Pharmacy Operations Flashcards
What are the requirements to become a Licensed Pharmacist?
NEW GRAD:
1) Screening (Background Check, Fingerprints)
2) Internship Hours
3) Graduating
4) Passing NAPLEX and MPJE
FOREIGN-TRAINED PHARMACIST:
1)FPGEC and TOEFL
2) Internship hours
You can obtain licensure by NAPLEX SCORE TRANSFER:
-Offered by NABP
-Must be requested within 89 days after taking NAPLEX
-Individual state specifies how long a passing score is valid
RECIPROCITY:
-Transfer existing license to another state
-Often requires one year of practice experience and other state-specific requirements
Continuing Pharmacy Education (CPE)
Boards of pharmacy grant a license that certifies a minimum skill level, and a certain number of CE hours must be completed within each license renewal cycle to maintain competency.
Pharmacist participate in live or correspondence CPE .
An active license is required. Reactivating an inactive license may require: retaking exams, becoming current with CPE and paying fees
Speciality Pharmacist
Speciality pharmacist licenses may be offered at the state level:
-Nuclear pharmacist
-Consultant pharmacist
-Mid-level practitioner with prescriptive authority
Additional requirements:
-Course work
-Supervised practice
-BPS certification
Pharmacy Technician
Registration:
->18 y.o.
-High school diploma
-Background check
Licensure:
-Work experience
-Examination
-Education/training program
Certification:
-Techs perform more complex activities such as Med hx, receive rx, transfer rx
Pharmacy Technician Certification Exams
1) Pharmacy Technician Certification Board (PTCB)
2) National Health-career Association (NHA)
CE is required to maintain certification.
Common Causes of Disciplinary Actions against Pharmacy Staff
Pharmacy Staff: Pharmacist, Interns, Technicians
Common Causes:
1) Impairment - Reporting to work under the influence of drugs or alcohol
2) Drug Theft - Stealing from stock
3) Drug Diversion - Stealing from patient supply
4) Violating federal, state or local pharmacy laws
5) Being convicted of a felony
6) Committing practice-related fraud
7) Unprofessional conduct
8) Falsifying pharmacy documents
9) Interfering with a licensing exam
10) Assisting or allowing non-licensed personnel to practice
11) Illegally sharing PHI aka. HIPAA violation
12) Failing to report certain information to the BOP
Actions against the Pharmacist License
1) Probation
-License restricted for a specified time
-Pharmacist can still practice while on Probation
- E.g. Practicing under the supervision of another RPh for 6 months
2) Suspension
-License inactivated; may be reinstated if conditions met
-Pharmacist cannot practice
-E.g. License suspended for 2 years
3) Revocation
-License taken away indefinitely (usually permanently)
-Pharmacist cannot practice
-E.g. RPh loses license for insurance fraud
4) Surrender
-License voluntarily given up, usually forced
-Pharmacist cannot practice
-E.g. RPh enters treatment program for substance use
Reporting Employees
-Employees should report any coworker who is known or suspected to be impaired (mentally, physically).
-Reporting is confidential to the state board of pharmacy
-Failure to report an impaired colleague may result in disciplinary action against you. E.g. any person working with an impaired pharmacist may face disciplinary action if they do not report.
What is needed to open a pharmacy?
Goal: Obtain a License
1) Pharmacy Physical Address
2) Pharmacy Classification (hospital, community)
3) Pharmacist-in-charge name and license number
4) Application fee
5) Pharmacy NPI number
*Each state has different permit requirements based on the type of pharmacy
When are Pharmacy Inspections done?
1) Initial Licensure
2) Periodic Inspections (May be annually or bi-annually or following license renewal cycle)
Pharmacies are inspected to ensure up-to-date:
-Record-keeping systems
-Controlled Substances compliance
-Refrigerator temperature logs
What are Out-of-State Facilities?
-Distributors
-Manufacturers/Repackagers
-Pharmacies
-Third-party logistics providers
-Wholesalers
*These must obtain licensure in each state in which they conduct business or where the patient is residing
What if the Pharmacy wants to dispense a Controlled Substance?
The pharmacy would have to register with the DEA in order to:
-Manufacture
-Distribute
-Prescribe
-Order/Dispense
Can facilities be disciplined?
Yes
Along with pharmacy personnel, all license holders including businesses can face disciplinary actions. This includes wholesalers, manufacturers, repackagers, distributors, pharmacies and third-party logistics providers.
What are Mail-Order Pharmacies?
-Dispense larger supply of mediations
-Deliver directly to patient’s home
-Facility and/or pharmacists may require licensure in multiple states
-Inspection requirements may vary
What are Out-of-State Pharmacies?
A.k.a Non-resident pharmacy
These provide centralized or shared services for another pharmacy. This means that patients may take their prescription to a local pharmacy and that pharmacy then outsources certain parts of the process to a centralized pharmacy that may be located out-of-state.
The pharmacy may provide:
1) Dispensing or processing claims
2) Perform DUR
3) Obtain refill authorizations
4) Make therapeutic interventions
It is generally required for each pharmacy to be licensed in both states. Also, it may be required that pharmacies using shared services, have the same owner, have a contract outlining the responsibilities of each pharmacy and also have shared electronic databases.
What is a Specialty Pharmacy?
These dispense speciality medications.
-Treat complex diseases
-Require greater patient education/monitoring
-REMS
-High cost and complex reimbursement processes
What is the Space Requirements for a Pharmacy?
Any area/pharmacy which stores and distributes prescription drugs, should comply with the standards set by USP.
-Minimum square footage for facility or workspace
-Keep pharmacy clean and orderly
-Restricted access and inventory controls to identify theft and diversion
-Display or have licenses readily available
Pharmacy Security
Any pharmacist on duty is responsible for the overall security of the pharmacy at that time. This includes both the security of the pharmacy and confidential records.
One way to ensure this is to limit the access to the pharmacy to only pharmacy personnel.
Pharmacy Signage and Advertising
-States usually allow advertising drug prices and compounding specific medications
-Most states also require posting about hours, pharmacist absence, right to counseling or interpreter services.
Renaming, Relocating or Closing a Pharmacy
If there is a name change, pharmacy closure, relocation or change in the Pharmacist-in-charge, you must notify the Board of Pharmacy & DEA would also need notification, since the Controlled Substances would also be changing locations.
Do pharmacies need to maintain Patient Profile records?
YES
Name, Address, Telephone number
Gender, DOB/Age
Current, previous medications
Allergies, Conditions, Social History
What is needed on a Dispensing Record?
-Prescription Number
-Drug Name, Qty and Manufacturer dispensed
-Dispensing Pharmacist name or initials
-Date filled/refilled and number of refills remaining
What information is needed on a Purchase Receipt?
-Invoices
-Transaction Information
-Transaction History
-Transaction statement
This is needed for all drugs received by the pharmacy. This is mandated by the Drugs supply chain and security act.
Documents that must be kept for Recordkeeping
1) Prescription
2) DEA Form 222 copies
3) Controlled Substances Inventory
4) Compounding Log
5) Sales of Pseudoephedrine products
What do they mean by Institutional Pharmacy?
-Hospitals
-Assisted Living Facilities
-Long-term Care facilities
-Nursing Homes
-Rehabilitation Centers
-Drug Treatment Centers
Can Nurses restock automated-dispensing-systems in an Institution?
YES
If the pharmacy is located in the facility, then the pharmacy will restock the medications.
If the Pharmacy is not located in the facility, then nurses can restock the ADS, through medication verification e.g. barcode scanning
What is a Chart Order?
This is an Institution’s version of a prescription which is entered directly into the patient’s record. These do not have a specified days-supply. The order will be continuous until the provider discontinues or until ‘stop date’ is reached.
What constitutes a valid Chart/Medication Order?
-Patient name
-Date of issue
-Prescriber signature
-Drug name, strength, dosage form, directions for use
Can a pharmacist be absent in an Institution?
YES
It is possible for a pharmacist to be absent for a limited period of time (but remain “on-call”)
-Medications should be stocked in a locked cabinet outside of the pharmacy
-Authorize access to pharmacy for designated individuals in emergencies only
What is an Emergency Kit?
-Utilized in an institutional facility
-Contains drugs needed in a timely manner to prevent patient harm.
-Can contain both controlled and non-controlled drugs.
-It is prepared and sealed by pharmacy and stored in a secure location
-Requires an expiration date - the earliest expiration date in the kit
-Chart order is required before drug removal
-Pharmacy notified when open
What are the Label Requirements for an Emergency Kit?
1) Drug: Name, Strength, Quantity, Expiration Date of contents
2) Expiration date of Kit
3) Pharmacy: Name, Address, Telephone number
What is a Telepharmacy?
This is the provision of pharmacist care by registered pharmacies and pharmacist, located within US jurisdictions, through the use of teleommunication to patients or their agents who are also located with US jurisdictions.
It was implemented to improve access to care in rural and underserved areas.
It allows for:
-Remote order verification
-Automated dispensing systems (ADS)
-Telephones
-Videoconfrencing
-Internet
-DUR or MUE
-Remote counceling
These must have a pharmacy license to receive third-party reimbursement
How do Telepharamacy work?
1) Prescription label and pre-packaged medication is dispensed from remote sites ADS
2) Technician scans barcode, attaches label and dispenses medication to patient.
3) Pharmacist councels patient in real-time
Policies and Procedures Manual
Most states require each pharmacy to have a current policies and procedures (“P&P”) maual.
These outline what to do in a specific stiuation.
What is the advantage of having a P&P manual?
1) Keep the pharmacy running efficiently
2) Can offer protection in case of a lawsuit
3) May be required for reimbursement
Quality Assurance
Most BOP require a Continuous Quality Improvement (CQI) program.
A root cause analysis should be preformed when a medication error occurs
Components of a CQI Program
1- Designated individual(s) responsible for the program. This person is in charge, and oversees implementation, maintenance and monitoring.
-NABP recommends 3 days to initiate CQI process once an error has occurred.
-NABP recommends reporting errors to an appropriate, nationally-recognized program such as the FDA or ISMP (Institute for Safe Medication Practices)
2) Formulation of a plan to amend the pharmacy system and workflow
3) Implementation of recommendations
Temporary Absence of the Pharmacist
Dispensing new prescriptions and patient counseling is generally prohibited
What are CGMPs?
Current Good Manufacturing Practices
These are standards that manufacturers, repackagers and pharmacies must comply with to ensure the identity, strength, quality and purity of products.
Any drug produced in a facility that does not meet CGMP is considered adulterated.
The Drugs Supply Chain Security Act (DSCSA) was passed in 2013 to prevent counterfeit, misbranded, adulterated and diverted drugs from entering the legitimate drug supply. It outlines steps to build a system to track and trace drugs as they are distributed within the US.
This law applied to PRESCRIPTION drugs intended for HUMAN use.
Exempted products from the DSCSA
1- OTC
2- Veterinary drugs
3- API
4- Blood products for transfusion
5- Radioactive drugs
6- Drugs used in Imaging Studies
7- Certain IV products
8- Certain medical gases
9- Homeopathic drugs
10- Compounded products
Under the DSCSA, all trading partners are required to provide subsequent purchaser with product tracing information.
What records must be present for all drug transfers?
Under the DSCSA, there are 3 types of records which must accompany all drug transfers:
1) Transaction Information (TI) - drug name, strength, dosage from, NDC, LOT, from, date, to
2) Transaction History (TH) - This is all the information that tells the hx of the drug all the way to the manufacturer.
3) Transaction Statement (TS) - Statement acknowledging compliance with the DSCSA
These may be in paper or electronic format. Must be kept for 6 years!
What are the situations which do not require TI, TH or TS?
1) Dispensing drugs to a patient
2) Providing drugs to a practitioner for office use
3) Distributing drug samples
Drug Storage in a Pharmacy
-Clean and Secure space
-Proper lighting and ventilation
-Humidity and temperature controls
If a specific temperature requirement if not listed, store medication at “controlled room temperature”. 68-77 per USP-NF
-Refrigerator and freezer temperatures should be documented at least once daily in a log book.
What medication should be quarantined?
I CARE
1) Investigational
2) Counterfeit
3) Adulterated Drugs (e.g. refrigerated drugs stored at room temperature)
4) Recalled
5) Expired
Quarantined drugs must be labeled appropriately to avoid accidental dispensing
Storage of Controlled Substances
1) All scheduled II drugs MUST be stored in a securely locked cabinet or vault.
2) Schedule III - V drugs can be stored with schedule II drugs. Alternatively, can be dispersed throughout the stock of non-controlled drugs (with approval from the local DEA office)
Storage of Investigational New Drugs
-Must be stored in a limited access location (essentially quarantined) <—to limit accidental dispensing
-Pharmacy must meet the manufacturer storage requirements
-The pharmacy must document transport, handling and receipt of the drugs
-Report breaches in protocol to investigator
Storage of Expired (outdated) drugs
Drug expiration dates are based on stability testing. The sale of expired drugs (prescription, or OTC) is prohibited by the FDCA.
-Do not dispense
-Applies to drug samples and donated drugs
All organizations (charities or nonprofits) must agree to dispose of our return any expired drugs.
Expired drugs must be quarantined prior to return or disposal.
Storage of Expired (outdated) drugs
Drug expiration dates are based on stability testing. The sale of expired drugs (prescription, or OTC) is prohibited by the FDCA.
-Do not dispense
-Applies to drug samples and donated drugs
All organizations (charities or nonprofits) must agree to dispose of our return any expired drugs.
Expired drugs must be quarantined prior to return or disposal.
Drug Samples
Distribution is regulated under the prescription drug marketing act (PDMA)
Drug samples can only be provided to:
-prescribers
-hospital pharmacies
-Other healthcare entities by written request of a prescriber (excludes retail pharmacies)
Samples should be easy to recognize . Sample label must include:
-Lot or control number
-a statement indicating that the product is a drug sample “ not intended for sale”
Samples must be stored separately from other inventory. Many states require the prescribers office to maintain receipts of samples received.
Written request for samples must be maintained vitamin manufacturer or distributor for at least three years.
Drug recall classifications
Recall our classified based on the level of severity.
Class 1: [poses the most danger to the patient] Reasonable probability that the drug will cause serious adverse consequences or death.
Class 2: Drug can cause temporary/reversible, adverse consequences or probability of harm is remote.
Class 3: [least dangerous] Drug is not likely to cause adverse health consequences.
What is required of the pharmacist for a drug recall?
The pharmacist needs to check the stock and remove the recalled drug from all storage areas.
The pharmacist must identify patients who may have received the recalled drug.
-Notify each patient’s prescriber
-keep a record of notifications
Who issues drug recalls?
FDA or Manufacturer
The manufacturer is responsible for notifying its customers, including distributors and patients. Notification can occur via press release, phone calls or email.
For a Mail notification , it should be addressed “DRUG RECALL” -bold, red type
“URGENT” - for class 1 and class 2 recalls.
Delivery by Mail
Mail-order pharmacies must have a valid state license. Some states require a toll-free number for patient to use if they would like counseling or have questions.
-The outside packaging should not have any identifying marks
-Inner labeling must include information, required under federal and state laws e.g. name and directions for use.
-Should include package tracking and delivery verification
-Temperature controlled Packaging e.g. insulin
What happens if the delivery location is not found for the patient refuses delivery?
The medication can be returned to stock if:
-It never left control of the pharmacy
-Medication has remained in its original, sealed packaging
-It must be returned on the same day as the unsuccessful delivery attempt
Delivery of controlled substances
This is generally permitted via the USPS, if the pharmacy is registered or exempt with the DEA.
- private shipping companies can be used, though they may have additional requirements such as a signature upon receipt
Packaging standards for delivering controlled substances
1) prescription label must contain dispenser name and address
2) Inner container is marked and sealed as required by law
3) outside container is free of markings indicating contents
Kiosks
-These may be used for new or refill prescriptions. The capabilities is very by device.
-The can only be maintained by a licensed pharmacy.
Limitations of vacuum tubes
Drugs that should not be tubed:
-Hazardous compounds, including chemotherapy
-Combustible products, including some gels and sprays
-Protein products (can become damaged from agitation)
Public Health Reporting Requirements
1) Potential Terrorist Events
-The pharmacy should have a terrorist attack response plan outline in its P&P manual. The plan should include strategies for evacuation, temporary relocation, and emergency dispensing.
2) Suspected Physical Abuse
-All states require mandatory reporting of suspected physical abuse. This includes child abuse, and neglect, elder abuse
3) Tuberculosis Infection or Treatment
