Medication SafetyPart 2

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

Outline

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

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

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

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

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

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

Recommendations for Preventing 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)

Monitoring Medication Errors

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

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

Actions Upon Error Detection

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)

Barriers to Reporting Medication Errors

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

To Encourage Medication Error Reporting

Adverse Drug Reactions (ADRs)

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 dosageadjustments),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, or9. Results in temporary or permanent harm, disability, or death.

Definition

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)

Assessment of ADRs1) Pharmacological Relationship

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

Assessment of ADRs2) Causality

Most frequently made by answering a series of yes/no questions

After answering the questions, the ADR is classified as preventable or unpreventable

Assessment of ADRs3) Preventability

Most frequently made by using scales

ADR may be classified as:◦Mild◦Mild/Moderate◦Moderate◦Moderate/Severe◦Severe

Assessment of ADRs4) Severity

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

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

Reporting ADRs: Pharmacist Role

1. Develops and manages the Medication Use Safety Improvement Plan

2. Participates in strategic and tactical planning and analysis of organization-wide patient safety activities

3. Identifies and facilitates medication safety improvement projects

4. Serves as an internal consultant on medication safety and other safety improvement projects

Medication Safety Officer Role

5. Manages data reporting and information related to medication safety

6. Reviews and trends reported medication occurrences to identify and resolve potential system vulnerabilities

7. Contributes to a culture of safety. Models optimal behavior and encourages others to participate in safety initiatives

8. Manages the pharmacy staff development, training and continuing education processes

Medication Safety Officer Role

9. Presents to professional and lay audiences; publishes results of professional activities

10. Works effectively and proactively with other pharmacy managers and staff to ensure that departmental goals and objectives are achieved

11. Able to perform all aspects of the staff pharmacist job function

12. Ensures compliance with all applicable regulations, laws, and standards of practice

Medication Safety Officer Role

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

National Pharmacovigilance 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

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

Objectives of Saudi Vigilance Center