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Clinical Practice Pharmacy Policy and Procedure Manual

This document outlines general information, security, and privacy policies for a clinical practice pharmacy. It includes details on pharmacy operations like hours, staffing, and position descriptions. It also covers security of the physical pharmacy and patient information, requiring alarms, access controls, and safe data transmission. Patient records must be securely stored for 5 years in compliance with standards.
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© © All Rights Reserved
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Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
214 views11 pages

Clinical Practice Pharmacy Policy and Procedure Manual

This document outlines general information, security, and privacy policies for a clinical practice pharmacy. It includes details on pharmacy operations like hours, staffing, and position descriptions. It also covers security of the physical pharmacy and patient information, requiring alarms, access controls, and safe data transmission. Patient records must be securely stored for 5 years in compliance with standards.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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________________________________________Clinical Practice Pharmacy: Policy & Procedure Manual

Policy and Procedure Manual

Clinical Practice Pharmacy

1|Page
________________________________________Clinical Practice Pharmacy: Policy & Procedure Manual

GENERAL INFORMATION

A. Pharmacy Information

Pharmacy Name: ________________________________________________________________

Address: _______________________________________________________________________

Office Phone: _________________________________________

Mobile Phone: ________________________________________

After Hours Phone (if applicable): _______________________

E-mail Address: ______________________________________

Hours of Operation: __________________________________


Standard 2.8.1 All pharmacies must be open for at least twenty-five (25) hours over a minimum of four
(4) days per week unless the pharmacy manager or owner can demonstrate to Council that fewer hours
will safely meet the needs of the patients receiving care from the pharmacy.

Standard 2.1.7 Access to services shall be available during all regular hours of operation. Where “on-call”
service exists, information on how to access after-hours clinical information services shall be posted.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

B. Staff Information

Pharmacy Manager: ____________________________________________________________________

Pharmacist(s): _________________________________________________________________________

Pharmacy Technician(s): _________________________________________________________________

Other Staff & Positions:


_____________________________________________________________________________________

_____________________________________________________________________________________
Standard 2.8.2 A licenced pharmacist does not need to be on site during all hours of operation of the
pharmacy, but the practice of pharmacy or any required supervision cannot occur without a licenced
pharmacist on site and the remaining staff must have access to the licenced pharmacist working off-site
in case of urgent situations requiring the involvement of a licenced pharmacist.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

2|Page
________________________________________Clinical Practice Pharmacy: Policy & Procedure Manual

C. Position Descriptions

PHARMACY MANAGER:
_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

PHARMACIST(S):

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________
Standard 2.1.2 All clinical information requests must be handled by a licenced pharmacist, or a
pharmacy resident (a person on the academic register) or a student or intern under the supervision
of a licenced pharmacist.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

PHARMACY TECHNICIAN(S):

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

OTHER STAFF MEMBER(S):


_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

_________________________________________________________________________________________________________

3|Page
________________________________________Clinical Practice Pharmacy: Policy & Procedure Manual

SECURITY & PRIVACY

A. Pharmacy Security

Alarm Company Contact Information: _____________________________________________________

Individuals with Key(s) to Pharmacy: ______________________________________________________

Opening and Closing Procedures: _________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________
Standard 2.4.2 The pharmacy must be constructed in a manner of materials that protect the records
from unauthorized access.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

B. Privacy and Security of Patient Files & Information

Storage of Patient Records: ______________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________
Standard 2.3 Record Keeping
2.3.1 In addition to the requirements of section 79 of the regulations and in compliance with the practice
direction related to Standard of Practice #12: Records and Information, the licenced pharmacist must
retain records described in this practice direction for five (5) years.
http://mpha.in1touch.org/uploaded/web/Legislation/Records%20and%20Information.pdf

4|Page
________________________________________Clinical Practice Pharmacy: Policy & Procedure Manual

Hardware and Software Security: _________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________
Standard 2.4.1 Safeguards must be implemented in the receiving and sending of data to ensure patient
personal health information is kept confidential.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

Fax Standard Compliance: _______________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________
Standard 2.4.1 Safeguards must be implemented in the receiving and sending of data to ensure patient
personal health information is kept confidential.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf
http://mpha.in1touch.org/uploaded/web/Legislation/Records%20and%20Information.pdf

Confidentiality Agreements: _____________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

Mail and Deliveries: ____________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

5|Page
________________________________________Clinical Practice Pharmacy: Policy & Procedure Manual

Computer Information:

Clinical Software (Software Used to Maintain Patient Information): ______________________________

_____________________________________________________________________________________

Repair Contact: ________________________________________________________________________

6|Page
________________________________________Clinical Practice Pharmacy: Policy & Procedure Manual

CLINICAL SERVICES

Patient Permission to Access Personal Health Information:

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________
2.5.1 When accessing patient medication profile information, the clinical practice pharmacy licenced
pharmacist must document:
2.5.1.1 Written permission from the patient for access to their personal health information;
2.5.1.2 A description of the information being requested with respect to patient care;
2.5.1.3 The name of the licenced pharmacist requesting the information and reason for the request
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

Documentation of Patient Information: ________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________
2.2.1 Documentation of Patient Information:
Licenced pharmacists shall maintain patient profiles for all patients, and that patient profile information
shall include:
2.2.1.1 Demographic information: name, address, telephone number, date of birth (age), gender;
2.2.1.2 Clinical information such as allergies and sensitivities and, where significant, disease state and/or
chronic conditions;
2.2.1.3 A comprehensive list of medications (e.g. drug name, strength);
2.2.1.4 Use of relevant devices (e.g. self-testing, compliance devices, etc.);
2.2.1.5 Relevant prior and present medical conditions;
2.2.1.6 Non-prescription, herbal and homeopathic drug use;
2.2.1.7 Non-medicinal use of drugs, alcohol, tobacco;
2.2.1.8 Laboratory and/or physical examination results, if available.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

7|Page
________________________________________Clinical Practice Pharmacy: Policy & Procedure Manual

Procedures for Processing Clinical Information Requests:

____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________
Standard 2.1.4 The licenced pharmacist shall use professional expertise and judgment in processing
clinical information requests. This includes:
2.1.4.1 Obtaining the necessary background information so that the request is received in a complete
and understandable form;
2.1.4.2 Interpreting the clinical information request;
2.1.4.3 Systematically and thoroughly conducting a literature search;
2.1.4.4 Evaluating the literature in an accurate, unbiased manner;
2.1.4.5 Formulating a relevant, coherent and informative response, and
2.1.4.6 Communicating the response in a verbal and/or written form in a manner that is clear and
understandable to the recipient.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

Procedures for Accessing Patient Health Information (ie. DPIN Profile, Laboratory Values): __________

____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

Procedures for Documenting Pharmacist Interventions: ______________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________
Standard 2.2.2 Documenting Interventions:
Licenced pharmacists shall obtain the best possible medication history of the patient, from available
sources such as the patient, DPIN profile, prescribers, other health care professionals, etc. When
providing complete clinical services, licenced pharmacists will intervene and appropriately document the
following:
2.2.2.1 Actual and potential medication related problems that are to be monitored;
2.2.2.2 Actual and potential adverse effects that are to be monitored;
2.2.2.3 Compliance;
2.2.2.4 Drug discontinuations;
2.2.2.5 Counseling on medications.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

8|Page
________________________________________Clinical Practice Pharmacy: Policy & Procedure Manual

Communication with Physician(s) and/or Other Healthcare Professionals:

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________
Standard 2.2.3 When an intervention is required, at the discretion of the licenced pharmacist, the
licenced pharmacist shall promptly forward the assessment, recommendations, and results to the most
appropriate practitioner and, if appropriate, the community licenced pharmacist, along with
recommendations to enhance patient care and quality of life. After an intervention has occurred, and the
recommendations have been made, the licenced pharmacist shall follow up with the patient within a
reasonable timeframe to ensure the recommendation has enhanced patient care.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

Patient Counseling Procedures: __________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________
Standard 2.6 Patient Counseling
2.6.1 Licenced pharmacists must comply with the practice direction regarding counseling the patient
with respect to content, follow-up and privacy, as stated in the community pharmacy, as well all other
practice requirements applicable to a patient accessing the pharmacy services.
2.6.2 Content of the patient counseling information needs to be individualized for the needs of the
patient, the condition(s) being treated and the knowledge and communication level of the patient.
2.6.3 All counseling areas must:
2.6.3.1 Have acoustic and visual privacy;
2.6.3.2 Have sound panels or opaque glass, unless in a separate room;
2.6.3.3 Ensure ready access to the reference resources and patient profile;
2.6.3.4 Ensure the physical needs of the patient are met.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

9|Page
________________________________________Clinical Practice Pharmacy: Policy & Procedure Manual

Reporting Adverse Events:

_____________________________________________________________________________________

_____________________________________________________________________________________
Standard 2.1.5 The licenced pharmacist shall contribute to the drug literature, by reporting any adverse
events that have impacted upon patient safety.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

Clinical References:

____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________
Standard 2.1.1 The pharmacy manager must ensure the pharmacy has the minimum information
resources as determined by Council
Standard 2.1.6 The licenced pharmacist shall be aware of more extensive sources of information and the
procedures necessary to access them.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

Complaints:

Managing Complaints: __________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

Incident/Discrepancy Reporting: __________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

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________________________________________Clinical Practice Pharmacy: Policy & Procedure Manual

Policy and Procedure Manual:


2.7.1 Written policies and procedures for pharmacy services shall guide all personnel in the performance
of their duties.
2.7.1 A comprehensive policy and procedure manual will contain information relating to professional
responsibilities, protecting confidentiality and integrity of patient information, compliance with federal
and provincial regulations and an operational Quality Assurance Program.
2.7.3. These policies and procedures shall be updated as circumstances in the pharmacy change (e.g.
change of ownership, change of manager, etc.) or at a minimum of every three years, and dates to
indicate the time of the last review and/or revision.
http://mpha.in1touch.org/uploaded/web/Legislation/PD%20Clinical%20Practice%20&%20appendix.pdf

11 | P a g e

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