Term
| What is the fastest-growing population subset looking toward self care? (Intro, 7) |
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Definition
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Term
| What did and did not the Pure Food and Drug Act of 1906 mandate? (Intro, 9) |
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Definition
| Drugs were required to meet standards of strength, quality, and purity. There was no mandate for safety. |
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Term
| What did the Federal Food, Drug, and Cosmetic Act of 1938 mandate? (Intro, 9) |
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Definition
| Required drugs to be safe |
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Term
| What did the 1962 amendment to the Federal Food, Drug, and Cosmetic Act of 1938 mandate? (Intro, 9) |
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Definition
| Required drugs to be safe AND effective |
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Term
| What did the Durham-Humphry Amendment of 1951 do? (Intro, 10) |
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Definition
| Separated Rx medications from nonprescription medications; gave the FDA the final authority over which category to place drugs. |
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Term
| What was the Drug Efficacy Study Implementation? (Intro, 11) |
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Definition
| Reviewed all drugs marketed between 1938-1962 to determine effectiveness and safety. |
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Term
| What was the OTC Drug Review intended to do? (Intro, 11) |
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Definition
| Reviewed 800 active ingredients to determine safety and effectiveness. Note: This is ongoing. |
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Term
| What are the four non-prescription product categories? (Intro, 13) |
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Definition
| OTC drugs, dietary supplements, homeopathics, drug-cosmetics |
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Term
| What organization regulates dietary supplements? (Intro, 13) |
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Definition
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Term
| What organization regulates OTC drugs, homeopathics, and drug-cosmetic products? (Intro, 13) |
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Definition
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Term
| What organization regulates advertising of non-prescription products? (Intro, 13) |
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Definition
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Term
| What are the pros and cons of a “behind the counter” non-prescription product category? (Intro, 14) |
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Definition
| Pros: Increase access, reduce costs, better ensure proper use; Cons: No access to medical records, no reimbursement |
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Term
| What are three major examples of “behind-the-counter” non-prescription products? (Intro, 15-17) |
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Definition
| Pseudoephedrine, Plan B, contraceptives |
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Term
| What elements should be included on OTC labels? (Intro, 19) |
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Definition
| Product name (statement of identity); active ingredients (purpose, dosage, dose form, net quantity); uses; warnings; name/location of manufacturer; directions for use; expiration date and lot number or batch code; description of tamper-resistant features |
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Term
| In 2006, what changes were made to OTC labels during standardization? (Intro, 20) |
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Definition
| Bigger font size; the purpose of each active ingredient; lay language (“use” instead of “indication”); more organized layout (headings, bullets, bold print) |
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Term
| Who can request a drug be reclassified? (Intro, 22) |
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Definition
| Manufacturer, FDA, or “other” |
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Term
| What is the main regulatory requirement for dietary supplements? (Intro, 23) |
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Definition
| Safety (there is no efficacy requirements) |
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Term
| What organization is required to prove dietary supplements are unsafe? (Intro, 24) |
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Definition
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Term
| What must be included on the label of a dietary supplement? (Intro, 25) |
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Definition
| Statement of identity (Must state the part of the plant used); net quantity of contents; structure-function claim (NOT a disease claim); directions; supplement facts panel; other ingredients in descending order of predominance and by common name or proprietary blend; name and place of manufacturer, packer, or distributor |
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Term
| When does a drug-cosmetic product need an OTC label? (Intro, 26) |
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Definition
| If the product has a “drug” intended use (e.g. antidandruff shampoo, toothpastes with fluoride, etc.) |
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Term
| What entity initiates product recalls? (Intro, 27) |
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Definition
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Term
| What does a Class I product recall imply? (Intro, 27) |
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Definition
| Dangerous/defective products that could cause serious health problems or death |
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Term
| What does a Class II product recall imply? (Intro, 27) |
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Definition
| Products that might cause a temporary health problem or pose only a slight threat of a serious nature |
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Term
| What does a Class III product recall imply? (Intro, 27) |
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Definition
| Products unlikely to cause any adverse health reactions but that violate FDA labeling or manufacturing regulations |
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Term
| What must a pharmacist do with any product recall? (Intro, 28) |
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Definition
| Remove recalled products from shelf |
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Term
| What must a pharmacist do with Class I product recalls? (Intro, 28) |
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Definition
| Remove recalled products from shelf and contact consumers |
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Term
| What did OBRA ’90 mandate? (Intro, 29) |
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Definition
| Law requiring pharmacists “offer to counsel” on prescriptions dispensed to Medicaid patients. Over-the-counter products DO NOT benefit from OBRA ’90 |
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Term
| When do the main medication errors from OTC products occur? (Intro, 30) |
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Definition
| When consumers: have limited reading skills or are illiterate; have language barriers; have poor vision or inadequate lighting in the retain setting; are uneducated on proper use; handle or store products improperly |
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Term
| What is the proper way to handle and storage OTCs? (Intro, 31) |
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Definition
| Avoiding heat and humidity exposure; storing in a cool, dry, dark place; out of reach of children; not outside the expiration dates |
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Term
| What are the steps to the patient care process? (Intro, 33) |
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Definition
| Assess the patient by interview and observation; triage (recommend no treatment; recommend self-care therapy; refer patient to other healthcare professional); suggest appropriate strategies; talk with the patient |
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Term
| Describe open-ended questions. (Intro, 35) |
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Definition
| Cannot be answered with one-word responses; valuable for information gathering; Who, What, Where, When, Why, How |
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Term
| Describe closed-ended questions. (Intro, 35) |
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Definition
| Can be answered with a one-word response; useful when clarifying responses from open-ended questions. |
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Term
| Describe leading questions. (Intro, 35) |
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Definition
| Restrict patients options in answering; AVOID THIS TYPE OF COMMUNICATION |
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Term
| What is the three-step process of the self-care consultation? (Intro, 37) |
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Definition
| Patient assessment; care plan development; follow-up |
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Term
| Define the acronym QuEST. (Intro, 38) |
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Definition
| Qu—Quickly and accurately assess patient. E—Establish that patient is an appropriate candidate for self-care. S—Suggest appropriate treatment strategies. T—Talk with the patient. |
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Term
| Define the acronym SCHOLAR (Intro, 40) |
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Definition
| Symptoms (What are the main and associated symptoms?), Characteristics (Describe the situation), History (What has been done so far? Has this happened before?), Onset (When did it start? Does it come and go?), Location (Where is the problem), Aggravating factors (What makes it worse?), Remitting/Relieving factors (What makes it better? |
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Term
| Overall, what are general exclusions from self-care therapy? (seven listed) (Intro, 41) |
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Definition
| Symptoms are too severe to be endured without definitive diagnosis and treatment; symptoms are results of unidentifiable cause; symptoms repeatedly return with no identifiable cause; you are unsure of diagnosis; patient is pregnant, elderly, or younger than two years of age; patient is self-treating to avoid medical care; symptoms are refractory to OTC treatment |
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Term
| What is the purpose of suggesting appropriate treatment strategies (S of QuEST)? (Intro, 42) |
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Definition
| Resolve drug therapy problems, meet goals for each medical condition, prevent future drug therapy problems |
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Term
| What are possible self-care routes in a care plan? (Intro, 42) |
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Definition
| Medication, alternative treatments, non-pharmacologic treatment, general care measures |
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Term
| Once you’ve chosen a self-care therapy, what should you advise the patient on? (Intro, 43) |
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Definition
| Reason for self-treatment, description of drug or treatment, administration of treatment, what to expect from treatment (side effects, precautions, etc.) |
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Term
| What is involved in the “Talk with the patient” part of QuEST? (Intro, 44) |
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Definition
| Explain to patient why you have chosen a particular treatment; advise patient on when to expect results from treatment; discuss what to do if patient does not see results in that time frame; decide on necessity of follow-up visit, if needed |
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Term
| What are the high-risk groups of self-care treatments? (Intro, 47-50) |
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Definition
| Pediatric, elderly, pregnant, and nursing patients |
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Term
| What is the rule of thumb when recommending OTC products to pregnant patients? (Intro, 49) |
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Definition
| Use the oldest drug possible |
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Term
| What is the rule of thumb when recommending OTC products to nursing patients? (Intro, 50) |
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Definition
| Use the oldest drug possible |
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Term
| What are some pharmacist barriers to self-care? (seven listed) (Intro, 51) |
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Definition
| Lack of time; physical barriers; patients may not understand pharmacist’s role, lack of knowledge, lack of confidence, nonverbal communication, language and cultural barriers |
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Term
| What are some patient barriers to self-care? (six listed) (Intro, 52) |
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Definition
| Financial; language barriers; poor health literacy; fear of healthcare providers; cultural differences; religious differences |
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Term
| There was one cultural considerations listed on the slides for Hispanic Americans. What was one? (Intro, 54) |
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Definition
| Health is a matter of luck (fatalism) |
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Term
| There was one cultural considerations listed on the slides for Asian Americans. What was it? (Intro, 54) |
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Definition
| Alternative medicines preferred, particularly of Chinese herbs |
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Term
| There was one cultural consideration listed on the slides for African Americans. What was it? (Intro, 54) |
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Definition
| Distrust of health care systems |
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Term
| There were two cultural considerations listed on the slides for American Americans. What were they? (Intro, 54) |
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Definition
| Sweat lodges and traditional medicine; prayer for cure |
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Term
| What are cultural considerations for non-English speaking patients? (six listed) (Intro, 55) |
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Definition
| Use a caring tone of voice/facial expression; speak slowly and clearly, not loudly; use pictures and gestures; repeat in many different ways; avoid medical terms; keep the message simple |
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Term
| What are two ways to handle health illiteracy? (Intro, 56) |
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Definition
| Never take for granted that the patient understands all aspects of their medical condition and their responsibility for self-care—ask them, “Can you tell me in your own words xxx?”; produce educational materials at a fifth-grade reading level with many different types of media |
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Term
| What are the responsibilities of a pharmacist in self-care? (three listed) (Intro, 57) |
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Definition
| Utilize principles of pharmaceutical care to more efficiently address patients’ self-care needs; learn aspects of culture that affect patients’ adherence and response to treatment; ensure safe, appropriate, effective, and economical use of OTCs |
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