88 terms

Therapeutics Quiz 1


Terms in this set (...)

Independent act of preventing, diagnosing, and treating illnesses without seeking professional advice
Non-prescription medications, nutritional dietary supplements, natural products, and homeopathic remedies
Who uses self-care therapeutics?
Factors increasing self-medication
Growth of aging population
Restricted access to prescriber through HMOs
Increasing costs of health care
High proportion of underinsured/uninsured individuals in US
Problems with self-medication
anti cholinergic effects, polypharmacy, poison exposure, medication errors/misuse, health literacy, source of knowledge, intentional misuse
Potential exclusions to self care
Advanced age
Infants and young children
Pregnant women
Breastfeeding women
Contraindications and drug interactions
Pharmacist's role in self care
1. Patient doesn't need anything
2. OTC
3. Referral to a primary care physician
Legend drug
Requires Rx
Can be dangerous
NDA process
Patient label
Non-Prescription (Dietary Supplement)
No Rx required
Can be dangerous
NDA or drug monograph
Supplemental label
Non-prescription (OTC)
No Rx required
Can be dangerous
NDA or drug monograph
Drug facts label
Drug monographs
Only available for non-prescription drugs and quicker than NDA
OTC Review Panel
GRASE (generally regarded as safe and effective)
does not go through FDA
Access to Non-prescription medication
"Surf" and self medicate
Community/retail pharmacies
Non-pharmacy retail outlets
Behind the counter (BTC)
Rx to OTC switch/Drug reclassification
other names for "Behind the Counter"
"pharmacist only" or "schedule 3"
Behind the Counter
greater patient access with safeguards
Factors of BTC
ability of pharmacist to provide necessary counseling
appropriate infrastructure in place in pharmacies
cost issues
BTC medicine in US
pseudoephedrine (makes methamphetamine)
BTC in Canada and UK
What is required to buy pseudoephedrine?
NTE: 3.6 g/day and 9g/30 days
gov't issued ID
record keeping
requirement for Rx to OTC switch
wide safety margin and effective
three ways an Rx can switch to OTC
1. non-prescription drug process
2. supplemental application to approved NDA
3. manufacturer or third party petition to FDA
Questions to consider when recommending OTC
Can the patient adequately identify the clinical abnormality?
Can the clinical abnormal condition be successfully self-treated?
Is the self-treatment product safe and effective for consumer use under condition of actual use?
something in the product that shouldn't be in the product
something is wrong with the label
Pure Food and Drug Act
adulteration and misbranding
Federal Food, Drug and Cosmetic Act
safety pre-approval
Durham Humphrey Amenment
OTC v. Rx drug
Kefauver Harris Amendment
efficacy pre-approval
OTC drug review
OTC monograph process
new drug application; applies to FDA for approval; switch from prescription product to OTC
Division of Non-Prescription Drug Products
drug development and validity of clinical trials
good manufacturing processes: manufacturer has followed quality standards
Product line extensions
new strengths, formulations or combinations of ingredients
Regulatory bodies and what they regulate
make sure that the drug is marketed correctly
ex: DSHEA (Dietary Supplement Health and Education Act of 1994)
Homeopathic Drugs
Federal Trade Commission regulates advertising
-objective truth
-obvious deception
-consumer harm
FDA regulates
OTC labeling
print, electronic, audio/audiovisual
everything that accompanies the bottle
Front Label of Drug
1. Generic and/or brand name, reason
2. active ingredient
3. Function of the 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
Drug Facts Label
(on the back)
presented the same way on every OTC product
10. GRASE active ingredient
11. Dosage unit
12. purpose of the active drug
13. uses
14. warnings
15. poison control help line (in case of overdose)
16. Directions for use
17. Dosing chart/device
18. inactive ingredients
19. Manufacturer hotline
found in liquid sucrose-free preparations
adverse reactions: headaches, caution in patients with PKU
Benzalkonium chloride
anti asthmatic drugs, nasal decongestants
airway constriction, contact dermatitis, contact lens discoloration, allergic reactions
Benzyl alcohol
liquid preparations
neonatal deaths, severe respiratory and metabolic complications, pruritus, erythema
capsules and tablets
diarrhea, dehydration, cramping
propylene glycol
liquid preparations
respiratory problems, irregular heartbeat, low BP, seizures, skin rashes, metabolic acidosis, hyperglycemia
liquid preparations
possible cross-sensitivity with sulfonamides, dermatologic reactions, pruritus, nausea, vomiting, diarrhea, alterations in case, gastrointestinal irritation
Adverse event reporting
Reasons for product recalls
adulteration, mislabeling, contamination, discovery of an unacceptable risk of adverse effects through post-marketing surveillance
Class I Recall
severe death
Class II Recall
may or may not be the cause; no death; reversible
Class III Recall
cosmetic, does not affect the patients
Tamper evident packaging requirements
OTC products must have one or more barriers to entry.
Tamper resistant packaging statement must be on all OTC items that require tamper evident features.
Must be visible and prominent.
Exceptions to tamper evident packaging
Dermatologic products
Insulin products
Tamper Resistant Packaging Statement
Do not use if seal is broken or missing.
made an error or failed to perform "duty" or exercise reasonable degree of care
Breach of Warranty
selling defective products or selling past warranty or date
Strict product liability
typically falls on the manufacturer; retail sellers may be held liable; product causes injury not due to negligence or warranty breaches
How to avoid liabilities?
maintain the best interest of the patient
Problem Solving Steps
1. Gather information
2. Assess and triage
3. Prepare and implement plan.
4. Patient education
5. Evaluate patient outcomes
putting problems in order of severity
Gather information tool
Scholar (subjective)
Aggravating factors
Remitting factors

Mac (objective)
Prepare and implement plan tool
Quickly and accurately assess the patient
Establish that the patient is an appropriate self-care candidate
Suggest appropriate self-care strategies
Talk with the patient
Patient education
description of the treatment and its administration
side effects and precautions
expected outcome and time to achieve it
who to contact in case of emergency

teach back method for understanding
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
Cultural competence
a set of congruent behaviors and attitudes among professionals that enables them to work effectively in cross-cultural situations
health disparities
individuals from some minority groups do not EQUALLY experience long life spans, good health and access to health services
Factors linked to health disparities
race, socioeconomic status, environmental exposures, discrimination, access to health care
Barriers to Self-care management
fear and mistrust of health care providers
language barriers
health literacy (reading and functional health)
health literacy
the degree to which individuals have the capacity to obtain, process, and understand basic health information to make appropriate decisions
Communication with culturally diverse groups tool
Listen with sympathy and understanding to the patient's perception of the problem
Explain your perceptions of the problem
Acknowledge and discuss the differences and similarities
Recommend treatment
Negotiate: agreement
need for patient care documentation
standard of practice, proof of service, 3rd party payer reimbursement, and agreement between patient and provider
Benefits regarding documentation
reimbursement and value of pharmacist driven services
Challenges regarding documentation
reimbursement and time
monitoring documentation
finding, assessment, recommendation, and management
assessment documentation
title, introduction, text, recommendation, signature
intervention documentation
subjective, objective, assessment, plan
Gold Standard
information obtained from the patient
-home medications, social history, review of systems
information obtained from physical findings
-vitals, current medications
Which takes priority, acute or chronic?
7 Drug Therapy problems
unnecessary drug, needs additional drug, wrong/ineffective drug, dose too high, dose too low, adverse drug reaction, adherence
Collaborative practice agreement
Agreement between pharmacist and healthcare provider
1. Collect Info
2. Medication assessment
3. Develop a plan
4. Implement a plan
5. Follow-up
SOAP applied to PPCP
S,O under collect information
A under medication assessment
P under develop a plan, implement plan and follow-up
ScholarMAC applied to PPCP
Collect info step
Pharmaceutical care
A patient-centered practice in which the practitioner assumes responsibility for a patient's drug-related needs and is held accountable for this commitment
Core elements MTM
Medication therapy review
Personal medication record
Medication action plan
Documentation and follow-up
comprehensive medication review; encompasses all 5 elements of MTM; in person/phone; time consuming
Targeted Intervention Program; drug therapy related problems
Outcomes or Marixa
Alerts are made from the insurance to the pharmacy for the pharmacist to access insurance claims