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42 Cards in this Set
- Front
- Back
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To qualify for a license, an applicant shall be an individual who meets the following requirements:
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-Be of good moral character
-At least 18 years old -Be a graduate of a school of pharmacy that is approved by the Board or accredited by ACPE -Completed the clinical pharmacy training that the Board requires -Pass the Boards |
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Requirements for reciprocity
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-Be of good moral character
-Pay a fee -Provide evidence that they were qualified to take the exam in the state where he/she was licensed -Provide evidence that they passed the exam in the state where he/she was licensed **No reciprocity in California |
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Standards of Practice are generally based on:
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-Technological standards or improvements in practice
-Ethical considerations -Legal considerations |
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A prescription must be presented within ______ days from when it was issued.
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120
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What needs to be on a prescription label?
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-Name and strength of medication
-Generic equivalent substitutions must also bear the name of the manufacturer -Expiration date (mo/yr) -Date dispensed -Special handling -Name of patient -Name of prescriber -Name and address of pharmacy |
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A pharmacist may substitute a generic drug or device product, of the same dosage form and strength, for any brand name drug or device product prescribed if:
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-Prescriber doesn't expressly state that the prescription is to be dispensed only as directed
-Substitution is recognized is the US FDA's current list of approved drug or device products w/ therapeutic equivalence evaluations -Consumer is charged LESS for the substituted drug or device than the price of the brand name drug or device |
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Under what circumstances may a pharmacist refill a prescription which the refill has not been authorized by the provider?
The pharmacist may provide... |
-Pharmacist attempts to get authorization but cannot reach prescriber
-Prescription is not Controlled Dangerous Substance (CDS) -Drug is essential to maintaining life -Pharmacist makes a notation in retrievable form -Pharmacist notifies prescriber within 72 hours -Only ONE refill -Not to exceed 14 day supply -Must conform to prescriber's directions |
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What are some of the things a pharmacist should include in a counseling session?
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-Name & description of med
-Route, dosage form, route of administration & duration of drug therapy -Special directions and precautions for preparation, administration and use -Common or severe side effects -Interactions & contraindications -Techniques for self monitoring -Proper storage -Refill information -Missed dose actions |
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Does a pharmacist have to counsel EVERY patient?
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In MD, a pharmacist is only REQUIRED to counsel patients receiving Medical Assistance
Does NOT apply to refills |
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For Schedule II drugs, written prescriptions are required except in emergencies where law then requires....
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-Quantity prescribed & dispensed is adequate to treat during emergency
-Pharmacist reduces to writing immediately -If prescriber not known, pharmacist must make reasonable effort to determine authority -Prescriber must have written Rx delivered to pharmacist within 7 days (or if mailed, must be postmarked within 7 days) |
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What are the labeling requirements for all CDS?
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-Patient name
-Prescriber name -Pharmacy name & address -Date of filling -Rx serial # -Transfer warning |
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How many times can a C-III, IV, and V prescription be refilled?
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-Up to 5 times within 6 months
-Only if authorized |
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New Drug Application (NDA)
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-Submitted after the IND (clinical trials)
-Includes everything about the drug including chemistry, preclinical, clinical studies, kinetics, manufacturing, labeling, etc. |
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Abbreviated New Drug Application (ANDA)
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-Used for generic drugs
-Must include 2 bioavailability studies -Must be bioequivalent to the brand name drug |
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Supplemental New Drug Application (sNDA)
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-Used for a switch from prescription to OTC drugs
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How are OTC drugs approved?
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-If a monograph for the drug already exists, OTC drugs can be marketed without prior FDA approval
-If no monograph exists, they would need an NDA |
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How are dietary supplements regulated?
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-Essentially, they're NOT
-There are no requirements for FDA approval UNLESS they make drug claims -This category includes vitamins, minerals, herbs, amino acids |
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Kefauver-Harris Amendments of 1962
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-Required drugs to be proven to be safe AND effective prior to marketing in interstate commerce
-Drugs on the market prior to 1938 were grandfathered in and allowed to remain on the market as long as they remained the same -Established the Drug Efficacy Study Implementation Review (DESI) |
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Durham-Humphrey Amendment of 1951
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-Established the category of prescription drugs (aka legend drugs)
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Food, Drug and Cosmetic Act of 1938
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-Passed following the sulfanilamide disaster
-Required drugs to be safe AND reviewed by the FDA prior to marketing |
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What was the sulfanilamide disaster all about?
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-Sulfanilamide was produced by Massengill Labs
-Used diethylene glycol as a vehicle for a liquid preparation -107 reported deaths |
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What was the thalidomide disaster all about?
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-Thalidomide was approved in Europe, but not yet in the US
-It was useful in controlling nausea associated w/ morning sickness in pregnancy -- so women in the US were obtaining the drugs from friends or relatives in Europe -BUT the drug caused major birth defects if taken by a woman during the 1st trimester of pregnancy -Reports came in from Europe about these birth defects so the FDA withheld approval |
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Subjective clues to non adherence
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-"What is this for anyway?"
-"Well, I'm supposed to..." -"I think it's supposed to be..." -I don't understand why I have to..." -Lack of eye contact -Hesitation in responding to questions -Doubt -Inconsistencies in statements or data -Frustration -Fear |
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Objective clues to non adherence
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-Patient profile review for refill dates
-Look for underutilization AND over utilization -Potential problems with profile review -Compliance monitoring devices (computer chip in cap, MDI actuation counter) -Drug concentrations (blood/urine) -Disease progression (signs and sx) -Test results (e.g., glucose, BP) |
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Practical or functional barriers to medication adherence
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-Hectic lifestyle
-Forgetfulness -Cognitive impairment -Adverse effects from med -Difficulty opening or manipulating -Poor eyesight or hearing -Inability to pay |
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Attitudinal issues re: medication adherence
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-Dislike or distrust of medications
-Denial -Lack of belief in benefit -Practical impediments not identified -Most difficult adherence problem to correct |
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Managing non adherence
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-Recognize potential compliance problems
-Identify factors that may be contributing to the problem -Obtain a compliance and health-belief history -Ask patient what obstacles they expect -Work WITH the patient to develop a solution |
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What are some strategies for managing non adherence?
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-Develop a "patient-friendly" medication schedule
-Identify what is important to the patient -Clarify treatment expectations -Reduce regimen cost, complexity, duration -Simplify dosing schedule (long acting formulation, longer half-life) |
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What are some ways to correct practical impediments to adherence?
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-Reminder systems
-Medication calendar -Dosing pill box -Wrist watch or pill box alarm -Bubble packs -Electronic aids |
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What are some ways to encourage open communication?
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-Avoid judging, blaming, accusing the patient
-Use universal statements like "a lot of people," "that's a common problem," etc. -Acknowledge your own past difficulties -Use an interactive approach to counseling -Focus on asking the patient questions -Identify what the patient already knows |
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Examples of open ended questions?
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-How
-Why -When -Where -What -What do you take this medication for? -How do you take this medication? -How does this medication make you feel? -Just to make sure I didn't leave anything out, how are you going to take your medication? |
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Educational diagnosis
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-What the patient ALREADY knows
-What the patient NEEDS to know -Focus on the knowledge GAP -Assess patient's ability to learn -Determine HOW best to educate -WHEN to educate |
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Before speaking with the patient, the pharmacist should analyze the situation. What does this include?
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-Determine objectives of the session (set limits)
-Evaluate the setting, environment, patient -Decide on terminology, methods to transmit information -Speak to patient -Determine what the patient already knows |
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What questions would you ask the patient when it comes to devices?
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-What do you use this for?
-Determine what the patient knows or expects -How are you using it? Could you show me how you use it -Assess technique and use -What types of problems are you having? -Assess adherence difficulties |
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How do I NOT commit plagiarism?
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-Attribute!!!
-When taking notes, mark what is someone else's work and what your thoughts are -Paraphrase -Use quotations and provide documentation -Keep drafts and keep track of your drafts -Get help -Read your work before you turn it in |
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Can a student be dismissed from school for plagiarism?
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YES!!!!!
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Nonadherence causes ____ deaths per year
Nonadherence leads to ____% of hospital admissions Nonadherence leads to ____% of nursing home admissions |
125,000
10% 23% |
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Components of non-verbal communication
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-Eye contact
-Facial expressions -Spacial relationships -Hand and body movement |
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What are some environmental barriers to communication?
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-Privacy issues
-Structural layout -Professional distractions |
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What are some personal issues/barriers to communication?
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-Self confidence
-Lack of skill -Motivation -Past experiences -Patient perception |
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What are some administrative barriers to communication?
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-Management priorities
-Lack of reimbursement -Lack of time |
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What are some populations that require special communication skills?
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-Children & their families
-Hospice patients & their families -Older adults -Victims of abuse -Members of various cultures |
