PAS presentation: Administering Drugs by Injection and Other Routes (Oct 15, 2015)

1. Saskatchewan College of Pharmacy Professionals
Pharmacy Association of Saskatchewan
Drug Plan and Extended Benefits Branch
October 16, 2015
8am-10am

2.  Stakeholders
 Training and education
 Overview of relevant legislation in Bill 151
 Documentation Requirements
 Overview of Influenza Immunization Program
 PAS Support Documents
 PAS Public Education Campaign
 FAQs
 Opportunity for Questions

3.  SCPP
◦ Establish and administer Advanced Method Certification for pharmacists
◦ Specify record-keeping requirements for influenza immunizations
administered by pharmacists
 Population Health Branch
◦ Purchase vaccine
◦ Develop 2015-2016 Seasonal Influenza Immunization Handbook for
Pharmacists
 Drug Plan and Extended Benefits Branch
◦ Develop Influenza Immunization Program policy
◦ Remunerate pharmacies the IIF upon receipt of the electronic claim
◦ Establish additional record-keeping requirements for the Program as
required
 PAS
◦ Assist in communicating policy and other requirements to PAS members

4.  Developed and provided by CPDP
◦ CCCEP Stage II accredited plus SK specific module
◦ Over 750 pharmacists will be trained by October (approx. 850 by end
November)
 Additional sessions through CPDP (spots still available)
◦ Nov 14, Regina
◦ Nov 29, Saskatoon
 Mini-Immunization Sessions
◦ Oct 18, Saskatoon
◦ Oct 24, Regina
 More sessions available in Spring 2016
 PAS has extended the grant to fund core injections training until Sept. 30,
2016 or for 1200 spots, whichever comes first
 If you do not show up for your live session, you will be charged for the spot

5.  Pharmacists must be certified by the SCPP office
before administering the flu vaccine. Refer to
recent invitation memo.
 Upon approval of your application, and when or
after the new bylaws are in force (expected to be
October 16th) SCPP will issue, via email, a certificate
showing the effective date upon which you may
begin to administer drugs by Advanced Method.

6.  Overview
◦ Legislation
 Bill 151
 Bylaws
◦ Guidance documents on standards and special
edition SCOPE Friday
 Issues
◦ Publicly funded vs non-publicly funded vaccines
 Extra billing and legal advice by PAS and/or SCPP as
needed
◦ Off site administration of flu vaccine
◦ Other drugs

7.  SCPP Bylaw record keeping requirements:
 patient's name and address;
 name of the drug and total dose administered;
 for an advanced method or vaccination by any method,
identification of the manufacturer, lot number and expiry
date of the drug;
 for an advanced method, the route of administration,
dosage and the location on the body where the drug was
administered;
 name of the licensed pharmacist administering the drug;
 date and the time of administration;
 adverse events; and
 price, if there is a charge for administration.

8.  Other
◦ As identified during training
◦ Provide Ministry of Health wallet card as proof of
immunization
 Documentation meeting SCPP bylaws and
standards, and DPEBB requirements available on
CPDP website and on PAS website
 Update as of Oct 15th: populatable-pdfs created by
CPDP and now on CPDP and PAS website

9.  Drug Plan and Extended Benefits Branch
program
◦ Influenza Immunization Season
◦ Eligibility
◦ Vaccine Product
◦ Distribution
◦ Influenza Injection Fee
◦ Billing Requirements
◦ Documentation
◦ Reporting to government

10. October 19, 2015
to
March 31, 2016

11.  Saskatchewan residents 9 years of age and older
 Valid Saskatchewan Health Services Card
 Includes NIHB, DVA etc.
 Ineligible patients must be referred to regional Public
Health Department for vaccination

12.  Saskatchewan pharmacies will use
Fluviral® DIN 02420686 multidose vial
0.5 mL IM
 No adjuvant, antibiotic-free
 Post-puncture shelf life
◦ 28 days, 2-8C
◦ For more details read product monograph
 May contain traces of egg proteins (ovalbumin) and formaldehyde.
Thimerosal is added as a preservative.
 Special Instructions –
◦ Pre-drawing is not recommended.
◦ The Ministry recommends that vaccines be administered directly
from the fridge or cooler and not warmed to room temperature
prior to administration.
See more details about Fluviral® in 2015-2016 Seasonal Influenza
Immunization Handbook for Pharmacists

13.  Public Health purchased vaccine and distributing pharmacy
portion to wholesalers
 Pharmacies order vaccine through McKesson and Kohl and
Frisch
 Must let DPEBB know your pharmacy will be participating to
be eligible to order publicly-funded vaccine
◦ Participation details on PAS homepage
◦ 235+ pharmacies across Saskatchewan registered
 Daily Ordering Limits
◦ Minimum 1 unit = one 10-dose vial
◦ Maximum 20 units = 200 doses
 Availability of vaccine for all providers is subject to
manufacturers’ ability to fulfill the amount of product
ordered by and the shipping schedule to provinces

14.  Administration must be
◦ Fluviral® by injection
◦ to eligible patient(s)
◦ within physical space of pharmacy
◦ by a trained and certified pharmacist
 pseudoDIN 00951105
 $13.00 per IIF
 Must be submitted as a quantity of one (1)
 IIF covers supply costs (alcohol swabs, needle etc.), patient
assessment, administration, monitoring, record keeping,
drugs and supplies related to managing adverse events
following injection

15.  Max 1 claim, in a 220 day period per patient
 Adjudication only during official flu season- Oct 19,
2015, - March 31, 2016
 No incentives shall be provided to any person in
relation to receiving the influenza immunization
(points, coupons, discounts, rebates etc.)
 More details in the DPEBB Influenza Immunization
Program Policy and Pharmacy Bulletins

16.  Provide vaccination and submit the record of the
vaccine product administered electronically for
capture to the DPEBB using the product DIN
 Submit the claim for the Influenza Immunization
Fee (IIF) electronically to the DPEBB on the same
day as the vaccine record using the appropriate
pseudoDIN
 Refer to the DPEBB Influenza Immunization Policy
and Pharmacy Bulletin

17.  As per Saskatchewan College of Pharmacy
Professionals
◦ Bylaws to specify record keeping
 As per DPEBB Policy
◦ Policy will utilize SCPP requirements as applicable
◦ Written and informed consent also required
 Immunizations are voluntary
 Pharmacists are responsible to obtain informed and
documented consent before immunization
 Following form meets all requirements of SCPP
and Drug Plan

19. ◦ Post-immunization, it is recommended that clients
receive an influenza wallet card as proof of
immunization
◦ Documented consent required to submit for
Influenza Injection Fee (IIF)

20. Influenza Wallet Cards
 100 wallet cards sent to every pharmacy that has
already indicated participation
 To order more cards, go to
http://www.publications.gov.sk.ca/ (create an
account if you don’t have one)
 “1” = a quantity of 1 card
 Cards and shipping for free
RECORD OF INFLUENZA IMMUNIZATION
Name:
Immunization Date:
Vaccine type: TIV QIV LAIV
Date of 2nd Dose for Child:*
HCW: Yes No Provider initials: _____
*NOTE: 2 doses are required for children younger
than 9 years old who are getting immunized with
influenza vaccine for the first time.
 Immunization Record App available at
www.immunize.ca/en/app.aspx
YY/MM/DD
 For more information about Saskatchewan’s
immunization programs, go to:
www.saskatchewan.ca/immunize Pneumococcal
23 immunization date:

21.  Cold Chain
◦ All cold chain breaks must be reported and faxed to the
Ministry at 306-787-3237 immediately upon discovery
using the Vaccine Cold Chain Interruption Incident
Report form (CS 03) available in the Saskatchewan
Immunization Manual (SIM), chapter 9 section 5.2
available at
(http://www.ehealthsask.ca/services/manuals/Document
s/sim-chapter9.pdf)
◦ Must maintain cold chain log, subject to audit
As set out in the 2015-2016 Seasonal Influenza
Immunization Handbook for Pharmacists

23.  As per SCPP guidelines at
https://scp.in1touch.org/uploaded/58/web/refmanual/Vaccine-Storage-
Handling-and-Transport-GuidelinesFor-09-10.pdf
 Purpose-built refrigerator (lab style unit) is the standard for large inventories of
vaccines
 Food storage refrigerator
◦ meet standards for maintaining cold chain. Ask supplier Re: suitability
 combination freezer and refrigerator units, there must be a separate external
freezer and refrigerator door
 frost free
 used solely for storing vaccines (other drugs or food should not be stored)
 maintain required vaccine storage temperatures through all seasons
 large enough to accommodate fluctuations in vaccine supply
 calibrated thermometer inside each storage compartment
 placed in a secure location away from unauthorized and public access
 other technical features can affect the safe storage of vaccines (consult
National Guidelines)
 attached freezer - know location and avoid placing vaccines directly under
this vent
 know location of thermostat inside the refrigerator
 Continued on next page

24.  Purpose built glass doors do not protect light sensitive
vaccines, or do not provide adequate insulation when
power out
 Bar fridges discouraged (leading cause of cold chain
breaks, unpredictable)
 Locate for proper heat exchange and cooling - coils on
back 10 cm away from the wall, wheels/legs 2.5 to 5 cm
above floor
 Do not place in direct sunlight, near a heat source, or
outside wall where temperature can fluctuate
Tracking and reporting temperature logs may be
subject to audit by DPEBB

25.  Post temperature log on outside of fridge/storage door
 Must document temperature minimum twice a day
◦ Record min and max. temperatures reached since the last
monitoring
◦ In morning before door opened for first time
◦ End of day just after door closed for last time
◦ Include date, time and initials
 Store vaccine in middle to upper shelves (avoid lower
shelves/areas of fridge, near cooling vents, do not store in
doors- less stable temperature)
 Allow space between products to allow air circulation
 DO NOT store food in fridge

26.  If space allows
◦ Place full plastic water bottles or thawed ice packs on bottom
and empty shelves, and door of fridge (to preserve
temperature inside, in the case of a power outage)
 Start monitoring fridge prior to receiving stock to
ensure stable temperature of 2°C ‐ 8°C
 Consider having a designated injection coordinator
 Ensure all staff are familiar with cold chain procedures
 Ensure dated punctured is recorded
 Check expiry date before every use
 Replace vaccine immediately after receiving/drawing up

27. Information adapted from Chapter 9 of the Saskatchewan Immunization Manual (SIM)
http://www.ehealthsask.ca/services/manuals/Documents/sim-chapter9.pdf
Protecting Vaccines During Immunization Clinics
Following these steps will ensure that the vaccines are maintained at the required
temperature throughout the process and that the vaccines that are returned to the
refrigerator have not been exposed to temperatures below 2°C (35°F) or above 8°C (46°F).
Pack only the amount of vaccine you expect to use during the immunization clinic.
Maintain the vaccines at the required temperature (between 2°C ‐ 8°C (35°F – 46°F)) during
the immunization clinic. It is important to ensure that the administered vaccine retains its
potency.
Minimize the number of times that the cooler is opened during the immunization clinic.
Monitor temperature readings in the insulated cooler often with a digital read out
thermometer if available.

28. Insulated Containers
• Vaccines should be transported in insulated containers that
have been qualified to ensure that they are capable of
maintaining the vaccine temperature of 2°C ‐ 8°C for the
necessary duration.
• The cooler criteria:
• It is large enough to store vaccines, ice/gel packs, and insulating
material during transport;
• The external surface material is strong and durable;
• The cooler insulation thickness is 30 mm to 80 mm;
• The lid is tight fitting; and
• It has strong handles for carrying or wheels for transport.

29. Acceptable containers:
• Hard‐sided plastic insulated coolers;
• Soft‐sided vaccine bags;
• Shipping containers the vaccines arrived in from the manufacturer; and
• Newer Styrofoam coolers with at least 2‐inch thick walls.
• Unacceptable containers (cannot reliably maintain appropriate
temperatures):
• Banged‐up old Styrofoam containers; and
• Thin‐walled Styrofoam coolers (such as those to hold beverages).

30. Ice Packs and Gel Packs
• The temperature inside the cooler is maintained with ice/gel packs, and
insulating materials. Keep enough ice packs frozen or gel packs refrigerated (at
+2°C to +8°C) and ready to meet the vaccine transport needs of your clinic or
health unit. Ensure that ice packs are completely frozen before use.
• There are two main types of cooling packs:
• Refrigerator‐conditioned (e.g., gel packs).
Note: Ice packs filled with tap water are the safest type for maintaining the
recommended vaccine storage temperature of 2°C ‐ 8°C inside a cold box;
• Gel coolant packs may have a freezing point below 0°C and may pose a risk of
freezing vaccines;
• Information about the product’s cold life and instructions on how to freeze and
condition the product before use should be asked of the manufacturer before
purchasing coolant products;
• Never use bagged or loose ice to transport vaccines; and
• If possible, set ice packs on their edge and allow space between them for air
circulation in the freezer. Stacking ice packs on top of each other in the freezer
may result in uneven or partial freezing, and decrease the efficacy of the
icepacks.

31. Insulating Materials:
• Insulating materials are used as a barrier to prevent
direct contact between vaccines and frozen packs.
• A layer of paper towelling is not sufficient as a barrier
to protect vaccine from contact with frozen material.
• Insulating materials include:
◦ Flexible insulating blankets
◦ Crumpled packing paper, paper
◦ Bubble wrap, Styrofoam peanuts.

32.  Ensure:
◦ Power supply: outlet, fuse box
◦ Thermometer working
◦ Thermostat set within range
◦ Thermometer placed in center of fridge
◦ Air circulation inside and outside fridge
◦ Door properly closed/closing
◦ Room temperature stable (affects inside fridge
temperature, adjust thermostat accordingly)

33. Vaccine Wastage
 Pharmacists must record wasted influenza vaccine doses on the
Vaccine Wastage Report form (CS 04) available in the SIM, chapter 9
section 5.3 Vaccine Wastage Report Form (CS 04)
(http://www.ehealthsask.ca/services/manuals/Documents/sim-
chapter9.pdf) and submit each event to the SDCL at 306-798-0071.
 Wasted vaccine is any vaccine that cannot be used. For example, a
multidose vial that has not been used up in the timeframe specified by
the manufacturer, or reconstituted vaccine that has not been used.
 Wasted vaccine also includes all leftover vaccine (open and closed vials)
at the end of the flu season.
 Must be disposed of locally according to provincial biomedical waste
policy and procedures
As set out in the 2015-2016 Seasonal Influenza Immunization Handbook
for Pharmacists

34.  Sharps Disposal
 Wasted influenza vaccine disposal: must be disposed of locally according
to the Saskatchewan Biomedical Waste Management Guidelines 2008
(http://www.environment.gov.sk.ca/adx/aspx/adxGetMedia.aspx?DocID=
217,216,104,81,1,Documents&MediaID=1099&Filename=Biomedical+Was
te+Management.pdf).
 Additional information on biomedical waste disposal can be found in the
Guidelines for Pharmaceutical Waste Disposal Services in the Reference
Manual for pharmacies from the Saskatchewan College of Pharmacy
Professionals
 (https://scp.in1touch.org/uploaded/58/web/refmanual/Pharmaceutical%2
0Waste%20Disposal%20Program.pdf) and at
https://scp.in1touch.org/uploaded/58/web/refmanual/Vaccine-Storage-
Handling-and-Transport-GuidelinesFor-09-10.pdf
◦ According to provincial biomedical waste guidelines
 Biological product disposal procedures vs. expired drug disposal

35.  All AEFI reports forms for publicly funded influenza vaccines must be
completed and submitted to the RHA public health department for
review and MHO recommendation
 Individuals reporting an AEFI of H1N1 vaccine or any past influenza
vaccines may need consultation with the MHO and/or specialist prior
to receiving a 2015-16 influenza vaccine
As set out in the 2015-2016 Seasonal Influenza Immunization
Handbook for Pharmacists

36.  Adhere to Bylaws of the Saskatchewan College of Pharmacy
Professionals (SCPP)
 Adhere to the 2015-2016 Seasonal Influenza Immunization Handbook
for Pharmacists from the Ministry of Health
 Conform to SCPP Guidelines Regarding Vaccine Storage, Handling and
Transport
 Ensure adequate supply of Anaphylaxis Management Kit contents
 Conform to the Drug Plan and Extended Benefits Branch (DBEBB)
Influenza Immunization Program Policy Document
 Confirm patient eligibility
 Refer all ineligible patients (those that are under 9 years of age or
without a valid Saskatchewan Health Services card) to regional Public
Health Department for vaccination
 Document written consent and SCPP record-keeping requirements
◦ Retain Informed Consent and Patient History Assessment for seven
(7) years from the date of service
◦ Please note: Information and Consent for Influenza Immunization
form meets program documentation criteria

37.  Prepare the vaccine
 Choose correct syringe and needle length
 Perform hand hygiene
 Administer injection
 Safely Dispose of Sharps as per SCPP Guidelines
 Provide post-injection patient care/place adhesive bandage over site,
monitor patient for 15 minutes
 Provide patient with Ministry of Health immunization wallet card
 Submit vaccine product record to the DPEBB and PIP
 Submit the claim for the IIF electronically to the DPEBB using pseudoDIN
 Complete any further required documentation
Report all cold chain breaks, wasted vaccine and adverse events as set out in
the 2015-2016 Seasonal Influenza Immunization Handbook for Pharmacists

38.  Sample Injection Supply Checklist
 Alcohol swabs
 Cotton balls or gauze pads
 Adhesive bandages (consider latex free and kid friendly
options)
 Gloves (consider nitrile and latex free)
 Sharps container(s)
 Hand sanitizer
 Syringes: 1cc and 3cc sterile syringes
 Needles: 25G - 5/8 inch, 1 inch and/or 1.5 inch
 Anaphylaxis management kit

40.  Sample Anaphylaxis Management Kit
 A clear, concise summary of the anaphylaxis emergency management
protocol
 Laminated table of dosage recommendations for epinephrine and
diphenhydramine hydrochloride (e.g. Benadryl®) by weight and by age
 2 – 1 cc syringes and 2 needles (25 – 27 gauge, 1" needle)
 1 – 1 cc syringe and 1 needle (25 – 27 gauge, 1 ½" needle)
 2 – 1 cc syringes and 2 needles (25 – 27 gauge, 5/8”) for SC route
 Extra needles (1” and 5/8”)
 2‐4 ampoules of epinephrine 1:1,000 (within expiration time frame)
 2 vials of diphenhydramine hydrochloride 50 mg/ml (within expiration
time frame); pills or oral solutions are optional

41. Additional Items
 Alcohol swabs
 Cotton balls/pads/swabs
 Pens/paper
 Gloves
 Cold compress
 Salbutamol inhaler
 A range of autoinjectors of epinephrine labelled by age and weight
 Scissors
 Yoga mat
 One nasopharyngeal airway and one oropharyngeal airway for each age range
anticipated in the clinic
 Pocket mask
 Stethoscope and sphygmomanometer
 Tongue depressors
 Flashlight
 Cell phone if no easy access to onsite phone

47.  Week of Oct 19th - sending all participating pharmacies
a first batch of FREE printed materials to promote the
flu shot service
◦ pharmacist badges, tent cards, posters, and bag stuffers.
 Further information on how to order additional
materials should you wish to shortly, for:
◦ stickers, floor decals, shelf talkers and poster stands that may suit
your pharmacy set-up.
*As more pharmacies are added to the participating list, they
will automatically get the free materials directly from Print
West.

48.  Oct 26th - Official Start of Campaign
 Billboards, bus boards, a public service announcement
commercial (that will run on CTV, Global, and CBC)
promoting pharmacists providing flu shots, and additional
web-based advertising.
 Advertisements in weekly newspapers and seniors
publications
 Media event October 29th
◦ Minister of Health, Dustin Duncan is immunized by a
pharmacist within a local pharmacy.
 More information forthcoming as details are finalized

50.  How do I register so I can legally provide
injections?
 When can I start injecting?
 Do I need to renew my intent to inject every year?
If so, what do I need to know?
 Can I scan a copy of my injection record
keeping/documentation for electronic filing?
 Do we need a separate fridge to store vaccines?
 Can a pharmacy student inject?
 Do I need to inject in a private room?
 At what age can I inject a patient?
 Am I required to get the flu shot if I’m injecting?

51.  What is the order number for flu vaccine?
 How much flu vaccine can I order?
 What if I don’t have an account with McKesson or Kohl and
Frisch, how do I order?
 Syringes are backordered, what do I do?
 Are 3cc (3ml) syringes accurate to draw up Fluviral®?
 Can we charge a mark-up for the vaccine?
 Can I inject outside of a pharmacy/can I have a flu clinic
outside of my pharmacy?
 Can I provide the publicly-funded flu shot to out-of-
province patients?

52.  Publically funded vaccines:
◦ Can we administer FLUMIST® under the program?
◦ Can we charge patients for FLUMIST® ?
◦ Can I charge to administer for pneumonia, Hepatitis B and HPV
vaccine?
 Can I bill the DPEBB for injections other than the flu
vaccine?
 Can I charge patients for other injections that aren’t
publically funded?
 Can pharmacies share Fluviral® vaccine?
 Can we pre-fill syringes for injection?
 Where can I learn more about the stability of Fluviral®?

53.  SCPP continuing to approve registrations, communicating
policy/standards documents
 PAS to continue to update website for pharmacists and
patients, update Special Edition PAS It On
 Legislation to come into force Friday October 16th
 October 19 begin injecting for Influenza Immunization
Program
 Week of October 19
◦ public education print material sent to pharmacies
◦ recorded webinar available
 October 26 official start of PAS public education campaign
 October 29 media event, injecting Minister Duncan
 Training in November
 Further training Spring 2016
 Training grant effective until Sept 30, 2016 or until 1200
trainees successfully competed.

54. Questions?