application for certificate of accreditation as a pharmacy for certificate... · entire pharmacy...
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Application for Certificate of Accreditation as a Pharmacy
110
Pharmacy Information
A
B
$1412.50
$847.50
$847.50
$1130
$282.50
$565
$1130
$1130
–
$282.50
$282.50
The pharmacy will operate a Remote Dispensing Location (Complete Section G)
The pharmacy will operate a NEW Remote Dispensing Location (Complete Section G)
The pharmacy will operate a NEW Remote Dispensing Location (Complete Section G)
The pharmacy will operate a Lock and Leave (Complete Section H)
The pharmacy will operate a NEW Lock and Leave (Complete Section H)
The pharmacy will operate a NEW Lock and Leave (Complete Section H)
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)
Address of Pharmacy:
City/Town: Province: Postal Code:
Proposed Date of Opening: Pharmacy Hours of Operation: Usual & Customary Fee:
Telephone Number: Fax Number: Email Address: Website:
(Check all that apply)
Fee (incl. HST) See page 10 for payment information
Existing Pharmacy to operate a Lock and Leave Complete sections A & H and submit a pharmacy Floor Plan
Relocation of a Pharmacy (30 days notice required)Complete sections A, B, C, D, F, a Declaration of Good Character, a Pharmacy Self Assessment and pharmacy Floor Plan
New Pharmacy Opening (45 days notice required) 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
Existing Pharmacy to operate a Remote Dispensing Location (45 days notice required)Complete sections A & G
Description of Pharmacy: Plaza/Mall Medical Clinic Freestanding Other:
Specialty Services:
Providing Central Fill Long Term Care/Nursing Home Utilizing Central Fill
Methadone for MMT Methadone for Pain Non-Sterile Preparations Hazardous Sterile Preparations
Non-Hazardous Sterile Preparations
Acquisition of an Existing Pharmacy or Amalgamation (30 days notice required for both)
Complete sections A, B, C, D, E, a Director of a Corporation Declaration of Good Character for every Pharmacist Director, a Pharmacy Self Assessment and submit a pharmacy Floor Plan
Specialty Services Definitions
Methadone for MMT The pharmacy is engaged in dispensing methadone for patients in a methadone maintenance treatment (MMT) program for addiction. See Methadone Maintenance Treatment (MMT) and Dispensing Policy
Methadone for Pain The pharmacy is engaged in dispensing methadone for patients for pain management. See Methadone Maintenance Treatment (MMT) and Dispensing Policy
Transfer custody of Methadone dose The pharmacy prepares methadone doses for transferring to a physician (who has received an exemption to delegate authority for the administration component of MMT) or his/her delegate. See Methadone Maintenance Treatment (MMT) and Dispensing Policy and Methadone Maintenance Treatment for Opioid Dependence (CPSO)
Non-sterile preparations The pharmacy, pursuant to a prescription, is producing moderate to complex compounds (e.g., hormone preparations, preparation of solid dosage forms such as capsules and tablets etc.) that require specialized equipment, facilities and or specialized training/knowledge to customize a medication for a patient.
Simple compounding The pharmacy, pursuant to a prescription, is producing simple compounding formulations, with existing formulas, which could be produced without additional training/knowledge in compounding sciences (i.e. with standard pharmacist education requirements) and without additional specialized equipment.
Hazardous sterile preparationsThe pharmacy, pursuant to a prescription, is producing compounded sterile preparations with hazardous products that require specialized equipment and specialized training/knowledge to customize a medication for a patient. This includes the reconstitution, manipulation or repackaging of sterile or nonsterile products to produce a sterile final product. See Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations for more information.
Non-hazardous sterile preparations The pharmacy, pursuant to a prescription, is producing compounded sterile preparations that require specialized equipment and specialized training/knowledge to customize a medication for a patient. This includes the reconstitution, manipulation or repackaging of sterile or nonsterile products to produce a sterile final product. See Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations for examples of non-hazardous sterile preparations and more information.
Utilize central fill The pharmacy, under contract or policy, sends prescription orders to a central fill pharmacy for preparation and packaging. See Centralized Prescription Processing (Central Fill).
Provide central fill The pharmacy, under contract or policy, prepares and packages prescription orders on the originating pharmacy’s direction. See Centralized Prescription Processing (Central Fill).
Long-term care/Nursing Homes The pharmacy provides medication management services to residents of licensed long term care and retirement homes.
Lock and leave The pharmacy has the ability to completely restrict the public, by physical impediments, from access to any drugs referred to in Schedule I, II or III when the pharmacist is not physically present. Any physical impediments or barriers shall be constructed such that the drugs are completely inaccessible to the public. (Note: Type of barrier determined by DM (not in DPRA)). The entire pharmacy area is accredited by OCP and the “Lock and Leave” permits the front shop area of the pharmacy to continue operating and allowing the sale of any drug in the unscheduled category (Schedule U) when the pharmacist is not present. See Operating a Lock & Leave for more information.
Application for Certificate of Accreditation as a Pharmacy
210
Corporation Information
DIRECTOR(S) OF THE CORPORATION
(1) Name: OCP Number:
(2) Name: OCP Number:
(3) Name: OCP Number:
SHAREHOLDERS
(1) Name: OCP Number:
Address: % Sharof es:
(2) Name: OCP Number:
Address: % Sharof es:
(3) Name: OCP Number:
Address: % Sharof es:
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.
For corporations which have never owned or operated a pharmacy in Ontario, the *Data License Agreement, Articles of Incorporation or Amending Articles and Share Certificates must be submitted with this application. For an amalgamation, please submit the *Data License Agreement, 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).
*A Signed Data License Agreement is required for all new corporations – contact [email protected] to obtain a copy
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.
C
Name: OCP Number:
Email Address: Telephone:
Signature of Director Liaison: Date:
CORPORATION NAME
3 10
NARCOTIC SIGNERS
(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:
D
Pharmacy Personnel DESIGNATED MANAGER
Name: OCP Number:
Email Address: (required)
Signature of Designated Manager: Date:
Application for Certificate of Accreditation as a Pharmacy
E
Acquisition of an Existing Pharmacy – Purchaser/Seller Agreement
Name Purof chaser: OCP Number: Signatur (re: equired)
Name of Seller: OCP Number: Signatur (re: equired)
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” and accept the responsibilities as defined in the Drug and Pharmacies Regulation Act (DPRA) Section 166
I agree
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.
As the new Designated Manager of the aforementioned pharmacy, please indicate your acknowledgment of the following four statements by initialing in each box and signing below:
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
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 policies mentioned above and I accept the responsibilities as defined in the Drug and Pharmacies Regulation Act (DPRA) Section 166.
I agree
New Designated Manager’s Signature: Today’s Date:
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.
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.
Review the regulations and operational requirements for the profession and the business as well as the policies and procedures that are in place at the pharmacy. Conduct a full inventory and reconciliation of all narcotic, controlled and targeted substances. This count can be used for future reconciliations. Review past assessment history which should be discussed with the owner. If the assessment reports are not available to review, once the change in Designated Manager has occurred with the College, previous assessment results are available to the DM through their online account.
Before starting the role of DM I will:
410
Application for Certificate of Accreditation as a Pharmacy
510
Relocation of an Existing Pharmacy – New Pharmacy Address
Application to Operate a Remote Dispensing Location
F
New Address of Pharmacy:
City/Town: Province: Postal Code:
Telephone Number: Fax Number: Email Address: Proposed Date of Opening:
Pharmacy Hours of Operation: Usual & Customary Fee:
G
Address of Remote Dispensing Location:
City/Town: Province: Postal Code:
Description Locof ation: Usual & Customary Fee:
Does the RD Location contain an Automated Pharmacy System with Council-approved technology? Yes No If yes, please describe the technology:
Is the RD Location a Dispensary? Yes NoIf yes, please provide Pharmacy Technician information:(1) Name of Pharmacy Technician: OCP Number:
(2) Name of Pharmacy Technician: OCP Number:
Signature Dirof ector Liaison: Date:
Methadone for Pain Non-Sterile Preparations
Description of Pharmacy: Plaza/Mall Medical Clinic Freestanding Other:
Specialty Services:
Providing Central Fill Long Term Care/Nursing Home
Proposed Opening Date:
_____
Methadone for MMT Hazardous Sterile Preparations
Non-Hazardous Sterile Preparations Utilizing Central Fill
610
Application for Certificate of Accreditation as a Pharmacy
Application to Operate a Lock & Leave
H
Signature Dirof ector Liaison: Date:
Please provide details about the fixtures used, including supporting documents such as floor plans, dimensions, pictures, etc. in order to demonstrate restricted public access.
710
Application for Certificate of Accreditation as a Pharmacy
1. I have truthfully completed my annual membership renewal in which I disclosed any current or completedproceedings against me in relation to my ongoing ability to maintain a certificate of registration as a pharmacist.
2. Are there any outstanding proceedings where any allegation of improper business practice was made against you inany jurisdiction, whether in relation to the operation of a pharmacy or any other regulated profession or business?
Yes No
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 aproceeding completed on its merits in which you were found not to have engaged in any improper business practice?
4. Is there anything in your past or present conduct that would provide reasonable grounds for the belief that thepharmacy would not be operated with decency, honesty and integrity and in accordance with the law?
Yes No
5. I agree and understand that as of the date of completion of this application, I am responsible for providing the Registrarwith the details of any new information that would change my response to any of the questions on the declaration. Iunderstand that this requirement will continue even after the date the Certificate of Accreditation 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. Iunderstand and agree that if I make a false or misleading statement or representation in respect of the application, Ishall be deemed not to have satisfied the requirements for issuance of a Certificate of Accreditation. I furtherunderstand and agree that if a Certificate of Accreditation is issued based upon a false or misleading statement orrepresentation, that Certificate of Accreditation may be revoked by the Accreditation Committee.
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.
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:
Name (please print): Signature: Date:
Yes No
Yes No
Yes No
810
Application for Certificate of Accreditation as a Pharmacy
Signage
Pharmacy Self Assessment
A
Name of Pharmacy: Accreditation Number:
Name of Designated Manager: OCP Number:
Date:
1. The Point of Care sign is displayed in an area visible to the public.
2. The Customary Fee and Notice to Patients signs are displayed in an area easily read by a person presenting a
Yes No
Standards of Accreditation and Operation
B
DPRA, O. Reg 264/16, Part IV. s19 Yes No
DPRA, O. Reg 264/16, Part IV1. Accredited Area and Dispensary
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
a) The total size of the accredited area is equal to or greater than the required minimum of 18.6 m2 or 200 ft2.
b) The dispensary floor area is equal to or greater than the minimum 9.3 m2 or 100 ft2.
c) 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’.
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.
f) There are two sinks (or one double sink) within the dispensary.
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
Yes Noi) There is a dedicated refrigerator to store drugs and medications with a device to accurately display the internal optimal
temperature of 2-8 OC.
j) 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
2. Accredited Area and Dispensary
Yes No
Yes No
Yes No
Yes No
a) The pharmacy area is clean, free from clutter.
b) All surface areas can be easily cleaned and disinfected.
c) There is a waste disposal service for drugs and other medication.
d) There is a shredder or service for disposal of confidential information.
e) The location of the fax machine protects patient confidentiality. Yes No
Yes No
prescription to be filled.
3. The licence of the Designated Manager is displayed or there is a sign identifying who the designated manager is.
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
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Application for Certificate of Accreditation as a Pharmacy
Specialty Services
C
B
3. Library
Yes No
Yes No
a) All required references are available in the pharmacy.
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
c) On-line access to the OCP legislation, Pharmacy Connection, and the ODB Formulary is available. Yes No• NOTE: the Required Reference Guide is available on the OCP website,
4. Drug Schedules/Inventory (DPRA, O. Reg 264/16, Part II)
Yes No
Yes No
Yes No
Yes No
a) All Schedule II medications are located in an area with no public access.
b) Non-prescription narcotics are located away from public view.
c) All Schedule III medications (Professional Products Area) are located within 10m (30 ft.) of the dispensary.
d) The narcotics and controlled drugs are stored in a way that they are ‘reasonably secure’.
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
5. Lock and Leave (DPRA, O. Reg 264/16, Part V, s.23)
Yes No
a) The prescription label includes the trading name and ownership name (as filed with OCP), as well as the pharmacy’s correctaddress and telephone number (including area code). Yes No
www.ocpinfo.com
A Practice Advisor will review this self assessment and contact you if there are any questions or concerns.
For questions, please contact a Practice Consultant in the Pharmacy Practice department at [email protected]
COMPLETE THIS SECTION IF THE PHARMACY ENGAGES IN ANY OF THE FOLLOWING SPECIALTY SERVICES:
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 No
Yes NoYes No
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/ ) Yes No
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) My account with Pharmapod has been activated and the Medication Incident Recording Platform has been implemented Yes No
7. Data License Agreement
1010
Application for Certificate of Accreditation as a Pharmacy
PAYMENT INFORMATION
Amount:
Expir Daty e:Credit Card Number:
Cardholder’s Name: (as it appears on credit card)
Cardholder's Signature: Date:
Telephone:
Visa
Mastercard
American Express
Amount:
I wish to pay by Credit Card
I am enclosing a cheque Payable to Ontario College of Pharmacists in the amount of:
Pharmacy Name: Accreditation Number: (for office use only)
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