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PR3145 > Quality Drug Use & Drug Evaluation > Flashcards

Quality Drug Use & Drug Evaluation Flashcards

1
Q

Define quality/rational use of medicines

A
  • Takes into account best available clinical evidence of efficacy & safety as well as cost-effectiveness

Requires:

  • Pts receive meds appropriate to their clinical needs
  • Doses to meet own indv requirements
  • Adequate period of time
  • Lowest $
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2
Q

What are the 12 core interventions recommended by WHO to promote quality/rational use of medicines?

A

1) Mandated multi-disciplinary national body to coordinate med use policies (ACE in SG - coordinates which drugs shld be subsidised, comes out with guidelines on drug use)
2) Evidence-based clinical guidelines (Helps direct standard of care)
3) Essential med list (SDL in SG)
4) Drugs (Pharmacy) & Therapeutics Committees in healthcare institutions
5) Prob-based pharmacotherapy training in undergraduate curricula
6) Continuing in-service medical education
7) Supervision, audit & feedback
8) Independent information on meds
9) Public education about medicines
10) Avoidance of perverse financial incentives
11) Appropriate & enforced regulation
12) Sufficient govt expenditure to ensure availability of medicines & staff

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3
Q

What might be the reasons for irrational drug use?

A
  • Costs, knowledge gaps, no good system in place to monitor appropriate use of meds
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4
Q

What is the Drugs (Pharmacy) & Therapeutics Committees for?

A
  • Serves evaluative, educational & advisory capacity in all matters pertaining to the use of medications
  • Resp for overseeing policies & procedures related to all aspects of medication use
    Eg.
  • Addition/deletion/review of drugs to/on the formulary (Inventory management helps to manage $ by streamlining few agents in same class)
  • DUE
  • Med error prevention
  • ADE monitoring & reporting
  • Development of clinical care plans & guidelines
  • Guideline on interaction & role of pharmaceutical company representatives & medical sci liaisons in a healthcare organisation
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5
Q

Requirements for GPP

A
  • Pharmacist’s 1st concern is pt’s welfare
  • Core of pharmacy activity is to help pts make the best use of medicines
  • Integral part of pharmacist’s contribution is promotion of rational (and economical) drug use
  • Objective of each element of pharmacy service is relevant to pt, is clearly defined & is effectively communicated to all those involved
  • Multidisciplinary collaboration for successfully improving pt safety
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6
Q

Roles & responsibilities of pharmacist in medication use process

A

1) Assuring integrity of med supply chain
- Detecting falsified/counterfeit meds, ensure proper storage, quality preparation of meds

2) Assuring proper prescribing & dispensing of meds
- Unnecessary treatments minimised & $ considered

3) Assist pts & those administering medicines to unds the impt of taking medicines properly
- 5R’s
- Food/med to avoid, what to expect aft taking med

4) Monitoring treatment

Note:

  • Optimising med use is a collaborative venture
  • Pharmacist to take ownership & assume accountability for outcomes related to med use (for indv & also on system level)
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7
Q

Roles & responsibilities of pharmacist in medication use process

A

1) Assuring integrity of med supply chain
- Detecting falsified/counterfeit meds, ensure proper storage, quality preparation of meds

2) Assuring proper prescribing & dispensing of meds
- Meds prescribed as indicated
- Dose regimens & forms appropriate, instructions for use clear
- Known & preventable adverse reactions avoided
- Unnecessary treatments minimised & $ considered

3) Assist pts & those administering medicines to unds the impt of taking medicines properly
- 5R’s
- Food/med to avoid, what to expect aft taking med

4) Monitoring treatment

Note:

  • Optimising med use is a collaborative venture
  • Pharmacist to take ownership & assume accountability for outcomes related to med use (for indv & also on system level)
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8
Q

Why is Quality/Rational/Responsible Drug Use important?

A
  • Impact on pts, need to optimise pt outcomes
  • Impact on society (health & resources)
  • -> Increasing healthcare expenditure in the face of finite resources
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9
Q

Why do we have a complex drug use envt?

A

Many drugs, uncertainties & a wide range of influences leading to:

  • variable prescribing & drug use
  • variable clinical outcomes
  • diff cost implications
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10
Q

What is MUE/DUE/DUR

A
  • Systematic QI activity
  • Focuses on evaluating & improving drug & medication-use
  • To achieve optimal patient outcomes
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11
Q

Objectives of DUE

A
  • Facilitate multidisciplinary consensus on drug use
  • Conduct regular audits to ensure standards of care met
  • Provide feedback of audit results to prescribers & stakeholders
  • Promote judicious, appropriate, safe & $-effective therapy through provision of info, advice & education
  • Minimise variations in practice
  • Enhance opportunities to assess the value of (innovative) medication-use practices
  • Meet/exceed internal & external quality standards
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12
Q

Goal of DUE

A

To improve safety, quality & $-effectiveness of drug use, optimising patient outcome & resource allocation

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13
Q

DUE Cycle

A

Quality improvement cycle of:

  • Evaluate/investigate
  • Improve/intervention
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14
Q

List steps in conducting DUE

A

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

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15
Q

[DUE] Step 1: Identifying drugs/MUP for evaluation

A

To consider:

  • Drugs under consideration for formulary retention/+/-
  • Drugs known to be assoc w adverse events
  • High-unit/volume cost
  • Drugs used by high risk pts
  • Suboptimal use will have -ve effect on pt outcomes/system cost
  • Adverse medication events
  • Signs of treatment failure

“Flags”/Indicators that may suggest need for DUE:

  • Adverse med events reporting
  • Hospital statistics
  • Pharmacist intervention report
  • Nonformulary meds requested/used
  • Pt feedback
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16
Q

[DUE] Step 2: Assemble DUE team

A
  • Multidisciplinary approach (include all stakeholders in MUP with expertise to ensure sound assessment of prac performance)
  • Obtain authorization
17
Q

[DUE] Step 3: Design of study

A

Types:
1) Retrospective
- Logically < challenging since therapy reviewed aft pt has received the medication
Retrospective review may:
–> Detect PATTERNS in prescribing/dispensing/administering to prevent recurrence of inappropriate use
–> Means for developing prospective standards & target interventions

2) Concurrent (eg. drugs that need TDM)
- Ongoing monitoring of drug tx during course of treatment

3) Prospective
- Evaluate pt’s drug therapy before/at time medication is initiated

  • Type of design should be documented prior to commencement
  • Include background, aims, pt selection, data collection methods & proposed method of analysis
18
Q

[DUE] Step 4: Approval of study

A
  • Mindful of ethical & pt privacy considerations
  • Ethical issues resolved before data collection
  • May require de-identification of pt-specific data
  • May require ethics committee/IRB approval
19
Q

[DUE] Step 5: Develop criteria & measurement instruments

A

Criteria has to be:
- Evidence-based, valid, practical, relevant, authoritative, explicit, pre-determined, easily measured & outcome oriented

Types of criteria:

i) National, independent, authoritative sources (eg. MOH Clinical Practice Guidelines)
- consider local relevance

ii) Drug availability criteria
- hospital restrictions

iii) DUE team may build inhouse criteria
- criteria explicitly agreed by team with input from expert clinicians or main users/stakeholders

20
Q

[DUE] Step 6: Data collection

A
  • Unambiguous & “user-friendly”
  • Simple & focused
  • Include only relevant demographic, clinical or drug therapy information
  • Protect pt confidentiality
  • Tested & refined in pilot studies
  • Take adv of automated info systems
21
Q

[DUE] Step 7: Evaluation with pre-determined criteria & analysis of results

A
  • Drug/MUP compared with pre-determined criteria (in step 5)
  • Marked as compliant/concordant/adherent
  • Identify & document area of divergence
  • -> May need to review w prescribers to determine valid justification for divergence (concurrent.prospective studies)
22
Q

[DUE] Step 8: Reporting & feedback

A
  • To be non-punitive & constructive
  • Report both +ve (encouraging) & -ve findings
  • Make recommendations on ways to improve problems identified
23
Q

[DUE] Step 9: Design & implementation of intervention strategies

A
  • Multifaceted interventions work best

1) High leverage (Most effective):
- Forcing functions & constraints (eg. removal of product from use), automation or computerization
2) Medium leverage (Mod effective):
- Simplification & standardization, reminders checklists & double checks
3) Low leverage (Least effective):
- Rules & policies, education & information

24
Q

[DUE] Step 10: Re-assessment & revision of problem

A

DUE is a cyclical process!

Re-evaluation via:

  • simple monitoring of consumption data
  • exception or threshold analysis
  • periodic screening
  • reassessment of areas or target groups
25
Q

Pitfalls of DUE

A

1) Lack of authority & involvement
- Med-use criteria should be developed through an interdisciplinary consensus process
- Lack of administrative support can severely limit effectiveness of DUE
- Authoritative medical staff & formal organization recognition of DUE process necessary
- DUE activity should be a standing agenda for appropriate quality-of-care committees responsible for aspects of medication use

2) Poor organisation & documentation
- Need clear definition of roles & resp of indvs involved
- DUE activities well documented
- Documentations should address recommendations made & follow-up actions

3) Lack of follow-through
- Effectiveness of initial actions assessed & action plan adjusted if necessary
- Impt not to lose sight of improvement goals

4) Lack of readily retrievable data & information management
- Need to balance accessibility & accuracy
- Assess existing data capabilities & max benefit obtained from available computerised info management resources

5) Evaluation methods impedes pt care
- Data collection should not consume so much time tht pt care activities suffer
- Interventions that can improve pt care should not be withheld

26
Q

Pharmacist’s role in DUE

A
  • Educate & promote goals & objectives of DUE
  • Develop an operational plan for DUE programs & processes tht are consistent with the healthcare system’s overall goals & resource capabilities
  • Work collaboratively with others to develop/review criteria for specific medications/design specific MUPs
  • Collect, analyse & review data
  • Develop strategies to identify resolve & prevent drug-related probs
  • Interpret & report DUE findings & recommend changes in MUPs
  • Provide info & education based on DUE findings
  • Document program outcome & $-benefit
  • Participate as member of hospital committees concerned with QI
  • Present DUE results @ meetings & conferences

PR3145 (10 decks)

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