Tiêu đề 6. CASE SERIES & SURVEY OF DRUG USE.pdf ✅

PHARMD GURU Page 1 CASE SERIES:  Case series, like case reports are observational descriptive studies in pharmaco- epidemiology. It is a qualitative (descriptive) non-experimental method and is considered stronger than Case Reports.  Case series are also known as a Clinical series. It is a group or cluster of case reports generated by single/group of clinicians or hospitals or pharmaceutical companies or regulatory agencies like Food and Drug Administration (FDA) or Drugs Controller.  It is a type of medical research study that tracks subjects with a known exposure, such as patients who have received same medicine.  A set of sequential case reports makes a case series. Case series are collections of patients all of whom have a single exposure and whose clinical outcomes are then evaluated and described. The patients can be identified for the case series either based on the exposure or on the outcome.  The case series studies are useful in quantifying the incidence of an adverse reaction and arc generally used for the study of newly licensed or marketed medicines.  The greater the number of common experiences occurred to patients, the stronger will be the signal to support a conclusion. If six patients developed aplastic anemia after administration of the same medications, that can raise a strong suspicion compared to one person developing aplastic anemia.  A classical example of Case Series occurred with Thalidomide induced phocomelia in the early 1960s when same type of malformations was reported in a cluster.  Case series does not have a formal trial protocol, but has many similarities with the open trial (both subjects and researcher knows the treatment). They are very much useful to enlarge our knowledge about the medicines and their risks and help to confirm ADR'S.  Generally it is necessary to compare cases with a group of controls to identify risk factors. The lack of comparison groups is considered as a major disadvantage of the case series studies. CASE SERIES & SURVEY OF DRUG USE
PHARMD GURU Page 2 ADVANTAGES:  Useful for hypothesis generation.  Informative for very rare disease with few established risk factors.  Characterizes averages for disorder. DISADVANTAGES:  Cannot study cause and effect relationships.  Cannot assess disease frequency. EXAMPLE OF THE CASE SERIES STUDY: During 1950, 8 cases of cancer lung were admitted to different hospitals during the same period of time. Taking history from these patients showed that they were miners. This unusual circumstance suggested that the miners may be exposed to something. Investigating this circumstance showed high concentration of radon gas. A hypothesis was formulated that lung cancer is related to exposure to radon. SURVEY OF DRUG USE:  Surveys of medicines like case series and case reports are observational descriptive studies in pharmacoepidemiology.  They are qualitative (descriptive) non- experimental method and are considered as effective tools in promoting health care and framing policy documents related to drug use.  Surveys often take simple format and provide crude data. The health surveys have primarily had their origin in the charting of major diseases in the population and etiological research.  Pharmacoepidemiological research based on drug surveys has been scattered and taken place in different research groups at global levels in different settings.  Drugs comprise the most common treatment and one of the most rapidly increasing costs in health care. There may be several explanations for the low research output. One of the reasons may be the poor access to information from issued prescriptions.  There are many areas in drug use where surveys can generate useful information and knowledge. University level surveys in the developed countries by pharmacy
PHARMD GURU Page 3 students helped to give an insight into drug use by breast feeding women versus non breast feeding women.  Drug surveys will also help to compare the usages in various states or among various sections of society like educated and non-educated, working class and office staff, high income and low income groups, youths and adults etc.  In countries like US, UK, Canada etc. it is easy for the researchers to conduct surveys as they have a computerized databases for filling of prescriptions at hospital and community levels.  However the Indian situation is totally different. We don't have a data base to analyze. Majority of Indian Community pharmacies are not computerized. Even the computerized pharmacies are not connected to net working and data banking.  No agency exists in India to co-ordinate such activities same is the case with hospitals also Medium and large hospitals are computerized, but keep the data as their private property and there is no agency to monitor and coordinate.  The potential for carrying out drug usage surveys in India is very high as it a country with over 1.3 crore population and annual production of drugs worth rupees one lakh crores. The Pharmacy students and working pharmacists can join together to conduct useful surveys at community levels or institutional levels. Drug Surveys are technically simple for students of pharmacy practice or Pharm.D programs.