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Questions and Answers
What is a primary limitation of health insurance records?
What is a primary limitation of health insurance records?
How can patient registries be characterized?
How can patient registries be characterized?
What type of registry would include patients using TNFα inhibitors?
What type of registry would include patients using TNFα inhibitors?
Who can set up and maintain patient registries?
Who can set up and maintain patient registries?
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What is a potential purpose of post-marketing registries?
What is a potential purpose of post-marketing registries?
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What is the primary purpose of drug utilization studies?
What is the primary purpose of drug utilization studies?
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Which factor is NOT mentioned as a proxy for assessing prescription drug misuse?
Which factor is NOT mentioned as a proxy for assessing prescription drug misuse?
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What type of data can be utilized to assess drug combinations such as polypharmacy?
What type of data can be utilized to assess drug combinations such as polypharmacy?
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Claims data are generated when which entity submits a request?
Claims data are generated when which entity submits a request?
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What type of information do sales data provide?
What type of information do sales data provide?
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In drug utilization studies, differences in drug use can be assessed across which dimensions?
In drug utilization studies, differences in drug use can be assessed across which dimensions?
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What does the term polypharmacy refer to?
What does the term polypharmacy refer to?
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Which data source is NOT typically associated with drug utilization studies?
Which data source is NOT typically associated with drug utilization studies?
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What is the purpose of the Defined Daily Dose (DDD)?
What is the purpose of the Defined Daily Dose (DDD)?
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Which statement accurately describes the relationship between DDD and individual patient doses?
Which statement accurately describes the relationship between DDD and individual patient doses?
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What does the ATC/DDD index lack in terms of drug classification?
What does the ATC/DDD index lack in terms of drug classification?
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Which type of data is considered aggregated data in drug utilization research?
Which type of data is considered aggregated data in drug utilization research?
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What is primarily assessed in pioneering drug utilization studies in Europe?
What is primarily assessed in pioneering drug utilization studies in Europe?
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What is a limitation of using electronic health records for drug utilization analysis?
What is a limitation of using electronic health records for drug utilization analysis?
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How does the existence of multiple health insurance companies affect drug utilization research?
How does the existence of multiple health insurance companies affect drug utilization research?
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What aspect of drug utilization research is closely related to pharmacoepidemiology?
What aspect of drug utilization research is closely related to pharmacoepidemiology?
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What is the role of reimbursement data in drug utilization research?
What is the role of reimbursement data in drug utilization research?
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Which of the following factors can influence drug utilization?
Which of the following factors can influence drug utilization?
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What can aggregated data help predict in terms of drug utilization?
What can aggregated data help predict in terms of drug utilization?
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Which system aids in clinical decision-making related to drug utilization?
Which system aids in clinical decision-making related to drug utilization?
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What role does the WHO International Working Group for Drug Statistics Methodology serve?
What role does the WHO International Working Group for Drug Statistics Methodology serve?
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Which of the following is NOT a component of drug utilization?
Which of the following is NOT a component of drug utilization?
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How does drug shortage impact drug utilization research?
How does drug shortage impact drug utilization research?
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What is a critical outcome of drug utilization research?
What is a critical outcome of drug utilization research?
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What is the primary aim of drug utilization research?
What is the primary aim of drug utilization research?
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Which factor significantly affects drug affordability for patients?
Which factor significantly affects drug affordability for patients?
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What role do regulatory agencies play in drug safety?
What role do regulatory agencies play in drug safety?
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What function do hospital formularies serve in medication management?
What function do hospital formularies serve in medication management?
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Which statement accurately describes the influence of physicians in drug utilization?
Which statement accurately describes the influence of physicians in drug utilization?
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What can market strategies influence in drug utilization?
What can market strategies influence in drug utilization?
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What is one purpose of drug utilization research?
What is one purpose of drug utilization research?
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When was the European Drug Utilisation Research Group (EuroDURG) established?
When was the European Drug Utilisation Research Group (EuroDURG) established?
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Which type of research is primarily focused on gaining a deeper understanding of medication consumption patterns?
Which type of research is primarily focused on gaining a deeper understanding of medication consumption patterns?
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Which component is NOT part of the Rational Use of Medicines framework?
Which component is NOT part of the Rational Use of Medicines framework?
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What type of data is considered primary for drug utilization studies?
What type of data is considered primary for drug utilization studies?
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The ATC/DDD methodology is used for what purpose in drug utilization research?
The ATC/DDD methodology is used for what purpose in drug utilization research?
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Which type of data is typically used secondarily for drug utilization research?
Which type of data is typically used secondarily for drug utilization research?
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Which of the following is NOT a measurement unit commonly used in drug utilization research?
Which of the following is NOT a measurement unit commonly used in drug utilization research?
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What is a key indicator used to identify inappropriate prescription practices?
What is a key indicator used to identify inappropriate prescription practices?
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What type of quantitative research tool can be used to analyze prescribing patterns?
What type of quantitative research tool can be used to analyze prescribing patterns?
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Which of the following is an indicator of medication abuse?
Which of the following is an indicator of medication abuse?
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What is an essential aspect of measuring drug utilization in populations?
What is an essential aspect of measuring drug utilization in populations?
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Study Notes
Drug Utilization
- Drug utilization is the exposure to drugs in a population within a specific period and socioeconomic environment
- Drug Utilization Research is dedicated to analyzing and assessing drug prescribing, dispensing and consumption, focusing on the resulting medical, social, and economic consequences.
- Aims of drug utilization research is to ensure rational use of medicines
- Aimed at right drug, right patient and indication; right dosing and dosage form; right route of administration; right duration of treatment; and acceptable costs.
- Drug utilization can be measured in various ways, including number of packages, prescriptions, weight units, prescribed daily doses (PDDs), defined daily doses (DDDs), proportion of patients using the medication, and financial costs.
Types of Research and Data
- Research can be primary or secondary. Primary data is collected for the specific research purpose while secondary data is collected for a different purpose but used for research purposes.
- Data can be aggregate or individual. Aggregate data is data collected from a large group of individuals or items. Individual data is info about an individual.
- Data sources include sales data, dispensing data, electronic health records, reimbursement data, and patient registries.
Measurement Units
- Drug expenditure
- Weight units
- Number of tablets
- Number of packages
- Number of prescriptions
- Number of DDDs
- Number of PDDs
- Percentage of patients using medication
ATC/DDD Methodology
- The ATC/DDD system standardizes drug utilization measures to enable global comparisons
- It helps to examine drug trends and is useful in different healthcare settings and regions.
- It is not appropriate to use for reimbursement or pricing decisions.
- The number of DDDs per package should be calculated for every medicinal product and integrated into a national registry.
DDD (Defined Daily Dose)
- DDD is the assumed average maintenance dose per day for a drug for its main indication in adults.
- DDD units include grams (g), milligrams (mg), micrograms (mcg), units (U), thousand units (TU), million units (MU), millimoles (mmol), and milliliters (mL).
- A single DDD per ATC code and route of administration is assigned.
Advantages and Limitations of DDD
- Advantages include standardized metric, independent of price, currencies, package size and strength.
- DDD allows analysis of drug utilization trends and enables comparisons between different countries.
- Limitations include often being a compromise, not reflecting recommended or prescribed daily dose, sometimes being an average of multiple commonly used doses and not reflecting duration of treatment.
Principles of DDD Assignment
- The Recommended dose for the main indication for the ATC code is used to determine the DDD, considering 70 kg as the average adult weight.
- The long-term, maintenance dose is generally used for determining the DDD.
- DDDs often may not be established for topical products, vaccines, antineoplastics, allergy extracts, anesthetics or contrast media.
Principles of Equipotence (DDD Assignment)
- DDD effects within the same ATC group should be similar.
Types of Data
- Aggregate: sales data, wholesale/distributor data, pharmacy dispensing data.
- Individual-level: pharmacy dispensing data (for example pharmacy dispensing data, reimbursements ,e-health records.
Types of Research Data
- Primary: data collected directly for the research
- Secondary: data for a different purpose which are used for research
Data Sources
- Customs/Import offices: aggregated data
- Distributors: aggregated data
- Manufacturers: aggregated data
- Hospitals: aggregated and patient-level data
- Medical practices: aggregated and patient level data
- Pharmacies: aggregated and patient-level data
- Reimbursement agencies: aggregated or patient-level data.
- Health Insurance: aggregated or patient-level data
Relationship between Drug Utilization Research and Pharmacoepidemiology
- Drug utilization research forms an essential part of pharmacoepidemiology by describing the extent and nature of drug exposure in a given population.
- Factors influencing drug utilization, such as patient and provider characteristics, diseases, marketing, regulations, and reimbursements are discussed within the scope of pharmacoepidemiology.
- Measures influence prescriptions, dispensing and consumption of drugs.
Significance of Drug Utilization Research
- Evaluating suitable prescriptions to standards.
- Monitoring prescription standards with current clinical guidelines, SmPC, antibiotic policy, and drug formularies.
- Monitoring overuse/underuse of drugs
- Assessing off-label use and medication abuse.
Prevalence vs Incidence
- Prevalence: existing users of a drug or condition at a given point in time
- Incidence: new users or occurrences of a condition or drug at a particular time.
Relative Measures
- Measures of Drug Use per 1000 inhab/day or 100 bed days.
Examples of Studies
· Examples of studies include the impact of published studies on drug usage, such as hydrochlorothiazide, which was found to be linked to skin-cancer risk. This publication led to a decrease in its use. · Examples of impact of regulatory interventions is the withdrawal of dextropropoxyphene that led to a decrease in its use after the European Medicines Agency (EMA) recommendation · Examples when recommended drug doses do not correspond to DDDs include examples relating to renal impairment, age, or off-label use.
Regulatory Agency
- In the Czech Republic, the State Institute for Drug Control (SÚKL), provides aggregate data reports from manufacturers, distributors and pharmacies.
###Record Linkage
- Linking data from various sources to form a comprehensive patient and prescriber profile for research to study the suitability of drug use. Record linkage assists in constructing drug exposure histories.
Drug Expenditure
- Expenditure means medicine price multiplied by volume.
- The various price types include ex-factory, wholesale, and pharmacy retail (net/gross).
Data Sources
- Aggregate data from manufacturers, distributors, pharmacies, and surveys.
- Individual data from health records, insurance claims, and patient registries.
- Regulatory agency reports (SÚKL, Czech republic)
Impact of Clinical Guidelines
- Analyzing changes in antihypertensive drug prescriptions before and after the implementation of new clinical guidelines.
Types of Research
- Quantitative: measuring prescribing, dispensing and consumption. Uses existing databases, representative populations. Described use of numerical and statistical measures.
- Qualitative: in-depth studies on prescribing, dispensing, and consumption for a deeper understanding. Typically uses in-depth interviews and rich information from patients, physicians, and stakeholders. Presented in a narrative fashion.
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