Extra Notes

National Drug Code Numbers

• The Drug Listing Act of 1972 states that once a brand name or generic name drug receives FDA approval it will be assigned a unique National Drug Code (NDC) number.

• Every drug has a ten or eleven-digit NDC number divided into three sections.

                      Example:  NDC 0591-0372-01

The first section is the manufacturer or labeler code

(consisting of 4 or 5 numbers)

The second section is the product code identifying the

drug (active ingredient and dosage form)

The third section is the package code, identifying the

 package size and type

Pharmacists and technicians use the NDC number to check that the correct drug is entered into the computer and dispensed.  The product and package code are used for filling the prescription, insurance reimbursement and inventory control.

Lot Numbers

• Federal regulations state that all manufactured drugs must have lot numbers, which are assigned by the manufacturer.

• Batches of drugs that are manufactured together have the same lot numbers.

• Lot numbers allow manufacturers to easily recall specific batches of drugs.

• Lot numbers can be comprised of all numbers, or all letters, or a combination of numbers and letters

Expiration Date

The FDA states that an expiration date is the final day that the manufacturer guarantees a drug product is stable, potent, and safe to use. 

The FDA requires every drug have an expiration date displayed on the manufacturer bottle and the medication bottle.

• An expiration date of 5/2024 means that the drug can dispensed until the last day of the given month.  In this example that would be 5/31/2024.

The shelf life of a drug is the time period between the date of manufacture and the expiration date. This is the period in which a pharmacy can dispense the drug

ie) famotidine vials for injection have an expiration date at   controlled refrigerated temperature, however, at room temperature they are only good for 6 months.

ie) insulin has an expiration date at controlled refrigerated temperature, however, only good for 28 days when removed.

Drug Recalls

• When a product has been determined to be a threat to public health a drug recall will be issued and pulled off the market

• Can be issued by the FDA or manufacturer.

• The FDA issues recalls when they receive multiple reports of adverse effects or misbranding. They then contact the manufacturer to issue a recall.

Medwatch is The FDA Safety Information and Adverse Event Reporting Program.  This is a voluntary reporting system that allows any healthcare professional or consumer to report a serious adverse event associated with the use of any drug, biological device, or dietary supplement.

• Reasons for a recall: defective product, contamination, incorrect labeling, FDA interference, or improper production.

The FDA determines the class of recall that is appropriate based on manufacturer actions, the healthcare situation, and customer data from MedWatch and other sources.  

Drug recalls are categorized into three classes.

Class 1 is the most urgent and Class 3 is the least dangerous type. A Class 1 recall presents an urgent, immediate danger.

The action that should be taken is to immediately notify all patients who received the product.

An example of a Class 1 recall is some tablets are superpotent while others are subpotent.

A Class 2 recall presents an intermediate danger with a slight threat of a more serious nature In this type of recall, it is left to the pharmacist to decide how and when to notify patients. An example of a Class 2 recall is packaging that is incorrect or missing text or figures.

A Class 3 recall is the least dangerous type of recall. The pharmacist must decide how and when to notify patients. An example of a Class 3 recall is children’s medicine which contains cherry flavor instead of strawberry.

What Happens When a Drug Recall Is Declared

The manufacturer will issue a formal notice to the wholesalers, sellers, and customers; it will be marked “URGENT PRODUCT RECALL”. Important information about the recall will be provided as to why the recall has been issued. They will identify the product by description (name, dose, dosage form), NDC number, lot number and package size, expiration date.

Pharmacies have specific policies and procedures in place to ensure that the recalled drug is pulled from the shelves, documented, and returned based on recall procedures.  This includes notifying the manufacturer and the FDA of compliance with the removal of the recalled drug.

The pharmacy is required to contact affected patients in a Class I recall.  In these cases the pharmacy or doctor’s office will contact the patient to check the lot number of the dispensed medication and the media will be used to alert the public.

If a patient has the recalled drug they are asked to return the medication for replacement.

FDA market withdrawals can happen when a product has a minor violation that does not require legal action, but the product still must be removed from the market to correct the violation.

Recalled medications should be placed in a designated area until they are returned or disposed of as required by the recall notice.

The form is then returned to the wholesaler with any recalled drug stock items.

If the recalled product is not in stock, the pharmacy must still send the recall form back to the manufacturer

Retail pharmacies generally have a return and refund policy in place when a company announces a product recall.

How Does a Drug become and Drug

Prescription Drug Approval Process

• 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.

  The Kefauver-Harris Amendments of 1962 were passed in response to the birth of thousands of infants—mostly in Europe—with severe abnormalities resulting from mothers who had taken a new tranquilizer called thalidomide while they were pregnant.

Investigational New Drug Application (INDA)

• Submitted to FDA after extensive animal trials

• Detailed description of proposed clinical studies in humans

• Why there is a need for the drug

• How it will be manufactured

• If FDA sees promise for treating devastating disease (HIV), it can fast-track

• FDA responsible for ensuring approved drugs are both safe and effective

• Drugs undergo lengthy research process before they come to market

• Center for Drug Evaluation and Research

A pharmaceutical company must do extensive preclinical laboratory research on animals before an investigational new drug (IND) application can be officially initiated with the FDA.

In its application, the developer must offer a compelling case for the human need for the drug, the results of the animal studies, an explanation of how the drug would be manufactured, and a detailed description of the proposed clinical studies on humans.

Drug Development Phases

• Drug Development Phases

1.Preclinical

• Compound developed and then tested on animals for toxicity

• Pharmacokinetic properties of the drug

2. Investigational New Drug Application (IND)

Clinical 

• Institutional Review Board (IRB)

• Informed Consent

  3. New Drug Application

–  Once clinical trials are complete, the sponsor files the NDA with the FDA.

–  NDA consists of all test results and proposed labeling.

      4. New Drug Application Review

–  Approval or rejection

The drug approval process can be broken down into four phases. In the preclinical phase, the compound is developed and then tested on animals for toxicity. If major risks or early toxicity markers are not seen, the drug sponsor submits an investigational new drug application to the FDA. The second phase is the clinical phase. This is when clinical trials are conducted on human volunteers. The third phase is the New Drug Application review. This phase occurs once clinical trials are complete, and the sponsor files the NDA with the FDA. The NDA consists of all test results and proposed labeling.

Clinical Trial

“Any research study that prospectively assigns human participants to one or more health-related interventions to evaluate the effects on health outcomes”

•  Clinical Trials are conducted to gather data regarding the safety and efficacy of new drugs

• Institutional Review Board (IRB) also known as the Human Use Committee

  • Scientists, practitioners, and consumers

  • Review, approves, and monitors all medical research involving humans

       –  The proposed studies must meet scientific and ethical 

            standards to be approved

• Informed consent

 – a document that states the purpose and risks of study in layman's 

    terms

Human Clinical Trials Testing

Clinical trials of new drugs proceed through four phases. In phase 1, the drug is tested on a small group of 20 to 100 healthy people. It evaluates safety, determines a safe dosage range, and identifies side effects. In phase 2, the drug is tested on patients who have the condition being treated. The goal in this phase is to determine whether the drug has a favorable effect. Phase 3 is when double-blind, placebo-to-drug or standard of care to drug comparisons occur. Dose escalations are used in this phase to determine efficacy. Phase 4 trials evaluate safety and how well the drug works in the real world. This last phase is also known as postmarketing surveillance.

New Drug Application 

• Once clinical trials are complete, the applicant files the New Drug Application (NDA) to the FDA

• It consists of all test results and proposed labeling

• Only 1 in 10,000 drugs make it to this phase

• May take 15-20 years to get to this phase

During clinical trials, patients are typically separated into two groups. The experimental group receives the drug being tested, while the control group receives standard treatment or placebo. A placebo is an inactive substance that the patient believes is a medication but that has no pharmacologic effect. In general, neither trial participants nor the study investigators know whether a particular participant is in the experimental or the control group. This type of study is called a double-blind study. It is considered the gold standard of clinical trials.

Clinical Trial

- Experimental Group: receives the drug being tested

-Control Group: Receives standard treatment or placebo

After the government approves a manufacturer’s IND, a drug must pass through three phases of testing on human subjects before it is ready for final review by the FDA.

Abbreviated New Drug Application (ANDA)

• Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman)

• Generic drugs must have same active ingredient, dosage form, and strength

• Must prove bioequivalence to brand

  • How much of the drug is absorbed, distributed, metabolized, and eliminated

Generic Drugs (Continued)

• A/B rating system for generic drugs

  • A rating - equivalent to the reference drug product in terms of pharmaceutical equivalence, bioequivalence, labeling and Current Good Manufacturing Practices

  • B rating - not therapeutically equivalent to the reference drug product

  • Information published in the FDA’s Orange Book

The FDA has devised an A/B rating system to establish the therapeutic equivalence of generic drugs. An A rating indicates that the drug is therapeutically equivalent to the reference drug product in terms of pharmaceutical equivalence, bioequivalence, labeling and Current Good Manufacturing Practices. A B rating indicates that the drug is not therapeutically equivalent to the reference drug product. This type of information is published in the FDA’s Orange Book.

Fast Track Process

• According to the FDA, fast track is a process created to support the development “and expedite the review of drugs to treat serious conditions and fill an unmet medical need.”

• In 1997, The FDA created a program in which new drugs could get to patients faster than through the standard review programs already in place.

• Under the program, drugs can be designated fast track if they meet two criteria:

  • Criteria 1: The drug must show promise in treating a serious, life threatening condition.

    • The drug must show an impact on factors such as day-to-day functioning and patient survival.

  –    Criteria 2: The drug must have the potential to address an unmet medical need.

• So no other drugs or treatments exist, or if one exists, a fast-track drug must show some advantage over those available treatments

• The purpose of fast tracking is to get important new drugs to patients earlier

• Drug companies can file for fast track approval at any time during a drug’s development.

  • The FDA reviews the request and makes a decision within 60 days based on whether or not the drug fills an unmet medical need of a serious condition.

  • Once the FDA approves an application into the program, it remains in close contact with the drug company during the approval process

Pharmacy Operations (Retail) 
These types of pharmacies provide pharmaceutical services and products to the general public.

The term "retail pharmacy" is often used to highlight the location (commercial or retail settings). The emphasis on "retail" emphasizes the business where they catering to a broad customer base and providing various over-the-counter products in addition to prescription medications.

On the other hand, the term "community pharmacy" often emphasizes the pharmacy's role within the local community. It underscores the importance of these pharmacies in providing accessible healthcare services to the community they serve. Community pharmacies are deeply integrated into the neighborhoods they serve and often foster close relationships with their patients.

Types of Pharmacy and What They Do

• Dispense Prescription Medications 

• Provide Over-the-Counter (OTC) Drugs 

• Health and Wellness Services

• Durable Medical Equipment (DME)

• Payment and Insurance Processing

• … and much more!

Retail Pharmacy Facilities
Two Store Areas:

1. Unrestricted Area:  OTC

    Medical Supplies

    Dietary Supplements

    Other Merchandise

2. Restricted Area:     Restricted to pharmacy personnel ONLY

    Prescription medications are stored and prepared for dispensing

    Secured area- off limits to friends and family

• A pharmacy counter or a transparent shield divides the two areas.

• If there is no pharmacist on duty the pharmacy must be closed and locked

The Roles of a Retail Pharmacy Technician
Roles and Duties:

• Prescription filling

• Retail activities

• Greeting customers

• Answering the telephone

• Initiating refill requests

• Clarifying prescription questions

• Updating patient profiles

• Entering and updating billing information

• Non-sterile compounding

• Entering new prescriptions

       –   Submitting online prescription claims

• Resolving eligibility and processing issues with insurance companies

• Counting, reconstituting, packaging products

• Affixing medication container labels

• Retrieving products from drug storage 

• Returning stock bottles to their locations

• Distributing labeled and verified medications to the patient

• Storing completed prescriptions

• Retrieving medications at pickup

• Offering a medication counseling opportunity for patients

• Accepting payments and co-payments

• Business Operations:

  • Handling insurance processing and chargebacks

  • Selling non-prescription products, dietary supplements, supplies

  • Ordering and receiving drug inventory

  • Organizing and stocking shelves

  • Help maintain a clean work environment:  vacuuming, cleaning counters and counting trays, bundling and removing trash, securing the disposal of patient specific information

   

Prescription

• Medication order

• Legally authorized prescriber

• Valid medical condition

To fill prescriptions every person involved in the filling process needs to be accurate and efficient.  Teamwork and communication between the pharmacy technician and the pharmacist is necessary to ensure our due diligence is done every time a prescription is filled.

Database Management System (DBMS):  pharmacy 

oriented computerized information system that

integrates and interfaces (communicates) with the 

many different software programs needed for 

pharmacy operations and online transmissions and 

Networking.

Pharmacy Software Interoperability: the ability to 

exchange and process information between various

internal and external databases, software, and 

technology. Creates the possibility of working together between different 

pharmacy functions and out-of-pharmacy stakeholders; prescriber and insurance representatives.


Types of Prescriptions

• E-prescriptions

• Written prescriptions

• Telephone

• Fax Orders

• Prescriptions on file

• Refill requests

• Partial fill

• Emergency Refills

• Transfer prescriptions
  
  E- prescriptions
  Approximately 70% of prescriptions are communicated from the prescriber to the pharmacy digitally via the internet. 

• Prescriptions are transferred to the pharmacy computer through a healthcare interface network (Surescripts and RxHub)

(+) speed

     accuracy

     improved billing

     minimizes risk of medication errors: handwriting, misinterpretation of abbreviations, 

     decreased wait time for patients

CS e-prescribing: reduced forgeries; must have a DEA number and state eligibility for prescribing, controlled-substance identity authentication and a protected software program

Written prescriptions

Always call if clarification is needed

• Hard copy of prescription will be scanned into the compute

Medicaid Prescriptions and Tamper Resistant Prescriptions

• CMS (The Centers for Medicare and Medicaid Services ) requires all medicaid scripts be written on tamper resistant prescription pads.

• TRP (Tamper-Resistant Prescription) is specifically designed to prevent copying, erasing or alteration

• If an  audit reveals that scripts were not written on TRP or authenticated by pharmacy personnel, claims for reimbursement can be denied.
  
  Telephone Prescriptions
  
  Telephone prescriptions must be taken by the pharmacist over the telephone. The pharmacist transcribes the telephone order onto a prescription pad and will verify it for accuracy.
  
  Partial Fills

  A partial fill refers to dispensing only a portion of the prescribed quantity of a medication at one time, with the intention of dispensing the remaining quantity at a later date. 

  
  

  Partial fills are often used for various reasons, such as 

  • medication shortages, 

  • insurance limitations, or 

  • when the patient does not need the full quantity immediately. 

  
  Before a partial fill, the pharmacy must communicate with the patient to determine if a partial fill is acceptable and appropriate for the medication in question. The patient's consent is essential before proceeding with a partial fill.

  
  Then, the pharmacy team documents the partial fill in the patient's medication profile and dispenses the medication noting the quantity dispensed and the remaining quantity that is available for future refills.

  
  Patient Profile Database
  
  The patient profile is the confidential data file in the pharmacy software that contains the customer’s demographic and insurance information. The profile lists all the prescriptions that have been dispensed at that particular pharmacy for that particular patient.
  

Every pharmacy patient must have a current, updated profile to have a prescription filled.

Essential Components of the Patient Profile:

Patient demographics

Insurance and billing information

Medical and allergy history

Medication and prescription history

Prescription preferences

HIPPA confidentiality

HIPAA Requirements:

Patients must be given a copy of the pharmacy’s personal information privacy policies to comply with the Health Insurance Portability and Accountability Act (HIPAA).

Patients will need to sign off that they have received the notice and this is usually scanned into the computerized patient profile.

Medical Reconciliation:

Medication reconciliation is a process used to prevent medication errors and ensure that a patient's current medication regimen is accurately documented during transitions of care. While it is commonly associated with hospitals, it is not exclusive to hospitals.

The goal of medication reconciliation is to prevent discrepancies in medication lists and avoid adverse drug events due to incomplete or inaccurate medication information. It promotes patient safety and improves communication among healthcare providers across various settings, ultimately leading to better healthcare outcomes.

Where does it occur?

Hospitals: 

Medication reconciliation is extensively practiced in hospitals during admissions, transfers, and discharges, as these are critical points where medication information can be prone to errors.

Primary Care Settings: 

Medication reconciliation is crucial in primary care clinics, where patients may receive prescriptions from multiple providers or change medications over time.

Outpatient Clinics: 

Ambulatory care facilities, such as specialty clinics or community health centers, also conduct medication reconciliation to ensure patients' medication lists are up-to-date.

Long-term Care Facilities: 

Nursing homes and assisted living facilities use medication reconciliation to manage medications for elderly or long-term residents.

Home Health Care: 

When patients transition from hospitals to home care, medication reconciliation ensures continuity and safety.

Pharmacies: 

Pharmacists play a vital role in medication reconciliation by reviewing patients' medication histories and reconciling prescriptions during dispensing.

Emergency Departments: 

When patients arrive at the emergency department, medication reconciliation is essential to provide immediate and accurate care.

Drug Utilization Review (DUR): scans the patient profile to identify any possible interactions/concerns that could occur as a result of the new prescription.

• Allergies

• Adverse drug reactions (ADR)

• Medical conditions

• Duplication

• Subtherapeutic or toxic doses

• Drug interactions

• Vulnerable patient populations

After an initial review of the prescription and completing or updating the patient profile, the technician enters the new prescription into the profile via inputting or scanning. 

The correct entry of the prescription is so critical because many drugs have similar names, and the incorrect drug or dose can be easily chosen from the dropdown menus in the computer database.

The first step is to run the drug utilization review which scans the patient profile to identify any problematic interactions that could occur as a result of the new prescription.

When the D-U-R detects potential problematic reactions, it offers warning alerts and action steps.

A D-U-R might detect an allergy or an adverse drug reaction.

Once a DUR message appears, the technician must show it to the pharmacist, who will then guide and help the technician to review and resolve the problem.

DURS:

1. administrative: NF- non-formulary

2. dosing/limits: HD: high LD: low NS: non-sufficient

3. drug conflict: DA, DD, ID ( ingredient duplication), TD ( therapeutic duplication)

4. DX management

5. Precautionary: SE ( side effects)
   

• A clinical DUR will give alerts/codes to alert the pharmacist to a potential adverse drug reaction. 

• DURs help address two main practice issues:

1. No one can remember all information provided

2. Patients often go to multiple pharmacies and physicians

• Pharmacy software catches issues regarding the patient profile

• Insurance software catches problems with medications received at other pharmacies.

• Notifications are categorized by potential severity: mild, moderate, and severe

Three Outcomes: 

1. Contact prescriber

  2. Counsel patient on potential issues prior to dispensing

  3. Override DUR and fill RX as is

What is the role of the pharmacy technician?

• contact other health care facilities, pharmacies, and providers for

       medical records

• meet with patients to assess their medication adherence and    

document any discrepancies for the pharmacist to review 

• forward any medical concerns or medication questions to the 

pharmacist

• to obtain the patient’s pharmacological history
  

Medical Selection:

1 in 4 filling errors is due to confusion of medication names.  This is preventable when using NDC checks.

Possible errors can occur in stock selection: wrong dose, wrong package size, products that look alike, LASA, different formulations (SR, XL,XR,DR)

Stock Selection and Medicine Preperation:

1. Retrieve correct stock bottle and verify NDC

2. Select the appropriate size medication container

3. Fill the prescription with appropriate number of units

4. Label the bottle

5. Return stock bottle to proper location

Dosage Forms/Dispensing:

Tablets and Capsules: most common drug form; clean the trays and spatulas with 70% isopropyl alcohol throughout the day.  The powder residue is known to cause allergic rxns (sulfa, pen, ASA)

Liquids: sometimes dispensed in original containers or poured into dispensing bottle; reconstituted liquids; flavoring 

Choose proper medication container: vials or bottles; amber colored; child resistant containers

Handling Prepackaged Drugs:

Manufacturer prepackaging is provided for prescription products such as otics, ophthalmics, suppositories, creams, ointments, respiratory and nebulizer drugs, syringes, MDI, and oral contraceptives. These are commercially available as Unit-of-Use Packaging:

• Fixed number of dosage units, sealed together in prepackaging

• The prescription label is attached directly to the product or box.

• Simplifies the filling process by eliminating the counting step

• The pharmacist must still check and approve the medication label, and ensure the proper drug, dosage form, and amount are chosen.

Unit-Dose Packaging (single dose): each unit dose of a tablet or capsule is a single dosage that is individually packaged in sealed foil and considered tamper-resistant. When dispensing these are usually placed in a vial or resealable bag with the prescription label attached. The unit-dose packaging label must include the manufacturer’s name, lot number, and expiration date in addition to the drug’s name and strength

(ex) ondansetron 4 mg ODT, suppositories, migraine meds

Automated Filling Technology:
High volume pharmacies

• Mail order pharmacies

• Provides greater speed and accuracy in filling

• Lowers cost per prescription 

      by reducing manual fills

• Reduces the time in counting, labeling

• Increase in medication safety by integrating barcode technologies

Automated Scales:
Medications that often require over 100 units

•   Never for controlled drugs

•   Must be calibrated and documented daily

•   Linked to DBMS

Internal scales that take into account the weight per unit of an individual tablet or capsule based on 10 dosage units, however, are not 100% accurate

Or 

Visual-precision counting equipment (Eyecon), 99.99% accurate; uses scanner technology 

Technician and Accuracy Checks:
Check NDC three times

1. Stock Bottle when initially pulled from inventory

2. Time of preparation

3. Check again when returning to the shelf

Medication Container Labels: reinforce dosage instructions of the prescriber.

Take as Directed (TAD):

1. Verify that prescriber gave the pt sufficient directions and match with usual directions

2. Call prescriber for specific directions, document on RX

3. If left TAD have RPh counsel patient on use

Medication Container Label

• Prescription serial number

• Pharmacy’s name, address phone #

• Patient name

• Prescriber name

• All directions  for use given on RX

• Medication strength

• Drug manufacturer’s name

• Drug quantity

• Drug expiration date or date after which drug should not be used

• Initials of licensed RPh

• Number of refills

• All necessary auxiliary labels

Auxillary Labels
Colorful labels used to highlight, provide additional information or reinforce information.

• Must prioritize which stickers to use because of limited space

• Never place stickers over drug names or expiration dates

• CII - V must have transfer warning

Patient Package Inserts:

Patient Package Inserts (PPIs) are required by the FDA for some potentially dangerous drugs and have information for patients on how to safely use the medication.  Oral contraceptives and estrogen-containing products are types of medications with PPIs; PPIs must be provided with the first dispensing and also with refills if 30 days has passed since the patient received a PPI. PPIs are part of the FDA-approved labeling

Medication Information Sheet

Preprinted sheet from the manufacturer or from the pharmacy software.  Goes out with each new prescription.  Tell the patient how to safely take the medication and what to expect and watch for.  May also include product identification.

Ingredient name    common uses    before using this medication   

How to use this medication    cautions     possible SEs    overuse

                                 Additional information

Medication Guides

• Enlarged FDA boxed warnings that advise consumers on potential adverse reactions or safe usage instructions. 

• MED Guides go into more depth than information sheets 

• NSAIDs, antidepressants, birth control

• Goes to patient with each fill

• If not dispensed pharmacy may besubject to fines

REMS

Targeted Risk Evaluation and Mitigation Strategies

• Certain drugs that are particularly dangerous for certain populations.  

• The FDA requires the manufacturers to develop extra strategies to ensure that the benefits or the drugs outweigh the risk.

• These high-risk drugs will require additional verbal and written communication and monitoring.

• Patients, prescribers, and pharmacies must be registered or certified, in order to, receive, prescribe or dispense these drugs.

• ex) Accutane (isotretinoin)/Ipledge, Bydureon, Suboxone, and Tikosyn

The Pharmacist’s Final Check:
Pharmacist checks each prescription before it is dispensed ( it is important and required by the law)

• The pharmacist makes sure the prescription was entered correctly, the correct drug was selected, the container is labeled correctly and the correct quantity was filled for the correct patient.

• Pharmacist may add auxiliary labels, as needed

Dispensing to the Patient

• After final verification of the prescription, it is ready for dispensing to the patient. Pt oftens receives a text or phone all notifying RX is ready for P/U

• Completed prescriptions are usually stored alphabetically. 

• Patients generally have 14 days to pick up a prescription before it is returned to stock. Insurance claims must be reversed.

• Insulin and suppositories should be stored in a refrigerator once the prescription is verified.

• Antibiotic suspensions must be mixed just prior to dispensing. SHAKE WELL

• Medicals errors often occur at pick-up. 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.  Signature required.

• Let patient know if the RX is a partial fill or if there has been a change in the manufacturer

• Offer the patient verbal counseling from the pharmacist.

• Pharmacy technicians are not allowed to provide counseling.

Additional Health Services in
Community Pharmacy

• Vaccinations

• Blood pressure Checks

• Blood glucose Checks

• Point-of-Care testing

• Smoking cessation

• Medication Therapy Management Services
  

  Medication Therapy Management:

  • Medication therapy management (MTM)

    • A patient-focused, multistep process in which a pharmacist meets with a patient and/or consults their primary healthcare provider to offer recommendations concerning the patient’s medication therapy for better results

    • Also called medication management services
      

• Potential types of recommendations 

  • Using less expensive medications

  • Identifying potential medication interactions or adverse reactions

  • Counseling on the best use of medications and durable medical equipment

  • Counseling on complying with the medication regimen

  • Providing information regarding disease-state management

• Recognition of MTM

  • Pharmacy benefit managers

  • Insurance companies

  • Federal law

  • Professional organizations

• Federal law such as the Medicare Modernization Act of 2003 supports MTM and has identified specific goals related to this practice.

• Goals of MTM identified by the Medicare Modernization Act

  • To provide patient education and increase patients’ understanding of their medications

  • To improve medication compliance and adherence

  • To detect adverse reactions and the misuse of medications

• Requirements of MTM

  • Professional judgment

  • Special knowledge

  • Pharmacist’s education, training, and licensure

  • Significant communication and documentation

• Roles of the entry-level pharmacy technician

  • Scheduling

  • Coordinating patients

• Roles of the experienced pharmacy technician

  • Scheduling

  • Coordinating patients

  • Collecting data

  • Conducting research

  • Constructing charts

  • Identifying health histories

  • Recording documentation

  • Managing billing

Common Data Points in MTM

• Patient name

• Medical history

• Patient address

• Current medication regimen

• Date of birth

• Adherence information 

• Gender

• Additional patient information 

• Medical ID/Record Number

• Primary care provider

• Height

• Lab tests and values

• Weight

• Follow-up information 

• Telephone contact

• MTM is a process during which a pharmacist meets with a patient and/or consults their primary healthcare provider to offer recommendations concerning the patient’s medication therapy for better results.

• Depending on experience, roles for the pharmacy technicians include scheduling, coordinating patients, collecting data, conducting research, constructing charts, identifying health histories, recording documentation, and managing billing. 

• Various data points are collected during interviews to help the pharmacist in making appropriate recommendations. 

Point of Care Testing

• Diagnostic testing which requires more oversight than screenings.

• Most sites that provide these services must receive a waiver from the CMS.

• Typically a patient provides a blood sample (finger prick) and then it is analyzed on site quickly.

• Examples: blood glucose; hemoglobin A1c (for diabetic patients); cholesterol profiles; and anticoagulation measurements.

• These quick results enable healthcare providers to make rapid treatment decisions

• Those that perform these tests require additional OSHA training, OSHA Bloodborne pathogens

Rx Insurance

Rising Costs of Healthcare:

• More innovative drugs

• Boosting AWP

• Fewer brand names off patent

• Overall pharmaceutical expenditures in US were $633.5 billion in 2022

The cost of health care, especially prescription drugs, is far outpacing the rate of inflation. In 2017, spending on prescriptions in the United States was $456 billion.

Costs have continued to rise. The reasons include an increase in innovative and expensive new drugs, manufacturers boosting the average wholesale prices (also known as A-W-Ps) of brand name drugs and generic brands; and fewer brand name drugs coming off patent. 

The A-W-P is the average price that pharmacies, hospitals, and other

healthcare facilities pay for stock of a specific drug. The A-W-P serves as the benchmark from which insurance companies estimate the percentage of pharmacy reimbursement.

The pharmacies then use the A-W-P to determine the retail price for patients.

Health Insurance Components:

• Commercial insurance

• Employer-paid insurance

• State/Federal programs

  • Medicare (Parts A, B,C, D)

  • Medicaid

  • Tricare

  • Children’s Health Insurance Programs 

Health insurance helps patients cover incurred medical costs for such items as pharmaceuticals, physician visits, laboratory costs, and hospitalization.  

Healthcare coverage in the United States may be provided by commercial insurance, which is paid by the individuals being insured; through their employers with shared premium costs; or by one of the state or federal programs:

Responsible Payment Parties: 

• First Party

• Second Party

• Third Party

The first party responsible for covering a medical bill is typically the person who directly receives the benefits, services, or product. In some cases, a parent, guardian, or other responsible party is considered the first part.

The second party is the healthcare provider. 

The third party is an organization other than the patient or healthcare provider involved in paying for medical expenses. Third party payers include insurance companies,government agencies, or individual employers.

Most of the prescription costs in the US are covered by third-party health insurance.

• Monthly Premium – fee for insurance coverage

• Insurance Policy – statement of benefits

• Benefits - specific health services and products covered

• Deductible – amount you must pay before insurance pays

• Copayment – the amount you pay for a healthcare service

• Coinsurance - specific %’s that insured must pay immediately when receiving a service or drug

• Pharmacy Benefit Manager (PBM) - companies that manage prescription drug benefits on behalf of health insurers

Copayments:

• Flat out-of-pocket fee that the patient is required to pay for each health visit, sevice, or product at the time of delivery; varies with each plan

• Copays vary by insurance companies

Tiered Copayment System:

1. Dual Copay: generic and brand

2. 3 to 4 Tiered Copay:  generic, preferred brands, nonpreferred 

                           brands, and specialty drugs

( health savings accounts) HSAs help pay for costs not covered in high deductible plans.  These type of plans can be started by the patients or the employers who will set aside tax-deferred money for healthcare costs not covered by insurance.  

*may accumulate from year to year

( flexible spending accounts) FSAs help pay for medical expenses and child and dependent care.  This money will need to be spent within the year however some plans do allow for a $500 carry over.

Insurance Billing Codes:

All insurance companies use established billing codes to communicate between providers and insurance plans. 

Three Types

1. ICD-10 (International Classification of Diseases, 10th edition) used to record diagnoses and disorders

2) HCPCS (Healthcare Common Procedure Coding System) used to    

       record supplies, equipment, and devices supplied for medical 

       purposes.

3) CPT (Current Procedural Terminology) used to record procedures 

       and services

Affordable Care Act:

• Requires  employers with more than 50 full-time employees to offer a health insurance option.

• Enacted to help U.S. citizens struggling with the rising cost of healthcare to have health insurance to help them with medical expenses and prescription drugs.

Commercial Health Insurance

Most patients have commercial insurance—or nongovernmental, private insurance— that they pay for on their own or that is subsidized by their employers as a benefit to employees and retirees. The employer contracts with the insurance company or companies to offer certain plans.

Many insurance and healthcare companies are seeking ways to cut costs by limiting

patient health choices to those contracted to be the most cost-efficient. These managed care organizations (  or M-C-Os) utilize preferred drug formularies and providers. Managed care insurance plans come generally in two types: HMO or PPO.

• Supplemental Health Insurance

  • Primary

  • Secondary 

• Other Forms of Insurance

• Workers’ compensation

• Consolidated Omnibus Budget Reconciliation Act (COBRA)

  The Consolidated Omnibus Budget Reconciliation Act (COBRA) mandates that an employer must retain its former employees in its coverage plans to allow transition to their next jobs without loss of health insurance.
  

Health maintenance organizations (HMOs) require members to get services and products only through their staff or contracted providers and facilities. Will require a referral from their primary physician.

Preferred provider organizations (PPOs) have some elements of the HMO model but with more choice. PPOs have tiered coinsurance percentages that

favor preferred in-network providers ( or those with whom the insurance company has a working contract) over out-of-network providers ( or those who have no contract with the insurance company).

Government Insurance Plans

Medicare Part A:

• Covers 80% of hospital stays

• Limited coverage of nursing homes or rehabilitation facilities

• Premium same for everyone over 65 regardless of income/assets

Medicare Part B:

• 80% of doctor's visits after small deductible is met

• Monthly premiums same for everyone

• Does not cover prescriptions

• Covers preventative medicine at 100% (vaccines & screenings)

• ICD-10

• Covers nebulizer, nebulizer solutions, insulin for pumps, diabetic test strips, durable medical equipment (DME)

*You will need the Healthcare Common Procedure Coding System (HCPCS) and ICD-10 code to bill Medicare Part B for diabetic test strips.

*A patient is ready to apply Medicare B insurance coverage to the purchase of medical supplies for diabetes. What is often required? A certificate of medical necessity (CMN) from the prescriber and ICD-10 diagnosis code.​

Medicare Part C:

• Comprehensive Program

• Patient does not need 3 separate plans

• Administered by private HMOs, PPOs, and fee for service plans

• Also called Medicare Advantage

Medicare Part D:

• Prescription drug insurance

• Contracts with private insurers to administer the program

• Copays, formularies, and premiums vary

• Deductible $505

• Patients have copay for first $4,430 then there is a coverage gap or "Donut Hole"

Medicaid:

• Run jointly by federal and state governments

• Covers eligible disabled, low-income, part-time, and unemployable state citizens of any age

• Some patients are "dual eligible" for Medicaid and Medicare

Tricare:

• Administered by Defense Health Agency (DHA)

• For active and retired military personnel and their families

• Financial incentives to use VA mail-order service

• Tricare Prime

• Tricare Select

Affordable Care Insurance Exchanges:

• The Affordable Care Act established Healthcare Exchanges so that eligible individuals can shop and compare different insurance plans.

• The monthly premium is based on a sliding scale related to one’s income

• This is for uninsured individuals, self-employed individuals and part-time individuals.  Provides a group discount and government subsidies

• Enrollment from November 1st thru January 30th

Insurance and Patient Responsibilities:

( Pharmacy Benefits Manager):

• Responsible for the processing of prescription drug claims.

  ex) Merck, Express Scripts International, CVS Caremark

• Each PBM has a Preferred Drug List – a formulary of medications that are fully covered or covered at a lower cost

• Using the formulary and the insurance policy the PBM processes insurance drug claims and pharmacy reimbursements

• Pharmacies have contracts with each PBM to provide prescription benefits at specified reimbursement rates to insurance enrollees managed by that PBM.  These rates are usually based on Usual and Customary Charges and the pharmacy dispensing fee

Processing Prescription Drug Claims:

• Processing Prescription Drug Claims

  • Pharmacy software

  • Online Adjudication – electronically submitting prescription claims to the PBM for its judgement on whether or not it will provide reimbursement.  Usually takes 30 seconds.

To work successfully in any community or mail-order pharmacy, technicians need to process drug claims on the spot with great efficiency— while the patient is watching and waiting.

Pharmacy software differs, but, in almost all cases, billing involves direct online transactions between the pharmacy and the customer’s insurance

PBM. The procedures to bill online PBMs for commercial insurance, federal or state governments’ plans, or workers’ comp are similar but not

identical. 

Online adjudication refers to the process of electronically submitting prescription claims to the appropriate P-B-M for its judgment on whether or not it will provide reimbursement. It usually takes less than 30 seconds to receive a reply.

Information on an Insurance Card:

• Name of the primary insured person

• Insurance carrier

• Patient identification number (ID)

• Group number

• Bank Identification Number (BIN), designating the pharmacy benefit manager, routing number

• processor control number (PCN), designating the kind of plan

• Date coverage became effective

• Person Code :

Represents the patient’s relationship to the cardholder

• 01 = cardholder

• 02 = spouse

• 03 = 1st born child

• 04 = 2nd born child

• 05 = 3rd born child, etc
  

Catching and Fixing Processing Errors:

1. ID Number issues

2. Name discrepancies

3. DOB discrepancies

4. Person Code

5. Prescriber NPI Issues

6. Out-Of-Network prescriber

7. DUR (Drug interactions)

8. Prior Authorizations

9. Refill to Soon/Exceeds max allowed refills/exceeds max qty

10. Incorrect Days Supply

11. Non-Formulary Drug
    
    

Prior Authorizations:

Resolving Claim Issues:

• Not covered without additional rationale from provider

• Drug might be atypical for the patient’s age, gender, or condition; not on the PBM formulary; pt already prescribed a similar drug; or continued used exceeds the medication’s short-term use recommendations

• Pharmacy lets the provider know the drug requires PA (electronically)

• Provider contacts the PBM and provides rationale

• Often take 72 hours or longer to resolve

• May be denied or approved

• The drug may have been previously approved and at a later date receive a PA

• Charge-backs

  • Certificate of medical necessity was not completed properly

  • Online processing mistake

  • The primary insurer of a dual eligible patient was not billed

• Audits

  • Ineligibility

  • Incorrect day’s supply calculations

  • Improper documentation

There are times when a claim is approved online and the prescription is filled and picked up by the patient, but later the P-B-M refuses to pay the claim.

The technician is often involved in resolving these “post-claim” functions: charge-backs and audits.

A charge-back is a post-claim rejection of a prescription claim by a PBM or insurance

provider that must be investigated and, if possible, resolved by the pharmacy technician. A charge-back may occur if The certificate of medical necessity for diabetes supplies was not completed properly or online processing was not functioning due to an internet malfunction or the primary insurer of a dual eligible patient was not billed or was billed second instead of first.

Assisting Uninsured Patients:
Generic Drug Recommendations

• Free or Lower-Cost Prescriptions

• Drug Discount Coupons and Cards

• Low-Fee and Charity Clinics
  

  Despite the passage of the A-C-A, approximately 10% of people in the United States still do not have any type of health or drug insurance. 

As a technician, there are steps to take when patients come in with prescriptions that they can’t afford.  Technicians can suggest various options to patients to make their prescription or drug therapy more affordable. Some suggestions include:

1. A generic drug is almost always dispensed if available, but prescribers sometimes forget that not all drugs have generic equivalents, so a call to the prescriber may sensitize them to the situation and have them consider a lower-cost, therapeutically equivalent drug.

2. Some pharmacies may advertise a list of “free” or low-cost prescriptions, usually for short-term antibiotic therapy.

Sometimes drug companies offer discount coupons for their products to prescribers or providers. Pharmacy technicians can check at their store or online as well as call the provider’s office to see if they have any

available.

3. Technicians may also refer patients to free or low-cost charity clinics voluntarily staffed by doctors, nurses, dentists, and pharmacists, offering medical, dental, or even pharmacy services.

Medications Not Covered by Insurance:

If a PBM does not cover a particular medication there are 3 options:

1. Pay the out of pocket costs

2. Place the prescription on file 

3. Request a less costly alternative if available from the prescriber (either the patient or the RPH)

Goal is to capture the claim and achieve reimbursement

Coordination of Benefits:

COB is the filing of multiple insurances or coupons in the correct order. (primary, secondary, manufacturer coupons, workman’s comp)

Insurance Fraud

• The filing of a false claim

• Subject to civil and criminal penalties if it is confirmed, and employment termination

• ex) post-billing

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 formulations are different.

  • Suspension = 15 drops/ml

  • Solution = 20 drops/ml

Dispense as Written (DAW) Codes

• DAW 0 = no product selection  

                specified (generic is given)

• DAW 1 = prescriber requests brand

• DAW 2 = patient requests brand

• DAW 9 = insurance requires brand
  

Suppositories

A suppository is a semisolid dosage created from a soft inactive base ingredient (cocoa butter or glycerin) that is formulated to melt at body temperature and release an active drug.

Uses of Suppositories
May have a localized or systemic effect

• an oral drug might be destroyed or diluted by acidic fluids in the stomach

• an oral drug might be too readily metabolized by the liver and eliminated from the body

• a patient is unconscious

• a patient may be unable to take oral drugs because of nausea and vomiting or because of severe acute disorders of the GI tract.

Disadvantages

• patient inconvenience and discomfort

• premature expulsion of the suppository

• erratic and irregular drug absorption

3 Routes of Adminsitration

Rectal: treatment of hemorrhoids (swollen clumps of veins in the rectum) and ulcerative colitis (sores in the large intestine); used  to cleanse the bowel (laxative). In children glycerin suppositories (mild constipation) and acetaminophen suppositories are used. For adults, promethazine suppositories (nausea and vomiting) and hydrocortisone suppositories (hemorrhoids) are used.

Vaginal: treatment of yeast infections (miconazole), bacterial infections (metronidazole) and pH balance (boric acid); slowly dissolve over about 30 minutes giving a prolonged local effect of the drug

Urethral: treatment of cancer, incontinence.

Compounding Suppositories

1. Melt the base material at a low temperature on a hot plate

2. Add the active ingredients and stir to disperse the drug.

3. Slowly pour into the mold and fill to the top, ensuring no air bubbles are entrapped.

4. Once filled, allow the contents of the mold to solidify at room temperature.

This is known as the fusion method.

The patient must remove the foil or plastic mold before using!!!

Medication Safety

By following these seven rights, pharmacy technicians can help ensure that medications are dispensed and administered safely and accurately.