Drug Information Science Week #1 Systematic Approach to Drug Information Types of Resources

Functions of a Drug Information Specialist, ie. Pharmacist Pharmacists must know how to: 1_____________________ 2_____________________ 3_____________________

Functions of a Pharmacist as an Information Source Provide drug information by: answering information requests writing patient specific consultations communicating information that wasn’t requested, but is necessary developing criteria/guidelines for drug use

Functions... Provide drug evaluations Develop policies for dept., P&T comm.. Bulletins, newsletters, journal columns, education for practitioners. Be involved with: ADR reporting, DUE’s, publishing, developing protocols, IRB, Poison Control Center information.

Information Sources Utilized by Pharmacists ________________________________

Systematic Approach to Answer Drug Questions 1. Secure demographics of requestor. 2. Obtain background information. 3. Determine and categorize ultimate question. 4. Develop strategy and conduct search. 5. Perform evaluation, analysis, and synthesis. 6. Formulate and provide response 7. Conduct follow-up and documentation

1. Request Demographics Obtain requestor’s knowledge base and position, training and knowledge of medicine. Obtain telephone #, address, fax, etc for follow-up later. Determine approximate age (elderly, adolescent, etc.) (usually no need to directly ask)

2. Background Information Think, “Why is requestor asking for this information?” Weigh time involved to get background info. Use tact, politeness and assertiveness Background questions should be specific for the nature of the request. Ask, “What sources have already been used?” Useful info: age, gender, weight, allergies, other disease states, other meds, lab values, etc

3. Determine and Categorize Ultimate Question Find ________________________ How _________________________ Use __________________________ Determine _______________________ ___________________________________

Categories of Questions Strength, manuf, availability of product, approval Tablet identification, general product information Laws/policies/procedures, Cost, Foreign products Compatibility, stability, administration rate\ Drug interactions (drug, lab, disease,food) Pharmaceutics (compounding, formulations) Pharmacokinetics (ADME/levels) Nutrition support

Categories of Questions... Therapy evaluation-- picking drug of choice Dosage, regimen, recommendations Adverse effects Poisoning, toxicology Pregnancy, Teratogenicity Lactation/ infant risks

4. Develop Strategy and Conduct Research 1. 2. 3.

Resources Available: Primary Literature Resources Research studies published in biomedical journals. Provide details of research methodology and scientific results that lead to therapeutic conclusions. Advantages: Most current resource for information. Least biased, so most accurate

Primary Literature Examples: New England Journal of Medicine Archives of Internal Medicine JAMA (Journal of the American Medical Association) CHEST (from the American College of Chest Physicians) Clinical Pharmacy and Therapeutics Annals of Pharmacotherapy British Medical Journal

What do we find in Primary Resources (journals)? Advertisements Abstracts Letters to the Editor, Correspondence Review articles (considered tertiary resource) Meta analysis (considered tertiary resource) Not everything in a primary resource (journal) is actually a primary resource!!!

What do we find in Primary Resources (journals)? Primary journal articles: clinical drug trials *** These articles are the primary resources we are talking about **** Clinical trial types: Intervention types (highly rated) Randomized controlled trial Parallel Crossover Before and After (time series) Interventional studies: investigators of study are the ones choosing the trial participants based on factors, gives the drug being investigated, controls for environmnent, control group to compare to, drug dose, time frequency in question) Parallel: investigator gives drug to one group of patients and a control to another group (no drug, placebo, another drug) and they watch both groups to see what develops (cure, reduction of symptoms, worsening of symptoms) Crossover: Only one group of patients- one half get drug and and one half get control, then they switch and investigators observe the group over both time periods. Before and After (time series): one group of patients; examine, test, measure before drug is given, give drug, then measure, test, exam after drug has been given.

Primary journal article resources Observational (weaker than interventional studies) Cohort (strongest in class) Case control Cross sectional Case series, Case report, descriptive Observational: no direct intervention; only observing patients who have been previously give drug or no drug (investigators of study do not give drug-- someone else does); the investigators only observe and follow patients to determine associations (NO cause and effect can be determined) Cohort: Investigators follow patients to find out who experiences the outcomes in the two different groups: those who received the intervention (drug) and those who didn’t. Case control: starts with patients who have an outcome (disease: cancer), identify a control group to compare with (those without cancer; and look backwards for risk factors (smoking) potentially causing the outcome. Cross-sectional: Take a look at a group of patients at one specified period of time (one ER visit, one year after surgery, at end of one month of drug therapy). Good for economic reports, epidemiologic studies (study diseases in populations) Case series, Case report, Descriptive: Reporting on a certain circumstance, event, program, etc ( 2 pts come to ER with Bird Flu after eating wild birds) and tries to make some inference or association.

Secondary Literature Resources Indexing and Abstracting Services Indexing service: provides only bibliographic information that is indexed by topic. Abstracting service: also provides a brief description or “abstract” of information contained in a specific citation. Both provide access to primary literature Each can cover different journals, texts, publicat. Cost will vary from $150 to $60,000 / year

Secondary Literature Resources: Medline- largest 380,000 ref, 4000 journals BIOSIS Embase Index Medicus IDIS (Iowa Drug Information System) PUBMED (access to Medline)

Tertiary Literature Resources Textbooks (Goodman and Gilman, Handbook of Non-Prescription Drugs, etc) Drug Encyclopedias (Martindales, Merck Index, etc) Review articles in primary journals, Meta Analysis articles in primary journals Drug Compendia (Facts and Comparisons, AHFS, PDR Full Text Computer Database(Micromedex)

Tertiary Literature Resources Advantages: provide rapid access to information detailed sufficiently for quick reference good general information condensed into easy to read format Disadvantages: Outdated quickly, may not reflect current standards of practice, incomplete, human bias, incorrect interpretation of research or lack of expertise by author

Alternate Sources for Drug Information Internet Sites Electronic Bulletin Boards (EBB’s): FIX, FDA, Helix, Pharmnet, Pharmline Local and National Professional Organizations Pharmaceutical Manufacturers Drug Information Centers, Poison Control Centers

5. Data Evaluation, Analysis, Synthesis 1. 2. 3.

6. Formulate and Provide Response

7. Follow Up and Follow Through Verify the appropriateness, correctness, and completeness of a response. Essential when judgement calls used. Essential when new data found or circumstances changed from original request. Document everything!

Ethical and Moral Responsibility How will they use your information? Are they asking for lethal dose of drug? Are they suicidal or homicidal? Are they seeking information for making illicit drugs? Are they trying to forge a prescription? Are they in serious need of an ER?

Ethical and Moral Responsibility…. 1. 2. 3.

Important Rules for Drug Information Be _______________ with information