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42 Cards in this Set
- Front
- Back
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Background questions
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Ask for general information on a disease or medicine e.g. how does paracetamol relieve pain
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Foreground questions
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Ask a specific question about the effect of an intervention in a particular group of patients e.g. is regular paracetamol as effective as an NSAID for pain relief in patients with osteoarthritis
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Three main groups of evidence
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Clinical studies, basic science, experience.
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Types of clinical studies (discuss pros and cons of each)
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Interventional (randomized control trials) – investigator selects whether participants receive the drug. Cons - expensive, take a long time to run, unethical, highly selected groups of patients, not provide evidence on adverse effects, or effect of drug in people other than those includes in study.
Observational (cohort studies, case-control studies and cross sectional studies) – patient selects whether or not they take the drug. Pros – easier to conduct, cheaper, faster, tackle a range of questions, more ethical, evidence on adverse effects. Cons – harder to analyse, may have other reason for choosing drug. |
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Influences on clinical evidence
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Medicines are a big market, publication bias, disease mongering (making a disease seem worse than it is), ghostwriting (companies pay doctors to attach there name to a research paper).
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Resource for clinical questions: Medical Dictionary
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Useful for side effects and symptoms.
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Resource for clinical questions: Harrison’s Online
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Medical textbook – great for background questions, more detail than required.
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Resource for clinical questions: AMH/APF
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Essential pharmacy texts. Pros – indications, local, doses, adverse effects, info on special populations [elderly, pregnant]. Cons – unreferenced, general.
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Resource for clinical questions: Therapeutic Guidelines
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Pros – local, therapeutic information, focus on drug selection, comprehensive. Cons – general, not focused on drug information.
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Resource for clinical questions: Micromedex
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Extensive drug information database. Pros – detailed referenced information, drug safety, toxicology, international. Cons – not local
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Resource for clinical questions: Clinical Evidence
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Brief summaries of evidence on specific clinical questions. Pros – perfect for answering foreground questions. Cons – limited in number of questions it can answer, reading requires fair bit of background knowledge.
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Resource for clinical questions: Cochrane Library
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Systematic reviews of clinical studies for specific questions. Pros – lots of detail, excellent summary. Cons – not all questions covered
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Where would you look if you were trying to answer: is regular paracetamol as effective as an NSAID for pain relief in patients with osteoarthritis?
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AMH, therapeutic guidelines (details)
Clinical evidence and Cochrane library for information on specific reviews and studies. |
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Where would you look if you were trying to answer: does the combination of NSAIDs and SSRIs increase bleeding risk?
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Micromedex, AMH, therapeutic guidelines. No information found in clinical evidence or Cochrane library. Need to rely on observational data and spontaneous reporting.
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Where would you look if you were trying to answer: is the new anticonvulsant pregabalin safe in pregnancy?
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AMH, APF, micromedex (pregnancy category), therapeutic guidelines. No information in clinical evidence or Cochrane library.
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Where would you look if you were trying to answer: do the benefits of OTC cough and cold remedies outweigh the harms in children younger than 2?
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Most provide little information. Rely on spontaneous reporting or meta-analysis of few studies. Cochrane and clinical evidence has some information but little is focused on children. Possibility of rare but severe adverse effects.
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Adverse Drug Reaction
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A response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for modification of physiological function.
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Adverse Drug Event
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Injury resulting from administration of drug. Often due to events surrounding its use (e.g. unintended administration)
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Side Effect
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Any effect caused by a drug other than the intended therapeutic effect, which may be beneficial, neutral or harmful.
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Thalidomide
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On market for 5 years, supposed to be safe hypnotic and antiemetic during pregnancy. Reports of phocomelia.
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FDA
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Food and Drugs Administration set up in 1962 after thalidomide adverse effects. Reviews all drugs before release for safety and efficacy.
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ADEC
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Australian Drug Evaluation Committee set up in 1963
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Epidemiology of ADRs
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Hospital – 5-10%
Community – hard to measure, 3-11% hospital admissions, with 50% preventable |
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Classification of ADRs (old system)
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Type A – predictable
Type B – Idiosyncratic(don’t know why)/ bizarre |
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Type A ADRs
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Occurs at therapeutic doses but will definitely occur is dose increased. Can be accentuation of normal drug effect (e.g. bradycardia with a beta blocker)
Common – 75% of all ADRs. High morbidity, low mortality. |
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Type B ADRs
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Not dose related, unrelated to normal drug effect, sudden and dramatic in onset, rare, low morbidity, high mortality.
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Mechanism of Type A ADRs
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Excessive therapeutic effect at usual dose due to decreased clearance (accumulation) or increased sensitivity at target organ.
Pharmacological effect at undesired location Another pharmacological action of drug becomes significant. |
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Mechanism of Type B ADRs
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Immunological (allergic reactions such as anaphylaxis, rash, organ damage)
Pharmacogenetic (factor predisposes the individual to the effect – enzyme deficiency) |
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New classification of ADRs
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DoTS
Do = Dose T = Time S = susceptibility |
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Dose relatedness to new ADR system
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Toxic effects (accumulation)
Collateral effects (another pharmacological action is significant) Hypersusceptibility (happens at low doses which is unusual) |
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Time course to new ADR system
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1) Time independent – could happen at any time, two drugs interacting.
2) Time dependent (1) – rapid (drug given to quick), first dose (only on first dose), early reaction (first week), intermediate (delayed but if has not occurred in set time, unlikely to occur), late reaction (withdrawal of drug/repeated exposure to drug), delayed (occurs sometime after exposure). |
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Role of Pharmacist
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Identify drugs with high risk, identify patients with high risk (extremes of age, patient history, genetics, impaired organ function, taking lots of drugs, lack of knowledge), appropriate monitoring, patient education, identify previous risk, encourage reporting from all.
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图片
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túpiàn (n)
picture |
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Process of legislation – HDPR
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Developed my government, administered by public service, interpreted by judiciary.
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Purpose – HDPR
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To protect the general public with relation to potentially toxic substances. Reason: poisons, abuse, pesticides, inappropriate use.
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Where does it fit into pharmacy practice – HDPR
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Under Health Act – protect public health
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Methods of achieving protection – HDPR
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Limit in supply (who can sell s3 etc), limit use and possession, make public aware of issues (labeling).
Previously very specific changing to more risk based |
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Major components of HDPR
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Who is affected, substances involved, grouping in poisons, pharmacy only medicines, prescription only medicines, drugs of addiction.
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Who is affected by HDPR
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General public, groups involved in supply, groups involved in administration of legislation
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Difference between drug and poison
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‘all substances are poisons, none are not, it is the correct dose that differentiates a poison from a remedy.
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Layout of HDPR
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Based on groupings of substances in schedules.
CH2 controlled drugs (S8) CH3 restricted drugs (S4) Ch4 Poisons (S2, S3, S5, S6, S7) CH5 Miscellaneous Appendices 1-9 summaries, stardards for computer generated prescriptions, controlled drug safes, special groups of restricted drugs and poisons. |
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SUSDP
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Schedules
S1 = blank S2 = pharmacy medicine S3 = pharmacist only S4 = prescription only S5 = caution S6 = poison S7 = dangerous poison S8 = controlled drug S9 = prohibited substance |
