Questions and Answers
How long do prescription records need to be kept?
Five years.
How long do controlled substance inventory records need to be kept?
Five years.
May records be stored off-site?
Yes, with permission from the Board.
How does a pharmacy invoice prescribers for medications for office use?
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What should be done if a pharmacy was robbed or broken into?
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What immunizations may a pharmacist provide?
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May a pharmacist administer a medication, such as a B12 injection?
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What acts may an intern perform?
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What medications are considered hazardous drugs?
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What is Kentucky law on generic substitution of a drug?
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Is an Authorized Generic Drug the same as a generic drug?
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What is Kentucky law on substitution of biologic products?
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Is it required for a pharmacist to obtain a Social Security Number (SSN) for a controlled substance?
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How frequently must a pharmacy submit controlled substance prescription data to KASPER?
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Must a prescription be reversed out of KASPER if not picked up?
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May I give my patient a copy of their KASPER report?
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How often must a controlled substance inventory be completed?
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Does a controlled substance inventory have to be completed when there is a change in pharmacist-in-charge?
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What information is required on the controlled substances inventory?
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Can a physician purchase stock bottles of controlled substances from a pharmacy for office use?
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Can an ambulance service purchase stock bottles of controlled substances from a pharmacy?
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Can a pharmacy purchase stock bottles of controlled substances from another pharmacy?
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Can a controlled substance be e-prescribed in Kentucky?
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How does a pharmacist know if a prescriber's software meets DEA requirements for e-prescribing?
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Can a prescriber use a pre-printed blank for controlled substances?
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Can a prescriber use a stamp for controlled substance prescriptions?
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Is it acceptable for a prescriber's name to be handwritten on the controlled substance security blank?
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Can a prescriber use another prescriber's controlled substance security blank for prescriptions?
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What changes can be made on a CII prescription?
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How long is a CII prescription valid?
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What is the maximum quantity of a CII that may be prescribed for acute pain?
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What is the maximum quantity of a CII that may be prescribed?
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If a physician issues multiple CII prescriptions with a 'do not fill until' date, can the pharmacist change that date?
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If a patient's insurance will not pay for the full amount of a CII prescription, can the pharmacist bill part to insurance?
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What are the prescribing limitations for CII stimulants?
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Study Notes
Prescription Record Keeping
- Prescription records must be retained for five years.
- Controlled substance inventory records also required to be kept for five years.
Off-site Record Storage
- Off-site storage of records requires Board approval detailing storage conditions and security measures.
- Even when approved, two years of records must remain on-site.
Pharmacy Invoicing for Office Use Medications
- Pharmacies can wholesale distribute up to 5% of total inventory for office use.
- Invoices must include recipient details, date, itemized quantity, and description.
Response to Robbery
- Report incidents of robbery or theft immediately to local law enforcement.
- Non-receipt issues regarding controlled substances should be reported to Kentucky State Police and USPS if applicable.
Pharmacist Immunizations
- Pharmacists can administer adult immunizations and to individuals aged 9-17 with parental consent.
Medication Administration by Pharmacists
- Pharmacists are authorized to administer medications, including B12 injections.
Intern Responsibilities
- Interns must be registered as technicians and can assist with prescription processing, counseling, and compounding.
Hazardous Drugs
- NIOSH maintains a list of hazardous drugs, including antineoplastic agents, to ensure safety in healthcare settings.
Generic Drug Substitution
- Generic drugs must be AB rated compared to brand-name drugs for substitution.
- If not AB rated, the pharmacist must obtain prescriber authorization before dispensing.
Authorized Generic Drugs
- Authorized generics are identical to branded drugs but sold without the brand label and may be offered at a reduced cost.
Biologic Product Substitution
- Substitution of biologic products requires the product to be deemed interchangeable according to FDA standards.
Social Security Number Requirements
- A Social Security Number (SSN) is obligatory for controlled substance prescriptions.
- Exceptions include using a driver's license or defaulting to 000-00-0000 for animals.
KASPER Reporting
- Pharmacies must submit controlled substance prescription data to KASPER within one business day of dispensing.
- Incorrect data submitted to KASPER can be corrected by contacting their office.
Inventory Compliance
- A controlled substance inventory must be conducted every two years, with an initial inventory taken at the pharmacy's opening.
- CII drugs must be accurately counted, while CIII-V drugs can be estimated if fewer than 1000 units are in stock.
Wholesaling to Physicians and Ambulance Services
- Pharmacies can only wholesale distribute controlled substances to physicians and ambulance services within a 5% limit of annual dispensing.
- Specific record-keeping and documentation requirements must be met, particularly for CII drugs.
E-prescribing Regulations
- E-prescribing of controlled substances (CII-CV) is allowed if both prescriber and pharmacy software comply with DEA regulations.
- All e-prescriptions must be verified through Surescripts.
Prescription Security Standards
- Prescribers cannot use pre-printed blanks, but stamped prescriptions are permissible for certain details, excluding date and signature.
- Changes to CII prescriptions have strict regulations; certain details may be added or modified after consultation with the prescriber.
CII Prescription Validity and Limits
- CII prescriptions are valid for 60 days, with specific limits on quantities for acute pain (3-day supply) and exceptions for documented medical necessity.
- Multiple CII prescriptions with "do not fill until" dates cannot be altered by pharmacists.
Billing Patients for CII Prescriptions
- If insurance won't cover the full amount, pharmacists can bill part but must retain the same prescription number in the system.
Prescribing Limitations for CII Stimulants
- Allowed for conditions like narcolepsy and ADHD; prohibited for obesity treatment.
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Description
Test your knowledge on the Kentucky Board of Pharmacy's requirements for record-keeping. This quiz focuses on prescription and controlled substances inventory records, including retention periods and off-site storage regulations. Perfect for pharmacy students and professionals.
