IPC II Exam One
Introduction to Non-Prescription Medication & Dietary Supplements
1. Definitions and Necessary Elements
Non-Prescription Medication (OTC)
Consumer Use: Consumers can safely and effectively use these medications without medical supervision.
Capabilities: Consumers must be able to self-diagnose, self-treat, and self-manage their conditions based on the product label.
Risk Profile: These medications have a low potential for abuse and misuse; the benefits of availability must outweigh the associated risks.
Regulation: Regulated by the FDA's Center for Drug Evaluation and Research (CDER) and held to high standards of safety and efficacy.
Dietary Supplements
Definition: A product taken by mouth containing a "dietary ingredient" that aims to supplement the diet.
Ingredients: May include vitamins, minerals, herbs/botanicals, amino acids, enzymes, or substances designed to increase dietary intake.
Regulatory Status: Regulated as food, not drugs, under the Center for Food Safety and Applied Nutrition.
Claims: Unlike drugs, dietary supplements cannot claim to prevent, treat, or relieve a disease or medical condition.
Homeopathic Products
Philosophy: Based on the principle of "like cures like," meaning treating symptoms with substances that produce similar effects in healthy individuals.
Composition: Derived from natural substances (plants, minerals, animals) and used in highly diluted doses.
Governance: Regulated under the Homeopathic Pharmacopoeia of the United States (HPUS).
2. Regulation: NDA vs. OTC Drug Monographs
Both processes require standards for safety and efficacy, adherence to Good Manufacturing Practices (GMP), and compliance with advertising regulations by the Federal Trade Commission (FTC).
New Drug Application (NDA)
Approval Process: Requires pre-market approval by the FDA.
Clinical Data: Requires clinical development, including trials and animal studies.
OTC Drug Monograph Approval
Approval Process: No pre-market approval needed if the product conforms to the established monograph.
Clinical Data: Clinical studies are not necessary.
Page 2: Labeling
Unique Aspects of Approved Labeling
Labeling: Unique to individual drugs, uniform for products with the same active ingredient (functioning like a "Recipe Book").
Use Case: NDA for new ingredients, Rx-to-OTC switches, or products not conforming to a monograph. For established ingredients deemed Generally Recognized as Safe and Effective (GRASE), monograph suffices.
Exclusivity: Manufacturers are granted marketing exclusivity for 18 months unless modified by legislative changes such as the CARES Act.
Monograph Reform (CARES Act)
Changes to the monograph system can be made through an administrative order procedure.
3. Components of the "Drug Facts" Label
Active Ingredient: Lists the ingredient, strength (per unit), and purpose (e.g., pain reliever).
Uses: Indicates specific symptoms treated or conditions addressed.
Warnings: Must specify:
Allergy alert
Contraindications (e.g., “Do not use if…”)
Cautions (e.g., “Ask a doctor before use if…”)
Side effects (e.g., “When using this product…”)
Stopping criteria (e.g., “Stop use and ask a doctor if…”)
Pregnancy/breastfeeding warnings.
Directions: Dosage instructions tailored to both adults and children (differentiated by age/weight).
Other Information: Conditions for safe storage (e.g., temperature).
Inactive Ingredients: Must be listed alphabetically.
Questions or Comments: Must include a toll-free contact number.
4. Dietary Supplements (DSHEA) vs. Non-Prescription Medication Regulation Under DSHEA (1994)
Supplement Regulation
Classification: Recognized as food, not a drug.
Pre-Market Review: Generally, manufacturers do not need to submit products for registration or approval prior to market launch.
New Ingredients (Post-1994): Evidence of safety must be submitted but not efficacy.
Old Ingredients (Pre-1994): Automatically grandfathered; no submissions required for safety or efficacy.
Burden of Proof: Rest on the FDA to demonstrate that a supplement is unsafe before it can be removed from the market.
Efficacy: No requirements for proving efficacy for dietary supplements.
Differentiation Summary
Non-Prescription Medications: Must demonstrate both safety and efficacy, subject to rigorous FDA review or adherence to strict monographs.
Dietary Supplements: No efficacy proof required; FDA monitors safety largely post-market via adverse event tracking.
Structure/Function Claims
Supplements cannot assert claims to treat or prevent diseases (e.g., stating that they "cure heart disease"). If disease claims are made, the product is classified as a drug.
5. Regulation and Labeling of Homeopathic Drugs
Regulation
Status: These products are "regulated" by the FDA but not in the same manner as standard OTC medications.
Review: The FDA has not historically reviewed homeopathic products for safety or efficacy, barring rare exceptions.
Efficacy: Homeopathic drugs have never been mandated to show safety or efficacy data.
Key Labeling Differences
"Homeopathic" Designation: Must include the term "homeopathic" in addition to the standard "Drug Facts" box.
Strength/Dilution: Ingredients are presented by dilution factor rather than by milligram strength:
X: Indicates a dilution of 10.
C or CK: Indicates a dilution of 100.
Example: 6X indicates a dilution of 10 raised to the sixth power.
Expiration Dates: Not mandatory for homeopathic products.
Label Type:
Non-Prescription: Uses the "Drug Facts" label.
Dietary Supplement: Uses the "Supplement Facts" label.
Homeopathic: Uses the "Drug Facts" label with modifications as noted.
Nonprescription Medication & The Role of the Pharmacist
1. Definitions: Self-Care Therapeutics & Pharmacist-Assisted Self-Care
Self-Care
Defined by the World Health Organization (WHO), self-care refers to individuals, families, and communities' abilities to:
Promote health.
Prevent disease.
Maintain health.
Cope with illness, supported or unsupported by healthcare providers.
Pharmacist-Assisted Self-Care
Encompasses the unique professional role of pharmacists, who are thoroughly trained in OTC medication therapy.
Includes recommendations for:
Nonprescription medications.
Medical devices.
Complementary and Alternative Medicine (CAM).
Non-pharmacologic interventions (lifestyle, diets, and wellness).
2. The QuEST SCHOLAR Method
QuEST Acronym (The Process)
Qu: Quickly assess the patient.
E: Ensure patient eligibility for self-care.
S: Suggest relevant self-care strategies (medication and non-medical).
T: Talk to the patient regarding medication expectations and follow-up.
SCHOLAR Acronym (The Subjective Assessment)
S: Symptoms (e.g., itching, sneezing).
C: Characteristics (e.g., worsening symptoms related to pollen).
H: History / Onset of symptoms (e.g., seasonal occurrence).
O: Origin (specific areas affected, such as eyes or nose).
L: Location (often combined with Origin).
A: Aggravating factors (e.g., exposure to allergens).
R: Remitting factors (e.g., staying indoors helps).
MCPHS Acronym (Medical History)
M: Current medications (both prescription and OTC).
C: Comorbid conditions (e.g., asthma, acne).
P: Use of herbal/dietary supplements.
H: Any known hypersensitivities or allergies.
S: Social history (e.g., educational status, living situation).
3. The FIRST Step/Question in a Consultation
Quickly assess the patient, beginning with inquiries about the current complaint (using SCHOLAR) and medical history (MCPHS).
Recognize that all data collected in this phase is subjective and self-reported.
4. Top 400 Drug List & Case Application
Ability to identify and compare medications using the provided "IG" case study, which analyzes a student with allergic rhinitis seeking all-day symptom relief.
First-Generation Antihistamines
Example: Diphenhydramine (Benadryl).
Dosing/Label: Every 4–6 hours; causes significant drowsiness.
Suitability: Not suitable for a student requiring all-day relief or studying.
Second-Generation Antihistamines
Example: Loratadine (Claritin).
Dosing/Label: Once daily for 24-hour relief; non-drowsy.
Intranasal Corticosteroids (INCS)
Example: Triamcinolone Acetonide (Nasacort).
Dosing/Label: Once daily for 24-hour relief; non-drowsy; effective for nasal congestion, runny nose, sneezing, and itchy nose.
5. Therapeutic Problem Solving & Exclusions to Self-Care
Reasons for patient exclusion must be verified as pharmacists do not have laboratory or historical health data resources and rely primarily on subjective reporting.
Potential exclusions may include:
Severe underlying health issues.
Special populations (e.g., pregnancy, age).
"Traffic Light" Logic for Referrals (Allergic Rhinitis Examples)
Red Light (Refer Immediately):
Symptoms suggesting infection (e.g., ear pain, fever).
Uncontrolled asthma or COPD.
Recent facial/head trauma or loss of sense of smell.
Yellow Light (Refer Soon):
Pregnant or lactating women.
Children aged 2-4 years.
Green Light (Self-Care Candidate):
Children aged 4-12, assuming they exhibit appropriate symptoms.
Adults with mild symptoms without significant comorbidities.
Selection Strategy
When advising on treatment strategies, select medications that:
Target specific symptoms (e.g., congestion vs. runny nose).
Are supported by literature and algorithms.
Align with patient preferences (including cost considerations).
Are safe regarding any existing drug allergies and possible drug-drug or drug-disease interactions.
Community Pharmacy Medication Use Process
1. The Medication Use Process (Workflow)
Definition: Sequence of processes through which a piece of work passes from initiation to completion (workflow).
Goal: To ensure prescriptions are dispensed accurately, safely, and efficiently while maximizing patient care quality.
Responsibility: Pharmacists supervise the entire process, which includes:
Triage and prioritization of tasks.
Delegation of responsibilities amongst staff.
Effective time management.
General Sequence of Workflow
Rx Received (Drop Off).
Data Entry.
Filling/Production.
Verification (both order entry and product).
Dispensing/Pickup.
Patient Consultation.
2. Stations and Responsibilities
A. Drop Off / Data Entry
Intake Process: Prescriptions can be received electronically or in-person; patient information must be updated (name, date of birth, insurance, allergies).
Data Entry: Inputting pertinent data into the pharmacy computer system (including patient information, medication details, directions, quantity, prescriber, DAW).
Billing: Submitting claims to insurance and resolving third-party issues.
Controlled Substances: Must follow the Good Faith Dispensing (GFD) process for Schedule IIs and resolve red flags (e.g., early fills).
B. Filling / Production
Process:
Generate patient pamphlet/monograph.
Locate stock bottles (either manually or via automation).
Scanning procedures to ensure the leaflet and stock bottle match via their NDC codes.
Counting medications appropriately, labeling it, placing it in vials.
Capture images of the filled vials for later pharmacist review.
C. Verification
Order Entry Verification: Confirm that entered data aligns with the original prescription, checking for:
Typing errors and appropriate dosing.
Drug interactions and patient allergies.
Product Verification: Physically check that the dispensed product matches the prescription, confirming:
Drug name/markings.
NDC code.
Safety features (e.g., child-proof cap).
D. Pickup
Tasks:
Verify patient identification.
Confirm that the correct medication is being released.
Ensure copay amount is reasonable.
Scan IDs when required for controlled substances.
Provide patient counseling regarding their medication.
E. Consultation Area
Role of Consultation: Though typically the last step, counseling may occur throughout the process.
Tasks Involve:
Asking open-ended questions to gather patient insights regarding their needs.
Providing thorough explanations of medication uses and regimen.
Screening for immunization needs.
3. Disruptions to the Medication Use Process
Common disruptions may include:
Resolving third-party rejections.
Interruptions from phone calls impacting workflow.
Stock availability issues that hinder filling.
Staffing shortages during peak hours.
Rush hour influx of patients.
4. Workflow Advancements and Future Direction
The industry is progressing to allow pharmacists to devote more attention to clinical services through the automation of routine tasks.
Current & Future Trends:
Micro-Fulfillment/Central Fulfillment: Implementing a central site for maintenance medications and auto-refills.
Automation: Increased use of automated dispensing cabinets and robotic filling solutions.
Pharmacy Lockers: Using secure lockers for patient prescription pickup, minimizing line waiting.
Delivery Services: Growth in same-day delivery and shipping options to reduce congestion.
Role Expansion:
Technician Roles: Enhanced responsibilities like "Tech-Check-Tech" and immunization administration.
Pharmacist Roles: Moving towards patient-centric models including Medication Therapy Management (MTM) and Comprehensive Medication Reviews (CMRs).
Telehealth, Telepharmacy, & Digital Health
1. Definitions: Telehealth vs. Telepharmacy
Telehealth Definition
Description: Refers to using electronic and telecommunications technologies for remote healthcare service delivery.
Key Points:
Encompasses video consultations and electronic communication.
Aims to enhance patient care, education, and follow-up.
Does not alter existing care standards or responsibilities.
Key Takeaway: Changes the methodology of care delivery.
Telepharmacy Definition
Description: Involves the remote provision of pharmaceutical care and services facilitated by technology according to regulations.
Key Points:
Applicable in both inpatient and outpatient settings.
Maintains oversight by licensed pharmacists.
Often serves rural or underserved communities.
Key Takeaway: Alters care delivery methods while upholding legal responsibilities of pharmacists.
2. Advantages of Common Telepharmacy Services
Inpatient Remote Order-Entry Review:
Process: A remote pharmacist reviews drug orders before administration.
Advantages:
Real-time oversight enhances medication safety.
Expands coverage during off-hours.
Outpatient Remote Dispensing:
Process: Pharmacy staffed by certified technicians under remote pharmacist supervision.
Advantages:
Cost efficiency by sharing pharmacy staff across locations.
Improved access in rural communities, reducing readmission rates and enhancing adherence.
IV Admixture Verification:
Process: Remote verification of IV preparations via image-based workflows.
Advantages:
Reduces contamination risk without entering cleanrooms.
Allows pharmacists to concentrate on clinical tasks.
Patient Counseling and Monitoring:
Process: Interactive counseling through video or telecommunications.
Advantages:
Facilitates real-time, specialized patient education on various conditions.
Note on Safety: Telepharmacy results in neither increased error rates compared to central pharmacies nor higher overall medication error rates.
3. Telepharmacy vs. Online Pharmacy
Telepharmacy Distinctions:
Linked to physical locations with pharmacist oversight.
Serves local patient bases while following local regulations.
Provides in-person or mail delivery options.
Online Pharmacy Characteristics:
Patients submit prescriptions electronically.
Primarily ships prescriptions without local pick-up points.
Safety issues reported by the FDA regarding counterfeit medications and illegitimate practices are prevalent in some online pharmacies.
4. Preparing and Conducting a Successful Virtual Encounter
Steps for a Professional Interaction
Prepare:
Instruct patients to gather their medications.
Ensure equipment functionality and find a quiet location.
Dress professionally, avoiding distractions.
Begin:
Ensure participant privacy and comfort.
Introduce each attendee and secure patient consent for the encounter.
Document the interaction parameters (especially in the presence of family).
Conduct:
Ensure visibility and audibility for all participants during the meeting.
Maintain eye contact, crucial in virtual settings.
Close:
Summarize the consultation and agree on follow-up steps.
Ensure thorough documentation and clarity on future action items.
Preparation, consent, privacy, and communication are fundamental to telehealth success.
5. Recommendation: Digital Ear Cleaning Tools
Device Type: Digital otoscopes for earwax removal (e.g., those linked with smartphone screens).
Recommendation: Do not advise for use.
Rationale: The American Academy of Otolaryngology states that earwax should be removed by qualified healthcare personnel due to injury risks.
6. General Rules for Recommending Digital Health Tools
Recommended Practices:
Prefer FDA-authorized digital therapeutics.
Suggest digital tools aligned with clinical guidelines.
Advocate for apps developed by trusted public health entities (e.g., CDC).
Cautionary Factors:
Avoid recommending poorly evidenced digital tools.
Devices posing physical risks should also be avoided.
Be wary of apps reliant solely on user ratings or social media endorsements.
Key Takeaway: If uncertain, further evaluation is necessary before recommending any digital health tool.
Immunizations
1. Recommended Vaccines for Pregnant Women
Vaccines Specifically Recommended:
Tdap: Recommended in each pregnancy, ideally between gestational weeks 27 to 36.
Inactivated Influenza Vaccine: Recommended to prevent flu complications.
Bivalent RSVPreF (Abrysvo): Given between 32 to 36 weeks of gestation during RSV season.
COVID-19 Vaccine: Administered following shared decision-making in clinical contexts.
JYNNEOS (Mpox): May be offered before potential exposure in at-risk pregnant women.
Important Note: Live vaccines and most inactivated vaccines not expressly recommended are generally deferred until after childbirth.
2. Classification of Vaccines
Live and Recombinant Vaccines:
Live Vaccines: Include:
Live Attenuated Influenza Vaccine (e.g., FluMist).
M-M-R II and Priorix (Measles, Mumps, Rubella).
Varicella (e.g., Varivax).
RotaTeq and Rotarix (Rotavirus).
Dengvaxia (Dengue).
JYNNEOS (Mpox).
Recombinant Vaccines: Include:
Recombinant Trivalent Influenza Vaccine (e.g., Flublok).
Recombinant Zoster Vaccine (e.g., Shingrix).
3. Special Considerations for Live Vaccines
Guidelines:
Contraindications: Live vaccines should be deferred during pregnancy and in immunosuppressed patients due to uncontrolled viral replication risks.
Household Contacts: Most live vaccines are safe for contacts of immunosuppressed persons, though caution is warranted post-rotavirus vaccine and with varicella-related skin lesions.
Simultaneous Administration: Ideally, two live vaccines should be administered on the same day; if not possible, there should be a minimum interval of 28 days between doses.
Timing Considerations:
No grace period applies to minimum dose intervals.
Must consider spacing from blood product administration and tuberculin skin tests (PPD) for optimal immunization scheduling.
4. Roles of Adjuvants in Vaccines
Knowledge Check: Understanding the role of adjuvants involves recognizing their purpose, yet specific discussions or identification of their roles are unfortunately not provided in this material. Examples of vaccines containing adjuvants include:
Fluad: Adjuvanted influenza vaccine.
Shingrix: Zoster vaccine.
Arexvy: RSV vaccine.