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what are the 3 ways non-Rx drugs can be brought to the market
OTC monograph process
New Drug Application
Drug Reclassification
T or F? OTCs and dietary supplements are required by the FDA to have drug facts labeling
False
drug facts labeling only applies to OTCs, not dietary supplements
what are the 4 factors that drive self-reliance (self-care therapeutics)
aging population
decreased availability of PCPs
increased health care costs
high proportion of under-/uninsured
the ____ Act of 1994 amended the 1993 Food, Drug, and Cosmetic Act to establish standards (including accurate labeling) for ____
Dietary Supplement Health and Education
dietary supplements
list some common forms of complementary and alternative medicine (CAM)
natural/herbal products
deep breathing
meditation
chiropractic and osteopathic care
massage
yoga
list some common natural/herbal products
cranberry
soy
saw palmetto
garlic
echinacea
what are the 3 big factors influencing self-care medication
cost
aging population
gender differences
list some benefits of nonprescription medicine
accessibility and convenience
number conditions can be treated by OTCs
variety of products and dosage forms
can be used to manage a condition while waiting for appointment with HCP
more affordable
how can product reformulation lead to safety concerns
Reformulated products may be labeled as "new and improved" but not indicate that active ingredient is changed → leading to confusion and misuse
what does QuEST for patient assessment stand for
Quickly and accurately assess patient
Establish that the patient is an appropriate self-care candidate
Suggest appropriate self-care strategies to the patient
Talk with the patient about these strategies
what does SCHOLAR-MAC stand for in assessing a patient to determine self-care candidate status and identify which treatments would be most appropriate
Symptoms
Characteristics of symptoms
History of symptoms
Onset
Location
Aggravating factors
Remitting factors (what makes the problem better?)
Medications (Rx, OTC, herbal, dietary supplements)
Allergies
Conditions
why is pseudoephedrine now behind-the-counter
can be used to illicitly manufacture methamphetamine
Emergency contraceptives have an efficacy of > ___% when used as indicated
95%
T or F? emergency contraceptives (ECs) inhibits implantation of a fertilized egg to prevent pregnancy
False
ECs inhibit or delay ovulation but do NOT inhibit implantation of a fertilized egg or terminate an established pregnancy
Emergency contraceptives are most effective if taken within _ of primary contraceptive failure or unprotected sex
72 hours
T or F? emergency contraceptives can be sold to patients of any age and gender without ID or counseling*
True*
allowing access to syringes with hypodermic needles without an Rx addresses what public health issue
the spread of blood-borne infections related to sharing of contaminated needles
T or F? syringes are usually stored in an area where the public can conveniently access
False
Syringes must be stored in an area not directly accessible to public
pharmacists may furnish syringes to patients age ___
18 or older
what are some pharmacist roles in nonprescription medicine
Be available to patients seeking preventative and self-care products
Interview, screen and perform physical assessment as needed
Assess patient risk factors (contraindications, precautions…)
Assist in product selection
Provide counseling (dosage, administration, duration…)
Maintain accurate drug profile including non-Rx meds
Assess the potential of non-Rx medicine to mask symptoms of more serious conditions
Educate on when to seek medical attention of no improvement or if symptoms worsen
T or F? the use of self-care are usually limited to mild illness or short-term management of illness
True
what are the 3 general categories of self-care products
nonprescription medicine
nutritional dietary supplements
natural products
what are the characteristics of nonprescription medicine
low potential for misuse/abuse
can be used for self-diagnosed conditions
adequately labeled
do not require access to HCP
what is an immunization neighborhood
collaboration, coordination and communication among immunization stakeholders dedicated to meeting the immunization needs of the patient and protecting the community from vaccine-preventable diseases
which of the following age groups tend to have the lowest annual influenza vaccination rates
c) 18 yrs through 49 yrs
what was the most common place of vaccination for children? how about for adults?
children- doctor's office
adults- pharmacy/store
an infant receiving antibodies from breast milk is an example of what type of immunity
passive immunity
what are the live vaccines
MMR
chikungunya
live attenuated influenza
varicella
oral rotavirus
oral typhoid capsules
yellow fever
why can't pure polysaccharide vaccines (PPSVs) be given to those under 2 years old
PPSVs activate B cells without the help of T cells but the immune system of young children is too immature to effectively respond to this to produce long-term immunological memory
can a patient 1 years of age receive a conjugate polysaccharide vaccine?
yes, because conjugate polysaccharide vaccines involve the stimulation of T-cells in producing immunological memory (unlike pure polysaccharide vaccines)
what is the minimum interval between 2 non simultaneous live vaccines
28 days
live vaccines followed by blood products require a minimum interval of…
2 weeks
live vaccine followed by a PPD skin test requires a minimum interval of…
28 days
when giving more than 1 vaccine on the same arm, the injection sites must be separated by ___
1 inch
ACIP counts ____days within of the minimum interval as grace period
4
which of the following are false contraindications? (select all that apply)
b) premature birth
d) mild fever
e) breastfeeding
what vaccines are recommended during pregnancy
Tdap (3rd trimester)
inactivated influenza
bivalent RSVPreF (3rd trimester)
if possible, live vaccines should be given how long prior to immunosuppression
4 weeks
what is the daily and monthly limit for purchase of pseudoephedrine
daily: 3.6 g
monthly: 9 g
what are the 7 risk factors for cold from lecture
increased population density
respiratory allergies
decreased diversity of social networks
smoking
sedentary lifestyle
chronic psychological stress
sleep deprivation
which of the following are NOT true risk factors for the cold (select all that apply)
a) enlarged tonsils
b) sudden chilling
which of the following is an appropriate candidate for self-treatment:
b) 49 y/o patient who's had a fever of 99.8 F for 1 day
what is the recommended therapy for infants experiencing a cold
non-pharmacological therapy-
keep upright
nasal aspirators
saline sprays/drops
humidifier/vaporizer
hydration
what is the dosing for pseudoephedrine for adults and children 12 yrs or older? for children 6-<12 yrs?
=12 y/o: 60 mg q4-6 hrs (240 mg per day)
6-<12 y/o: 30 mg q4-6 hrs (120 mg per day)
what is the dosing for phenylephrine for adults and children 12 yrs or older? for children 6-<12 yrs?
=12 y/o: 10 mg q4 hrs (60 mg per day)
6-<12 y/o: 5 mg q4 hrs (30 mg per day)
the use of topical decongestants is limited to ___ days. otherwise long-term use could lead to ___
3-7 days
rhinitis medicamentosa
what can someone with HTN use for nasal congestion instead of pseudoephedrine
Coricidin (contains 1st gen antihistamine instead of systemic decongestant)
what are the 4 first generation antihistamines that can be used for cold symptoms
diphenhydramine
dimenhydrinate
doxylamine
chlorpheniramine
first generation antihistamines exhibit what type of side effects
anticholinergic and sedative effects
__ can cause paradoxical excitation in young children who have an extra CYP2D6 gene
antihistamines
besides non-drug therapy, which of the following is PREFERRED for treating pregnant or lactating patients with cough/cold symptoms
c) topical oxymetazoline
Should try to avoid systemic decongestants, first gen antihistamines, combination products, extra-strength products
children recovering from viral illness should avoid taking Aspirin due to risk of having
Reye's Syndrome
a patient has been experiencing a cough without mucus for the last 4 weeks. what would the patient's cough be classified as?
d) subacute, non-productive
which of the following is on the Beer's list and should be avoided in elderly
d) diphenhydramine and all first generation antihistamines
what OTC medicine has a caution against phencyclidine-like euphoric effect
dextromethorphan
as a general guide, self-treatment should not exceed _ days
3-5
what part of SOAP notes does discussing the pros and cons of treatment options belong to
Assessment
what should be avoided in children younger than 2 y/o due to risk of methemoglobinemia
benzocaine
what is the dosing for dextromethorphan for adults >=12 y/o and children 6-<12 y/o
=12 y/o: 10-20 mg q4h or 30 mg q6-8h prn (120 mg)
6-<12 y/o: 5-10 mg q4h or 15 mg q6-8h prn (60 mg)
what is the dosing for diphenhydramine for adults >=12 y/o and children 6-<12 y/o
=12 y/o: 25 mg q4h prn (150 mg)
6-<12 y/o: 12.5 mg q4h prn (75 mg)
what is the dosing for guaifenesin for adults >=12 y/o and children 6-<12 y/o
=12 y/o: (IR) 200-400 mg q4h prn or
(ER) 600 mg to 1.2 g q12h prn (max 2.4 g/day)
6-<12 y/o: (IR) 100-200 mg q4h prn (max 1.2 g/day)
Cold Myths
Cold or wet environments
Sudden chilling or exposure to central heating
Walking barefoot outside
Teething
Enlarged tonsils or adenoids
Cold - When to Refer
Fever
Chest pain
Shortness of breath
Worsening of symptoms or development of additional symptoms during self-treatment
Concurrent underlying chronic cardiopulmonary diseases
AIDS or chronic immunosuppressant therapy
Elderly, frail patients
Infants < 3 months of age
Hypersensitivity to recommend OTC medications