, or excessive response to a drug that: 1. Requires discontinuing the drug (therapeutic or diagnostic), 2. Requires changing the drug therapy, 3. Requires modifying the dose (except for minor dosage adjustments), 4. Necessitates admission to a hospital, 5. Prolongs stay in a health care facility, 6. Necessitates supportive treatment, 7. Significantly complicates diagnosis, 8. Negatively affects prognosis, or 9. Results in temporary or permanent harm, disability, or death.

16. Assessment of ADRs1) Pharmacological Relationship • Type A • Those that result from extension of the drug pharmacological activity & is expected to occur with increasing doses of the drug • E.g. Morphine induced respiratory depression • Type B • Have no relationship to the drug’s pharmacological activity or dose administered • Referred to as allergies (e.g. penicillin induced anaphylaxis) • Type C (associated with long term drug use) • Type D (carcinogenicity and teratogenicity)

17. Assessment of ADRs2) Causality • Most frequently made by using Naranjo Algorithm • It involves answering yes/no questions • After answering the questions, a score is provided ranking the causality of the event into definite, probable, possible or doubtful

18. Assessment of ADRs3) Preventability • Most frequently made by answering a series of yes/no questions • After answering the questions, the ADR is classified as preventable or unpreventable

19. Assessment of ADRs4) Severity • Most frequently made by using scales • ADR may be classified as: • Mild • Mild/Moderate • Moderate • Moderate/Severe • Severe

20. Reporting ADRs: Pharmacist Role 1. Analysis of each reported ADR 2. Identification of drugs and patients at high risk for being involved in ADRs 3. The development of policies and procedures for the ADR-monitoring and reporting program 4. A description of the responsibilities and interactions of pharmacists, physicians, nurses, risk managers, and other health professionals in the ADR program 5. Use of the ADR program for educational purposes

21. Reporting ADRs: Pharmacist Role 6. Development, maintenance, and evaluation of ADR records within the organization 7. The organizational dissemination and use of information obtained through the ADR program 8. Reporting of serious ADRs to the FDA or the manufacturer (or both) 9. Publication and presentation of important ADRs to the medical community

22. Medication Safety Officer Role • Develops and manages the Medication Use Safety Improvement Plan • Participates in strategic and tactical planning and analysis of organization-wide patient safety activities • Identifies and facilitates medication safety improvement projects • Serves as an internal consultant on medication safety and other safety improvement projects

23. Medication Safety Officer Role • Manages data reporting and information related to medication safety • Reviews and trends reported medication occurrences to identify and resolve potential system vulnerabilities • Contributes to a culture of safety. Models optimal behavior and encourages others to participate in safety initiatives • Manages the pharmacy staff development, training and continuing education processes

24. Medication Safety Officer Role • Presents to professional and lay audiences; publishes results of professional activities • Works effectively and proactively with other pharmacy managers and staff to ensure that departmental goals and objectives are achieved • Able to perform all aspects of the staff pharmacist job function • Ensures compliance with all applicable regulations, laws, and standards of practice

25. National Pharmacovigilance Center • The Pharmacovigilance Center is concerned with detection, assessment and prevention of adverse drug reaction "ADR". • Adverse Drug Reactions Reporting • Healthcare professionals "Physicians, Pharmacists, dentists...etc" and the public can report ADR via special forms

26. Objectives of Saudi Vigilance Center • Early detection of adverse drug reactions • Detection of increase in frequency of known adverse reaction • Identification of risk factors and possible mechanisms underlying adverse reactions • Estimation of quantitative aspects of benefit/risk analysis and dissemination of information needed to improve drug prescribing and regulation

27. Objectives of Saudi Vigilance Center • Prevention of adverse drug reactions • Drug quality surveillance • Encouraging rational and safe use of drugs • Communication with international institutions working in pharmacovigilance