Community Pharmacy Theory

Chapter 1: The Profession of Pharmacy

The Origins of the Profession

• Teams of professionals work together to diagnose, monitor and treat patients
• Pharmacists
  • Educate about drugs and supplements
  • Oversees, check, work by pharmacy technicians
• Technicians
  • Help fill prescriptions
  • Gather patient information
  • Various duties essential to the running of the pharmacy
• The practice of pharmacy has been mentioned in
  • Greek
  • Roman
  • Arab Muslim
  • Jewish
  • Christian Cultures
• Various Pharmacopoeias have been found through history detailing medications
• Modern Pharmacopoeias are called formularies
• Hippocrates: father of modern medicine
• Galen: pioneered in dissection of animals
• Eventually the Pharmacopeia became standard. It was created to set standards

The 20th-Century Evolution of Pharmacy Education

• 1892 was when the first college of Pharmacy was created and regulated
• After WWII the compounding of drug shifted from the pharmacy to giant pharmaceutical manufacturing
  • Pharmacies were becoming retail merchants
  • The emerging field of pharmacology: the study of drugs, their use and effects, and modes of action made it necessary for pharmacist to receive more formalized higher-education
• Longer life spans due to advanced medication
• Because of longer life spans there are more drugs
• Pharmacists became counsels and case managers
• Helping patients choose, use, and monitor their drugs is known as medication therapy management (MTM)
• Collaborative Practice Agreement: a relationship between Pharmacists, Doctors, and Nurse
• In CPA, a provider supervises patient care and refers those patients to a pharmacist
• Two types of pharmacies
  • Community: independent, chain, intuitional, HMOs, and mail-order
  • Institutional: hospitals, long term care facilities, home healthcare pharmacies, and specialty compounding pharmacies
• Pharmacists are responsible for
  • assessing information of patient history
  • age appropriate dosing
  • counseling
  • screening
  • injections
  • minor ailments consultations
  • Rx renewals
• Technicians are responsible for
  • Injections
  • Engage with customers
  • Filing and checking prescriptions

Drugs and Supplement Development

What is a drug?

• Prescription Drugs
  • Prescriber’s name, address, phone number, date written, and signature
  • 10-digit National Provider Identifier (NPI) and the ~~prescriber’s Drug Enforcement Administration (DEA) number~~
  • Patient’s name, address, and date of birth, and the drug’s name, dosage, duration, and prescribing date
• Over the Counter
  • Drugs that may be sold without a prescription
• Homeopathic remedies
  • Products comprised of natural substances that purportedly stimulate the body’s immune system Dietary supplements (vitamins, minerals, herbs) are not considered

Classification for Drugs

• Medication falls into one of five classifications:
  • Therapeutic Agents
  • Prophylactic Agents
  • Destructive Agents
  • Pharmacodynamic Agents
  • Diagnostic Agents

Major Scientific Discoveries Medicine and Drug Therapies

• Advances in science
  • germ theory of disease
  • the first vaccine

Drug Ingredients and Sources

• Drugs have both active ingredients and inert ingredients
• Natural Sources: can be made or taken from single-celled organisms, plants, animals, minerals, and humans
• Armour thyroid, a medication for poorly functioning thyroids, is an extract from dried pig thyroids
• Laboratory Sources
  • Synthetics drugs
  • Synthesized drugs
  • Semisynthetic drugs
  • Bio genetically engineered drugs
• Active ingredient
  • Biochemically active components
  • Exert desired effects (low BP)
• Inert Ingredients
  • Inactive ingredients
  • Ensure stability preserve drug
  • Provide a vehicle for the active ingredient such as a cream

Prescription Drug Approval Process

• HPB responsible for insuring approved drugs are both safe and effective
• Drugs undergo lengthy research process before they come to market
• Strict regulations developed in response to thalidomide tragedy in the 1960s:
  • This sedative was marketed for morning sickness but caused birth defects.
  • The event catalyzed a major push for safety and efficacy.
• Nonprescription drugs (OTCs): less potent and less dangerous than prescription drugs
• Not regulated as tightly by HPB as prescription drugs
• Manufacturer required to show drug is safe and effective to use following labeled directions
• OTC drugs: must have standardized labeling, written in easily understood terms:
  • Ingredients
  • Uses of the product
  • Age-appropriate dosing
  • Warnings

DIN Number

• Drug Identification Number (DIN)
• A computer-generated eight digit number assigned by Health Canada to a drug product prior to being marketed in Canada
• Uniquely identifies the following product characteristics: manufacturer; product name; active ingredient(s); strength(s) of active ingredient(s); pharmaceutical form; route of administration
• DIN number appears on the stock bottle and the prescription label bottle.
• The barcode on the stock bottle also contains the DIN

FDA Medication Safety Surveillance

• All drugs: risk of toxicity.
• Adverse Drug Reaction (ADR): negative consequence from taking a medication
• ADRs are not always preventable or predictable.

HC Maintains a Nationwide drug safety review

• Adverse Event Reporting System
• Summary safety review is a short, plain language document that provides the reader with an overview of the safety issue that was reviewed by Health Canada, and the outcome of the review.
• Can recall drugs, require additional warnings be added to packaging, restrict distribution of high risk medications

MedEffect

• Provides consumers, patients, and health professionals with easy access to:
• Report an adverse reaction or side effect;
• Obtain new safety information on drugs and other health products; and
• Learn and better understand the importance of reporting side effects.
• https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html

Routes of Administration and Dosage Formulations

Routes of administration

• Way of getting a drug into or onto the body
  • Systemic effect
  • localized effect

Systemic Effect

• Route of Administration
  • Oral enteral: tablets, capsules, syrups, suspensions
  • Transmucosal: Lozenges, sprays, troche tablets (dissolving), effervescent tablets
  • Topical transdermal: Creams, ointments, pastes, patches, plasters
  • Inhalations/intrarespiratory: Dry powder inhalers, metered-dose inhalers, nebulizer solutions
  • Parenteral/injection: Injection shots, injectable pen solutions, IV solutions
  • Rectal/vaginal: rings, suppositories, solutions
  • Implants: Pumps, radiation seeds, stents, wound dressings

Inert Drug Ingredients

• Binder: promotes adhesion of the materials in the tablet
  • ex. methylcellulose
• Coating: assists the patient’s swallowing of the tablet, improves the flavor of the tablet; protects the stomach lining from the side effects of the drug; delays the release of the medication once it has been consumed
  • ex. saccharine
• Coloring: provides tablet identification
  • ex. FDA-Approved colouring agent and dyes
• diluent: allows for appropriate concentration of the medication in the tablet; provides built and cohesions
  • lactose
• disintegrant: helps break up the ingredient once the tablet has been consumed
  • ex. starch
• Lubricating Agent: gives the tablet a slippery sheen, aids in the manufacturing process
  • ex. talc
• Solubilizer: maintains the ingredient in solution; helps ingredient pass into solution in the body
  • ex. cyclodextrin
• Other than their specific purposes do not have a medical effect

Oral Routes of Administration

• Enteral routes of administration
  • gastrointestinal tract
• Topical application
• Metabolizing

Common Dosage Forms

• Tablets
  • Easier and less costly to produce
  • Sugar-coated and film coated
  • Chewable tablets can get used to treat flatulence
  • Compression tablets

Routes of Administration

Transmucosal Routes

• Sublingual route
• Buccal route
• Ocular route
• Otic route
• Intranasal route

Topical Routes

• Dermal
• Transdermal

Inhalation routes of administration

• Aerosols and metered-dose inhalers
• Inhalation solutions and nebulizers

Parenteral Dosage Forms

• Subcutaneous (subq or SC): under the skin
• Intramuscular (IM): into a muscle
• Intravenous (IV): into a vein

Drug Delivery Systems

• Liquid dosage forms:
  • Solutions
  • Suspensions
  • Emulsions
  • Colloids
  • Shake all of the above solutions do not need it

Chapter 6: Pharmacy Measures and Calculations

Numerical Systems

• Arabic
• Roman

Basic Mathematical Principles Used in Pharmacy Practice

• Fractions
  • Numerator
  • Denominator
• Decimals
  • Converting decimals to fractions
  • 0.36 → 36/100

Figuring Ratio and Proportions

• Ratios
  • Comparing in a whole
• Proportional Equations
  • Equivalent ratios

Systems for Measuring Time and Temperature

• Time
  • Greenwich mean time
  • Military time
• Temperature
  • Fahrenheit
  • F to C (F-32)/ 1.8
  • Celsius
  • C to F (C*1.8)+32

Traditional Systems for Measuring Distance, Weight, and Volume

• Old Systems

  • Avoirdupois
  • Apothecary
  • Household

• Modern Pharmacy

  • Metric
  • Meter
  • Liter
  • Gram
  • Benefits of the Metric System
  • Clear proportional correlations
  • Based on decimal notation
  • “universal language”

  

Chapter 7: Community Pharmacy Dispensing

The Roles of a Retail Pharmacy Technician

• Prescription Filling
• retail Activities
• greeting customers
• answering the telephone
• initiating refill requests
• clarifying prescription questions
• updating patient profiles
• entering and updating billing information
• affixing medication container labels
• managing inventory
• retrieving products from drug storage
• returning stock bottles to their locations
• distributing labeled and verified medications to the patient
• Transferring prescriptions to and from another pharmacy
• Ensuring accuracy of the prepared prescription
• performing a final check on the packaging or pre-packaging of drugs, container selection, and labeling

Overview of Prescription Processing

• Prescription
  • medication order
  • legally authorized prescriber
  • valid medical condition
• Definitions:
  • Prescribers information: Name, address, telephone number, and other information identifying the prescriber; NPI and ~~DEA numbers~~
  • Date: Date on which the prescription was written; this date may differ from the date on which the prescription was received
  • Patient’s Information: Full name, address, telephone number, and date of birth
  • Rx: Symbol B, from the Latin verb recipe meaning "to take"
  • Inscription: Medication prescribed, including generic or brand name, strength, and amount
  • subscription: Instructions to the pharmacist on dispensing the medication
  • Signa: Directions for the patient to follow (commonly called the sig)
  • Signature: Any additional instructions that the prescriber deems necessary Signature of the prescriber

Computer Communications and Efficiencies

• Database Management System
  • Computerized
  • Interoperability
  • E-Prescription
• Definitions
  • Identifying Information: Patient's full name including middle initial in some cases, street address, telephone number, birth date, and sex (Increasingly, some programs are entering email addresses so that refill notifications and other communications can be made.)
  • Insurance and Billing Information: Information necessary for billing
  • Medical and Allergy History: Information concerning existing conditions; for example, diabetes or heart disease, known allergies, and adverse drug reactions the patient has experienced
  • Medications and Prescription History: Any prescriptions filled at this pharmacy location; some software includes OTC medications and supplements (The pharmacy software reviews this information for the pharmacist to make sure that the prescription will not cause adverse drug interactions [i.e., negative consequences] because of the combined effects of drugs and/or other drugs or foods.)
  • Prescription Preferences: Patient preferences as they apply to prescriptions; for example, child-resistant or non-child-resistant containers, generic substitutions, large print labels, foreign language preference, and so on
  • HIPAA Confidentiality: Each new patient is required by law to receive and sign a statement of patient confidentiality, which is then documented and stored on the patient profile (This statement is for the protection of the pharmacy.)

Medication Reconciliation Process

• Drug Utilization Review (DUR)
  • Allergies
  • Adverse Drug Reaction

Technician and Accuracy Checks

• Check DIN x3
  • stock bottle
  • barcode scan
  • check again when returning to the shelf

The Pharmacist’s Final Check

• Pharmacist/Technician checks each prescription before it is dispensed
• They make sure the prescription was entered correctly, the correct drug was selected, and the correct quantity was filled for the correct patient
• They may add aux labels, as needed

Dispensing to the Patient

• After final verification and filing of the prescription, it is ready for dispensing to the patient.
• Completed prescriptions are usually stored alphabetically.
• Patients generally have at least seven days to pick up a prescription before it is returned to stock.
• Insulin and suppositories should be stored in a refrigerator once the prescription is verified.
• Antibiotic suspensions must be mixed just prior to dispensing.
• Verify the correct patient is receiving the medication using the patient’s address and birth date.
• Ask for a photo ID when dispensing controlled substances.
• Offer the patient verbal counseling from the pharmacist.
• Pharmacy technicians are not allowed to provide counseling.

Additional Health Services in a Community Pharmacy

• Medication Therapy Management Services
• Vaccinations
• Blood Pressure Checks
• Point-of-Care Testing

Chapter 8: Prescription Drug Insurance in Health Care

Rising Costs of Healthcare

• More innovative drugs
• boosting AWP
• Fewer brand names off patent

Health Insurance Components

• Commercial Insurance
• Employer-paid insurance
• Provincial/Federal Programs
  • Medicare
  • NB Prescription Drug Program

New Brunswick Prescription Drug Program

• Seniors: persons who receive Federal Guaranteed Income Supplement (GIS) from Employment and Social Development Canada are covered by the New Brunswick Prescription Drug Program (NBPDP)
• Seniors who do not receive the Federal Guaranteed Income Supplement (GIS) from Employment and Social Development Canada but whose income falls below a certain amount may be eligible for coverage under the New Brunswick Prescription Drug Program (NBPDP)
• Eligibility: Persons are >65 years of age
• Are a permanent resident of the Province
• Have a valid Medicare Care Card
• Do not have prescription drug coverage from another plan
• Nursing Home Residents
  • Individuals who reside in a registered nursing home. Eligibility for drug coverage through this plan is determined by the Department of Social Development
  • No copays for other added fees

New Brunswick Drug Plan

• The New Brunswick Drug Plan is a prescription drug plan that provides drug coverage for uninsured New Brunswick residents who have an active Medicare Card
• Costs for the patent range from approx. $5-220/ month and have copays at 30% with maximums of approx. from $4-$33/ prescription
• Responsible Payment Parties
  • First Party
  • Second Party
  • Third Party
  • Monthly Premiums
  • Insurance Policy
  • Benefits
  • Deductible
  • Copayment
  • Pharmacy benefit
  • Manager (PBM)

Commercial Health Insurance

• Health Maintenance Organizations (HMO’s): Plans that have their own staff of doctors. Patients are required to use the HMO’s doctors
• Preferred Provider Organizations (PPO’s): Plans that encourage patients financially to use doctors that have contracts with the plan. The patients costs are lower if they see in-network providers
• Traditional Insurance Plans: Patients can choose any doctor , pay at a set percentage
• Supplement Health insurance
• Other forms of health insurance
  • Workers compensation
• Pharmacy Benefit Manager (PBM)- Contracts and Reimbursements
  • different billing rates
  • annually renewable contracts
  • usual and customary charges
• Processing Prescription Drug Claims
  • Pharmacy Software
  • Online Adjudication
  • name of primary insured person
  • insurance carrier
  • patient identification number
  • group number/employer
  • date coverage became effective

Calculating Medication Quantity and Days’ Supply

• Days Supply: the correct amount of medication to fit the prescription duration until refill or end of use
  • solution and suspension formulation are different

Helping with Insurance Issues

• Why isn’t this drug insurance covered by my insurance?
• Expired?
• why isn’t the baby covered?
• the plan changed"?
• why did my copay go up

Resolving Claim Issued

• Chargebacks
  • certified of medical necessity was not completed properly
  • online processing malfunctions
  • the primary insured of a dual eligible patient was not billed
• Audits
  • ineligibility
  • incorrect day’s supply calculations
  • improper documentation

Assisting Uninsured Patients

• generic drug recommendations
• free or lower cost prescriptions- manufactured assistance programs
• drug discount coupons and cards
  • Innovicares

Chapter 9: The Business of Community Pharmacy

Nonprescription Retail Sales

• Over the counter drugs
  • increased rate of OTC sales
  • Rising cost of brand name medication
• Role of the Pharmacist
  • Counsel patients on OTC use
  • Only pharmacists can legally address questions
• Role of the pharmacy technician
  • help customers find the brands and types of medications
  • help customers understand the OTC product labels
  • cite Health Canada recommendations
• Restricted Sale of Certain OTC product
  • Schedule II drugs such as 8 mg of Codeine or less (must be documented) Plan B
  • Schedule III drug sales, such as Acetaminophen in packages greater than 50 units; vaginal clotrimazole

Complementary and Alternative Medicine

• Non Conventional treatments
  • natural products (vitamins, minerals, dietary supplements)
  • Specialized diets
  • Acupuncture
  • Meditation
• Dietary Supplements
  • Echinacea
  • Ginger
  • Melatonin

Medical and Home Health Supplies and Equipment

• Durable Medical Equipment (DME)
  • Canes/wheelchairs/walkers
  • Blood pressure monitors
  • Glucose Monitors
  • Nebulizers
  • Oxygen Equipment

Acquisition Cost and Pharmacy Reimbursements

• Acquisition Cost
• Average wholesale price (AWP)
• Pharmacy Benefit Managers (PBMs)
• Estimating Insurance Reimbursements
  • AWE x reimbursement percentage rate + dispensing fee= reimbursement amount

Inventory and Technicians

• Locate stock and label shelves
• Store products and restock
• Document reorder levels
• Check expiration dates
• Stocking prescription supplies

Pharmacy Informatics

• Productivity Reports
• Security and Stability of Information System
• Computer Maintenance

Medication Safety

• The Seven Prescription Rights That patients have
  • Right Patient
  • Right Drug
  • Right Strength
  • Right Time
  • Right Dose
  • Right Documentation
  • Right Route

Medication Error

• Preventable Event
• Inappropriate medication
• Patient harm
• Adverse drug reaction
• No national Laws
• 4 out of 250 prescriptions
• 65% of errors resulted in negative impact on patient health
• The Canadian Medication Incident Reporting and Prevention System
  • https://www.cmirpsscdpim.ca/?p=14&lang=en

Root-cause Analysis of Medication Errors

• Preventing Medication Error
  • What is the Error
  • Where did the Error Occur
  • What caused the Error
• Root-cause Analysis
  • Organizational Failure
  • Technical Failure
  • Human Failure
• Addressing Psychosocial Causes of Human Errors
  • Incomplete information Error
  • Incorrect assumption error
  • Selection error
  • Capture error
  • Rushed Error
  • Distraction Error
  • Fear Error

Root-Cause Analysis of Medications Errors

• During the computer order enter and printing of the label
• When the medication is taken for the shelf
• when the DIN/ barcode scan is verified
• During the counting of the dosage to fill the prescription
• Patient or Caregiver Drug Administration Errors
  • Writing time error
  • Extra Dose error
  • Omission error

Step-by-step Overview of filling and administration education

1. Received and Review the prescription

   1. Legibility
   2. prescriber information
   3. patient information
   4. medication information

2. Enter Prescription into the Computer

   1. Brand and generic options
   2. dosages
   3. Formulations
   4. Concentrations
   5. Increments of measure

3. Perform Drug Utilization Review and Resolve Medication Issues

   1. Repetitive drug therapies
   2. dosing ranges
   3. existing allergies
   4. contraindications in pregnancy
   5. interactions with other medications

4. Generate Prescription Label

   1. patient information
   2. label/prescription
   3. leading/trailing zeros
   4. matching data elements

5. Retrieve Medication

   1. DIN Matchups and bar Code Scanning
   2. Manufacturer’s label
   3. Label match product container
   4. Dose Strength

6. Compound or fill Prescription

   1. Increment of measure
   2. measurement conversion
   3. equipment calibration
   4. warning labels

7. Obtain a Pharmacist Review and Approval

   1. Prepared medication
   2. prescription validity
   3. patient information
   4. medication information

8. Store Completed Prescription

   1. Well-Organized System
   2. Back-up database
   3. Temperature-Controlled

9. Deliver Medication to patient or Nursing Unit for Administration

   1. New Appearance
   2. Correct Medication
   3. Instructions
   4. Expectations
   5. Everything Included

Manufacturers’ Innovations to Promotes Safety

• Improving medication Safety
  • Unique Colors
  • Different Shapes
  • Distinguishing marking
  • patient education materials

Medications Error Reporting Systems

• The Institute for Safe Medications Practices (ISMP)
  • Medication Errors Reporting Program (MERP)
  • Vaccine Errors Reporting

Health Adverse Reaction Reporting Systems

• Nationwide post-marketing surveillance system
• Canada Vigilance Program
  • adverse reaction online database
• MedEffect Canada
• Canadian Adverse Events Following Immunization Surveillance System

Safety and Controlled Substances

• Prescription and illegal drug abuse
  • drug tolerance
  • psychological dependance
  • physical dependance
  • addiction
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