Everything You'll Ever Need to Know about OTCs and Self Care

Module 1 Lecture Objectives
Lecture 1.1 (Li)
1.List the components associated with self-care
-Affordability, Trust, Access, Empowerment
The Seven Pillars of Self-Care include:
1) Health literacy
2) Self-awareness of physical and mental condition
3) Physical activity
4) Healthy eating
5) Risk avoidance or mitigation
6) Good hygiene
7) Rational and responsible use of products, services, diagnostics and medications
2. Describe the concerns with the possible problems
associated with improper use of OTC agents
 Improper drug selection
 Improper dosing
 Pediatric dosing
 Drug interactions
 Duplicating therapies
 Brand name extensions – reuse of a well-known proprietary name to introduce a new
product that may contain an active ingredient different from the original.
 Allergies – inactive/active ingredients
 Storage issues
3. Compare and contrast the barriersassociated with OTCs
from the patient and the pharmacist’s perspective
Patient’s Viewpoint Pharmacist’s Viewpoint
 Confusing Marketing
 Large selection of products
 Cultural beliefs/Health Literacy
 Privacy concerns
 Patients utilization of pharmacists low
 Lack of full access to a patient’s
medication profile
 Time constraints
 Knowledge gaps in OTC
medications/therapies

4. List the information a drug label for an OTC agent.
 Drug Facts (active ingredient)
 Uses
 Warnings
 “Keep away from children” warning
 Directions
 Other information
 Inactive ingredients
5. Identify the specific components of SCHOLARMAC and be
able to demonstrate the ability to use this assessment process
in case examples
 Symptoms
 Characteristics
 History
 Onset
 Location
 Aggravating factors
 Remitting factors
 Medications
 Allergies
Conditions
6. Explain the steps of the PPCP process and how this can be
utilized in the self-care environment
 Collect – collecting information using things like scholarmac
 Assess – analyzing that information and choosing the medication therapy problem (DTP)
and choosing appropriateness of self-care
 Plan – Goals of therapy, recommendations (including pharmacologic and non-
pharmacologic), time frame in which outcome is expected
 Implement – Implement the plan and provide education/patient empowerment,
schedule a follow-up
 Follow-up – Monitor and evaluate the patient for appropriateness (is the medication
still indicated?), effectiveness, safety (side effects?), and adherence.
Can be utilized to promote the best possible outcome for patients and prevent possible ADR’s.

7. Demonstrate the ability to effectively complete a self-care
consultation
Sure thing
Lecture 1.2 (Li)
1.List the typical special populations that you might encounter
during a self-care consult
 Elderly (>65)
 Patients with chronic illness
o Includes diabetes, heart failure, impaired kidney function, liver disease, HTN,
prostate problems, glaucoma, hypothyroidism
 Pregnant women
 Lactating women
 Pediatrics
2. Explain some of the reasons each of these patient
populations are unique and list some examples of common
OTC medication concerns with this population
These populations are unique because they:
 May have altered ADME properties
 Are more sensitive to the effects of medications
 Have a higher risk of adverse effects
 Are more likely to have cognitive impairments due to disease (altered
judgements)
 May have problems with administration (ie older patients with dysphagia,
adherence, etc)
3. Explain the purpose of the Beer’s Criteria

The Beer’s Criteria keeps track of potentially inappropriate medications for use in older adults
(over 65 y/o).
4. Provide reasons why anticholinergics, proton pump
inhibitors, and NSAIDs are listed in the Beer’s criteria
Anticholinergics May cause confusion, constipation, dry mouth
Mineral Oil Increased aspiration risk
PPI’s Increased risk of bone loss, fractures
NSAIDs Increased risk of bleeding
5. Explain why patients with chronic illness should be included
in the “special population” category
 Chronic illness patients are usually taking many medications, putting them at risk for
polypharmacy.
 Patients are usually more fragile due to their disease state.
 Patients may be more sensitive to side effects from OTC agents
6. Compare and contrast the old pregnancy risk category due
to the pregnancy and lactation labeling rule and how this
impacts OTC medications
 Safety data in pregnancy is still limited today.
 An “A, B, C, D and X” category has been used historically. This labeling systemseems to
be confusing and also has overlap between grades. “A” was the safest, while “X” was
the most dangerous.
 The new Pregnancy and Lactation Labeling Rule (PLLR), established on June 30, 2015,
requires labels of prescription medications to have specific sections and categories
including:
o Pregnancy

 A Pregnancy Exposure Registry
 If there is a scientifically acceptable pregnancy exposure registry
for the drug, the following statement must appear: “There is a
pregnancy exposure registry that monitors pregnancy outcome in
women exposed to ____ during pregnancy.”
 Risk Summary – provides “risk statements” associated with drug use.
 Clinical considerations – provides information to inform prescribing and
risk-benefit counseling
 Data – human and animal data that provide the scientific basis for
information presented in the risk summary section.
o Lactation
o Female and Male Reproductive Potential (if necessary)
OTC agents are NOT included in the PLLR – still rely on ABCDX.
7. Provide general recommendationsto a pregnant patient
seeking recommendationsfor self-care
 Try nondrug therapy
 Always determine the trimester
 Take lowest recommended OTC dose
 Consider topical dosage form instead of systemic
 Use short acting agents, avoid long acting agents
 Avoid combination products
 Read the drug facts label closely
8. Provided general recommendationsto a patient seeking
recommendationsfor self-care while breast-feeding
 Drug properties that lead to a lower chance of transferring drug to the infant via
breastfeeding:
o Volume of Distribution: 1-20L/kg
o % of maternal protein binding >90%
o High molecular weight (>800Da)
o A more acidic pH
o A high-water solubility

 First consider nonpharmacological therapy
 If the OTC medication must be taken, take it immediately after nursing or before the
longest sleeping period
 Avoid long acting, maximum strength, or combination agents
 Counsel the mother to monitor the child for any adverse effects
Lecture 1.3 (Monasco)
1.Explain why the pediatric patient population is unique and
lists some examples of common OTC medication concerns
with this population
Similar to the geriatric population, pediatrics display variable pharmacodynamic and
pharmacokinetic (ADME) properties. They also have decreased ability to cope with illness or
drug side-effects. Pediatrics may have unique drug effects and or adverse reactions (e.g. a child
given Benadryl may become excited and hyper rather than drowsy).
There are major concerns regarding cough and cold products. Other common products used are
those that treat common ailments including fever, allergies, diarrhea/constipation, skin issues,
etc.
2. Discuss general considerations when recommendingOTC
products to pediatric patients
 Most pediatric doses are based on weight (mg/kg) or BSA
o Important to distinguish between mg/kg/day and mg/kg/dose – most common is
mg/kg/dose.
 Most OTC products include age-based dosing
 Liquid doses should be in mL and rounded to the nearest 0.1, 0.5 or 1mL.
3. List common indications for uses of OTC medications in
pediatric patients for both treatment and prevention
Treatments:
 Cough/Cold
 Fever

 Allergies
 Diarrhea/Constipation
 Gastroenteritis
 Skin/Dermatologic issues
Prevention/Health:
 Nutrition
 Multivitamins/Iron supplements
 Sunscreen
 Insect Repellant
4. List the various dosing errorsthat can occur while treating a
pediatric patient and provide recommendationsfor how to
increase safety
Dosing errors:
 Always include leading zero
 Never include trailing zero
 Using the wrong measuring device (Don’t use a spoon, always recommend use of device
provided with the medication)
 Poorly calibrated measuring devices (ie dosing cups)
 Low health literacy
How to increase safety:
 Never give two medicines at the same time that have the same active ingredient
 Only give the medicine that treats your child’s specific symptoms
 Never use an OTC med to sedate a child
 Never give aspirin to a child for cold/flu symptoms
 Don’t use OTC cough and cold medications for children <2 y/o, be cautious if <4 y/o
 Avoid combination products
 Think about nonpharmacologic therapies
5. Demonstrate the ability to calculate pediatric doses (weight
based) for common OTC medications
Got it

Lecture 1.4
1.Value the role the pharmacist plays in counseling the patient
on dietary and herbal supplements
I value it
2. Differentiate between drug and extract
 A drug is defined two ways:
o Usually the finished product that includes a defined active pharmaceutical
ingredient and various inert substances
o For herbal products, drug refers to the plant material that is used for extraction,
it is sometimes also referred to as raw plant material
 Before modern synthetic pharmacy, raw plant material was considered
the drug which was used for treatment after extraction.

 A drug extract usually contains a wide range of compounds; raw plant material (e.g. a
tea bag is just dried herbal material). The dosage or active ingredients may be
inconsistent.
o The extraction utilizes solvents to remove unwanted and inactive ingredients,
helping to concentrate desired compounds.
o The most common extraction process is liquid extraction.
3. Apply the calculations for the DER and extract
standardization
 The amount of active ingredient in the extraction may vary between batches depending
on harvest, environment or season. The use of a DER (the ratio of raw plant material to
final extract) helps establish consistency.
o DER = Amount of raw plant material/amount of final extract
 Standardization is a higher test of quality. It quantifies specific compounds in the final
extract that are regarded either as marker compounds or contribute to the activity of
the extract
 Standardization occurs after extraction when the compounds in the extract have been
quantified
 Standardization involves the dilution of an extract to meet or exceed the concentration
of specific marker or proposed active compounds

 The biomarker for standardization does not have to be the active ingredient
 Standardization indicates the amount of specific compound present, while DER
measures the ratio of raw plant material to the final product.
4. Explain the use of quality control and GMP in the
manufacture of herbal supplements
 Quality control is a process of ensuring the quality of the product at each step during
production
 Involves sampling and testing of raw materials, fillers, solvents, intermediate products,
and the final product
 Quality control helps control things such as pesticide residue or microbial
concentrations
 Quality control of the plant, extraction method, solvent, and extraction process should
be considered.
 GMP is not required for herbal products.
Module 1 Readings Study Guide
Intro to Self-Care readings:
1. List examples of why patients seek self-care and
nonprescription medications
Consumers are motivated and empowered by their ability to use self-care to manage their
health.
 They feel less dependent on physicians and want more control over their health care
 They appreciate the convenience of nonprescription medications
 Consumers report to trust nonprescription meds for themselves and their children
 They prefer using non-Rx vs Rx as a first line of therapy for certain minor ailments.
 High out-of-pocket health care costs and restricted access to providers
2.List common ailments which patients commonly self-treat
-Pain
-Cough
-Colds
-Acid reflux

-Upset stomach
3.Provide examples of components listed under the seven
pillars of self-care
The seven pillars of self-care are defined by the International Self-Care Foundation as:
1) Health literacy - includes the capacity of individuals to obtain, process and understand basic
health information.
2) Self-awareness of physical and mental condition - includes knowing one's BMI, cholesterol,
BP, and engaging in health screening
3) Physical activity - moderate intensity (walking, cycling, sports)
4) Healthy eating - balanced diet with appropriate caloric intake
5) Risk avoidance or mitigation - tobacco/alcohol cessation, vaccinations, safe sex, sunscreen
6) Good hygiene - washing hands, brushing teeth, washing food before consumption
7) Rational and responsible use of products, services, diagnostics and medications - includes
being aware of dangers, using responsibly when necessary.
4.Define health literacy and give examples of ways a patient
can demonstrate health literacy
Definition: the degree to which individuals have the capacity to obtain, process and understand
basic health information and services needed to make appropriate health decisions.
Health literacy can be demonstrated by:
1) Showing numeracy skills (i.e. understanding lab values, selecting proper dose medication,
reviewing medical bills)
2) Being able to fill out forms
3) Being able to locate physicians and services
4) Being able to discuss their health information and engaging in self-care
5. List the three categories of products available for self-
medication
1) Nonprescription medications (namely respiratory, oral care, GI, internal analgesic and eye
care products)
2) Dietary supplements (multivitamins, mineral products, vitamin D, vitamin V, calcium
products)
3) Complementary and integrative health therapies (yoga, chiropractic or osteopathic

manipulation, meditation, massage therapy)
6. Provide the two broad key elements pharmacistsmust
consider when providing self-care
1) The pharmacistmustensure the medication selected for use is the most efficacious,takinginto consideration
the patient’s uniqueneeds and factors such as diseases,currentmedication use,lifestyle,daily routine,personal
priorities and preferences,and desired outcome.
2)Ensuringthe patient’s safety by addressingmany of the concerns and possibleproblems tha tcan ariseto cause
the patient harm.
So choosingthe best medication and ensuringpatient safety.
Intro readings continued
1. List the 5 components of the PPCP
Collect, Assess, Plan, Implement, Follow-up
2. Provide key components of each section of the PPCP
-Specifically listthe three areas that can be included in the assess step when workingin the self-carepracticearea -
above
-Give examples of areas you can screen for preventative care
-Give examples of exclusionsfor self-care
-Providethe components that should be listed in the plan section of the PPCP
Key components:
1) Collect - Gather subjective and/or objective data. Include the CC, HPI, PMH, FH, SH, taking
BP, possible physical examination, etc. SCHOLAR-MAC.
2) Assess - can be broken down into three categories
 Medication Assessment
o Analyze each medication for appropriateness (indication), effectiveness, safety and
adherence (IESA)
o Identify the DTP (if any): unnecessary drug therapy, needs additional drug therapy,
ineffective drug, dosage too low, adverse drug reaction, dosage too high, and
adherence.
 Patient history/Risk Assessment

o Use patient's health, functional status, risk factors, health data, cultural factors,
health literacy and access to medications to influence your recommendation or care
decision
 Preventative Care Assessment
o Identify opportunities to educate patient to improve overall health or prevent future
problems
o E.g. if the pharmacist sees a patient is sunburnt, assess the need for sunburn
prevention counseling or if it is flu season, assess patient's influenza immunization
status.
 In summary, the pharmacist will assess the information collected and analyze the clinical
effects of the patient’s therapy in the context of the patient’s overall health goals in order
to identify and prioritize programs and achieve optimal care.
3)Plan - Will generally lead to:
1) a self-care recommendation (pharmacological, non-pharmacological, or
complementary/alternative
2) a reference to another health care provider or
3) a recommendation of self-care until another provider can be consulted.
 Should include a patient-centered recommendation that is pharmacologic or even non-
pharmacologic, goals of therapy (SMART), and patient engagement via education,
empowerment and self-management. Finally, the plan should include care continuity
through follow-up, referrals and transitions of care, and also a time frame in which the
outcome is expected to occur.
 Of all your recommendation options, choose your best option based on the patient’s
specific factors. Provide a rationale as to why this option was selected.
 The pharmacist has the responsibility of identifying exclusions for self-care in the assess
step; therefore, the plan may not include any pharmacologic or nonpharmacologic
recommendations. The plan may simply be referral to another health care provider.
4)Implement - The pharmacist implements the care plan in collaboration with other health care
professionals and the patient or caregiver.
5) Follow-up: Monitor and Evaluate
 Sometimes follow-up will not occur
Exclusions for self-care:
 Situations that lead to an assessment of "inappropriate for self-treatment."

 If the patient needs a prescription medication (and therefore requires a physician visit)
 If no drug therapy problem exists (I.e. they don't need a drug/medication, they need to
see a different type of health-care provider).
 Symptoms or characteristics are beyond the scope of self-treatment (e.g. patient presents
with headache for >10 days)
 Patient specific factors (age, pregnancy, etc)
 Previous treatment with non-prescription drugs was ineffective after an adequate trial
 If patient-specific factors preclude treatment with nonprescription medications (e.g. For
an 8y/o child with water-clogged ears, non-Rx therapy would not be indicated because
the child is <12y/o).
Readings for Special Populations and PPCP in Self-Care (pgs 24-29)
1. Provide physiologic changes that occur in older adults based
on pharmacokinetics
 Absorption – increased GI secretions and motility, decreased surface area and blood
flow, increased pH
 Distribution – decreased total body water and muscle mass, increased body fat
 Metabolism – Decreased hepatic blood flow and enzyme activity
 Elimination- Decreased renal/liver function
 Makes it difficult to accurately predict the pharmacokinetic profile of a specific drug in
older adults. The pharmacist must assume that these age-related changes have
occurred if they do not know for sure.
2. List other reasonsin which older adults can be vulnerable in
the healthcare setting
 They generally take more medications, increasing their risk for drug-drug interactions
 Generally have more chronic disorders
 They have alterations in senses
 Cognition and memory changes
 Misbeliefs that symptoms are just a part of the aging process
 Dysphagia
 Sensitivity to anticholinergic mediations that can cause blurred vision, decreased
salivation, etc.
3. Explain why it is vital to ask a pregnant patient what stage
of pregnancy she is currently in

Many medications have the ability to cross the placenta, so the medication can be exposed to
the fetus. Homeopathic and herbal remedies should be discouraged. Choose medications with
the shortest half-life and consider nonpharmacologic therapy options.
4. Describe what reliable resourcesare available to help
determine the safety of medications for women who are
currently lactating.
LactMed is a free database that is peer reviewed and available online and through application.
The database contains information on maternal and infant drug levels, effects on lactation and
breastfed infants, and alternative drugs to consider.
5. Illustrate ways to collect, assess, implement, and plan self-
care recommendationsfor pediatric patients
6. Give examples of medication administration strategies to
infants, toddlers, and preschool children
7. Describe an appropriate dosing device for oral
nonprescription liquids
8. Summarize the non-pharmacologic therapy for colds in
pediatric patients
9. Recognize the FDA’s stance on use of non-prescription
cough and cold products in children
Module 2 Lecture Objectives
Lecture 2.1

1. Describe the labeling requirementsfor dietary supplements
He asks the same question in lecture 2.3 (question 2)
2. Distinguish between dietary and herbal supplements,
cosmetics and drugs
Dietary/herbal supplements:
 Must be taken orally
 Are only intended to supplement the diet
 Are not treated as or regulated as drugs by the FDA
 Most commonly cited uses for DS are:
o To improve overall health
o To maintain health
 Most common DS used:
o Multivitamins
o Vitamin C
Cosmetics are products of which may be topically applied. Drugs define other routes of
administration such as IM, IV, etc.
3. Recognize and utilize appropriate literature sources for
evidence-based research on herbal supplements (PubMed,
Natural Standard, FDA).
When using PubMed, the search strategy should include the following:
 Supplement or ingredient name
 Clinical condition
 Results limited to clinical trials and reviews
The FDA dietary supplement website is useful for:
 Current status of dietary supplements
 Adverse event reporting
 Useful consumer tips
Natural Standard (Natural Medicine) is very comprehensive and has a quick interaction and
effectiveness checker that is useful in clinical practice.

4. Apply SCHOLAR-MAC when evaluating a patient for
supplement use (see case vignettes) and case study discussion
Engage with the patient about their reasons for using a dietary supplement. Do not discourage
use altogether, but suggest alternative supplements if interactions are known.
Lecture 2.2
Does not really need further elaboration on lecture objectives.
- Be comfortable with PPCP model
-Consider individual patient and understand why they wish to take supplements
-Do not discourage the use of any supplement, instead recommend supplements with EBM
data which do not interfere with medication
-Counsel patient on healthy lifestyle choices
-Remind patient to disclose all medications (including supplements and OTC) with HCP.
Medications used in this lecture:
Medication Uses Interactions/Effects/Other
Lovastatin Antihyperlipidemic
Niacin Antihyperlipidemic
Aspirin Headaches/Analgesia Increased bleeding risk
Omega-3 Antihyperlipidemic Minor interaction b/w fish
oil and aspirin
Digitalis Cardiac Insufficiency –
Antiarrhythmic
St. John’s Wort Seasonal Affective Disorder Do not take > 3mo
Passion Flower Mood/Anxiety/Nervousness Do not take > 3mo
Multivitamin General Health Only useful if there is a
deficiency
Creatinine Increase athletic
performance
Soy protein Build muscle
Enalapril HTN
Furosemide HTN
Metformin Diabetes Mellitus

Cinnamon Hyperglycemia - may help
lower blood glucose levels
- Moderate interaction with
metformin
- May influence absorption
of other drugs
Aloe Hyperglycemia - may help
lower blood glucose levels
- Moderate interaction with
metformin, furosemide and
enalapril
- May influence absorption
of other drugs
Green Tea Maintain cardiovascular
health
Antioxidant
Vitamin C Maintain cardiovascular
health
Antioxidant
Ginger Nausea, indigestion Interacts with blood thinners
(warfarin)
Zicam Cold and allergy Withdrawn from market due
to risk to sense of smell
Lecture 2.3
1. Define what constitutes an herbal and dietary supplement
As defined by the Dietary Supplement Health and Education Act (DSHEA):
A dietary supplement is a product (other than tobacco) intended to supplement the diet that
bears or contains one or more of the following ingredients:
 A Vitamin
 A mineral
 An herb or other botanical
 An amino acid
 A dietary substance for use by man to supplement the diet by increasing total
dietary intake or;
 A concentrate, metabolite, constituent, extract or combination of the above
The DS is not represented for use as a conventional food or as a sole item of a meal or
the diet and must be labeled as a dietary supplement. The DS must be taken orally.
A dietary supplement does include new drugs registered as biologics or antibiotics that
have been marketed as dietary supplements prior to approval – unless the Secretary has issued

a regulation on that product. In other words, a dietary supplement can contain FDA-approved
drugs (prior to approval as such) as long as no regulation prevents such use.
A dietary supplement does not include new drugs that were not marketed as dietary
supplements prior to approval and also does not include new drugs that are under
investigation.
2. Describe FDA labeling requirements for herbal supplements
and the laws that guide them (DSHEA and FSMA)
 A publication is not considered labeling if it presents a dietary supplement claimas an
independent, balanced view.
 Retailers can actually use books and other publications to facilitate the dietary
supplement sale and the claims.
 Burden of proof lies with the US (FDA) to prove that any article or publication is false or
misleading.
 So as long as the research is conducted independently, and is not directly linked to a
particular manufacturer/brand, and doesn’t promote it directly, then it is not defined as
labeling and can be freely used as a claim
Dietary supplements can claimstructure and function relationships (e.g. maintaining
general well-being. Maintaining cardiovascular health. Maintaining bone health. Supporting GI
health, etc). They cannot claimto treat, diagnose, cure or prevent anything. Rather, claims of
structure or function of maintaining or supporting something that is already there is allowed.
Claims regarding general well-being may also be made.
You can make deficiency disease claims for a vitamin where the DS may have a specific claim
that it makes (e.g. for vitamin D deficiency), but you cannot do that for an herbal supplement.
They must state the following: “This statement has not been evaluated by the Food and
Drug Administration. This product is not intended to diagnose, treat, cure or prevent any
disease.”
Food Safety Modernization Act (FSMA):
 Addresses two main things: Production and Processing
 Aims to impose stricter regulations and quality control and shift the burden to
manufacturers to prove that no contamination occurs.
 Promote preventative approach to reduce foodborne illnesses
 Production and processing facilities need to be inspected prior to manufacture of
products

 New Dietary Supplements have to be approved by the FDA prior to use (safety must be
shown by the manufacturer, a significant change to the DSHEA requirement). Older DS
grandfathered in.
3. Evaluate supplements based on labeling for quality and
safety
Safety of dietary supplements has to be proven by the FDA. If adulteration or safety issues are
suspected, the burden of proof lies on the U.S. government.
Manufacturers are not required to follow good manufacturing processes (GMP).
Evaluation of quality
 There is no unified system of quality evaluation for DS.
 The USP provided verification process, allows their label to be put on products.
Compares and tests the product against the standard.
 The NSF provides a GMP mark after accreditation – focuses on production quality.
 Consumer Labs establishes quality guidelines for specific supplements and then tests
available products against their standard. An independent certification.
 Natural Products Association (NPA) provides certification for personal care products
(only topical use). Similar GMP guidelines as NSF.
4. Recommend supplements based on labeling and
information provided
If they have the required FDA statements, don’t make any illegal or misleading
statements/claims, are certified by USP, NSF or Consumer Labs, if they provide drug amounts in
standardized form on the label, etc.
PC1 Module 2 Reading Objectives

1. Describe the federal funding agencies involved in CIM
(complementary integrative medicine) research (mainly the
NIH, NCCIH, and NCI).
 Within the NIH (National Institute of Health) is the Office of Alternative Medicine that,
like the others, aims to research and qualify the efficacy and safety of CIM.
 The mission of the NCCIH (National Center for Complementary and Integrative Health) is
to “define, through rigorous scientific investigation, the usefulness and safety of
complementary and integrative health interventions and their roles in improving health
and health care.”
o Classifies CIMtherapies into three broad categories
 Natural products (vitamins, minerals, probiotics, etc).
 Mind-body practices are taught and conducted by a trained practitioner
(chiropractic manipulation, acupuncture, guided imagery, hypnotherapy,
yoga, massage, etc).
 Other complementary health approaches including traditional healers,
energy therapies, Ayurveda, TCM, homeopathy and naturopathy.
 The NCI (National Cancer Institute) aims to increases the amount of high-quality cancer
research and information on the use of CIM.
o Established the Office of Cancer Complementary and Alternative Medicine
(OCCAM).
Issues these organizations have in obtaining efficacy and safety data:
 Many CIM studies are reported in foreign languages and in journals that are not peer
reviewed
 There is a lack of standardization in CIM (different techniques, dosages etc)
 Some providers of CIM do not need to be licensed or formally trained
 Experimental design is the most problematic issue
o Blinding and double blinding is difficult or impossible for some CIM methods.
 As far as implementation of CIM, many healthcare providers lack resources and training
to respond to patients’ CIM inquiries.
Complementary Integrative Medicine Vs Alternative Medicine
If a non-mainstream practice is used together with conventional medicine,
it’s considered “complementary.”
 If a non-mainstream practice is used in place of conventional medicine,
it’s considered “alternative.

 Complementary medicine is using a non-mainstream approach together with
conventional medicine
 Integrative medicine is defined as integrating nontraditional approaches into
conventional medicine.

2. Summarize the techniques used in homeopathy,
naturopathy, TCM (traditional Chinese medicine), massage,
Ayurveda, and chiropractic care.
Homeopathy:
 Based on the principle that “like cures like” or “law of similars.”
 The more dilute a homeopathic medicine, the greater its potency
 The efficacy of homeopathic medicines is believed to depend not only on
dilution factor, but also on vigorous shaking (succussion) which is
performed with each dilution.
 Substances are serially diluted and succussed – which is thought to
increase potency. This process is called attenuation or potentization
 A substance attenuated 4 times would be labeled as 4X, 4C or LM4.
Naturopathy:
 Encourages lifestyles and therapies as close to nature as possible.
 Employs natural forces such as light, heat, air, water and massage.
 Focus is on building health rather than curing disease.
 Based on six principles
o The body has the inherent ability to maintain and restore health
o The naturopathic HCP aims to identify and treat the cause rather
than the symptoms
o Methods designed to treat only symptoms may be harmful and
should be avoided or minimized
o The HCP treats the whole person – taking into account physical,
spiritual, mental and social aspects.
o The HCP educates and encourages patients to take responsibility
for their own health
o The HCP assesses risk factors and hereditary susceptibility to
disease and makes appropriate interventions to prevent further
patient harm

 Nutritional counseling and support are major components of
naturopathic treatments. Often implement dietetics, fasting and
nutritional supplementation.
 Trained in methods of therapeutic manipulation of bones, muscles, and
spine. HCP’s use ultrasound, acupuncture, etc.
 Provide natural childbirth care
 Some states allow minor outpatient surgeries such as repair of superficial
wound or removal of foreign bodies or cysts.
 Promote healing at the psychological level
 Some states allow prescribing of certain substances
` Traditional Chinese Medicine (TCM):
 Emphasizes herbal medicine
 Acupuncture may be used to support the herbal therapy
 The person is viewed as an ecosystemthat is embedded in the larger
ecosystem of nature and is therefore subject to the same laws.
 Nature and laws that govern the ongoing, harmonious flow of life energy
through the natural world also govern the body and health
 The life force called chi circulates through the body. Health is a function of
balanced, harmonious flow of chi and illness results when there is a blockage
or imbalance in the flow of chi.
 Yin and yang are composite and complementary qualities of life energy (chi).
Yin is regarded as feminine, yang masculine.
 Chi flows through body channels called meridians, that correspond to specific
organs/organ systems.
 Effectiveness remains debatable
 The body has five organ networks, each corresponding with a particular
element
Chiropractic Care:
 Focuses on relationship between spinal structure and body function
mediated by nervous system
 “Innate intelligence” flows through the body via the NS. The clearer the NS,
the most the innate intelligence can express itself to enliven the person’s
body and organs.
Ayurveda:
 Oldest systemof medicine
 Goal is to achieve optimal health on physical, psychological and spiritual
levels

 Relies on individual’s willingness to participate in lifestyle and behavior
changes
 Vital energy (prana) is the basis of all life and healing. Prana circulates
through the body and is governed by earth, air, fire, water and ether. Health
is a balance of the elements.
o Pairs of elements called doshas include vata (ether and air), pitta (fire
and water), kapha (earth and water).
 Regulation of diet is a central idea
 The thought there “there is nothing in the world that is not a medicine or
food.”
Massage:
 Goals is to help the body heal itself. Touch is fundamental.
 Therapists locate painful or tense areas and establish patient relationships
3. Critique each of the CIM techniques for their safety and
benefits
Homeopathy:
o Homeopathic remedies are regulated as drugs, but not evaluated for their safety
or effectiveness.
o Due to such dilute concentrations, studies have suggested that adverse effects
are less frequent with homeopathic use than in patients receiving conventional
care.
o Many argue that because concentrations are so dilute that any efficacy is due to
placebo.
Naturopathy:
o Safety depends on the treatment and the condition
o Naturopathic methods generally considered safer alternatives for some
conventional drugs or treatments
o Safety of methods such as fasting or other dietary restrictions are dependent
upon the individual.
Traditional Chinese Medicine (TCM):
o Adverse events with acupuncture, cupping, and moxibustion are rare
 Caution advised during pregnancy, frail or medically complex
patients.

o Cupping leaves temporary bruising of skin, moxibustion may leave temporary
discoloration.
o Chinese herbs may have adverse effects, contain heavy metals or toxins.
Chiropractic care:
o Spinal manipulation may be associated with mild-moderate adverse effects
o Potentially strong placebo effect; high rate of spontaneous recovery
o Treatment for some conditions, like ear infections, have little clinical evidence
o Chiropractors have traditionally discouraged use of vaccinations
o Avoid in patients with anticoagulant therapy, vascular insufficiency, aneurysms,
arteritis, unstable spondylolisthesis, or osteoporosis
Ayurveda:
o Potential toxicity of herbs
o Lack of standardization
o Heavy metal contamination of herbs/medicines
Massage:
o Fractures, discomfort, bruising, swelling of massaged tissues, liver hematoma.
o Avoid in bleeding patients, peripheral vascular disease, antithrombotic therapy
patients.
o Allergies to oils used.
4. Recommend when a CIM may be appropriate for a patient

*acupressure is massage stimulation at acupuncture points
Module 3 Reading Objectives
1. Identify the therapeutic uses for each of the supplements
Ginkgo:
 Alzheimer’s disease
 Vascular dementia
 ADHD
 Tardive dyskinesia
 Intermittent claudication
 Tinnitus
 Acute mountain sickness
 Age-related macular degeneration
Kava:
 Mild anxiety and sleep disturbances
Valerian:
 Alleviation of insomnia and anxiety
Red Yeast Rice:
 Used to lower lipid concentrations
Cinnamon:
 Used to help to lower blood glucose
Fish Oil:
 Used to lower triglyceride levels
 Used to improve cardiac health
 Aid in treatment of depression
 Relieve anti-inflammatory conditions such as RA/psioriasis

Saw Palmetto:
 Used to treat benign prostate hyperplasia
Chasteberry:
 Used to treat PMS, pre-menstrual dysphoric disorder (PMDD), dysmenorrhea,
mastalgia, and menopausal symptoms, and hyperprolactinemia
Black Cohosh:
 Treat symptoms of premenstrual syndrome, dysmenorrhea, menopause
 Treat symptoms of RA
2. Recall the clinical evidence for each of the supplements and
how this will affect your patient counseling recommendations.
Ginkgo:
 While some evidence shows Ginkgo leaf extract is modestly effective in
improving symptoms of Alzheimer’s (in both cognitive and social function), a
summary of the evidence concludes that Ginkgo is not associated with a
decreased risk of developing dementia or prevent the disease progression in
Alzheimer’s.
Kava:
 The majority of evidence shows that Kava is effective in treating anxiety.
However, the differences in the Hamilton Anxiety scores showed no significant
differences. Women and younger patients showed the most improvement. Kava
is possibly safe, but many cases of liver failure and toxicity have been associated
with its use. The cause is unclear, and some countries have restricted its use.
“Until further data that identify the cause of liver injuries are available, patients
should avoid taking Kava.”
Valerian:

 Subjective improvements were reported for insomnia, although overall
effectiveness could not be assessed.
 Because Valerian is generally well tolerated, I would recommend for patients not
taking other CNS depressants or are not pregnant/becoming pregnant
Red Yeast Rice:
 RYR has been shown to be equally effective in reducing cholesterol as statins,
but RYR has no effect on increasing HDL and so statins should be preferred over
RYR in patients with cardiac risk.
 Some RYR products are illegal in the U.S. due to an “unauthorized drug.” For
current RYR products still on the market, it may be hard to find an effective or
high-quality product.
 If a patient “doesn’t take chemicals” and wants a “natural” drug, education on
the source of lovastatin and the fact that RYR products may contain the
nephrotoxin monascidin A (citrinin) may be effective.
Cinnamon:
 Overall, the evidence indicates that the effect of cinnamon on fasting plasma
glucose or hemoglobin A1C is small. The favorable safety profile suggest that
cinnamon could be considered for adjunctive therapy in some patients,
especially those attempting to control blood sugar through lifestyle changes.
Fish Oil:
 Effective for reducing TG levels and increasing omega-3 intake.
 When recommending fish oil, choose a product where the EPA + DHA are similar
in weight to the amount of fish oil stated (E.g. if a gel has 1g fish oil with 480mg
EPA and 370g DHA, 480+370=850, close to 1g).
 Krill oil may be better absorbed vs. fish oil and although similar effects have been
shown in studies, human clinical trials need to be conducted before a
recommendation can be made. Krill oil is more expensive.
 “Patients who are interested in fish oil specifically for reduction of general
cardiovascular risk should be counseled that the potential benefit may be low
and may be affected by many factors, including concomitant statin therapy.”
Saw Palmetto:
 Saw Palmetto is not effective for BPH symptoms/evidence does not support its
use.

Chaste berry:
 May be effective in PMS, PMDD and latent hyperprolactinemia.
Black Cohosh:
 Efficacy is pretty mixed. Analysis of studies suggests no significant difference was
made vs. placebo for menopausal scores or hot flushes.
3. Explain the mechanism of action/physiological activity of
each supplement. Based on this, conclude if there is a
potential for a pharmacokinetic* or pharmacodynamic*
interaction.
*PK drug-drug interactions occur at the level of absorption/distribution, elimination, and metabolism (e.g.drugs
that cause changes in gastric emptying/motility [cinnamon]). Basically, modifications in concentrations of the drugs.
*PD drug-drug interactions occur when a drug directly influences another drug’s effects (e.g. two sedatives can
potentiate each other’s effects).Modifications of effects.
Ginkgo:
 The ginkgolides (A, B, C and M) and bilobalides in Ginkgo may be responsible for
the supplement’s neuroprotective properties. Ginkgolide B is a potent platelet-
activating factor antagonist.
 Bioflavonoids and flavone glycosides such as quercetin and kaempferol may have
antioxidant properties, helping to eliminate reactive oxygen species.
Kava:
 Binding of kavalactones to the GABA-A receptor at different sites than
benzodiazepines allow enhanced binding of GABA to the receptor.
 Also binds and blocks sodium and calcium ion channels and NMDA receptors,
thereby inhibiting excitatory transmission. Pharmacodynamic interactions.
Valerian:
 Constituents of the volatile oils (valerenal and valtrate) may cause the CNS
effects.
 Valeric acid and others likely interact with GABA receptors, producing sedation.
 Interaction with GABA receptors may produce barbiturate-like CNS
depressant effects. A pharmacodynamic interaction.
Red Yeast Rice:

 Monacolin K (lovastatin analogue) and increased bile acid excretion are thought
to be responsible for lowering lipid concentrations.
Cinnamon:
 Proanthocyanidin and cinnamtannin B1 (a polyphenol) are involved in
autophosphorylation of the insulin receptor, thereby increasing insulin
sensitivity.
 Cinnamaldehyde (essential oil) increases cellular glucose uptake by stimulating
GLUT-1 and GLUT-4 receptors.
 Activation of PPAR-alpha and PPAR-gamma, and display inhibition of amylase or
sucrose.
 Cinnamon inhibits inactivation of insulin receptors by tyrosine phosphatase
 Whole cinnamon may delay gastric emptying.
 Anti-inflammatory actions occur through changes in multiple cytokines.
Fish Oil:
 Omega-3 fatty acids may decrease intestinal cholesterol absorption and inhibit
enzymes involved in synthesis, excretion and degradation of VLDLs, thus
decreasing LDLs.
 May also help improve glucose concentrations and insulin resistance
 EPA and DHA in fish oil influences cytokine production by competitively
inhibiting arachidonic acid.
o This would also decrease thromboxane A2 production, increase risk for
bleeding.
 Plaque inflammation is decreased through mediators, resolvins, and protectins –
derived solely from omega-3 fatty acids
Saw Palmetto:
 Lipophilic compounds in the extract inhibit 5-alpha-reudctase and cytosolic
androgen receptor binding -> thus testosterone cannot convert to DHT, which is
thought to promote prostate growth.
 Anti-inflammatory/antiestrogenic effects on the prostate
Chaste berry:
 Fruits contain essential oils, diterpenes, glycosides, and flavonoids.
 The dopaminergic diterpenes bind to D2 receptors, suppressing prolactin
release. This may be responsible for its effects on menstrual regulation.
 May have weak estrogenic activity
Black Cohosh:
 Active components are triterpene glycosides: acetein, cimicifugoside, 27-
deoxyacetin. These may reduce release of catecholamines via antagonism of
nicotinic acetylcholine receptors.

 May act as a partial serotonin agonist
 Probably does not exhibit estrogenic activity and has no effect on vaginal
epithelium, endometrium, or hormone concentrations.
4. Devise a treatment plan based on the clinical evidence and
safety considerations provided with each monograph.
Ginkgo:
Treatment Plan
 Recommended dosages for dementia, intermittent claudication, and ADHD
range between 120-240 mg/day divided into 2-3 doses with extract
specifications of 24% ginkgo flavone glycosides and 6% terpenoids.
Safety Considerations
 Ginkgo may cause mild GI effects, headache, dizziness and allergic skin reactions.
 Avoid during pregnancy and lactation
 There is an increased risk of bleeding, esp. in concurrent antithrombotic use.
 Stop concurrent usage 7-10 days before surgery
Kava:
Treatment Plan
 For anxiety, 60-120mg/day or 1.5-3g dried root per day in 1-3 doses, with the
standardized extract containing 30-70% kavalactones. Expect anxiolytic effects to
develop over a week.
 Kava is possibly safe, but many cases of liver failure and toxicity have been
associated with its use. The cause is unclear, and some countries have restricted
its use. “Until further data that identify the cause of liver injuries are available,
patients should avoid taking Kava.”
Valerian:
Treatment Plan

 For insomnia, take 400-900mg valerian root extract 30-120minutes before
bedtime (lecture says 270mg-900mg). The patient may prepare teas, but often
they have an unpleasant taste and smell due to the valerenic acid.
 Generally well-tolerated. Benzodiazepine-like withdrawal symptoms have been
reported after discontinuation and if high doses are taken, daytime sedation may
occur.
 Do not take concomitantly with other CNS depressants, as the effects can be
potentiated (increased).
 Contraindicated in pregnancy due to induction of uterine contractions
Red Yeast Rice:
Treatment Plan
 For hyperlipidemia, take 1.2-2.4g/day in 2 doses. Lecture says 1.5-2.5
 RYR is illegal in the U.S. due to an “unauthorized drug.” For current RYR products
still on the market, it may be hard to find an effective or high-quality product.
 Allergic reactions, headache, mild GI symptoms including boating, heartburn and
flatulence.
 May cause increased liver enzymes – monitoring recommended
 Not recommended in patients with heavy alcohol use (>2drinks/day), due to
potential hepatotoxicity.
 Contraindicated in pregnancy or patients with CKD
 Extracts may contain the nephrotoxin citrinin. GMPs are crucial.
 Risk of rhabdomyolysis.
 Do not take with other statins
Cinnamon:
Treatment Plan
 For hyperglycemia/reducing blood sugar, 0.5-1g/day for aqueous extract, 2-6g in
divided doses for dry/ground cinnamon, and 80mg for alcoholic extract.
 Be sure the patient doesn’t confuse cinnamon supplements with cinnamon oil, as
hypersensitivity/poisoning with oil can occur.
 Coumarins in cinnamon can be hepatotoxic
 Potentiation of hypoglycemic reactions in patients already taking
antihyperglycemic medications

 Otherwise, relatively safe.
Fish Oil:
Treatment Plan
 For hyperlipidemia, 2-4g/ day in divided doses, with an EPA:DHA ratio of 1.2-1.5
to 1.
 Increased risk of bleeding -> patients taking antithrombotic agents should use no
more than 3g/day.
 Generally safe otherwise. Enteric coating preferred to avoid fish burps.
Saw Palmetto:
Treatment Plan
 160mg twice daily or 320mg/day with the extract containing 80-95%
standardized fatty acids.
 Not shown to be effective for BPH or UTI’s.
 Mild GI complaints, fatigue, headache
 Avoid with patients taking antithrombotic agents
 Avoid if taking androgenic drugs/HRT/contraceptives
 Highly contraindicated in pregnancy and lactation
Chaste berry:
Treatment Plan
 1.6-4.2mg/day for commercial extract or 30-40mg of dried fruit extract/day,
standardized to 0.11-0.18% casticin (a flavonoid)
 GI complaints, dry mouth, headache, rashes, itching, acne, menstrual disorders,
agitation.
 Avoid during pregnancy and lactation
 Avoid in men
 May interfere with dopamine therapies, HRT, or contraceptive medications.
Black Cohosh:
Treatment Plan
 40mg-80/day in 1-2 doses, with the extract standardized to 1mg of triterpene
glycosides (27-deoxyactein) per 20mg extract tablet.

 GI complaints, headache, weight gain.
 Case reports of acute hepatitis, potential hepatotoxicity
 Should not be used longer than 6 months
 Possible additive effect with tamoxifen
 Avoid in pregnancy or lactation due to its potential hormonal effects
Module 4.1 Lecture Objectives
1. Recall the clinical uses for the supplements discussed in this
lecture.
 Ginseng
o American (Panax Ginseng):
 Mainly used to support immune system functions and prevent repeated
cold infections
 May reduce risk of respiratory tract infections in immunocompromised
patients
 Most commonly used version
 Not beneficial in preventing cold infections or shortening an already
existing cold
o Siberian (Korean) (Eleutherococcus senticosus):
 When used in combination with andrographis, may reduce
symptoms/severity and shorten duration of symptoms of the common
cold
 Echinacea
o All three species mostly associated with prevention of the common cold as there
is less data available for treatment
o Has anti-inflammatory effect after IV administration (obviously not a DS then)
o Only use short-term in children and during pregnancy due to limited evidence of
safety, and it also may lose its effectiveness over time
 Elderberry
o Treatment of influenza
o Potential immune system activation
o Anti-hepatotoxic

 Green Tea
o Ergogenic (enhance stamina/performance/recovery)
o Neuroprotective
o Nootropic effects (enhance cognition)
o Cardiovascular protection
o Antimicrobial
o Prevention of cold/flu in patients who consume green tea/extracts frequently
 Vitamin C (ascorbic acid)
o May reduce cold duration, but studies mixed
o Need higher doses (more than 2g/day)
 But that may cause adverse effects such as development of kidney stones
and GI upset
o NO relationship between vitamin C supplementation and reduced sick of
developing/contracting cold in adults or children
o Only oral is a DS. Obviously, the IV version is FDA approved.
 Zinc
o May reduce severity and duration of common cold IF taken right at symptom
onset and every 2 hours thereafter
2. Illustrate the proposed mechanism(s)of action for each
supplement and the active ingredient(s) that may be used for
standardization of extracts
 Ginseng
o MOA: Isn’t directly stated
o AI:
 American:
 Active component is likely triterpenoid saponins, including
ginsenosids (also referred to as panaxosides).
 Siberian (Korean):
 Eleutherosides
o Standardizations:
 American:
 3-5% ginsenosides
 Siberian (Korean):
 0.1-0.3% eleutherosides
 Short term use in adults for up to 10 days in doses of 100mg-3,000mg per
day are regarded as safe.
 Lower doses (up to 30mg) has been used short-term in children ages 3-17
without any significant adverse effects

 Echinacea
o MOA:
 Inhibits hyaluronidase
 Inhibition of prostaglandin E2 synthesis through inhibition of COX-2
 Effect mediated through echinacosides and considered the
strongest effect
 Root extracts may exhibit antiviral/antifungal properties
 Leaf and Aerial parts exhibit immunomodulatory effects

o AI:
 Technically, no active ingredients have been identified. But for
reference…
 Echinacosides (present in the leaves)
 Alkamides (present in the roots)
 Polysaccharides (present in both leaves and roots)
o Standardizations:
 Because no active ingredients have been identified, standardization may
not be linked with effectiveness
 Roots or herbs of E. purpurea are used
 Herb of E. angustifolia or E. pallida are used
 Most common standardization of root extracts are to the alkamides and
polysaccharides
 Most common standardization of the above-ground extracts are to
echinacosides or complex polysaccharides
 Aerial parts of E. purpurea should be used, standardized to 3.5%
echinacosides, 900mg/day in 3 doses
 Liquid hydroalcoholic extracts used as well; 5mL 2-6 times daily for
treatment or prevention (mostly prevention)
 Elderberry
o MOA:
 Prevents hemagglutination of viral particles for influenza A/B strains
 Reduces HIV/Herpes virus replication by stimulating antigen production
 However, both of these have only been shown in in-vitro studies
and therefore should not be used as an antiviral for HIV/herpes
o AI:
 Anthocyanins
 Sambunigrin (toxic cyanogenic glycoside, should not be part of the
extract)
 Plant lectins (responsible for hemagglutination)
 Plant lectins similar to ricin, which also causes hemagglutination.
o Standardizations:

 No well-established dose range, most preparations contain 150-150mg
anthocyanins or flavonoids, daily doses range from 400mg-2g dried berry
extract
 Mainly berries used
 Green Tea
o MOA:
 Caffeine responsible for stimulant/nootropic effects
 L-theanine responsible for calming/anxiolytic effects via action on
GABA-a receptors
 Epigallocatechin-gallate (EGCG) for strong antioxidant/antiviral effect
o AI:
o Standardizations:
 Pure caffeine taken in doses of 100-200mg, no more than 500mg/day
 Polyphenol-rich extracts may contain up to 800mg of (EGCG)
I’ll just leaveallthis info here:
 Zinc
o Upper limit of intake is 40mg
o Only take the recommended number of lozenges per day (they very between 9-
34mg)
o High doses may lead to copper deficiency
o Do not exceed more than 6 lozenges/day in adults, 4 in children
o Short-term use is safe, possible C/N/V
o Loss of smell from ZICAM product.
3. Differentiate between different extracts from Echinacea
and their respective composition and effectiveness
All are a part of the Asteraceae family
Echinacea pallida – uses the herb
Echinacea angustifolia – uses the herb
Echinacea purpurea – uses the root or herb, but the herb should be used in extracts
Due to the different extracts, effectiveness varies.
Most clinical trials have reported no greater reduction in duration and incidence of the
common cold than patients taking placebo.

4. Identify both supplement and FDA approved indications for
green tea extracts and know the names of FDA approved
medications
Veregen and Polyphenon E are Rx-only, FDA approved for genital warts.
They are a special form of sinecatechins, which contain EGCG.
5. Recognize the major and moderate drug interactions for
each of the supplements.
Ginseng
 Moderate with CNS active drugs (alcohol, benzodiazepines)
 Moderate in MAOI’s
 Moderate in Antihypertensives (may counteract them due to stimulatory effect)
 MAJOR in patients taking warfarin
 CONTRAINDICATED in pregnancy due to potential teratogenic effects
Echinacea
 Moderate interactions with caffeine, CYP 1A2 substrates, CYP3A4 substrates
 Moderate interactions with immunosuppressants
 Should not be given intravenously due to potential allergic reactions and
leukopenia (from its immunosuppressant effects)

 Avoid in chemotherapeutic drugs and immunosuppressant drugs
 Adverse effects rare – mild GI upset that resolves after initial use
 Counsel patients on prior use of chamomile or calendula because these are in
the same family (Asteraceae) of echinacea, and may have allergies.
 NOT contraindicated in pregnancy/lactation
Elderberry
 Moderate interactions with immunosuppressants
Green Tea
 Moderate with things like barbiturates, anticoagulants, fluvoxamine, ginger, ginkgo,
ginseng, lithium, MAOI’s, verapamil, theophylline, phenylpropanolamine, alcohol
 MAJOR with ephedra
 Interactions are mostly due to caffeine, especially diuretics and antihypertensives
(caffeine would counteract the antihypertensive drug)

Module 4.1 reading objectives
1. Identify the therapeutic uses for each of the supplements
Echinacea
 Used to prevent or treat colds and other respiratory infections
o Mostly PREVENT
Elderberry
 Juices/extracts are used primarily for prevention or treatment of flu and other
URI’s
Eleuthero (Siberian Ginseng)
 Used as an adaptogen for improvement of athletic performance, chronic stress,
upper respiratory conditions, and immune deficiency
 Other uses include treatment of herpes Type 2 infections, blood pressure,
prevention of atherosclerosis and diabetes
Panax Ginseng (Asian Ginseng)
Used to improve:
 Mental and physical stress
 Anemia
 Diabetes
 Immune response
 Insomnia
 Impotence
 Cancer prevention
Green Tea
 Considered a performance enhancer because of stimulatory caffeine effects
 Used to prevent cardiovascular disease, cancer and liver disorders
2. Recall the clinical evidence for each of the supplements and
how this will affect your patient counseling recommendations.
Echinacea
 Effective for prevention; may reduce risk of developing a recurrent cold by 35%
 Effectiveness of treatment is best when administered at the first sign of
symptoms.
 May have immunostimulatory effects

Elderberry
 A study found that Elderberry reduced duration of fever during an outbreak of
influenza B
 A study found that during an influenza A epidemic, patients improved up to 50%
faster than placebo when using a VAS (visual analog scale) to assess symptom
improvement
 Combination echinacea and elderberry hot drink was comparable to oseltamivir
in patients with influenza at day 5 and day 10, with significantly greater recovery
at day 10 than the oseltamivir group.
 Elderberry extracts may be an appropriate option for individual patients
 May shorten symptoms of the common cold when used in combination with
andrographis
 Improved performance, mental fatigue, and alertness when combined with
professional stress management.
 Beneficial effect on the frequency, severity and duration of herpes simplex type 2
infections
Panax Ginseng (Asian [American] Ginseng)
 Lack of an effect on blood glucose/A1C/2-hour postprandial glucose in type 2
diabetics
o But another study found improvement in fasting glucose (but NOT in
hemoglobin A1C values or insulin resistance)
 Possible benefit for ED
 Evidence does not support use for cognition/quality of life
 A study identified that patients with AD did not benefit from its use
Green Tea
 Studies have shown that daily consumption may protect against cardiovascular and
metabolic diseases
 May help reduce TC and LDL, and (to a much smaller extent) SBP
 Systematic review stated that green tea was not useful for weight loss or weight
maintenance in obese patients.
 Lack of quality evidence supporting reduction in breast, prostate, lung, bladder,
ovarian, digestive and oral cancers.

3. Explain the mechanism of action/physiological activity of
each supplement and how this will affect your patient
counseling and recommendations
Echinacea
 Increases cytokine secretion, lymphocyte activity, and phagocytosis.
 Direct inactivation of viruses, bacteria, and fungi have been observed
 Anti-inflammatory activity and decreases in mucin production are likely
responsible for decreased symptoms of upper respiratory infections
 Some of the immunostimulatory activity of echinacea is caused by the LPS and
xanthienopyran from the endophytic bacteria that live within the plant. The
activity is lost when extracts from plants grown from sterilized seeds are used.
 The bacterial load may vary between plants, and the extraction processes may
affect the content of these components, which may explain the varied results
from chemical trials
Elderberry
 Inhibition of replication of viruses, increased production of anti-inflammatory and
inflammatory cytokines, increased viral antibodies
 Inhibition of hemagglutination of the influenza virus, preventing entry into cells
 Has strong antioxidant capacity
 Liquid extracts have inhibited growth of several gram negative and positive bacteria
 The active compounds, derived from the root and leaf, are referred to as
eleutherosides (subtypes A and M).
 Other compounds include hydroxycinnamates, flavonoids, sesamin, isofraxidin, B-
sitosterol and hederasponin B
 Animal and in-vitro studies suggest these compounds have antiplatelet,
immunostimulant and antioxidant properties.
 Active component is likely triterpenoid saponins, including ginsenosids (also referred
to as panaxosides.
Green Tea
 Active ingredients include caffeine and flavanols such as epigallocatecin-gallate
(EGCG)
 EGCG shown to have antioxidant and antitumor effects.
 Catechins (polyphenolic compounds) and caffeine may contribute to weight loss.

4. Devise a treatment plan based on the clinical evidence and
safety considerations provided with each monograph.
Echinacea
Treatment Plan
 Many “echinacea” products may be chemically different plants or plant parts
due to the various species and various parts of the plant used in extracts.
 Many echinacea products in the US are less concentrated or labeled for use
at a lower dose than used in trials and may be ineffective if used as directed.
 There are many formulations available, each with different doses. Teas,
extracts, juices, throat sprays, capsules, tablets, etc. are examples.
 For greatest efficacy, all formulations must be taken at first sign of illness.
 Contraindicated in patients with allergies to the Asteraceae
o Ragweed, chrysanthemums, chamomile, calendula = contraindicated
 May cause mild GI discomfort, tingling sensation of the tongue with liquid
preparations, and headache
 AVOID in patients with severe systemic illnesses such as HIV or AIDS, mulsiple
sclerosis, tuberculosis, and autoimmune disorders.
 AVOID in patients taking immunosuppressants
Elderberry
Treatment Plan
 No well-established dose range
 Extracts mostly contain 100-150mg anthocyanins
 Doses from clinical trials range from 400mg – 2g dried berry extract
 Most commercial extracts are well-tolerated.
 May contain cyanogenic glycosides (Sambunigrin), which are metabolized in
the GI tract to cyanide.
o There have been reports of N/V, dizziness, weakness and stupor with
home-prepared juices and extracts. Possibly from using unripe
berries, stems, or leaves that have been insufficiently cooked.

Treatment Plan
 Commercial products often standardized to eleutheroside B or E
 Dosage of 300-400mg/day
 DISCONTINUE after 2 months of daily use for a period of at least 2 weeks
 Drowsiness and stimulant effects have been reported with eleuthero.
 AVOID in patients with hypertension/taking antihypertensives
 Do NOT use in pregnancy/lactation
 May interfere with digoxin assays because of structural likeness for its
glycosides
 Monitor diabetic patients for hypoglycemia
Treatment Plan
 Standardized to 3-5% ginsenosides at 200mg/day in divided doses
 Decoctions and tea preparations are common
 Do NOT use in pregnancy/lactation (teratogenic effects)
 Adverse effects include insomnia, headache, BP changes, anorexia, rash,
gastralgia, and menstrual abnormalities
 Use in caution with patients who have cardiovascular disease, diabetes or
acute illness
 Prolonged use not recommended
 Interactions (moderate) with antidiabetic drugs, antihypertensives, and
MAOI’s
o May counteract antihypertensive drugs (due to a possible stimulatory
effect)
 Interactions (major) with warfarin)
Green Tea
Treatment Plan
 3-5 cups daily, or up to 1200mL/day with a minimum 250mg/day of catechins
 Pure caffeine is taken in doses of 100-200mg, but nore more than
500mg/day
 Polyphenol-rich extracts may contain up to 800mg of EGCG
 Can cause CNS and cardiac stimulation because of the caffeine content
 Avoid of other stimulating drugs are ingested
 Tea extracts have been associated with liver toxicity

 Use cautiously during pregnancy and lactation because of caffeine
consumption and potential folic acid concerns
 May antagonize warfarin because of small amounts of vitamin K.
Module 4.3 (Cough and Cold) lecture objectives
1) Describe the clinical presentation of cold, cough, and flu
Usually cough is the last symptom to go away
Usually fever is the first symptom that goes away
Cold usually lasts 7-10 days

Cough usually due to post-nasal drainage due to sputum production, and sore throat is usually
due to drainage causing inflammation
2) Choose when to treat and refer (exclusioncriteria)
Exclusion criteria:
1. Fever >100.4 (38C, oral)
2. Chest pain/SOB
3. AIDS or chronic immunosuppressant therapy
4. Underlying heart or lung disease
5. Frail patients of advanced age
6. Infants ≤ 3mo
7. Hypersensitivity to recommended OTC meds
8. A cough with thick, yellow sputum or green phlegm or foreign object aspiration
3) Summarize the general treatment approach to cold,
cough and flu
The goals for treatment are to:
 Reduce symptom frequency
 Reduce symptom severity
 Prevent spread
 Refer when necessary
When forming a plan for treatment, we should keep the following in mind:
 Use single-entity products to target specific symptoms
 May consider combo products
o Pros:
 Can increase compliance
 Can reduce cost
 Can decrease product burden
o Cons:
 Can expose patient to unnecessary medication
 Can diminish effectiveness of certain medications (for example, Mucinex
DM has dextromethorphan and guaifenesin in it. Ideally, you should take
these at separate times because together the effectiveness of both is
reduced. Guaifenesin is supposed to make cough more productive,
dextromethorphan is supposed to suppress cough. They counteract each
other).

4) Discuss the pharmacological options available for
self-care of cough, cold and flu
Symptoms Medication Examples
Congestion Decongestants or ICS Decongestants:
 Pseudoephedrine
 Oxymetazoline
ICS:
 Fluticasone prop.
 Budesonide
Runny nose/sneezing Antihistamines, ICS, MCS +
decongestant for best relief
Antihistamines:
 Loratadine
 Diphenhydramine
(best for pregnancy)
MCS:
 Cromolyn Sodium
(NasalCrom)
Fever Antipyretics APAP/Ibuprofen
Sore throat NSAIDs/APAP/Benzocaine
Cough Antitussives/Expectorants Productive cough
expectorants:
 Guaifenesin
 Mucinex
Non-productive, dry cough
antitussives:
 Dextromethorphan
 Codeine

 Diphenhydramine (an
antihistamine with
magical powers)
5) Choose appropriate pharmacological and non-
pharmacological recommendations to manage
symptoms based on patient factors
Symptoms Therapy
Congestion Neti-Pot/VapoRub (menthol)
Runny nose/sneezing Idk? Lmk
Cough Humidifier/Vaporizer
Dark honey
Fever Idk? Lmk
Sore throat Salt water gargle
6) Apply the PPCP to a patient case
Lol
Module 4.3 (Cough and Cold) Reading objectives
1. List common causes of colds, including most
common cause.
Most common cause of colds: Rhinovirus
2. List factors that increase susceptibilityto
colds.
 The season (season is from late August through early April)
 Weakened immune systems from smoking
 A sedentary lifestyle
 Less diverse social networks
 Chronic (>1mo) psychological stress
 Sleep deprivation

3. Describeclinical presentation of colds
1) Sore throat is the first symptom, followed by nasal symptoms 2-3 days later
 Nasal symptoms may be clear, thin and watery
o As cold progresses, becomes thick yellow/green
2) Cough develops in 30% of patients by day 4-5
Physical assessment may show:
 Sore throat, nasal congestion, sneezing, chills, headache, rhinorrhea
 Slightly red pharynx with evidence of postnasal drip
 Nasal obstruction
 Tender sinuses on palpation
 Rarely is oral temperature above 100.4F (38C) or rectal/tympanic temp
above 100.9F (38.3C)
 Symptoms persist for 7-14 days.
4. List possible complications from colds.
Most people do not experience complications. However, some complications include:
 Sinusitis
 Middle ear infections
 Bronchitis
 Pneumonia
 Exacerbation of asthma/COPD
5. List goals of therapy for treating colds.
 Cold cannot be cured.
o Reduce bothersome symptoms
o Prevent transmission of cold virus to other people
6. List exclusionsfor self-treatment of colds.
 Fever >100.4F (38C, oral)
 Chest pain
 SOB

 Worsening of symptoms or development of additional symptoms during self-
treatment
 Concurrent underlying chronic cardiopulmonary diseases (e.g. uncontrolled
asthma, COPD, CHF)
 AIDS or chronic immunosuppressant therapy
 Frail patients/advanced age
 Infants 3 years or younger
 Hypersensitivity to recommended OTC meds
7. Describegeneral treatment approach to colds.
Mainstay of treatment is nonpharmacologic therapy
 Increased fluid intake
 Adequate rest
 Nutritious diet
 Increased humidification with steamy showers
 Vaporizers or humidifiers
o Vaporizers superheat water to produce steam and can accommodate
medications such as Vicks Vapo Steam
o Humidifiers use fans or ultrasonic technology to produce a cool mist and
cannot accommodate for additives
 Saline nasal sprays or drops
o Moisten irritated mucosal membranes and loosen encrusted mucus
 Salt gargles
o Ease sore throats, natural anti-inflammatory, has an osmotic effect to draw
out mucous.
 Upright positioning
o Especially important for infants because children cannot blow their nose
until about 4 years of age
8. Explain the roll of antibiotics in treating colds.
They don’t play a role; cold is caused from viruses.
9. Describe non pharmacologic treatment options for
colds (including Vicks VapoRub and hand sanitizers).
 Vicks VapoRub contains camphor, a natural decongestant. Can also help sooth be
a cough suppressant if applied directly to throat.
 Hand sanitizers prevent transmission of the virus

 Alcohol-based preferred, but short acting
10. Describe pharmacologictreatment options
for colds
 Decongestants
o Treat sinus and nasal congestion
o Are adrenergic agonists that constrict blood vessels, helping to
reduce mucus buildup and sinus engorgement
o Three types of decongestants
 Direct-acting (oxymetazoline) bind directly to the adrenergic
receptor
 Indirect-acting
 Mixed (pseudoephedrine) have both indirect and direct activity
o May exacerbate diseases sensitive to adrenergic stimulation, such
as HTN, heart diseases, diabetes, hyperthyroidism, prostatic
hypertrophy, or elevated intraocular pressure
o Should not be taken with MAOI’s, SSRI or SNRI’s, ergot derivatives,
or antibiotics like linezolid.
 Antihistamines
o Greatest benefit if started on day 1 or 2 of cold onset
o Info is in allergic rhinitis section
 Local anesthetics
o Benzocaine for sore throat
 Systemic anesthetics
o Aspirin, acetaminophen, ibuprofen, naproxen are effective for
aches/fevers associated with colds
o Don’t use aspirin in children/teens (Reye’s syndrome risk)
 Antitussives/Protussives (Expectorants)
o Colds usually are non-productive, so antitussive
(codeine/dextromethorphan) use is not recommended.
 Combination products
o Many analgesics, decongestants and antihistamines are marketed in
combination
o Often marketed as daytime or nighttime, of which nighttime products
contain sedatives
 Summary
o Evidence does not support use of antitussives and expectorants for
colds, limit use to antihistamines
o Treatment with local anesthetics and systemic analgesics for pain
related to sore throat or fever related to colds is supported
o Limits topical decongestant use for nasal congestion to 3 days
(keeping in line with lecture) to avoid RM development

11. List the steps for correctly using Nasal Pump
Sprays.
12. List causes and symptoms of Rhinitis
Medicamentosa and explain steps for
treating it.
Otherwise known as rebound congestion, RM is thought to be caused by short-
acting products, long duration of therapy and the preservative benzalkonium chloride
(BAC). Treat for a maximum of 3 days with nasal decongestants (e.g. oxymetazoline).
Treatment for RM includes slowly withdrawing the topical decongestant (one
nostril at a time); replacing the decongestant with normal saline, which sooths the
irritated nasal mucosa; and, if needed, using topical corticosteroids and systemic
decongestants. May take 2-6 weeks before mucous membranes return to normal.
13. Summarize best options for treating colds in
pediatric, pregnant, or elderly patients
Pediatric
 Pseudoephedrine is compatible with breastfeeding
 Decongestants may reduce milk production – drink extra fluids
 Dextromethorphan, guaifenesin, benzocaine and camphor are compatible with
breastfeeding
 FDA does not recommend use in children <2 years
Pregnant
 Nondrug therapy preferred
 Avoid “extra strength,” “maximum strength,” or “long-acting”
 Avoid systemic decongestants; oxymetazoline topical (nasal) decongestant is
preferred due to poor systemic absorption
Elderly
 Lozenges, soft chews, and nasal drug delivery may be preferred for patients with
difficulty swallowing
 Beware of multiple disease states that could complicate OTC recommendations


14. Explain evidence for using Zinc and/or
Vitamin C to help with cold symptoms/duration
Zinc
 High local concentrations block adhesion of rhinovirus to nasal epithelium, and
inhibit viral replication by disrupting capsid formation
 Only has a modest effect
 Nasal formulation removed from market because of loss of smell
 Best effect if started within 24 hours of symptom onset and every 2 hours while
patient is awake
 Prophylaxis show with zinc usage for at least 5 months
Vitamin C
 Not shown to be effective for preventing colds in general population
 High dose may be effective at prevention for patients under severe physical
stress (athletes, marathon runners)
o But did not reduce severity or duration after onset of cold/once the cold
was already contracted.

15. List patient education points for colds
 The objectives for self-treatment are:
1. Reduce symptoms
2. Improve functioning and sense of well-being
3. Prevent spread of disease
 Cough related to a runny nose (postnasal drip) may be treated with a sedating histamine
(1st gen) and decongestant combination
 Nasal congestion may be treated topically (oxymetazoline) or systemically
(pseudoephedrine) with decongestants that constrict blood vessels
 Nondrug measures may be effective
 Describe the purpose of each medication recommended
 Only use meds that target the patient’s specific symptoms
 Clearly explain adverse effects, drug interactions, precautions, warnings
 Explain the signs and symptoms that indicate the disorder is worsening and that medical
care should be sought.
 Seek medical attention if signs and symptoms worsen or if signs of bacterial infection
develop:
o Nasal or respiratory secretions become thick and are not clear
o Temperature > 101.5F (38.6C, oral)
o SOB
o Congestion
o Wheezing

o Rash
o Significant ear pain
Module 4.2 (Allergic Rhinitis) lecture objectives
1) Describe the clinical presentationof allergicrhinitis
Symptoms mostly effect the nasal area (rhinitis = inflammation of the nasal membranes). AR is
commonly caused by dust mites, cockroaches, and pet dander. It can also be triggered by
pollen, mold spores and pollution
The primary signs/symptoms include itching, sneezing, runny nose, and congestion.
Sometimes, can present with cough/sore throat/fatigue.
The cascade:
***Congestion is a 2nd phase response due to untreated phase 1 allergies**
2) Differentiate between colds and allergies
Symptoms Cold Allergies
Sore throat Often Sometimes
Sneezing Sometimes Often
Congestion or runny nose Often – appears
cloudy/yellow-green
Often – clear
Itchy, watery eyes Rarely Often
Coughing Often Rarely
Fever Sometimes Never
Headache Sometimes Sometimes

Contagious? Yes No
Duration 7-10 days Varies (sometimes weeks)
3) Choose when to treat and refer (exclusioncriteria)
Exclusions:
1. Symptoms of ear infection, sinus infection, bronchitis
2. Symptoms of undiagnosed or uncontrolled breathing disorder (wheezing/SOB)
3. Children <12 years*
4. Pregnancy/lactation*
* = unless already diagnosed with AR and non-Rx therapy is approved by PCP
4) Summarize the general treatment approach to
allergicrhinitis
The treatment plan should consist of:
1) Eliminating symptoms to restore quality of life
2) Minimize adverse events
3) Reduce exposure to triggers
4) Prevent recurrence of symptoms
5) Educate the patient on allergen avoidance, pharmacotherapy and immunotherapy
Algorithm for treatment based on patient factors:
Mild+Intermittent symptoms
 Recommend 2nd-gen antihistamine or intranasal antihistamine
Symptoms that are persistent or affect quality of life:
 Recommend intranasal corticosteroid alone
Severe, persistent symptoms
 Recommend intranasal corticosteroid + intranasal antihistamine or MCS

5) Discuss the pharmacological options available for
self-care of allergicrhinitis
- DO NOT USE VISINE FOR RELIEF OF OPTHALMIC ALLERGY SYMPTOMS
- Artificial tears like Refresh Optive or Systane can help lubrication and dryness and have no
max use
- Ophthalmic antihistamines include Naphazoline (All Clear, Naphcon) and Ketotifen (Zaditor,
Alaway)
6) Choose appropriate pharmacological and non-
pharmacological recommendations to manage
symptoms based on patient factors
 Allergen avoidance
 Nasal saline irrigation
 Local honey
o The idea is you take a teaspoon per day and since it’s local, it has

all those allergens in it that are in your area and over time your body would
desensitize you to them.
7) Apply the PPCP to a patient case
No im just here to brain dump sorry.
Module 4.2 (Allergic Rhinitis) Reading objectives
1. List the factors for allergicrhinitis
 A family history of atopy (allergic disorders) in one or both parents
 Filaggrin (a skin barrier protein) gene mutation
 Elevated serum IgE greater than 100IU/mL before age 6
 Higher socioeconomic level
 Eczema
 Positive reaction to allergy skin tests
 Possibly diet in children/teens
2. List common triggers or causes for allergicrhinitis
 Airborne allergens such as pollen/mold spores
 Pollutants (ozone, tobacco, smoke, diesel exhaust particles)
 Allergens from house dust-mites/cockroaches
 Pet dander
 Wool dust
 Latex
 Resins
 Biologic enzymes
 Organic dusts (e.g. flour)
 Various chemicals
3. Describe clinical presentationof allergicrhinitis
Sore throat: Sometimes
Sneezing: Often
Congestion/runny nose: Often
Itchy/watery eyes: Often

Coughing: Rarely
Fever: Never
Headache: Sometimes
Contagious?: No
Duration: Varies
4. Classify allergicrhinitis symptoms as intermittent
mild/moderate-severe or as persistentmild/moderate-
severe (table 11-10)
5. List acute or chronic complications with allergic
rhinitis
Acute complications:
 Sinusitis
 Otitis media with effusion
Chronic complications:
 Nasal polyps
 Sleep apnea
 Sinusitis
 Hyposmia (diminished sense of smell)

Allergic rhinitis and asthma share a common pathology, and allergic rhinitis has been implicated
in the development of asthma and in exacerbations of preexisting asthma in children and
adults.
Depression, anxiety, delayed speech development, and facial or dental abnormalities have also
been linked to allergic rhinitis.
6. List goals of therapy for treating allergicrhinitis
 Allergic rhinitis cannot be cured
 Goals are simply to reduce symptoms and improve patient’s functional status/sense of
well-being.
7. List exclusions for self-treatmentof allergicrhinitis
 Children <12 years (unless already diagnosed with allergic rhinitis and non-Rx therapy is
approved by a PCP)
 Pregnant or lactating women
 If the patient has or experiences symptoms of non-allergic rhinitis
 Symptoms of otitis media, sinusitis, bronchitis, or other infection
 Symptoms of undiagnosed or uncontrolled asthma (wheezing, SOB)
 COPD or other lower respiratory disorder
 Severe or unacceptable side effects of treatment
8. Describe general treatment approach for allergic
rhinitis
Can be broken down into three steps:
1) Allergen avoidance
2) Pharmacotherapy
3) Immunotherapy
Nonprescription therapy with intranasal corticosteroids, antihistamines, or decongestants can
usually control most symptoms.
9. Describe non-pharmacologictreatment options for
allergicrhinitis
Most this is all pretty much common sense so sorry to bore you here
ALLERGEN AVOIDANCE
In mite allergies:

 lower household humidity to less than 40%
 apply acaricides (poisons to mites)
 remove carpets/upholstered furniture, stuffed animals, bookshelves, etc
 Encase mattresses, box springs, and pillows with mite-impermeable materials
 Wash beddings at least weekly in hot (131F/55C) water
In mold spore allergies:
 Avoid activities disturbing decaying plant material (e.g. raking leaves)
 Lower indoor humidity
Remove houseplants
 Vent food preparation areas and bathrooms
 Repair damp basements/crawl spaces
 Apply fungicide to moldy areas
In Cat-derived allergies:
 These allergens can stay airborne for hours as they are small and light
 Possibly cat baths
 Get a dog �♂️
In cockroach allergies:
 Major source of urban allergies
 Keep kitchen areas clean
 Keep stored food tightly sealed
In pollutant/environmental allergies:
 Trees produce pollen in spring
 Grasses produce pollen in early summer
 Ragweed produces pollen from mid-August to the first fall frost
o Knowledge of pollen counts may help plan outdoor activities.
 Counts are highest in the early morning and lowest after rainstorms
o Ventilation with HEPA filters remove pollen, mold spores, cat allergens, etc, but
not fecal particles from house-dust mites
 Nasal wetting or nasal irrigations with sterile water may help
10. Describe pharmacologictreatment options for
allergicrhinitis

Intranasal corticosteroids have been shown to be the most effective treatment for allergic
rhinitis symptoms. Antihistamines and mast cell stabilizers are also effective and should be used
regularly rather than episodically.
Intranasal corticosteroids
Highly effective for itching, rhinitis, sneezing and congestion
Fluticasone propionate/furoate has additional FDA approval for ophthalmic symptoms such as
itchy or watery eyes
Low systemic absorption
Well tolerated (possible nasal bleeding, N/V/D)
Antihistamines
We pretty much know all this; page 205 and 209 of 19th ed. if you want more info
Use combination products with caution
 Usually combine antihistamines, analgesics, and decongestants
Decongestants
Mast Cell Stabilizers
 Cromolyn Sodium is thought to work by blocking the influx of calcium into mast cells,
preventing mediator release
 CS has no systemic activity
 Approved in patients 2+ (1 spray in each nostril, 3-6 times daily)
 Effect may take 3-7 days and 2-4 weeks for maximal effect
 Sneezing is the most common adverse reaction
 No drug interactions reported
11. Compare sedating characteristics of antihistamines
(table 11-13).
Highly sedating
 Doxylamine
 Diphenhydramine
Moderately sedating
 Bropheniramine
 Chlorpheniramine
Minimally sedating
 Levocetirizine
 Cetirizine
Nonsedating
 Fexofenadine
 Loratadine

12. Summarize best options for treating allergicrhinitis
in pediatric, pregnant or elderly patients
Pregnancy
 ONLY treat if AR is confirmed by PCP and approves non-Rx therapy
 Intranasal Cromolyn is compatible
 Diphenhydramine and chlorpheniramine are compatible
 Intranasal corticosteroids are compatible
o But avoid systemic use of budesonide and triamcinolone
Lactating
 Intransal Cromolyn is a good choice
 Intranasal corticosteroids “probably” compatible
 Antihistamines are contraindicated
o If necessary, use chlorpheniramine, fexofenadine or loratadine under PCP
supervision
 Take dose at bedtime after the last feeding of the day
Pediatrics
 Refer children <12 y/o unless approved by PCP for non-Rx therapy. If approved:
 Children 2 and up are able to use:
o Intranasal Cromolyn
o Sensimist (fluticasone furionate)
o Triamcinalone
 Children 4 and up can use:
o Intranasal fluticasone propionate
 Children 6 and up can use:
o Budesonide
 Loratadine is the antihistamine of choice and can be used in ages 2+
 Avoid sedating histamines
 All intranasal corticosteroids have been linked to growth inhibition in children, contact
PCP before long term usage of any product.
Elderly
 Avoid sedating histamines
 Loratadine and Cromolyn are drugs of choice for this population
 Adjust dosage in renal/hepatic impairment
13. List patient education points for allergicrhinitis
 The provider should emphasize that the best method of treating AR is to avoid allergens

 Patient counseling should include information about proper use of recommended
medications and about adverse effects, interactions, and other warnings/precautions.
 Emphasize to the patient signs and symptoms that indicate the disorder is worsening
and when to seek medical care
 Intranasal steroids are effective for itchy eyes and noses, sneezing, runny nose, and
congestion
 Antihistamines are effective for itching, sneezing and runny nose but have little effect
on nasal congestion
 Decongestants are effective for nasal congestion but have little effect on other
symptoms
 Allergy medications are more effective if used regularly rather than episodically
1. Explain what heartburn is and the differences between
heartburn, dyspepsia, and GERD
Heartburn is typically a burning sensation in the chest likely due to acid regurgitation up into
the esophagus.
Dyspepsia is a more severe feeling in the stomach. Likely, a patient will be experiencing pain,
burning, early satiation and a feeling of fullness after eating. Patient may also be belching,
bloating, have nausea or vomiting.
GERD is, in most cases, the cause of heartburn. Heartburn is just a symptom of GERD.
Ermahgerd.
2. List possible contributors to heartburn symptoms
Lifestyle Dietary Medications Diseases Other

 Exercise
(running)
 Obesity
 Tight
clothes
 Smoking
 Stress
 Supine
(horizontal)
body
position
 Alcohol
 Caffeine
 Carbonated
beverages
 Fattyfoods
 Chocolate
 Spicyfood
 Mints
 Tomatoes
 Anticholinergics
 Benzos
 Bisphosphates
 CCB’s
 Doxycycline
 Opioids
 Potassium
 Iron
 Estrogen
 Tricyclic
antidepressants
(amitryptiline)
 PUD
 Gastroparesis
 Scleroderma
 Zollinger-
Ellison
Syndrome
 Pregnancy
 Genetics
3. Utilize informationgathered through an assessment and
identify exclusions for self-care for the treatment of heartburn
 Frequent heartburn for more than 3 months
 Heartburn while taking recommended dosages of non-Rx H2RAs or PPIs
 Heartburn that continues after 2 weeks of treatment with a non-Rx H2RA or PPI
 Severe heartburn and dyspepsia
 Nocturnal heartburn
 Difficulty or pain when swallowing solid foods
 Heartburn and dyspepsia that occur with taking a prescription H2RA or PPI
 Vomiting up blood or black material or passing black, tarry stools
 Chronic hoarseness, wheezing, coughing or choking
 Continuous nausea, vomiting, or diarrhea
 Chest pain accompanied by sweating, pain radiating to shoulder, arm, neck or jaw, and
shortness of breath
 Children <2years (for antacids), 12 years (H2RAs), 18 years (PPIs)
4. Provide nonpharmacologicaltreatments for heartburn
 Keep a diary to identify agents that trigger heartburn symptoms
 Refrain from spicy food
 Smoking cessation
 Elevate the bed or use a GERD pillow
 Eat small, healthy meals and limit fat intake
 Do not lay down within 3 hours of eating
 Discuss medications that could be causing the symptoms
 Limit caffeine and alcohol intake

5. Identify exclusions for self-treatment in given cases
See Q3
6. Assessa patient’s complaints to determine if it is episodic
or frequent heartburn and recommend appropriate therapy
options
Episodic = less than twice a week
Frequent = twice or more per week
Episodic
 Mild, infrequent
o Lifestyle/dietary modifications AND:
 An antacid OR
 A low-dose H2RA OR
 Alginic acid/antacid OR
 An OTC H2RA/antacid
 Moderate, infrequent
o Lifestyle/dietary modifications AND:
 An antacid OR
 A higher dose H2RA
Frequent
 Lifestyle/dietary modifications AND
 OTC PPI once daily for 14 days OR
 OTC H2RAs as needed
Basically an obvious difference is you only use PPIs in frequent heartburn
7. Explain the difference in onset of action and duration of
action for antacids, H2Ras, and PPIs
Antacids H2RAs PPIs
Onset < 5mins 30-45 mins 2-3 hours, but likely
won’t experience
significant relief until
1-4 days

Duration 20-60mins on an
empty stomach, up
to 3 hours when
taken on a full
stomach within 1
hour after eating
4-10 hours 12-24 hours
8. List conditions in which a patient should seek medical care
when using a PPI
 If symptoms persist for more than two weeks
 If symptoms continue while taking the PPI
 If symptoms recur within 4 months of OTC PPI treatment
9. List some concerns associated with long term use of PPIs
It is important to only use PPIs for 14 days and in as low a dosage as possible. With long-
term/high dosage use, there may be adverse effects associated with their use.
Possible ADR’s include:
 Clostridioides difficile
 Malabsorption
o Hypomagnesemia, Vitamin B12 malabsorption, Calciummalabsorption leading to
increased fracture risk, iron malabsorption
 Kidney disease
o Acute interstitial nephritis
o CKD or ESRD (end-stage renal disease)
 Dementia
 Pneumonia
o Primarily from hospital use
10. Develop treatment plans for patients who are classified
under “special populations.”
 Always consider nonpharm options first
 No OTC treatment for <2 y/o
Antacids H2RAs PPIs

 Should not be used in
renal insufficiency
 Antacids preferred in
pregnancy*
 Antacids are safe
during lactation
 Can be used in renal
insufficiency, but
adjust dose
 PPIs are on the Beers
list (but Dr.
Moorman-Li basically
said it didn’t matter?)
*If that is not an option, go with the H2RA ranitidine (Zantac) or the PPI
omeprazole (Prilosec)
Module 5.1 Reading Objectives
1. List common exclusion for self-treatmentin
heartburn and dyspepsia
 Frequent heartburn for more than 3 months
 Heartburn while taking recommended dosages of non-Rx H2RAs or PPIs
 Heartburn that continues after 2 weeks of treatment with a non-Rx H2RA or PPI
 Severe heartburn and dyspepsia
 Nocturnal heartburn
 Difficulty or pain when swallowing solid foods
 Heartburn and dyspepsia that occur with taking a prescription H2RA or PPI
 Vomiting up blood or black material or passing black, tarry stools
 Chronic hoarseness, wheezing, coughing or choking
 Continuous nausea, vomiting, or diarrhea
 Chest pain accompanied by sweating, pain radiating to shoulder, arm, neck or jaw, and
shortness of breath
 Children <2years (for antacids), 12 years (H2RAs), 18 years (PPIs)
2. Explain which classes of OTC medications should be
considered for mild, infrequent heartburn/dyspepsia

Antacids should be considered for mild, infrequent heartburn. These work with cations
interacting with chloride ions, while anions interact with the hydrogen. Duration of action
transient (lasts only as long as the antacid remains in the stomach) and is short (20-30min) due
to fast clearance by the stomach. Duration can be extended (up to 3hr) with food. Antacids
cause an increase in intragastric pH, and once pH is above 5, conversion of pepsin to
pepsinogen is blocked. Antacids also increase LES pressure.
H2RAs can also be used for mild, infrequent heartburn. They block the H2 receptor.
3. Compare and contrast the pros and cons of antacids
in comparisonto H2Ras and PPIs
Antacids H2RAs PPIs
 Fastest onset (<5min)
 Shortest duration (20-
30min, max 3hr)
 Recommended for
only mild, infrequent
heartburn
 Usually taken at onset
of symptoms rather
than proactively
 Each antacid has
specific side-
effects/cautions
 First choice in
pregnancy (besides
non-pharm options)
 Well tolerated,
caution use in renal
impairment. Most
common side effect is
diarrhea from
magnesium-
containing antacids
 All H2RAs are
interchangeable
 Can be used
proactively and
reactively
 Help relieve fasting,
nocturnal heartburn
symptoms
 Onset is not as fast at
antacids (30-45mins)
 Duration is longer (4-
10hr)
 Well tolerated, side
effects include
diarrhea, constipation
and headache.
 More prolonged effects
than H2RAs/antacids
 For frequent heartburn
(2+ days/week)
 Bioavailability of PPIs
increase with regular
dosing
 More for prevention
than reactiveness.
o Onset is 2-3hr,
effective in ~1-4
days
o Most effective
taken 30-60 mins
before the first
meal of the day
 PPIs are almost
completely absorbed,
regardless of presence of
food
 Most common side
effects are the same as
H2RAs (D/C/ha)

 Limit self-treatment to 2
weeks every 4 months
 Potential infection risk
(C-diff)
 Potential fracture risk,
B12 deficiency,
hypomagnesemia, and
iron malabsorption with
>1 year of PPI use
 Chronic kidney disease
and dementia also a
possibility with long
term use.
4. Explain when a PPI can be recommendedover a
H2RA
When a patient has frequent heartburn, defined as greater than 2 or more days per week.
5. Provide important counseling points for antacids,
H2RAs, and PPIs
Antacids:
 Relief will be seen in 5 minutes for mild, infrequent heartburn
 Should not be used more than 4 times per day, or regularly for more than 2 weeks
 Diarrhea may occur for magnesium containing antacids
 Constipation may occur with aluminum containing antacids
 Approved for children older than 2 years old – use calciumcarbonate products
 Pregnancy women may use calciumor magnesium antacids
 Consult PCP before using antacids with renal dysfunction
 Do not take concurrently with tetracyclines, iron supplements, levothyroxine,
fluoroquinolones, azithromycin, ketoconazole, or itraconazole.
H2RAs:

 May be used for relief or prevention
 Should be used for mild-moderate, infrequent heartburn
 Expect relief in 30mins-1hr and a duration of 4-10hr
 Take as needed, up to twice a day for 2 weeks. If no relief after 2wks, go to PCP
 Don’t even bother with cimetidine
PPIs:
 Used for mild-moderate frequent heartburn that occurs >2 days/week
 Not intended for relief of mild, occasional heartburn
 For best results, take 30mins before first meal of the day for 14 days.
 Be sure to take the full course of 14 day treatment
 Do not take more than 1 tablet/day
 If no relief in 2 weeks or symptoms recur within 4 months, contact PCP
 Do not crush or chew (enteric-coated)
6. Provide all informationon antacids, H2Ras, PPIs and
Bismuth Subsalicylate (see slide 4) and use this
informationin given cases
I would refer to the PowerPoint (5.1) for this information. Tables are nicely organized and more
in-depth than in the book.
1. Explain the most commonreasons for nausea and
vomiting
 Motion sickness
o Rare in children <2y/o
o More common in women than men (due to menstruation and pregnancy)
 Pregnancy
 Viral gastroenteritis
o Most frequently caused by rotavirus and norovirus, commonly in fall and winter
o Can be dangerous for children due to dehydration
 Indigestion secondary to overeating

**Nausea and vomiting are really symptoms of conditions, not the condition itself**
2. Utilize informationgathered through an assessment
to identify exclusions for self-care for the treatment of
nausea and vomiting
N/V Exclusions for ADULTS
 Urine ketones and/or high BG with signs of dehydration in patients with diabetes (may
indicate DKA or HHS)
 Suspected food poisoning that does not clear up after 24 hours
 Severe abdominal pain in the middle or right lower quadrant (may indicate appendicitis
or bowel obstruction)
 N/V with fever and/or diarrhea (may indicate infectious disease)
 Severe right upper quadrant pain, especially after eating fatty foods (may indicate
cholecystitis or pancreatitis)
 Blood in vomitus (may indicate ulcers, esophageal tears, or severe nasal bleed)
 Yellow skin or eye discoloration and dark urine (may indicate hepatitis)
 Stiff neck with or without headache and sensitivity to brightness of normal light (may
indicate meningitis)
 Head injury with N/V, blurry vison, or numbness and tingling
 Persons with glaucoma, BPH, chronic bronchitis, emphysema, or asthma (may react
adversely to OTC antiemetics)
 Pregnancy (with severe symptoms) or breastfeeding
 N/V caused by cancer chemotherapy; radiation therapy; serious metabolic disorders;
CNS, GI, or endocrine disorders
 Drug-induced N/V: adverse effects of drugs used therapeutically (e.g. opioids, NSAIDs,
antibiotics, estrogens); toxic doses of drugs used therapeutically (e.g. digoxin,
theophylline, lithium); ethanol
 Psychogenic-induced N/V: bulimia, anorexia
 Chronic disease-induced N/V: gastroparesis with diabetes; DKA or HHS with diabetes;
GERD
N/V Exclusions for CHILDREN
 Signs of severe dehydration
 Caregiver is unable/unwilling to manage child’s N/V at home
 N/V is accompanied by 1 of the following conditions:
o Stiff neck
o <6mo of age or weight <17.6lb (8kg), vomited clear fluids 3 times, watery dh
o Refusal to drink fluids

Everything You'll Ever Need to Know about OTCs and Self Care

Everything You'll Ever Need to Know about OTCs and Self Care

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