Pharmacies > Operating a Community Pharmacy > Community Pharmacy and Remote Dispensing Location Assessments

Community Pharmacy and Remote Dispensing Location Assessments

During a community pharmacy assessment, a College operations advisor reviews the pharmacy’s operations. The assessment is designed to ensure the pharmacy is adhering to operations standards and has the proper processes and procedures in place.

The frequency of routine pharmacy assessments is dependent on the activities performed at the pharmacy and the risk of harm those activities pose to the public.

The status and outcome of assessments can be found on Find a Pharmacy or Pharmacy Professional.

Preparing for a Community Pharmacy Assessment

The Designated Manager of the pharmacy will receive an email from the College informing them of an upcoming community pharmacy operations assessment. This email will contain important information about the timing and requirements of the assessment and should be carefully reviewed. The Designated Manager may also be asked to complete a questionnaire and/or submit documentation ahead of the assessment.

Designated Managers should review the following resources prior to the assessment:

Assessment Types

There are several types of operational assessments that may take place at a community pharmacy and remote dispensing location.

Routine Assessments

All community pharmacies undergo routine assessments on a cycle depending on the activities performed at the pharmacy and the risk of harm those activities pose to the public. For example, a pharmacy dispensing methadone or doing sterile compounding will be assessed more often than a pharmacy where those activities aren’t occurring.

New opening assessments

All community pharmacies are assessed and given authorization to operate (accredited) prior to opening day. Additionally, an operations advisor will conduct a follow-up assessment within six months or as soon as operationally possible after opening. Read more about opening a pharmacy.

Acquisition assessments

A change in ownership (if an existing pharmacy is purchased by a new owner) is equivalent to opening a new pharmacy and requires an assessment before opening day. Additionally, an operations advisor will conduct a follow-up assessment within six months or as soon as operationally possible. Learn more about changes in ownership/purchasing a pharmacy. This is similar to assessments that occur at the time of a merger or amalgamation.

Relocation assessments

A change in location (if an existing pharmacy moves to a new address) also requires an assessment before opening day. Additionally, an operations advisor will conduct a follow-up assessment within six months or as soon as operationally possible. Learn more about changes in location/relocating a pharmacy. Pharmacies may also require an assessment because of significant renovation.

Re-assessments and re-assessments ordered by the Accreditation Committee

Re-assessments may be ordered by a College operations advisor or may be escalated and ordered by the Accreditation Committee. The timing of a re-assessment is determined by the severity of the issues identified during the previous assessment, the potential time required to fix any deficiencies, and the risk of harm to the public.

Assessment Outcomes

When community operations advisors visit a pharmacy, they assess its operations and processes to determine if it is operating safely. The operations advisor uses the operational assessment criteria to determine if the pharmacy is safe, or if further action is required.

There are several potential outcomes, depending on what the operations advisor observes at the time of the assessment.

Pass

If no notable issues are identified at the time of the assessment, the pharmacy receives a Pass and the assessment is complete.

If only minor issues are identified at the time of the assessment, the pharmacy is granted the opportunity to rectify the issues. The operations advisor will follow up to ensure they are satisfied that the issues have been addressed. The pharmacy then receives a Pass and the assessment is completed. Usually, the time frame to rectify the issues is 30 days but could be longer depending on the issue.

Re-assessment required

If issues that have the potential to affect public safety are identified at the time of the assessment, the operations advisor may choose to order a re-assessment and a re-visit of the pharmacy will occur to ensure that all issues are rectified.

When an operations advisor re-visits the pharmacy:

  • If no notable issues are identified at the time of the re-assessment, the pharmacy receives a Pass and the assessment is complete.
  • If only minor issues are identified at the time of the re-assessment, the pharmacy is granted the opportunity to rectify the issues (as above under “minor issues”). Assuming all issues are rectified, the pharmacy will receive a Pass and the assessment is complete.
  • If issues that have the potential to affect public safety are identified at the time of the re-assessment, the operations advisor will refer the pharmacy to the Accreditation Committee for further consideration (see below). Pharmacies that are awaiting review by the Accreditation Committee have an outcome of Referred to Accreditation Committee on Find a Pharmacy/Professional.

Referred to Accreditation Committee

If there are potential public safety issues, the operations advisor may refer the pharmacy to the Accreditation Committee. Pharmacies that are awaiting review by the Accreditation Committee have an outcome of Referred to Accreditation Committee on Find a Pharmacy/Professional.
Only a small number of community pharmacies are referred to the Accreditation Committee each year. Most of these have already undergone a routine assessment and a re-assessment and continue to have challenges satisfying the assessment criteria which then has the potential to affect public safety.
The Accreditation Committee will review the pharmacy’s file, including information provided by the pharmacy as to how they may have resolved or addressed the issues of concern, and may do one or more of the following:

  1. Determine the pharmacy’s operations to be satisfactory and issue a Pass if they feel that the pharmacy has appropriately addressed the issues identified. The assessment is then complete.
  2. Following a referral to the Accreditation Committee, the committee may issue an outcome of Pass with Conditions if they are not assured that operational issues have been addressed. An operations advisor will conduct a re-assessment and the results will be returned to the committee for further review.
  3. Order an operations advisor to re-assess the pharmacy. If the Committee chooses this option, an operations advisor will return to the Committee with a report, and the Committee will decide whether the pharmacy’s operations are now satisfactory (as above in #1) or whether the pharmacy should have conditions on its right to operate (as above in #2), or if further action should be taken. The pharmacy will have an outcome of Pending Committee Report on Find a Pharmacy/Professional while awaiting the committee’s consideration of the re-assessment report from the operations advisor.

The Accreditation Committee may also refer the pharmacy’s owner and Designated Manager to the Discipline Committee. A referral to the Discipline Committee is not an outcome of an assessment and usually coincides with either a re-assessment or conditions on the pharmacy’s right to operate. A referral to the Discipline Committee will require the pharmacy’s Designated Manager or Director Liaison to appear before the Committee, usually on allegations of proprietary misconduct. The pharmacy itself will stay under the review of the Accreditation Committee.

Remote Dispensing Location Assessments

Remote dispensing locations (RDL) are facilities where medications are dispensed or sold to the public. They are operated by a pharmacy whose certificate of accreditation permits its operation but are not in the same location.

RDLs are assessed alongside an accredited community pharmacy as part of that pharmacy’s routine assessment.

Assessment Fees

Pharmacies are required to pay a Pharmacy Re-Inspection (Compliance Audit) fee for each re-assessment. See the Schedule of Fees (line 25) for the current fee amount.

Pharmacies are also required to pay a Pharmacy Re-Inspection fee for each re-assessment ordered by the Accreditation Committee. See the Schedule of Fees (line 35) for the current fee amount.

Documentation Submission Ahead of the Assessment

The initial encrypted email you receive will specify the documentation that must be submitted ahead of your assessment. Ideally, all documentation should be submitted approximately two weeks after you receive your assessment notification. This allows the operations advisor to review the documents thoroughly and to contact you for clarification or for missing documents.

All submissions must be made through the encrypted web portal, as outlined in the notification of assessment. The College is unable to accept mailed documentation. Please do not mail any documentation to the College. If you have unique circumstances around documentation submission please consult with your organization, if required, and discuss directly with your College advisor.

Please review the emails you receive from us carefully to understand the documentation we are requesting as it will vary depending on the types of services your pharmacy offers. The purpose of asking for a variety of different documents is so that the operations advisor is able to get a good picture of the breadth of your operations and the types of services you manage. The documents and questionnaire will also enable your operations advisor to understand your policies and procedures.

See the FAQs below for additional details on the document submission process.

FEATURED RESOURCES

FAQs

  • We take patient privacy very seriously at the Ontario College of Pharmacists. All document submissions containing personal health information (patient name, etc.) are done via an encrypted web portal.

    The web portal has end-to-end security, meaning all information is secure from the moment you send the email to the moment we receive it at the College, i.e., secure lifecycle management of information.

    Redaction of patient information should be done according to your organization’s policies. Operations advisors do not need access to patient identities in order to perform the assessment. However, it is important for YOU to know the identity of your patients to provide any additional information during the assessment. If redacted copies are sent to OCP, you should keep a record of the patient’s name for your own use.

  • When you first receive the encrypted email from the College, you will be asked to create an email encryption account with a username and password (details will be attached to your encrypted email). Once you have created this account, you are able to log-in at any time.

    For all of the requested documentation, it is suggested you either scan the documents and save screen shots as PDF or take a picture and save as JPEG (picture). All of these types of documents can be ATTACHED to an encrypted email via the portal. Please ensure the quality of the picture is of good clarity and reasonable size so the operations advisor can read it easily.

    PLEASE NOTE: compressed files are NOT permitted.

    You will NOT have the ability to compose a new email in the encrypted account. Please REPLY to the original encrypted email that was sent to you, and add attachments as you normally would. There is a 35MB limit per email, so you may need to send multiple emails with attachments. This is perfectly acceptable.

    Please also note that the encrypted email AUTO-DELETES after 30 days. If you do not submit your documentation within 30 days, you will need to email [email protected] to request a new link.

  • OCP is committed to providing the highest level of security, controls and integrity to support secure email encryption for information transfer. As such our email encryption service provider adheres to the following standards:

    • Web Trust Certified
    • PCI DSS Level 1 Certified
    • Encryption Standards:
      • RSA 2048-bit asymmetric encryption
      • RSA PKCS cryptographic protocols; PKCS#1, #7, #10, #12
      • AES-256 symmetric encryption
      • SHA2 hashing algorithm
      • ANSI X.509 certificates and certificate revocation lists
      • IETF MIME and S/MIME email

  • In order to ensure that the operations advisor knows which documents correspond to which type of activity, we ask that you please NAME the document attachments to indicate this clearly. For example: “Narcotic reconciliation August 2020,” “Mixture Listing Report” or “Blister pack label.”

  • If you keep individual pages for each controlled substances, send in reconciliation logs for five different narcotics (e.g. oxycodone), logs for five controlled drugs (e.g. amphetamine), and logs for five targeted substances (e.g. lorazepam). Include a description of how your process ensures that all controlled medication received and dispensed every six months have been reconciled with your current process. Please also ensure that all records of reconciliation are available for the onsite or remote assessment.

  • The Designated Manager should send in two complete reconciliations completed for narcotics, controlled drugs and targeted substances (one of which should be from at least 6 months ago). The reasons and investigations for any discrepancy found in the reconciliation is to be documented and available for assessment by the operations advisor. It is best if this documentation can be available on one page for each discrepancy or documented on the full count if it is clear. If your reconciliation documentation for submission exceeds 40 pages total, please contact your advisor directly to discuss what documents are required. All documents pertaining to reconciliation of controlled substances in the past two years must be available for the onsite or remote assessment.

  • The operations advisor will review the documentation submitted. If clarifications or further information is needed, the Designated Manager will be contacted directly.

  • The Designated Manager of the pharmacy will be able to access the pharmacy assessment report after the assessment. Please do not respond to the action plans via email or encrypted email.
    To access your assessment report:

    1. Go to https://members.ocpinfo.com.
    2. Enter your OCP username (OCP#) and password.
    3. Click on Pharmacy Assessment on the upper right side of the screen.
    4. Then click Pharmacy Assessment Report/Action Plan on the left-hand menu. This will bring you to the Quill site.
    5. Enter your OCP Username (OCP#) and password again. Please note: the initial sign in to the OCP portal is not case sensitive, but the Quill login is case sensitive.
    6. The assessment report can be accessed by clicking View Inspections

    If the outcome of your assessment requires an action plan to be submitted, the action plan can be accessed by clicking View Active under Action Plan Summaries.

Print page