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PR3145 > Drug Use Evaluation > Flashcards

Drug Use Evaluation Flashcards

1
Q

What constitutes the rational use of drugs?

A
  • Patients receive meds appropriate to their clinical needs
  • Doses meet individual requirements
  • For adequate amt of time
  • At lowest cost to pt and their community

*Must take into account best clinical practices (efficacy/safety) + assess comparative cost-effectiveness

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2
Q

What are common examples of IRRATIONAL drug use? (according to WHO report)

A
  • Unnecessary polypharmacy
  • Using injectables over oral formulation that are more appropriate
  • Inadequate dose/duration of antimicrobial or Abx prescribed for non-bacterial infections
  • Prescriptions not following guidelines
  • Inappropriate self-medication by pt/non-adherence
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3
Q

What are some root causes of IRRATIONAL drug use?

A
  • Lack of knowledge from healthcare provider (HP) -> dk latest evidence (knowledge gap)
  • Lack of knowledge from pt –> no idea who to ask –> cannot make informed & correct decisions
  • Insufficient resources (pt) to buy all the needed doses -> split the doses up to lengthen use of medication
  • Insufficient funding and monitoring from govt
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4
Q

What is the estimated scale of IRRATIONAL drug use?

A

50% of all prescribed medicines are dispensed/sold inappropriately
50% of all pts fail to take meds correctly

*Yet few countries are monitoring medicine use or taking enough action to correct situation

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5
Q

What are the 12 core interventions WHO proposed to promote rational use of medicines?

A
  1. Mandated multi-disciplinary national body to coordinate medicine use policies (i.e. ACE in SG, incl. all stakeholders)
  2. Evidence based clinical guidelines
  3. Essential medicines list based on tx of choice (SG SDL)
  4. Drugs (pharmacy) and Therapeutics committee in healthcare institutions (TOR)
  5. Problem based Learning for pharmacotherapy in undergrad training (better learning outcomes)
  6. Continual Education as licensure requirement
  7. Supervision, audit, feedback (i.e. pcist interventions, DUE)
  8. Independent info on medicines (unbiased)
  9. Public education on medicines
  10. Avoidance of perverse financial incentives
  11. Appropriate and enforced regulation
  12. Sufficient govt expenditure to ensure availability of medicines and staff (i.e. CE, audits)
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6
Q

Describe the Drugs (pharmacy) and Therapeutics committee (TOR) role

A
  • Advises, educates and evaluates medical staff/administration in medication related matters
  • Oversees policies and procedures related to all aspects of medicine use
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7
Q

What are 6 aspects of medicine use overseen by the TOR?

A
  • Addition/deletion/review of formulary drugs
  • Drug use evaluation (DUE)
  • Adverse event monitoring and reporting
  • Med error prevention
  • Development of clinical guidelines/care plans (specific to institution)
  • Guidelines on interaction with pharma reps and medical science liaisons in a healthcare organisation (ensure only unbiased info is provided)
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8
Q

Why is it important to continuously evaluate the formulary?

A
  1. not possible to stock all health products registered in SG (more hassle than benefit)
  2. makes medication management easier
  3. inventory costs money (inventory depreciates in value over time) –> better use of resources
  4. less monitoring and stocking inventory concerns (time and labor cost) + less drug expiry –> less wastage
  5. as we limit the number of meds that are frequently used, we can order in larger bulk –> cheaper –> save cost –> this savings can be passed onto pts
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9
Q

Why does stocking fewer medications improve safety of drug use?

A

Safety aspect i.e. only stock 3-4 ACEI instead of the 10 in SG

  • Healthcare professionals (HP) will be more familiar with the 3-4 ACEI and less mistakes vs when 10 ACEI with some ACEI used less frequently –> can result in mistakes due to not being familiar)
  • Increases familiarity –> safety
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10
Q

What is the general process when adding a drug to the formulary?

A
  • Doctors who want to prescribe new drugs on market have to apply to add the new drug to formulary
  • pharmacist evaluate + discuss at D&T committee –> if yes, consider if new drug replaces any old drug –> formulary review
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11
Q

What are some key roles a pharmacist can play in the TOR?

A
  • Pharmacist also heavily involved in selection, dosing & monitoring of drugs –> should take ownership and join in drafts (review literature and discuss with other HPs tgt) -> make use of speciality in pharmacotherapy + provide our perspective
  • Formulary Review (key work of D&T and pharmacists) i.e. not stocking medications with poor R/B or new meds with overlapping clinical use (compared to current formulary drugs)
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12
Q

What are we looking for when we want independent information of medicines?

A

Independent from drug companies

  • info provided by pharma companies to hospitals and public need to be balanced and unbiased
  • better for HPs to provide info to pts rather than drug companies to pts (more biases* possible)

*e.g. focusing more on benefits and less on the risk

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13
Q

What are some key codes of conduct that pharma reps must adhere to, when interacting with stakeholders (i.e. prescribers)?

A
  • Discourage and disallow sponsorships and gifts from pharma to HPs
  • Promote transparency and avoid COI when it comes to med use
  • Provide unbiased, scientifically accurate information
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14
Q

Why is public education about medicines important?

A
  • health/med literacy among pts are lacking –> huge role pharmacist can play in informing and giving pts confidence in their medicine + carefully relaying info on side effects –> so pts can be confident in taking meds but know what to do when ADR occurs
  • proper education improves adherence (including outreach projects) –> let public know pharmacists are a source of drug information
  • also includes labelling on OTC meds so that are sufficient instructions for lay person to self-medicate

*also includes advertising control (prescription drugs not allowed to advertise in SG, only GSLs)

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15
Q

How is the SG landscape Regarding the avoidance of financial incentives?

A
  • Incentivized prescriber (GPs) gives meds more frequently/sell more expensive medicines compared to un-incentivized prescribers
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16
Q

What are key roles/responsibilities of a pharmacist in the medication use process?

A
  • Assuring integrity of medicine supply chain
  • Assuring proper prescribing and dispensing of medicines
  • assisting patients and those administering medicines to understand the importance of taking med properly
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17
Q

What can a pharmacist do in assuring integrity of medicine supply chains?

A
  • Detecting falsified/counterfeit medicines (able to read QA docs)
  • Ensuring proper storage of medicines
  • Quality preparation of medicines when needed (aseptic dispensing, TPN, chemotherapeutic prep)
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18
Q

What can a pharmacist do in assuring proper prescribing of medicines when needed?

A

Ensure prescribed medicine:

  • Indicated
  • Appropriate dose regimen and dosage form (i.e. avoid PO for comatose pt)
  • Clear instructions for use (for pts/caregivers to allow self medication)
  • DDI/Food-Drug interactions prevented
  • Known/predictable ADRs (i.e. allergies, contraindications) avoided
  • Minimize unnecessary tx and consider cost (affects adherence)
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19
Q

Why is the drug use environment complex?

A

Many drugs, uncertainties and wide range of influences that lead to:

  • Variable prescribing and drug use
  • Variable clinical outcomes
  • Different cost implications
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20
Q

It is known that rational drug use is not easily accomplished. What can we do to overcome this?

A

Use tools to help evaluate how we use drugs and make improvements (as needed) to ensure rational drug/resource usage

*MUE/DUE/DUR

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21
Q

What is DUE/MUE/DUR?

A
  • A systematic quality improvement activity
  • Focused on evaluating and improving quality, safety and cost-effectiveness of drug use and medication-use processes
  • Aims to achieve optimal patient outcomes
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22
Q

What are the 7 objectives of DUE?

A
  1. Facilitate multi-disciplinary consensus on drug use
  2. Regular audits to ensure drug tx in concordance with best practices
  3. Provide audit feedback to stakeholders and prescribers
  4. Inform, advise and educate on rational and cost effective drug use
  5. Minimize variations in practice that contribute to suboptimal outcomes
  6. Enhance opportunities to assess innovative medication use practices
  7. Meet or exceed internal/external quality standards
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23
Q

Why is getting a multi-disciplinary consensus so important for DUE?

A
  • need a definition of appropriate drug use within practice setting
  • many permutations or no consensus on dosing with varying reasons –> difficult to decide on action to take
  • consensus makes it clear and standardizes care –> contributing to optimal clinical outcomes
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24
Q

What is the Quality improvement cycle in DUE?

A
  1. Evaluate/Investigate
    - Identify/define/measure drug use
    - Evaluate against pre-determined standards
    - Look at new strategies implemented (if applicable)
  2. Improve/Intervention
    - Problem solving, consensus building
    - Implement strategies/solutions
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25
Q

What are the 10 steps involved in conducting a DUE ?

A
  1. Identification of Drugs/MUP for evaluation
  2. Assemble DUE team
  3. Design of study
  4. Approval of study
  5. Development of criteria and measurement instruments
  6. Data collection
  7. Evaluation with pre-determined criteria + result analysis
  8. Reporting and feedback
  9. Design and implementation of intervention strategies
  10. Re-assessment and revision of problem
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26
Q

How can we proceed with step 1 (Identification of Drugs/MUP for evaluation)?

A

Drugs:

  • consideration for formulary addition/deletion/retention
  • associated with adverse events (interactions) or poor patient outcomes
  • used in high risk patients
  • with high unit/volume cost
  • where suboptimal use is likely/shown to result in negative effect on pt outcomes/system cost
  • Adverse Medication events (actual/averted)
  • Signs of tx failure
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27
Q

What are some flags/indicators for the need for DUE?

A
  • Adverse medication event* reporting
  • Hospital stats (i.e. unexpected readmissions, increased incidence of bacterial resistance)
  • Pcist intervention reports
  • Non-formulary medication use/request
  • Patient feedback - dissatisfaction or deterioration in QoL

*aka hospital occurrence report

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28
Q

What needs to be done for step 2 (Assemble DUE team)?

A
  • Ensure multidisciplinary approach
  • Include all stakeholders* in the MUP (with expertise to ensure sound assessment of clinical practice)
  • Obtain authorization (CEO/CMB) with oversight from institutional committee (TOR)

*Ensure consensus

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29
Q

What are the 3 designs we can use for step 3 (Design of DUE)?

A
  1. Retrospective (review of drug tx AFTER pt use)
  2. Concurrent (ONGOING monitoring during tx course)
  3. Prospective (evaluation BEFORE/AT THE TIME medication initiated)
30
Q

What are things to note when designing a DUE?

A
  • DUE study design must be documented prior to commencement of study
  • Include background, aims, pt selection, data collection methods and proposed method of analysis
  • Sampling (cost/labour limitations)

*Ensure data collection is standardized and consistent

31
Q

Why are retrospective DUEs the most common DUE?

A

Simplest to perform

  • no need to race against time
  • can review a larger number of patients
  • can conduct when free
32
Q

How is a retrospective DUE conducted?

A

Pt medical charts/computerized records screened to determine if drug tx met approved criteria
- Aids prescribers in improving pt care (individuals and groups of pts)

33
Q

What are the benefits/limitations of a retrospective DUE?

A

+ Detect patterns to prevent occurrence of irrational drug use (prescribing, dispensing, administration patterns)
+ Serves as a means for developing prospective standards and target interventions
- Benefits future pts only
- Dependent on accuracy and completeness of data recorded

34
Q

What must we consider for step 4 (approval of DUE)?

A
  • All DUE studies must be mindful of the ethical and pt privacy concerns
  • Ethical issues resolved before data collection
  • May require de-identification of pt specific data
  • Ethics committee/Institutional Review Board (IRB) may be needed
35
Q

How can de-identification of pt specific data be done?

A
  • separate master file containing pt identifiers and data file (only code/number)
  • data file cannot allow tracing to the pt (esp sensitive info i.e. HIV/mental status)

*files should be password protected

36
Q

How can we tell if the DUE requires IRB approval?

A
  • IRB approval needed if group has the intention to publish/share study outside hospital i.e. meeting/symposium
  • if pure quality improvement project within institution, may not need IRB approval (domestic use), TOR approval is sufficient
37
Q

Under Criteria and measurement instruments (step 5 DUE process), how should we choose our criteria to ascertain if drug use is according to standard of care?

A

Criteria must be

  • evidence based
  • valid, practical, relevant
  • authoritative (multi-disciplinary team helps)
  • explicit
  • pre-determined
  • easily measured (objective measures)
  • Outcome orientated

Use National, Independent, authoritative sources
- MOH, WHO, Medical associations, National guidelines Clearinghouse, National Institute for Health and clinical Excellence (UK)

38
Q

What are 2 things to note regarding national, independent, authoritative sources we can use to establish criteria?

A
  1. Note their respective methods of assessing info and evidence
  2. Usually guidelines not updated frequently
    - look at date of guidelines–> need to be relevant and up-to-date
    - i.e. 5 year old guidelines may contain 6 year old data
    - most frequently updated guidelines –> HIV guidelines (every 6mnths)
39
Q

Where can we obtain drug availability criteria?

A

The hospital may already have their own recommendations/restrictions

40
Q

If there are no criteria to reference, what can a DUE team do?

A
  • DUE team may build in-house criteria

- Ensure quality + input and consensus from expert clinicians or main users/stakeholders

41
Q

What are some scenarios where a prospective* DUE may be preferred?

*evaluation BEFORE/AT THE TIME medication initiated

A

Preferred for costly drugs to ensure money well spent and to save pt lives

42
Q

When are concurrent* DUEs not preferred?

*ONGOING monitoring during tx course

A
  • When monitoring for drug in question is part of usual care (not exclusive to this drug)
  • When the drug is given single dose
  • When there are no requirements for therapeutic drug monitoring/dose adjustments
43
Q

How should we conduct data collection (step 6 of DUE)?

A

Data collection instrument (i.e. form) should be:

  • Unambiguous and user-friendly
  • Simple and focused
  • Inclusive of relevant demographic/clinical/drug tx info only
  • Protective of confidentiality
  • Tested and refined in pilots
  • Taking advantage of existing automated info systems
  • MUST BE ACCURATE
44
Q

How can we make our data collection instrument unambigious and user friendly?

A

field names need to be intuitive

  • everyone can understand
  • clearly defined (including time frame for collection) –> i.e. choosing mortality as an outcome (must define the time period where we define this outcome) –> in infectious disease, usually 30day mortality (need to count day 1 i.e. from when abx started or when blood culture drawn)
  • user friendly in the sense that you dont have to click so many places (microsoft access looks like a form, no need to scroll to the end to view data, can manage on the same page via drop down)
45
Q

How can we make our data collection instrument simple and focused?

A
  • not more than 2 pages DUE form
  • not more than 30mins (too long forms/duration = fatigue = poor data)
    Note: always focus on the purpose of DUE –> analysis must be able to answer our question
  • avoid free text, hard to interpret
46
Q

What is a good general rule of thumb for data collection?

A
  1. what data we want to collect (define all data fields)
  2. where this data should be obtained (medical records can include discharge summary, admission note)
  3. which time point do you want to collect the data
  4. how is the time points defined
  5. try analysis with some sample data and see if it answers our question (collecting too much data = cut down, collecting too little data = collect the missing data)
47
Q

How can we take advantage of existing software to help with data collection?

A

number 1 qn: ask if this info can be found electronically

  • save labour cost
  • vlookup function in excel is useful (allows matching of things in minutes) or other tricks in excel
  • start from electronically available data (or include them)
  • usually collected into excel/access (microsoft software that helps create files) -> export through excel -> import into statistical software SPSS for analysis
  • also other software: redcap (official software for massive clinical data)
48
Q

How can we conduct Evaluation with pre-determined criteria and analysis of results (step 7 DUE)?

A
  • Compare Drug/MUP with pre-determined criteria
  • Mark as compliant/not compliant
  • identify and document area of divergence
  • May need to ask prescribers for justification for divergence* (easier for concurrent/prospective DUE**)
  • institution restriction to allow/disallow override
  • *Retrospective DUEs may not document reason, prescriber may no longer recall reason
49
Q

How can we conduct Reporting and Feedback (step 8 DUE)?

A
  • Non-punitive and constructive feedback
  • To prescribers and stakeholders, relevant committees and department-under-review
  • Report both positive and negatives
  • Report recommendations
  • Can be via articles in bulletin, presentation at grand rounds, publication in journals, presentation at scientific/clinical meetings (needs IRB)
50
Q

How can we design and implement intervention strategies (step 9 DUE)?

A

Multi-faceted interventions are best

  • Education
  • Guidelines
  • Restrictions (formulary changes, access restriction)
  • Persuasion (i.e. rewards, opinion leaders)
  • Workflow modifications (checklists, double checks)
  • Additional pharmacy services (i.e. Anti-microbial stewardship)
  • IT integration/enhancement
51
Q

Under the hierarchy of effectiveness, what are some examples of LOW leverage risk mitigation strategies?

A

Person based:

  • Rules and policies (i.e. policy inhibiting borrowing doses from other areas)
  • Education and information

*low effectiveness but cannot be ignored

52
Q

Under the hierarchy of effectiveness, what are some examples of MEDIUM leverage risk mitigation strategies?

A

Person based:
- Reminders, checklists, double checks
System based:
- Simplification and standardization

53
Q

Under the hierarchy of effectiveness, what are some examples of HIGH leverage risk mitigation strategies?

A

System based:

  • Forcing functions and constraints (i.e. removal of product)
  • Automation/computerization (i.e. automated pt specific dispensing)
54
Q

How can we re-assess and revise the problem (step 10 DUE)?

*recall DUE is a cycle –> revisit and see if problem still there (incorporate lessons from prev cycles)

A

Re-evaluation via:

  • Simple monitoring of consumption data (i.e. for overuse)
  • Exception/threshold analysis (i.e. if use > x number/year –> trigger DUE)
  • Periodic screening
  • Reassessment of areas/target groups (i.e. narrowing of focus compared to initial DUE to departments with higher incidence of problems)
55
Q

What are 5 pitfalls of DUE?

A
  • Lack of authority and involvement
  • Poor organization and documentation
  • Lack of follow through
  • Lack of readily retrievable data and information management
  • Evaluation methods impedes patient care
56
Q

How can Lack of authority and involvement contribute to DUE failure and how can we avoid this?

A

Lack of administrative support can severely limit effectiveness of DUE

  • Authoritative medical staff support and formal organization recognition is necessary (i.e. data collection, time/manpower set aside for analysis)
  • Needs to be standing agenda* for TOR
  • Convey benefits of DUE in terms of pt outcomes improvement and minimizing cost (better relevance)

*- standing importance –> discussed at every meeting on updates/what is upcoming/planned/gaps to close

57
Q

How can Poor organization and documentation contribute to DUE failure and how can we avoid this?

A

Without a clear definition of roles and responsibilities of individuals, the DUE process may not succeed

  • Need to take Ownership of DUE
  • Needs to be well documented (including summaries of DUE actions, findings/conclusions from collective evaluations)
  • Documentation should address recommendations made and follow up actions
58
Q

How can Lack of follow through contribute to DUE failure and how can we avoid this?

A
  • One-time study/evaluations independent of overall DUE process will have limited success in improving pt outcomes
  • Effectiveness of initial actions must be assessed and adjusted if needed
  • Impt not to lose sight of improvement goals
59
Q

How can we avoid lack of readily retrievable data and information management?

A

Existing data capabilities need to be assessed and maximum benefit* obtained from available (computerized info management resources

*Improve efficiency (time and labor cost) and do random checks on the data to ensure data is accurate

60
Q

How can we avoid evaluation methods that impede pt care?

A
  • Data collection should not consume too much time to the point pt care activities suffer
  • Interventions that can improve care should NOT be withheld for the purposes of sampling/evaluation methodology

*Pt care is the aim here

61
Q

What is the pharmacist’s role in the DUE process

A
  1. Lead and manage
  2. Educate and promote goals/objectives
  3. Develop operational plan consistent with health system’s goals and resources
  4. Work collaboratively to develop/review criteria, design effective DUEs
  5. Collect, analyze and evaluate data
  6. Develop strategies to solve DUE problems
  7. Interpret and report findings, recommend changes
  8. Inform and educate based on DUE findings
  9. Document outcome, effectiveness and cost benefit
  10. Participate in hospital committees concerned with quality
  11. Presentation of DUE results at meetings/conferences (IRB)
62
Q

How does IPE play into the DUE process?

A
  • Multidisciplinary consensus and criteria building
  • Help data collection (esp if DUE includes diagnostic issues, Dr can help)
  • Ensure valid interpretation of data and workable solutions (get Dr input esp when topic is not pcist forte/not based on objective evidence)
  • Gives confidence and credibility to DUE
63
Q

Why is participating in hospital committees concerned with quality useful for a pharmacist looking to start a DUE process?

A
  1. helps pcist understand what hospital committee is concerned with
  2. give input on which medication to conduct DUE on
64
Q

What is one way to motivate fellow pcists to get onboard with the DUE process?

A

if IRB approval, DUE can be a research project

  • can motivate people to complete in good time
  • can present at PSS or even overseas meetings
  • esp if alot of time is going to be spent on this DUE
  • can get more pcist on board and put more rigor into DUE (esp if new innovative methods/ideas to share w larger audience)
65
Q

What are DUE pearls*?

*factors that improve likelihood of success

A
  1. Choose worthwhile projects
  2. Obtain management buy-in (authority)
  3. Plan properly
  4. Know the purpose
  5. Make it collaborative and multi-disciplinary
  6. Focus on system improvement and knowledge management
66
Q

How can we Choose worthwhile projects for DUE?

*We are limited in resources

A
  • Begin with low hanging fruit (easily reachable) i.e. drugs of high concern to hospital
  • Go for obvious problems (plenty of feedback and data pointing to issue)
  • Great implications
67
Q

What is an expected timeframe for a DUE?

A

Assessing drug use and suggesting strategies for drug improvement can be done in 5weeks

68
Q

How can we ensure proper planning for a DUE?

A

KEY

  • purpose
  • background info
  • look at existing guidelines if any, or make your own
  • literature research on guidelines available (local/overseas)

Form: ensure objective is answered with not too much or too little info
- Test data collection form (pilot), database

69
Q

How can we focus on system improvement and knowledge management?

A

System improvement: making the right thing easy

Knowledge management: help stakeholders internalize information (translate to knowledge) to improve medication process

70
Q

As a pharmacist, why is DUE important?

A
  • it is our job to look at data + we have access to drug use data
  • need to be alert to drug use issues -> suggest DUEs + know which drug to conduct DUE on
  • there is a need to guide use of new drugs
  • countless lives can be saved when good DUEs conducted
  • Raise profile and role of pharmacists

PR3145 (10 decks)

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