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Compliance CA2 Revision > Quality Drug Use & Evaluation > Flashcards

Quality Drug Use & Evaluation Flashcards

1
Q

According to WHO, what is Quality Drug Use?

A

The rational use of drugs requires that

  1. Patient receive medications to their clinical needs
  2. Doses meeting individual requirements
  3. Treatment for adequate period of time
  4. Treatment at lowest cost to patients and community
  5. Treatment takes account of best clinical evidence of efficacy and safety, as well as cost-effectiveness
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2
Q

According WHO’s report, what are some common examples of irrational drug use

A
  1. Polypharmacy, or too many medications
  2. Injections used where PO more appropriate
  3. Abx inadequate dose, duration, or for non-bacterial infection
  4. Rx do not follow clinical guidelines
  5. Patients non-adherence, or inappropriate self-medication
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3
Q

What are the possible root causes for irrational drug use?

A
  1. HCP knowledge gap, Rx using outdated guidelines
  2. Patients concern about cost of medications, buy less medication that are unable to fill Rx, or split dose themselves
  3. Poor quality of drug, unable to fulfil therapeutic purpose
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4
Q

12 Core Interventions:
“A mandated multi-disciplinary national body to coordinate medicine use policies”

Which national body is co-ordinating this effort in Singapore?

A

Agency for Care Effectiveness (ACE)

Notes on what other bodies do:

  • HSA: Drug safety, CBA
  • NPS: Pharmacy services, improve healthcare in SG
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5
Q

12 Core Interventions:
“Evidence-based clinical guidelines”

How does this promote rational use of medicines?

A

Guidelines developed in a multi-disciplinary approach, allowing HCP to stay updated in their healthcare setting, hence narrowing any knowledge gaps

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6
Q

12 Core Interventions:
“Essential Medicines list based on treatments of choice”

What is the equivalent of “Essential medicines list” in SG called?

A

Standard Drug List: Medications most essential to treat certain disease, and no residents should be deprived of these meds

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7
Q

12 Core Interventions:
“Drug (Pharmacy) and Therapeutics Committees in healthcare institutions”

Describe the role of Drugs and Therapeutics Committee (TOR) in promoting rational use of medications

A
  • Serves in an evaluative, educational and advisory capacity in health institutions pertaining to use of medications
  • Responsible for overseeing policies/procedures related to all aspects of medication uses, e.g.:
  • Add/delete/review drugs to/on formulary, DUE, ADE monitoring and reporting, etc. (slide 9)
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8
Q

12 Core Interventions:
“Independent information on medicines”

Explain this intervention. In Singapore, describe the association that is in charged of ensuring independent information on medications

A

Independent information: Info to public and HCP should be balanced and unbiased. Companies should not accentuate benefits and hide the risks of any medications

SG: SG association of pharmaceutical industries (SAPI) governs how pharma companies should interact with stakeholders and:

  • Remove conflict of interest
  • Prevent biased influence onto HCP by companies
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9
Q

12 Core Interventions
“Avoidance of perverse financial incentives”

Explain

A

It’s the scheme where prescriber earns commissions for prescriptions. They may over prescribe to earn more money. Hence this is a conflict of interest, and strongly promotes irrational drug use. Avoiding this may help promote rational use of medications

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10
Q

12 Core Interventions
“Sufficient govt expenditure to ensure availability of medicines and staff”

How does having INSUFFICIENT expenditure in availability of medicines and staff promote irrational drug use

A

Lack of trained personnel and improper drug leads to irrational drug use and Rx

Hence budget set aside to train HCP properly, and also proper use of medication

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11
Q

List WHO’s 12 core interventions to promote rational use of medicines

A
  1. Mandated multi-disciplinary national body to coordinate medicine use policies
  2. Evidence-based clinical guidelines
  3. Essential medicines list based on treatments of choice
  4. TOR
  5. Problem-based pharmacotherapy training in undergrad curriculum
  6. Continuing in-service medical education as a licensure requirement
  7. Supervision, audit and feedback
  8. Independent info on medicines
  9. Public education about medicines
  10. Avoidance of perverse financial incentives
  11. Appropriate and enforced regulation
  12. Sufficient government expenditure to ensure availability of medicines and staff
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12
Q

What are the joint FIP/WHO guidelines on good pharmacy practice (GPP)?

A
  1. Pharmacists first concern is welfare of patients in all settings
  2. Core of pharm activity: help patients make the best use of medications
  3. Promotion of rational and economic drug use
  4. Each element of pharmacy service is relevant to patient. This should be communicated to all involved (i.e. multidisciplinary collab is important)
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13
Q

What are the roles and responsibilities of pharmacist in the medication use process

A
  1. Assure integrity of medicine supply chain
  2. Assure proper Rx and dispensing of medications
  3. Assist patients and those administering medicines to understand the importance of taking medicines properly (Right drug, route, time, dose, patient, foods, effect)
  4. Monitor treatment to verify effectiveness/AE
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14
Q

Why is quality drug use important?

A
  1. Impact on patients: need to optimise patient outcomes

2. Impact on society: Health and resources

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15
Q

What is the quality improvement tool used in attempt to accomplish quality drug use?

A

Drug use evaluation (DUE)/ Medication use evaluation (MUE) / drug use review (DUR) /drug utilisation review (DUR)

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16
Q

Why is quality drug use not easily accomplished?

A

Due to complex drug use environment as there are many drugs, uncertainties and influences leading to:

  • Variable Rx and drug use
  • Variable clinical outcomes
  • Different cost implications
17
Q

Combining the definitions of MUE/DUE/DUR from USA, WHO and Australia, define MUE/DUE/DUR.

A
  • A systematic quality improvement activity
  • focusing on evaluating and improving quality of drug use
  • with the aim to achieve optimal patient outcomes
18
Q

State the DUE cycle and its purpose

A
  1. Observe and measure drug use
  2. Identify and share issues
  3. Develop consensus approach
  4. Initiate and implement change strategies

Purpose: Identify the problematic drug and improve its usage

19
Q

List the steps in conducting DUE

A
  1. Identify drug/MUP for evaluation
  2. Assemble DUE team
  3. Design and obtain approval of study
  4. Develop criteria and measurement instruments
  5. Data collection
  6. Evaluate with pre-determined criteria and analysis of results
  7. Reporting and feedback
  8. Design and implement intervention
  9. Re-assess and revise problem
20
Q

When conducting DUE, what are the indicators that can help identify the need for DUE?

A
  1. Adverse medication events reporting
  2. Hospital stats (e.g. unexpected re-admission)
  3. Pharmacist interventions report
  4. Non-formulary medications used/requested
  5. Patient feedback: Dissatisfaction/deterioration in quality of life
21
Q

When conducting DUE, what are the type of drugs that are usually identified for DUE?

A
  1. under consideration for formulary retention/addition /deletion
  2. associated with AE (e.g. narrow TI)/poor patient outcomes
  3. used in high-risk patients
  4. high-unit/ high-volume cost
  5. Suboptimal use has shown negative effects on patients or system cost
  6. Adverse events, both actual or averted
  7. Signs of treatment failure
22
Q

When conducting DUE, who should your DUE team be comprised of?

A

Anyone appropriate so long as:

  • Multidisciplinary approach ensured, include all stakeholders in MUP wiith expertise to ensure proper assessment of practice performance
  • Authorisation obtained, usually by CEO or CMB, with oversight from institutional committee responsible for regulating drug use (e.g. TOR)
23
Q

In the conduct of DUE, briefly describe the 3 designs of DUE

A
  1. Retrospective - Review after patient received medication
  2. Concurrent: ongoing monitoring, of therapy during treatment
  3. Prospective: Evaluate therapy before or at time of medication is initiated
24
Q

In the conduct of DUE, what documentations regarding the design of DUE should be kept?

A
  • Background, aims, patient selection, data collection methods, proposed method of analysis, exclusion criteria, etc.
25
Q

In the conduct of DUE, what must be ensured before the design of DUE is approved?

A

Studies are mindful of ethical and patient privacy considerations:

  • Ethical issues resolved before data collection
  • May require de-identification of patient specific data, especially sensitive information like mental health
  • Ethics committee or IRB approval may be required
26
Q

In the conduct of DUE, during the development of criteria and measurement instrument, what are some properties that the developed criteria should have?

A
  1. Evidence-based
  2. Valid, practical, relevant
  3. Authoritative
  4. Explicit
  5. Pre-determined
  6. Easily measured with objective measurements
  7. Outcome oriented
27
Q

In the conduct of DUE, during data collection, what are the properties that data collection instrument should have?

A
  1. Unambiguous and user-friendly
  2. Simple and focused
  3. Include only relevant demographics, clinical or drug therapy info
  4. Protect patient confidentiality
  5. Tested and refined in pilot studies
  6. Make use of existing automated info systems
28
Q

In the conduct of DUE, describe the step “Evaluation with pre-determined criteria and analysis of results”

A
  • Drug/MUP compared with criteria
  • Mark as compliant if need be
  • Identify and document area of divergence
  • May require review with prescriber to determine valid justification for any divergence
29
Q

In the conduct of DUE, describe the step “Reporting and Feedback”. State who should the report and feedback go to, and what the report/feedback should contain

A

Go to: prescribers + relevant stakeholders

Means of reporting: articles, clinical meetings, etc.

Contains

  • Encouraging and negative findings
  • Recommendations on ways to improve
30
Q

In the conduct of DUE, multi-faceted interventions works best. What are some possible interventions that can be designed and implemented?

A
  1. Educational activities
  2. Publication of guidelines
  3. Restrictions like formulary changes and institution policies
  4. Persuasive strategies
  5. Workflow modifications like checklists, double-checks
  6. Additional pharmacy services
  7. IT integration and enhancements
31
Q

In the conduct of DUE, briefly describe the hierarchy of effectiveness in the design of effective strategies

A
  1. Low Leverage, least effective
    - Rules and policies
    - Education and information
  2. Medium Leverage, moderately effective
    - Simplify and standardise
    - Reminders, checklists, double checks
  3. High Leverage, Most effective (System-based)
    - Forced functions and constraints
    - Automation/ computerisation
32
Q

In the conduct of DUE, briefly describe the step “Re-evaluation and revision of problem”

A

DUE is a cyclical process:

  • Monitor changes implemented (e.g. periodic screening)
  • reassess target groups if required
  • Carry out threshold analysis
33
Q

Describe the role of pharmacists in DUE

think about the 10 steps of DUE. Pharmacists lead those steps

A
  1. Oversee, lead and manage process
  2. Educate and promote objectives of DUE
  3. Develop operational plan for DUE aligned to institution’s interest
  4. Collab with relevant stakeholders to develop/review criteria for specific meds to design effective MUPs
  5. Collect, analyse and evaluate data
  6. Develop strategies to identify, resolve and prevent DRP
  7. Interpret and report findings
  8. Recommend changes in MUP
  9. Provide info and education based on DUE finding
  10. Document outcome, effectiveness and cost benefit
  11. Participate as member of hospital committees concerned with quality improvement to share ideas
  12. Present DUE results at meetings and conferences
34
Q

What are some possible pitfalls of DUE?

A
  1. Poor organisation and documentation
  2. Lack follow-through
  3. Lack authority and involvement of appropriate stakeholders
  4. Lack readily retrievable data and info management
  5. Evaluation methods impede patient care
35
Q

How should re-evaluation of systems be done?

A
  • simple monitoring of consumption data
  • exception or threshold analysis
  • periodic screening
  • reassessment of areas or target groups
36
Q

What should documentations made during DUE address?

A
  • DUE activities: summary of DUE actions and findings as well as conclusions from collective evaluations
  • Address recommendations and follow-up actions – Check follow up actions after that

Compliance CA2 Revision (5 decks)

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