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PubMed2004

Pharmacoepidemiology I: a review of pharmacoepidemiologic study designs.

This article is the first of two parts on pharmacoepidemiology, a relatively new science that explores drug efficacy or toxicity using large observational study designs. The number of pharmacoepidemiologic studies published in medical journals has increased, as these studies have explored drug-related questions that at times cannot be answered in randomized clinical trials. Four pharmacoepidemiologic study designs will be discussed that explore the association between a specific pharmacologic agent and a disease of interest: cohort studies, case-control studies, case-crossover studies, and case-time-control studies.

Case-Control Studies↗
PubMed2004

Pharmacoepidemiology II: the nested case-control study--a novel approach in pharmacoepidemiologic research.

This article on pharmacoepidemiology, the second of two parts, is a more focused discussion of the methodology of cohort studies and case-control studies, the basic methodologies of which were discussed in part I. The nested case-control study incorporates the strengths of both the cohort and case-control studies but may alleviate some of the methodologic challenges inherent in both types of studies. In a nested case-control study, a cohort of individuals is followed during certain time periods until a certain outcome is reached. The analysis is conducted as a case-control study in which cases are matched to only a sample of control subjects. Matching allows for control of potential confounding variables such as age, calendar time, and disease duration. Also, the time dependency of an exposure can be quantified without complicated statistical techniques. Matching the cases and controls by time allows the investigator to stratify exposure based on current, past, or intermittent use. By using the principles of epidemiology, the nested case-control study allows for the control of confounding variables, as well as better quantification of time-dependent exposures.

Case-Control Studies↗
PubMed2000

Patterns of hypertension management in Italy: results of a pharmacoepidemiological survey on antihypertensive therapy. Scientific Committee of the Italian Pharmacoepidemiological Survey on Antihypertensive Therapy.

OBJECTIVE: To collect statistically significant information on patterns of antihypertensive therapy in medical practice, with particular attention to the drugs used in the pharmacological management of hypertensive patients and the reasons for the limited achievement of therapeutic goals during treatment DESIGN: A survey conducted among general practitioners, specialists, and hypertensive patients. METHODS: A total of 28,000 physicians were contacted by letter and 3,394 declared their willingness to participate and received a questionnaire. Subsequently, 1,255 questionnaires suitable for analysis (corresponding to 37.0% of adhering physicians) were received. In addition, 4,612 questionnaires completed by patients were pooled and evaluated. The prevalence of hypertension was calculated from a base of 254,192 patients, seen by general practitioners. RESULTS: The prevalence of hypertension, defined as systolic blood pressure > or = 160 mmHg or diastolic blood pressure > or = 95 mmHg, or current treatment, was 19.7%. The average number of hypertensive patients in each general practitioner's file, covering the previous 12 months, was approximately 230. Physicians reported a 66% rate of discontinuation of treatment or switching to another drug. Physicians and patients both considered inadequate blood pressure control and side effects to be the two main reasons for switching antihypertensive therapy, but in opposite order. Furthermore, physicians indicated a prevalence of drug side effects between 10 and 20%, according to class of drug used, whereas 69% of patients reported to have experienced side effects. In the doctors' opinions, there were many reasons for poor patient adherence: complexity of the drug regimen, appearance of side effects, forgetfulness, reduced patient understanding of the need for long-term continuation of treatment, and refusal to accept a chronic pathological condition. CONCLUSIONS: The survey showed awareness of the disease among physicians and provides a representation of the experiences of both general practitioners and specialists, in addition to that of their patients. During antihypertensive therapy, a disconcerting degree of discontinuation and switching of drugs occurred. Insufficient blood pressure control and side effects accounted for most of the observed treatment changes. This survey revealed the existence of a gap between the physicians' perception of tolerability and the real experience of patients, a clear need for greater tolerability of treatments, and a need for an enhancement of patient-physician communication.

Antihypertensive Agents↗
PubMed2006

Challenges and opportunities for pharmacoepidemiology in drug-therapy decision making.

Pharmacoepidemiology is a relatively new and evolving science that attempts to quantify mainly adverse drug events and patterns of drug use in a large population. The strength of pharmacoepidemiology over randomized trials is the ability to quantify rare adverse events that may occur over long periods. Recently, discordance in the results of pharmacoepidemiologic studies has made it difficult for clinicians and policy makers to make informed drug-therapy decisions. This commentary addresses the strength of pharmacoepidemiology and the advances in the methodology of pharmacoepidemiologic studies over the years. We also discuss the potential problem of discordant results and urge pharmacoepidemiologists to develop good practice guidelines for the conduct of pharmacoepidemiologic studies.

Adverse Drug Reaction Reporting Systems↗
PubMed2002

Presence of pharmacoepidemiology in three bibliographic databases: Medline, IPA and SCI.

OBJECTIVE: The objective of this study is to make a comparative description of the evolution and distribution of international research into pharmacoepidemiology, using three bibliographic databases, in order to select the most appropriate for future bibliometric studies. METHODS: Bibliographic searches were performed using the following databases: Medline (1966-99), IPA (1970-99) and SCI (1990-99), using the term 'pharmacoepidemiology'. On the basis of these searches, the number of original articles per year and per journal title were noted. The growth of the output of scientific writing was found to fit Price's law. RESULTS: A total of 845 original articles were recovered: 467 from IPA, 219 from Medline and 159 from SCI. The highest mean number of original articles per year (33.4) was obtained with the IPA database. Price's exponential growth pattern was observed among all three databases. The total numbers of journals in which the original articles were published were 102 in Medline, 65 in IPA and 60 in SCI. The journals providing a single original article comprised 65% of the Medline titles and 61% of those in IPA and SCI. CONCLUSIONS: International research into pharmacoepidemiology presents an exponential growth pattern, in accordance with Price's law. There is a large degree of publishing dispersion. IPA was found to be the bibliographic database that recovered the greatest number of original articles, nearly half of which were published in Pharmacoepidemiology and Drug Safety. We therefore consider the latter database appropriate for bibliometric studies in the field of pharmacoepidemiology.

Bibliometrics↗
PubMed2006

Use of health care databases in pharmacoepidemiology.

Pharmacoepidemiology is the study of the use and effects of medications in populations. Large health care databases are often used to address research questions within pharmacoepidemiology. This paper briefly describes the kinds of research questions that can be addressed using pharmacoepidemiology databases, provides an overview of pharmacoepidemiologic databases, describes some differences between medical records and administrative databases, discusses factors that should be considered when choosing a database for a particular study, and considers what the future holds.

Databases, Factual↗
PubMed1995

Pharmacoepidemiology in practice. Current status and future trends.

Pharmacoepidemiology is the application of epidemiological reasoning, methods and knowledge to the study of the uses and effects (beneficial and adverse) of drugs in human populations. As referred to by the term 'pharmacoepidemiology', the discipline now enters into its second decade, although its origins go back to the beginnings of this century. This article reviews the opinions of leading pharmacoepidemiologists on the scope and prospects for pharmacoepidemiology, and summarises the most important challenges that the discipline faces on its way towards the next century. The future of pharmacoepidemiology requires the development of research methods more able to cope with the specific problems posed by the study of drugs, notably the issue of confounding by indication and the ability to adjust accurately for severity of disease. Capacity building should also continue during the next years; training of professionals, the optimisation of computerised databases for research purposes and their joint use with more traditional epidemiological methods are major challenges. From a public health perspective, a critical task is to assess the impact that vaccines and drugs have on the overall patterns of disease in well defined populations.

Cost-Benefit Analysis↗
PubMed1992

Pharmacoepidemiology and military medical automation: opportunity for excellence.

Fielding of the Composite Health Care System (CHCS) brings an unparalleled opportunity for medical research. This sophisticated automated medical record system promises pharmacoepidemiologic research of a quality and quantity never before possible. Pharmacoepidemiology provides answers about the validity of beneficial and adverse drug events and aids in individualizing drug therapy. When CHCS eventually encompasses an estimated 9.1 million patients at 166 military hospitals and 588 clinics around the world, it will provide a database capable of supporting sophisticated automated research. In addition to the unprecedented size of this resource, advantages of pharmacoepidemiology performed with the CHCS database include integration of inpatient and outpatient care records, the completeness of prescription and medical records, and the wide socioeconomic spectrum covered in a defined population. Limitations and potential biases of such a database include separate drug formularies at each medical treatment facility, only limited information about nonprescription drug use and single-dose drug orders in clinics, and the mobility of military service members and their families. Pharmacoepidemiology is a tool that will benefit individual members of the military family, as well as advancing the sciences of pharmacy and medicine. Using the CHCS database for this form of research is in the best tradition of military medical research.

Attitude to Health↗
PubMed2000

The interface between pharmacoepidemiology and pharmacogenetics.

One of the most challenging areas of research in pharmacoepidemiology is to understand why individuals respond differently to drug therapy, both in terms of beneficial and adverse effects. Pharmacogenetics focuses on the question to what extent variability in genetic make-up is responsible for these observed differences. Pharmacoepidemiologic research can contribute to pharmacogenetics by explaining the observed variability in drug response in 'real life' patient populations with known polymorphisms in their genetic profile. Genetic pharmacoepidemiologists also are interested in the distribution of polymorphisms and correlated frequencies of responders and non-responders in the general population, and in searching for unknown genetic links to variability in drug response. In the future, we will probably have fewer drugs that suit all individuals. Genetic pharmacoepidemiology is going to play a major role in the development and evaluation of the concept of 'tailor-made' pharmacotherapy.

Animals↗
PubMed1993

Benzodiazepine substitution in medical practice. Analysis of pharmacoepidemiologic data based on expert interviews.

Pharmacoepidemiologic data have shown a consistent reduction in benzodiazepine (BZ) prescriptions over the past decade. The question remains as to whether BZs are simply put aside or whether other medications are used as substitutes. Expert interviews, at which a stratified sample of 114 psychiatrists, internists, and general practitioners were presented with case studies, were conducted to learn about the therapeutic alternatives in the field of benzodiazepine-related indications administered in daily practice. These results were used to analyze trends in pharmacoepidemiologic prescription data for all patients under the general health insurance plan from 1981 to 1988. The experts identified distinct alternatives to BZs in different clinical situations, including neuroleptics, antidepressants, phototherapeutics, and analgesics. When these findings were transferred to pharmacoepidemiologic data, results revealed an increase in the prescription of alternative medications that apparently compensated for reduced BZ use. Overall there was no change (or, rather, no increase) in the total of psychotropic prescriptions during the period of reduced BZ prescriptions. Our findings indicate that reduction in benzodiazepines prescription is associated with substitution by various other psychotropic drugs. This has positive as well as negative consequences, and there must be discussed in detail before sound recommendations can be given as to which type of drug. BZs included, is the best choice in which type of illness.

Adult↗
PubMed2002

Causal association in pharmacovigilance and pharmacoepidemiology: thoughts on the application of the Austin Bradford-Hill criteria.

The methods used for the evaluation of drug safety signals (including major signals leading to withdrawal of products from the market) are inconsistent and sometimes of poor quality. While the assessment of the safety of medicines needs to consider specific issues such as drug interactions and variation in compliance, the general principles, which are used to study environmental hazards, can be applied for this purpose. The criteria proposed by Sir Austin Bradford-Hill more than 35 years ago for attributing disease causation to environmental factors have been used widely in epidemiology, are applicable to pharmacovigilance and pharmacoepidemiology. The Austin Bradford-Hill criteria include strength, consistency, specificity, temporality, biological gradient, plausibility, coherence, experimental evidence and analogy. The paper reviews each of these criteria with emphasis on pharmacovigilance and pharmacoepidemiology and with some examples. The application of the Austin Bradford-Hill criteria to the evaluation of causal association in pharmacovigilance and pharmacoepidemiology is very useful. However, it requires understanding of the limitations of the data, such as, under-reporting, poor quality of information from third parties and misclassification. Further work is required to develop strategies to handle these limitations.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

The role of pharmacoepidemiology and pharmacoeconomics in promoting access and stimulating innovation.

Answering the demanding questions asked of pharmacotherapy in the 21st century will require more reliance on the disciplines of pharmacoepidemiology and pharmacoeconomics. Pharmacoepidemiology can help assess patterns and appropriateness of drug utilisation, provide explanations for poor compliance, quantify the frequency and severity of side effects, and aid in the design and evaluation of interventions to improve drug use and outcomes. Pharmacoeconomics can help determine whether a new costlier product offers sufficient clinical advantage over its predecessors to justify the increased cost. Taken together, pharmacoepidemiology and pharmacoeconomics represent the next logical step in the evolution of medication assessment; their judicious deployment can help ensure both access to new medicines and innovation.

Cooperative Behavior↗
PubMed2006

Pharmacoeconomics and pharmacoepidemiology: curious bedfellows or a match made in heaven?

Pharmacoepidemiology is an established subdiscipline of epidemiology concerned with estimating the efficacy, effectiveness and safety of pharmaceutical products. Pharmacoeconomics is an established subdiscipline of health economics concerned with the evaluation of pharmaceutical products in terms of their value for money. Despite a common focus on the evaluation of pharmaceuticals, practitioners in the two disciplines appear to work largely in isolation of each other, as evidenced by lines of reasoning developed in one field that do not appear in the other. The purpose of this paper is to explore the interface between pharmacoepidemiology and pharmacoeconomics with the aim of identifying the potential synergies that exist from greater communication of ideas between practitioners in both disciplines. Issues are illustrated by means of a simple example of safety and efficacy in deep vein thrombosis prophylaxis. Issues surrounding safety and efficacy exemplify the need for a framework that allows trade-off between such benefits and risks of drug therapy. Health economics provides such a framework and it is suggested that those working in pharmacoepidemiology might make more of this framework in seeking to address essential trade-offs and inform policy. Similarly, it is argued that pharmacoeconomics could benefit from the robust methods of estimation used in epidemiological research as part of evaluation studies, in particular surrounding issues of unbiased estimation and scale of measurement. A closer working relationship between the disciplines could allow for economic assessment to be made earlier in the product cycle, which could bring benefits to society in terms of delaying the uptake of cost-ineffective products and speeding the uptake of products offering clear value for money.

Drug Therapy↗
PubMed2000

Pharmacoepidemiology and gastroenterology: a close couple.

UNLABELLED: The discipline of pharmacoepidemiology has always been strongly linked with the problem of gastrointestinal injury caused by non-steroidal anti-inflammatory drugs, and has led to a close liaison between gastroenterology and pharmacoepidemiology. AIM: This paper discusses three important areas of pharmacoepidemiological interest relevant to gastroenterologists: confounding by indication and channeling bias, drug exposure patterns, and postmarketing surveillance studies. (i) Drug prescribing is associated with a patient's prognosis and disease status, called indication for treatment. These patient disease characteristics can drive drug channeling in risk populations and create confounded drug-effect associations. (ii) Drug exposure is the result of the 'natural' experiment of pharmacotherapy over time. Reliable information on the time-sequence of events in relation to drug exposure is required to evaluate both beneficial and adverse effects of drug therapy. (iii) Postmarketing surveillance studies provide intensive learning about drug effects when large spectra of patients with various medical backgrounds, prognoses, co-morbidity, and the like, are exposed to the drug. Information on drug use and patient outcomes in 'real life' populations is necessary to bridge normal practice experiments with randomized clinical trials.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMedDate not supplied

Prolongation of the QT interval and cardiac arrhythmias associated with cisapride: limitations of the pharmacoepidemiological studies conducted and proposals for the future.

Not all hazards can be identified from clinical studies prior to marketing of medicinal products. Pre-marketing large-scale trials for cisapride did not report any serious cardiac arrhythmias. After a long period of availability in several countries it was withdrawn in 2000 because of reports of serious, and in many cases fatal, cardiac events. Whilst spontaneous reporting systems for adverse drug reactions (ADRs) have limitations such as under-reporting, they are an effective system for signal generation, particularly of rare ADRs. Pharmacoepidemiological studies aim to identify and calculate the incidence of adverse reactions, with increased sensitivity to less common ADRs compared to randomised controlled trials, yet cohort sizes may be insufficient to detect very rare ADRs such as drug-induced Torsade de Pointes, with an estimated incidence of the order of 1 per 12,000 to 1 per 120,000 patients. Several pharmacoepidemiological studies investigated adverse events associated with cisapride, one of which specifically examined the association between serious cardiac arrhythmias and cisapride. These observational studies were conducted using large population databases, but each failed to identify sufficient cases to establish a causal relationship. Explanations include that the cohort sample sizes were too small, and either under-, or mis-reporting of events of interest may have occurred. To estimate the risk of very rare adverse events, pharmacoepidemiological studies require very large numbers. Furthermore, the events in question need to be clinically recognisable by doctors and adequately documented in patients' notes, computer records, or on study questionnaires. The establishment of a national registry for drug-induced QT prolongation to identify cases and correlate clinical information may help to better identify these rare ADRs earlier. Such proactive surveillance could avoid unnecessary delays for other drugs where QT prolongation and serious cardiac arrhythmias may be an issue.

Adverse Drug Reaction Reporting Systems↗
PubMed1995

An overview of pharmacoepidemiology.

Pharmacoepidemiology is the application of epidemiological principles and methods to the study of drug effects in human populations. The goal of this discipline is to characterize, control and predict the effects and uses of pharmacological treatment modalities. Pharmacoepidemiology is also concerned with the economic impact and health benefits of unintended drug effects. The increasing importance of pharmacoepidemiology has been created by the need to develop a more accurate portrait of how drugs are used in the general population. Sophisticated and potent drug therapies require surveillance beyond the scope of the carefully controlled clinical trials of Phases I, II and III. Case-control and cohort studies, which allow scientists to evaluate the effects of patient variables on clinical outcomes, provide a wealth of information regarding the study of unexpected drug effects, drug utilization, treatment costs and the individualization of therapy.

Case-Control Studies↗
PubMed1991

Pharmacoepidemiology as a focus for clinical epidemiology in developing countries.

We present a concept of pharmacoepidemiology as a branch of clinical epidemiology having particular relevance to public health in developing countries. Planning to incorporate pharmacoepidemiology into the clinical epidemiology curriculum of the International Clinical Epidemiology Network (INCLEN) is discussed and an outline of training programs in pharmacoepidemiology at INCLEN universities is given.

Curriculum↗