| Internet | Black Box and Pregnancy Labeling/Warning | Internet Continued | More pregnancy shiz | MORE PREGO SHIZ |
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What is reputable, evidence-based, feasibility, timeliness, and ease of use
What are the 5 characteristics when evaluating an internet resource?
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What is on the package insert and a thick black box drawn around the warning. Only FDA adds them
Where are black box warnings located and what do they look like?
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What is consumerlab.com pharm lib pg, https://ods.od.nih.gov/ office dietary supplements, https://nccih.nih.gov/ Nat center complementary and alt meds (Natural products)
What are the website titles for natural products? What domain are they?
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What is which medical and disease factors should be considered
What is the pregnancy clinical consideration?
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Description of scientific reasonings behind risk summary and clinical considerations. Human descriptions include: type of study, number of subjects, study duration, exposure info, and limitations of data.
Animal Descriptions include: type of study, species studied, animal doses, and basis for exposures, duration of exposure, study findings, maternal toxicity, and limitations of data
What is pregnancy data?
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What is .com for commercial/profit business, .org for not for profit, .net for businesses/backbone/major server, .edu for educational institution, .gov for government, .biz for exclusively business, .tv for television/streaming video
What are the 7 internet domains and what are their purposes (profit/commercial, educational, gov't, etc)?
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What is new serious adverse effects, Strongest warning from he FDA, clinical pharmacology/E-facts
What are the 3 main reasons why are black box warnings added?
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What is fda.gov/ndc/database NDC code directory, http://www.fda.gov/cder/ob Electronic Orange book-bioequivalence, fda.gov/cder center for drug eval and research (FDA)
What are the website titles for FDA resources? What domain are they?
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What is known risks in context with background risks. I.E. based on: human data, animal data, pharmacology(not included when no risk info), info in general pop, info in disease pop(not included when no risk info)----Data to support risk summary needed in format
Must have info on drug is contraindicated during pregnancy with major birth defects and miscarriage listed, animal data, and pharmacology(MOA and potential risks)
What is the pregnancy risk summary?
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When drug is contraindicated during lactation, presence of drug in human milk, effects of drug on breastfed child, effects of drug on milk production, risk and benefit statement, drug absorption/no drug absorption statement
What is the lactation risk summary?
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What is drugdigest.org, rxlist.com, webmd.com, http://nlm.nih.gov/medlineplus (consumer)
What are the website titles for consumer info? What domain are they?
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What is all prescription drugs on or after June 30, 2001 must revise content and format for Pregnancy and Lactation labeling-- letter categories replaced with integrated risk summary
What is the new pregnancy and lactation labeling rule?
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What is database for natural and prescription drugs/helpful for retail pharmacists-retail focussed (PL- subscription)
What is the purposes of "Pharmacist's Letter"?
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Registry that monitors outcomes of pregnant women exposed to a drug during their term.
What is the pregnancy exposure registry?
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Minimizing exposure and monitoring for adverse reactions
Description of clinical lactation study Description of animal lactation study (only when no human data)
What is clinical considerations and data for lactation?
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What is looking at efficacy and side effects of drugs (WPBP-online with school account)
What is the purposes of "Worst Pills, Best Pills"(.org)?
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What is Pregnancy, Lactation, and Female and males of reproductive potential (new). Old is pregnancy, labor and delivery, and nursing mothers
What are the new vs old labeling sections via the PLLR?
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What is harmful side effects and medical devices/who to contact for legal cases(DW)
What is the purposes of "Drug Watch"(.com)?
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Drug absorption is listed here unless its not systemically absorbed, then it will have a statement saying it is not systemically absorbed
What is pregnancy risk summary
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When theres requirements or recommendations for pregnancy testing/contraception and when human/animal data suggest effect on fertility
1)Pregnancy testing 2)Contraception 3)Infertility
What is females and males of reproductive potential?
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What is centerwatch.com IRB approved clinical trials, medicine.iupui.edu/flockhart Cytochrome P450 Drug interactions, www-sci.lib.uci.edu/HSG/Pharmacy.html Virtual Pharmacy Center, pharmj.com/noticeboard/info/translators Translators and Dictionaries, pharmj.com/noticeboard/info/pip/foreignmedicines Foreign Drug ID, dictionary.com, freetranslation.com Seven Languages, babelfish.altavista.com Altavista Babel Fish Translation, synonym.com/synonym/ Synonyms and Antonyms
What are the website titles for misc resources and what are they for?
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Pregnancy registry, risk summary, clinical considerations, and data
What is included in the revised format?
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What is Info on different diseases and medical advances/options(TML-online pharm database, no account)
What is the purposes of "The Medical Letter"(.org)?
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Info to further inform prescribing and risk-benefit counseling
1) Disease-Associated Maternal and/or Embryo/Fetal Risk 2) Dose Adjustments during Pregnancy and the Post-Partum Period 3) Maternal adverse reactions 4) Fetal/Neonatal Adverse Reactions 5) Labor or Delivery
What are the pregnancy clinical considerations?
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Many drugs don't have pregnancy safety data, check pregnancy registries (may have limited sample size/power or confounding variables and high lost of follow up), get larger cohort studies(exposure may be small even in large group of pregnancies), administrative or claim databases (difficult to confirm if and when exposure happened)
What is challenges of including human data in the new label?
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