1. Growth of aging population 2. Restricted access to prescribes through HMOs 3. Increasing costs of health care 4. High proportion of under-insured or uninsured individuals in US 5. Advertisement 6. Access to Non-prescription medication
What are 4 ways to access non-prescription medication?
1. Internet pharmacies 2. Community/retail pharmacies 3. Non-pharmacy retail outlets 4. Behind the counter
What are 5 special considerations for the elderly participating in self-care?
1. Anticholinergic effect (fall risk) 2. Substitute or therapy 3. Polypharmacy 4. Cognitive function 5. GI drugs of concern
What are 2 problems with children participating in self-care?
1. Medication errors and misuse of OTC products 2. Many poison exposure cases
What are 5 problems with the general public participating in self-care?
1. Health literacy 2. Source of knowledge 3. Many people take more than the recommended dose of OTC medicine 4. Many people don't read the package label for usage information 5. Intentional misuse
What/who are 6 potential exclusions to self-care?***
1. Advanced age 2. Infants and young children 3. Pregnant women 4. Breast feeding women 5. Contraindications and Drug interactions 6. Allergies
What are 10 roles of a pharmacist in self-care?***
1. Assess patient's complaint/symptoms 2. Differentiate self-treatable conditions 3. Advise and counsel patient 4. Follow-up and assessment 5. Ensure patients can read and understand label 6. Help patients avoid food/drug interactions 7. Ensure that ingredients are not duplicated 8. Warn patients about potential allergic reactions 9. Warn patients about potential side effects 10. Discuss appropriate handling and storage of products
Legend Drug:*** Require Rx? Dangerous? How does it become available on the market? Type of label?
-Requires Rx -Can be dangerous -NDA approval process -Patient Label
Dietary Supplement:*** Require Rx? Dangerous? How does it become available on the market? Type of label?
-Doesn't require Rx -Can be dangerous -NDA or Drug Monograph -Supplemental Label
OTC Drug:*** Require Rx? Dangerous? How does it become available on the market? Type of label?
-Doesn't require Rx -Can be dangerous -NDA or Drug Monograph -Drug Facts Label
What act regulates the sale of products that contains pseudophedrine?***
Combat Methamphetamine Epidemic Act of 2005
What is the max daily amount of pseudoephedrine that can be purchased daily per person?***
What is the max monthly amount of pseudoephedrine that can be purchased monthly per person?***
9 g/30 day period
How does the Combat Methamphetamine Epidemic Act of 2005 regulate the sale of products that contains pseudophedrine?***
By limiting the quantities that can be purchased at retail, requiring IDs of purchasers, and imposing record-keeping requirements for sellers.
What regulates adulteration (impurities) and misbranding of drugs?***
Pure Food and Drug Act
What regulates safety pre-approval of drugs?***
Federal Food, Drug, and Cosmetic Act
What regulates OTC vs Rx drug?***
Durham Humphrey Amendment
What regulates efficacy pre-approval of drugs?***
Kefauver Harris Amendment
What regulates OTC monograph process?***
OTC Drug Review
Of the 2 routes to OTC Marketing, which one applies to the FDA for approval?***
NDA (new drug application)
Of the 2 routes to OTC Marketing, which one involves a review panel?***
Of the 2 routes to OTC Marketing, which one establishes safety and efficacy of OTC active ingredients through clinical trials along with dosing and formulation?***
Of the 2 routes to OTC Marketing, which one allows for a switch from prescription product to OTC?***
NDA (new drug application)
What are 3 ways of Identifying and Removing Dangerous Products from the market?
1. Non-prescription drug process 2. Supplemental application to approved NDA 3. Manufacturer or third party petition to FDA
What was the result of the Rx to OTC switch of Nicotine Replacement?
150 to 200 percent increase in their purchase and use in the first year of the switch
What was the result of the Rx to OTC switch of Heartburn medication?
average consumer savings of $174 per year in avoided prescription costs and office visits, and $750 million saved by the healthcare system
What legal body regulates marketing of Dietary supplements?
DSHEA (dietary supplement health and education act)
What legal body regulates marketing of Homeopathic Drugs?
HPUS (homeopathic pharmacopoeia of the united states)
What legal body regulates OTC advertising?
FTC (federal trade commission)
What legal body regulates OTC labeling?
What is OTC advertising? What is OTC labeling?
Advertising: Print, Electronic, Audio/Audiovisual Labeling: Everything that accompanies the bottle
What are 9 parts of an OTC Front label?
1. Generic and/or Brand name 2. Active ingredient 3. Function of drug 4. Formulation 5. What the product does or does not contain 6. Approved consumer age (if applicable) 7. Flavor (if applicable) 8. Dose/Concentration 9. Container Quantity
What are 10 components of an OTC Drug Facts label?
1. GRASE Active ingredient 2. Dosage Unit 3. Purpose of active drug 4. Uses 5. Warnings 6. Poison control helpline 7. Directions for use 8. Dosing chart/dosing device 9. Inactive ingredients 10. Manufacturer hotline
What are 4 complex interactions that may cause health disparities?
1. Genetic variations 2. Environmental factors 3. Socioeconomic factors 4. Specific health beliefs and behaviors
What are 5 factors linked to health disparities?
1. Race 2. Socioeconomic status 3. Environmental exposures 4. Discrimination 5. Access to health care
What is Acculturation?
The process by which members of a specific cultural group adopt the beliefs and behaviors of a dominant group, but they may still value and practice their own traditional beliefs and behaviors when in the presence of their own group members
What is cultural competence?
A set of behaviors and attitudes among professionals that enables them to work effectively in cross cultural situations
What are the 5 steps taken in the route to cultural competence?
1. Cultural Destructiveness 2. Cultural Incapacity 3. Cultural Blindness 4. Cultural Precompetence 5. Cultural Competence
What are 3 barriers to self care management?
1. Fear and mistrust of health care providers 2. Language barriers 3. Health literacy
What does LEARN stand for?
Listen Explain Acknowledge Recommend Negotiate
What technique is used to improve communication and care in cross-cultural settings?
What are the 3 elements of the Patient Care Process?
1. Assessment 2. Care Planning 3. Evaluation/follow up
What tool is used for assessing a patient?
What tool is used for care planning/evaluation of a patient?