Download NAVIGATING THE AISLES: CLINICAL PEARLS OF OTC

NAVIGATING THE AISLES:
CLINICAL PEARLS OF OTC MEDICATIONS
SATURDAY/3:15-4:15PM
ACPE UAN:
0107-9999-17-016-L01-T
0.1 CEU/1.0 hr
Activity Type: Knowledge-Based
Learning Objectives for Pharmacy Technicians: Upon completion of this CPE activity participants should be
able to:
1. List products that have recently changed from prescription to over-the-counter (OTC) status
2. Discuss the role of the pharmacy technician in promoting safe use of OTC medications
3. Review a product label to avoid duplication of therapy
4. Identify patients who may benefit from further consultation with a pharmacist to ensure appropriate
use of OTC medications
Speaker: Marie Sirek, PharmD
Marie Sirek is a second year Ambulatory Care Resident at the University of Iowa Hospitals and Clinics
in Iowa City, IA. She received her Doctor of Pharmacy from North Dakota State University in May
2015. Following graduation, she completed her first year Ambulatory Care Focused Residency at the
University of Iowa Hospitals and Clinics. Her primary interests include ambulatory care,
hematology/oncology, and pediatrics.
Speaker Disclosure: Marie Sirek reports no actual or potential conflicts of interest in relation to this
CPE activity. Off-label use of medications will not be discussed during this presentation.
2/4/17
Navigating the Aisles:
Clinical Pearls of OTC Medications
Marie E. Sirek, PharmD
PGY2 Ambulatory Care Pharmacy Resident
University of Iowa Hospitals and Clinics
Faculty Disclosure
Marie E. Sirek reports no actual or potential conflicts of interest
associated with this presentation
•
Marie E. Sirek indicates that off-label use of medication will not
be discussed during this presentation
•
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Learning Objectives
•
List products that have recently changed from prescription
to over-the-counter (OTC) status
•
Review a product label to avoid duplication of therapy
•
Discuss the role of the pharmacy technician in promoting
safe use of OTC medications
•
Identify patients who may benefit from further consultation
with a pharmacist to ensure appropriate use of OTC
medications
PRE-ASSESSMENT
QUESTIONS
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Pre-Assessment Question
OTC medications are safe for all patients and do not
routinely require a pharmacist consultation.
TRUE
FALSE
Pre-Assessment Question
Once a medication is FDA approved as a prescription
product, it cannot be changed to an OTC product.
TRUE
FALSE
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Pre-Assessment Question
OTC products can be used safely by many patients prior to
being seen by their physician.
TRUE
FALSE
Outline
•
Prescription to OTC switch
•
Reading an OTC label
•
Identifying differences between similar OTC products
•
Limitations to self-care
•
Technician role in OTC medications
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Flonase®
Sensimist
Allergy Relief
Allegra®
Rhinocort ®
Allergy
Spray
Nasacort ®
Allergy 24
HR
PRESCRIPTION TO
OTC SWITCH
Flonase®
Allergy
Relief
Nexium®
24 HR
Differin
Gel® 0.1%
Oxytrol®
for
Women
Growth in Rx to OTC Switch
•
Strict evaluation process through the U.S. Food and Drug
Administration1
• Key question: Can patients achieve the desired medical result
without compromising safety?
•
Estimated healthcare savings of $20 billion due to Rx to
OTC switches1
•
106 ingredients, indications, or dosage strengths switched
or newly approved since 19762
1. U.S. Food & Drug Administration.
2. Page M. Rx-to-OTC
http://www.fda.g ov/D ru gs/ Res ou rc es Fo rYo u/C ons u me rs/ uc m1 43 54 7.h tm .
switches: trends
to watch. Pharmacy
Accessed 11/27/16.
Times. 2015 Feb.
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Rx to OTC Switch: Allergic Rhinitis
Prescription Name†
† Generic
OTC Name
Approval Date
Veramyst ®
8/2/16
Flonase® Sensimist™ Allergy
Relief (fluticasone furoate)
Rhinocort ®
3/23/15
Rhinocort ® Allergy Spray
(budesonide)
Flonase®
7/23/14
Flonase® Allergy Relief
(fluticasone proprionate)
Nasacort AQ®
10/11/13
Nasacort ® Allergy 24 HR
(triamcinolone acetonide)
name does not change when prescription
product is switched to OTC
Prescription to over-the-cou nt er (OTC) switch list. U.S. Food and Drug Administration.
http://www.fda.g ov/A bo ut FDA/ Ce nte rs Offic es/ Offi ce of Me dicalP ro du cts an dT ob acc o/C DER/ uc m1 06 37 8.h tm .
Accessed 11/27/16.
Rx to OTC Switch: Antihistamines
Prescription Name†
Allegra D®, Allegra®
1/24/11
Allegra D® 12 HR, Allegra® 24
HR, and Allegra® (fexofenadine ±
pseudoephedrine)
Zyrtec-D®, Zyrtec ®
11/9/07
Zyrtec-D® (cetirizine ±
pseudoephedrine)
11/27/02
Claritin-D®, Claritin-D® 24 HR,
Claritin® (loratadine ±
pseudoephedrine)
Claritin-D®,
† Generic
OTC Name
Approval Date
Claritin®
name does not change when prescription
product is switched to OTC
Prescription to over-the-cou nt er (OTC) switch list. U.S. Food and Drug Administration.
http://www.fda.g ov/A bo ut FDA/ Ce nte rs Offic es/ Offi ce of Me dicalP ro du cts an dT ob acc o/C DER/ uc m1 06 37 8.h tm .
Accessed 11/27/16.
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Rx to OTC Switch: Heartburn
Prescription Name†
Nexium®
N/A‡
Similar Rx product: Prevacid®
N/A‡
Similar Rx product: Zegerid®
N/A‡
Similar Rx product: Prilosec®
† Generic
‡ Not
name does not change when prescription
a true switch since the conditions
OTC Name
Approval Date
3/28/14
Nexium® 24 HR
(esomeprazole magnesium)
5/18/09
Prevacid® 24HR
(lansoprazole)
12/1/09
Zegerid® OTC (omeprazole/
sodium bicarbonate)
6/20/03
Prilosec ® OTC
(omeprazole)
product is switched to OTC
of use were not marketed
as a prescription
product
under an approved
Prescription to over-the-cou nt er (OTC) switch list. U.S. Food and Drug Administration.
http://www.fda.g ov/A bo ut FDA/ Ce nte rs Offic es/ Offi ce of Me dicalP ro du cts an dT ob acc o/C DER/ uc m1 06 37 8.h tm .
NDA prior to being approved
for marketing
OTC
Accessed 11/27/16.
Rx to OTC Switch: Other Indications
Indication
Approval Date
OTC Name
Anti Acne
7/8/16
Differin Gel® (adapalene), 0.1%
Overactive Bladder
1/25/13
Oxytrol® for Women (oxybutynin)
Weight Loss Aid
2/7/07
Alli® (orlistat)
Emergency
Contraceptive
8/24/06
Plan B One-Step® (levonorgestrel)
Prescription to over-the-cou nt er (OTC) switch list. U.S. Food and Drug Administration.
http://www.fda.g ov/A bo ut FDA/ Ce nte rs Offic es/ Offi ce of Me dicalP ro du cts an dT ob acc o/C DER/ uc m1 06 37 8.h tm .
Accessed 11/27/16.
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Future Directions
High cholesterol1,2
Erectile dysfunction2
Migraine1,2
Overactive bladder1,2
Benign prostatic hypertrophy1,2
Oral contraceptives 3
1. Moody
ML, Wisner JH. OTC products
in patient self-care and the role of pharmacy
technicians.
ProCE. 2014 August.
2. Page M. Rx-to-OTC switches: trends to watch. Pharmacy Times. 2015 Feb.
3. Ocs OTC Working Group. http://ocsotc.or g/ Accessed Dec 7 2016
REVIEWING AN OTC
DRUG LABEL
Palmer A. The best over-the-cou nte r
15848 Accessed 7 Dec 2016.
acne treatments.
https://www.veryw ell.c om /h ow- to -ch oo se -a n- otc -ac ne -t re at me nt- pr od uct -
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OTC Label Requirements
Active ingredient(s), including the amount in each dose
• Purpose
• Uses
• Warnings
• Dosage instructions
• Inactive ingredients
• Other information including storage, expiration date, lot or
batch number, manufacturer information, net quantity,
overdose information
•
The over-the-cou nt er
medicine
label: take a look. U.S. Food and Drug Administration.
OTC Drug Facts Label. U.S. Food and Drug Administration.
28 Sept 2016.
05 June 2015.
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WHAT’S IN A NAME
Comparing brand name, store brands, generics, and
combinations products
Patient Knowledge Gap
ABCNews.go.com.
Accessed 12/3/16.
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Therapeutic Duplications
BRAND NAME
VS.
STORE BRAND
VS.
GENERIC
Brock KA. Over-the-co unt er
analgesics. PharmacyTec h
New. Dec 2010.
Therapeutic Duplications
More than 600 medications
(OTC and prescription) contain
acetaminophen
Brock KA. Over-the-co unt er
analgesics. PharmacyTec h
New. Dec 2010.
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Comparing OTC Products
Active Ingredients
Brand Name
Acetaminophen
Aspirin
Caffeine
Excedrin® Extra
Strength
X
X
X
Excedrin®
Tension
Headache
X
Excedrin®
Migraine
X
Excedrin® Sinus
Headache
X
Excedrin® PM
X
Anderson
SP, Ciliberto F, Liaukonyte
J. Marketing
Diphenhydramine
Phenylephrine
X
X
X
X
X
Science Institute Working Paper. 2008 Feb.
Let’s Practice!
Equivalent or Different?
JointFlex ®
Capzasin-HP®
Otclabels.com. Accessed 12/2/16.
CVS.com. Accessed 12/2/16.
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JointFlex ®
Capzasin-HP®
Otclabels.com. Accessed 12/2/16.
CVS.com. Accessed 12/2/16.
or Different?
Unisom®
Wal-som®
Unisom.com. Accessed 12/2/16.
Walgreens.com
Accessed 12/2/16.
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EQUIVALENT!
Unisom SleepGels ®
Unisom.com.
Benadryl.com
Benadryl® Allergy LiquiGels
Accessed 12/2/16.
Accessed 12/2/16.
Equivalent or
Alka-Seltzer Plus ® Cold
?
Tylenol® Cold & Flu Severe
Alkaseltzerplus.co m.
Accessed 12/2/16.
CVS.com. Accessed 12/2/16.
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Equivalent or Different?
Alka-Seltzer Plus ® Cold
Alkaseltzerplus.co m.
Walmart.com.
Tylenol® Cold & Flu Severe
Accessed 12/2/16.
Accessed 12/2/16.
FIRST, DO NO HARM
When an OTC may be un-safe and when
to consult a pharmacist
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OTC Medication Abuse
•
•
•
Rarely primary substance of
abuse1
Regulation changes on the sale
and availability of products
Common Medications
Implicated in OTC Abuse1,2,4
Antidiarrheal medications
(e.g. loperamide)
Codeine-based medications
(especially compound
analgesics)
Cough products (particularly
dextromethorphan)
Behind-the-counter OTC
medications3
First generation (sedative)
antihistamines
(e.g. diphenhydramine)
• OTC insulin
• Pseudoephedrine
Decongestants
(e.g. pseudoephedrine)
• Codeine-based cough medications
Laxatives
1.
2.
3.
4.
Cooper RJ. Over-the-cou nt er medicine abuse – a review of the literature. Journal of Substance Use. 2013.18;2, 82-107.
Johnston L, et al. National Institute on Drug Abuse University of Michigan. http://www.monit ori ng th efu tu re. or g// pr ess rel ea ses /1 4d ru gp r_c o mpl ete .p df.
Pray WS, Pray G. US Pharm. 2011;36(9): 11 -1 5. Accessed 1/28/17.
Hee Han D. MPR. http://www.emp r.c o m/n ews /se oul -vi rus -in fec tio n-wil d- no rw ay- ra ts- cdc /a rticl e/6 33 25 8/.
Accessed 1/28/17
Accessed 11/28/16
Pharmacist Referral: When and Why
Possible contraindications or reasons for consultation
Examples:
Decongestants
• High blood pressure, thyroid disease, heart disease,
diabetes, enlarged prostate, or duration of use
Pseudoephedrine
First
Generation
Antihistamines
• Advanced age, glaucoma, or enlarged prostate
Diphenhydramine,
chlorpheniramine
Cough
Suppressants
• Concerning purchase quantity
• Varying recommendations for type of cough
Dextromethorphan
Pain/Fever
Relievers
• Maximum dosing guidance
• Compromised liver function (acetaminophen), kidney
function (NSAIDs), or history of GI bleed or heart
disease
Acetaminophen,
ibuprofen,
naproxen
Abbreviations: non-steroidal anti-inflammatory drug=NSAID; gastrointestinal=GI
PL Technician
Training Tutorial,
OTC Cough and Cold Products.
Pharmacist’s
Letter/Pharmac y
Technician’s
Letter. March 2009 (full update October 2011).
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Pharmacist Referral: When and Why
Possible contraindications or reasons for consultation
Examples:
Nasal Sprays
for Allergic
Rhinitis
• Administration technique
Acid
Reducers for
Heartburn
• Optimal timing of administration
Fluticasone
Omeprazole,
esomeprazole,
ranitidine
Additional patient considerations and consultation points: drug-drug
interactions, duplicate therapy, pregnancy/breastfeeding, alternative dosage
forms, pediatrics, maximum doses, non-pharmacologic management
PL Technician
Training Tutorial,
OTC Cough and Cold Products.
Pharmacist’s
Letter/Pharmac y
Technician’s
Letter. March 2009 (full update October 2011).
EMBRACING YOUR
ROLE AS A PHARMACY
TECHNICIAN
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Role of the Pharmacy Technician1,2
Pharmacy technicians are located at the front-line
and able to help identify patient questions,
concerns, and pharmacist referrals.
Recognize that OTC products are NOT harmless and are
an integral part of the medication list
ü
ü
Identify worrisome purchasing patterns
Locate OTC products
ü Understand OTC medication label
ü
1. Moody ML, Wisner JH. OTC products in patient self-care and the role of pharmacy technicians.
2. PL Technician Training Tutorial, OTC Cough and Cold Products. Pharmacist’s Letter/Pharmac y
ProCE. 2014 August.
Technician’s Letter. March 2009 (full update October 2011).
Case 1
Ms. Smith is a new patient at your pharmacy. She
presents to the counter to fill a prescription for
Nexium® (esomeprazole) 20 mg capsules
(directions: take 1 capsule by mouth daily). She
saw a box of esomeprazole 20 mg tablets in the
over-the-counter medication section and is
wondering if this is the same product.
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Case 1
What is the most appropriate response?
a. Complete her transaction while noting that they are
“pretty much the same”
b. Explain that the two products are equivalent by
describing the Rx to OTC switch process and that
esomeprazole 20 mg is available both over the counter and
as a prescription
c. Recommend consultation with a pharmacist
Case 2
Mr. Green is an 89 year old male presenting to the
counter to pick up refills of his tamsulosin
(enlarged prostate) and lisinopril (high blood
pressure). He has two different over-the-counter
sleep aids in hand and wants to know which one
works better. See below for the two products.
Riteaid.com.
Accessed 12/3/16.
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Case 2
What is the most appropriate recommendation?
a. ZzzQuil® (diphenhydramine)
b. Melatonin
c. Neither, Unisom® (doxylamine) is best
d. Consultation with the pharmacist
Summary
•
A growing number of prescription products are being
switched to OTC and patients are more likely than ever
before to be self-managing associated health conditions
•
Although OTC medications are easily accessible, they
may still require pharmacist consultation and can be
harmful if used inappropriately
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Summary
•
The large variation of OTC products can be overwhelming
and confusing to patients and pharmacy technicians can
be a valuable resource
•
Always compare active ingredients in an OTC product to
determine equivalency
•
Be a proponent of pharmacy! Know your role and when to
defer to a pharmacist
POST-ASSESSMENT
QUESTIONS
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Post-Assessment Question
All of the following prescription products are available in an OTC
form except…
a. Nexium® (esomeprazole)
b. Lipitor® (atorvastatin)
c. Flonase® (fluticasone proprionate)
d. Oxytrol® (oxybutynin)
Post-Assessment Question
You notice a young woman wandering through the OTC cough
and cold aisle of your pharmacy. You do not recognize her as a
regular patient. Eventually she makes her way to the pharmacy
counter with the following two products: Midol® Complete
(acetaminophen/caffeine/pyrilamine maleate) and store brand
Cold Multi-Symptom (acetaminophen/phenylephrine
HCl/dextromethorphan HBr).
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Post-Assessment Question
What is the most appropriate next step?
a. Let the cashier complete the transaction as is
b. Suggest she substitutes Tylenol® Cold Multi-Symptom Severe
for the store brand product because it is more effective
c. Suggest she only buy one of the two products because they
both contain acetaminophen
d. Explain that these products may represent duplicate therapy
and recommend consultation with the pharmacist
Post-Assessment Question
What is the most appropriate and accurate way to review medications for
therapy duplications?
a. Review the Drug Facts of each product and compare active
ingredient(s)
b. Compare product brand names – if these are different, no duplications
will exist
c. Only review OTC products – no ingredients in a prescription product will
also be available OTC
d. A pharmacy technician should not review medications to identify
therapy duplications
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Post-Assessment Question
True or False. Over-the-counter medications are
completely safe, do not interact with prescription
medications, and do not require any counseling by a
pharmacist.
a. True
b. False
Post-Assessment Question
Which of the following OTC medication class is matched
incorrectly with the respective possible contraindication or
reason for pharmacist referral?
a. Nasal decongestant – high blood pressure
b. First generation antihistamine – advanced age
c. Acid reducers – diabetes
d. Cough suppressant – purchase of five boxes two weeks in a
row
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Questions?
[email protected]
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