Quality drug use

Question 1

Define quality/rational drug use

Answer 1

Patient receives medication that is:

1) Appropriate for clinical need (indicated)
2) At correct dose that meets individual requirements
3) For adequate duration
6) Most cost-effective

Question 2

WHO 12 Core Interventions to Promote Rational use of Medications

Answer 2

1) Mandate multi-disciplinary national body to coordinate national use policies
- SG: ACE

2) Evidence-based clinical guidelines

3) Essential medicines list based on treatments of choice
- SG: Standard Drug List (SDL)

4) Drug (Pharmacy) & Therapeutics Committee at every healthcare institute
- Oversee rational drug use at that particular healthcare institute

5) Problem-based pharmacotherapy training for undergraduates
6) Continuing education of license renewal
7) Supervision, audit, feedback

8) Independent information on medicines (independent from drug company)
- SAPI Code of Conduct
- Sunshine Act in US

9) Public education
- Public needs sufficient knowledge on risks & benefits of medicines & on proper use of medications to get expected clinical outcomes & reduce side effects
- Includes labeling of OTC drugs
- WHO recommends monitoring & regulating advertisements of medications (SG bans advertisement of prescription drugs)

10) Avoid perverse financial incentives
11) Appropriate & enforced regulations
12) Sufficient government expenditure to ensure availability of medications & staff

Question 3

Drug & Therapeutics Committee is responsible for

Answer 3

Overseeing policies & procedures related to all aspects of medication use, including:

1) Addition/Deletion/Review of drugs in formulary
2) Drug use evaluation
3) Development of clinical care plans & guidance
4) Adverse drug event monitoring & reporting
5) Medication error prevention
6) Guidelines on interaction between pharmaceutical company representative & medical science liaison

Question 4

Roles & responsibilities of pharmacist in medicine use process - Medicine supply chain

Answer 4

1) Detecting spurious / falsely labelled / counterfeit / falsified medications
2) Ensure proper storage
3) Quality preparation of medicine when needed

Question 5

Roles & responsibilities of pharmacist in medicine use process - Prescribing & dispensing

Answer 5

1) Ensure medicines prescribed are indicated
2) Ensure appropriate dosage form & dosing regimen
3) Ensure clear instructions for use
4) Prevent drug interactions (DDI/drug-food)
5) Prevent known & predictable ADRs
6) Minimize unnecessary treatments & cost of medicines is considered
7) No untreated condition

Question 6

Roles & responsibilities of pharmacist in medicine use process - Administration

Answer 6

1) Right drug
2) Right dose
3) Right route
4) Right patient
5) Right time
6) DDI/Drug-food interactions
7) What to expect after administration

Question 7

Roles & responsibilities of pharmacist in medicine use process - Monitoring

Answer 7

1) Continue monitoring throughout treatment
2) Monitor for effectiveness, if treatment goals are effective, how patient feels about medication, any concerns
3) Should have more than one encounter with patient

Question 8

Roles & responsibilities of pharmacist in rational drug use

Answer 8

Must take ownership & assume accountability for outcomes related to medication use
On a system level, provide input on:
- Proper use of medication, quality healthcare
- Guidelines

Question 9

Define drug use evaluation (DUE)

Answer 9

Systematic quality improvement activity
Focuses on evaluating & improving quality of drug use & medication use processes
Aims to achieve optimal patient outcomes

Question 10

Objectives of DUE

Answer 10

1) Facilitate multi-disciplinary consensus on drug use, based on most current, best available evidence
2) Conduct regular audits to ensure standards are met
3) Provide feedback of audit results
4) Promote judicious, safe & cost-effective therapy through provision of information, advise & education
5) Minimize variations in practice
6) Enhance opportunities to assess the use of value of (innovative) medication use processes
7) Meet/Exceed internal & external quality standards

Question 11

Steps in conducting DUE

Answer 11

1) Identify drugs/medication use processes for evaluation
2) Assemble DUE team
3) Design of study
4) Approval of study
5) Development of criteria & measurement instruments
6) Data collection
7) Evaluation with pre-determined criteria & analysis of results
8) Reporting & feedback
9) Design & implement intervention strategies
10) Re-assessment & revision of problem

Question 12

Steps in conducting DUE - Identify drugs/medication use

• Drugs with higher priority to be evaluated
• ‘Flags’/Indicators to identify need for DUE

Answer 12

Drugs with higher priority to be evaluated:

1) Under consideration for formulary addition / retention / deletion
2) Associated with adverse events or poor patient outcomes
3) High unit cost / High volume cost
4) Suboptimal use likely to/showed signs of negative effects on patient outcomes & system cost
5) High risk patients
6) Adverse medication events
- ADRs or medication errors
- Actual or missed
7) Treatment failure

‘Flags’/Indicators to identify need for DUE:

1) Adverse medication events reporting
2) Hospital statistics (e.g. increased admission, increased antibiotic resistance)
3) Pharmacist intervention reports
4) Non-formulary medications used/requested
5) Patient feedback

Question 13

Steps in conducting DUE - Assemble DUE team

Answer 13

DUE team should be multi-disciplinary

Obtain authorization from CEO/CMB

Question 14

Steps in conducting DUE - Study design

• Types of studies
• What to include in study design

Answer 14

Types of studies:

1) Retrospective
- Review drug use/MUP after patient receives medication (review patient medical charts / computerized records)
- Advantages: Simple, convenient, flexible
- Limitations: Only benefits future patients, depends on accuracy and completeness of documentation
2) Concurrent
- Ongoing monitoring throughout course of treatment
3) Prospective
- Evaluation before/at time of prescription

What to include in study design:

1) Background
2) Aims
3) Patient selection (sampling)
4) Data collection method
5) Proposed method of analysis

Question 15

Steps in conducting DUE - Approval of study

Answer 15

Consider ethical & patient privacy
- De-identification
Approval from ethics committee / Institutional Review Board (IRB) may be needed
- Generally needed if publishing/presenting study outside of the institute

Question 16

Steps in conducting DUE - Development of criteria & measurement instruments

• Criteria requirements
• Criteria can be based on

Answer 16

Criteria requirements

1) Evidence based
2) Valid, practical, relevant
3) Pre-determined
4) Authoritative
5) Explicit
6) Well accepted
7) Easily measured
8) Outcome oriented

Criteria can be based on:

1) National, independent, authoritative sources
- E.g. MOH clinical guidelines (SG); National Institute for Health & Clinical Excellence (UK); WHO; Medical associations; National Guidelines Clearinghouse
2) Drug availability criteria (hospital restrictions)
3) In-house criteria
- Must be good quality, evidence based
- Must be explicitly agreed on by team, with input from expert clinicians, main users, stakeholders

Question 17

Steps in conducting DUE - Data collection

Answer 17

Data collection instrument should be:

1) Unambiguous & user friendly
2) Simple & focused
3) Only include relevant demographics, clinical & drug therapy information
4) Tested and refined in pilot studies
5) Take advantage of existing automated information systems

Question 18

Steps in conducting DUE - Evaluation with Pre-Determined Criteria & Analysis of Results

Answer 18

Data collected compared with pre-determined criteria - mark for compliant / concordant / adherent
Identify and document any divergence
- May have to review with prescriber to determine valid justification for divergence

Question 19

Steps in conducting DUE - Reporting & Feedback

• Who to report/give feedback to
• What to include in report/feedback
• Means of reporting

Answer 19

Report/Give feedback to

1) Prescribers & other stakeholders
2) Relevant committees & department under review

Report/Feedback should:

1) Non-punitive & constructive
2) Include both positive & negative findings
3) Include recommendations on how to improve problems identified

Means of reporting:

1) Articles in hospital bulletin
2) Presentation at grand rounds / scientific or clinical meetings
3) Publication in journals

Question 20

Steps in conducting DUE - Design & Implementation of Intervention Strategies

Answer 20

Possible strategies:

1) Education
2) Publish guidelines
3) Restrictions
- E.g. Formulary changes
- E.g. Institutional policies (e.g. restrict use to certain patient groups only)
4) Persuasive strategies (e.g. rewards, opinion leaders)
5) Workflow modifications (e.g. checklists, double checks)
6) Additional pharmacy services (e.g. antimicrobial stewardship)
7) IT enhancement/integration

Question 21

Steps in conducting DUE - Re-Evaluate & Revision of Problem

Answer 21

1) Simple monitoring of consumption data
2) Threshold/Exception analysis
3) Periodic screening
4) Reassessment of areas/target groups

Question 22

DUE may fail due to

Answer 22

1) Lack of authority & involvement
- Should be multi-disciplinary
- Lack of administrative support
- Benefits of DUE should be conveyed in terms of improving patient outcomes & decreasing health system costs
- Authoritative medical staff support & formal organization recognition of DUE process are necessary

2) Poor organization & documentation
- No clear definition of roles & responsibilities
- Documentation should include actions taken, findings, conclusions, recommendations & follow-up actions

3) Lack of follow-through
- Should not be one-time study
- Effectiveness of initial actions must be assessed & action plan adjusted if needed

4) Lack of readily retrievable data & information management
- Existing data capabilities need to be assessed
- Maximum benefit obtained from available computerized information management resources

5) Evaluation method impedes patient care
- Intervention that improves care should not be withheld due to sampling technique / evaluation methodology

Question 23

Pharmacist’s Role in DUE

Answer 23

1) Exert leadership, manage process
2) Educate & promote goals & objectives of DUE
3) Develop operational plan for DUE programs & processes that is consistent with health system goals & resource capabilities
4) Work collaboratively with prescribers/others to develop/review criteria for specific medications & design effective MUPs
5) Collect, analyse & evaluate data
6) Interpret & report DUE findings & recommend changes in DUE
7) Provide information & education based on DUE findings
8) Document program outcomes, effectiveness & cost benefits
9) Develop strategies to identify, resolve & prevent drug-related problems
10) Participate as member of hospital committee concerned with quality improvement
11) Present DUE at meetings & conferences