Podcast
Questions and Answers
What is included in the definition of a 'signature' as per the requirements?
What is included in the definition of a 'signature' as per the requirements?
- Customer verification codes
- An electronic signature, when applicable (correct)
- A digital stamp or seal
- A physical signature only
Which of the following must be present on a written prescription?
Which of the following must be present on a written prescription?
- The patient's name, address, and age (correct)
- The drug's international brand name
- The pharmacy's license number
- The prescriber's social security number
When can a pharmacist forego entering the patient’s address and age on the prescription?
When can a pharmacist forego entering the patient’s address and age on the prescription?
- If the prescriber does not request it
- If the information is readily available in pharmacy records (correct)
- When the prescription is electronic
- Whenever it is convenient for the pharmacist
Which of the following constitutes unprofessional conduct in pharmacy practice?
Which of the following constitutes unprofessional conduct in pharmacy practice?
What must prescription labels be, according to the guidelines?
What must prescription labels be, according to the guidelines?
What aspect of prescription orders for inpatients in healthcare facilities is mentioned?
What aspect of prescription orders for inpatients in healthcare facilities is mentioned?
Which information is not required on a written prescription?
Which information is not required on a written prescription?
What is the maximum scope of the term 'sign' as used in the prescriptions context?
What is the maximum scope of the term 'sign' as used in the prescriptions context?
What must be included in the daily record of prescriptions to ensure readiness for retrieval?
What must be included in the daily record of prescriptions to ensure readiness for retrieval?
Which circumstance allows for the orders for drugs in a health care facility to not be numbered?
Which circumstance allows for the orders for drugs in a health care facility to not be numbered?
What is required if a pharmacy uses a computerized system during downtime?
What is required if a pharmacy uses a computerized system during downtime?
Which of the following is not a necessary component when maintaining a computerized prescription record?
Which of the following is not a necessary component when maintaining a computerized prescription record?
Who is permitted to enter prescription data into a computerized system?
Who is permitted to enter prescription data into a computerized system?
What does the computerized system need to ensure regarding prescription records?
What does the computerized system need to ensure regarding prescription records?
For all refills of a prescription, which of the following is sufficient?
For all refills of a prescription, which of the following is sufficient?
What constitutes the record of the initial filling of prescriptions?
What constitutes the record of the initial filling of prescriptions?
What is the purpose of the safeguards in a computerized system?
What is the purpose of the safeguards in a computerized system?
What is necessary for the pharmacy records to ensure completeness?
What is necessary for the pharmacy records to ensure completeness?
What is the minimum number of hours a supervising pharmacist must work to be considered full-time?
What is the minimum number of hours a supervising pharmacist must work to be considered full-time?
What must occur if a pharmacy fails to provide prescription drug prices upon request?
What must occur if a pharmacy fails to provide prescription drug prices upon request?
Which of the following is NOT a condition for returning a compounded or dispensed prescription to stock?
Which of the following is NOT a condition for returning a compounded or dispensed prescription to stock?
When advertising prescription prices as part of a larger advertisement, what is required?
When advertising prescription prices as part of a larger advertisement, what is required?
What should be included on the labels of repacked drugs for proper identification?
What should be included on the labels of repacked drugs for proper identification?
What documentation is required when a prescriber or patient requests a non-child-resistant container?
What documentation is required when a prescriber or patient requests a non-child-resistant container?
Which entity must be notified within seven days of a change in the supervising pharmacist?
Which entity must be notified within seven days of a change in the supervising pharmacist?
Which practice is prohibited when it comes to advertisements of prescription drugs?
Which practice is prohibited when it comes to advertisements of prescription drugs?
Under what condition can unit doses of medication be returned for redispensing in a healthcare facility?
Under what condition can unit doses of medication be returned for redispensing in a healthcare facility?
Who must supervise the repacking of drugs in a pharmacy?
Who must supervise the repacking of drugs in a pharmacy?
What is the primary purpose of the policy adopted by the medical or authorized board regarding drug labeling?
What is the primary purpose of the policy adopted by the medical or authorized board regarding drug labeling?
Which information must a pharmacist include when writing down an oral prescription for controlled substances?
Which information must a pharmacist include when writing down an oral prescription for controlled substances?
When a prescription is refilled, what must be done with the date on the label?
When a prescription is refilled, what must be done with the date on the label?
What is implied if different ingredients are used by a pharmacist without clear documentation?
What is implied if different ingredients are used by a pharmacist without clear documentation?
What constitutes an unauthorized use or substitution of a drug in a prescription?
What constitutes an unauthorized use or substitution of a drug in a prescription?
What must a pharmacist do when receiving an oral order to refill a prescription?
What must a pharmacist do when receiving an oral order to refill a prescription?
What is the required action if a pharmacist dispenses a drug that is a generic product?
What is the required action if a pharmacist dispenses a drug that is a generic product?
What information is not necessary on a prescription order transmitted to the pharmacy?
What information is not necessary on a prescription order transmitted to the pharmacy?
What happens if a pharmacist fails to sign or initial a dispensed prescription legibly?
What happens if a pharmacist fails to sign or initial a dispensed prescription legibly?
What could potentially happen if the date of a refill is not documented properly?
What could potentially happen if the date of a refill is not documented properly?
What information is NOT required to be included in a repacking record?
What information is NOT required to be included in a repacking record?
What is the maximum allowable expiration date for drugs repacked for in-house use only?
What is the maximum allowable expiration date for drugs repacked for in-house use only?
For how long must repacking records be maintained?
For how long must repacking records be maintained?
Which of the following is NOT a requirement for medications packaged in customized patient medication packages?
Which of the following is NOT a requirement for medications packaged in customized patient medication packages?
Which of the following medications can be repackaged in customized patient medication packages?
Which of the following medications can be repackaged in customized patient medication packages?
What must be done if a medication included in a customized patient medication package is discontinued?
What must be done if a medication included in a customized patient medication package is discontinued?
Which regulatory parts govern the repacking of drugs by manufacturers and wholesalers?
Which regulatory parts govern the repacking of drugs by manufacturers and wholesalers?
What information must a record for a customized patient medication package include to allow for future preparation of an identical package?
What information must a record for a customized patient medication package include to allow for future preparation of an identical package?
What criteria is used to determine if a drug is considered adulterated?
What criteria is used to determine if a drug is considered adulterated?
Which of the following is a requirement for the labeling of customized patient medication packages?
Which of the following is a requirement for the labeling of customized patient medication packages?
What is the requirement for medications identified as unstable in relation to customized patient medication packages?
What is the requirement for medications identified as unstable in relation to customized patient medication packages?
Under what condition can a drug be sold after its expiration date?
Under what condition can a drug be sold after its expiration date?
What is the signature requirement for individuals involved in the repacking operation?
What is the signature requirement for individuals involved in the repacking operation?
What is a requirement for drugs that need special storage conditions?
What is a requirement for drugs that need special storage conditions?
Which of the following is NOT considered a violation when selling drugs?
Which of the following is NOT considered a violation when selling drugs?
What does the expiration date of a drug indicate?
What does the expiration date of a drug indicate?
Which information is required to be included in the record for each medication in a customized patient medication package?
Which information is required to be included in the record for each medication in a customized patient medication package?
What can happen to drugs found unfit for human use during an auction?
What can happen to drugs found unfit for human use during an auction?
What is one requirement when preparing a customized patient medication package?
What is one requirement when preparing a customized patient medication package?
Which actions are strictly prohibited for unlicensed persons?
Which actions are strictly prohibited for unlicensed persons?
What must be done before dispensing any drug with the assistance of an unlicensed person?
What must be done before dispensing any drug with the assistance of an unlicensed person?
Under what conditions can individuals involved in unit-dose drug distribution systems be exempt from ratio requirements?
Under what conditions can individuals involved in unit-dose drug distribution systems be exempt from ratio requirements?
Which statement correctly reflects the ownership provisions related to unlicensed persons in pharmacy practice?
Which statement correctly reflects the ownership provisions related to unlicensed persons in pharmacy practice?
Which of the following actions is permissible for an unlicensed person in a pharmacy setting?
Which of the following actions is permissible for an unlicensed person in a pharmacy setting?
In which scenarios must the regulations as provided apply to nonresident establishments?
In which scenarios must the regulations as provided apply to nonresident establishments?
Which activity is an example of exercising professional judgment that is prohibited for unlicensed persons?
Which activity is an example of exercising professional judgment that is prohibited for unlicensed persons?
What condition must be met for the supervision provided by pharmacists?
What condition must be met for the supervision provided by pharmacists?
What must a registrant do to avoid having their premises deemed abandoned?
What must a registrant do to avoid having their premises deemed abandoned?
Which task is NOT allowed for an unlicensed person in assisting a pharmacist?
Which task is NOT allowed for an unlicensed person in assisting a pharmacist?
Under which condition can a pharmacist employ more than two registered pharmacy technicians?
Under which condition can a pharmacist employ more than two registered pharmacy technicians?
What is the maximum number of unlicensed persons a pharmacist can employ for non-licensed activities?
What is the maximum number of unlicensed persons a pharmacist can employ for non-licensed activities?
Which of the following activities must a pharmacy intern undertake under supervision?
Which of the following activities must a pharmacy intern undertake under supervision?
What is required from a pharmacist before accepting electronically transmitted prescriptions?
What is required from a pharmacist before accepting electronically transmitted prescriptions?
Which aspect does NOT fall under the responsibilities allowed for unlicensed personnel?
Which aspect does NOT fall under the responsibilities allowed for unlicensed personnel?
What action is permitted when handling electronically transmitted prescriptions?
What action is permitted when handling electronically transmitted prescriptions?
What could lead to the abandonment of a pharmacy establishment?
What could lead to the abandonment of a pharmacy establishment?
In what situation are pharmacy interns not restricted by the limitations on assistance ratios?
In what situation are pharmacy interns not restricted by the limitations on assistance ratios?
Study Notes
Electronic Prescriptions
- Electronic prescriptions must comply with the same requirements as written prescriptions unless indicated otherwise.
- "Signature" includes electronic signatures, and "sign" encompasses affixing an electronic signature.
Prescription Requirements
- Prescriptions must include:
- Patient's name, address, age
- Date written
- Name, strength, quantity of the drug
- Directions for use (if applicable)
- Prescriber's name, address, phone number, profession, and signature
- Pharmacists can supplement missing information if it is available in pharmacy records.
Legibility and Labeling
- Prescription labels must be legible.
- Orders for inpatients can be transmitted with approved procedures, omitting non-essential information already in facility records.
Controlled Substances and Oral Prescriptions
- Controlled substances must comply with Article 33 of the Public Health Law.
- Oral prescriptions must be documented in writing, including required information and the signature of the person receiving the order.
Refilling and Documentation
- Refills must be documented with the date and initials of the pharmacist involved.
- Refills can be placed as “pro re nata” (abbreviated prn) meaning "as needed."
Drug Substitution and Generic Identification
- Unauthorized substitution of drugs is prohibited without prescriber consent.
- Pharmacists must document any substitution details on the original prescription.
Record Keeping and Accessibility
- Prescriptions should be consecutively numbered and retrievable.
- Daily records must identify the practitioner, patient, pharmacist initials, and prescription number.
Computerized Systems for Prescription Management
- Computer systems must safeguard against manipulation and ensure continuity.
- Records of prescriptions must include signatures at the time of dispensing.
Child-Resistant Packaging
- Drugs must be packaged in child-resistant containers unless a request is made by the prescriber or patient, with documentation required for such exceptions.
Supervision and Operation of Pharmacies
- A supervising pharmacist must be a full-time employee (>30 hours/week).
- Changes in supervisory personnel must be reported to the State Board of Pharmacy within seven days.
Advertising Regulations
- Prescription drug advertisements must display prices that are effective for a stated period.
- Price advertising must be separated from general merchandise promotion.
Returns and Repackaging of Medications
- Returned prescriptions cannot be reused except under certain conditions in healthcare facilities.
- Repackaged drugs must be labeled with identification information and maintained with detailed records.
Customized Patient Medication Packages (Patient Med-Paks)
- Customized packages must be moisture-proof and contain detailed labeling and instructions.
- Consent is required from the patient or prescriber for dispensing in such packages; controlled substances must not be included.
Adulterated and Misbranded Drugs
- Drugs deemed adulterated/misbranded must meet federal safety and labeling standards.
- Sale of drugs beyond their expiration dates is prohibited unless properly segregated.
Compliance with Good Manufacturing Practices
- Drugs must be manufactured according to standards; pharmacies can follow specific protocols for in-house medications.### Expiration Dates and Drug Storage
- Expiration dates expressed by month and year indicate the last day of the specified month.
- Drugs requiring special temperature storage must comply with specified conditions throughout their sale period.
Auction Regulations for Drugs
- Auctioning drugs requires a notice to the State Board of Pharmacy at least seven days prior.
- Drugs in bulk or open containers may only be sold to a registered pharmacy.
- Immediate removal of purchased drugs is mandatory, and the Board must be notified of their disposition.
- Drugs deemed unfit by the Board's representative must be destroyed or quarantined.
Licensing and Distribution of New Drugs
- Distribution of new or investigational drugs must be compliant with Part 310 or 312 of Title 21, Code of Federal Regulations.
- A registered establishment is considered abandoned if the registrant vacates without proper certification and disposal arrangements.
Assistance in Drug Dispensing
- Unlicensed individuals can assist licensed pharmacists under certain conditions, including:
- Receiving and processing written or electronic prescriptions (with approval from a pharmacist).
- Typing labels and entering prescription data into records.
- Counting and packaging dosage units of drugs.
- Delivering completed prescriptions to patients after pharmacist's approval.
Limitations on Assistance by Technicians and Unlicensed Persons
- Pharmacists can work with a maximum of two registered pharmacy technicians or four unlicensed individuals.
- In facilities licensed under Article 28 of the Public Health Law, the ratio of assistants is limited to ensure compliance with regulations.
- Pharmacy interns are exempt from this ratio but require supervision.
Restrictions for Unlicensed Personnel
- Unlicensed individuals cannot:
- Receive oral prescriptions.
- Interpret or evaluate prescriptions for legality and accuracy.
- Make therapeutic equivalency determinations for generic drugs.
- Measure, compound, or mix ingredients.
- Sign dispensing records or counsel patients.
- All drug dispensing must be reviewed and approved by a licensed pharmacist prior to completion.
Ownership and Professional Practice Regulations
- Unlicensed persons can own firms or corporations providing professional pharmacy services.
- Contracting salary based on service receipts is permissible.
- Nonresident establishments must adhere to specified sections of New York State regulations.
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Description
This quiz covers the regulations regarding written and electronic prescriptions in pharmacy practice. It highlights the definition and requirements for signatures and discusses unprofessional conduct within the field. Test your knowledge on important legal standards in pharmacy.
