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Oregon Pharmacy Licensing Requirements and Regulations: A Comprehensive Guide, Exams of Pharmacy

A comprehensive overview of pharmacy licensing requirements and regulations in oregon. It covers key aspects such as board composition, licensure requirements, continuing education, pharmacist responsibilities, and grounds for discipline. The document also includes information on prescription requirements, drug labeling, and adulteration, providing valuable insights for aspiring pharmacists and those seeking to understand the legal framework governing pharmacy practice in oregon.

Typology: Exams

2024/2025

Available from 02/07/2025

Smartsolutions
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MPJE OREGON 2025 STUDY SET WITH COMPLETE
SOLUTIONS 100% VERIFIED!!
How many board members? What are their backgrounds?
9 board members:
5 licensed pharmacists (in good standing)
2 licensed pharmacy technicians (in good standing)
2 public members (public members may not be licensed pharmacists, or a spouse,
domestic partner, child, parent or sibling of a pharmacist)
Is the board a separate entity or under another organization/department?
Separate entity
Who chairs the board?
A licensed pharmacist; board president (pharmacy is a self-regulated profession - BOP
reports to the governor)
Where do board members come from?
The governor appoints each member of the board to serve for 4 years, with confirmation
by the state senate and they can be reappointed (all members sign licensing
documents)
How long are the terms of office?
4 years
How frequently does the board meet?
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Download Oregon Pharmacy Licensing Requirements and Regulations: A Comprehensive Guide and more Exams Pharmacy in PDF only on Docsity!

MPJE OREGON 2025 STUDY SET WITH COMPLETE

SOLUTIONS 100% VERIFIED!!

How many board members? What are their backgrounds?

9 board members:

5 licensed pharmacists (in good standing)

2 licensed pharmacy technicians (in good standing)

2 public members (public members may not be licensed pharmacists, or a spouse, domestic partner, child, parent or sibling of a pharmacist)

Is the board a separate entity or under another organization/department?

Separate entity

Who chairs the board?

A licensed pharmacist; board president (pharmacy is a self-regulated profession - BOP reports to the governor)

Where do board members come from?

The governor appoints each member of the board to serve for 4 years, with confirmation by the state senate and they can be reappointed (all members sign licensing documents)

How long are the terms of office?

4 years

How frequently does the board meet?

every 3 months

Who may attend meetings?

Meetings are open to the public

Who controls the board's budget?

State legislature

What part of the government is the BOP part of?

Part of the executive branch (governor)

What are the licensure requirements to become a pharmacist?

  1. Provide evidence from a school or college of pharmacy approved by the board that they have successfully completed all the requirements for graduation, and including not less than 1440 hours of internship hours
  2. Passing the NAPLEX > 75
  3. Passing the MPJE > 75
  4. Licensure application, including providing the board with a valid email address and a fingerprint card or other documentation to complete the criminal background check (and the fees are paid!)
  5. Completed one hour of CE in pain management, provided by the Pain Management Commission of the OHA
  6. Be at least 18 years of age, of good moral character and temperate habits

A pharmacist practicing in an out of state pharmacy who only provides the professional services of interpretation, evaluation, DUR, counseling and verification related to their dispensing of a drug to a patient in Oregon are exempt from licensure by the board unless they are the PIC

Grounds for Discipline

  1. Unprofessional conduct
  2. Repeated or gross negligence
  3. Inability of a type that renders a person unable to practice the activity for which the person is licensed with reasonable skill, competence and safety to the public
  4. Impairment
  5. Having been found guilty of violating pharmacy or drug laws of the state
  6. Having been found guilty of a felony
  7. Fraud or false statement by a licensee or registrant in securing or attempting to secure a license
  8. Practicing pharmacy without a license, or assuming the title of pharmacist (or technician)
  9. Professional discipline by another state in a manner that is related to licensure
  10. Failure to fulfill the obligations of a pharmacist

Pharmacist responsibilities

A Pharmacist and pharmacy are responsible for the actions of Interns, Certified Oregon Pharmacy Technicians, and Pharmacy Technicians.

(3) Only a Pharmacist may practice pharmacy as defined in ORS 689.005, to include the provision of patient care services. Activities that require reasonable professional judgment of a Pharmacist include but are not limited to:

(a) Drug Utilization Review;

(b) Counseling;

(c) Drug Regimen Review;

(d) Medication Therapy Management;

(e) Collaborative Drug Therapy Management or other post-diagnostic disease state

management, pursuant to a valid agreement;

(f) Practice pursuant to State Drug Therapy Management Protocols;

(g) Ordering a drug or device, as permitted by statute;

(h) Ordering, interpreting and monitoring of a laboratory test;

(i) Oral receipt or transfer of a prescription; and

(j) Verification of the work performed by those under their supervision.

a pharmacsit shall

Comply with all state and federal laws and rules governing the practice of pharmacy;

(b) Control each aspect of the practice of pharmacy;

(c) Ensure each Intern, Certified Oregon Pharmacy Technician and Pharmacy Technician only assists in the practice of pharmacy under the supervision, direction, and control of a Pharmacist;

(d) Ensure non-Pharmacist personnel only perform duties they are licensed and trained to perform.

(e) Know the identity of each Intern, Certified Oregon Pharmacy Technician and Pharmacy Technician under their supervision, direction and control at all times;

(f) Not to supervise non-Pharmacist personnel beyond the capacity to provide adequate supervision by reason of workload and services being provided.

(g) The Licensee shall always conduct themselves with a professional dignity and not act in a manner that is discriminative, harassive, intimidating, or an assault in any workplace.

(h) Ensure and enforce the drug outlet written procedures for use of Certified Oregon Pharmacy Technicians and Pharmacy Technicians as required by OAR 855-025-0035;

(i) Ensure the security of the pharmacy area including:

(A) Providing adequate safeguards against theft or diversion of prescription drugs, and records for such drugs;

(B) Ensuring that all records and inventories are maintained in accordance with state and federal laws and rules;

(C) The pharmacy is closed and access is limited to a Pharmacist.

Food or drug that's labeling or packaging is false or misleading

Ex: labeling errors or omissions (includes advertising claims), counterfeit drugs (expensive biologic agents, weight loss and ED drugs -- frequently sold online)

Adulterated

  • Consists in whole or in part of any filthy, putrid or decomposed substance
  • If it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health
  • if the strength differs, or quality or purity fall below standards
  • A drug is adulterated unless it is manufactured in accordance with good manufacturing practice *** (manufacturers are normally inspected for compliance once every 2 years) ***

Other examples

poisonous/insanitary ingredients

  • strength, quality or purity differing from its original compendium
  • misrepresentation of strength
  • mixture with or substitution of another substance
  • devices not in conformity with performance standards
  • certain class III devices(devices requiring approved application before use)
  • banned devices
  • manufacture, packaging, storage or installation of a device no inc conformity with applicable requirements or conditions

Failure to comply with requirements under which device was exempted for investigation use

Delayed, denied or limited inspection

example of misbranding

An "organic" supplement that contains non-organic ingredients

A weight loss product is labeled with false or misleading claims about its effectiveness

examples of adulterated drugs

product is found to have lower strength compared to original compendium

What are the required elements for a valid prescription?

dispensed upon dispensing an authorized substituted drug. If, for an active drug which has been dispensed, brand name does not exist, then prescription container is to be labeled with its generic name by its manufacturer.

  • A prescription filled by a pharmacist shall indicate on the label the name of the drug in the container or be labeled as directed by the prescriber
  • The substitution of any drug by a pharmacist or the pharmacist's employer pursuant to this section does not constitute the practice of medicine

A substitution of drugs made by a pharmacist or the pharmacist's employer in accordance with this section and any rules that the State Board of Pharmacy may adopt thereunder does not constitute evidence of negligence if the substitution was made within reasonable and prudent practice of pharmacBiosimilars substitution

A pharmacy or pharmacist filling a prescription order for a biological product shall not substitute a biological product for the prescribed biological product unless:

(a) The substitute biological product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biological product;

(b) The prescribing practitioner has not designated on the prescription that substitution is prohibited;

c) The patient for whom the biological product is prescribed is informed of the substitution in a manner reasonable under the circumstances; and

d) The pharmacy or pharmacist retains a record of the substitution for a period of not less than three years

The State Board of Pharmacy shall maintain a link, if available, on a website maintained by the board to the current list of biological products determined by the United States Food and Drug Administration to be interchangeable.

Refills (noncontrolled substances)

Where refill authority is given other than by original prescription, documenting that such refill authorization was given, date of authorization, and name or the authorizing prescriber or prescribers agent must be recorded

Refills may be combined into a single filling if the prescription is not a controlled substance or psychotherapeutic drug, where the prescriber is notified by the change

emergency refills (when is it ok, how much.)

in emergency situations a pharmacist may give a 72 hour supply of the drug as long as the medication is not a controlled substance, the practitioner should be notified

autofill programs - when can a patient be put on this, conditions

A mail order or retail pharmacy may utilize an auto refill program which automatically refills non-controlled prescription medications that have existing refills available and that are consistent with the patient's current medication therapy only under the following conditions;

a patient enrolls each prescription medcation into the program prior to the pharmacist adding it in

the prescription is not a controlled substance

  • the pharmacy must stop the program upon request of the patient
  • when fill is complete, pick up notification is sent
  • if an auto refill rx is returned to stock or delivery refused, that rx is removed from the autofill program for that patient

can patients fax their prescriptions

no, patients can't fax their prescriptions. When receiving a faced prescription, a

full name, address, and dea # (address and dea required if controlled substance)

name, strength, dosage forms of substance, quantity prescribed and if different form quant prescribed, the quant dispensed

directions for use

date of filling

total number of refills authorized by prescribing practitioner

a practitioner may specify that there may be no substitutions by saying "brand medically necessary" or some equivalent

what controlled substances are allowed to be sent electronically?

CII-V (all of them)

are pharmacists allowed to make additions in the electronic prescription?

yes, notes of clarification and changes in the prescription are directly tagged with the electronic format of the prescriptions

what information is needed when providing a phone rx

  • date when oral rx was taken
  • patient's name or animal owner where the drug will be dispensed
  • The practitioner's full name and, where the practitioner wants, in addition, his address and DEA registration number

,

  • In an oral prescription presented for an animal, the species for which the drug is prescribed;
  • the name, strength, dosage form of the substance, quantity prescribed;

the

  • direction for use;

the

  • the total number of refills authorized by the prescriber

written signature or initials or electronic identifier of the receiving Pharmacist or Intern and identity of the person transmitting the prescription

Who can call in prescriptions?

a practitioner or someone designated by the practitioner which would include a clinical associate of the practitioner or any other practitioner acting in the practitioner's absence

can interns get new prescriptions

yes, interns can take new rx and refills orally and reduce them to writing or on the electronic system (After completing their first year of school)

Can Technicians Receive New Prescriptions Via Phone/Voicemail? Refills?

a technician shall not communicate or accept by oral communication a new or transferred rx of any nature

a technician may initiate or accept oral and electronic refill authorization from a practitioner or practitioner's agent, provided that nothing about the prescription has changed

Can Clerks/Cashiers/Others Receive New Prescriptions Via Phone/Voicemail? Refills?

rules; and

(b) By the end of the next business day of the request.

Can interns transfer prescriptions?

yes (even controls - obviously not CIIs)

Can technicians transfer prescriptions?

no - cannot receive or transfer a prescription to another pharmacy without the prior verification of a pharmacist

How Many Fills Can Be Transferred?

as many times as there are refills (exception: controls only can be transferred once)rules to transfer a controlled medication

may only be transferred once

has to be filled once only a refill can be transfer not a new rx

it is not consider a transfer of the same data base ex) Kroger to Kroger

since C2s are not refills it cant be transfer even in a same database

label requirements

information needed for the label for prescription

-name and address and tel# of the pharmacy

  • date
  • identifying#

-name of the pt

  • name of drug, strength, and quantity dispensed; when a generic name is used, the

label must also contain the identifier of the manufacturer or distributor

  • directions for use
  • name of practitioner
  • required precautionary info regarding controlled substances
  • such other and further accessory cautionary information as required for patient safety
  • expiration date

expiration dates on packaging/labels

an expiration date after which the patient shall not use the drug or medicine. Dates on prescriptions must be the same as that on original container or one year from the date the drug was originally dispensed and placed in the new container whichever date is earlier. Any drug expiring before the expected time for course of therapy must not be dispensed

Special authority or restrictions by type of provider?

it shall be unlawful for a person to practice pharmacy unless a person is licensed under this chapter. Nothing in this section prevents physicians, dentists, veterinarians or other practitioners of the healing arts who are licensed under the laws of this state from dispensing and administering prescription drugs to their patients in the practice of their respective professions where specifically authorized to do so by the law of this state

counseling requirements

-the pharmacist or intern shall orally counsel the patient or patient's agent on the use of a drug or device as appropriate

-the pharmacist/intern shall counsel the patient on a new prescription and any changes in therapy, including but not limited to a change in directions or strength, or a prescription which is new to the pharmacy

only the pharmacist/intern may accept a patient's request not to be counseled. If in their professional judgment they believe the safety of the patient may be impacted, at their

Can patients return controlled substances

Pharmacists, pharmacy technicians and interns may not accept the return of controlled substances

When are medication/device returns allowed?

Pharmacists, pharmacies, pharmacy technicians, certified Oregon pharmacy technicians and interns may accept the return of drugs or devices as defined by ORS 689.005 once the drugs or devices have been removed from the pharmacy only if;

(a) The drugs or devices are accepted for destruction or disposal and;

(b) The drugs or devices were dispensed in error, were defective, adulterated, misbranded, dispensed beyond their expiration date, were unable to be delivered to the patient, or are subject of a drug or device recall; or

(c) After consultation, a pharmacist determines that, in the pharmacist's professional judgment, harm could result to the public or a patient if the drugs or devices were not accepted for return.

Not withstanding (2) of this rule, drugs or devices previously dispensed or distributed may be returned and redispensed or redistributed provided all the following conditions are met:

(a) The drug is in an unopened, tamper-evident unit;

(b) The drugs or devices have remained at all times in control of a person trained and knowledgeable in the storage and administration of drugs in long term care facilities or supervised living groups using the services of a consultant pharmacist;

(c) The drug or device has not been adulterated or misbranded and has been stored according to the manufacturer recommendations.

What may a charitable pharmacy accept

A prescription drug received in original, sealed, tamper-evident packaging that displays the lot number and expiration of the drug

sealed single unit dose packages received in opened packages containing multiple single unit doses (so they could not accept a blister packet of meds no longer in their original packaging)

What is a charitable pharmacy NOT allowed to accept?

Any controlled substance or any kit, package, blister pack that contains any controlled substance

A non-prescription drug

A drug in a container or package that lacks a product identification label (PIL), except that a drug in a manufacturer's original container or manufacturer's blister pack is exempt from bearing a PIL

An FDA REMS drug

A drug donated from another state

Drug take back days

A pharmacy that operates a drug take back collection program or that participates in a drug take-back program under ORS 459A.200 to ORS 459A.266 as an authorized collector shall be registered with the DEA as an authorized collector to collect controlled and non-controlled drugs for destruction.

(2) A pharmacy that operates as a Drug Enforcement Agency (DEA) authorized collector must notify the board within 30 days of initiating or terminating the program and must establish and enforce policies and procedures, including but not limited to:

a. Provision of a secure location of the collection receptacle inside the retail drug outlet, which is accessible to the public, within view of the pharmacy counter and must not be located behind the pharmacy counter; and

b. Provision of adequate security measures, including proper installation and