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Professional Practice > JP2 > Flashcards

JP2 Flashcards

1
Q

OCP regulates the member under ______ and practice site under _____

A

member under RHPA and pharmacy act

practice site under DPRA

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2
Q

what does the DPRA regulate

A

Licensing and ownership of pharmacies

Standards for accreditation

Dispensing of drugs

Record keeping

Accountability and responsibility

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3
Q

what other legislations does the DPRA work with

A

Food and Drugs Act

Controlled Drugs and Substances Act

Privacy Legislation: PIPEDA, PHIPA

Drug Interchangeability and Dispensing Fee Act

Ontario Drug Benefit Act

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4
Q

how is a drug defined

A

Scheule 1:

  • scheulde 1-VIII of CDSA
  • Scheule G (I,II,III) of FDA
  • PDL
  • Schedule 1 of NAPRA

Scheule II

  • exempted codeine preparations
  • schedule II of NAPRA

Schedule III

  • Schedule III of NAPRA
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5
Q

NPH are not considered drugs, what are the exceptions

A

Pseudoephedrine and ephedrine

*defined as drugs in the DPRA

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6
Q

what are schedule I drugs

A

Require a prescription

Are the same as the drugs listed Schedule I

Includes all the drugs listed in the Prescription Drug List (PDL)

Includes all the drugs in the Schedule of the Controlled Drugs and Substances Act

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7
Q

Schedule II Drugs

A

Do not require a prescription

Only available through professional intervention by a pharmacist

Kept in restricted area of a pharmacy not accessible to the public

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8
Q

Schedule III Drugs

A

Available without a prescription

Can only be sold in a pharmacy from the dispensary or from an area of a pharmacy (as required by the College) that allows for patient self-selection (10m rule)

A member must be available if needed

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9
Q

conditions for sale of scheudle 1 drugs

A
  1. The pharmacist must be physically present
    • For remorse dispensing locations (RDL), the pharmacist must be physically present at the RDL or at the accredited pharmacy that operates the RDL
    • Drugs must only be sold from an automated pharmacy system or the dispensary at the RDL
  2. There must be a prescription
  3. The pharmacist must approve the sale
  4. The drugs can only be sold from the dispensary
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10
Q

conditions for selling Schedule II drugs in Pharmacy

A
  1. Pharmacist must be physically present in the pharmacy
  2. Pharmacist must approve and intervene in the sale
  3. Drugs can only be sold from the dispensary
  4. For remote dispensing locations (RDL), the pharmacist must be physically present either at the RDL or at the accredited pharmacy that operates the RDL; and
  5. Drugs must only be sold from the automated pharmacy system or the dispensary at the RDL
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11
Q

Conditions fo Selling Schedule III drugs in pharmacy

A
  1. Pharmacist must be physically present in the pharmacy
    • For remorse dispensing locations (RDL), the pharmacist must be physically present at the RDL or at the accredited pharmacy that operates the RDL
  2. Drugs must only be available for sale in the pharmacy from the dispensary or from an area of the pharmacy that allows for patient self-selection
    • For RDL, drugs must be only available from the automated pharmacy system or dispensary
  3. Member must be available for consultation with the patient as needed
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12
Q

who can accept verbal Rxs?

A

Narcotic drugs

  • Not acceptable UNLESS during COVID, but ONLY pharmacist

Non-narcotics

  • pharmacist, intern or pharmacy student all under supervision of pharmacist
  • pharm tech cannot accept verbal for controlled drugs or targeted sub

*must recrod date, refils and name of who received rx

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13
Q

required info for transfers

A

Name and address of patient

Name and strength of drug prescribed

Directions for use

Name and address of prescriber

Name of manufacturer of the drug most recently dispensed

Identification number of prescription

Total quantity of drug remaining

The quantity most recently dispensed if different from quantity prescribed (e.g. drug plan rules)

The name of the member transferring the prescription; can be given verbally or under the signature of the member making the transfer

The date the drug was first dispensed and last dispensed date (Exception: for benzodiazepines also need date prescription was issued)

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14
Q

what info is required on a patient record?

A
  1. An electronic record of the original prescription
  2. Prescription information
  3. Dispensing record of all prescriptions with pharmacist/technician signature
  4. Any documentation or information about the patient

Examples of records and documents include:

  1. MedsCheck documentation
  2. Prescription initiation, adaptation and refill documentation
  3. Pharmaceutical opinion
  4. Medication management
  5. Identified drug therapy problems
  6. Consent forms
  7. Documentation of dialogue with patients
  8. Any other information
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15
Q

how long of a notice do you need to give OCP for relcoation

A

30 days before relocating

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16
Q

when does the acceditation committee get involved

A
  • if registrar has reason to believe that applicate wont opperate pharmacy in accordance with legislation
  • accreditation committee can direct registrar to:

Refuse the certificate

Place terms, conditions and limitations or

Issue the certificate of accreditation

17
Q

terms of an accreditation certificate

A
  • expire yearly on May 10th -> must be renewed
  • registrar has authority to refuse to renew under certain conditions of DPRA like non paymeny of fees

*may then refer to accreditiation committee

  • qualifications for renewal are similar to issueance of a new certificate
18
Q
A
19
Q

what are the responsibilites for Owners/DM

A
  • Every owner or DMis responsible and liable for any offense against the DPRA made by a person under their supervision or employment
  • Every director of a corporation operating a pharmacy is liable for any offense against the DPRA made by anyone under the corporation (hospital pharmacies exempt DPRA s. 166(3)

** for hospital pharmacies, a contact person must be designated

20
Q

Who can accreditation committee refer to discipline committee

A

Person who is issued a certificate of accreditation

Directors of a corporation which has been issued a certificate of accreditation

Designated manager of the pharmacy

21
Q

Referral to discipline happens if the Accreditation Committee believes that

A

A pharmacy is not operating according to the DPRA and its regulations

A pharmacy is not complying with any term, condition or limitation that its certificate of accreditation requires and

An act of proprietary misconduct has been committed

22
Q

outcomes of discipline committee

A

Revoke the certificate

Suspend the certificate for a period of time

Impose a fine of not more than $100,000

Impose terms, conditions or limitations on the certificate

23
Q

when can a pharmacy disclose prescription info

A

Written agreement between pharmacy certificate holder and the person to whom disclosure is made

Does not include anything that could identify a patient and

Designated manager or contact person of the pharmacy (where applicable) is aware of the existence of the written agreement

24
Q

what must be done if a pharmacy is closing

A

Owner must remove all signage related to the pharmacy

Must notify Registrar with seven days of closing

Must notify the Office of Controlled Substances about the disposal of its narcotics, controlled drugs and benzodiazepines/targeted substances

Pharmacy to inform patients before they close

25
Q

who can own a pharmacy in ontario

A
  • Ontario requires a pharmacy to be owned and operated by a pharmacist
  • Majority of directors must be pharmacists and the majority of each class of shares must bee owned/registered in the name of a pharmacis

Exemptions

  • “Pre-54 Charter”
    • Allows a non-pharmacist to own a pharmacy
    • Majority of directors of the corporation must be pharmacists
    • Must have a designated manager to operate the pharmacy
  • Non-profit, multi-disciplinary health care facilities
    • Example: hospitals
26
Q

what are the designated names that only accredited pahrmacies can use

A

Drug store

Drug department

Drug or drugs

Medicines

Pharmacy

Drug sundries

Drug Mart

27
Q

what happens if your license is revoked

A
  • When a pharmacist’s license is revoked:
    • No longer a member of the College
    • Cannot be employed as a pharmacist in a pharmacy
    • Cannot act as a director or shareholder of a corporation owning a pharmacy
  • If this happens, the corporation can:
    • Use the name of the revoked pharmacist as a director or shareholder for up to six months
    • During this time, the revoked pharmacist cannot act in the capacity of director or shareholder. Ex. Cannot vote or make decisions
28
Q

what happens if your license is suspended

A
  • If a member is suspended, they are not considered a member of the College
  • To maintain the required composition of directors and shareholders, a suspension of a pharmacist’s license does not affect the corporation’s ability to continue naming that person as a director or shareholder during the suspension
  • This allows the pharmacy to remain open
29
Q

what happens if a pharmacy owner dies

A
  • For the death of a sole owner of a pharmacy, a personal representative may own and operate the pharmacy for four years
  • gives time to sell the pharmacy or form a corporation with a pharmacist who would own the majority of shares and be the director of the company
  • They can also operate the pharmacy for four years, or period approved by Council
30
Q

how can a pharmacy be allowed to “lock and leave”

A

If a pharmacist wants to operate a Lock and Leave, they must:

  • Apply to the Registrar
  • Submit floor plans with their application and have an inspection by the College
  • Ensure that all scheduled drugs are completely inaccessible to the public
31
Q

Standards of Accreditation of pharamacy

A
  • Safe, clean and properly maintained environment
  • Secure and safeguarded pharmacy
  • Patient confidential information protected
  • Equipment and technology as needed for site
  • Appropriate staffing and resources
  • Information management system
  • Audit trail for drugs
32
Q

Computer system must have

A
  • Storing and reporting patient records and dispensing transactions
  • Sufficient security
  • Ability to uniquely identify each staff member who accesses system
  • Control functions allowed by each staff member
  • Ability to create an audit trail
  • Capable of collating and generating reports
  • Sufficient speed and capacity
33
Q

Pharmacy Structure Requirments

A
  • Community pharmacies must be a minimum of 18.6 sq. meters or 200 sq. feet in size
  • must provide an area that offers acoustical privacy to ensure patients can discuss their health conditions and medications privately
  • A separate and distinct patient consultation area
  • Constructed and finished to allow the effective cleaning of all surfaces
  • Sufficient shelving, drawers and fixtures for the appropriate storage of all drugs, natural health products and unscheduled products
  • OCP symbol visible
34
Q

Standards of Accreditation of RDL

A
  • An RDL cannot operate independently and can only exist if there is an accredited pharmacy operating it
  • The designated manager is accountable and responsible for the proper operation of the remote location
  • The operation of a RDL is restricted to the opening hours of the pharmacy operating it where a pharmacist is physically present to provide services
  • The accredited pharmacy is responsible for all the record-keeping
  • All RDLs must be equipped with live, real time, two way audio-visual links
  • All RDLs have to meet the same standards as a regular pharmacy, except under certain circumstances as specified by the regulations:
  • must be situated indoors in a well lit, ventilated areas, Areas should provide ample space or privacy
  • The APS does not have to meet the same standards for the dispensary such as sinks, equipment, fixtures, minimum floor area or designated areas for Schedule III drugs.
  • The technology of the APS unit must:
  • Be able to easily verify the authenticity of the prescription or determine if any alterations have been made
  • Maintain a temperature between 2-8 degrees Celsius if they contain refrigerated items
35
Q

conditions for advertising prescription prices

A
  • advertising of prescription prices, which includes advertising the usual and customary fee, must include at least 15 different drugs from 10 different therapeutic categories
  • It must also include the quantity, total cost (including the dispensing fee), brand name, strength, and dosage form of the drug as well as the period of time it will be advertising
  • only price that can be advertised without all these requirements is the Ontario Drug Benefit (ODB) co-payment or dispensing fee

Professional Practice (23 decks)

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