Fiancee Lee A Banzon RPh.RN Mindanao Medical Foundation College PHARMACY INFORMATICS Fiancee Lee A Banzon RPh.RN College of Pharmacy Mindanao Medical Foundation College

PHARMACY INFORMATICS A new field that integrates drug information, clinical information and toxicity information for use by pharmacists, health care providers and patients.

Pharmacy Informatics Clinical Information Toxicity Information Drug information Pharmacy Informatics Informatics affects all three curricular areas of emphasis: Our working model for the pharmacy informatics course is based on the idea that pharmacists must use information and technology skills to integrate information about drugs and information about patient-related issues from a variety of sources in order to achieve patient-centered care Pharmacists Health Care Providers Patients

Uses and Application Support for clinical services Pharmacy and Therapeutics activities Publications Education Drug usage evaluation Investigational drug research Coordination of reporting programs Poison information

Tasks in Informatics Access Search Information Retrieval Evaluation Selection Organization Database Development

Types of relevant information in Pharmacy Drug Information Availability – strength, dosage forms, supplier Identification General Product Information Laws & Policies Cost Foreign/Investigational Stability/Compatibility Drug Interactions Pharmaceutics – compounding, formulations Pharmacokinetics – ADME, levels Therapy Evaluation/ Drug of Choice Dosage/Regimen Recommendations Adverse Effects Poisoning/Toxicology Teratogenicity/ Genetic Effects Lactation/Infant Risks

Types of relevant information in Pharmacy Medical Information Pathophysiology Symptomatology Risk Factors Causative Agents Complications Pharmacotherapy Non-drug management Lifestyle changes, etc. Drug Development Process Pharmacognosy Pharmacopeial Information Biotechnology Pharmaceutical Chemistry Pharmaceutical Technology Behavioral Studies Basic & Applied Research, etc. Pathophysiology it is the branch of medicine which deals with any disturbances of body functions, caused by disease or prodromal symptoms.

ACCESS RELEVANT RESOURCES ARE WITHIN REACH AVAILABILITY OF RESOURCES FOR USE FAMILIARITY WITH RELIABLE RESOURCES

SEARCH ABILITY TO LOOK FOR INFORMATION FAMILIARITY ON HOW TO USE VARIOUS SOURCES OF INFORMATION USE OF APPROPRIATE SEARCH STRATEGY

INFORMATION RETRIEVAL ABILITY TO GET THE INFORMATION NEEDED SKILL IN USING KEYWORDS, SYNONYMS, RELATED WORDS USE OF BOOLEAN OPERATORS Of or relating to a combinatorial system devised by George Boole that combines propositions with the logical operators AND and OR and IF THEN and EXCEPT and NOT

Example: Hierarchical Tree GENERAL CNS DRUGS Antihypertensives Calcium Channel Blocker Nifedipine SPECIFIC

Example: Synonyms, Keywords, Related Terms PARENTERALS Injectables Sterile Products IV Admixtures IV Hyperalimentation Total Parenteral Nutrition Intramuscular Intrathecal Subcutaneous Injection

BOOLEAN OPERATORS A B A B A + B A not B A B (A + B) not C C

EVALUATION ABILITY TO DETERMINE RELEVANCE AND QUALITY OF INFORMATION RETRIEVED SKILL IN EVALUATING VARIOUS FORMS OF LITERATURE KNOWLEDGE OF RESEARCH DESIGNS STATISTICAL INTERPRETATION CRITICAL ANALYSIS

Critical thinking has been described as "reasonable reflective thinking focused on deciding what to believe or do. Critical thinking is thinking that questions assumptions It is a way of deciding whether a claim is always true, sometimes true, partly true, or false.

SELECTION ? CHOICE OF THE BEST INFORMATION AVAILABLE RATIONAL DECISION-MAKING ADHERENCE TO CRITERIA OF QUALITY "rationality" means "sane," "in a thoughtful clear-headed manner," or knowing and doing what's healthy in the long term.

ABILITY TO INTEGRATE CHOSEN INFORMATION LOGICALLY ORGANIZATION ABILITY TO INTEGRATE CHOSEN INFORMATION LOGICALLY WRITING SKILL LOGICAL THINKING

Logical reasoning In logic, three kinds of logical reasoning can be distinguished: deduction, induction and abduction. Deduction means determining the conclusion. It is using the rule and its precondition to make a conclusion. Example: "When it rains, the grass gets wet. It rained today. Therefore, the grass is wet." Mathematicians are commonly associated with this style of reasoning. Induction means determining the rule. It is learning the rule after numerous examples of the conclusion following the precondition. Example: "The grass has been wet every time it has rained. Therefore, if it rains tomorrow, the grass will get wet." Scientists are commonly associated with this style of reasoning. Abduction means determining the precondition. It is using the conclusion and the rule to support that the precondition could explain the conclusion. Example: "When it rains, the grass gets wet. The grass is wet, therefore, it may have rained." Diagnosticians and detectives are commonly associated with this style of reasoning.

Application of Pharmacy Informatics

Drug Information Service (DIS) Refers to the access, evaluation, selection and organization of drug literature for the use of health professionals, patients and the public Also involves the interpretation & application of drug information to patient care problems

Drug Literature Is comprised of primary, secondary & tertiary literature that can be used as basis for optimizing the use of drugs in patients

Why the need for it? Vast drug literature Increasing drug therapy problems Growth of clinical pharmacy practice

THE DIS PROCESS 1. Determining the primary question 2. Developing an appropriate strategy 3. Choosing sources of information 4. Accessing printed sources of information 5. Critical Appraisal of information sources 6. Formulating a response 7. Communicating a response Documentation and follow-up

1. Primary Question Ask clarifying questions Restate the question Ask when and whom to contact when answer becomes available

Types of DI Questions ADRs (eg. description, allergies) Drug administration (dosage form, methods, compatibility, stability) Indications & therapeutic use Product-specific Concerns Dosing Drug interactions Poisoning & toxicology Miscellaneous

2. Appropriate Strategy Match question w/ sources of information Determine if question is for approved, investigational or unapproved drugs Identify appropriate search keywords, terms, synonyms Be flexible in searching

3. Sources of Information Oral Written or Printed Primary literature original article, research or case reports published in journals, presentations and proceedings Secondary literature abstracting and indexing services Tertiary literature textbooks, compendia, full-text databases & review articles Secondary sources involve generalization, analysis, synthesis, interpretation, or evaluation of the original information.

Tertiary source A tertiary source is an index and/or textual condensation of primary and secondary sources. Some examples of tertiary sources are almanacs, guide books, survey articles, timelines, and user guides. Depending on the topic of research, a scholar may use a bibliography, dictionary, or encyclopedia as either a tertiary or a secondary source. As tertiary sources, encyclopedias and textbooks attempt to summarize and consolidate the source materials into an overview, but may also present subjective commentary and analysis (which are characteristics of a secondary source).

secondary source is a document or recording that relates or discusses information originally presented elsewhere. A secondary source contrasts with a primary source, Secondary sources involve generalization, analysis, synthesis, interpretation, or evaluation of the original information. Examples; review article or meta-analysis, academic journals, medical peer reviewed

Primary source Primary sources are original materials. It serves as an original source of information about the topic. From a letter of Philip II, King of Spain, 16th century

4. Printed Info Sources Textbooks Journals Individual Files Manual Indexes Computerized databases Internet

Biomedical Journals Lancet Journal of American Medical Association British Medical Journal Annals of Internal Medicine Archives of Internal Medicine New England Journal of Medicine Am J Health Sys Pharm, Am J Pharm Ed Annals of Pharmacotherapy Clinical Pharmacy & Therapeutics

Computerized databases CD FORMAT MicroMedex Current Contents Iowa Drug Information Service (IDIS) Intl Pharm Abstracts Medline Clinical Pharmacology Mayo Family Pharmacist ONLINE FORMAT Medline MicroMedex Medscape Fulltext OVID Health Notes Online WEBSITES www.medscape.com www.nlm.nih.gov www.uspharmacist.com

Specific Sources of Info Pharmacotherapy Pediatric Dosing Pharmacokinetics General Drug Information Pharmacology Patient Counseling Medical Info Geriatric Dosing

Specific Sources of Info Pharmacotherapy Clinical Pharmacy and Therapeutics Applied Therapeutics Washington’s Manual of Medical Therapeutics Pediatric Dosing Pediatric Dosage Handbook Harriet Lane Handbook Nelson Textbook of Pediatrics Pharmacokinetics Basic Clinical Pharmacokinetics SIMKIN Handbook of Therapeutic Monitoring Applied Pharmacokinetics

General Drug Information AHFS Drug Information Physician’s Desk Reference USP Dispensing Information MicroMedex - DrugDex Drug Facts & Comparisons Pharmacology Goodman & Gilman’s Pharmacological Basis of Therapeutics Principles of Pharmacology Basic and Clinical Pharmacology by Katzung

The Internet- WWW servers These are computers connected to the to the Internet to provide a graphical interface to a variety of information that is available as text, pictures, databases & other electronic files. Makes use of Web browsers such as Microsoft Explorer and AOL Netscape Some websites allow downloading of files for free or fee Quality & quantity of information vary per website

Good Websites American Diabetes Association www.diabetes.org American Heart Association www.amhrt.org American Society of Health-System Pharmacists www.ashp.org Drug Info Net www.druginfonet.org American Healthfinder www.healthfinder.gov Healthline www.healthline.com Medical Matrix www.medmatrix.org Onhealth www.onhealth.com RxList www.rxlist.com

American Pharmaceutical Association www.aphanet.org National Consumers League vm.cfsan.fda.gov/~lrd/fdinter.html Drug Facts & Comparisons www.factsandcomparisons.com US Food and Drug Administration www.fda.gov Sunnybrook Health Sciences www.icomm.ca/shsc/index/minibag.html Pharmaceutical Technology Journal www.iptonline.com The Merck Manual www.merck.com/mrkshared/mmanual/home.jsp Pub Med www.ncbi.nlm.nih.gov/entrez/query.fcgi NIAAA www.niaaa.nih.gov/publications/aa27.htm Safe Medication www.safemedication.com US Pharmacist www.uspharmacist.com/index.asp Web MD my.webmd.com

Alternate Sources of Information Electronic Bulletin Boards List Servers Local, National & International Organizations Pharmaceutical Manufacturers Drug Information and Poison Control Centers It is similar to a traditional mailing list — a list of names and addresses — as might be kept by an organization for sending publications to its members or customers, but typically refers to four things — a list of email addresses, the people ("subscribers")

5. Appraisal of Info Sources Textbooks: date of publication, authorship, agreement with other sources Literature Reviews: same as those for textbooks’ methods of selection Original Research: abstract, basic research design, setting, participants, outcome measures & results

Categories of Drug Literature I. PRIMARY A. Evaluative studies 1. Experimental - Clinical trial - Pharmaceutical Research - Educational Assessment 2. Observational - Case Control - Cohort - Follow-up - Cross-sectional Cohort (biology)

B. Descriptive Reports 1. Case reports or series 2. Pharmaceutical practice 3. Clinical series 4. Program 5. Population II. SECONDARY A. Manual retrieval systems B. Computerized retrieval systems

Secondary Resources Indexing- consist of providing bibliographic citation information (eg. Title, author and citation of the article) Abstracting- includes a brief description (or abstract) of the information provided by the article or resource cited.

Availability of Secondary resources

III. TERTIARY A. Reference text or databases B. Reviews C. Compendia D. Practice Guidelines IV. OTHER SOURCES A. Expert Communication B. Investigator’s brochures C. Pharmaceutical Manufacturers

EVALUATIVE STUDIES Experimental the study is designed to answer a question or a hypothesis in a prospective manner involves a measurement of an intervention requires control of variables

EVALUATIVE STUDIES Observational the study records the results from an observation of subjects or a specific set of data shows an association between an event and the environment or other factors answers a question from what has already occurred (retrospective)

EVALUATIVE STUDIES Observational Case Control Studies - evaluates a specific event and its association with some factors Ex. Ca Px who took OC vs. Ca Px who did not take OC Cohort studies - observe the effects of the exposure to an agent over time Ex. Px taking OC vs. Px not taking OC

EVALUATIVE STUDIES Observational Follow-up Studies evaluate the effect of an agent over time but is not compared with a control a large number of patients taking a drug may be observed over a longer period of time (i.e. 10 years) Ex. NSAID users and future hospitalization

EVALUATIVE STUDIES Observational Follow-up Studies evaluate the effect of an agent over time but is not compared with a control a large number of patients taking a drug may be observed over a longer period of time (i.e. 10 years) Ex. NSAID users and future hospitalization

Components of Evaluative Studies Title Author Abstract Introduction Methods Results Discussion of results Conclusions References

Title- tells about the topic of the article Author- who conducted the study Abstract- identifies the purpose, design and methodology of the study and briefly reviews the results and the conclusions Introduction- lays the framework for the purpose of the study & provides an overview of the literature that support the purpose of the study

Methods most important part of an evaluative study & should be appropriate to address the hypothesis and purpose of the study contains description of experimental design and its controls, # of subjects, exclusion and inclusion criteria, type of blinding, data analysis method, data collection method, outcome criteria or expected results of intervention Results- organizes and simplifies the raw data emanating from the study

Discussion of Results the author compare his/her finding with similar studies from the literature interprets the data and state significance of the findings explains inadequacies, limitations, anomalies in the study and explains them Conclusions- provides a few sentences summary of the study’s purpose and results References- lists of literature cited in the study

DESCRIPTIVE REPORTS explain individual experiences, new programs, new therapies, or adverse events do not involve an experimental procedure or address a specific hypothesis just explain what happened and the perceived outcomes may be used as basis for evaluative studies

CASE REPORT - talks of an individual patient & his/her experience with a drug PHARMACEUTICAL PRACTICE - usually describes a new procedure or analytical method CLINICAL SERIES - collection of reports on a similar topic or treatment

Descriptive Report of a PROGRAM - new pharmacy program instituted Descriptive Report of a POPULATION - describes a specific preference or characteristic of a population

Components of Descriptive Reports Title Author Abstract Introduction Observations- where the details of the project is described Discussion- clinical relevance Conclusions References

TERTIARY LITERATURE provides a scholarly overview of a particular topic at a specific time used to find factual information they compile primary literature in a user-friendly format highlights the widely accepted information from the primary literature

Components of Review Articles Title Author Abstract Introduction - explains why the review is made Body- examination of the literature Conclusions References

Characteristics of other Sources Expert report - unpublished report from an expert, maybe opinion or data from unpublished evaluative study Investigator’s brochure - unpublished information about an investigational drug Pharmaceutical manufacturer- available data from the manufacturer which may be published or unpublished

6. Formulating the Response Summary of information or evidence Recommendations References 7. Communicating the Response Oral Written

Practical Checklist in the Preparation of Written Materials Do research first Put yourself in the reader’s position Use proper grammar and spelling Make the document look professional Keep things simple & direct Avoid abbreviations & acronyms Avoid writing in the first person

Practical Checklist in the Preparation of Written Materials Avoid using passive sentences Avoid slash construction (he/she) Avoid contractions Cite references when appropriate Use the easier order of ideas Get everything down on paper before revising Edit, edit, edit! A contraction is a shortened version of the written and spoken forms of a word, For example, "can't" is the contraction for "can" and "not".

8. Documentation & Follow-up Document: drug information, the recommendations and sources of information Follow-up the outcomes of recommendations

Basic DIS Record Requestor Info (name, status/occupation, address, contact no., when response is needed) Date and time request is made Patient Background Info (name, age, sex, race, height, weight, test results, chronic conditions, acute conditions, medications- name, dose, freq, start & end) Question (Initial & Primary) Search Strategy Index (drug, disease, descriptors) Response (content, date, time required, references) Researcher

Ethics (in Pharmacy Informatics) A generic term for “several ways of examining the moral life” It is a process of deliberation & justification that is necessary when confronted with a moral dilemma

Analytical Approach to PARTICULAR JUDGMENTS OR ACTIONS Ethical Dilemmas ETHICAL THEORIES PRINCIPLES RULES PARTICULAR JUDGMENTS OR ACTIONS

Ethical Theories – integrated bodies of principles & rules that may include mediating rules that govern cases of conflicts Rules and Principles are action - guides “Often, there is no straightforward application of theory in particular judgments” “Theory is invoked to help develop action-guides that are more specific and that fit the context”

Specific Ethical Rules & Principles frequently Applied in Medical Ethics Inquiry Respect for autonomy Consent Confidentiality Privacy Respect for Persons Veracity Fidelity Nonmaleficence Beneficence Justice Respecting Patient-professional relationship

Selling of Drug Samples ? Euthanasia Capital Punishment by Lethal Injection Selling of Drug Samples

How do we start? Build up your resources Be systematic in answering drug info questions Develop good search strategies Update yourself regularly

“An effective pharmacist is a good provider of drug information regardless of the area of practice.”