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Labeling on prescription drugs is written for... - Answers -✔✔ healthcare providers
Labeling on OTC drugs is written for... - Answers -✔✔ patients
If any required OTC labeling information is missing, the drug is considered - Answers -
✔✔ misbranded
Requirements for an OTC drug label - Answers -✔✔ 1) Principal Display Panel
2) Statement of Identity - drug name + pharmacological category/intended action
(*should be on principal display panel*)
3) Net quantity of contents (weight, measure or numerical count)
4) Name AND address of manufacturer/packager/distributor
5) Adequate directions for self-use
6) "Drug Facts" Panel
This should be on the Principal Display Panel of an OTC drug - Answers -✔✔
Statement of Identity = drug name + pharmacologic category/intended action
Is the "Drug Facts" Panel on OTCs FDA approved? - Answers -✔✔ Yes
In an NDC require on the OTC labeling? - Answers -✔✔ Requested but *not required*
Adequate directions for self use include: - Answers -✔✔ - dosing
- preparation
- frequency
- duration
- time
- route
Required elements of "Drug Facts" Panel - Answers -✔✔ 1) Active Ingredient (including
quantity per dose)
2) Purpose (pharmacologic category/intended use)
3) Uses (indications)
4) Warnings
5) Directions (for specific age groups/populations)
6) Other information (Electrolyte labeling, inactive ingredients)
7) Contact information ("Questions" + phone #)
,What is included in the "other information" section of a "Drug Facts" panel? - Answers -
✔✔ - electrolyte information ( Na, Ca, Mg, K)
- inactive ingredients
- other info required by monograph, regulations or labeling
Unique OTC drug warnings to remember - Answers -✔✔ - sore throat
- allergic reaction and asthma alert
- flammability
- Reye's syndrome
- Choking
- Dosage for Sodium Phos
- STD
- "Keep out of reach of children" + accidental ingestion/overdose
Which OTC drugs are exempt from "If pregnant or breastfeeding...." warning - Answers
-✔✔ - If drug is intended to benefit the fetus or nursing infant
- If labeled exclusively for pediatric use
What OTC drugs require a special additional pregnancy warning? - Answers -✔✔
Aspirin-containing products
"Ask a doctor before use if you have... " is for ________ - Answers -✔✔ Conditions
"Ask a doctor or pharmacist before use if you have..." is for _______ - Answers -✔✔
Drug-drug and drug-food interactions
"When using this product..." is for_______ - Answers -✔✔ Side effects and substances
to avoid
"Stop and ask a doctor if..." is for_______ - Answers -✔✔ signs of toxicity
"Do not use..." is for ______ - Answers -✔✔ Contraindications
Which electrolytes have to be labeled with a warning if they exceed a certain threshold
in an OTC product?
What is the warning? - Answers -✔✔ Na
K
Mg
Ca
Ask a doctor before use if you have kidney stones/kidney disease or a Na/K/Mg/Ca
restricted diet
Must also list amount of electrolyte *per dose*
,Which electrolytes require kidney *stone* warning? - Answers -✔✔ K, Mg, Ca (all but
Na)
Which electrolytes require kidney *disease* warning? - Answers -✔✔ K, Mg
Sodium Threshold - Answers -✔✔ >140 mg per day (based on maximum daily dose)
Electrolyte thresholds are based on - Answers -✔✔ maximum daily dose
Calcium Threshold - Answers -✔✔ >3.2 g per day (based on maximum daily dose)
Magnesium Threshold - Answers -✔✔ >600 mg per day (based on maximum daily
dose)
Potassium Threshold - Answers -✔✔ >975 mg per day (based on maximum daily dose)
Sodium Free = - Answers -✔✔ <=5 mg per day
Very Low Sodium = - Answers -✔✔ <= 35 mg per day
Low Sodium = - Answers -✔✔ <= 140 mg per day
Emergency Contraceptive Pills and Rx vs. OTC - Answers -✔✔ Levonorgestrel (Rx and
OTC)
Ulipristal = Ella (Rx Only)
Are there any gender or age restrictions for buying Plan B? - Answers -✔✔ NO
(Even though package may say for women 17+ on generics)
How long is emergency contraceptive approved for?
How long can pharmacists recommend it for? - Answers -✔✔ 72 hrs
120 hrs
Preferred emergency contraception when >72 hrs - Answers -✔✔ Ulipristal (Ella) but Rx
only...
Does the Affordable Care Act cover emergency contraception? - Answers -✔✔ Yes but
only with a prescription
Review WA laws for Pharmacists furnishing emergency contraceptions - Answers -✔✔
***
, Behind the Counter drugs are technically considered... - Answers -✔✔ OTC
Rules for OTC Schedule V drugs - Answers -✔✔ Not allowed in WA state
How many members serve on the Board of Pharmacy? How many are public members?
- Answers -✔✔ 10 pharmacists, licensed in WA for at least 5 years, geographically
representative, and representing various areas of practice
4 public members, not affiliated with any aspect of pharmacy, citizens of US and
resident of WA
1 pharmacy technician, licensed by Commission; no mention of citizenship or residency
4-year terms
May serve 2 terms
Members appointed by governor
Executive officer hired by Commission
Executive officer reports to Undersecretary of DOH for Health Systems Quality
Assurance
Staff are employees of Department of Health, Health Professions Quality Assurance
Division
Commission currently has own investigators within HPQA pool
Licenses paid to HPQA Office
Which of the following can prescribe legend drugs: O.D., Nurse Practitioner, Clinical
Nurse Specialist,
Physician's Assistant, Midwife, Nurse Midwife,
Chiropractor, Naturopath, Clinical Psychologist,
Physical Therapist, Respiratory Therapist,
Pharmacist? - Answers -✔✔ Physicians (MD, DO, Podiatrist)
Dentists
Veterinarians
Mid-level practitioners (NP, PA, Naturopath, OD, PharmD, Midwife)
May any prescribers purchase legend drugs for use in their practice? - Answers -✔✔
Pharmacies may transfer legend drugs to other pharmacies or prescribers without
registering as wholesalers "to meet an urgent need"
May not exceed 5% of total sales during any previous 12 months
Commission has recently suggested that "routine" sales to physicians violate this rule
Repackaging may make the transferred drug misbranded, and should not be done
Which of the following can prescribe CSA drugs
(and which classes):
O.D., Nurse Practitioner, Clinical Nurse Specialist,
Physician's Assistant, Midwife, Nurse Midwife,
Chiropractor, Naturopath, Clinical Psychologist,
Physical Therapist, Pharmacist? - Answers -✔✔ MD or DO - all schedules
DMD, DDS - all schedules
DVM - all schedules