Quality Management Operation of a Community Pharmacy Policies and Procedures Date last modified by Pharmacy manager Name of Pharmacy manager: Date last revised: Table of Contents Introduction .................................................................................................................................................. 3 Pharmacy Manager Responsibilities ............................................................................................................. 4 Dress Codes and Name Badges ..................................................................................................................... 7 Employee Registrant Information ................................................................................................................. 8 Staff Contact Information and Signature Log ............................................................................................... 8 New Information Accessibility ....................................................................... Error! Bookmark not defined. Pharmacy Staff Duties .................................................................................... Error! Bookmark not defined. Inventory Management ................................................................................. Error! Bookmark not defined. Narcotic Reconciliation .................................................................................. Error! Bookmark not defined. Product Selection ........................................................................................... Error! Bookmark not defined. Expired/Unusable Medications...................................................................... Error! Bookmark not defined. Patient Returned Medications ....................................................................... Error! Bookmark not defined. Drug Disposal ................................................................................................. Error! Bookmark not defined. Security and Storage ...................................................................................... Error! Bookmark not defined. Drug Recalls.................................................................................................... Error! Bookmark not defined. Confidentiality of Records and Unauthorized Access, Collection, Use, Disclosure, or Disposal of Personal Information .................................................................................................... Error! Bookmark not defined. Premises Security ........................................................................................... Error! Bookmark not defined. Licensed Operating Name .............................................................................. Error! Bookmark not defined. Internet Services ............................................................................................ Error! Bookmark not defined. Emergency Preparedness Plan....................................................................... Error! Bookmark not defined. 2 Brought to you by the BC Pharmacy Association Introduction The BCPhA has developed Policy and Procedure Manuals to support pharmacies in documenting policy and procedures that ensure operational activities are compliant with the regulatory framework governing pharmacy practice. Each section includes open field description boxes to be completed with your practice’s policies/procedures or checkboxes meant to act as an acknowledgement that the statement that follows applies to your practice. Description fields and check boxes are marked in grey so that they are easily identified. Description fields are simple to use, just click and type into the space. Checkboxes require a double-click followed by selecting “Checked”. You may choose to print this booklet out upon completion to have a copy available for your staff that need to refer to this guide while keeping the electronic copy saved when updates need to be applied. BCPhA has no objection if you add your organization’s logo or otherwise customize the template. If you do so, please retain the footer crediting BCPhA. BCPhA has made its best effort to develop this template to assist members. The user is solely responsible for its obligations. 3 Brought to you by the BC Pharmacy Association Pharmacy Manager Responsibilities PODSA Bylaw 3 2(a to z) A manager must do all of the following: a) actively participate in the day-to-day management of the pharmacy; b) confirm that the staff members who represent themselves as registrants are registrants; See: Employee Registrant Information c) notify the registrar in writing of the appointments and resignations of registrants as they occur; See: Employee Registrant Information d) cooperate with inspectors acting under section 17 of the Act or sections 28 or 29 of the Health Professions Act; e) ensure that registrant and pharmacy assistant staff levels are commensurate with the workload volume and patient care requirements at all times; f) ensure that new information directed to the pharmacy pertaining to drugs, devices and drug diversion is be immediately accessible to registrants and pharmacy assistants; See: New Information Accessibility g) establish policies and procedures to specify the duties to be performed by registrants and pharmacy assistants; See: Pharmacy Staff Duties, See Pharmacist Refusal to Provide PPP-35 h) establish procedures for inventory management, See: Inventory Management See: Narcotic Reconciliation product selection, and See: Product Selection proper destruction of unusable drugs and devices; See: Destruction of Unusable Drugs and Devices See: Expired / Returned Medications See: Patient Returned Medications See: Disposal of Medications i) ensure that all records related to the purchase and receipt of controlled drug substances are signed by a full pharmacist; 4 Brought to you by the BC Pharmacy Association j) ensure appropriate security and storage of all Schedule I, II, and III drugs and controlled drug substances for all aspects of pharmacy practice including operation of the pharmacy without a registrant present; See: Security and Storage k) ensure there is a written drug recall procedure in place for pharmacy inventory; See: Drug Recalls, See: Automated Pharmacy Dispensing System PPP-43 l) ensure that all steps in the drug recall are documented, if the procedure is initiated; See: Drug Recalls m) ensure that each individual working in the pharmacy wears a badge that clearly identifies the individual’s registrant class or other status; See: Dress Codes and Name Badges n) ensure that confidentiality is maintained with respect to all pharmacy and patient records in accordance with all applicable legislation; See: Confidentiality of Records o) make reasonable security arrangements in respect of unauthorized access, collection, use, disclosure or disposal of personal information kept on the pharmacy premises; See: Unauthorized Access, Collection, Use, Disclosure or Disposal of Personal Information See: Duration of Record Keeping See: Destruction of Records, See: Confidentiality Undertakings p) notify the registrar as soon as possible in the event that he or she will be absent from the pharmacy for more than eight weeks; q) notify the registrar in writing within 48 hours of ceasing to be the pharmacy’s manager; r) ensure the correct and consistent use of the community pharmacy operating name as it appears on the community pharmacy license for all pharmacy identification on or in labels, directory listings, signage, packaging, advertising and stationery; See: Licensed Operating Name s) ensure that appropriate security is in place for the premises generally; See: Premises Security 5 Brought to you by the BC Pharmacy Association t) in the event of a pharmacy closure or relocation, i. notify the registrar in writing at least thirty days before the effective date of a proposed closure or relocation, unless the registrar determines there are extenuating circumstances, ii. provide for the safe transfer and appropriate storage of all Schedule I, II, and III drugs and controlled drug substances, iii. advise the registrar in writing of the disposition of all drugs and prescription records at the time of a closure, iv. provide the registrar with a copy of the return invoice and any other documentation sent to Health Canada in respect of the destruction of all controlled drug substances, v. arrange for the safe transfer and continuing availability of the prescription records at another pharmacy, or an off-site storage facility that is secure, and vi. remove all signs and advertisements from the closed pharmacy premises; u) Ensure sample medications are dispensed in accordance with the requirements in the Drug Schedules Regulation; See: Sample Medications v) advise the registrar if the pharmacy is providing pharmacy services over the internet, and provide to the registrar the internet address of every website operated or used by the pharmacy; See: Internet Services w) ensure the pharmacy contains the reference material and equipment approved by the board from time to time x) require all registrants, owners, managers, directors, pharmaceutical representatives, pharmacy assistants and computer software programmers or technicians who will access the in-pharmacy computer system to sign an undertaking in a form approved by the registrar to maintain the confidentiality of patient record information; y) retain the undertakings referred to in paragraph (x) in the pharmacy for 3 years after employment or any contract for services has ended; z) be informed of the emergency preparedness plan in the area of the pharmacy that he or she manages and be aware of his or her responsibilities in conjunction with that plan. See: Emergency Preparedness Plan See: Pharmacy Disaster Preparedness PPP- 2 6 Brought to you by the BC Pharmacy Association Dress Codes and Name Badges Policy The pharmacy manager is responsible for establishing dress codes for all pharmacy staff and for ensuring that each individual working in the pharmacy wears a badge that clearly identifies the individual’s registrant class or other status. Purpose To ensure that all pharmacy staff are aware of the dress code expectations and that they have name badges that identify their registrant class or other status. Applicability Applies to all pharmacy staff. References Pharmacy Manager Responsibilities PODSA Bylaw 3, 2(m) Implementation Procedures Dress Code Each person working in the pharmacy must wear a badge that clearly identifies the individual’s role (requirement). Describe your uniform or attire expectations: Describe your pharmacist attire expectations 7 Brought to you by the BC Pharmacy Association Employee Registrant Information Policy The pharmacy manager is responsible for confirming that all staff members who represent themselves are registrants and the manager must notify the registrar in writing of the appointments and resignations of registrants as they occur. Purpose To ensure that all registrant staff in the pharmacy are correctly registered and that the Registrar is aware of the place of employment for each registrant. Applicability Applies to all registrants (pharmacists and pharmacy technicians). References Pharmacy Manager Responsibilities PODSA Bylaw 3, 2(b, c) Implementation Procedures When hiring/terminating employees the pharmacy manager: Checks with the College to confirm that each registrant staff member is registered and in good standing at the time of initiating employment. Notifies the Registrar at the time of hiring a registrant. Notifies the Registrar at the termination of employment of a registrant. The pharmacy manager maintains a record of the name, registrant status, contact information, and registration number of each registrant. This information can be incorporated into a signature log so that the registrant‘s initials and signature are identifiable in the future. 8 Brought to you by the BC Pharmacy Association Sign up today as a Pharmacy (Corporate) member to gain access to the full version of this Policy & Procedures Manual and enjoy many other Pharmacy member benefits. Please contact Linda Tinnion at 604269-2864 or by email at linda.tinnion@bcpharmacy.ca to sign up or learn more. 9 Brought to you by the BC Pharmacy Association