Definition and scope of Pharmacoepidemiology

In these slides I shared the information of definition and scope of pharmacoepidemiology. Types of studies - cohort studies, cross-sectional studies etc.

1. Definition and scope of Pharmacoepidemiology Submitted By : Abu Bakr Ansari Pharm. D 5 th Year Roll No. 1601096001 Enroll No. 1600100627 Submitted To : Dr. Mohd Khustar Sir Associate Professor Integral University, Lucknow Faculty of Pharmacy PRY – 502 Pharmacoepidemiology and Pharmacoeconomics

2. Definition and Introduction Pharmacoepidemiology is derived from the words ‘pharmacology’ and ‘epidemiology’; the study of population or diseases in a population. The pharmacoepidemiology is applying of principles of epidemiology into pharmacology. It is a specialized branch of epidemiology that looks into the effects of drugs approved in the market. Pharmacoepidemiology can be applied in drug utilization studies (prospective or retrospective), outcomes studies and data analytics.

3. It is the bridging between clinical pharmacology a nd epidemiology . Pharmacoepidemiology Pharmakon - Drug Epi – upon or among Demos – People or district Logos - Study

4. Aim WHO targets its pharmacoepidemiological efforts to ensure the quality, safety and efficacy of drugs. The studies focus on Global trends in prescribing Appropriateness of drug use Medication adherence Lifestyle effects on drug therapy Special population (Elderly, Pediatric, etc.) drug therapy Drug Interactions Predictable ADRs Uncommon and unpredictable ADRs

5. Sources of Data The sources of drug data includes: - Insti t u t i on a l i z e d m edic a l re c o r ds and da t abas e s f r om h o spit a l a n d pharmacy claims - System wide databases from health insurance claims or pharmaceutical organization. - National d a t a bases li k e M e dic a l Expenditure P a nel S u r ve y , N a t io n al Ambulatory Medical Care Survey. - Field data l i ke re c o r ds from disp e nser s , s e l l ers o r dist r ib u t e rs o r from small groups. - Experimental clinical trial data.

6. Types Epidemiological studies can be divided into two main types: Observational Study Intervention Study

7. Cross Sectional Study These studies are examinations of the use of drugs at one specific point in time. They are usually done through surveys, chart reviews and data base analyses. They provide a view of the state of affairs at that time and an estimate of the prevalence of utilization and of outcomes. Such information can be used for formulary management and policy development. Used to compare drug use between countries or regions within in a country.

8. Eg : cross-sectional studies was published by Dua and colleagues, who examined inappropriate sale of antibiotic use in pharmacies in Nagpur. Such studies can identify problem areas and suggest where remedial action should be directed.

9. Case Control Study These studies compare cases with disease to controls without disease.

10. Ad v an t ages Useful to study multiple possible causes of a single disease. Useful to study uncommon diseases. Relatively easy to carry out. Rapid and inexpensive. Requires comparatively few subjects. Does not need an ethical clearance. There is no risk to the subject . Disadvantages It introduces bias. To select an appropriate control could be difficult . It may be difficult to distinguish between the cause of a disease and an associated factor.

11. Cohort Study Cohort studies identify subsets of a defined population and follows them over time, looking for differences in their outcome. They are useful to compare exposed patients to unexposed patients.

12. Ad v an t ages There is no bias. It is effective for studying rare exposures. It allows the study of the natural history of the disease. It assists in determining the temporal relationship between the etiological factor & the disease. Can study multiple outcomes. Disadvantages It takes a long time. It is expensive. Large no of subjects are needed. There could be changes in the standard methods or diagnostic criteria .

13. Need of Pharmacoepidemiology There are 3 main reasons why there is a strong need for PE. Source of supplementation of information available from pre-marketing studies: It is useful for the better quantification of the incidence of known adverse and beneficial effects.Advantages of being a source of supplemental information are: higher precision in results, provides information of patients not studied in pre-marketing studies (for eg ; elderly, pregnant population etc), provides understanding of how a drug is modified by other drugs and illnesses and helps to compare with other drugs for the same indication in terms of safety and efficacy. Source of new information not available from pre-marketing studies: These PE studies provide information on (a) undetected adverse events and beneficial effects (b) pattern of drug utilization (c) effects of drug over doses (d) economic implications.

14. 3. General contributions of PE: PE studies can reassure drug safety and also fulfill certain ethical and legal obligations.Aims of PE: The aim of PE is to describe, explain, control and predict the uses and effects of drugs in a defined time, space and population.

15. Applications of PE Government agencies & Health care plans: Pharmacoepidemiology research is important for the government agencies like the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS) and Healthcare plans. Practitioners: Pharmacoepidemiological studies can help Pharmacists, Physicians, Nurses and other Public health care practitioners to make informed decisions about treatment for patients.

16. Pharmaceutical industries: The pharmaceutical industry want to understand how a drug is prescribed, used and what are all the positive and negative outcomes. Academicians: Acade m i c i a ns often c o n duct p h a r m a c oe p i d e m iolo g i c al s t u d i e s t o find answers to practice related questions. Attorneys: F i n d i n g s f r om p h ar m a c o e pi d e m i o lo g i c al s t u d i e s ca n b e us e d as ca n b e us e d as evidence that a drug product did or didn’t cause an event. Consumers and Patients: T o lear n a bout s a fe t y a nd ef f e c t i v e ness o f d r ug p r oduc t s, pati e nts a n d consumers rely on pharmacoepidemiological studies.

17. Reference Textbook of clinical pharmacy practice, pharmacoepidemiology , by Jayashri Sankaranararyanan and Thomas R Einarson ; page no: 467- 483. https://en.wikipedia.org/wiki/Pharmacoepidemiology https:// www.slideshare.net/DivjyotKaur/pharmacoepidemiology

18. THANK YOU Faculty of Pharmacy