Pharmacy Regulations and Electronic Prescriptions

Questions and Answers

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?

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?

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?

Dispensing a written prescription lacking required information Signup and view all the answers

What must prescription labels be, according to the guidelines?

Legible and clear Signup and view all the answers

What aspect of prescription orders for inpatients in healthcare facilities is mentioned?

They can be transmitted following approved written procedures Signup and view all the answers

Which information is not required on a written prescription?

The empanelled insurance provider's address Signup and view all the answers

What is the maximum scope of the term 'sign' as used in the prescriptions context?

Affixing an electronic signature as applicable Signup and view all the answers

What must be included in the daily record of prescriptions to ensure readiness for retrieval?

The signature or identifiable initials of the pharmacist Signup and view all the answers

Which circumstance allows for the orders for drugs in a health care facility to not be numbered?

If the orders are readily available and retrievable Signup and view all the answers

What is required if a pharmacy uses a computerized system during downtime?

All data collected during downtime must be entered into the computer later Signup and view all the answers

Which of the following is not a necessary component when maintaining a computerized prescription record?

Details of the patient’s medical history Signup and view all the answers

Who is permitted to enter prescription data into a computerized system?

Pharmacists and pharmacy interns Signup and view all the answers

What does the computerized system need to ensure regarding prescription records?

It must provide information retrieval services for past prescriptions Signup and view all the answers

For all refills of a prescription, which of the following is sufficient?

Initials or signature of the pharmacist at the time of dispensing Signup and view all the answers

What constitutes the record of the initial filling of prescriptions?

The original prescriptions filed appropriately Signup and view all the answers

What is the purpose of the safeguards in a computerized system?

To prevent unauthorized access and modifications Signup and view all the answers

What is necessary for the pharmacy records to ensure completeness?

There must be provisions for continuity if data processing services terminate Signup and view all the answers

What is the minimum number of hours a supervising pharmacist must work to be considered full-time?

30 hours per week Signup and view all the answers

What must occur if a pharmacy fails to provide prescription drug prices upon request?

They may face legal consequences. Signup and view all the answers

Which of the following is NOT a condition for returning a compounded or dispensed prescription to stock?

The return of opened medication is allowed. Signup and view all the answers

When advertising prescription prices as part of a larger advertisement, what is required?

Prescription prices must be physically separated. Signup and view all the answers

What should be included on the labels of repacked drugs for proper identification?

Manufacturer's control number and expiration date Signup and view all the answers

What documentation is required when a prescriber or patient requests a non-child-resistant container?

It must be documented in the pharmacy records. Signup and view all the answers

Which entity must be notified within seven days of a change in the supervising pharmacist?

The State Board of Pharmacy Signup and view all the answers

Which practice is prohibited when it comes to advertisements of prescription drugs?

Offering lower prices than competitors Signup and view all the answers

Under what condition can unit doses of medication be returned for redispensing in a healthcare facility?

If they are unopened and no longer needed by the patient Signup and view all the answers

Who must supervise the repacking of drugs in a pharmacy?

A pharmacist or under their immediate supervision Signup and view all the answers

What is the primary purpose of the policy adopted by the medical or authorized board regarding drug labeling?

To ensure availability of legally required information and uphold accuracy and safety Signup and view all the answers

Which information must a pharmacist include when writing down an oral prescription for controlled substances?

All information required by law and the signature of the receiver Signup and view all the answers

When a prescription is refilled, what must be done with the date on the label?

It should reflect the date of the refill Signup and view all the answers

What is implied if different ingredients are used by a pharmacist without clear documentation?

An improper substitution is presumed unless confirmed otherwise Signup and view all the answers

What constitutes an unauthorized use or substitution of a drug in a prescription?

Using one or more drugs without the prescriber's consent Signup and view all the answers

What must a pharmacist do when receiving an oral order to refill a prescription?

Reduce the order to writing or electronic record and sign it Signup and view all the answers

What is the required action if a pharmacist dispenses a drug that is a generic product?

The manufacturer's name must be recorded on the prescription Signup and view all the answers

What information is not necessary on a prescription order transmitted to the pharmacy?

Items not crucial to executing the order Signup and view all the answers

What happens if a pharmacist fails to sign or initial a dispensed prescription legibly?

The audit trail may be compromised Signup and view all the answers

What could potentially happen if the date of a refill is not documented properly?

Legal consequences may arise for the pharmacist Signup and view all the answers

What information is NOT required to be included in a repacking record?

The date of sale to the pharmacy Signup and view all the answers

What is the maximum allowable expiration date for drugs repacked for in-house use only?

12 months or 50% of the manufacturer's expiration date, whichever is less Signup and view all the answers

For how long must repacking records be maintained?

5 years Signup and view all the answers

Which of the following is NOT a requirement for medications packaged in customized patient medication packages?

They can be labeled with minimal patient information Signup and view all the answers

Which of the following medications can be repackaged in customized patient medication packages?

Medications for which the patient has provided consent Signup and view all the answers

What must be done if a medication included in a customized patient medication package is discontinued?

The patient or caregiver must be properly instructed Signup and view all the answers

Which regulatory parts govern the repacking of drugs by manufacturers and wholesalers?

Parts 210 and 211 of Title 21 Signup and view all the answers

What information must a record for a customized patient medication package include to allow for future preparation of an identical package?

Description of the package design and its specifications Signup and view all the answers

What criteria is used to determine if a drug is considered adulterated?

It has been manufactured in a state that does not meet the standards of good manufacturing practices. Signup and view all the answers

Which of the following is a requirement for the labeling of customized patient medication packages?

The label must include the quantity of each medication Signup and view all the answers

What is the requirement for medications identified as unstable in relation to customized patient medication packages?

They must not be dispensed in customized packages Signup and view all the answers

Under what condition can a drug be sold after its expiration date?

If it is marked as outdated and segregated from regular stock. Signup and view all the answers

What is the signature requirement for individuals involved in the repacking operation?

The signature of the person performing repacking is required along with the supervising pharmacist's signature Signup and view all the answers

What is a requirement for drugs that need special storage conditions?

Special temperature control must be maintained throughout the holding period. Signup and view all the answers

Which of the following is NOT considered a violation when selling drugs?

Selling drugs past their expiration date if clearly labeled as outdated. Signup and view all the answers

What does the expiration date of a drug indicate?

The drug can be safely used until the last day of that month. Signup and view all the answers

Which information is required to be included in the record for each medication in a customized patient medication package?

Name of the manufacturer or labeler and the lot number. Signup and view all the answers

What can happen to drugs found unfit for human use during an auction?

They will be destroyed in the presence of the appointed representative. Signup and view all the answers

What is one requirement when preparing a customized patient medication package?

Documenting the name or initials of the preparing pharmacist. Signup and view all the answers

Which actions are strictly prohibited for unlicensed persons?

Receive oral prescriptions from prescribers Signup and view all the answers

What must be done before dispensing any drug with the assistance of an unlicensed person?

The pharmacist must review and approve the dispensing Signup and view all the answers

Under what conditions can individuals involved in unit-dose drug distribution systems be exempt from ratio requirements?

They are not engaged in prohibited activities outlined in the regulation Signup and view all the answers

Which statement correctly reflects the ownership provisions related to unlicensed persons in pharmacy practice?

Unlicensed persons can own firms as long as they don't engage in dispensing Signup and view all the answers

Which of the following actions is permissible for an unlicensed person in a pharmacy setting?

Prepare medication carts for distribution Signup and view all the answers

In which scenarios must the regulations as provided apply to nonresident establishments?

As specified in section 63.8 of the Title Signup and view all the answers

Which activity is an example of exercising professional judgment that is prohibited for unlicensed persons?

Determining therapeutic equivalency for generic substitution Signup and view all the answers

What condition must be met for the supervision provided by pharmacists?

It must ensure compliance with specified sections of the regulations Signup and view all the answers

What must a registrant do to avoid having their premises deemed abandoned?

Surrender the certificate of registration to the State Board of Pharmacy Signup and view all the answers

Which task is NOT allowed for an unlicensed person in assisting a pharmacist?

Reviewing the safety and efficacy of a drug Signup and view all the answers

Under which condition can a pharmacist employ more than two registered pharmacy technicians?

If the pharmacist is not working in a facility licensed under Article 28 Signup and view all the answers

What is the maximum number of unlicensed persons a pharmacist can employ for non-licensed activities?

Four Signup and view all the answers

Which of the following activities must a pharmacy intern undertake under supervision?

Receiving and processing prescriptions Signup and view all the answers

What is required from a pharmacist before accepting electronically transmitted prescriptions?

Review the prescription for professional judgment approval Signup and view all the answers

Which aspect does NOT fall under the responsibilities allowed for unlicensed personnel?

Assessing patient medication history Signup and view all the answers

What action is permitted when handling electronically transmitted prescriptions?

Pharmacists must initially verify and sign off before proceeding Signup and view all the answers

What could lead to the abandonment of a pharmacy establishment?

Vacating the premises without arrangement for drug disposal Signup and view all the answers

In what situation are pharmacy interns not restricted by the limitations on assistance ratios?

If they are under the supervision of a registered pharmacist Signup and view all the answers

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.