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Drug utilization studies

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Gama H Drug Utilization Studies
REVISÃO ISSN 0871-3413 • ©ArquiMed, 2008

Drug Utilization Studies

Helena Gama
Departamento de Investigação e Desenvolvimento, Bial, Porto

Drug utilization studies aim to evaluate factors related to the prescribing, dispensing, administering and taking of
medication, and its associated events (either beneficial or adverse).
Since the early 1960’s the interest in Drug Utilization Studies has been increasing, first with market-only purposes,
then for evaluating the quality of medical prescription and comparing patterns of use of specific drugs.
Presently drug utilization studies are an evolving area. Their scope is to evaluate the present state and future trends
of drug usage, to estimate crudely disease prevalence, drug expenditures, appropriateness of prescriptions and ad-
herence to evidence-based recommendations.
The increasing importance of drug utilization studies as a valuable investigation resource in pharmacoepidemiology
has been bridging it with other health related areas, such as public health, pharmacovigilance, pharmacoeconomics,
eco-pharmacovigilance or pharmacogenetics.
Key-words: epidemiology; pharmacology; pharmacoepidemiology; drug utilization.

ARQUIVOS DE MEDICINA, 22(2/3):69-74

The World Health Organization (WHO) addressed drug local health programs (3). Initially a great emphasis was
utilization as the marketing, distribution, prescription and placed on the study of the quality of physician prescrib-
use of drugs in a society, considering its consequences, ing habits, in particular with respect to antibiotics, in both
either medical, social, and economic (1). Studies on the hospital and outpatient settings (8,9,14). In Europe, the
process of drug utilization focus on the factors related to Scandinavian countries, Scotland, and Northern Ireland
the prescribing, dispensing, administering, and taking of (9,15,16) pioneered the research at the national and in-
medication, and its associated events, covering the medi- ternational levels. The European drug utilization studies
cal and non-medical determinants of drug utilization, the have been predominantly quantitative, describing and
effects of drug utilization, as well as studies of how drug comparing patterns of use of specific groups of drugs
utilization relates to the effects of drug use, beneficial or according to geographic regions and time, showing wide
adverse (2-4). The therapeutic practice is expected to be variations in the utilization of drugs pertaining to several
primarily based on evidence provided by pre marketing pharmaceutical classes (e.g.: anti-diabetics (15), psycho-
clinical trials, but complementary data from post market- tropics, nonsteroidal anti-inflammatory drugs [NSAIDS]
ing period are needed to provide an adequate basis for (17), antihypertensive drugs, antibiotic drugs (12), and
improving drug therapy (5). lipid-lowering drugs (18)).
The interest in drug utilization studies began on both
sides of the Atlantic in the early 1960s (3), and is still
increasing (6,7). The first investigations (5,8,9) were SCOPE OF DRUG UTILIZATION STUDIES
conducted mostly for marketing purposes and data were
not widely available for use by academic researchers Drug utilization studies may include descriptive epi-
or health authorities. The boost in the marketing of new demiological approaches to the study of drug utilization,
drugs, the wide variations in the pattern of drug prescribing but also the assessment of how drug utilization relates to
and consumption, the growing concern about the delayed the effects of drug use, beneficial or adverse.
adverse effects, and the increasing concerns regarding The research in this field aims to analyse the present
the cost of drugs, as reflected in the increase of both state and the developmental trends, of drug usage at
the sales and the volume of prescriptions all contributed various levels of the health care system, whether national,
to the increasing importance of drug utilization studies regional, local or institutional. Drug utilization studies may
(10-13). evaluate drug use at a population level, according to age,
In the United States drug utilization research has been sex, social class, morbidity, among other characteristics.
primarily developed at an institutional level or as part of as These studies are useful to provide denominators to cal-
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ARQUIVOS DE MEDICINA Vol. 22, Nº 2/3

culate rates of reported adverse drug reactions, to monitor commercial reasons, the data are usually expressed in
the utilization of drugs from therapeutic categories where terms of cost or volume of sales in units or weight that,
particular problems can be anticipated (e.g., narcotic although useful for measuring or comparing the economic
analgesics, hypnotics and sedatives, and other psycho- impact of drug use, does not provide information on the
tropic drugs), to monitor the effects of informational and amount of drug exposure in the population. Tablet sizes
regulatory activities (e.g., adverse events alerts, monitoring vary, making it difficult to translate weight into even the
urgent safety restrictions). Drug utilization data may me number of tables. Prescription sizes also vary, so it is
used to produce crude estimates of disease prevalence difficult to translate number of tablets into the number
(e.g., cardiovascular disease (19), antidiabetic drugs (20)), of exposed patients (3). The WHO Drug Collaborating
to plan drug importation, production, and distribution, and Centre for Drug Statistics, intend the use of the defined
to estimate drug expenditures. daily dose (DDD) as a technical unit of consumption to
The characterization of drug utilization may be ex- be employed in these type of studies (27).
tended linking prescription data to the reasons for the drug
prescribing. They include the concept of appropriateness The information on sales available through pharmacy
(3,8,9,14) that must be assessed relative to indication for records is the measure most frequently used in drug
treatment, concomitant diseases (that might contraindicate utilization studies (16,18,20). They provide detailed in-
or interfere with chosen therapy) and the use of other formation on the drugs themselves although data on the
drugs (interactions). Therefore they can document the consumer is usually very limited. This could be improved
extent of inappropriate prescribing of drugs (e.g. antibiot- if a patient is allowed to purchase drugs at only one
ics, NSAIDs) and even the associated adverse clinical, designated pharmacy, as is the case of the Netherlands,
ecological, and economic consequences (8,9,21,22). where reimbursement regulations require accurate re-
Moreover, they can also explore the percentage of drugs cording of pharmacy data (28). But even in this situation,
that adhere to the evidence-based recommendations in information such as the indication for use or extent to
place for its indications (23,24). which patients actually consume the drugs will remain
largely unknown and it should be noted that all these
units represent approximate estimates of true consump-
DATA SOURCES tion (3). The County of Jämtland Project (Sweden) is an
example of longitudinal patient-specific studies of drug
A considerable amount of data on drug usage is utilization (16,29,30). All drug prescriptions dispensed to
available as part of databases with administrative, com- 14% of the Jämtland population (approximately 17 000)
mercial or clinical purposes, and specific investigations have been continuously monitored since 1970. The re-
may be conducted to collect different types of information, corded information includes the patient’s unique identity
qualitatively and quantitatively, or referring to a particular number; name, dosage, quantity, and price of the drug;
population. date of dispensing; dispensing pharmacy; and prescribing
physician. Information relating to morbidity (diagnoses),
Databases currently available for purposes of drug however, is missing.
utilization studies may be classified as non-diagnosis- The Odense Pharmacoepidemiologic Database
linked or diagnosis-linked (3). While the latter consider (OPED) and the pharmacoepidemiology prescription
drug utilization linked to its indications and outcomes database of the County of North Jutland are two similar
(e.g. treatment of peptic ulcer (25), trends in prescribing databases that include about half a million inhabitants in
for heart failure (26)), the former concerns only about Denmark (31). These databases contain all dispensed
describing drug consumption in a population (e.g. use of prescriptions since the early 1990s. The following in-
antimicrobial drugs (22), statin consumption (18)). formation is captured for each prescription: a unique
Most of currently available data sources lack infor- person identifier, the date of dispensing, identification of
mation on morbidity and are mostly used for generat- the dispensed product, the pharmacy, and the prescriber.
ing drug statistics and descriptive studies of patterns The databases do not include information on over-the-
of drug consumption. Some collect data in the form of counter medications (laxatives, analgesics, ibuprofen,
drug sales (e.g., The Portuguese National Authority for antihistamines, antitussives, and certain antacids) and
Medicines and Health Products (INFARMED), the Danish non-subsidized drugs (oral contraceptives, hypnotics,
Medicines Agency, the National Agency for Medicines and and sedatives). They have been used for a number of
Social Insurance in Finland, the Norwegian Institute of population-based pharmacoepidemiologic surveys such
Public Health, the National Corporation of Pharmacies in as the use of the new antidepressants (13), inappropriate
Sweden,), drug movement at various levels of the drug use of inhaled steroids in asthma treatment (32), inap-
distribution channel (e.g, IMS-Health [www.imshealth. propriate use of sumatriptan (33) and low use of long-term
com]), pharmaceutical or medical billing data or all pre- hormone replacement therapy (34).
scriptions dispensed (Prescription Pricing Authority in The Community of Tierp Project is run by the Center for
the UK, Spain’s Drug Data Bank, Medicaid Management Primary Care Research, University of Upsalla, Sweden.
Information System). However, since most statistics on Prescription and morbidity data are routinely collected
drug consumption were compiled for administrative or from all pharmacies and the health center within the
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Gama H Drug Utilization Studies

community for all residents since 1972. The Swedish database (41).
prescribed Drug register is a new register that contains In Portugal, the National Observatory of Health
data on all dispensed prescriptions for the entire Swedish (ONSA) analyses data related to health status and its
population (about 9 million inhabitants) linking to the use determinants among the Portuguese residing population
of a unique personal identification number (7). The register (42). It has a primary care surveillance network includ-
does not include data on over-the-counter drugs, herbal ing 150 General Practioners across the country and has
drugs, drugs used in hospitals or from drugs storerooms some published drug utilization studies regarding use of
sometimes used in nursing homes. It has information several therapeutic classes such as antibacterials (43),
about individual’s age, sex and dispensed drugs (amount antiepileptics and antidepressives (44,45) and antacids
of drug, date of redemption and dosage, i.e. from the (25). It has also an observational instrument created with
prescription written by the prescriber). the purpose of obtaining data and indicators on health
The Portuguese National Pharmacy Association (ANF) with the help of a sample of Portuguese families with
has also been developing an interesting work. It has land-line telephones (“ECOS”).
created since 1994 a centre for pharmacoepidemiology Data on drug utilization may be obtained directly from
studies (CEFAR) and a database containing information the population through Health surveys, including national
on medicine consumption, based on dispensing data surveys such as Statistics Canada’s National Population
information from the Portuguese pharmacies. It has been Health Survey, or the Portuguese National Health Survey
conducting several drug utilization studies with a number (also from the National Observatory of Health), or smaller
of published work addressing different drug utilization is- surveys conducted in specific settings such as among
sues such as self-medication (35,36) and antiasmaticals university students (46), female population (47) or elderly
usage (37). outpatients (48). Such studies provide information on drug
Data from general practioners (GP) records of pre- use from consumers themselves (49), and are a source
scriptions can be more informative about the indication of data on many other health-related issues (28).
for drugs prescribed, diagnoses and other health-related
data, although these records are not always consistently
completed (28). The National Disease of Therapeutic INSTRUMENTS FOR DATA COLLECTION ON DRUG
Index (NDTI), by IMS America, is an ongoing study of UTILIZATION
physician prescribing which is conducted mainly for use
by pharmaceutical companies in their marketing activi- Patient files and computer registries are widely used
ties (38). This study employs a rotating sample of office- as instruments for collecting information on drug utiliza-
based physicians who record all patient encounters and tion. Home inventories are also used and considered by
corresponding «drug mentions» for two-day periods, four some authors as the best method of obtaining accurate
times a year. A special prescription form is used to collect and complete drug use data (19,50,51). In this scenario,
information on the drug (specific product, dosage form, an interviewer visits the home of the respondent and lists
new versus continuing therapy), patient characteristics all the drugs in the medicine cabinet. Questionnaires,
(sex), prescriber (speciality, location, region), type of con- however, are one of the easiest tools for data collection
sultation (first versus subsequent), concomitant drugs and on drug utilization and the most widely used in popula-
diagnoses, and the desired pharmacological action. Data tion surveys.
has been made available to Academic Researchers and Self-reported data in epidemiological studies obtained
the US Food and Drug Administration (11). Although use- through questionnaires is commonly used as a source of
ful for studies of prescribing, longitudinal patient-specific drug exposure information (52). Data collected by self-re-
studies are not possible with this database. port is, however, subject to recall inaccuracy (50,53-55). In
The Integrated Primary Care Information (IPIC) data- some questionnaire-based studies only a limited number
base, established at Erasmus University in The Nether- of drug categories were evaluated (53-55). In others, the
lands, consists on the computer-based patient records completeness and quality of reference sources were deba-
of 150 general practioners. To date the database has table (56,57). In several studies questionnaire information
accumulated data on approximately 500 000 patients. This was compared with pharmacy records (53,54), which are
database has been used to study preventive strategies a reliable source of drug exposure, with an acceptable
in patients receiving NSAIDS (39) and trends in primary degree of agreement (28,51,52,58,59).
care prescribing for heart failure (26). Despite being accurate, carefully constructed question-
The Tayside Medicines Monitoring Unit (MEMO) and naires can be subject to recall bias due to its characteris-
the General Practice Research Database (GPRD), in tics, and noncompliance can also influence the reliability.
the United Kingdom, are databases developed primar- Furthermore, questionnaire design also influences recall
ily for drug safety studies, but have also been used to and may lead to different estimates on drug exposure
study drug utilization (40). GPRD exists since 1987, and (50,52,53,55).
is still growing in the number of practioners contributing Drug utilization data collected through questionnaires
data from over 460 general practioners, covering about is commonly used in epidemiological studies but variations
5.5% of the population of UK (3.5 million currently active in questionnaire structure may affect recall. Therefore, in
research quality patients) being today the most published addition to a careful design of the data collection instru-
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ARQUIVOS DE MEDICINA Vol. 22, Nº 2/3

ments, the characteristics of the questionnaires used Pharmacoeconomics

to obtain information on medicines need to be taken Drug utilization reviews can be used for the improve-
into account in the interpretation of results from studies ment of medical care and cost-containment, and are
quantifying drug utilization by self-report. useful for measuring or comparing the economic impact
of drug use in the population. By identifying adherence to
guidelines in the current use of medicines, it is possible to
FUTURE PERSPECTIVES reduce drugs expenditure and improve the allocation of
the limited resources available, when the chosen drugs
The study of drug utilization is an evolving field. The are not usually the most cost-effective.
use of large computerized databases that allow the link-
age of drug utilization data to diagnosis, albeit subject to
some inherent limitations, is contributing to expand this Eco Pharmacovigilance
area of study. Pharmaceuticals are environnement polluants. It is
Drug utilization studies have been having an increas- important to observe the differences in national and in-
ing importance in pharmacoepidemiology by means of ternational patterns of drug utilization in order to address
bridging more closely to other areas: and minimize the environmental impact of pharmaceuticals
whilst continuing to deliver patient benefit.

Public health
From a public health perspective, the differences Pharmacogenetics
observed in national and international patterns of drug Trying to assess genetic mechanisms related to drug
utilization require much further study. Many strategies safety issues is also a challenge for drug utilization studies,
aimed at modifying prescribing behaviours have been pro- while comparing consumers’ characteristics and linking
posed and adopted. Several studies have demonstrated it to the benefit and risk of drugs.
the efficacy of face-to-face methods in improving drug
prescribing by identifying physicians who were prescrib-
ing drugs assessed as inappropriate and targeting for
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e-mail: helena.gama@bial.com

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