Title 20. CRITICAL EVALUATION OF DRUG INFORMATION AND LITERATURE.pdf ✅

PHARMD GURU Page 1 CRITICAL EVALUATION OF DRUG INFORMATION AND LITERATURE DRUG LITERATURE EVALUATION:  Among the skills of drug information is knowledge of drug literature evaluation which allows one to provide a critical analysis of the literature and have a better understanding of the studies done in health and medicine.  It is a key component to provide a good quality answer to a requester.  Being able to separate good data from poor data is essential.  Knowing the limitations of any study can help in evaluating the usability of its data.  Drug information specialists will often use some standard questions to help in this process.  Several references provide guides to evaluate the medical and pharmacy literature. NEED OF THE LITERATURE EVALUATION:  Increasing sophisticated patient population who educate themselves about drug therapy (from various sources such as healthcare professionals, purveyors of alternative meds, family and friends), internet and reading some medical literatures and lay press.  The physicians and other health care often contact the pharmacist for opinion on various aspects of the therapy.  Addition and deletion of the drugs from the formulary. These responses can only be made after careful analysis of the available studies by the pharmacist. DRUG & POISON INFORMATION

PHARMD GURU Page 3  The background information states that the study is important and ethical. It familiarizes the readers with the research subject. Previous investigations and their limitations; need of the present study; and should clarify that the benefits of the study outweighs the risks tot eh patients entering the study. Superscriptions of references made for cross references.  Study objectives or goals should be precise and clearly stated that it will not confuse the readers and come to an erroneous conclusion regarding study results.  The ill stated objective shows that the study was not well planned.  Some studies state the null hypothesis and research hypothesis (researchers expect to find during the course of their study) in the introduction part.  Ethical issues are either addressed in the introduction part or in the methodology part. This is to ensure that the risks to subjects are minimal and they know about the possible benefits and hazards of the study. Also mention regarding the informed consent form if necessary. 3. Methodology:  The most important section of a clinical study.  Results of studies that show methodological flaws are unreliable.  The main contents of the methodology can include: the research site, study period, ethical committee approval statement, study design, study population, instrumentation, and statistics used for the investigation. 4. Study Design:  Two major types of study design seen in the true experiments: Parallel studies and Cross – Over studies.  In parallel study the patients/ subjects (either the control or the treatment group) receives only one treatment throughout the study. Whereas in case of cross-over study subjects receive all study drugs.  Parallel studies are appropriate in case when therapies are definitive or when disease states are self – limited (e.g., antimicrobials for infectious diseases).
PHARMD GURU Page 4  Cross – over studies are appropriate in case diseases are chronic and/or variable (e.g., glaucoma, migraine headache). In this study the error caused by variability among subjects are minimized since the each subject serves as his or her own control. 5. Study Criteria: Inclusion criteria:  List the subject characteristics that must be present for enrolment into the study. Exclusion criteria:  List the characteristics in the target population that should not be included in the study.  Subjects who are harmed by the therapy or who may confound the results of the study.  Diagnosis criteria for the disease state should be clearly defined. (Clinical, laboratory and demographic criteria that justifies the diagnosis).  The reader should check whether the enrolled subjects represent the patients routinely encountered in the clinical practice. 6. Sample size:  A sample is a subgroup from the entire population of patients with a particular disease state.  Samples are used because of logistic, financial, and resource constraints that prohibit studying an entire population.  The study needs a relevant sample size. Depends on the study objectives and design.  Can be confident about the study in case the number of patients who completed the study equals the investigator’s initial sample size calculations presented n the methodology.  A discussion on the sample size calculation should be made by the investigator and whether the final number of subjects equals this calculation.  Many investigators add 10 – 20% of the sample size calculation keeping in mind about the drop outs or death of the subject that can happen during the study.