Drug and Pharmacies Regulation Act (DPRA)

Question 1

DPRA

Answer 1

Its regulations are provincial legislation that apply to pharmacy practice in Ontario

Question 2

Purpose of DPRA

Answer 2

Regulating Pharmacy’s Operations

• Licensing and ownership of pharmacies
• Standards for accreditation and operation
• Dispensing of drugs
• Record Keeping
• Accountability and responsibility

Question 3

DPRA - Ontario Regulation

Answer 3

Part II - drug schedules
Part VI - Prescriptions refills, and transfers
Part VII - Child resistant packaging
Part X - Record keeping

Question 4

Definition of a Drug

Answer 4

Any substance or preparation containing any substance manufactured, sold or presented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state or the symptoms thereof, in humans animals or fowl

Question 5

Schedule I Drugs

Answer 5

• Require a prescription
• Are the same as the drugs listed in Schedule I of the manual
• Includes all the drugs listed as Schedule F, Parts I and parts II of the food and drugs act
• Includes all the drugs in the schedule of the controlled drugs and substances act

Question 6

Conditions for selling Schedule I Drugs

Answer 6

• Pharmacist must be physically present
• There must be a RX
• Pharmacist must approve for sale

Question 7

Conditions for sale of Schedule III Drugs

Answer 7

• Pharmacist or intern must be available for consultation with the patient
• Drugs must be available for sale in the pharmacy from the dispensary or from an area within 10m from the dispensary

Question 8

Accepting prescriptions from another province

Answer 8

Prescriptions can be accepted from any prescriber within Canada as long as they are a licenced prescriber in their jurisdiction of Canada

Question 9

Verbal Prescriptions

Answer 9

• No narcotics, except verbal prescription narcotics
• Must be received by pharmacist, intern, pharmacy student or pharmacy technician (all under supervision of a pharmacist)
• ph tech may not accept verbal rx for: verbal narcotics, controlled drugs or targeted substances

Question 10

Prescription Label

Answer 10

• RX or transaction number
• Name, address and telephone number of the pharmacy in which the Rx is dispensed
• Drug name, strength and manufacturer (unless directed otherwise by prescriber)
• Quantity of drug dispensed
• Name of owner of the pharmacy
• Date the Rx is dispensed
• Name of prescriber
• Name of person for whom it is prescribed
• Directions for use as prescribed
• college policies on labelling may list beyond what is required in legislation
• Single-entry drug products: policy dictates that chemical name must also be listed, along with manufacturer
• Multi-medication compliance aids: drug in the package, description of each tablet must also be added to the label such that it can be clearly identified

Question 11

Prescription Transfers

Answer 11

Once a prescription has been transferred to another pharmacy , all authorizations are transferred with it.
Benzodiazepines and targeted substances can only be transferred once, and rx’s for these schedules are only valid for 1 year from date prescribed

Question 12

Information required for prescription transfers

Answer 12

• 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 a drug remaining
• The date the drug was first dispensed and last dispensed date (exception for benzodiapines also need date prescription was issued

Question 13

The pharmacy accepting the transfer

Answer 13

• The name of the pharmacy where the prescription originated (must validate that the originating pharmacy is licensed)
• The information regarding the prescription from that pharmacy is complete as required by this regulation
• The name and signature of the member receiving and recording the information

Question 14

Certificate of Accreditation

Answer 14

• Only pharmacies with a certificate of accreditation issued by the Registar of the college may operate a pharmacy in Ontario
• Application form, background information, payment of fees. Additional info may be requested

Question 15

Referral to the accreditation committee

Answer 15

Certificate holder is notified by the college
Certificate holder is given 30 days to submit a written response in their defence
1) Direct the registrar to renew the certificate
2) direct the registar to renew the certificate with terms conditions or limitations
3) direct the registar not to renew the certificate

Question 16

Revoke or Suspend Certificate of Accreditation

Answer 16

-Shows deficiencies or fails to comply with standards of accred
-Provides false information at issurance or renewal
Certificate holder is notified by the college and given 15 days to make a submission. no extension is allowed

Question 17

Referral to Discipline Committee

Answer 17

• 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

Question 18

Referral to discipline happens if the accreditation committee believes that:

Answer 18

• 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 and act of proprietary misconduct has been committed

Question 19

Discipline Committee will direct the Registrar to:

Answer 19

-Revoke the certificate
suspend the certificate for a period of time
-impose a fine of not more than $100,00
-impose terms, conditions or limitations on the certificate

Question 20

Ownership of Pharmacies

Answer 20

-majority of directors must be pharmacists
-Majority of each class of shares must be owned/registered in the name of a pharmacist
-In the event of death of an owner or shareholder:
shares goes to their personal representative who may or may not be a pharmacist
shares are considered registered in the name of a pharmacist for up to 4 years

Question 21

Designations

Answer 21

Only an accreditated pharmacy in ontario can use the following designations

• drug store
• pharmacy
• drug department
• drug sundries
• drug or drugs
• drug mart
• medicines

Question 22

Impact of revocation/ suspension of a pharmacists licence

Answer 22

• no longer a member of the college
• cannot be employed as a pharmacist in a pharmacy
• cannot act as director or shareholder of a corporation owing a pharmacy

Question 23

Impact of revocation/suspension of a pharmacists license in a corporation

Answer 23

• Use the name of the revoked pharmacist as a director or shareholder for up to 6 months
• During this time, the revoked pharmacist cannot act in the capacity of director or shareholder
• A suspension of a pharmacists licence does not affect the corporations ability to continue naming that person as a director or shareholder during the suspension

Question 24

Standards for accreditation and operation

Answer 24

-Pharmacist must be physically present when the pharmacy is open
-a pharmacist named by the owner to manage the pharmacy: DM
DM must ensure that their name, certificate of registration, or BOTH are clearly displayed in the pharmacy

Question 25

Lock and leave requirement

Answer 25

• Apply to the registrar-submit floor plans with their application and leave inspection by the college
• ensure that all scheduled drugs (even schedule ii) are completely inaccessible to the public

Question 26

Requirements for dispensary

Answer 26

• Dispensary are not less than 9.3 sq m
• Sink with hold and cold running water, separate hand washing facility from equipment washing
• Refridgerator only for dugs maintained between 2-8c and equipment to maintain that temperature
• computer with internet
• equipment to receive, send, copy, scan and store documents
• torsion/electronic balance
• bottles, caps, vials, ointment jars, child resistant packages