L12-L13 Quality Drug Use & Drug Use Evaluation Flashcards

1
Q

Define ‘quality/rational/responsible use of medicines’.

A

Rational use of drugs requires:

  • Patients receive medications appropriate to their clinical needs
  • In doses that meet their own individual requirements
  • For an adequate period of time
  • At the lowest cost to them and their community

Needs to take account of the best available clinical evidence of efficacy & safety, as well as an assessment of comparative cost-effectiveness.
- Draw parallels w/ quality healthcare: Safe, Effective, Patient-centered, Accessible, Efficient & Equitable

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2
Q

Name some root causes of why irrational drug use occurs.

A

1) Knowledge gap from HCP (i.e. NOT kept up-to-date)
2) Knowledge gap from consumers/patients
3) Cost & availability issues, resulting in adherence
- e.g. split dose to lengthen use of medication, leading to subtherapeutic doses
4) Accessibility (esp. in developing countries)
5) Lack of systems approach to monitor appropriate use of medication
- From lack of information to improve on

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3
Q

Articulate the 12 core interventions recommended by

WHO to promote quality/rational use of medicines.

A

1) Mandated multi-disciplinary national body to coordinate medicine use policies
- i.e. ACE is the main national body coordinating better use of medication, better stewardship of resources, clinical guidelines & subsidies
2) Evidence-based clinical guidelines
3) Essential medicines list based on Tx of choice (i.e. SDL)
4) Drugs (Pharmacy) and Therapeutics Committees in healthcare institutions
- Serves as an evaluative, educational and advisory capacity to the medical staff and organisational administration in all matters pertaining to use of medications (e.g. DUE)
- Usually have representation from various disciplines
5) Problem-based pharmacotherapy training in undergraduate curricula
6) Continuing in-service medical education as a licensure requirement
7) Supervision, audit & feedback
8) Independent information on medicines
- e.g. Singapore Association of Pharmaceutical Industries (SAPI) Code of Conduct 2019 requires transparency between drug companies and HCP
9) Public education about medicines
- Direct advertisement for POM prohibited in SG
- Must have good quality of medicine & quality of information regarding medicine to minimise non-adherence (up to 50% of DRP)
10) Avoidance of perverse financial incentives
- i.e. prescribers may over-prescribe if they can earn from selling certain products
11) Appropriate and enforced regulation
- e.g. marketing authorisation for industries, HCP licensing & institutions
12) Sufficient government expenditure to ensure availability of medicines and staff

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4
Q

Describe the role of the Drug (Pharmacy) & Therapeutics Committee (D&T/P&T) in the promotion of quality/rational use of medicines.

A

Responsible for overseeing policies & procedures related to ALL aspects of medication use as a multi-disciplinary advisory committee

  • Addition, deletion, review of drugs to/on the formulary
  • Drug use evaluation (DUE)
  • Adverse drug event monitoring & reporting
  • Medication error prevention
  • Development of clinical care plans & guidelines
  • Guidelines on interaction & role of pharmaceutical company representatives and medical science liaisons in a healthcare organisation
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5
Q

Why is there a need to regularly review the drug formulary?

A

1) List of medicine kept in healthcare institutions for prescribing can be too long
- Too much hassle to stock every single drug registered in HSA
- Allows HCP to be more familiar w/ specific medications with smaller list of drugs

2) Better prices due to bulk purchase of specific medication
- Translates to greater cost-savings for patients

3) Cost of inventory, cost of maintaining inventory and wastage can be reduced.

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6
Q

According to Joint FIP/WHO guidelines, what are the requirements for good pharmacy practice?

A

1) A pharmacist’s first concern in all settings is the welfare of patients.

2) The core of the pharmacy activity is to help patients make the best use of medicines, in which fundamental functions include:
- Supply of medication & other healthcare products of assured quality
- Provision of appropriate information & advice to patient
- Administration of medication when required
- Monitoring of effects of medication use

3) An integral part of the pharmacist’s contribution is the promotion of rational (and economic) drug use.

4) The objective of each element of pharmacy service is relevant to the patient, is clearly defined and is effectively communicated to all those involved.
- Multi-disciplinary collaboration among HCP is the key factor for successfully improving patient safety.

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7
Q

Discuss the roles of pharmacists in ensuring the quality use of medicines.

A

Medication supply chain -> Prescription -> Dispensing -> Administration -> Monitoring

1) Assuring integrity of medicine supply chain
- Detecting spurious / falsely-labelled / falsified / counterfeit / adulterated medicines
- Ensuring proper storage of medicines
- Quality preparation of medicines when needed

2) Assuring proper prescribing & dispensing of medicines
- All medicines prescribed are correctly indicated
- Dosing regimens & dosage forms are appropriate
- Instructions for use are clear.
- DDI & FDI are prevented
- Known & predictable ADRs, including allergies & other C/I, are avoided
- Unnecessary Tx administered & cost of medicines considered

3) Assisting patients & those administering medicines to understand the importance of taking medicines properly
- Right drug, right dose, right route, right time, right patient
- DDI & FDI to avoid when taking a dose
- What to expect after taking medications (i.e. side effects & ADRs)

4) Monitoring Tx to verify effectiveness & adverse medicine events is also an important part of process of quality use of medicines.

Optimising medication use w/in a health system is a collaborative venture necessitating partnership across disciplines

  • Pharmacists must take ownership & assume accountability for outcomes related to medication use across the continuum of care in healthcare system
  • For individual patients and also on a healthcare system level
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8
Q

Define what is “drug use evaluation”.

A

Combining keywords from all well-established definitions of MUE/DUE/DUR:

  • Is a systematic quality (performance) improvement activity that
  • Focuses on evaluating and improving quality of drug use and medication-use processes with the
  • Aim to achieve optimal patient outcomes.
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9
Q

What is the goal of DUE?

A

To improve quality, safety & cost-effectiveness of drug use, thereby optimising patient outcome & resource utilisation.

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10
Q

List the objectives of DUE.

A

1) Facilitate multi-disciplinary consensus on drug use
2) Conduct regular audits to ensure that drug therapy meets current standard of care (i.e. concordance with best practice)
3) Provide feedback of audit results to prescribers and stakeholders
4) Promote judicious, appropriate, safe and cost-effective therapy through provision of information, advice & education
5) Minimise variations in practice that contribute to suboptimal clinical outcomes
6) Enhance opportunities, to assess the value of (innovative) medication-use practices
7) Meet or exceed internal & external quality standards

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11
Q

Briefly describe what a DUE cycle is like.

A

Quality improvement cycle (mirrors PDSA cycle)

1) Evaluate / Investigate
- Identify, define & measure drug usage (problems)
- Drug use is evaluated against pre-determined standards

2) Improve / Intervention
- Problem-solving, consensus-building w/ development & implementation of strategies & innovations to improve drug use

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12
Q

Briefly describe the steps involved in conducting a DUE.

A

1) Identification of drug/medication use process to review
2) Assemble the DUE team
3) Design of study
4) Approval of study
5) Development of criteria & measurement instruments
6) Data collection
7) Evaluation w/ 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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13
Q

What are some drug usage / problems or issues with the medication use process the DUE team may identify to start a DUE?

A

1) Drugs under consideration for formulary retention, addition or deletion
- Retention: esp. after 6 months to 1 year as of first entry into formulary
- Deletion: e.g. less & less of drug prescribed

2) Drugs known to be associated w/ adverse events (including interactions) or poor patient outcomes

3) Drugs used in high-risk patients
- Neonates, infants, children
- Elderly
- Immunocompromised, ICU

4) Drugs w/ high-unit or high-volume cost
- High-unit e.g.: chemotherapy & immunotherapy drugs
- High-volume e.g. PPI

5) Drugs or processes where suboptimal use is likely to have or showed signs of negative effect on patient outcomes or system costs (e.g. Abx)
6) Adverse medication events (actual or averted as near-miss)
7) Signs of Tx failure (not showing efficacy in population)

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14
Q

Where should investigators from the DUE team go to identify the need for DUE?

A

Through certain “flags” or indicators:

1) Adverse medication events reporting
2) Hospital statistics (e.g. unexpected readmissions, increase incidence of bacterial resistance via antibiograms etc)
3) Pharmacist intervention reports
4) Non-formulary medication used or required
5) Patient feedback (e.g. dissatisfaction or determination in QoL)
6) Consumption of drug use trend (e.g. surge or dip)

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15
Q

A DUE committee can be formed by solely pharmacists. True or false? Why so?

A

False!

Ensure multi-disciplinary approach by including ALL stakeholders in the medication use process w/ various expertise to ensure sound assessment of practice performance

  • To identify standard of practice clinically agreed upon by ALL stakeholders
  • Need to obtain authorisation: frequently from CEO or CMB (chief of medical board), w/ oversight from institutional committee responsible for regulating drug use (i.e. D&T committee)
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16
Q

Describe the types of DUE study design available for adoption.

A

1) Retrospective
- i.e. review of drug therapy after pt received medication
- More common as time period is more flexible, simplest to perform & logistically less challenging
- Used to detect patterns in prescribing, dispensing or administering drugs to prevent recurrence or inappropriate use or abuse
- Serves as a means for developing prospective standards & target interventions
- Patient medical charts or computerised records are screened to determine whether drug therapy met approved criteria & aids prescribers in improving care for the patients, individually & w/in groups of patients

2) Concurrent
- Ongoing monitoring of drug therapy during course of Tx
- Starts when drug is prescribed

3) Prospective
- Evaluation of a patient’s drug therapy before or at the time medication is initiated (i.e. a “snapshot” in time)
- NOT an ongoing study
- e.g. antimicrobial stewardship

17
Q

What are some disadvantages of using a retrospective study design in a DUE study?

A

(-) Only impact patient care in future & not patient in the study
(-) Dependent on data & completeness of documentation (may be inaccurate)

18
Q

A DUE study design can be a full research (e.g. publication) or at a smaller scale (e.g. in-house), but it should be (1) prior to commencement of study & data collection needs to be (2). This research proposal should include (3), (4), (5), (6) & (7).

A

1) well-documented
2) consistent
3) background
4) aims
5) patient selection
6) data collection methods (incl. sampling strategy & PICOT)
7) proposed method of analysis

19
Q

Development of criteria and measurement instruments for a DUE study should be:

A

1) Evidence-based
2) Valid, practical, relevant to local context
3) Authoritative (i.e. based on authorised healthcare institution / CPG)
4) Explicit (i.e. minimal guesswork adopted)
5) Pre-determined
6) Easily measured / objective measures
7) Patient-oriented outcome

20
Q

Data collection instruments for DUE should be:

A

1) Unambiguous & “user-friendly”
- e.g. clearly defined checklist w/o free text
- Not more than 30 mins or 2 pages
2) Simple & focused
3) Include only relevant demographics, clinical or drug therapy information
4) Protect patient confidentiality
- Collect separately from investigators to protect blinding
5) Tested & refined in pilot studies
6) Taking advantage of existing automated information systems

21
Q

During the evaluation with pre-determined criteria & analysis of results from the DUE study, drug/MUP is (1) and mark as (2). (3) are identified and documented & may require review with prescribers to determine if there is a valid justification for doing so, especially for (4) study designs.

A

1) compared with pre-determined criteria
2) compliant/concordant/adherent
3) Areas of divergence
4) concurrent & prospective

22
Q

Feedback after a DUE evaluation should be (1) and (2), so that (3) & (4) findings are reported to relevant committees and departments under review, so as to (5). Other means of reporting includes: (6)

A

1) non-punitive
2) constructive
3) positive
4) negative
5) make recommendations on ways to improve problems identified
6) articles on hospital bulletins, presentation on grand rounds, journal publications, presentations at scientific or clinical meetings

23
Q

List all mitigation strategies by the hierarchy of effectiveness, as part of the intervention step of a DUE.

A

High leverage (most effective):

1) System-based: Forcing functions & constraints (e.g. removal of product from use)
2) System-based: Automation or computerisation (e.g. automated patient-specific dispensing)

Medium leverage (moderately effective):

3) System-based: Simplification & standardisation
4) Person-based: Reminders, checklists, double-checks (e.g. independent double checks for high-alert medications)

Low leverage (least effective):

5) Person-based: Rules & policies (e.g. policies to prohibit borrowing doses from other areas)
6) Person-based: Education & information (e.g. education sessions on high-alert medications)

24
Q

When is it appropriate to re-assess a DUE?

A

1) Simple monitoring of consumption data
2) Threshold analysis (require full-fledged DUE)
3) Periodic screening
4) Re-assessment of areas or target groups

May not require a full-fledged DUE except threshold analysis.

25
Q

What are some pitfalls in conducting a DUE?

A

1) Lack of authority & involvement
- DUE is NOT a one-person task, NOT responsibility of a single department or professional group, BUT developed thru an interdisciplinary consensus process
- Should be a standing agenda item for appropriate quality-of-care committees responsible for aspects of medication use
- Authoritative medical staff and support and formal organisation recognition of DUE process are necessary (e.g. D&T committee)

2) Poor organisation & documentation
- Should be well-documented, including summaries of DUE actions & findings & conclusions from collective evaluations
- Should address recommendations made & follow-up actions

3) Lack of follow-through
- One-time study or evaluation independent of overall DUE process has limited success in improving patient outcomes
- Need to intervene in order for improvement to occur
- Effectiveness of initial actions must be assessed & action plan adjusted if necessary

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

5) Evaluation methods impede patient care
- Data collection should NOT consume so much time that patient care activities suffer
- Intervention that can improve care for individual patients should NOT be withheld because of sampling technique or evaluation methodology

26
Q

Describe the role of pharmacists in DUE.

A
  • Exert leadership, manage process
  • Educate & promote the goals & objectives of DUE
  • Develop an operational plan for DUE programs and processes that are consistent w/ healthcare system’s overall goals & resources capabilities
  • Work collaboratively w/ other HCPs to develop & review criteria for specific medications & to design effective MUPs
  • Collect, analyse & evaluate data
  • Develop strategies to identify, resolve and prevent drug-related problems
  • Interpret & report DUE findings & recommend changes in MUPs
  • Provide information & education based on DUE findings
  • Document program outcome, effectiveness & cost-benefit analyses
  • Participate as a member of hospital committees concerned with quality improvement
  • Presentation of DUE results at meetings & conferences