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Drug Utilization Studies 
Dr. Mansij Biswas, SYR 
Department of Pharmacology & Therapeutics 
Seth G S Medical College & KEM Hospital
Introduction & Definition: 
 Pharmaco-epidemiology is the study of use and effects 
or side-effects of drugs in large number of people with 
the purpose of supporting the rational and cost effective 
use of drugs in population, thereby improving health 
outcomes. 
 WHO defines drug utilization research as, “the 
marketing, distribution, prescription and the use of 
drugs in a society with special emphasis on the resulting 
medical, social and economic consequences.”(WHO, 
1977) 
June 7th, 2014 
INTRODUCTION TO DRUG UTILIZATION RESEARCH, WHO International Working Group For 
Drug Statistics Methodology, WHO Collaborating Centre For Drug Statistics Methodology, WHO, 2003. 
2
Looking back… 
 Initiated in Northern Europe and The UK in the mid 
1960s 
 Arthur Engel in Sweden and Pieter Siderius in Holland 
described importance of comparing drug use between 
different countries and regions 
 Differences in sales of antibiotics in six European 
countries between 1966 and 1967 inspired WHO to 
organize first meeting on drug consumption in Oslo, 
1969 
June 7th, 2014 3
 Constitution of WHO European Drug Utilization 
Research Group (DURG) 
 Development of a new unit of measurement, initially 
called the agreed daily dose and later the Defined Daily 
Dose (DDD), by researchers from Ireland, Norway & 
Sweden 
 The first study used anti-diabetic drugs as an example 
 Among the first countries to adopt the DDD 
methodology was the former Czechoslovakia 
 First comprehensive national list of DDD was published 
in Norway in 1975 
June 7th, 2014 4
Why drug utilization research? 
 The principal aim is to facilitate the rational use of 
drugs in populations. 
 Rational use of medicines (RUM) is defined as 
“Patients receive medications appropriate to their 
clinical needs, in doses that meet their own individual 
requirements, for an adequate period of time, and at the 
lowest cost to them and their community” (WHO, 1985) 
June 7th, 2014 
Promoting Rational Use of Medicines: Core Components - WHO Policy Perspectives on 
Medicines, No. 005, September 2002 5
Objectives: 
 Description of drug use pattern 
 Early signals of irrational use of drugs 
 Interventions to improve drug use – follow up & 
assessing the impact 
 Quality control of drug use 
June 7th, 2014 6
 Description of drug use pattern : - 
Drug utilization research will increase our understanding of 
how drugs are being used by- 
 Estimating the numbers of patients exposed to specified 
drugs within a given time period. 
 Getting extent of use at certain moment or area. 
 Estimating to what extent drugs are properly used, 
overused or underused. 
June 7th, 2014 7
 Determining pattern or profile of drug use and the 
extent to which alternative drugs are being used to 
treat particular conditions. 
 Comparing the observed patterns of drug use for the 
treatment of certain disease with current guidelines. 
 Giving feedback of the drug utilization data to 
prescribers. 
 Assessing the potential magnitude of the problem 
June 7th, 2014 8
 Early signals of irrational use of drugs: 
 Comparing drug utilization patterns and cost 
between different regions or time period 
 Comparing observed patterns of drug use with 
current recommendation or guidelines for the 
treatment of certain disease 
June 7th, 2014 9
 Interventions to improve drug use-follow 
up: 
 Monitoring and evaluating the effects of measures 
taken to improve undesirable patterns of drug use 
 Following the impact of regulatory changes or 
changes in the insurance or reimbursement schemes 
 To which extent promotional activities of the 
pharmaceutical industry and educational activities of 
the society impact on the patterns of drug use 
June 7th, 2014 10
 Quality control of drug use: 
Drug use should be controlled according to a quality control 
cycle that offers a systematic framework for continuous 
quality improvement 
Step 1 : PLAN – 
Analyze the current 
situation to establish 
plan for improvement 
Step 2 : DO – 
Implement the plan on 
small scale 
Step 4 : ACT – Revise 
plan or implement plan 
Step 3 : CHECK – 
Check to see if 
expected results are 
obtained 
June 7th, 2014 11 
on large scale
Types of drug use information 
 Drug based information 
 Problem or encounter based information 
 Patient based information 
 Prescriber based information 
 Cost based information 
June 7th, 2014 12
A) Drug based informations 
◦ Data on drug use on various levels, and 
information on indications, doses and dosage 
regimen is usually necessary 
◦ Level of drug use aggregation : The level at 
which data on drug use are aggregated will 
depend on question being asked. 
 E.g. Hypertension 
June 7th, 2014 13
 Indication – 
◦ For drugs with multiple indications, it will 
usually be important to divide data on use 
according to indication to allow a correct 
interpretation of the overall trends. 
E.g.- 
◦ antibiotic utilization 
◦ Use of beta-blockers 
June 7th, 2014 14
B) Problem based informations 
◦ Useful to address the question – how a particular 
problem is managed. 
 Questions that might be addressed: 
◦ Does the severity of the disease influence the 
choice of single or combination therapy ? 
◦ Is the management of newly-presenting patients 
different to that of patients already receiving 
treatment ? 
◦ Are there likely to be any drug interactions with 
co-prescribed treatments ? 
◦ Is the choice of drug influenced by evidence 
based outcome data ? 
June 7th, 2014 15
C) Patient based informations 
Information on demographic factors and other 
details about the patient are useful 
Age distribution – to assess the likelihood of severe 
adverse effects with some drugs 
Comorbidities of patient 
Knowledge, beliefs and perceptions of patients and 
their attitudes to drugs are important 
June 7th, 2014 16
D) Prescriber based informations 
This information is useful to understand how 
and why drugs are prescribed. 
◦ Some questions that might be addressed: 
 Are prescribing profiles influenced by the 
prescriber’s medical education? 
 Do the prescribing profiles of specialists differ from 
those of general practitioners ? 
 Does the age or gender of the prescriber influence 
the prescribing profile? 
June 7th, 2014 17
 Are there differences in prescribing behavior 
between urban and rural practices or between 
small and large practices ? 
 Who are those prescribers who rapidly adopt to 
recently released drugs ? 
 Can the factors that determine and change 
prescribing behavior be identified ? 
June 7th, 2014 18
E) Cost based informations 
It will always be important in managing policy 
related to drug supply, pricing and use. 
E.g. Use of antipsychotic drugs in Australia 
June 7th, 2014 19
The DUS cycle: 
Planning 
Data 
collection 
Evaluation 
Feedback of 
results 
Feedback of 
results 
Interventions 
June 7th, 2014 20 
Reevaluation
Steps involved in 
conducting a drug 
utilization study:- 
June 7th, 2014 21
Step 1:- Identify drugs or therapeutic 
areas of practice for inclusion in the 
program 
Drug-use Chain 
a) The systems and structures surrounding drug use 
 e.g. how drugs are ordered, delivered and administered in 
a hospital or health care facility 
b) The processes of drug use 
 e.g. what drugs are used and how they are used and does 
their use comply with the relevant criteria, guidelines or 
restrictions 
June 7th, 2014 22
c) The outcome of drug use 
 e.g. efficacy, adverse drug reactions and the use of 
resources such as drugs, laboratory tests, hospital 
beds or procedures. 
 Drug utilization studies can be targeted towards any 
of the above links in the drug use chain. 
June 7th, 2014 23
 Generally drugs with a high volume of use, high cost or 
high frequency of adverse drug reactions are subjected to 
DU studies 
 Common targets:- 
 Commonly prescribed drugs e.g. Antibiotics, PPIs, etc. 
 Drugs with significant drug interactions e.g. Warfarin, 
Phenytoin 
 Expensive drugs e.g. LMWH, Cephalosporins 
 Newer drugs 
 Drugs with a narrow therapeutic index e.g. Digoxin, 
Theophylline, Lithium 
 Drugs with serious ADRs e.g. aminoglycoside, NSAIDs etc. 
 Drugs in high risk patients e.g. elderly, pediatric patients 
 Drugs in the management of common conditions e.g. RTI or 
UTI, HTN, T2DM etc 
June 7th, 2014 24
Step 2:- Design of study 
In designing the DU study, observational research methods 
are more commonly used. 
 Accordingly, DU study can be 
Either :- 
• Quantitative 
• Qualitative 
Or :- 
 Cross-sectional 
 Longitudinal 
 Continuous longitudinal 
June 7th, 2014 25
 Quantitative:- 
Used to describe present situation and the trends in the 
drug prescription and drug use at various levels of the 
health care system. 
 Qualitative:- 
Assess the appropriateness of drug utilization and link 
the prescribing data to reasons for prescribing. It can be 
referred as Drug Utilization Review or Drug Utilization 
Evaluation. This process is one of the 
therapeutic/prescription audit. 
June 7th, 2014 26
Cross sectional studies- 
 Provide a snapshot of drug use at a particular time like 
over a year, a month or a day 
 Used for making comparisons with similar data 
collected over the same period in a different country, 
health facility or a ward 
 Can be carried out before and after an intervention 
 Studies can simply measure drug use, or can be utilized 
to assess drug use in relation to guidelines 
June 7th, 2014 27
Longitudinal studies- 
 Data can be on total drug use or on a statistically valid 
samples from pharmacies or medical practices. 
 Often obtained from repeated cross sectional surveys. 
 Data collection is continuous but the practitioner surveyed 
and therefore patients are continuously changing. 
 Such data gives information about overall trends but not 
about prescribing trends. 
 Provide information about concordance with treatment 
based on the period between prescriptions, duration of 
treatment, PDD etc 
June 7th, 2014 28
Continuous longitudinal study- 
◦ This data can address a range of issues 
including reasons for change in therapy, 
adverse effects and health outcomes 
June 7th, 2014 29
Step 3:- Define criteria and 
standards 
 With an exhaustive literature search, identify the 
key literature in the chosen area of interest and 
the drug criteria that can be derived from this 
evidence based literature. 
 Must be valid, unambiguous, realistic, easily 
measured and outcome oriented. 
June 7th, 2014 30
Step 4:- Design the data collection form 
 It is impossible to address all aspects of use for each 
◦ Patient demographics 
◦ Prescriber details 
◦ Indication/ 
Contraindications 
◦ Side/adverse effects 
◦ Dosing information 
◦ Drug or drug class duplication 
◦ Drug interactions 
◦ Monitoring of drug therapy 
◦ Patient education/instructions 
◦ Cost of therapy 
individual drug BUT 
 It is important to limit data collection to only the most 
important and relevant aspects of drug use 
 Aspects of drug use commonly surveyed are - 
June 7th, 2014 37337
Step 5:- Data collection 
 Physicians, pharmacists and nurses make 
ideal data collectors. 
 Different types of drug use information 
are required depending upon the problem 
being examined. 
June 7th, 2014 32
Source of data 
◦ Large databases 
◦ Data from drug regulatory agency 
◦ Supplier (distribution) data 
◦ Practice setting data 
◦ Community setting data 
June 7th, 2014 33
Large databases:- 
◦ Efficient use of health care resources - Computer 
databases or medical record sections 
◦ May be international, national or local- comparative 
studies can be planned at various levels. 
◦ May be diagnosis linked or non-diagnosis linked 
◦ Diagnosis linked data enable drug use to be 
analyzed according to patients characteristics, 
therapeutic groups, diseases or conditions and, 
clinical outcome. 
June 7th, 2014 34
Data from drug regulatory agencies:- 
 Are repositories of data on which drugs have been 
registered for use, withdrawn or banned within a 
country. 
 Agencies have the legal responsibility of ensuring the 
availability of safe, efficacious and good quality drugs 
 Possible to obtain data on the number of drugs 
registered in a country from such agencies. 
 Importation data like product type (i.e. generic or 
branded), volume, port of origin, country of 
manufacture, batch number and expiry date may be 
collected. 
June 7th, 2014 35
Supplier (distribution) data:- 
 Drug importation; local manufacture; customs 
service, whole salers 
 In countries where licenses are required from drug 
regulatory authorities before importation of drugs 
 Generally be used to describe total quantities of 
specific drug or drug group, origins of supplies 
and type (i.e. branded or generic) 
 Distribution at different levels of supplies can be 
compared 
June 7th, 2014 36
Practice setting data:- 
Generate indicators that provide information on 
prescribing habits and aspects of patient care. 
 Prescribing data 
 Dispensing data 
 Aggregate (facility) data 
 Over-the-counter and pharmacist-prescribed drugs 
 Telephone and internet prescribing 
June 7th, 2014 37
 Prescribing data: 
◦ Usually extracted from outpatient and inpatient 
prescriptions. 
◦ Information that may be obtained from 
prescriptions includes 
 Patient’s demography 
 Drug name, dosage form, strength, dose, frequency of 
administration and duration of treatment. 
 Where diagnoses are noted on prescriptions, is 
possible to link drug use to indications. 
 Trends in utilization for specific drugs and diseases 
can also be established. 
June 7th, 2014 38
 Dispensing data:- 
Drug dispensing is a process that ends with a client 
leaving a drug outlet with a defined quantity of medication 
and instructions for using it. 
◦ Information available from dispensers may include 
 Drug (s) prescribed 
 Dose(s) prescribed 
 Average number of items per prescription 
 Percentage of items prescribed that were actually supplied 
(an indicator of availability) 
 Percentage of drugs adequately labeled 
 Quantity of medications dispensed 
 Cost of each item or prescription. 
June 7th, 2014 39
 Aggregate data 
◦ Source include – pharmacy stock and dispensing 
records, medication error records, adverse drug reaction 
records and patient medical records. 
◦ Used to obtain information on 
 The cost of individual drugs and classes of drug 
 The most and least expensive drugs 
 The per capita consumption of specific products. 
 The prevalence of adverse drug reactions. 
 The prevalence of medication errors. 
 The percentage of the budget spent on specific drugs 
or classes of drug. 
June 7th, 2014 40
 Over-the-counter and pharmacist-prescribed 
drugs: 
◦ Pharmacists and other drug outlet managers may 
prescribe over the counter (OTC) preparations or 
pharmacist prepared drugs that do not require 
prescription by physician. 
◦ When such information is available from stock or 
dispensing records, it broadens the understanding of 
drug utilization patterns. 
June 7th, 2014 41
 Telephone and Internet prescribing: 
 Mostly in developed countries. 
 Innovative ways need to be devised to collect 
information on this type of transaction. 
June 7th, 2014 42
 Community setting data:- 
 Drugs available in households have either been 
prescribed or dispensed at health facilities, 
purchased at pharmacy or are over the counter 
medications. 
 The drugs may be for the treatment of current 
illness or are left over from previous illness. 
 Data can be collected by performing household 
surveys, counting left over pills etc. 
June 7th, 2014 43
Step 6:- Evaluate results 
Data evaluation is the most critical step in a DUS 
 Summarize data into the major categories of results 
 Check where exactly the data shows deviation from the 
guidelines and usage criteria 
 Check whether true deviation exists 
 Evaluate reasons for this deviation 
 May be necessary to redefine the criteria 
June 7th, 2014 44
 Reasons for deviation may include: 
◦ Drug being used for new indication 
◦ Outdated procedures 
◦ Inadequate resources 
◦ Gaps in knowledge or misinformation / 
misunderstanding 
 Evaluation is done with the help of:- 
Drug Utilization Metrics 
Drug Use Indicators 
Drug classification systems 
June 7th, 2014 45
Drug utilization metrics include:- 
 Defined daily dose 
 Prescribed daily dose 
 Other units for presentation of volume 
 Cost 
June 7th, 2014 46
Defined daily dose (DDD):- 
The DDD is the assumed average maintenance dose per 
day for a drug used for its main indication in adults. 
DDD is a unit of measurement and does not necessarily 
correspond to the recommended or prescribed daily dose 
(PDD). 
Doses for individual patients and patient groups will 
often differ from the DDD as they must be based on 
individual characteristics (e.g. age and weight) and 
pharmacokinetic considerations. 
June 7th, 2014 47
 It give a rough estimate of consumption and not an exact 
picture of actual use. 
 DDDs provide a fixed unit of measurement independent 
of price, currency, package size and strength enabling 
the researcher to assess trends in drug consumption and 
to perform comparisons between population groups. 
 Drug utilization figures should ideally be presented as 
numbers of DDDs per 1000 inhabitants per day or, 
when drug use by inpatients is considered, as DDDs per 
100 bed-days. 
June 7th, 2014 48
 DDDs per 1000 inhabitants per day:- 
◦ Provide a rough estimate of the proportion of the 
study population treated daily with a particular drug or 
group of drugs. 
◦ E.g.- 
10 DDDs per 1000 inhabitants per day indicates that 1% 
of the population on average might receive a certain 
drug or group of drugs daily. 
◦ Most useful for chronically used drugs 
June 7th, 2014 49
 DDDs per inhabitant per year:- 
◦ Estimate of the average number of days for which 
each inhabitant is treated annually 
E.g. - 
◦ 5 DDDs per inhabitant per year indicates that the 
utilization is equivalent to the treatment of every 
inhabitant with a five-day course during a certain year. 
June 7th, 2014 50
 DDDs are not established for:- 
◦ Topical products 
◦ Sera, vaccines 
◦ Antineoplastic agents 
◦ Allergen extracts 
◦ General and Local anesthetics 
◦ Contrast media 
June 7th, 2014 51
Prescribed daily dose (PDD):- 
 The prescribed daily dose (PDD) is defined as the 
average dose prescribed according to a representative 
sample of prescriptions. 
 Can be determined from studies of prescriptions or 
medical or pharmacy records 
 Gives the average daily amount of a drug that is actually 
prescribed 
June 7th, 2014 52
 The PDD can vary according to both the illness treated 
and the national therapeutic traditions. 
 The PDDs differ: 
◦ Between countries and ethnic groups 
◦ Between areas or health care facilities within 
the same country 
◦ For different indications of the same drug 
June 7th, 2014 53
 PDD does not necessarily reflect actual drug 
utilization. 
 Specially designed studies including patient 
interviews are required to measure actual drug 
intake at the patient level (i.e. the consumed 
daily dose). 
June 7th, 2014 54
Other units for presentation of volume: 
These units can be applied only when the use of a single 
drug or of well defined combination product is evaluated. 
 Grams of active ingredient:- 
◦ Drugs with low potency will account for a larger 
fraction of the total than drugs with high potency 
◦ Combined products may also contain different 
amounts of active ingredients from plain products 
June 7th, 2014 55
 Number of tablets:- 
◦ Counting numbers of tablets does not reflect the 
variations in strengths of tablets, with the result that 
low-strength preparations contribute relatively more 
than high-strength preparations to the total numbers 
 Numbers of prescriptions:- 
◦ Do not accurately reflect total use, unless total 
quantities of drugs per prescription are also considered. 
◦ Valuable in measuring the frequency of prescriptions 
June 7th, 2014 56
Cost:- 
◦ Cost figures are suitable for an overall analysis of 
expenditure on drugs. 
◦ International comparisons based on cost parameters 
can be misleading and have limited value in the 
evaluation of drug use. 
◦ Difficulties in evaluation may be due to 
 Price differences between alternative preparations 
 Fluctuations in currency 
 Changes in price 
June 7th, 2014 57
Drug Use Indicators:- 
 Prescribing indicators 
◦ Average number of drugs per encounter 
◦ Percentage of drugs prescribed by generic name 
◦ Percentage of encounters with an antibiotic prescribed 
◦ Percentage of encounters with an injection prescribed 
◦ Percentage of drugs prescribed from essential drugs 
list or formulary 
June 7th, 2014 58
 Patient care indicators 
◦ Average consultation time 
◦ Average dispensing time 
◦ Percentage of drugs actually dispensed 
◦ Percentage of drugs adequately labelled 
◦ Patients' knowledge of correct dosage 
 Facility indicators 
◦ Availability of copy of essential drugs list or formulary 
◦ Availability of key drugs 
◦ Availability of clinical guidelines 
June 7th, 2014 59
 Complementary drug use indicators 
o Average medicine cost per encounter 
o Percentage prescriptions in accordance with clinical 
guidelines 
o Percentage of patients treated without drugs 
o ** WHO-INRUD (International Network for the 
Rational Use of Drugs) –WHO-1993 
June 7th, 2014 60
Prescribing indicators:- 
1. Average number of drugs per encounter 
total number of different drug products prescribed 
Average = -------------------------------------------------------------- 
number of encounters surveyed 
2. Percentage (%) of drugs prescribed by generic name 
number of drugs prescribed by generic name × 100 
% = --------------------------------------------------------------- 
total number of drugs prescribed 
June 7th, 2014 61
3. Percentage of encounters with an antibiotic prescribed 
4. Percentage of encounters with an injection prescribed 
Number of patient encounters during which an antibiotic or an 
injectable are prescribed x 100 
% = ----------------------------------------------- 
Total number of encounters surveyed 
June 7th, 2014 62
5. Percentage of drugs prescribed from essential drugs list 
or formulary 
The number of products prescribed which are listed on the 
essential drugs list or local formulary x 100 
% = -------------------------------------------------- 
The total number of drugs prescribed 
June 7th, 2014 63
Patient care indicators:- 
1. Average consultation time 
Total time for a series of consultation 
Average=------------------------------------------------------ 
Number of consultations 
2. Average dispensing time 
Total time for dispensing drugs to a series of patients 
Average=------------------------------------------------------ 
Number of encounters 
June 7th, 2014 64
3. Percentage of drugs actually dispensed 
number of drugs actually dispensed 
at the health facility × 100 
%= ------------------------------------------------------------- 
total number of drugs prescribed 
4. Percentage of drugs adequately labeled 
number of drug packages containing at least 
patient name, drug name and when × 100 
the drug should be taken 
%= ----------------------------------------------------------------- 
total number of drug packages dispensed 
June 7th, 2014 65
5. Patients' knowledge of correct dosage 
 To reliably evaluate the correctness of patients' 
responses about when they are to take the drugs, clear 
guidelines should be developed about common dosage 
regimens 
number of patients who can adequately report the dosage 
schedule for all the drugs x 100 
%= -------------------------------------------------------------- 
total number of patients interviewed 
June 7th, 2014 66
Facility indicators:- 
1. Availability of copy of essential drugs list or formulary 
2. Availability of clinical guidelines 
◦ A national essential drugs list or a local formulary and a 
clinical guideline must exist 
◦ Scored as ‘Yes’ or ‘No’, per facility 
3. Availability of key drugs 
number of specified products actually in stock × 100 
% = ---------------------------------------------------------------- 
total number of drugs on the checklist 
June 7th, 2014 67
Model list of Key Drugs for testing drug 
availability:- 
Diarrhoea oral rehydration salts 
cotrimoxazole tablets 
Acute respiratory tract infections cotrimoxazole tablets 
procaine penicillin injection 
paediatric paracetamol tablets 
Malaria chloroquine tablets 
Anaemia ferrous salt + folic acid tablets 
Worm infestations mebendazole tablets 
Conjunctivitis tetracycline eye ointment 
Skin disinfection iodine, gentian violet or local alternative 
Fungal skin infection benzoic acid + salicylic acid ointment 
Pain/fever acetylsalicylic acid or paracetamol tablets 
Prophylactic drugs retinol (vitamin A) 
ferrous salt + folic acid tablets 
June 7th, 2014 77 68
Drug classification system:- 
 The main purpose of having an 
international standard is to be able to 
compare data between countries. 
 Different classification systems : - 
◦ Anatomical Therapeutic Chemical (ATC) 
classification develop by Norwegian researchers. 
 serve as a tool for presenting drug utilization statistics 
 recommended by WHO for international comparisons 
June 7th, 2014 69
◦ Anatomical Therapeutic (AT) classification developed by 
the European Pharmaceutical Market Research 
Association (EPhMRA) 
 The EPhMRA classification system is used worldwide 
by IMS (International Marketing Services) for 
providing market research statistics to the 
pharmaceutical industry. 
June 7th, 2014 70
Step 7:- Provide feedback of results 
 Prepare a scientific interpretation of the results 
rather than a value judgment. 
 Success of any DUS depends on feedback of 
results to prescribers, other hospital staffs 
involved in the study and to administrative 
heads. 
 The results can also be circulated to hospital 
staff via newsletters or the hospital’s academic 
meetings. 
June 7th, 2014 71
Step 8:- Develop and implement 
interventions 
 If a drug use problem is identified the next step is to 
consider how the problem can be addressed. 
 Interventions:- 
◦ Educational - educational meetings, development of 
protocols, letters to individual physicians. 
◦ Operational - modification of drug order forms, 
development of stringent drug use policy, manual or 
computerized reminders, prescribing restrictions, 
formulary additions/deletions etc. 
June 7th, 2014 72
Step 9:- Re-evaluate to determine 
if drug use has improved 
 Drug use and prescribing patterns need to be 
monitored to determine the success of intervention 
 Re-evaluation is usually done 3-12 months after the 
introduction of the intervention 
 Collection of data as in original DUS 
 Should be a continuous process at regular interval 
June 7th, 2014 73
Step 10:- Re-assess and revise the 
DUS program 
Results of the previous DU studies help to 
improve quality, efficacy and effectiveness 
of future DU studies. 
June 7th, 2014 74
Step 11:- Feedback results 
 Circulate results of the DUS 
 Obtain opinions about success of interventions 
and improvement of drug use. 
 Analyze and act accordingly 
June 7th, 2014 75
DU 90% 
 Reflects the number of drugs that account for 90% of 
drug prescriptions and adherence to local or national 
prescription guidelines 
 Can be applied at different levels 
◦ Individual prescriber 
◦ Group of prescribers 
◦ Wards 
◦ Hospitals 
◦ County 
 Gives a rough estimate of the quality of prescribing. 
June 7th, 2014 76
Drug utilization evaluation 
 Drug utilization evaluation (DUE) is defined as an 
authorized, structured, ongoing review of physician 
prescribing, pharmacist dispensing and patient 
using medication. 
 DUE is ongoing, systematic process designed to 
maintain the appropriate and effective use of drugs 
 Synonymous- Drug Utilization Review (DUR) 
 Medication use evaluation (MUE) is similar to 
DUE but emphasizes on improving patient’s clinical 
outcome and individual quality of life. 
June 7th, 2014 77
Objectives of DUE:- 
 To ensure that drug therapy meets current 
standards of care 
 To control drug costs 
 To prevent problem related to medication, ADRs 
 To evaluate effectiveness of drug therapy 
 To identify areas of practice that require further 
education of practitioners. 
June 7th, 2014 78
Classification of DUE: 
A) Prospective DUE:- 
◦ Involves evaluating a patient’s planned drug therapy 
before a medication is dispensed. 
◦ Pharmacists perform prospective reviews by assessing 
prescription medication’s dosage and it’s directions 
and reviewing patient information for possible drug 
interactions or duplication of therapy. 
June 7th, 2014 79
 Typical criteria reviewed in prospective 
studies include the following:- 
 Indications 
 Drug selection 
 Doses prescribed 
 Dosage form and routes of administration 
 Duration of therapy 
 Costs 
 Therapeutic duplication 
 Quantity dispensed 
 Contraindications 
 Therapeutic outcomes 
 Adverse drug reactions and drug interactions 
 Generic substitution 
June 7th, 2014 80
B) Concurrent DUE:- 
◦ Performed during the course of treatment and involves 
ongoing monitoring of drug therapy to ensure positive 
patient outcomes. 
 Typical criteria reviewed:- 
◦ Drug interactions 
◦ High or low dosages 
◦ Duplicate therapy 
◦ Drug-disease interaction 
◦ Over and under utilization 
◦ Drug-age precautions 
◦ Drug-gender precautions 
◦ Drug-pregnancy precautions 
June 7th, 2014 81
C) Retrospective DUE :- 
◦ Simplest to perform since drug therapy is 
reviewed after the patient has received 
medication. 
◦ Patients medical chart or computerized 
records are screened to determine whether the 
drug therapy met approved criteria. 
June 7th, 2014 82
 In retrospective studies, the criteria 
reviewed include:- 
 Evaluation of indications and contra-indications 
 Monitoring high cost medicines 
 Comparison of prescribing between physicians 
 Cost to patient 
 Over and under utilization 
 Incorrect drug dosage 
 Inappropriate duration 
 Adverse drug reaction 
 Drug interactions 
June 7th, 2014 83
Statistical application in Drug 
utilization research:- 
 Statistical Package for social science (SPSS) can be 
used. 
 Chi square test can be used to test the difference 
between the proportions. 
June 7th, 2014 84
Future Perspectives: 
 The study of drug utilization in an evolving field. 
 The use of large computerized databases that allow 
linkage of drug utilization data to diagnosis, subject to 
some inherent limitations, is contributing to expand this 
area of study. 
 Importance of drug utilization studies in 
pharmacoepidemiology has been increasing due to their 
close association to other areas like- public health, 
pharmacovigilance, pharmacoeconomics and 
pharmacogenetics 
June 7th, 2014 85
Conclusion:- 
 Successful research in drug utilization requires 
multidisciplinary collaboration between clinicians, 
clinical pharmacologists, pharmacists and 
epidemiologists. 
 Without the support of the prescribers, this research 
effort will fail to reach its goal of facilitating the 
rational use of drugs. 
 Only by a combination of regulatory, informative and 
educational actions, together with a general 
improvement of the quality of in and out-patient 
medical care in the National Health System, the use of 
drugs can be more rational. 
June 7th, 2014 86
June 7th, 2014 87

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DUS_Dr. Mansij Biswas

  • 1. Drug Utilization Studies Dr. Mansij Biswas, SYR Department of Pharmacology & Therapeutics Seth G S Medical College & KEM Hospital
  • 2. Introduction & Definition:  Pharmaco-epidemiology is the study of use and effects or side-effects of drugs in large number of people with the purpose of supporting the rational and cost effective use of drugs in population, thereby improving health outcomes.  WHO defines drug utilization research as, “the marketing, distribution, prescription and the use of drugs in a society with special emphasis on the resulting medical, social and economic consequences.”(WHO, 1977) June 7th, 2014 INTRODUCTION TO DRUG UTILIZATION RESEARCH, WHO International Working Group For Drug Statistics Methodology, WHO Collaborating Centre For Drug Statistics Methodology, WHO, 2003. 2
  • 3. Looking back…  Initiated in Northern Europe and The UK in the mid 1960s  Arthur Engel in Sweden and Pieter Siderius in Holland described importance of comparing drug use between different countries and regions  Differences in sales of antibiotics in six European countries between 1966 and 1967 inspired WHO to organize first meeting on drug consumption in Oslo, 1969 June 7th, 2014 3
  • 4.  Constitution of WHO European Drug Utilization Research Group (DURG)  Development of a new unit of measurement, initially called the agreed daily dose and later the Defined Daily Dose (DDD), by researchers from Ireland, Norway & Sweden  The first study used anti-diabetic drugs as an example  Among the first countries to adopt the DDD methodology was the former Czechoslovakia  First comprehensive national list of DDD was published in Norway in 1975 June 7th, 2014 4
  • 5. Why drug utilization research?  The principal aim is to facilitate the rational use of drugs in populations.  Rational use of medicines (RUM) is defined as “Patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community” (WHO, 1985) June 7th, 2014 Promoting Rational Use of Medicines: Core Components - WHO Policy Perspectives on Medicines, No. 005, September 2002 5
  • 6. Objectives:  Description of drug use pattern  Early signals of irrational use of drugs  Interventions to improve drug use – follow up & assessing the impact  Quality control of drug use June 7th, 2014 6
  • 7.  Description of drug use pattern : - Drug utilization research will increase our understanding of how drugs are being used by-  Estimating the numbers of patients exposed to specified drugs within a given time period.  Getting extent of use at certain moment or area.  Estimating to what extent drugs are properly used, overused or underused. June 7th, 2014 7
  • 8.  Determining pattern or profile of drug use and the extent to which alternative drugs are being used to treat particular conditions.  Comparing the observed patterns of drug use for the treatment of certain disease with current guidelines.  Giving feedback of the drug utilization data to prescribers.  Assessing the potential magnitude of the problem June 7th, 2014 8
  • 9.  Early signals of irrational use of drugs:  Comparing drug utilization patterns and cost between different regions or time period  Comparing observed patterns of drug use with current recommendation or guidelines for the treatment of certain disease June 7th, 2014 9
  • 10.  Interventions to improve drug use-follow up:  Monitoring and evaluating the effects of measures taken to improve undesirable patterns of drug use  Following the impact of regulatory changes or changes in the insurance or reimbursement schemes  To which extent promotional activities of the pharmaceutical industry and educational activities of the society impact on the patterns of drug use June 7th, 2014 10
  • 11.  Quality control of drug use: Drug use should be controlled according to a quality control cycle that offers a systematic framework for continuous quality improvement Step 1 : PLAN – Analyze the current situation to establish plan for improvement Step 2 : DO – Implement the plan on small scale Step 4 : ACT – Revise plan or implement plan Step 3 : CHECK – Check to see if expected results are obtained June 7th, 2014 11 on large scale
  • 12. Types of drug use information  Drug based information  Problem or encounter based information  Patient based information  Prescriber based information  Cost based information June 7th, 2014 12
  • 13. A) Drug based informations ◦ Data on drug use on various levels, and information on indications, doses and dosage regimen is usually necessary ◦ Level of drug use aggregation : The level at which data on drug use are aggregated will depend on question being asked.  E.g. Hypertension June 7th, 2014 13
  • 14.  Indication – ◦ For drugs with multiple indications, it will usually be important to divide data on use according to indication to allow a correct interpretation of the overall trends. E.g.- ◦ antibiotic utilization ◦ Use of beta-blockers June 7th, 2014 14
  • 15. B) Problem based informations ◦ Useful to address the question – how a particular problem is managed.  Questions that might be addressed: ◦ Does the severity of the disease influence the choice of single or combination therapy ? ◦ Is the management of newly-presenting patients different to that of patients already receiving treatment ? ◦ Are there likely to be any drug interactions with co-prescribed treatments ? ◦ Is the choice of drug influenced by evidence based outcome data ? June 7th, 2014 15
  • 16. C) Patient based informations Information on demographic factors and other details about the patient are useful Age distribution – to assess the likelihood of severe adverse effects with some drugs Comorbidities of patient Knowledge, beliefs and perceptions of patients and their attitudes to drugs are important June 7th, 2014 16
  • 17. D) Prescriber based informations This information is useful to understand how and why drugs are prescribed. ◦ Some questions that might be addressed:  Are prescribing profiles influenced by the prescriber’s medical education?  Do the prescribing profiles of specialists differ from those of general practitioners ?  Does the age or gender of the prescriber influence the prescribing profile? June 7th, 2014 17
  • 18.  Are there differences in prescribing behavior between urban and rural practices or between small and large practices ?  Who are those prescribers who rapidly adopt to recently released drugs ?  Can the factors that determine and change prescribing behavior be identified ? June 7th, 2014 18
  • 19. E) Cost based informations It will always be important in managing policy related to drug supply, pricing and use. E.g. Use of antipsychotic drugs in Australia June 7th, 2014 19
  • 20. The DUS cycle: Planning Data collection Evaluation Feedback of results Feedback of results Interventions June 7th, 2014 20 Reevaluation
  • 21. Steps involved in conducting a drug utilization study:- June 7th, 2014 21
  • 22. Step 1:- Identify drugs or therapeutic areas of practice for inclusion in the program Drug-use Chain a) The systems and structures surrounding drug use  e.g. how drugs are ordered, delivered and administered in a hospital or health care facility b) The processes of drug use  e.g. what drugs are used and how they are used and does their use comply with the relevant criteria, guidelines or restrictions June 7th, 2014 22
  • 23. c) The outcome of drug use  e.g. efficacy, adverse drug reactions and the use of resources such as drugs, laboratory tests, hospital beds or procedures.  Drug utilization studies can be targeted towards any of the above links in the drug use chain. June 7th, 2014 23
  • 24.  Generally drugs with a high volume of use, high cost or high frequency of adverse drug reactions are subjected to DU studies  Common targets:-  Commonly prescribed drugs e.g. Antibiotics, PPIs, etc.  Drugs with significant drug interactions e.g. Warfarin, Phenytoin  Expensive drugs e.g. LMWH, Cephalosporins  Newer drugs  Drugs with a narrow therapeutic index e.g. Digoxin, Theophylline, Lithium  Drugs with serious ADRs e.g. aminoglycoside, NSAIDs etc.  Drugs in high risk patients e.g. elderly, pediatric patients  Drugs in the management of common conditions e.g. RTI or UTI, HTN, T2DM etc June 7th, 2014 24
  • 25. Step 2:- Design of study In designing the DU study, observational research methods are more commonly used.  Accordingly, DU study can be Either :- • Quantitative • Qualitative Or :-  Cross-sectional  Longitudinal  Continuous longitudinal June 7th, 2014 25
  • 26.  Quantitative:- Used to describe present situation and the trends in the drug prescription and drug use at various levels of the health care system.  Qualitative:- Assess the appropriateness of drug utilization and link the prescribing data to reasons for prescribing. It can be referred as Drug Utilization Review or Drug Utilization Evaluation. This process is one of the therapeutic/prescription audit. June 7th, 2014 26
  • 27. Cross sectional studies-  Provide a snapshot of drug use at a particular time like over a year, a month or a day  Used for making comparisons with similar data collected over the same period in a different country, health facility or a ward  Can be carried out before and after an intervention  Studies can simply measure drug use, or can be utilized to assess drug use in relation to guidelines June 7th, 2014 27
  • 28. Longitudinal studies-  Data can be on total drug use or on a statistically valid samples from pharmacies or medical practices.  Often obtained from repeated cross sectional surveys.  Data collection is continuous but the practitioner surveyed and therefore patients are continuously changing.  Such data gives information about overall trends but not about prescribing trends.  Provide information about concordance with treatment based on the period between prescriptions, duration of treatment, PDD etc June 7th, 2014 28
  • 29. Continuous longitudinal study- ◦ This data can address a range of issues including reasons for change in therapy, adverse effects and health outcomes June 7th, 2014 29
  • 30. Step 3:- Define criteria and standards  With an exhaustive literature search, identify the key literature in the chosen area of interest and the drug criteria that can be derived from this evidence based literature.  Must be valid, unambiguous, realistic, easily measured and outcome oriented. June 7th, 2014 30
  • 31. Step 4:- Design the data collection form  It is impossible to address all aspects of use for each ◦ Patient demographics ◦ Prescriber details ◦ Indication/ Contraindications ◦ Side/adverse effects ◦ Dosing information ◦ Drug or drug class duplication ◦ Drug interactions ◦ Monitoring of drug therapy ◦ Patient education/instructions ◦ Cost of therapy individual drug BUT  It is important to limit data collection to only the most important and relevant aspects of drug use  Aspects of drug use commonly surveyed are - June 7th, 2014 37337
  • 32. Step 5:- Data collection  Physicians, pharmacists and nurses make ideal data collectors.  Different types of drug use information are required depending upon the problem being examined. June 7th, 2014 32
  • 33. Source of data ◦ Large databases ◦ Data from drug regulatory agency ◦ Supplier (distribution) data ◦ Practice setting data ◦ Community setting data June 7th, 2014 33
  • 34. Large databases:- ◦ Efficient use of health care resources - Computer databases or medical record sections ◦ May be international, national or local- comparative studies can be planned at various levels. ◦ May be diagnosis linked or non-diagnosis linked ◦ Diagnosis linked data enable drug use to be analyzed according to patients characteristics, therapeutic groups, diseases or conditions and, clinical outcome. June 7th, 2014 34
  • 35. Data from drug regulatory agencies:-  Are repositories of data on which drugs have been registered for use, withdrawn or banned within a country.  Agencies have the legal responsibility of ensuring the availability of safe, efficacious and good quality drugs  Possible to obtain data on the number of drugs registered in a country from such agencies.  Importation data like product type (i.e. generic or branded), volume, port of origin, country of manufacture, batch number and expiry date may be collected. June 7th, 2014 35
  • 36. Supplier (distribution) data:-  Drug importation; local manufacture; customs service, whole salers  In countries where licenses are required from drug regulatory authorities before importation of drugs  Generally be used to describe total quantities of specific drug or drug group, origins of supplies and type (i.e. branded or generic)  Distribution at different levels of supplies can be compared June 7th, 2014 36
  • 37. Practice setting data:- Generate indicators that provide information on prescribing habits and aspects of patient care.  Prescribing data  Dispensing data  Aggregate (facility) data  Over-the-counter and pharmacist-prescribed drugs  Telephone and internet prescribing June 7th, 2014 37
  • 38.  Prescribing data: ◦ Usually extracted from outpatient and inpatient prescriptions. ◦ Information that may be obtained from prescriptions includes  Patient’s demography  Drug name, dosage form, strength, dose, frequency of administration and duration of treatment.  Where diagnoses are noted on prescriptions, is possible to link drug use to indications.  Trends in utilization for specific drugs and diseases can also be established. June 7th, 2014 38
  • 39.  Dispensing data:- Drug dispensing is a process that ends with a client leaving a drug outlet with a defined quantity of medication and instructions for using it. ◦ Information available from dispensers may include  Drug (s) prescribed  Dose(s) prescribed  Average number of items per prescription  Percentage of items prescribed that were actually supplied (an indicator of availability)  Percentage of drugs adequately labeled  Quantity of medications dispensed  Cost of each item or prescription. June 7th, 2014 39
  • 40.  Aggregate data ◦ Source include – pharmacy stock and dispensing records, medication error records, adverse drug reaction records and patient medical records. ◦ Used to obtain information on  The cost of individual drugs and classes of drug  The most and least expensive drugs  The per capita consumption of specific products.  The prevalence of adverse drug reactions.  The prevalence of medication errors.  The percentage of the budget spent on specific drugs or classes of drug. June 7th, 2014 40
  • 41.  Over-the-counter and pharmacist-prescribed drugs: ◦ Pharmacists and other drug outlet managers may prescribe over the counter (OTC) preparations or pharmacist prepared drugs that do not require prescription by physician. ◦ When such information is available from stock or dispensing records, it broadens the understanding of drug utilization patterns. June 7th, 2014 41
  • 42.  Telephone and Internet prescribing:  Mostly in developed countries.  Innovative ways need to be devised to collect information on this type of transaction. June 7th, 2014 42
  • 43.  Community setting data:-  Drugs available in households have either been prescribed or dispensed at health facilities, purchased at pharmacy or are over the counter medications.  The drugs may be for the treatment of current illness or are left over from previous illness.  Data can be collected by performing household surveys, counting left over pills etc. June 7th, 2014 43
  • 44. Step 6:- Evaluate results Data evaluation is the most critical step in a DUS  Summarize data into the major categories of results  Check where exactly the data shows deviation from the guidelines and usage criteria  Check whether true deviation exists  Evaluate reasons for this deviation  May be necessary to redefine the criteria June 7th, 2014 44
  • 45.  Reasons for deviation may include: ◦ Drug being used for new indication ◦ Outdated procedures ◦ Inadequate resources ◦ Gaps in knowledge or misinformation / misunderstanding  Evaluation is done with the help of:- Drug Utilization Metrics Drug Use Indicators Drug classification systems June 7th, 2014 45
  • 46. Drug utilization metrics include:-  Defined daily dose  Prescribed daily dose  Other units for presentation of volume  Cost June 7th, 2014 46
  • 47. Defined daily dose (DDD):- The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. DDD is a unit of measurement and does not necessarily correspond to the recommended or prescribed daily dose (PDD). Doses for individual patients and patient groups will often differ from the DDD as they must be based on individual characteristics (e.g. age and weight) and pharmacokinetic considerations. June 7th, 2014 47
  • 48.  It give a rough estimate of consumption and not an exact picture of actual use.  DDDs provide a fixed unit of measurement independent of price, currency, package size and strength enabling the researcher to assess trends in drug consumption and to perform comparisons between population groups.  Drug utilization figures should ideally be presented as numbers of DDDs per 1000 inhabitants per day or, when drug use by inpatients is considered, as DDDs per 100 bed-days. June 7th, 2014 48
  • 49.  DDDs per 1000 inhabitants per day:- ◦ Provide a rough estimate of the proportion of the study population treated daily with a particular drug or group of drugs. ◦ E.g.- 10 DDDs per 1000 inhabitants per day indicates that 1% of the population on average might receive a certain drug or group of drugs daily. ◦ Most useful for chronically used drugs June 7th, 2014 49
  • 50.  DDDs per inhabitant per year:- ◦ Estimate of the average number of days for which each inhabitant is treated annually E.g. - ◦ 5 DDDs per inhabitant per year indicates that the utilization is equivalent to the treatment of every inhabitant with a five-day course during a certain year. June 7th, 2014 50
  • 51.  DDDs are not established for:- ◦ Topical products ◦ Sera, vaccines ◦ Antineoplastic agents ◦ Allergen extracts ◦ General and Local anesthetics ◦ Contrast media June 7th, 2014 51
  • 52. Prescribed daily dose (PDD):-  The prescribed daily dose (PDD) is defined as the average dose prescribed according to a representative sample of prescriptions.  Can be determined from studies of prescriptions or medical or pharmacy records  Gives the average daily amount of a drug that is actually prescribed June 7th, 2014 52
  • 53.  The PDD can vary according to both the illness treated and the national therapeutic traditions.  The PDDs differ: ◦ Between countries and ethnic groups ◦ Between areas or health care facilities within the same country ◦ For different indications of the same drug June 7th, 2014 53
  • 54.  PDD does not necessarily reflect actual drug utilization.  Specially designed studies including patient interviews are required to measure actual drug intake at the patient level (i.e. the consumed daily dose). June 7th, 2014 54
  • 55. Other units for presentation of volume: These units can be applied only when the use of a single drug or of well defined combination product is evaluated.  Grams of active ingredient:- ◦ Drugs with low potency will account for a larger fraction of the total than drugs with high potency ◦ Combined products may also contain different amounts of active ingredients from plain products June 7th, 2014 55
  • 56.  Number of tablets:- ◦ Counting numbers of tablets does not reflect the variations in strengths of tablets, with the result that low-strength preparations contribute relatively more than high-strength preparations to the total numbers  Numbers of prescriptions:- ◦ Do not accurately reflect total use, unless total quantities of drugs per prescription are also considered. ◦ Valuable in measuring the frequency of prescriptions June 7th, 2014 56
  • 57. Cost:- ◦ Cost figures are suitable for an overall analysis of expenditure on drugs. ◦ International comparisons based on cost parameters can be misleading and have limited value in the evaluation of drug use. ◦ Difficulties in evaluation may be due to  Price differences between alternative preparations  Fluctuations in currency  Changes in price June 7th, 2014 57
  • 58. Drug Use Indicators:-  Prescribing indicators ◦ Average number of drugs per encounter ◦ Percentage of drugs prescribed by generic name ◦ Percentage of encounters with an antibiotic prescribed ◦ Percentage of encounters with an injection prescribed ◦ Percentage of drugs prescribed from essential drugs list or formulary June 7th, 2014 58
  • 59.  Patient care indicators ◦ Average consultation time ◦ Average dispensing time ◦ Percentage of drugs actually dispensed ◦ Percentage of drugs adequately labelled ◦ Patients' knowledge of correct dosage  Facility indicators ◦ Availability of copy of essential drugs list or formulary ◦ Availability of key drugs ◦ Availability of clinical guidelines June 7th, 2014 59
  • 60.  Complementary drug use indicators o Average medicine cost per encounter o Percentage prescriptions in accordance with clinical guidelines o Percentage of patients treated without drugs o ** WHO-INRUD (International Network for the Rational Use of Drugs) –WHO-1993 June 7th, 2014 60
  • 61. Prescribing indicators:- 1. Average number of drugs per encounter total number of different drug products prescribed Average = -------------------------------------------------------------- number of encounters surveyed 2. Percentage (%) of drugs prescribed by generic name number of drugs prescribed by generic name × 100 % = --------------------------------------------------------------- total number of drugs prescribed June 7th, 2014 61
  • 62. 3. Percentage of encounters with an antibiotic prescribed 4. Percentage of encounters with an injection prescribed Number of patient encounters during which an antibiotic or an injectable are prescribed x 100 % = ----------------------------------------------- Total number of encounters surveyed June 7th, 2014 62
  • 63. 5. Percentage of drugs prescribed from essential drugs list or formulary The number of products prescribed which are listed on the essential drugs list or local formulary x 100 % = -------------------------------------------------- The total number of drugs prescribed June 7th, 2014 63
  • 64. Patient care indicators:- 1. Average consultation time Total time for a series of consultation Average=------------------------------------------------------ Number of consultations 2. Average dispensing time Total time for dispensing drugs to a series of patients Average=------------------------------------------------------ Number of encounters June 7th, 2014 64
  • 65. 3. Percentage of drugs actually dispensed number of drugs actually dispensed at the health facility × 100 %= ------------------------------------------------------------- total number of drugs prescribed 4. Percentage of drugs adequately labeled number of drug packages containing at least patient name, drug name and when × 100 the drug should be taken %= ----------------------------------------------------------------- total number of drug packages dispensed June 7th, 2014 65
  • 66. 5. Patients' knowledge of correct dosage  To reliably evaluate the correctness of patients' responses about when they are to take the drugs, clear guidelines should be developed about common dosage regimens number of patients who can adequately report the dosage schedule for all the drugs x 100 %= -------------------------------------------------------------- total number of patients interviewed June 7th, 2014 66
  • 67. Facility indicators:- 1. Availability of copy of essential drugs list or formulary 2. Availability of clinical guidelines ◦ A national essential drugs list or a local formulary and a clinical guideline must exist ◦ Scored as ‘Yes’ or ‘No’, per facility 3. Availability of key drugs number of specified products actually in stock × 100 % = ---------------------------------------------------------------- total number of drugs on the checklist June 7th, 2014 67
  • 68. Model list of Key Drugs for testing drug availability:- Diarrhoea oral rehydration salts cotrimoxazole tablets Acute respiratory tract infections cotrimoxazole tablets procaine penicillin injection paediatric paracetamol tablets Malaria chloroquine tablets Anaemia ferrous salt + folic acid tablets Worm infestations mebendazole tablets Conjunctivitis tetracycline eye ointment Skin disinfection iodine, gentian violet or local alternative Fungal skin infection benzoic acid + salicylic acid ointment Pain/fever acetylsalicylic acid or paracetamol tablets Prophylactic drugs retinol (vitamin A) ferrous salt + folic acid tablets June 7th, 2014 77 68
  • 69. Drug classification system:-  The main purpose of having an international standard is to be able to compare data between countries.  Different classification systems : - ◦ Anatomical Therapeutic Chemical (ATC) classification develop by Norwegian researchers.  serve as a tool for presenting drug utilization statistics  recommended by WHO for international comparisons June 7th, 2014 69
  • 70. ◦ Anatomical Therapeutic (AT) classification developed by the European Pharmaceutical Market Research Association (EPhMRA)  The EPhMRA classification system is used worldwide by IMS (International Marketing Services) for providing market research statistics to the pharmaceutical industry. June 7th, 2014 70
  • 71. Step 7:- Provide feedback of results  Prepare a scientific interpretation of the results rather than a value judgment.  Success of any DUS depends on feedback of results to prescribers, other hospital staffs involved in the study and to administrative heads.  The results can also be circulated to hospital staff via newsletters or the hospital’s academic meetings. June 7th, 2014 71
  • 72. Step 8:- Develop and implement interventions  If a drug use problem is identified the next step is to consider how the problem can be addressed.  Interventions:- ◦ Educational - educational meetings, development of protocols, letters to individual physicians. ◦ Operational - modification of drug order forms, development of stringent drug use policy, manual or computerized reminders, prescribing restrictions, formulary additions/deletions etc. June 7th, 2014 72
  • 73. Step 9:- Re-evaluate to determine if drug use has improved  Drug use and prescribing patterns need to be monitored to determine the success of intervention  Re-evaluation is usually done 3-12 months after the introduction of the intervention  Collection of data as in original DUS  Should be a continuous process at regular interval June 7th, 2014 73
  • 74. Step 10:- Re-assess and revise the DUS program Results of the previous DU studies help to improve quality, efficacy and effectiveness of future DU studies. June 7th, 2014 74
  • 75. Step 11:- Feedback results  Circulate results of the DUS  Obtain opinions about success of interventions and improvement of drug use.  Analyze and act accordingly June 7th, 2014 75
  • 76. DU 90%  Reflects the number of drugs that account for 90% of drug prescriptions and adherence to local or national prescription guidelines  Can be applied at different levels ◦ Individual prescriber ◦ Group of prescribers ◦ Wards ◦ Hospitals ◦ County  Gives a rough estimate of the quality of prescribing. June 7th, 2014 76
  • 77. Drug utilization evaluation  Drug utilization evaluation (DUE) is defined as an authorized, structured, ongoing review of physician prescribing, pharmacist dispensing and patient using medication.  DUE is ongoing, systematic process designed to maintain the appropriate and effective use of drugs  Synonymous- Drug Utilization Review (DUR)  Medication use evaluation (MUE) is similar to DUE but emphasizes on improving patient’s clinical outcome and individual quality of life. June 7th, 2014 77
  • 78. Objectives of DUE:-  To ensure that drug therapy meets current standards of care  To control drug costs  To prevent problem related to medication, ADRs  To evaluate effectiveness of drug therapy  To identify areas of practice that require further education of practitioners. June 7th, 2014 78
  • 79. Classification of DUE: A) Prospective DUE:- ◦ Involves evaluating a patient’s planned drug therapy before a medication is dispensed. ◦ Pharmacists perform prospective reviews by assessing prescription medication’s dosage and it’s directions and reviewing patient information for possible drug interactions or duplication of therapy. June 7th, 2014 79
  • 80.  Typical criteria reviewed in prospective studies include the following:-  Indications  Drug selection  Doses prescribed  Dosage form and routes of administration  Duration of therapy  Costs  Therapeutic duplication  Quantity dispensed  Contraindications  Therapeutic outcomes  Adverse drug reactions and drug interactions  Generic substitution June 7th, 2014 80
  • 81. B) Concurrent DUE:- ◦ Performed during the course of treatment and involves ongoing monitoring of drug therapy to ensure positive patient outcomes.  Typical criteria reviewed:- ◦ Drug interactions ◦ High or low dosages ◦ Duplicate therapy ◦ Drug-disease interaction ◦ Over and under utilization ◦ Drug-age precautions ◦ Drug-gender precautions ◦ Drug-pregnancy precautions June 7th, 2014 81
  • 82. C) Retrospective DUE :- ◦ Simplest to perform since drug therapy is reviewed after the patient has received medication. ◦ Patients medical chart or computerized records are screened to determine whether the drug therapy met approved criteria. June 7th, 2014 82
  • 83.  In retrospective studies, the criteria reviewed include:-  Evaluation of indications and contra-indications  Monitoring high cost medicines  Comparison of prescribing between physicians  Cost to patient  Over and under utilization  Incorrect drug dosage  Inappropriate duration  Adverse drug reaction  Drug interactions June 7th, 2014 83
  • 84. Statistical application in Drug utilization research:-  Statistical Package for social science (SPSS) can be used.  Chi square test can be used to test the difference between the proportions. June 7th, 2014 84
  • 85. Future Perspectives:  The study of drug utilization in an evolving field.  The use of large computerized databases that allow linkage of drug utilization data to diagnosis, subject to some inherent limitations, is contributing to expand this area of study.  Importance of drug utilization studies in pharmacoepidemiology has been increasing due to their close association to other areas like- public health, pharmacovigilance, pharmacoeconomics and pharmacogenetics June 7th, 2014 85
  • 86. Conclusion:-  Successful research in drug utilization requires multidisciplinary collaboration between clinicians, clinical pharmacologists, pharmacists and epidemiologists.  Without the support of the prescribers, this research effort will fail to reach its goal of facilitating the rational use of drugs.  Only by a combination of regulatory, informative and educational actions, together with a general improvement of the quality of in and out-patient medical care in the National Health System, the use of drugs can be more rational. June 7th, 2014 86

Notas del editor

  1. Drug utilization research is an essential part of Pharmaco-epidemiology.
  2. Without a knowledge of how drugs are being prescribed and used, it is difficult to initiate a discussion on rational drug use or to suggest measures to improve prescribing habits.
  3. To assess whether interventions undertaken to improve drug use have had desired impact or not
  4. Last point eg - Relative use of drug groups in the treatment of hypertension- ACEI, diuretics, CCBs Relative use of different beta blockers in hypertension
  5. E.g. Hypertension, URTI, gastric ulcer
  6. Age- NSAID causing more gastric damage & Sulphonylureas causing more hypoglycemia in elderly Co-morbidity – b-blocker not in asthmatic for HTN, aminoglycosides not in renal compromised pt for any infection Knowledge- pressure on doctors for prescribing drugs
  7. 3rd point eg Digoxin
  8. Do these variations indicate a need to target education to particular sectors ?
  9. Difficult to obtain especially in environments with weak drug regulation and poor record keeping.
  10. Most internet prescriptions are for nutritional supplements and herbal preparations.
  11. Dispensing data and utilization data may not be equivalent.
  12. E.g. Amoxicillin – 500mg TDS usual dose, but DDD is 1 gm.
  13. Azithromycin for uncomplicated urti -500mg od*3days, for gonococcal urethritis 1gm stat, for typhoid-500mg bd*1day-500mg od*4days Metronidazole for Invasive Amoebiasis and for Moniliasis PDDs are often lower in Asian than in Caucasian populations.
  14. Increase in du90 reflects better quality drug use & policy adherence
  15. E.g. blood glucose levels in males and females, drug use in males and females