PHARMACY PRE-OPENING INSPECTION REPORT

HOSPITAL

1. PHARMACY INFORMATION
Operating Name
Click here to enter text. / PharmaCare Code
Click here to enter text. / Proposed Licensure Date
Click here to enter a date.
MMM | DD | YYYY
Pharmacy Address
Click here to enter text. / City
Click here to enter text. / Province
BC / Postal Code
Click here to enter text / Software Vendor (for dispensing)
Click here to enter text.
Email Address
Click here to enter text. / Phone Number
Click here to enter text. / Fax Number
Click here to enter text. / Website
Click here to enter text.
2. PHARMACY SERVICES
TYPE / YES / NO / TYPE / YES / NO / If “YES”, PROVIDE PHARMACY NAME(S) INVOLVED
Methadone (Pain) / ☐ / ☐ / Contracts - BC Transplant / ☐ / ☐
Methadone (Maintenance) / ☐ / ☐ / Contracts - Center for Excellence / ☐ / ☐
Compounding (Specialty) / ☐ / ☐ / Other - Delivery / ☐ / ☐
Compounding (Sterile Product) / ☐ / ☐ / Other - Internet / ☐ / ☐
Compliance Packaging / ☐ / ☐ / Other - Drive Thru / ☐ / ☐
Clinical - Injection Drug Administration / ☐ / ☐ / Residential Care Services / ☐ / ☐
Clinical - Medication Management/Review / ☐ / ☐ / Centralized Prescription Processing Services / ☐ / ☐ / Provided to:Click here to enter text.
Clinical - Education Clinics / ☐ / ☐ / Outsourced Prescription Processing Services / ☐ / ☐ / Received from:Click here to enter text.
Contracts - Renal Agencies / ☐ / ☐ / Telepharmacy Services (Central Pharmacy) / ☐ / ☐ / Provided to:Click here to enter text.
3. HOURS OF OPERATION
TYPE / SUN / MON / TUE / WED / THU / FRI / SAT
Pharmacy Hours / Enter opening & closing hours / Enter opening & closing hours / Enter opening & closing hours / Enter opening & closing hours / Enter opening & closing hours / Enter opening & closing hours / Enter opening & closing hours
4. PHARMACY ROSTER*
STAFF / REGISTRATION # / FIRST NAME/INFORMAL NAME / LAST NAME / REGISTRATION CLASS
Pharmacy Manager / Registration # / Click here to enter text. / Click here to enter text. / ☒ Pharmacist
Staff #1 / Registration # / Click here to enter text. / Click here to enter text. / ☐ Pharmacist
☐ Pharmacy Technician
Staff #2 / Registration # / Click here to enter text. / Click here to enter text. / ☐ Pharmacist
☐ Pharmacy Technician
Staff #3 / Registration # / Click here to enter text. / Click here to enter text. / ☐ Pharmacist
☐ Pharmacy Technician
Staff #4 / Registration # / Click here to enter text. / Click here to enter text. / ☐ Pharmacist
☐ Pharmacy Technician
Staff #5 / Registration # / Click here to enter text. / Click here to enter text. / ☐ Pharmacist
☐ Pharmacy Technician
Staff #6 / Registration # / Click here to enter text. / Click here to enter text. / ☐ Pharmacist
☐ Pharmacy Technician
Staff #7 / Registration # / Click here to enter text. / Click here to enter text. / ☐ Pharmacist
☐ Pharmacy Technician
Staff #8 / Registration # / Click here to enter text. / Click here to enter text. / ☐ Pharmacist
☐ Pharmacy Technician
Staff #9 / Registration # / Click here to enter text. / Click here to enter text. / ☐ Pharmacist
☐ Pharmacy Technician
Staff #10 / Registration # / Click here to enter text. / Click here to enter text. / ☐ Pharmacist
☐ Pharmacy Technician
Staff #11 / Registration # / Click here to enter text. / Click here to enter text. / ☐ Pharmacist
☐ Pharmacy Technician
Staff #12 / Registration # / Click here to enter text. / Click here to enter text. / ☐ Pharmacist
☐ Pharmacy Technician

*Use a separate sheet if more space is needed

5. PRE-OPENING INSPECTION
Confirm whether your new pharmacy currently complies with each of the following requirements.
  • If compliant,select “Yes” under the “Compliant” column and submit digital evidence (e.g. photos/videos) along with this form.
  • If not applicable,enter “N/A” under the “Compliant” column and provide the reason in the comment field.

Pharmacy/Dispensary

# / Item / Reference and Requirements / Compliant / Comment / Non-Compliance(s) and Action Item(s) / CPBC Use
1a / Placeholder for College license / PODSA s.2(4)
The manager must display the College license in a place within the pharmacy where it is conspicuous to the public. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
1b / Main Dispensary/Packaging area / PPP-59 Policy Statement #3
All hospital pharmacies and hospital pharmacy satellites must beadequately equipped to provide safe and proper medicationcompounding, dispensing and/or preparation of medication orders,and for the provision of patient-oriented and administrative pharmacyservices. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
1c / Bulk or batch packaging area
OR N/A / PPP-59 Policy Statement #3
All hospital pharmacies and hospital pharmacy satellites must beadequately equipped to provide safe and proper medicationcompounding, dispensing and/or preparation of medication orders,and for the provision of patient-oriented and administrative pharmacyservices. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐

Security

# / Item / Reference and Requirements / Compliant / Comment / Non-Compliance(s) and Action Item(s) / CPBC Use
2a / Narcotic storage equipment / Narcotic Control Regulations s.43
A pharmacist shall take all reasonable steps that are necessary to protect narcotics on his premises or under his control against loss or theft.
PPP-47 PolicyStatement #4
Targeted Substances received by the community pharmacy, hospital pharmacy department or nursing unit must be stored in a secure environment.
PODSA Bylaws s.4(4)
Every registrant practicing in a pharmacy is responsible for the protection from loss, theft or unlawful sale or dispensing of all Schedule I, II, and III drugs and controlled drug substances in or from the pharmacy. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
2b / Security system
(Select all that apply)
☐ Motion sensors
☐ Security Camera System
☐ Monitored Alarm
☐ Other - Describe system used / PODSA Bylaws s.15(2)
When a hospital pharmacy or hospital pharmacy satellite is closed,the premises must be equipped with a security system that will detectunauthorized entry.
HPA Bylaws s.77(1)
A registrant must protect personal information about patients bymaking reasonable security arrangements against such risks as unauthorized access, collection, use, disclosure or disposal. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
2c / After hours services:
☐Locked cabinet OR
☐Other secure enclosure
OR N/A / PODSA Bylawss.15(1)
If continuous pharmacy services are not provided in a hospital, the hospital pharmacy’s manager must ensure that urgently needed drugs and patient-oriented pharmacy services are available at all times by
a) providing a cabinet which must
(i) be a locked cabinet or other secure enclosure located outside of the hospital pharmacy, to which only authorized persons may obtain access,
(ii) be stocked with a minimum supply of drugs most commonly required for urgent use,
(iii) not contain controlled drug substances unless they are provided by an automated dispensing system,
(iv) contain drugs that are packaged to ensure integrity of the drug and labeled with the drug name, strength, quantity, expiry date and lot number, and
(v) include a log in which drug withdrawals are documented.
b) by arranging for a full pharmacist to be available for consultation on an on-call basis. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐

Equipment and References

# / Item / Reference and Requirements / Compliant / Comment / Non-Compliance(s) and Action Item(s) / CPBC Use
3a / Computer terminals for prescription processing / PODSA Bylaws s.20(b)
A pharmacy must connect to PharmaNet and be equipped with a terminal that is capable of accessing and displaying patient records, located in an area of the pharmacy which
(i) is only accessible to registrants and support persons,
(ii) is under the direct supervision of a registrant, and
(iii) does not allow information to be visible to the public, unless intended to display information to a specific patient. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
3b / Equipment (Cold Chain)
  1. Refrigerator
  2. Thermometer
  3. Temperature log
/ PPP-68 Policy Statement:
The Board of the College of Pharmacists of BC adopts the BCCDC guidelines on the Cold ChainManagement of Biologicals. Refer to BCCDC’s Communicable Disease Control ImmunizationProgram: Section VI – Management of Biologicals.
Communicable Disease Control Immunization Program Section VI – Management of Biologicals (2015) s.3.3.2
Maintain the refrigerator temperature between +2°C to +8°C.
Standard bar fridges (small volume combinationfridge/freezer with one exterior door) are not adequatebecause they do not maintain even temperatures.
Do not store items such as food and beverages in medicationrefrigerators, to prevent unnecessary opening of the refrigerator.
Use a constant temperature-recording device or digital minimum/maximum thermometer (with probe) to monitor both the current refrigerator temperature and the minimum/maximum temperatures reached.
At the start and end of each work day, record the minimum and maximum temperatures reached since the last monitoring, on the Temperature Form.
On the Temperature Log, record the date, time and three temperatures (the current refrigerator temperature, the minimum temperature reached since last check, and the maximum temperature reached since last check.) Also record the refrigerator dial setting. / Choose an item. / Click here to enter text. / Click here to enter text. / REFR
☐
TMM
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TLOG
☐
3c / References / PODSA Bylaws s.3(2)(w)
The manager must ensure the pharmacy contains the reference material and equipment approved by the board from time to time.
PPP-3Electronic Database References
Electronic database references are acceptable for any of the authorized choices within any of the required categories, provided that they are as comprehensive as the printed version and meet the same updating requirements.
PPP-3 Page 3
All hospital pharmacies and hospital pharmacy satellites must beequipped with a reference library of current references relevant tomedication compounding, dispensing and/or preparation ofmedication orders, and current patient-oriented references for theprovision of patient-oriented pharmacy services. / Choose an item. / Provide list of references available:
Click here to enter text. / Click here to enter text. / ☐

Medication Administration Record

# / Item / Compliant / Comment / Non-Compliance(s) and Action Item(s) / CPBC Use
4a / Medication administration record / HPA Bylaws Schedule F Part 2 s.14(3) (a) to (h)
The medication administration record must include
a) the patient’s full name and identification number,
b) the patient’s location in the hospital,
c) the presence or absence of known allergies, adverse drugreactions, and intolerances,
d) the date or period for which the drug administration record is tobe used,
e) the name, dosage and form of all drugs currently ordered,
f) complete directions for use for all drugs,
g) stop or expiry dates for drug orders for which there is anautomatic stop policy (if not reported by another means)
h) predetermined, standard medication administration times for regularly scheduled drugs / Choose an item. / Click here to enter text. / Click here to enter text. / ☐

Confidentiality

# / Item / Reference and Requirements / Compliant / Comment / Non-Compliance(s) and Action Item(s) / CPBC Use
5a / ☐Shredder
OR
☐Contract with a document destruction company / HPA Bylaws s.75
A registrant must ensure that records referred to in section 74 are disposed of only by (a) transferring the record to another registrant, or (b) effectively destroying a physical record by utilizing a shredder or by complete burning, or by (c) erasing information recorded or stored by electronic methods on tapes, disks or cassettes in a manner that ensures that the information cannot be reconstructed.
HPA Bylaws s.78
A registrant must ensure that, if personal information about patients is transferred to any person or service organization for processing, storage or disposal, a contract is made with that person which includes an undertaking by the recipient that confidentiality and physical security will be maintained. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
5b / Offsite storage contract
OR N/A / HPA Bylaws s.74(b)
A registrant must ensure that all records pertaining to his or her practice, and containing personal information about patients are safely and securely stored off site. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐

Inventory Management

# / Item / Reference and Requirements / Compliant / Comment / Non-Compliance(s) and Action Item(s) / CPBC Use
6a / Drug receiving area / PODSA Bylaws s.5(3)
All drug shipments must be delivered unopened to the pharmacy or a secure storage area. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
6b / Automated dispensing cabinet(s) or units
OR N/A / PPP-59 Policy Statement #3
All hospital pharmacies and hospital pharmacy satellites must beadequately equipped to provide safe and proper medicationcompounding, dispensing and/or preparation of medication orders,and for the provision of patient-oriented and administrative pharmacyservices. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
6c / Storage area for non-usable and expired drugs / PODSA Bylaws s.5(4)
Non-usable and expired drugs must be stored in a separate area of the pharmacy or a secure storage area until final disposal. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
6d / Storage area for unused dispensed drugs / HPA BylawsSchedule F Part 2s.5(1)
Unused dispensed drugs must be returned to the hospital pharmacy. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
6e / Hazardous drugs storage area
OR N/A / PPP-59 Policy Statement #3
All hospital pharmacies and hospital pharmacy satellites must beadequately equipped to provide safe and proper medicationcompounding, dispensing and/or preparation of medication orders,and for the provision of patient-oriented and administrative pharmacyservices. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐

Dispensed Products

# / Item / Reference and Requirements / Compliant / Comment / Non-Compliance(s) and Action Item(s) / CPBC Use
7a / Drug packaging / HPA Bylaws Schedule F Part 2 s.3(2)
A unit dose, monitored dose, multiple pouch packaging or individualpatient prescription drug distribution system must be used fordispensing drugs. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
7b / Drug container label / HPA BylawsSchedule F Part 2s.4(1)
Drug container labels must include
(a) the generic name of the drug, strength and dosage form, and
(b) Hospital approved abbreviations and symbols. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
7c / Inpatient prescription label
☐Medication Label (Oral Solid, etc.)
☐IV label
☐ Compounded drug prescription labels / HPA BylawsSchedule F Part 2s.4(3)
Inpatient prescription labels must include:
a) a unique patient name and identifier,
b) the generic name of the drug, strength and dosage form,
c) parenteral vehicle if applicable, and
d) Hospital approved abbreviations and symbols.
HPA BylawsSchedule F Part 2s.4(4)
The following information must be included on the inpatientprescription label if not available on the medication administrationrecord:
a) the frequency of administration;
b) the route of administration or dosage form;
c) auxiliary or cautionary statements if applicable;
d) The date dispensed.
NAPRA Guidelines to Pharmacy Compounding (2006) s.8.2
Labels of compounded products should include but not be limited to:
a) list of active ingredients;
b) prescription or identification number of the compoundedproduct; and
c) Estimated beyond-use-date printed at the end of the dosageduration. / Choose an item. / Click here to enter text. / Click here to enter text. / MED
☐
IV
☐
CMP
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7d / Inpatient pass label
OR N/A / HPA BylawsSchedule F Part 2s.7(4)
Labels for inpatient pass and emergency department take-home drugs must include
a) the hospital’s name,
b) the patient’s name,
c) the practitioner’s name,
d) the drug name, strength and directions for use,
e) identification of the person preparing the drug, and
f) The date the drug is issued. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
7e / Labels for emergency department take-home drugs
OR N/A / HPA BylawsSchedule F Part 2s.7(4)
Labels for inpatient pass and emergency department take-home drugs must include
a) the hospital’s name,
b) the patient’s name,
c) the practitioner’s name,
d) the drug name, strength and directions for use,
e) identification of the person preparing the drug, and
f) The date the drug is issued. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
7f / Filling supplies (e.g. vials and bottles including caps) / HPA Bylaws Schedule F Part 2 s.7(5)
Drugs must be dispensed in a container that is certified as childresistant unless…. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐

Non-Sterile Compounding*

*All pharmacies who compound non-sterile preparations will have to follow NAPRA’s new Model Standards for Pharmacy Compounding ofNon-Sterile Preparation, which will replace their Guidelines to Pharmacy Compounding (2006), when the publication is released in 2017. Visit the College’s website for updates and more information:

☐ Check this box and skip this section if your pharmacy does not compound non-sterile preparations.

# / Item / Reference and Requirements / Compliant / Comment / Non-Compliance(s) and Action Item(s) / CPBC Use
8a / Non-sterile compounding area / PPP-59 Policy Statement #3
All hospital pharmacies and hospital pharmacy satellites must beadequately equipped to provide safe and proper medicationcompounding, dispensing and/or preparation of medication orders,and for the provision of patient-oriented and administrative pharmacyservices.
NAPRA Guidelines to Pharmacy Compounding Oct 2006 s.4
(1) The compounding area should be clean, sanitary, and orderly.
(2) Premises should permit effective cleaning of all surfaces.
(3) Premises should prevent contamination of medication and the inadvertent addition of extraneous material to the medication. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐
8b / Non-sterile compounding equipment / NAPRA Guidelines to Pharmacy Compounding Oct 2006 s.5.1
Equipment used for compounding should:
a) be situated in an area that permits it to function in accordancewith its intended use. Equipment should be operated in a manner that prevents contamination;
b) be easily and routinely cleaned to minimize potential forcontamination;
c) be suitable for the preparation of the desired compound; and
d) be kept clean, dry, and protected from contamination duringstorage to prevent the addition of extraneous materials. / Choose an item. / Click here to enter text. / Click here to enter text. / ☐

Hazardous & Non-Hazardous Sterile Compounding

The College has set out a four-year implementation plan for pharmacies that compound sterile preparations to fully adopt NARPA’s new model standards by May 2021 when the new bylaws come into effect. The new standards include Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations. For more information, visit the College’s website at .