Pharmacy Regulations and Electronic Prescriptions

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Questions and Answers

What is required on a written prescription for it to be considered valid?

The signee's electronic signature alone.

The name, address, and age of the patient, and the prescriber's details. (correct)

Only the medication name and dosage instructions.

The name of the medication and the pharmacist's name.

Under what condition can a pharmacist omit information from a prescription?

If the required information is readily available in pharmacy records. (correct)

If the prescription is incomplete but submitted by a known prescriber.

Only when dealing with electronic prescriptions.

If the patient requests the omission.

What constitutes 'unprofessional conduct' in pharmacy practice?

Dispensing medications without a patient history.

Following instructions provided by the patient.

Providing written prescriptions without the prescriber's profession listed. (correct)

All of the above.

What does the term 'signature' include in the context of pharmacy practice?

An electronic signature as defined in relevant regulations. Signup and view all the answers

When can an inpatient's prescription be transmitted to the pharmacy?

In accordance with written procedures approved by the medical board. Signup and view all the answers

What information is NOT required on a prescription label?

The age of the patient. Signup and view all the answers

How should a pharmacist act if the patient's name is missing from a prescription?

Record the patient's name from their electronic records if available. Signup and view all the answers

What key aspect should a pharmacist confirm before filling a prescription?

That all required prescription details are present and valid. Signup and view all the answers

What constitutes a valid prescription transmitted to a pharmacy for dispensing?

An order for a drug issued by a practitioner authorized to prescribe Signup and view all the answers

What information is NOT typically required on a prescription label according to health care facility policies?

Patient's address within the hospital or health care facility Signup and view all the answers

Which of the following actions violates the requirements regarding prescription execution?

Using a generic product without specifying the manufacturer Signup and view all the answers

What should a pharmacist do if they receive an oral order to refill a prescription?

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

When refilling a prescription, which detail must be entered on the label?

Date of the refill Signup and view all the answers

What constitutes an improper substitution in compounding or dispensing a prescription?

Using a drug not specified without documented authorization Signup and view all the answers

What must be included in a record if a pharmacist substitutes a drug without authorization?

Details of the substitution including date, time, and pharmacist's signature Signup and view all the answers

What is the implication of a pharmacist failing to sign or initial a dispensed prescription?

The prescription may not be valid for legal purposes Signup and view all the answers

How should refill instructions be specified by a pharmacist?

By providing a time period or the term 'prn' Signup and view all the answers

What must be done when a prescription is filled by an intern?

The intern's supervisor must co-sign the prescription Signup and view all the answers

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

Doctor's name who prescribed the drug Signup and view all the answers

For drugs repacked for in-house use, which expiration date is applicable?

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

What is the maximum duration for which repacking records must be maintained?

5 years Signup and view all the answers

Which of the following statements about customized patient medication packages is true?

The medications must be dispensed in non-reclosable containers. Signup and view all the answers

What information must be included on the label of a customized patient medication package?

Expiration date of the personalized package Signup and view all the answers

What is a requirement for repacking medications in customized packages?

Patients must be consented to receive medications in customized packages. Signup and view all the answers

Which condition must NOT be met in order to dispense controlled substances in customized patient medication packages?

Controlled substances are completely allowed without any conditions. Signup and view all the answers

What happens if a medication is deemed therapeutically incompatible in relation to customized packaging?

It must not be dispensed in customized patient medication packages. Signup and view all the answers

Who is responsible for signing the repacking record to indicate supervision?

The pharmacist who supervised the process Signup and view all the answers

What is the requirement for packaging a drug in a child-resistant container?

It is not necessary if the prescriber or patient requests otherwise. Signup and view all the answers

How many hours per week qualifies as a full-time employee for a supervising pharmacist?

30 hours or more per week. Signup and view all the answers

What should occur within seven days of a change in the supervising pharmacist?

Notify the State Board of Pharmacy. Signup and view all the answers

What is required when advertising prescription drug prices?

Prices must be separately stated and remain in effect for a disclosed period. Signup and view all the answers

What is the policy regarding the return of compounded or dispensed prescriptions?

They cannot be put back into stock, except in specific health care settings. Signup and view all the answers

Who is allowed to supervise the repacking of drugs in a pharmacy?

The pharmacist or under the immediate supervision of a pharmacist. Signup and view all the answers

What must be included on the labels of repacked drugs?

Information for proper identification and safety. Signup and view all the answers

What action can pharmacies take with prescription blanks provided to physicians?

Imprint the names of the pharmacy and the pharmacist. Signup and view all the answers

How must the price information for a prescription drug be made available to potential consumers?

Via personal communication upon request. Signup and view all the answers

What is required from a pharmacy that operates for less than 30 hours per week regarding the supervising pharmacist?

The supervising pharmacist must work the entire duration of the pharmacy's operation. Signup and view all the answers

Which records must identify the practitioner who ordered the prescription?

Daily record of prescriptions filled and refilled Signup and view all the answers

What is a requirement for a computerized system used for managing pharmacy prescriptions?

It must provide safeguards against manipulation Signup and view all the answers

In what scenario can prescriptions for inpatients in a health care facility not be numbered?

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

Which document can constitute the record of the initial filling of prescriptions?

Original prescriptions filed correctly Signup and view all the answers

Which of the following is NOT a requirement for handling prescription records in a computerized system?

Pharmacists must sign prescriptions within 24 hours Signup and view all the answers

What should a pharmacy do if its computerized system experiences downtime?

Use an auxiliary procedure for documentation Signup and view all the answers

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

Pharmacists and pharmacy interns only Signup and view all the answers

What is required for the printout or electronic record of prescriptions filled each day?

Signature or initials of the dispensing pharmacist Signup and view all the answers

What information must be included in the patient's record regarding the customized patient medication package?

The name of the pharmacist who prepared it Signup and view all the answers

What ensures completeness and continuity of prescription records during a change in service providers?

Arrangements made for data transition Signup and view all the answers

What is the last day of the month indicated when expressing an expiration date?

The last day of the month indicated Signup and view all the answers

What is the purpose of requiring pharmacists' signatures on prescription records?

To indicate accuracy of dispensing records Signup and view all the answers

Under which condition can a drug be held beyond its expiration date without being considered a violation?

If it is segregated from regular stock or otherwise identified Signup and view all the answers

Which of the following can cause a drug to be classified as adulterated?

It does not meet good manufacturing practices Signup and view all the answers

What activities are unlicensed persons prohibited from performing?

Performing patient counseling Signup and view all the answers

What requirement is necessary for the storage of drugs that need special temperature control?

They must comply with temperature control during the entire storage period Signup and view all the answers

Which function must always involve the review and approval of a pharmacist?

Dispensing of drugs with the assistance of unlicensed persons Signup and view all the answers

What type of information about medications should be documented in the records?

Identification of the manufacturer and lot number Signup and view all the answers

Under what condition are individuals engaged in placing drugs in unit-dose packaging exempt from the ratio of supervision?

If they are part of an approved unit-dose drug distribution system Signup and view all the answers

What action is required at least seven days before selling drugs at auction?

A notice detailing the auction must be filed with the State Board of Pharmacy Signup and view all the answers

What does NOT constitute a professional function that unlicensed persons can perform?

Signing dispensing records Signup and view all the answers

What must be included regarding the expiration date on prescription records?

The date of preparation of the medication package Signup and view all the answers

Which of the following statements is true regarding the ownership of firms by unlicensed persons?

Unlicensed persons can own firms and engage in professional services within strict limits Signup and view all the answers

Which type of drugs is subject to special labeling instructions according to the requirements?

Customized patient medication packages Signup and view all the answers

What is required of nonresident establishments according to the rules described?

They must comply with specified requirements applicable within the state Signup and view all the answers

How should drugs found to be unfit for human use at an auction be handled?

They must be quarantined pending action for seizure and destruction Signup and view all the answers

Which of the following aspects should NOT be included in the review of a prescription's validity?

Type of insurance coverage of the patient Signup and view all the answers

What does therapeutic equivalency refer to in the context of pharmacy regulations?

Evaluating whether two drugs can be substituted safely Signup and view all the answers

What constitutes an abandoned premises for a registered establishment?

Failing to surrender the certificate of registration after vacating Signup and view all the answers

Which of the following actions can unlicensed persons perform in assisting a pharmacist?

Typing prescription labels for approval Signup and view all the answers

How many registered pharmacy technicians may a pharmacist obtain assistance from at one time?

Two registered technicians Signup and view all the answers

What is NOT an allowed action for unlicensed persons when assisting with prescription dispensing?

Reviewing prescription accuracy before dispensing Signup and view all the answers

What is the total limit on the number of individuals a pharmacist can have assisting them, including both registered pharmacy technicians and unlicensed persons?

Seven individuals at one time Signup and view all the answers

In terms of record-keeping, what action must pharmacists take regarding the information input by unlicensed persons?

Initial or identifier input into the records after verification Signup and view all the answers

Which of the following can pharmacy interns do that unlicensed persons cannot?

Supervise unlicensed persons in their tasks Signup and view all the answers

According to the provision, which activity is NOT directly related to the dispensing process?

Reviewing prescription insurance coverage Signup and view all the answers

What must pharmacists do with the records related to electronically transmitted prescriptions?

Verify and initial them before dispensing Signup and view all the answers

Study Notes

Electronic Prescriptions

Written prescription requirements also apply to electronic prescriptions.
“Signature” includes electronic signatures and signing entails affixing electronic signatures when applicable.

Prescription Requirements

Prescriptions must include patient’s name, address, age, date, drug details (name, strength, quantity), and prescriber’s information.
Pharmacists may fill in missing patient and prescriber details from pharmacy records.
Legibility is essential for prescription labels.

Health Care Facility Protocols

Drug orders for inpatients can be transmitted through approved procedures.
Essential information not included on the order must be readily accessible within institutional records.
Inpatient patient addresses may use the health care facility's address for prescriptions.

Controlled Substances

Prescriptions for controlled substances must adhere to Article 33 of the Public Health Law.
Oral prescriptions must be documented by the pharmacist, including signatures or initials for verification.

Refill Procedures

Refills must be documented with dates and signatures or initials.
A pharmacist can accept refill instructions specifying times, such as "prn" (as needed).

Unauthorized Drug Use

Unauthorized drug substitutions are prohibited and must be documented if they occur.
Generic products must clearly identify the manufacturer and distributor on prescriptions and labels.

Record Keeping

Prescriptions must be filed sequentially for easy retrieval, excluding certain in-facility orders.
Daily records must include clear details of all prescriptions filled, including practitioner identification, and pharmacist signatures.

Computerized Systems

Systems must protect against data alteration and ensure continuity of records.
Pharmacists and interns are authorized to enter and access prescription data; auxiliary procedures are needed during system downtimes.

Child-Resistant Packaging

Medications must be dispensed in child-resistant containers unless otherwise requested, and such requests must be recorded.

Supervision

A supervising pharmacist must work full-time (30+ hours per week) and must notify the State Board of any changes in supervisory personnel within seven days.

Advertising Regulations

Prescription drug price advertisements must meet certain hygiene, separation, and information requirements, including compliance with federal regulations.

Return and Repacking of Medications

Returned medications by patients cannot be restocked unless stringent conditions for health care facilities are met.
Repacking requires sufficient labeling and maintenance of records, including drug details and supervising pharmacist's information.

Customized Medication Packaging

Customized packages for patients must be properly labeled, include all required information, and have a record maintained by the pharmacist.
Controlled substances cannot be included in customized packages, and other restrictions apply to ensure safety and correct labeling.

Adulterated or Misbranded Drugs

Drugs are considered adulterated/misbranded if not manufactured under specific federal good manufacturing practices.
Selling outdated drugs is prohibited unless they are properly segregated and identified.### Expiration Dates and Storage Requirements
Expiration dates specified as month and year indicate the last day of the given month.
Drugs needing special temperature-controlled storage must meet those conditions continuously while on sale.

Auction Regulations for Drugs

Auctions of drugs require filing a notice with the State Board of Pharmacy at least seven days prior.
Only registered pharmacies can purchase bulk or open container drugs in a single lot at auctions.
Unfit drugs must be destroyed or quarantined by a board representative.

Handling New and Investigational Drugs

Selling or distributing drugs not recognized as new or investigational under specific FDA regulations is prohibited.

Premises Abandonment

Premises are classified as abandoned if the registrant vacates without returning the registration certificate or arranging for drug disposal.

Assistance in Drug Dispensing

Unlicensed individuals may assist pharmacists under strict supervision and guidelines, including receiving prescriptions and preparing labels.
Pharmacists must verify all prescription data entered by unlicensed persons before dispensing.

Limitations on Assistance

Pharmacists can only work with a limited number of unlicensed assistants; up to two registered technicians and four unlicensed individuals.
Pharmacy interns have no limitation but require supervision.

Prohibited Actions for Unlicensed Persons

Unlicensed individuals cannot receive oral prescriptions, evaluate prescriptions, or measure ingredients.
They are not authorized to counsel patients or sign dispensing records.

Drug Dispensing Approval

All drugs dispensed with unlicensed assistance require the pharmacist's review and approval.

Ownership and Employment Regulations

Unlicensed persons can own firms but must comply with specific contractual arrangement regulations concerning professional employee compensation.

Applicability to Nonresident Establishments

Guidelines in this section also apply to nonresident establishments as defined by state education laws.

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Description

Explore the key concepts of pharmacy regulations, focusing on written and electronic prescriptions. This quiz delves into the definitions and requirements set forth for professional conduct in pharmacy practice. Test your understanding of the legal aspects and standards that govern pharmacy operations.