Application for Certificate of Accreditation as a Pharmacy (Check all that apply)

Fee (incl. HST)

See page 10 for payment information

❏ New Pharmacy Opening

❏ The pharmacy will operate a

$565

❏ The pharmacy will operate

❏ Acquisition of an Existing Pharmacy or Amalgamation $847.50 ❏ The pharmacy will operate a

$1130

❏ The pharmacy will operate $282.50

$1130

❏ The pharmacy will operate $282.50

$1412.50

Complete sections A, B, C, D, a Director of a Corporation Declaration of Good Character for every Pharmacist Director of the corporation applying for a Certificate of Accreditation and submit a pharmacy Floor Plan

NEW Remote Dispensing Location (Complete Section G)

Complete sections A, B, C, D, E, a Director of a Corporation Declaration of Good Character for every Pharmacist Director of the corporation applying for a Certificate of Accreditation, a Pharmacy Self Assessment and submit a pharmacy Floor Plan

$847.50

❏ Relocation of an Existing Pharmacy

Remote Dispensing Location (Complete Section G)

❏ The pharmacy will operate a

NEW Remote Dispensing Location (Complete Section G)

Complete sections A, B, C, D, F, a Pharmacy Self Assessment and submit a pharmacy Floor Plan

a Lock and Leave (Complete Section H)

–

a NEW Lock and Leave (Complete Section H)

a NEW Lock and Leave (Complete Section H)

$1130

❏ Existing Pharmacy to operate a Remote Dispensing Location

Complete sections A & G

❏ Existing Pharmacy to operate a Lock and Leave

$282.50

Complete sections A & H and submit a pharmacy Floor Plan

Pharmacy Information Owner of Pharmacy/Corporation Name:

Accreditation Number: (if existing)

Current Name of Pharmacy: New Name of Pharmacy: (complete if current pharmacy name is being changed)

A

Address of Pharmacy: City/Town:

Province:

Proposed Date of Opening:

Pharmacy Hours of Operation:

Telephone Number:

Fax Number:

Description of Pharmacy:

❏ Plaza/Mall

Email Address:

Postal Code:

Usual & Customary Fee: Website:

B Specialty Services:

❏ Medical Clinic

❏ Methadone for Pain ❏ Specialty Non-Sterile Compounding ❏ Central Fill ❏ Long Term Care/Nursing Home ❏ Mail Order 1

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January 2016

❏ Methadone for MMT ❏ Sterile Compounding

❏ Freestanding ❏ Other:

Application for Certificate of Accreditation as a Pharmacy Corporation Information For corporations which have never owned or operated a pharmacy in Ontario, Articles of Incorporation or Amending Articles and Share Certificates must be submitted with this application. For an amalgamation, please submit Articles of Amalgamation and Share Certificates for the amalgamated corporation. Every pharmacist Director of the corporation must also complete a Director of a Corporation Declaration of Good Character (see pg. 7 of this application form). NOTE: In accordance with Section 142 of the Drug and Pharmacies Regulation Act, the majority of the directors of the corporation must be pharmacists and the majority of each class of share of the corporation must be owned by and registered in the name of pharmacists or in the name of a valid health profession corporation. CORPORATION NAME

DIRECTOR(S) OF THE CORPORATION (1) Name:

OCP Number:

(2) Name:

OCP Number:

(3) Name:

OCP Number:

SHAREHOLDERS (1) Name:

C

OCP Number:

Address: (2) Name:

% of Shares: OCP Number:

Address: (3) Name:

% of Shares: OCP Number:

Address:

% of Shares:

DIRECTOR LIAISON The Director Liaison (DL) is the director of the corporation who will act as the representative of the corporation to the College and serve as the primary contact person with respect to this application. Name:

OCP Number:

Email Address:

Telephone:

Signature of Director Liaison:

Date:

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Application for Certificate of Accreditation as a Pharmacy Pharmacy Personnel DESIGNATED MANAGER Name:

OCP Number:

Email Address: (required) I hereby acknowledge that I have read and understand the Model Standards of Practice for Pharmacists, as approved by the Council of the Ontario College of Pharmacists and the attached document entitled “The Role of the Designated Manager” I agree and accept the responsibilities as defined in the Drug and Pharmacies Regulation Act (DPRA) Section 166. Signature of Designated Manager:

Date:

NARCOTIC SIGNERS

D

(1) Name:

OCP Number:

(2) Name:

OCP Number:

(3) Name:

OCP Number:

PHARMACISTS (without Narcotic Signing Authority) (1) Name:

OCP Number:

(2) Name:

OCP Number:

(3) Name:

OCP Number:

PHARMACY TECHNICIANS (1) Name:

OCP Number:

(2) Name:

OCP Number:

(3) Name:

OCP Number:

Acquisition of an Existing Pharmacy – Purchaser/Seller Agreement

E

Name of Purchaser:

OCP Number:

Signature: (required)

Name of Seller:

OCP Number:

Signature: (required)

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Application for Certificate of Accreditation as a Pharmacy Relocation of an Existing Pharmacy – New Pharmacy Address New Address of Pharmacy: City/Town:

F

Province:

Telephone Number:

Fax Number:

Email Address:

Pharmacy Hours of Operation:

Description of Pharmacy: Specialty Services:

Postal Code: Proposed Date of Opening:

Website:

Plaza/Mall

Medical Clinic

Freestanding

Methadone for MMT

Methadone for Pain

Sterile Compounding

Central Fill

Other: Specialty Non-Sterile Compounding

Long Term Care/Nursing Home

Mail Order

Application to Operate a Remote Dispensing Location Address of Remote Dispensing Location: City/Town:

Province:

Description of Location:

Postal Code: Proposed Opening Date:

Does the RD Location contain an Automated Pharmacy System with Council-approved technology?

G

Yes

No

If yes, please describe the technology:

Is the RD Location a Dispensary?

Yes

No

If yes, please provide Pharmacy Technician information: (1) Name of Pharmacy Technician:

OCP Number:

(2) Name of Pharmacy Technician:

OCP Number:

Signature of Director Liaison:

Date:

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Application for Certificate of Accreditation as a Pharmacy Application to Operate a Lock & Leave Please provide details about the fixtures used, including supporting documents such as floor plans, dimensions, pictures, etc. in order to demonstrate restricted public access.

H

Signature of Director Liaison:

Date:

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Application for Certificate of Accreditation as a Pharmacy The Role of the Designated Manager While the College holds all its members accountable for their practice, Designated Managers carry additional responsibilities related to their role. The Designated Manager (DM) accepts the same accountability and responsibility as the owner and corporate directors for ensuring that the pharmacy conforms to the requirements set out in the Drug and Pharmacies Regulation Act and Regulations, which govern the accreditation, ownership, and operation of pharmacies. The Standards of Practice applicable to DMs are those directed to pharmacists regardless of the role they are fulfilling, including those addressing responsibilities likely to be within the DM’s purview, and standards specifically directed to pharmacists when managing a pharmacy. The DM also serves as the primary contact for the College. The DM is accountable for the following pharmacy functions: • Professional Supervision of the Pharmacy • Facilities, Equipment, Supplies and Drug Information • Record Keeping and Documentation • Medication Procurement and Inventory Management • Training and Orientation • Safe Medication Practices The DM is required to display their name or certificate of registration for public view and it is the expectation of the College that the DM actively and effectively participates in the day-to-day management of the pharmacy. Before accepting the role of DM, it is important for the pharmacist to review the roles and responsibilities expected of this position. The DM must be familiar with the legislation and operational requirements for the profession and the business as well as the policies and procedures that are in place at the pharmacy. The College recommends that the DM be familiar with the past inspection history which should be discussed with the owner. The DM is required to be up-to-date with any changes in College policies and guidelines, which affect the operation of a pharmacy. The College has developed policies to clarify the obligations of the DM with respect to Medication Procurement and Inventory Management, Professional Supervision of Pharmacy Personnel and Required Signage in a Pharmacy. These policies can be found on the College’s website, www.ocpinfo.com under the ‘Regulations & Standards > Practice Policies & Guidelines ( http://www.ocpinfo.com/regulations-standards/policies-guidelines/ )

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Application for Certificate of Accreditation as a Pharmacy Director of a Corporation Declaration of Good Character A declaration form must be completed by every Pharmacist Director of the corporation applying for a certificate of accreditation to operate a pharmacy in Ontario. As a Director of a corporation that is applying for a certificate of accreditation to operate a pharmacy in Ontario, I make the following declarations: 1. I have truthfully completed my annual membership renewal in which I disclosed any current or completed proceedings against me in relation to my ongoing ability to maintain a certificate of registration as a pharmacist. Yes No In addition to the requirements for good character relating to my individual license, I make the following additional declarations relating to my role as Director of a Corporation that holds a Certificate of Accreditation for the operation of a pharmacy. 2. Are there any outstanding proceedings where any allegation of improper business practice was made against you in any jurisdiction, whether in relation to the operation of a pharmacy or any other regulated profession Yes No or business? 3. Are there any completed proceedings where any allegation of improper business practice was made against you, whether in relation to the operation of a pharmacy or any other regulated profession or business, other than a proceeding completed on its merits in which you were found not to have engaged in any improper business Yes No practice? 4. Is there anything in your past or present conduct that would provide reasonable grounds for the belief that the pharmacy would not be operated with decency, honesty and integrity and in accordance with Yes No the law? 5. I agree and understand that as of the date of completion of this application, I am responsible for providing the Registrar with the details of any new information that would change my response to any of the questions on the declaration. I understand that this requirement will continue even after the date the Certificate of Accreditation Yes No is issued or renewed. 6. I hereby declare, that the contents of this application are true and complete to the best of my knowledge and belief. I understand and agree that if I make a false or misleading statement or representation in respect of the application, I shall be deemed not to have satisfied the requirements for issuance of a Certificate of Accreditation. I further understand and agree that if a Certificate of Accreditation is issued based upon a false or misleading statement or representation, that Certificate of Accreditation may be revoked by the Accreditation Yes No Committee.

Name (please print):

Signature:

Date:

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Application for Certificate of Accreditation as a Pharmacy Pharmacy Self Assessment Name of Pharmacy:

Accreditation Number:

Name of Designated Manager:

OCP Number:

Date:

Signage

A

DPRA Reg 58/11, Part IV. s.26

1. The Point of Care sign is displayed in an area visible to the public.

Yes

No

2. The Customary Fee and Notice to Patients signs are displayed in an area easily read by a person presenting a prescription to be filled.

Yes

No

3. The licence of the Designated Manager is displayed or there is a sign identifying who the designated manager is.

Yes

No

NOTE: A fillable certificate that can be used for this purpose and can be found on the College’s website at: http://www.ocpinfo.com/library/forms/download/Designated%20Manager%20Certificate.pdf

Standards of Accreditation and Operation

DPRA Reg 58/11, Part IV

1. Accredited Area and Dispensary – Section 21 & 22: a)

B

The total size of the accredited area is equal to or greater than the required minimum of 18.6 m2 or 200 ft2.

Yes

No

b) The dispensary floor area is equal to or greater than the minimum 9.3 m2 or 100 ft2.

Yes

No

c)

Yes

No

The dispensary is constructed in a way that is not accessible to the public.

d) The pharmacy has a separate and distinct patient consultation area offering ‘acoustical privacy’.

Yes

No

e) If the accredited area is part of a larger area (e.g. part of a medical centre) the accredited area can be kept secure/physically separated from the non- accredited area when a pharmacist is not present.

Yes

No

f)

Yes

No

g) The dispensary sink has hot and cold running water.

Yes

No

h) There is a minimum of 1.12m2 (12 ft2) of work surface for the preparation for dispensing and for the compounding of drugs.

Yes

No

There is a dedicated refrigerator to store drugs and medications with a device to accurately display the internal optimal temperature of 2-8 OC.

Yes

No

There is a torsion or electronic balance in the dispensary. If electronic, the sensitivity level is appropriate to meet the needs of the specific compounding practice.

Yes

No

Yes

No

b) All surface areas can be easily cleaned and disinfected.

Yes

No

c)

i) j)

There are two sinks (or one double sink) within the dispensary.

2. Accredited Area and Dispensary – Section 21 & 22: a)

The pharmacy area is clean, free from clutter.

There is a waste disposal service for drugs and other medication.

Yes

No

d) There is a shredder or service for disposal of confidential information.

Yes

No

e) The location of the fax machine protects patient confidentiality.

Yes

No

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Application for Certificate of Accreditation as a Pharmacy 3. Library (DPRA Reg 58/11, Part IV s. 25) a)

All required references are available in the pharmacy.

Yes

No

b) There are references appropriate to the specialty practice of the pharmacy. • (e.g.) Geriatric dosage handbook for those servicing long-term care or retirement facilities; pediatric dosing guide

Yes

No

c)

Yes

No

Yes

No

b) Non-prescription narcotics are located away from public view.

Yes

No

c)

Yes

No

d) The narcotics and controlled drugs are stored in a way that they are ‘reasonably secure’.

Yes

No

e) The pharmacy has a system that has been established to monitor the N/CD/TS inventory and perform reconciliations as per the DM Policy on Inventory Management.

Yes

No

Yes

No

Yes

No

On-line access to the OCP legislation, Pharmacy Connection, and the ODB Formulary is available. • NOTE: the Required Reference Guide is available on the OCP website, www.ocpinfo.com

4. Drug Schedules/Inventory (DPRA Reg 58/11, Part II)

B

a)

All Schedule II medications are located in an area with no public access.

All Schedule III medications (Professional Products Area) are located within 10m (30 ft.) of the dispensary.

5. Lock and Leave (DPRA Reg 58/11, Part V, s.38) a)

The area completely restricts public access to the Schedule I, II and III drugs when a pharmacist is not present. • NOTE: Lock and Leave must be operational and ready for approval prior to use.

6. Prescription Label (DPRA, S. 156) a)

The prescription label includes the trading name and ownership name (as filed with OCP), as well as the pharmacy’s correct address and telephone number (including area code).

Specialty Services COMPLETE THIS SECTION IF THE PHARMACY ENGAGES IN ANY OF THE FOLLOWING SPECIALTY SERVICES:

C

1. Methadone • The pharmacy has fulfilled the requirements as outlined in the Fact Sheet - Key Requirements for Methadone Dispensing: ( http://www.ocpinfo.com/practice-education/practice-tools/fact-sheets/methadone/ ) Yes No 2. Long-term Care • The pharmacy will adhere to the Standards for Pharmacists Providing Services to Licensed Long-Term Care Facilities ( http://www.ocpinfo.com/regulations-standards/standards-practice/ltc-standards/ ) Yes 3. Compounding • Specialty Non-sterile compounding • Sterile compounding • The pharmacy will adhere to the Guidelines for Compounding Preparations ( http://www.ocpinfo.com/regulations-standards/policies-guidelines/compounding/ )

No

Yes Yes

No No

Yes

No

An inspector will review this self assessment and contact you if there are any questions or concerns. For questions, please contact a Practice Advisor in the Pharmacy Practice department or an inspector at [email protected]

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Application for Certificate of Accreditation as a Pharmacy

PAYMENT INFORMATION Pharmacy Name:

❏

Accreditation Number: (for office use only)

Amount:

I wish to pay by Credit Card

Credit Card Number:

Expiry Date:

❏ ❏ ❏

Visa Mastercard American Express

Cardholder’s Name: (as it appears on credit card)

Cardholder Signature:

Date:

Telephone:

❏

I am enclosing a cheque

Amount:

Payable to Ontario College of Pharmacists in the amount of:

Submit completed forms by email to [email protected] , or fax to 416-847-8399, or mail to the attention of Pharmacy Applications & Renewals at 483 Huron St, Toronto, ON M5R 2R4

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