BC Pharmacy Association Supporting Pharmacy Practice Change Administration of Injections
BC Pharmacy Association Supporting Pharmacy Practice Change Administration of Injections Resource Guide Updated August 22, 2013 How to use this document This resource guide contains materials prepared by the BC Pharmacy Association (BCPhA) to provide pharmacists with information supporting the medication management practice of administering injections issued by the College of Pharmacists of BC (CPBC). This document and its resources are meant to serve as examples and may be customized to suit your work environment. It should be read in conjunction with the BCPhA Administration of Injections training workshop material and the BCPhA Policy and Procedure manual template for Administration of Injections. The BCPhA is committed to providing leadership, advocacy and on-going support to British Columbia pharmacists. Disclaimer This document is intended for use in conjunction with the CPBC-Certified Practice-Drug Administration by Injection HPA Bylaws. It is not intended to supersede or replace procedures issued by CPBC or employers. Please note that hyperlinks included in this document are current as of publication date. Should a hyperlink no longer direct you to the appropriate webpage, please proceed to the homepage of the relevant website and use the search function to find the required information. 1 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Table of Contents Section I - Preparation ......................................... 4 Vaccine Administration Guidelines ................................................. 5 Scope of Practice ..................................................................................................... 5 Publicly Funded Vaccine ......................................................................................... 6 Non-Publicly Funded Vaccine ................................................................................ 7 Vaccine Drug Scheduling........................................................................................ 7 Vaccine Prescription Requirements ...................................................................... 8 Administration of Injections Supplies .............................................. 9 Maintaining Cold Chain ................................................................ 10 CPBC PPP-68: Cold Chain Management of Biologicals ................................. 10 Vaccine Refrigerator and Min/Max Thermometer Vendors ............................. 11 Transportation of Vaccines ................................................................................... 11 Recommendations for Cold Chain Management .............................................. 12 Cold Chain Incidents.............................................................................................. 13 Designated Area for Injections ..................................................... 14 Promoting Injection Service to Patients ........................................ 14 Precautions .................................................................................. 15 Standard Precautions for Any Injection .............................................................. 15 Needlestick Injury Prevention ............................................................................... 15 Needlestick Injury Treatment................................................................................ 15 Post-exposure Management ................................................................................ 16 Section II – Providing Injections ....................... 18 Administering Injections Checklist ................................................ 19 Latex Allergy Precautions ............................................................. 20 Informed Consent ......................................................................... 21 Example Patient Pre-Vaccination Questionnaire .......................... 22 Section III – Post injection ................................ 23 Post-injection Treatment Options ................................................. 24 Adverse Events Following Immunization (AEFI) ........................... 24 Anaphylaxis Treatment................................................................. 25 Documentation ............................................................................. 26 Pharmacy Record................................................................................................... 26 Patient Record ........................................................................................................ 26 Public Health Records ........................................................................................... 27 Payment ....................................................................................... 28 2 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Section IV – Appendices ................................... 29 Appendix 1 ................................................................................... 30 College of Pharmacists of BC – standards, limits and conditions for immunization ........................................................................................................... 31 College of Pharmacists of BC - scope of practice ............................................ 33 College of Pharmacists of BC – Recertification of Injection Authority ........... 34 College of Pharmacists of BC – PPP 68 – Cold Chain Management of Biologicals ............................................................................................................... 35 Criteria for Pharmacist Access to Publicly Funded Vaccines ......................... 36 Appendix 2 ................................................................................... 37 Safety Needles Required, WorksafeBC ............................................................. 38 Sharps Disposal Providers ................................................................................... 40 Latex Content in Vaccines, BCCDC.................................................................... 41 Appendix 3 ................................................................................... 42 Handle vaccines with care, BCCDC.................................................................... 43 Cold chain checklist, BCCDC ............................................................................... 44 Cold chain temperature form, BCCDC ............................................................... 45 How to store vaccines in the refrigerator ............................................................ 48 Packing an Insulated Cooler ................................................................................ 49 Equipment malfunction or power failure ............................................................. 50 Appendix 4 ................................................................................... 52 BCPhA professional liability insurance – FAQ .................................................. 53 Appendix 5 ................................................................................... 55 Pharmacy sign - patient safety reminder ............................................................ 56 Appendix 6 ................................................................................... 57 Vaccine Consent Form - Adults Incapable of Giving Consent ........................ 58 Appendix 7 ................................................................................... 60 Anaphylaxis kit supply checklist ........................................................................... 61 Anaphylaxis Guidelines ......................................................................................... 62 Adverse Event (Reaction) Following Immunization form ................................. 65 Adverse Events Following Immunization (AEFI) Algorithm ............................. 68 Appendix 8 ................................................................................... 69 Provincial Immunization Record .......................................................................... 70 Appendix 9 ................................................................................... 71 Online Resources ................................................................................................... 72 Immunization Schedules, BCCDC ...................................................................... 73 Vaccines Drug Schedules, CPBC ....................................................................... 76 3 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Section I - Preparation 4 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Vaccine Administration Guidelines Scope of Practice Pharmacists authorized to administer injections by the College of Pharmacists of BC are able to administer immunizations, as well as drugs for the treatment of anaphylaxis, by intradermal, intramuscular or subcutaneous injection. A pharmacist must not administer an injection to a child under five years old. Authorized pharmacists must also possess current certification in CPR and firstaid from a recognized provider such as St. John Ambulance or the Canadian Red Cross. An authorized pharmacist’s scope of practice may include administration of any immunization via IM, SC or ID routes in accordance with the standards established by the College of Pharmacists of B.C. and limits of the pharmacists’ own competencies. However, which vaccines are available for pharmacists to administer may be limited by guidelines and/or supply from Public Health (publicly funded vaccine supply) and/or supply from wholesalers (non-publicly aka privately funded vaccine supply). See Appendix 1 for information on the CPBC Scope of Practice 5 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Publicly Funded Vaccine BC residents who meet the eligibility criteria can receive specific immunizations including childhood vaccinations, annual influenza vaccinations and specific vaccines to manage infectious outbreaks at no cost through publicly funded immunization programs. Pharmacists authorized to administer immunizations are able to receive and administer certain vaccines from the public supply in specific situations. These are set forth in the “Criteria for Pharmacist Access to Publicly Funded Vaccines” information sheet (see Appendix 1). The online version of the BC Centre for Disease Control (BCCDC) Immunization Manual is the definitive vaccine reference for administration of publicly funded vaccine programs in BC. Its guidelines supersede information that may be found in other provinces’ guidelines, federal agencies or organizations, or information provided by a manufacturer in a product monograph. Be aware however, that region specific guidelines may be prepared within a Health Authority for situations such as management of a local outbreak. In these situations, follow the direction of the Health Authority’s guidelines or consult your local health unit if you have questions about policy differences. Get familiar with all relevant sections of the Immunization Manual. It contains information on vaccine products, vaccine scheduling, vaccine product preparation, cold chain management, client assessment, considerations in the administration of multiple injections, vaccine administration supplies, selecting injection sites, client observation, managing pain and anxiety before and during an immunization, managing fever and pain after immunization, and documentation (including adverse events following immunization – AEFI). The manual is updated frequently and BCCDC publishes a list of revisions to the manual in an Admin Circulars Newsletter. It is recommended you subscribe to the Admin Circulars Newsletter to receive email updates directly. Updates will include revisions made to all chapters of the BCCDC Communicable Disease Manual, but careful attention should be made to revisions of Chapter II (BCCDC Immunization Manual). To assist in your understanding of how to access, navigate and integrate publicly funded vaccines into your pharmacy practice please review the Pharmacists and Publicly Funded Vaccines in B.C. General Information guide developed by PIWG. 6 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Non-Publicly Funded Vaccine B.C. residents may purchase a variety of vaccines (some may require a prescription but most do not) and may pay to have these vaccines administered by a health care professional including an authorized pharmacist. Vaccine costs, including administration supplies and services, are paid for by individuals (out of pocket). Selected private drug plans may also cover vaccine costs. Please note that private drug plans currently require a valid prescription for the vaccine to be eligible for coverage, even if the vaccine can be provided without a prescription. Patients who do not meet the BCCDC criteria for publicly funded vaccines may obtain them though private purchase. Patients may also purchase vaccines that are not part of a publicly funded program or initiative; for example, patients may wish to purchase cholera or typhoid vaccines before travelling to other parts of the world. Sources of information for non-publicly funded vaccine include: BCCDC Immunization Manual ImmunizeBC National Advisory Committee on Immunization Public Health Agency of Canada Centers for Disease Control and Prevention Compendium of Pharmaceuticals and Specialties (login required) Vaccine Drug Scheduling Vaccines that require a prescription from an authorized prescriber in order to be dispensed and sold to a member of the public are those vaccine products that: are listed in Schedule I of the provincial drug schedules, are not listed as recommended by any provincial, national, or international organization, and are not part of a publicly funded vaccine program in BC. Once the prescription is dispensed, a pharmacist authorized to administer injections can administer a Schedule I vaccine to a patient. 7 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Vaccine Prescription Requirements Use the following flow chart to determine if a prescription is required prior to dispensing a vaccine. Patient presents for immunization Publicly funded vaccine Vaccine covered by third party Patient pays No prescription required Prescription required for some third party plans reimbursement Schedule II Vaccine?* Patient pays $0 Patient pays deductable/ co-payment No Yes Prescription required for Schedule I vaccines No prescription required Patient pays U&C Patient pays U&C * Schedule II vaccines, which do not require a prescription, include: Vaccines listed as schedule II on the provincial drug schedules Any preventative vaccine listed as recommended by any provincial, national or international organization (e.g. PHAC, NACI, BCCDC). Vaccines currently included in publicly funded vaccine programs in BC BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Administration of Injections Supplies 1. Syringes and Safety Needles* For vaccine needle and syringe selection refer to Canadian Immunization Guide (Section on “Syringe and Needle Selection”). a. b. c. d. if SC: 25G, 5/8” safety needles if IM: 22–25G, 1”–1.5” safety needles if ID: 26-27G, 3/8" safety needles 1cc & 3cc syringes *As per WorkSafe BC, any medical procedure that involves the use of hollow bore needles requires safety engineered needles or needless systems. For information on WCB safety needle requirements see Appendix 2. 2. Sharps container Refer to Appendix 2 for information on Sharps Disposal Providers 3. Vinyl gloves (non-latex preferred due to latex allergic patients) 4. Hand sanitizer (alcohol based) 5. Alcohol swabs 6. Cotton swabs/balls 7. Bandages 8. Instant cold compress 9. Supplies for anaphylaxis management a. EpiPen® Auto-injector (Junior & Adult) b. Epinephrine 1:1000 (1mg/mL) c. Diphenhydramine 50mg/mL d. Salbutamol HFA e. Resuscitator bag to maintain airways including adult & child airways Refer to the BCCDC’s Immunization Manual (Section V - Management of Anaphylaxis in a Non-Hospital Setting) for more information on the treatment of anaphylaxis. Refer to Appendix 7 for a suggested Anaphylaxis management kit checklist 10. Patient education (see Healthlink BC Healthfiles) & consent forms 9 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Maintaining Cold Chain CPBC PPP-68: Cold Chain Management of Biologicals Effective as of July 1, 2012 (See Appendix 1): To assist with compliance and implementation the key requirements are listed below: Type of Refrigerator: Biological products should preferably be stored in a purpose-built refrigerator, (also called a pharmacy, vaccine, biologicals, laboratory or industrial grade refrigerator). Domestic frost free refrigerators can be used, however, temperatures may fluctuate in different compartments of the refrigerator, and vaccines can only be stored in certain areas. See National Guidelines (Section 3) for more information about refrigerators. Although the Guidelines specify that a standard 'bar' fridge is not acceptable because they are not able to maintain even temperatures, the reference is to a small, under the counter fridge that has a combination fridge/freezer with one exterior door. A domestic 'frost free' refrigerator, which could be under the counter size, may be acceptable as long as it is able to maintain the required temperature range of +2°C to +8°C, at all times. Monitoring of Temperature: Each pharmacy is required to have a traceable memory refrigerator/freezer thermometer and to maintain a temperature log, at least two times daily, to ensure that the temperature inside the refrigerator is kept within the acceptable range of +2°C to +8°C, at all times. http://www.bcpharmacists.org/news_events/news/news176.php 10 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Vaccine Refrigerator and Min/Max Thermometer Vendors There are several companies that manufacturer vaccine and laboratory grade refrigerators; some examples are listed below: 360 Medical Roxon Sanyo Biomedical There are many places to order thermometers; some examples are listed below: ACR Systems Inc Canadawide Scientific Health Care Logistics Pharmasystems VWR International Transportation of Vaccines When picking up publicly-funded vaccines from your local public health unit, pharmacists should bring a cooler and icepack/gel-pack(s), and insulating material capable of maintaining temperatures within the desired range (2°- 8°C). The cooler should meet the following 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/top is tight fitting. 11 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Recommendations for Cold Chain Management Refer to the BCCDC’s Immunization Manual (Section VI – Management of Biologicals). Additional information is also available on the BCCDC Cold Chain Information webpage. 1. Designate a person to be responsible for storage & monitoring of vaccines 2. Store products in a “purpose-built” refrigerator – check seals and vacuum coils regularly. 3. Set the temperature @ 5°C to account for fluctuations 4. Use a constant temperature recording device or digital min/max thermometer with probe (thermometers should be accurate within +/- 1°C) 5. Place thermometer probe centrally at the middle shelf 6. Record min/max temperatures reached TWICE daily (see Appendix 3 for temperature form) 7. Make note of temperature indicator cards if included with publicly funded vaccine orders a. If too warm (>10°C), paper discoloured RED b. If too cold (frozen), white background discoloured VIOLET c. Time of exposure indicated by how deep circular window is stained 12 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Cold Chain Incidents If refrigerator malfunction is suspected on the basis of temperature readings, obtain servicing immediately and store the vaccine in an alternative refrigerator in the meantime. In the event of an identified cold chain break, seek advice from your local public health authority about whether the vaccine(s) may continue to be used; while awaiting advice, keep the vaccines stored in appropriate cold chain conditions and ensure that they are not administered until a determination has been made by the public health authority. When a cold chain break is identified after vaccine has been administered, consult with the local health department about management of the situation. Information required to assess the circumstances will include the name of the vaccine(s), and the duration and temperatures of exposure. People immunized with vaccines whose potency is likely to have been jeopardized may need to be tested for serologic evidence of immunity or be re-vaccinated. See Appendix 3 for additional cold chain management resources 13 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Designated Area for Injections The Standards, Limits and Conditions issued by the College of Pharmacists of BC in item 7 states that pharmacists must “maintain a setting within which the injection is to be administered that is clean, safe, comfortable and appropriately private and furnished for the patient.” Ensure the setting is maintained onsite and/or offsite. Pointers to maximize comfort and minimize anxiety 1. 2. 3. 4. 5. 6. Seat patient before immunization Maintain cool temperature, fresh air Avoid long line-ups in mass clinics Prepare injection out of view Provide privacy during injection If anxious/pale, allow time to lie down with feet elevated and cool, wet cloth on face Promoting Injection Service to Patients Consult with your pharmacy manager/owner. Considerations to take into account 1. 2. 3. 4. 5. 6. 7. 14 Provide list of injections available at your pharmacy. Which non-publicly funded vaccines require a prescription? When will you provide the service? Will you accept walk in requests for administration of injections? Will you accept appointment based requests only? Promote patient convenience and access. Determine your administration fee for non-publicly funded vaccines. BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Precautions Standard Precautions for Any Injection 1. Wash hands/sanitize in between patients 2. NEVER recap standard needles; if available, engage safety mechanism IMMEDIATELY after injection 3. IMMEDIATELY discard used needle and attached syringe in sharps container Needlestick Injury Prevention 1. Plan for disposal before beginning procedure 2. Place sharps container within arm’s reach and place directly into container after injection The “NEVERS”: 1. NEVER bring a used needle towards an unprotected hand or another person 2. NEVER re-cap a used needle Risks of disease development post-exposure: HIV < 1% Hepatitis B/C – up to 7% (depending on type of injury and personal immunization history) Needlestick Injury Treatment 1. Wash gently with soap & water for several minutes (do NOT rub) 2. Allow wound site to bleed freely then cover lightly 3. Do NOT cut, scratch, squeeze, or puncture the skin, do NOT apply bleach, which may damage the tissue and increase uptake of pathogens 15 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Post-exposure Management Refer to BCCDC’s Communicable Disease Control Manual (Chapter I: Blood and Body Fluid Exposure Management) Post-exposure management is required if all the following are present: 1. Percutaneous (potential introduction to bloodstream), permucosal (mucous membranes), or non-intact skin exposure (wound < 3 days old OR compromised skin integrity); 2. Exposure is to blood, potentially infectious body fluid or tissue (refer to Table 1 on following page); 3. Source considered potentially infectious (positive test, or in a high risk group, or exposure occurred in a high risk setting); AND 4. Exposed person is considered susceptible to either HIV, HBV, or HCV. Steps to follow in the event of a needlestick injury or other body/body fluid exposure requiring management: 1. Inform the patient of the incident and request that they remain available for future questioning if necessary (eg. contact information, HIV/HBV/HCV status, informed consent for anti-HIV, anti-HCV, HBsAg, anti-HBs, antiHBc). 2. Cleanse the site: a. If mucous membrane or eye, rinse well with normal saline or water b. If skin, wash well with soap & water c. Allow wound site to bleed freely, then cover lightly d. Do NOT promote bleeding of injuries by cutting, scratching, pinching, or squeezing as this only damages the underlying tissues and increases the potential penetration of the pathogen e. Do not apply or soak injury/wound in bleach 3. Seek emergency medical attention immediately for a risk assessment, preferably within 2 hours 16 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections 17 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Section II – Providing Injections 18 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Administering Injections Checklist Preparation 1. Assess the necessity, safety and effectiveness of the injection for the patient 2. Check patient eligibility for publicly funded vaccine; and /or Check appropriateness for providing a non-publicly funded vaccine as a schedule II product; and /or Check appropriateness for a prescription order 3. Check time of last dose with patient, on PharmaNet, local profile, or with local health unit 4. Obtain informed consent 5. Wash hands 6. Assess potential injection sites 7. Wash hands 8. Assemble: tray; alcohol swabs; needle; syringe 9. Check medication 10. Vial Clean top with alcohol swab; Inject air into multi-dose vial Ampoule Remove lodged medication from head by tapping; Cautiously open without contamination 11. Fill syringe, remove air bubbles, check medication 12. Re-cap & check amount in syringe with medication order 13. Dispose of vial/ampoule in sharps container 14. Wash hands Administration 15. Verify patient identity and check medication 16. Provide private area 17. Re-iterate purpose of injection 18. Wash hands or use sterile gloves 19. Landmark injection site, and cleanse in circular motion from centre out 20. Inject Post-Administration 21. Dispose of equipment 22. Wash hands 23. Monitor patient for 15 - 30 minutes post-injection 24. Documentation 19 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Latex Allergy Precautions Latex is a sap from the commercial rubber tree. Latex is processed to form natural rubber latex and dry natural rubber. Both products contain the same plant impurities (plant proteins and peptides) found in natural latex that are believed to trigger allergic reactions. Dry natural rubber is used in some syringe plungers, vial stoppers, and needle shields. It is possible the allergic proteins could be introduced into the product being administered during immunization and cause an anaphylactic reaction. Synthetic rubber and synthetic latex do not contain natural rubber or natural latex and, therefore, do not contain the impurities linked to allergic or anaphylactic reactions. Assess a client for a previous anaphylactic reaction to latex when the biological product vial stopper or needle shield contains latex. The most common type of latex sensitivity is contact-type allergy, usually as a result of prolonged contact with latex-containing gloves. Contact dermatitis is not a contraindication to immunization with a latexcontaining vaccine. If a person reports an anaphylactic allergy to latex, do not administer vaccines supplied in vials or syringes that contain natural rubber. Nonlatex containing alternatives may be found in other packaging formats (ampoules vs. vials) or through another manufacturer. **Contact the manufacturer if unsure of the latex content of a product** See Appendix 2 for BCCDC’s list of latex content in vaccines 20 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Informed Consent Refer to the BCCDC’s Immunization Manual (Section 1B – Informed Consent) Definition of informed consent: “Voluntary agreement of a capable individual (or representative) to injection services after having been provided with standard information about the medication.” Obtaining informed consent requires the following standard information to be discussed BEFORE injection: Step 1: Determine Authority to Provide Informed Consent Step 2: Assess Capability to Give Informed Consent Step 3: Provide Standard Information Standard Information addresses: 1. That consent is obtained for a vaccine series 2. That consent is valid until completion of the series or consent is revoked 3. Vaccine information contained in BCHealthLink Files or other provincial resources if applicable: Benefits of vaccination (personal, community) Risk of not getting vaccinated (possibility of getting the disease) Eligibility for the vaccine(s) Common and expected adverse events Possible serious or severe adverse events and their frequency Contraindications Disease(s) being prevented Step 4: Confirm Understanding of Standard Information and Rationale for Waiting Period Step 5: Provide Opportunity for Questions Step 6: Confirm Consent Step 7: Document Informed Consent or Refusal A copy of the appropriate HealthLink BC Vaccine HealthFile should be provided to each patient as part of the consent process. Vaccine HealthLink BC Files are searchable from the HealthLink homepage www.healthlinkbc.ca . HealthLink BC Files are updated frequently, so be sure to return to the site regularly for updated information. 21 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Example Patient Pre-Vaccination Questionnaire Seasonal flu vaccine PATIENT PERSONAL INFORMATION Last Name First Name Carecard Number Gender Middle Name Pregnant Address Emergency Contact Name Date of Birth Tel. Number Emergency Contact Tel. Number Indications: The influenza vaccine (i.e. Flu shot) will be injected into your deltoid (shoulder muscle) by your pharmacist. The ingredients of the vaccine include 3 strains of the flu virus that are circulating around BC. There are other strains of the flu that exist that could potentially infect you. The flu shot only provides you with protection against the strains it contains. Expected reactions: The vaccine is generally well tolerated however you may experience the following: soreness, redness, swelling at the injection site. These symptoms should not interfere with your daily activities. Less common reactions include mild fever and/or muscle aches (i.e. Flu-like symptoms); these symptoms typically resolve with 2-3 days; this vaccination cannot give you the flu. Very rare reactions (ie. about 1 per million injections) such as anaphylaxis or a nervous system condition may also occur. Do any of the following apply to you? Please circle answer 1. Is this your first ever flu shot? YES 2. Do you have any allergies to any foods or medications? YES 3. Have you ever had a severe reaction (hives, throat swelling, difficulty breathing, shock) after an injection, food (EGGS), or medication? YES 4. Do you currently have a fever or are feeling unwell? YES 5. Do you take any anti-coagulant medications (blood thinners)? YES 6. Do you have any immunological, neurological, or blood disorders? YES NO 7. Have you received any vaccinations in the last 6 weeks? YES 8. Have you ever fainted during or after an injection? YES 9. (females) Are you pregnant or breast-feeding? YES NO NO NO NO NO NO NO NO If you have answered “yes” to any of these questions, please discuss with the pharmacist BEFORE vaccination. 22 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Section III – Post injection 23 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Post-injection Treatment Options For pain, inflammation, fever & other systemic symptoms: 1. Apply a clean, cool wet washcloth for 15 to 20 minutes over the immunization site 2. Acetaminophen @ 10-15mg/kg q4-6h (max. 65mg/kg in 24h) for 2 days 20mg/kg is appropriate in children with history of febrile seizures (same max. daily dose) Can be started immediately after injection Shown to be INEFFECTIVE as a prophylactic measure for febrile seizures in children 3. Ibuprofen – 2nd line ONLY 4. AVOID ASA Adverse Events Following Immunization (AEFI) Pharmacists should note that adverse reaction reporting for vaccines differs from ADR reports for most medications. Adverse reactions to vaccines are reported to the Local Health Unit (LHU) using an Adverse Events Following Immunization Form. The LHU will then obtain recommendations from their Medical Health Officer and send the report back to the pharmacist. The pharmacist would then be responsible for informing the patient about the MHO recommendations and documenting according to College standards. All adverse reactions to vaccines should be reported to your Local Health Unit, regardless of whether the vaccine was publicly-funded or private. Adverse Events Following Immunization forms are available on the BCCDC website. Completed forms should be submitted to your local public health unit. See Appendix 7 - Process for the Follow-Up of AEFI for Pharmacists 24 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Anaphylaxis Treatment Immediately 1. Call 9-1-1 or Ambulance 2. Administer epinephrine 1:1000, 0.01mg/kg body weight, (max 0.5mg), IM into an unimmunized thigh or deltoid. o If both thighs and both arms were used for IM immunizations, give epinephrine SC into upper outer triceps area of the arm(s). o DO NOT give epinephrine into the same muscle mass as vaccine was given. (Local injection of epinephrine into an IM vaccination site is contraindicated because it dilates vessels and speeds absorption of the vaccine) OR Administer EpiPen/TwinJect (0.3mg) Auto-injectors or EpiPen Jr/TwinJect (0.15mg) Auto-injectors into an unimmunized thigh. 3. Position client in recumbent position and elevate legs, as tolerated symptomatically 4. Monitor respiratory effort, pulse, and level of consciousness If a person’s breathing is more labored or level of consciousness decreases: 1. 2. 3. 4. 5. Repeat epinephrine twice at 5 minute intervals, as needed (max. 3 doses) Alternate right and left thigh or arm sites for repeat doses of epinephrine Elevate head and chest slightly If airway is impaired, use held tilt, chin lift or jaw thrust If vomiting is likely, turn person to side lying position If symptoms are not controlled or to maintain symptom control if client cannot be transferred to acute care facility within 30 minutes: 1. Give one dose of diphenhydramine hydrochloride 50 mg/ml IM preferably at a different site to that in which epinephrine was given. If necessary, use same thigh as the one in which epinephrine was given. Can also be given into same muscle mass as vaccine was given. 2. Can give at any time interval, either after the initial or repeat doses of epinephrine. See Appendix 7 for anaphylaxis guidelines 25 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Documentation Pharmacy Record Pharmacists must document their rationale and decision to sell, dispense, or administer a vaccine product. Vaccine administration documentation should include, but is not limited to: Patient or patient’s agent contact information Informed consent Drug, dose and lot number Route and site of administration Date and time of administration Patient response (before, during and following the 15 – 30 min wait period) Adverse reactions and management Plans for follow-up if necessary It is recommended that all vaccines administered (publicly and non-publicly funded) or dispensed to a patient be recorded in their local pharmacy profile and PharmaNet, in addition to any manual administration records kept by a pharmacy. Recording vaccine lot numbers Recording of vaccine lot numbers is also mandatory as per Section IV– Administration of Biological Products (subsection 12) of the BCCDC Immunization Manual. This information is required in the rare event of a vaccine recall or an adverse event following immunization (AEFI). It is recommended pharmacists enter the lot number in the SIG field in the local dispensary software system as this is a convenient way to retrieve the information when needed. Patient Record Each client immunized should be given a personal record of the immunization. Individuals should be instructed to keep the record in a safe place and bring it to future immunization appointments. See Appendix 8 for a standardized provincial immunization record 26 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Public Health Records Pharmacists are expected to provide documentation records of publicly funded vaccinations to the local health unit to ensure accurate and complete public health record-keeping, particularly for children under the age 19. Detailed documentation requirements may vary by health authority and vaccine. Specific documentation instructions and forms will be provided by the health authority or local health unit at the time of vaccine pick-up. Some health authorities also have web pages with information specifically for pharmacists or community vaccine providers. Reporting of vaccine administration as part of the publicly funded school-based programs is expected. Documentation requirements may vary by health authority and vaccine. Please contact your local health unit for details. Returning documentation to your local health unit assists in provincial vaccine program forecasting and planning and may contribute to maintaining accurate and complete immunization records for B.C. residents. 27 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Payment Publicly Funded Vaccines (PFV) $10 is paid for each publicly funded vaccine administered by an authorized pharmacist. Pharmacies cannot claim $10 if not administered by an authorized pharmacist (eg: a hired nurse). Collect payment by submitting administration of injection Product Identification Numbers (PINs) through PharmaNet. For more information on PharmaNet Public Health and Vaccination information, refer to the PharmaNet website: Information for Pharmacists and Other Medical Suppliers. Entering Claims on PharmaNet for Administration of PFV PharmaNet Fields DIN/PIN Quantity Days Supply Prescriber ID reference Prescriber ID Drug Cost Cost Up Charge Professional Fee Pharmacist ID Sig field (suggested) Data Entry Notes Use appropriate PIN for administration of publicly-funded vaccines. 1 1 Enter the pharmacist ID reference here Enter the pharmacist ID here Enter as zero Enter as zero Enter as zero Enter the pharmacist ID here Enter vaccine lot number Enter site of administration (eg: Left deltoid) Enter route of administration (eg: IM, SC) A PharmaCare response of “Patient not entitled to drug claim” is expected and does not indicate that the administration fee will not be paid. A report identifying claims using the PINs for publicly funded vaccines is run after the close of each week’s pay period and, after a delay of one week, is added to the pharmacy payment. Non-publicly Funded Vaccines Private pay pricing at the discretion of the pharmacy. 28 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Section IV – Appendices 29 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Appendix 1 College of Pharmacists of BC – standards, limits and conditions for immunization College of Pharmacists of BC - scope of practice College of Pharmacists of BC – recertification for injection authority College of Pharmacists of BC - PPP 68 – Cold Chain Management of Biologicals PSD - Criteria for Pharmacist Access to Publically Funded Vaccines 30 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections HPA BYLAWS SCHEDULE F Part 4 – CERTIFIED PRACTICE – DRUG ADMINISTRATION BY INJECTION STANDARDS, LIMITS AND CONDITIONS FOR IMMUNIZATION Page 1 of 2 STANDARDS 1. Obtain informed consent from the patient or patient’s agent with regards to: Name of the injection to be administered Disease prevention or treatment of anaphylaxis Benefits and risks of the injection Expected reactions Usual and rare side effects Rationale for the 15-30 minute wait period following the injection 2. Prepare and provide care of the injection site including: Assessment of the injection site Selecting and landmarking the injection site Determining the requirement for dressings 3. Prepare the injection for administration including: Using aseptic technique in preparation and administration of the injection Checking the drug product and expiry date Determining the stability/compatibility Assembling appropriate equipment and supplies (syringes, needles and administration sets) Drawing the injection product from the vial or ampoule Maintain asepsis throughout the process Applying universal precautions Properly storing prepared injections/solutions 4. Document history, assessment and injections administered including but not limited to: Drug, dose and lot number given Route of administration Date and time of administration Patient response (before, during and following the 15 – 30 minute wait period) Patient or patient’s agent contact information Provide patient or patient’s agent with the administering pharmacists contact information Patient teaching done Adverse reactions and management Plans for follow-up 5. Implement appropriate emergency measures including but not limited to: Performing basic first aid procedures Use of adrenalin/epinephrine Performing CPR Establishing procedures for handling sensitivity/anaphylactic reactions Management of needlestick injuries 5099-HPA_Bylaws_Injection_Drug_Administration v2012.1 Oct 29, 2012 College of Pharmacists of BC – Certified Practice – Drug Administration By Injection – Standards, Limits, And Conditions For Immunization Page 1 College of Pharmacists of British Columbia | 200 - 1765 West 8th Ave Vancouver, BC, V6J 5C6 | Tel: 604.733.2440 | Fax: 604.733.2493 | www.bcpharmacists.org HPA BYLAWS SCHEDULE F Part 4 – CERTIFIED PRACTICE – DRUG ADMINISTRATION BY INJECTION STANDARDS, LIMITS AND CONDITIONS FOR IMMUNIZATION Page 1 of 2 6. Develop, maintain and review, at least annually, a policy and procedure manual including but not limited to: Emergency procedure protocol Emergency treatment protocol including the following minimum equipment or supplies: o Adrenalin/epinephrine and appropriate syringes for administration o Diphenhydramine o Appropriate equipment including a resuscitator bag to maintain airways including adult and child airways o Ice or cold compress Precautions required for patients with latex allergies 7. Maintain a setting within which the injection is to be administered that is clean, safe, comfortable and appropriately private and furnished for the patient. 8. Notify and provide relevant information to other health professionals, as appropriate. LIMITS 1. A practising pharmacist must not administer an injection to a child under 5 years old. CONDITIONS 1. A practising pharmacist must apply to the College of Pharmacists of B.C. for certification to administer injections within 1 year of successful completion of the required certification program. 2. A practising pharmacist must not provide injection services in B.C. prior to receiving notification from the College of Pharmacists of B.C. of their certification to administer injections. 5099-HPA_Bylaws_Injection_Drug_Administration v2012.1 Oct 29, 2012 College of Pharmacists of BC – Certified Practice – Drug Administration By Injection – Standards, Limits, And Conditions For Immunization Page 2 College of Pharmacists of British Columbia | 200 - 1765 West 8th Ave Vancouver, BC, V6J 5C6 | Tel: 604.733.2440 | Fax: 604.733.2493 | www.bcpharmacists.org Administration of Injection – Scope of Practice: The Regulation allows for qualified pharmacists to administer a drug (Schedule I, IA or II) or substance (Schedule III) by intradermal, intramuscular or subcutaneous injection for the prevention of disease, disorders or conditions and for the treatment of anaphylaxis. (note: this initial authorization is restricted to injections for the purpose of preventing disease, disorders or conditions such as immunizations and travel clinics. Further development regarding authorization for other injections is being explored by the College). Q: Does the authorization to administer injections apply only inside a pharmacy setting or is an authorized pharmacist able to administer injections outside of a pharmacy? A: Pharmacists would be authorized to administer injections outside of a pharmacy, as long as CPBC Standards, Limits, and Conditions are being met. The Standards, Limits and Conditions, item 7 states that pharmacists must “Maintain a setting within which the injection is to be administered that is clean, safe, comfortable and appropriately private and furnished for the patient.” From CPBC Readlinks Vol 28 No 2 – April/May 2013 POLICY CATEGORY: POLICY FOCUS: PROFESSIONAL PRACTICE POLICY-68 Cold Chain Management of Biologicals POLICY STATEMENT(S): The Board of the College of Pharmacists of BC adopts the BCCDC guidelines on the Cold Chain Management of Biologicals. Refer to BCCDC’s Communicable Disease Control Immunization Program: Section VI – Management of Biologicals. http://www.bccdc.ca/NR/rdonlyres/571A2C6D-8E4A-440E-BB4135A6725B9FE5/0/SectionVI_ManagementofBiologicals_July.pdf BACKGROUND: “Cold chain” refers to the process used to maintain optimal temperature conditions during the transport, storage and handling of vaccines and other refrigerated pharmaceuticals, starting at the manufacturer and ending with the administration of the product to the client. Vaccines are sensitive biological products; protection of vaccine potency and stability is important. The recommended temperature for vaccine storage is, at all times, +2ºC to +8ºC. Biologicals may be inactivated by exposure to excess light or heat or freezing, depending on the nature of the product, the temperature reached and the duration of exposure. Freezing will reduce the potency of inactivated vaccines and exposure to heat and light can compromise the stability of live-virus vaccines. Any loss of vaccine potency is permanent and irreversible. Damage from successive exposures to adverse conditions is cumulative. It is important to know the correct storage conditions for each biological product and to ensure that each is kept under the recommended conditions. When the temperature is in the 0°C to 2°C range, adjust the refrigerator temperature and restore the temperature to within the +2°C to +8°C range immediately. All biological products freeze at temperatures below 0°C; products that have been exposed to temperatures below 0°C should not be used. Consult with BCCDC Vaccine and Pharmacy Services, as there may be specific exceptions to this (e.g., lyophilized products.) Committee endorsement: The B.C. Centre for Disease Control guidelines were endorsed by the following College committees: Community Pharmacy Practice Committee, Residential Care Committee and the Hospital Pharmacy Committee. First approved: 18 November 2011 Revised: Reaffirmed: 5003-PGP-PPP v2012.1 PPP-68 Criteria for Pharmacist Access to Publicly Funded Vaccines This information is a supplement to Pharmacists and Publicly Funded Vaccines in B.C– General Information. VACCINES RELEASE PROCEDURES 1 – For administration to eligible B.C. residents who present to the pharmacist Local health units may provide these vaccines to an immunizing pharmacist to provide 1) Td immunization services to immunocompetent patients. 2) MMR 3) Seasonal Influenza 4) Pneumococcal polysaccharide (23 valent) 5) Hepatitis A Local health units may provide these vaccines to an immunizing pharmacist who provides services (such as needle distribution or methadone) to high-risk clients. 6) Hepatitis B (for adults) 2 – For administration to eligible B.C. residents as a supplement to school-based programs 1) Tetanus/Diphtheria/acellular Pertussis (Tdap) Local health units may provide these vaccines to an immunizing pharmacist on a case-bycase basis specifically for an eligible recipient who is unwilling or unable to participate in a 2) Varicella school-based setting. 3) Hepatitis B 4) HPV (Gardasil® only) 5) Meningococcal C Conjugate Note: In 2012, HPV (Cervarix®) is available as a one-time program while supplies last 3 – For administration to eligible B.C. residents during an outbreak 1) MMR 2) Hepatitis A 3) Pertussis containing vaccines (for children age 5+) (Tdap or DTaP-IPV) 4) Pneumococcal polysaccharide (23 valent) 5) Meningococcal C Conjugate 4 – For administration to household contacts in post-exposure situations 1) MMR 2) Hepatitis A 3) Pertussis containing vaccines (for children age 5+) (Tdap or DTaP-IPV) 4) Meningococcal C Conjugate 5 – For administration to eligible B.C. residents on a case-by-case basis 1) Varicella for adults/Others 2) Tetanus/Diphtheria/acellular Pertussis (Tdap) for previously unimmunized Adults 3) Td/IPV or IPV (for travel) Pharmacist Vaccine Resource Sheet These vaccines are scheduled for administration in grades 6 or 9, but students in grade 6 or older who have not been immunized will always be eligible to receive grade 6 vaccines (hepatitis B, meningococcal C, varicella, and HPV- girls only), and those in grade 9 or older will always be eligible to receive Tdap. Local health units may provide these vaccines to an immunizing pharmacist to assist in community-based vaccination under direction of the Medical Health Officer. Local health units may provide these vaccines to an immunizing pharmacist on an as-needed basis when recommended by the Medical Health Officer for a specific post-exposure situation and when the pharmacist can administer the vaccine in the timeliest manner. Local health units may provide these vaccines to an immunizing pharmacist on a case-bycase basis when requested by a pharmacist for an eligible patient when the pharmacist can administer the vaccine in the timeliest manner. Pharmaceutical Services Division | Ministry of Health | December 2012 Appendix 2 Safety Needles Required, WorksafeBC Sharps Disposal Providers Latex Content in Vaccines, BCCDC 37 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Are you required to use safety-engineered needles? FAQs by BC Medical Practitioners Changes to WorkSafeBC’s Occupational Health and Safety Regulation (OHSR) that come into effect on January 1st, 2008, affect all medical practitioners who use hollow bore needles to treat or care for patients. These changes were made in response to the estimated 5,000 needlestick injuries BC healthcare workers sustain each year. What are these changes? Any medical procedure that involves the use of hollow bore needles now requires safety engineered needles or needleless systems. These procedures include: • Withdrawal of body fluids • Accessing a vein or artery • Administration of medications or fluids • Any other procedure — for example, immunizations — involving the potential for an exposure to accidental parenteral contact for which a needleless system or safety-engineered needle system is available Who do these changes apply to? The OHSR applies to all workplaces in the province. Included are medical offices, clinics, hospitals, long-term care facilities, and patients’ homes where a medical practitioner treats or cares for a person. Since suppliers are also covered by these requirements, needles that are available on the market may change. Are there any exceptions? The only two exceptions where conventional needles can still be used for medical procedures are: 1. A safety engineered needle is not commercially available to replace the conventional needle and no alternative systems (such as patches or jet injectors) are available to eliminate the use of the needle. W o r k e r s’ C om p e n s a ti o n B o a r d o f B r i t i s h C ol um bi a 2. The use of a safety engineered needle or needleless device is not clinically appropriate because either the medical practitioner or patient would be at increased risk of injury. This determination can be made by educated, trained, and/or experienced persons — such as medical practitioners — who are knowledgeable about the work and hazards involved and the means to control these hazards. The use of safety engineered needles or needleless devices may require modification of a medical procedure. What if there are choices? If there are two or more types of safety engineered needles commercially available that are clinically appropriate for a medical procedure, you must select the device that provides the highest level of protection from accidental parenteral contact. Consider the following: • Evidence of reduced risk of exposure • Consideration and review of the different types of engineering controls that are commercially available • Information provided by manufacturers, independent testing agencies, objective product evaluation, or other reliable sources • Periodic review to ensure that the devices selected are appropriate based on the most current scientific knowledge of protection from sharps injuries Will there be further changes? Yes. On October 1st, 2008, any medical sharp — including sutures, scalpels, and lancets — used to treat or care for a person must be a safety engineered medical sharp. The same criteria and exceptions that apply with hollow bore needles will apply. Where is more information available? If you would like more information, please visit our website at www.worksafebc.com for both the regulations and guidelines associated with these changes — Reference OSHR 6.36(1) — or call the Prevention Information Line at 1 888 621-7233 to contact your local WorkSafeBC Occupational Hygiene Officer. W o r k e r s’ C om p e n s a ti o n B o a r d o f B r i t i s h C ol um bi a Sharps Disposal Service Providers Company Bio-Tox Medical Systems Environmental Control Systems Address 337 - 17 Fawcett Road Coquitlam, BC V3K 6V2 Phone: 604-523-6200 Fax: 604-523-6203 19 – 7157 Honeyman St Delta, BC V4G 1E2 Phone: 1-800-263-1857 Envirosmart PCB Services Green Check Canada 505 - 8840 210th St Langley, BC V1M 2Y2 Phone: 604-888-7921 Toll Free: 1-866-388-7921 Fax: 604-888-7924 Unit H, 31053 Peardonville, Abbotsford, BC V2T 6K4 Phone: 1-877-855-7444 Stericycle 5549 - 180th Street Surrey, BC V3S 5Y5 Phone: 604-574-4644 Toll Free: 1-877-8984644 Fax: 604-574-4652 40 Container cost 20 Litre (5 Gallon): $34.95 Service fee Service area Medication Disposal $1.50 per Litre for disposal of expired medications. Additional info Depending on pharmacy location, may not be able to provide same day pick up. No service contract required. Monday Friday 9:00am 5:00pm Whistler through Hope $120 per bio$39 hazard box; dangerous $160 for 6 X goods fee 5L container (cost includes supply and removal of containers) Varies by volume and frequency of service. Please contact Envirosmart directly for pricing information. PRN – courier service Entire province Available. Contact ECS for more details. Monday Friday 8:00am 8:00pm Lower Mainland. Available. Contact Envirosmart for more information. Regular office hours: Monday Friday 8:30am - 5:30pm Green Check supplies containers for sharps at no additional costs to clients. Service is provided quarterly, but can be scheduled annually or semi-annually as required. call dispatcher at ext #21 to arrange pickup. Victoria to Nanaimo; Lower Mainland; the Interior; North to PG and West to New Hazleton. Contact Stericycle to confirm if service is provided in your area. May be available. Contact Green Check for more information. Referrals: A referring office may qualify for a 5% referral discount on their next scheduled service fee. 85L box disposal: $150 $44.50 flat rate per pickup. Pick up times $135 per pick up, < or = 12 gallons. Overage charge of $20.00 per additional gallon. $42.00 stop charge Available. Contact Stericycle for more information. BC Pharmacy Association Supporting Pharmacy Practice: Medication and Sharps Disposal Communicable Disease Control Immunization Program Section IIB – Contraindications and Routine Precautions April 2010 Page 7 4.1 LATEX CONTENT IN VACCINES VACCINES CONTAINING LATEX Product Description DTaP-HB-IPV-Hib Hepatitis A Vaccine inactivated Hepatitis A Vaccine inactivated Hepatitis A Vaccine, purified, inactivated Trade name INFANRIX hexa Havrix 720 Junior® Presentation single dose syringe 0.5mL syringe Manufacturer GlaxoSmithKline GlaxoSmithKline Havrix 1440® 1mL syringe GlaxoSmithKline Vaqta® 0.5mLsingle dose vial Merck Frosst Hepatitis B Vaccine Recombivax-HB® 1.0mL single dose vial, 10 µg/mL Merck Frosst Hepatitis B Vaccine (Renal/Kidney Dialysis) Hepatitis B Vaccine, Pediatric(T-free) Immune Serum Globulin Immune Serum Globulin Recombivax-HB® 1.0mL single dose vial, 40 µg/mL 0.5mL single dose vial, 5µg/mL 2.0mL vial 2.0mL vial Merck Frosst 0.5mL single dose vial sanofi pasteur Meningitec® 0.5mL single dose vials Wyeth Menomune® 0.5mL single dose vial sanofi pasteur Meningococcal Conjugate A/C/Y/W-135 Meningococcal C Conjugate Vaccine Meningococcal Polysaccharide A/C/Y/W135 Vaccine Rabies Immune Globulin Tetanus Immune Globulin Tetanus Immune Globulin BCG Vaccine 1.0mL single dose vial Recombivax HB® Baygam® (Bayer) GamaSTAN®S/D Talecris Menactra® Merck Frosst Bayer Talecris 10 dose vial HyperRab® Baytet®(Bayer) HyperTET®(Talecris) 2.0mL vial 1 dose syringe, 250 U 1 dose syringe, 250 U 10 dose vial Talecris Bayer Talecris sanofi pasteur “Latex Content in Vaccines” adapted from BCCDC Vaccine and Pharmacy Services March 2010 chart. Appendix 3 Handle vaccines with care, BCCDC Cold chain checklist, BCCDC Cold chain temperature form, BCCDC How to store vaccines in the refrigerator, PHAC Packing an Insulated Cooler, BCCDC Equipment malfunction or power failure, BCCDC 42 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections HANDLE VACCINES WITH CARE Protect the vaccines. Protect your patients Temperature Maintain a refrigerator temperature of between 2.0º C to 8.0º C. Check temperature twice daily (am & pm) and record on the Temperature Form. Store bottles of water (if space allows) on the empty refrigerator shelves and in the door. Store ice packs in the freezer Open the refrigerator door only when necessary. Do not store food, beverages or lab specimens in the refrigerator Have a refrigerator maintenance check done annually. Transportation • Use a hard-sided insulated cooler with a tight–fitting lid along with frozen ice packs and Insulating material to transport vaccines at all times. Refrigerate vaccines a soon as you return to the office. Storage & Handling Store vaccine on the middle shelves of the fridge, never on the doors or in the crispers. Keep vaccines in their original packaging to protect from light. Use a separate tray in the refrigerator for opened vaccines and keep in original packaging. Use these before opening new vials/packages. Clearly print the opening date on the label of a multi-dose vial. Use a multi-dose vial within 30 days of opening, unless there are specific directions in the product insert for discarding sooner. Do not reconstitute vaccines or pre-fill syringes until ready to administer. Use the correct diluent to reconstitute lyophilized vaccines. Inventory Management • • • • • Rotate vaccines according to expiry date (place those with the longest expiry date at the back). Check for expired products every month. Never use expired vaccine and always return them to the public health unit/office. Keep vaccine stock at a minimum. Order only the quantity of vaccine required for one month until the next scheduled pick-up of vaccines. For more information, see Section VI, management of Biologicals at http://www.bccdc.ca/dis-cond/comm-manual/CDManualChap2.htm 2013 IMPORTANT THINGS TO SAFEGUARD YOUR VACCINES. A Checklist for safeguarding the storage and handling of your vaccine supply Yes 1. We have a designated person in charge of ordering vaccines, inventory management and refrigerator monitoring 2. 3. Our staff have been provided with training about the importance of good vaccine management All our vaccines are unpacked and refrigerated IMMEDIATELY upon delivery 4. 5. If there is a break in the cold chain, any exposed vaccines are labeled as "DO NOT USE" in the refrigerator We contact public health (Biological Products Consultant) to report cold chain incidents and determine if vaccines are useable 6. 7. 8. 9. 10. We use a laboratory or industrial fridge, or a domestic frost-free fridge to store vaccines We DO NOT store any food or beverages in the refrigerator Our vaccines are rotated on the "FIRST IN FIRST OUT" principle Vaccines that will expire soonest are used first Our vaccines are checked for EXPIRY dates at the beginning or end of every month No 11. Expired vaccines are removed from the refrigerator 12. We return damaged/expired vaccines to public health (public health returns to BCCDC) 13. We order vaccines monthly based on clinic needs 14. The temperature of the refrigerator is maintained between +2ºC to + 8ºC 15. Our vaccines are stored in the MIDDLE shelves of the refrigerator and NOT on the shelves in the door of the refrigerator 16. Our refrigerator is equipped with a Min/Max digital thermometer, or a Data logger. 17. A "TEMPERATURE LOG" is posted on the refrigerator and the temperature of the refrigerator, the ambient (room) temperature, and the dial setting of the refrigerator is recorded and initialed TWICE daily (morning and evening) 18. Sealed water bottles or flexible insulating blankets are stored (if space allows) on the upper and lower shelves and in the door of the refrigerator. Ice packs are stored in the freezer 19. A "DO NOT UNPLUG" sign has been placed next to our refrigerator's electrical outlet. 20. A hard-sided insulated cooler with a tight-fitting lid along with icepacks and insulating material is always used in transporting vaccines for short periods of time, and at clinic workstations. 21. An EMERGENCY PLAN for power outages or refrigeration malfunction has been established 22. We have a copy of BCCDC's Immunization Program, Section VI Management of Biologicals as a detailed reference for storage & handling of vaccines If all of the above answers are "YES", we are doing a great job of safe guarding our vaccines. If not, we have assigned someone to implement changes Temperature Form All vaccines should be maintained at +2.0°C to +8.0°C. Biological products can be inactivated by exposure to excess heat or to freezing, depending on the nature of the product, the temperature reached and the duration of exposure. Damage from successive exposures to adverse conditions is cumulative. This log will help you monitor if your vaccine fridge’s temperature is adequate to maintain the potency of your vaccines. Fridge temperatures between +0.0ºC to +2.0ºC do not compromise vaccine integrity, but the temperature should be restored to the +2.0ºC to +8.0ºC range immediately. If the fridge temperature is outside the +0.0°C to +8.0°C range, the vaccines may not be effective in preventing disease. If this occurs, contact your local Biological Products Consultant to find out if your vaccines can still be used. You can download more copies of this form from www.bccdc.ca under the Immunization and Vaccines\For Health Professionals\Cold Chain Information section http://www.bccdc.ca/imm-vac/ForHealthProfessionals/coldchain/default.htm Instructions 1. Record the current, minimum and maximum fridge temperature twice each business day. Record the temperature when you first open the office and before closing. 2. Place an “X” in the box that corresponds to the current fridge temperature. Place a “” in the box that corresponds to the minimum and maximum temperature the vaccines were exposed to since they were last checked. 3. Record the time the reading was taken, the dial setting of the fridge, the room temperature and your initials. 4. Remember to reset your min-max fridge thermometer. 5. Keep vaccines refrigerated between +0.0°C to +8.0°C at all times. 6. If the temperature recorded is in the shaded zones, follow the Cold Chain Incident guidelines available in Section VI of the Immunization Chapter at http://www.bccdc.ca/dis-cond/comm-manual/CDManualChap2.htm 7. Retain these records for three years or as locally determined. May 2011 Temperature Form (Celsius) Day of Month 1 2 3 Month/Year: _____/20____ Days 1-15 4 5 6 7 8 9 10 11 12 13 14 15 Time a m °C Temp p m a m p m a m p m a m p m a m p m a m p m a m p m a m p m a m p m a m p m a m p m a m p m ≥ 11° Take immediate action if temperature is in shaded section* 10° Refrigerator temperature 9° 8° 7° 6° 5° 4° 3° 2° 1° Take immediate action if temperature is in shaded section* 0° ≤ -1° Dial Setting of Fridge Room Temp Initials May 2011 a m p m a m p m a m p m Temperature Form (Celsius) Day of Month Exact Time 16 a m °C Temp p m 17 a m p m 18 a m p m Month/Year: _____/20____ Days 16-31 19 a m p m 20 a m p m 21 a m p m 22 a m p m 23 a m a m 24 p m p m 25 a m p m 26 a m p m 27 a m p m 28 a m p m ≥ 11° Take immediate action if temperature is in shaded section* Refrigerator temperature 10° 9° 8° 7° 6° 5° 4° 3° 2° 1° Take immediate action if temperature is in shaded section* 0° ≤ -1° Dial Setting of Fridge Room temp Initials May 2011 29 a m p m 30 a m p m 31 a m p m Packing an Insulated Cooler 624 g (22 oz) ice pack 12 cm w x 19 cm l x 3 cm h Preconditioned in freezer at -10°C to -20° Place frozen ice pack in the interior tray Outer 12mL flexible insulating blanket preconditioned in fridge at +2°C to +8°C and wrapped around vaccines and inner flexible insulating blanket Vaccines from fridge at +2°C to +8°C Inner 12mL flexible insulating blanket preconditioned in fridge at +2°C to +8°C and wrapped around vaccines 15 liter insulated cooler 2011 Establish an office-specific emergency plan for power failures or equipment malfunction EQUIPMENT MALFUNCTION: The most important action to take is to protect the vaccines as quickly as possible. If the temperature is outside the +2°C to +8°C range, follow these steps: Record the date, time, and temperature on the Temperature Form. Move the vaccines to a properly functioning, monitored refrigerator. If an alternate refrigerator is not available, place the vaccines in an insulated cooler, along with ice pack(s) and insulating material to prevent the vaccines from freezing. Check that the thermometer is working correctly, the battery may need to be changed. Check that the refrigerator plug has not become disconnected. Adjust your fridge dial setting or have the refrigerator serviced, and check that the temperature is between +2°C to +8°C before returning the vaccines to the refrigerator. Place vaccines exposed to temperatures outside the +2°C to +8°C range in a container and label it “DO NOT USE.” Record the date and time on the container. Contact your local Public Health Office for further guidance about whether the vaccines can still be used. DO NOT DISCARD OR USE THE EXPOSED VACCINE UNTIL THE SITUATION HAS BEEN ASSESSED BY PUBLIC HEALTH. Protect the vaccines Protect your patients Community Providers 2011 POWER FAILURE: The most important action to take is to protect the vaccines as quickly as possible Record the temperatures (maximum-minimum and current) and time as soon as possible after the start of the power failure on the Temperature Form. If the power failure is expected to be less than 4 hours, keep the refrigerator door closed, and continue to monitor the temperature. Water bottles stored on empty shelves and in the door will maintain the temperature longer. Place a “Do Not Use” sign on the refrigerator. Do not open the refrigerator unless it is to remove vaccines for alternate storage. If the power failure is expected to be more than 4 hours, or if the refrigerator temperature is going outside the +2°C to +8°C range, take the vaccines to a facility that has a functioning monitored fridge (e.g. with power or back-up generator). If an alternate refrigerator is not available, place the vaccines in an insulated cooler, along with ice pack(s) and insulating material to prevent the vaccines from freezing. When the power is restored, record the time and temperature on the Temperature Form. Place vaccines exposed to temperatures outside the +2°C to +8°C range in a container and label it “DO NOT USE.” Record the date and time on the container. Contact your local Public Health Office for further guidance about whether the vaccines can still be used. DO NOT DISCARD OR USE THE EXPOSED VACCINE UNTIL THE SITUATION HAS BEEN ASSESSED BY PUBLIC HEALTH Protect the vaccines Protect your patients Community Providers 2011 Appendix 4 BCPhA professional liability insurance – FAQ 52 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Professional Liability Insurance Ensure you have professional liability insurance coverage. Professional liability insurance is mandatory under the College bylaws of the Health Professions Act of 2009. Authority to administer injections is included in the scope of practice regulations subject to the process explained by the College here: http://www.bcpharmacists.org/about_us/key_initiatives/index/articles70.php BCPhA membership includes personal professional liability insurance coverage of $2 million per occurrence and $4 million in aggregate per year insured by Grain Insurance and Guarantee Company. This policy is “personal and portable”. Personal: it is issued in the pharmacists’ name and the coverage amounts are specific to the insured pharmacist even if an employer pays for/reimburses the membership fee. Portable: As long as the membership is paid up, the policy will continue to operate even if the pharmacist changes employer or practice location. Other frequently asked questions about the BCPhA insurance program policy: 1. If a BCPhA member stops his/her membership, will future lawsuits filed as a result of an incident that occurred during an active membership period still fall under the protection of the BCPhA group insurance? Answer: Yes, this is the advantage of being covered under an occurrence policy. In spite of the fact you may have terminated your coverage, the policy still responds to incidents which occurred while you were practicing pharmacy even though the claim is reported after the policy was terminated. 2. Does my policy cover me in situations like: a. relief assignments in pharmacies other my employment location/s b. if I work as a contractor rather than employee, or both c. in flu clinics other than my usual practice location d. practice in multiple locations at various times during the year e. practice outside normal business hours and days Answer: Yes, the policy will provide protection in all practice settings as long as you provide professional advice within your scope of practice. 3. Does my policy cover me when I am supervising pharmacy students? Answer: Yes, coverage will apply if the student makes an error that results in a claim being brought against you as the supervising pharmacist 4. Does my policy cover me for advice I may give in social settings? Answer: Yes, if professional advice you give in social settings like your child’s soccer game result in a claim being brought against you, your policy will provide you with protection. 5. What if my employer asks me to work temporarily in another province? Answer: Your policy will cover you while practicing pharmacy anywhere in Canada. Appendix 5 Pharmacy sign - patient safety reminder 55 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections For your safety… Please remain in the pharmacy for 15 minutes after your injection If you are unable to stay, please see the pharmacist for instructions BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Appendix 6 Vaccine Consent Form for Adults Assessed as Incapable of Giving Consent 57 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections CONSENT FOR VACCINE FOR ADULTS ASSESSED AS INCAPABLE OF GIVING INFORMED CONSENT SECTION 1: CLIENT PERSONAL INFORMATION Client Last Name Client First Name CareCard Number Date of Birth (YYYY / MM / DD) Gender Male Female SECTION 2: PERSONAL GUARDIAN / REPRESENTATIVE / TEMPORARY SUBSTITUTE DECISION MAKER (TSDM) INFORMATION AND CONSENT Association to Client Personal Guardian Representative TSDM – list relationship to client: (see back page for definitions) Daytime Phone Number Name of Personal Guardian / Representative / TSDM I have read or had explained to me the HealthLinkBC File information on the vaccine available at http://www.healthlinkbc.ca/healthfiles/httoc.stm. I understand the benefits and possible reactions of the vaccine and the risk of not getting immunized. I have been informed of any medical reason why the above named vaccine should not be given to the above named client. I have had the opportunity to ask questions that were answered to my satisfaction. vaccine series. I consent to the above named client receiving Signature of Personal Guardian / Representative / TSDM Date Signed (YYYY / MM / DD) SECTION 3: HEALTH CARE PROVIDER USE ONLY – CLIENT IMMUNIZATION RECORD I confirm the above named client is incapable of giving informed consent for the above named vaccine. CONSENT PROVIDED BY: Personal Guardian / Representative OR Temporary Substitute Decision Maker (TSDM): I am administering the above named vaccine no more than 21 days after the consent was signed. OR Health Care Plan: I confirm that the health care plan is in effect and was signed within the last 12 months. Signature of Nurse Date Given (YYYY / MM / DD) Date Signed (YYYY / MM / DD) Site Lot # Nurse Signature LARA Personal information collected on this form may be used by the health authority to update the client’s immunization record. The information will be used and disclosed in accordance with the Freedom of Information and Protection of Privacy Act. Summary statistical information may be reported to the Ministry of Health. If you have any questions about the collection and use of this personal information, contact your local health unit. You may be contacted to request your participation in the evaluation of this immunization program. HLTH 2389 2011/09/21 The following information is from sections of the Health Care (Consent) and Care Facility (Admission) Act (HCCCFAA) PERSONAL GUARDIAN The following provisions of the Health Care (Consent) and Care Facility (Admission) Act (HCCCFAA) authorize a health care provider to act upon consent given on behalf of an adult. “Personal Guardian” means a committee of a person who is declared under the Patients Property Act to be: (i) incapable of managing himself or herself, or (ii)incapable of managing himself or herself and his or her affairs. REPRESENTATIVE A representative is a person named by an adult in a representation agreement to help the adult make health care decisions or to make health care decisions on behalf of the adult. TEMPORARY SUBSTITUTE DECISION MAKER (TSDM) A temporary substitute decision maker, chosen by a health care provider as provided for in the HCCCFAA may consent to healthcare. s.16(1) To obtain substitute consent to provide major or minor health care to an adult, a health care provider must choose the first, in listed order, of the following who is available and qualifies under subsection (2): (a) the adult’s spouse; (d) the adult’s brother, sister, grandparent or grandchild; (b) the adult’s child; (e) anyone else related by birth or adoption to the adult; (c) the adult’s parent; (f) a close friend of the adult; (g) a person immediately related to the adult by marriage. (2) To qualify to give, refuse or revoke substitute consent to health care for an adult, a person must (a) be at least 19 years of age, (b) have been in contact with the adult during the preceding 12 months, (c) have no dispute with the adult, (d) be capable of giving, refusing or revoking substitute consent, and (e) be willing to comply with the duties in section 19. (3) If no one listed in subsection (1) is available or qualifies under subsection (2) or if there is a dispute about who is to be chosen, the health care provider must choose a person, including a person employed in the office of the Public Guardian and Trustee, authorized by the Public Guardian and Trustee. (4) A health care provider is not required to do more than make the effort that is reasonable in the circumstances to comply with this section. AUTHORITY OF A TEMPORARY SUBSTITUTE DECISION MAKER s.17(1) Subject to section 9 (2), a person chosen under section 16 has the authority to decide whether to give or refuse substitute consent. (2) The health care provider must, no more than 21 days before that health care begins, confirm in writing that (a) the adult is still incapable, and (b) the person who earlier consented to the health care being provided confirms that the health care should begin. s.17(2.1)Despite subsection (2) and whether or not the health care that is the subject of the decision made under subsection (1) has begun, if at any time a health care provider has reasonable grounds to believe that the adult may be capable of giving or refusing consent to health care, the health care provider must again determine whether the adult remains incapable. (2.2)If, at any time after a decision is made under subsection (1), the adult is capable of giving or refusing consent to health care (a) the authority to give or refuse substitute consent to health care for the adult is terminated, (b) the decision made under subsection (1) is rescinded, and (c) before the health care that is the subject of the decision made under subsection (1) is begun or continued, the adult must give consent to that health care. (2.3)Subsection (2.2) does not invalidate anything that is otherwise validly done before the decision made under subsection (1) is rescinded. HEALTH CARE PLAN A health care plan is developed by a health care provider, and is signed and dated by both the health care provider and the substitute decision maker. The health care plan should contain the following information for an immunization to be given: • statement of consent • client identification (name and date of birth) • date of consent • statement that the person providing consent has reviewed and understood the vaccine-specific Standard Information • signatures of health care provider and substitute decision maker • name of vaccine series Appendix 7 Anaphylaxis kit supply checklist Anaphylaxis guidelines Adverse Event (Reaction) Following Immunization Temporal Criteria and reporting form Link to Fill and Print form Adverse Events Following Immunization (AEFI) Algorithm 60 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Supplies for Anaphylaxis Management Checklist Qty Supplies 1 3 1 2 2 Date Expiry Date Date BCCDC anaphylaxis treatment guidelines: sections 2.3, 10.0 and 11.0 1cc syringe and safety needle (25 – 27G, 1”) 1cc syringe and safety needle (25-27G, 1½”) 3cc syringe and safety needle (25-27G, 1” and 1½”) 1cc syringe and safety needle (25-27G, 5/8”) for SC route Extra needles 4 Epinephrine 1:1,000 1mL ampoule 2 Diphenhydramine HCl 50mg/mL 1mL vial 2 Epinephrine auto-injector 2 Children’s epinephrine auto-injector 1 Ice or cold compress 1 Resuscitator bag – Adult 1 Resuscitator bag - Child 1 Sharps container Pen/Paper Staff initials: 61 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Date Communicable Disease Control Immunization Program Section V – Anaphylaxis April 2013 Page 5 2.3 Anaphylaxis versus fainting and anxiety ANAPHYLAXIS FAINTING DEFINITION An acute systemic and potentially fatal allergic reaction to a foreign substance. IgE-mediated antibody induces histamine release from tissue mast cells. A temporary unconsciousness caused by diminished blood supply to the brain due to painful stimuli or emotional reaction. A protective physiological state recognized as fear, apprehension, or worry. ONSET Usually slower, most instances begin within 30 minutes after immunization. Sudden, occurs before, during, or shortly after immunization; recovery occurs within 1-2 minutes Sudden, occurs before, during, or shortly after immunization; recovery occurs within 1-2 minutes SKIN - flushed, red blotchy areas (not necessarily itchy) - itchy, generalized hive-like rash - tingling sensation often first felt about the face and mouth - progressive, painless swelling about the face, mouth, and tongue - pale - excessive perspiration - cold, clammy - pale - excessive perspiration - cold, clammy BREATHING - sneezing, coughing, wheezing, laboured breathing - upper airway swelling (indicated by hoarseness and/or difficulty swallowing) possibly causing airway obstruction - normal or shallow, irregular, laboured - rapid and shallow (hyperventilation) PULSE - rapid, weak - slow, steady - rapid BLOOD PRESSURE - decreased systolic and diastolic - decreased systolic and diastolic - normal or elevated systolic SYMPTOMS & BEHAVIORS - uneasiness, restlessness, agitation - fearfulness - fearfulness - hypotension, which generally develops later and can progress to cause shock and collapse - light-headedness - light-headedness - dizziness - dizziness - numbness, weakness - numbness, weakness - not all signs/symptoms will be exhibited in each person; usually one body system predominates. - sometimes accompanied by brief clonic seizure activity ANXIETY - tingling around lips and spasm in the hands and feet associated with hyperventilation - hyperventilation GASTROINTESTINAL - nausea and vomiting OTHER SYMPTOMS - loss of consciousness - abdominal pain, diarrhea - progression of injection site reaction beyond hives and swelling - nausea - nausea Communicable Disease Control Immunization Program Section V – Anaphylaxis April 2013 Page 12 10.0 EMERGENCY TREATMENT OF ANAPHYLAXIS IMMEDIATELY Call 9-1-1 or ambulance Give epinephrine (1:1,000) IM into an unimmunized thigh. If both thighs were used for immunization: o give epinephrine IM into deltoid if client is > 12 months old o give epinephrine SC into upper outer triceps area of the arm(s) if client is < 12 mos old If both thighs and both arms were used for IM immunizations, give epinephrine SC into upper outer triceps area of the arm(s) or into the fatty area of the anterolateral thigh. DO NOT give epinephrine into the same muscle mass as vaccine was given. Dose: 0.01ml/kg to maximum of 0.5ml OR: AGE EPINEPHRINE 2 – 6 months 7 – 12 months 13 months – 4 years 5 years 6 – 9 years 10 – 13 years ≥ 14 years 0.07 ml 0.10 ml 0.15 ml 0.20 ml 0.30 ml 0.40 ml 0.50 ml Position client in recumbent position and elevate legs, as tolerated symptomatically Monitor respiratory effort, pulse, and level of consciousness IF PERSON’S BREATHING IS MORE LABORED OR LEVEL OF CONSCIOUSNESS DECREASES Repeat epinephrine twice at 5 minute intervals, as needed (max. 3 doses) Alternate right and left thigh or arm sites for repeat doses of epinephrine Elevate head and chest slightly If airway is impaired use held tilt, chin lift or jaw thrust If vomiting is likely, turn person to side lying position IF SYMPTOMS ARE NOT CONTROLLED or TO MAINTAIN SYMPTOM CONTROL IF CLIENT CANNOT BE TRANSFERRED TO ACUTE CARE FACILITY WITHIN 30 MINUTES Give one dose of diphenhydramine hydrochloride 50 mg/ml IM preferably at a different site to that in which epinephrine was given. If necessary, use same thigh as the one in which epinephrine was given. Can also be given into same muscle mass as vaccine was given. Can give at any time interval, either after the initial or repeat doses of epinephrine. Communicable Disease Control Immunization Program Section V – Anaphylaxis April 2013 Page 13 AGE Diphenhydramine hydrochloride < 2 years 2 – 4 years 5 – 11 years ≥ 12 0.25 ml 0.50 ml 0.50-1.00ml 1.00ml 11.0 ENHANCED SURVEILLANCE OF SUSPECTED ANAPHYLAXIS FOLLOWING VACCINATION The form titled: “Enhanced Surveillance and Worksheet for Events Managed as Anaphylaxis Following Immunization” found at http://www.bccdc.ca/discond/CDSurveillanceForms/default.htm or at “Enhanced Surveillance and Worksheet for Events Managed as Anaphylaxis Following Immunization”should be completed by the immunizing health care professional who observed and treated the client for each case of suspected anaphylaxis following administration of vaccine. After filling and printing the form, please submit the form to the appropriate Medical Health Officer (MHO) for review. The MHO or delegate will then submit the completed form to Dr. Monika Naus, Medical Director, Immunization Programs, BC Centre for Disease Control, fax 604 7072515. Please also complete an iPHIS/ Panorama / PARIS report on this adverse event. Updated reports and other supporting documentation can be submitted as information becomes available. IDENTIFIER NO. REPORT OF ADVERSE EVENT (REACTION) FOLLOWING IMMUNIZATION OFFICE CODE CASE NO local use only. CLIENT INFORMATION CLIENT’S LAST NAME GIVEN NAMES PERSONAL HEALTH NUMBER PARENT/GUARDIAN LAST NAME GIVEN NAME(S) CLIENT'S STREET ADDRESS CITY/TOWN NAME OF CLIENT'S PHYSICIAN DATE OF BIRTH YYYY MM POSTAL CODE ADDRESS SEX DD MALE FEMALE PHONE No. PHONE No. NAME OF PERSON WHO ADMINISTERED VACCINE DATE VACCINE ADMINISTERED YYYY MM DD VACCINE INFORMATION AGENT OR VACCINE(S) GIVEN MANUFACTURER INDICATE WHICH DOSE IN SERIES LOT NO. SITE ADVERSE EVENT (REACTION) Report only events which cannot be attributed to coexisting conditions. Reactions preceded by an asterisk(*) must be diagnosed by a physician. Time interval between vaccine administration and onset of each reaction must be recorded as number of minutes, hours or days LOCAL REACTION AT INJECTION SITE: * * * TIME IN NUMBER OF Min. or Hrs. or Days Abscess, Infected Acute disseminated encephalomyelitis (ADEM) Abscess, Sterile Anaesthesia/paresthesia Bell’s Palsy Convulsions/seizures Cellulitis * Nodule Pain, redness or swelling extending past nearest joint Pain, redness or swelling lasting 10 days or more SYSTEMIC REACTIONS: Adenopathy/Lymphadenopathy Fever in conjunction with another reportable adverse event: > 40.5 C (105 F) 39.0 - 40.4 C (102.2 - 104.9 F) Temperature not recorded but believed to be very high and accompanied by other symptoms. * * TIME IN NUMBER OF Min. or Hrs. or Days NEUROLOGIC EVENTS: * * * * * * Orchitis Rash, requiring medical attention or hospitalization Meningitis Other neurologic events Subacute Sclerosing Panencephalitis (SSPE) OTHER EVENTS OF INTEREST: * Arthritis 24+ hours * Hematochezia Intussusception Hypotonic-Hyporesponsive Event (HHE) Parotitis Encephalopathy Encephalitis Guillain-Barre Syndrome (GBS) * Syncope with injury Thrombocytopenia Other severe or unusual events (specify in comments section) Screaming/persistent crying Severe vomiting/diarrhea ALLERGIC REACTIONS (describe in comments): History of previous reaction - specify: Event managed as anaphylaxis Gastrointestinal manifestation Generalized edema Hives Localized Puffiness Oculo-Respiratory Syndrome Wheezing HLTH 2319 page 1 of 2 Rev. 2013/02/21 Date (YYYY / MM / DD) Vaccine given Health Unit/Dept. where reported COMMENTS FURTHER DESCRIBING ADVERSE EVENT(S) OUTCOME To be completed when event(s) resolved or within 30 days of initiation of report SEEN BY PHYSICIAN? YES HOSPITALIZED BECAUSE OF REACTION? NO YES FULLY RECOVERED FREEDOM OF INFORMATION NO NOT YET RECOVERED (describe below) INITIAL ISSUES DISCUSSED WITH CLIENT/PARENT/GUARDIAN? YYYY MM DD DATE ADMITTED: YYYY MM PERMANENT DISABILITY / INCAPABILITY (describe below) UNKNOWN DEATH FORM COMPLETED BY (PLEASE PRINT) NAME: DD DATE DISCHARGED: YYYY SIGNATURE: MM DD DATE: TO BE COMPLETED BY MEDICAL HEALTH OFFICER OR DESIGNATE AFTER OUTCOME SECTION IS COMPLETED RECOMMENDATION RECOMMENDATION: NO CHANGE TO IMMUNIZATION SCHEDULE EXPERT REFERRAL (SPECIFY) DETERMINE PROTECTIVE ANTIBODY LEVELS CONTROLLED SETTING FOR NEXT IMMUNIZATION NO FURTHER IMMUNIZATIONS WITH RELEVANT VACCINE (SPECIFY) DO NOT VACCINATE AGAIN UNLESS CIRCUMSTANCES STRONGLY WARRANT USE OTHER (SPECIFY) CONSULTATION WITH BCCDC REQUESTED? YES NO REASON CONSULTATION REQUESTED: YYYY MEDICAL HEALTH OFFICER OR DESIGNATE (PLEASE PRINT) NAME: SIGNATURE: MM DD DATE: BCCDC USE ONLY FOLLOW UP REQUIRED? HLTH 2319 Rev. 2013/02/21 page 2 of 2 When COMPLETED, mail form to your local Health Unit. YES NO CONSULT COMPLETED? YES NO ADVERSE EVENTS FOLLOWING IMMUNIZATION - TEMPORAL CRITERIA The length of time between vaccine administration and onset of symptoms is an important consideration in casuality assessment. Temporal criteria guidelines in this table are generally agreed upon approximate timelines. Temporal Criteria Inactivated Vaccines Adverse Event Following Immunization Live Attenuated Vaccines 0 – 48 hours Pain or Redness or Swelling Infected Abscess 0 – 7 days Sterile Abscess 0 – 7 days Nodule 0 – 7 days Cellulitis 0 – 7 days Timing in conjunction with other reportable adverse events Fever Rash 0 – 7 days MMR: 0 – 30 days, Varicella: 0 – 42 days Adenopathy / Lymphadenopathy 0 – 7 days MMR: 5 – 30 days, Varicella: 5 – 42 days Hypotonic-hyporesponsive Episode (HHE) 0 – 48 hours Screaming / Persistent Crying 0 – 72 hours Parotitis Not applicable MMR: 5 – 30 days Orchitis Not applicable MMR: 5 – 30 days Severe Vomiting / Diarrhea 0 – 72 hours 0 – 7 days for rotavirus vaccine Anaphylaxis 0 – 24 hours Oculo-Respiratory Syndrome (ORS) 0 – 24 hours Other Allergic Reactions 0 – 48 hours Convulsion / Seizure 0 – 72 hours MMR: 5 – 30 days, Varicella: 5 – 42 days Encephalopathy / Encephalitis / ADEM 0 – 42 days MMR: 5 – 30 days, Varicella: 5 – 42 days Meningitis 0 – 15 days MMR: 5 – 30 days, Varicella: 5 – 42 days Anaesthesia / Paraesthesia 0 – 15 days MMR: 0 – 30 days, Varicella: 0 – 42 days Paralysis 0 – 15 days OPV: 5 – 30 days, Varicella: 5 – 42 days Guillian-Barré Syndrome 0 – 8 weeks Bell’s Palsy 0 – 3 months Subacute Sclerosing Panencephalitis (SSPE) Not applicable Thrombocytopenia Up to 10 years following a measles-containing vaccine 0 – 30 days Arthralgia / Arthritis 0 – 30 days MMR: 5 – 30 days, Varicella: 0 – 42 days Intussusception Not applicable Rotavirus: 0 – 42 days Syncope with Injury 0 – 30 minutes Other, severe or unusual A temporal association to immunization, and for which there is no other known cause and not covered under the other categories previously described. MHO OR DESIGNATE RECOMMENDATION CODES 1 = No change in immunization schedule 5 = Determine protective antibody / antitoxin levels (specify) 6 = No further immunizations with relevant vaccine 8 = Controlled setting for next immunization 10 = Do not give vaccine again unless circumstances strongly warrant use (specify) 11 = Expert referral (specify) 12 = Other (specify) Process for the Follow-Up of Adverse Events Following Immunization (AEFI) for Pharmacists Pharmacist Responsibilities Client reports Adverse Event (AE) to pharmacist who administered immunization. Check with client if AE reported elsewhere. Yes No No AE report required. Provide client with clinical management advice. No Confirm reaction meets temporal and case definition criteria Yes Unsure Refer to Communicable Disease Control Manual, Chapter II section IX Complete all details, including FOI and Outcome box, on AE form HLTH 2319 Adverse Events Form If medical attention sought, access a copy of medical report from physician. Adverse Events Form Send HLTH 2319 and medical report to local Health Unit within 24 hours of receiving information Pharmacist informs client of MHO recommendations Public Health stores HLTH 2319 record, obtains and documents MHO recommendations, and provides a copy to the reporting pharmacist Pharmacist documents/files AEFI paperwork and updates patient’s local and/or PharmaNet profile. August 20 2012 Appendix 8 Provincial immunization record 69 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Appendix 9 Online Resources Immunization Schedules, BCCDC Vaccine Drug Schedules, CPBC 71 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Online Resources Provincial Links: BC Pharmacy Association Administration of Injections (BCPhA members only) BC Centre for Disease Control Immunization Manual Information for Health Professionals BC Public Health Units Finder Complete list of BC Public Health Units Healthlink BC. For all non-emergency health information call 8-1-1. ImmunizeBC Immunization Communication Tool for Immunizers National Links: Public Health Agency of Canada Canadian Immunization Guide Immunize Canada National Advisory Committee on Immunization (NACI) 72 BC Pharmacy Association Supporting Pharmacy Practice Change: Administration of Injections Communicable Disease Control Immunization Program Section IIA – Immunization Schedules May 2012 Page 6 1.4 Schedule C: Children 7 Years To 17 Years (Inclusive) When Starting Immunization VISIT Initial visit One month after initial visit 16 weeks after first HB AND 8 weeks after second HB 6 months after 1st visit 6 – 12 months after 2nd visit VACCINE Tetanus/Diphtheria/acellular Pertussis (ADACEL®) IPV MMR Varicella (if susceptible) Hepatitis B Meningococcal C Conjugate Hepatitis A (aboriginal children only) Tetanus/Diphtheria/acellular Pertussis (ADACEL®) IPV MMR Hepatitis B Hepatitis B Hepatitis A (aboriginal children only) Tetanus/Diphtheria/acellular Pertussis (ADACEL®) IPV Grade 6 Hepatitis B (2 doses; if not previously immunized) Meningococcal C conjugate HPV (girls only) Varicella (if susceptible) Grade 9 Tetanus/Diphtheria/acellular pertussis(ADACEL®) A susceptible child has a history of chickenpox < 12 months of age, no history of chickenpox disease at >1 year of age, and no previous receipt of varicella vaccine. For susceptible adolescents ≥13 years of age, testing is required to determine varicella status prior to immunizing. An individual ≥13 years of age who is Varicella IgG negative requires two doses of vaccine, given 6 weeks apart. The following children are eligible for a hepatitis B vaccine series when presenting prior to Grade 6: those born on or after January 1, 2001 and those under 12 years of age who are new immigrants (within the past year) to Canada from regions of high hepatitis B prevalence (e.g., Asia and Africa). Provided to children born on or after July 1, 2002 when presenting prior to grade 6. Provided to adolescents who present after grade 6. The hepatitis B vaccine two dose schedule (0 and 6 months) is used for students in grade 6, and for individuals from ≥11 to ≤15 years of age. A grade 6 student is considered up-to-date for MCC vaccine if they have a dose of a MCCcontaining vaccine on or after their 10th birthday. The interval between MCC doses is a minimum of 8 weeks. There should be a minimum of 6 months since receipt of a previous booster dose of a tetanus/diphtheria –containing vaccine (applies to the Grade 9 Tdap booster only.) Communicable Disease Control Immunization Program Section IIA – Immunization Schedules May 2012 Page 7 1. 5 Schedule D: Unimmunized Adults Age 18 and Older When Beginning Immunization VISIT Initial visit VACCINE Tetanus/Diphtheria/acellular Pertussis (ADACEL®) IPV (if indicated) MMR Assess varicella status Hepatitis B Meningococcal C conjugate Hepatitis A (Aboriginal adults 18 years of age only) 4 weeks after initial visit MMR Td or Td/IPV Varicella Hepatitis B 6 weeks after second visit Varicella 6 months after initial visit Hepatitis A (Aboriginal adults 18 years of age only) Six months after 2nd visit Td or Td/IPV Hepatitis B Routine primary immunization against poliomyelitis of adults living in Canada is not considered necessary. Primary immunization with polio vaccine is recommended only for unimmunized adults who are at higher risk of exposure to wild polioviruses: Refer to BC Communicable Disease Control Manual, Chapter 2, Immunization Program, Section VII, Polio Vaccine Measles protection: two doses of MMR are recommended for all individuals born on or after January 1, 1957 who do not have a history of lab confirmed measles infection, lab evidence of immunity, or documentation of 2 doses of a live measles-containing vaccine at ≥12 months of age and given at least 4 weeks apart. Mumps protection: two doses of MMR are recommended for all individuals born on or after January 1, 1970; one dose is recommended for all individuals born January 1, 1957 to December 31, 1969 who do not have evidence of mumps immunity. Rubella protection: one dose of MMR is recommended for all individuals born on or after January 1, 1957 who have not received at least 1 dose of a rubella-containing vaccine or who do not have serologic evidence of rubella immunity. One dose of MMR for rubella protection is recommended for health care workers regardless of age. One dose is considered evidence of immunity to rubella. Assess varicella susceptibility before providing vaccine (i.e., a history of chickenpox disease < 12 months of age, no history of chickenpox disease at >1 year of age, and no previous receipt of varicella vaccine). A susceptible adult requires testing to determine varicella status. Individuals who are Varicella IgG negative require two doses of vaccine, given 6 weeks apart. Individuals born on or after January 1, 1980 are eligible for hepatitis B vaccine series. Individuals born on or after January 1, 1988 are eligible for one dose of Meningococcal C conjugate vaccine. Communicable Disease Control Immunization Program Section IIA – Immunization Schedules January 2012 Page 8 1.6 Schedule E: Immunization For Adults Who Have Completed A Primary Series Of Childhood Vaccines NOTE: For all unimmunized adults see Schedule D. Immunization within the parameters of the provincial immunization policy is provided to any adult upon request and encouraged for adults at risk for reasons of occupation, travel, lifestyle, health status, or age. Vaccine Tetanus -Diphtheria (Td) Group Any adult upon request. • Every 10 years. Adults with a tetanus prone wound. • Refer to Tetanus Prophylaxis in Wound Management. Poliomyelitis Persons at higher risk of exposure to wild polioviruses (i.e., health care workers, travelers to areas of countries where wild polio viruses are circulating, workers in refugee camps in polio endemic areas, laboratory workers handling specimens that may contain polio viruses, military personnel). • Measles, Mumps, Rubella (MMR) Influenza Vaccine All individuals who require protection against measles, mumps, or rubella. • All individuals ≥ 65 years of age. • Individuals who are at high risk of influenza and its related complications. • Individuals who are capable of transmitting influenza to those at high risk. • Individuals who provide essential community services. Refer to Section VII Biological Products for complete list of indications for influenza vaccine. All individuals ≥ 65 years of age. Pneumococcal Polysaccharide Vaccine Individuals with specific medical conditions. See Section VII Biological Products Pneumococcal Polysaccharide Vaccine (Pneumo23). Frequency Of Immunization A single booster dose, 10 years after the primary series, is recommended if individual completed IPV or OPV vaccine series in childhood and is a member of a group identified as being at higher risk of exposure to wild polioviruses. A 2nd dose is provided free. Annual vaccination. Once only revaccination, 5 years after initial dose, as required for specific medical risk conditions. See Section VII Biological Products Pneumococcal Polysaccharide Vaccine (Pneumo23). 6 Vol 37 no 3 | Jun / jul / aug 12 On Call Questions About Injections Injection authority is a recent expansion of pharmacists’ scope of practice that has proven exceptionally popular with both the public and pharmacists. Over 1800 pharmacists in BC have received authorization to inject from the College after completing an approved injections course and first aid training. For those who have received authorization and are administering injections, this information is relevant to you. Q: Which vaccines and drugs can I inject? Q: Which vaccines can I administer without a prescription? A. Pharmacists authorized by the A. A pharmacist authorized to administer College to give injections are permitted to administer a drug (Schedule I, IA or II) or substance (Schedule III) by intradermal, intramuscular or subcutaneous injection for the prevention of disease, disorders or conditions and for the treatment of anaphylaxis. This is detailed in the College’s Standards, Limits, and Conditions for Immunization available on our website. These pharmacists may inject any vaccine but may not inject other drugs, such as Vitamin B12, unless they have a delegated authority from the patient’s physician. injections may inject any Schedule II vaccine defined as follows: • Influenza, • vaccines which are part of a routine immunization program, • vaccines requiring special enhanced public access due to disease outbreaks • cholera vaccine (oral, inactivated) when used for prophylaxis against traveller’s diarrhea due to enterotoxigenic escherichia coli (ETEC). Examples of routine immunization programs are ones led by the Public Health Agency of Canada or other Canadian programs such as the BC Centre for Disease Control. Pharmacists must use their knowledge, skills and abilities to decide whether a patient is eligible to receive the vaccine under Schedule II. The pharmacist must process this vaccine on PharmaNet using their ID in the prescriber field. This means that pharmacists authorized to inject may decide to dispense and inject a Schedule II vaccine that is part of a routine immunization program in Canada (e.g. Zostavax, Hepatitis A and B immunizing agents, Twinrix) without having to send the patient to the physician for a prescription. Ensure you document your rationale if you make the professional decision to either sell or dispense and inject a vaccine. If you do not have injection authority, but have the knowledge, skills and abilities to decide the patient is eligible to receive the vaccine under Schedule II, you may sell the vaccine to the patient for injection by a physician, RN or pharmacist authorized to inject. Please note that you need special authorization from the Public Health Agency of Canada in order to provide or inject Yellow Fever vaccinations. 6 Vol 38 no 1 | JAN / FEB / MAR 13 On Call In the previous issue of ReadLinks, we received some questions regarding immunization. After the feedback we feel the need to further clarify some issues that we have identified within the article. In the Drug Schedules, a Schedule 2 Vaccine is defined as follows: she may provide it under Schedule 2. Pharmacists must ensure they document their rationale and decision to sell, dispense or administer an injection. • vaccines requiring special enhanced public access due to disease outbreaks For example: Zostavax is presently not part of the BC’s publicly funded program, however the BCCDC does recommended Zostavax for individuals over 50 for the prevention of herpes zoster in patients with prior chickenpox infection. Therefore, it could be considered Schedule 2 for this indication. • cholera vaccine (oral, inactivated) when used for prophylaxis against traveler’s diarrhea due to enterotoxigenic escherichia coli (ETEC). www.bccdc.ca/NR/rdonlyres/ 9C32CA14-634C-46DE-9538-4FC168E10D8D/0/ SectionVII_Biological_ProductsOctober32012FINAL.pdf The confusion may arise due to the interpretation of the word “program”. The word “program” is not limited to publicly funded programs. “Vaccines which are part of a routine immunization program” apply to any immunization usage recommended for the prevention of disease by any provincial, national or international organization (such as the BC Centre for Disease Control or National Advisory Committee on Immunization). Therefore, if the pharmacist has the knowledge, skills and abilities to identify the patients need for a vaccine, then he or Also note that a pharmacist may not inject other drugs such as B vitamins unless they have consent from the patient and a delegated authority from that patient’s physician. A delegated authority is an authorization issued by the College of Physicians and Surgeons under a medical directive from a physician to a qualified individual. You should also note that a Schedule 1 drug still requires a prescription from a practitioner, regardless of any medical directive. This authority cannot be delegated. • Influenza, • vaccines which are part of a routine immunization program, Remember: Verify PHNs Before Dispensing Medications Case Study #1 A patient was brought into the ER complaining of chest pains. The doctor on duty printed the PharmaNet record and prescribed drugs based on what was on her profile. When the nurse went to administer the medications, the patient stated “those don’t look like my pills”. After a lengthy discussion between the doctor and the patient, it seemed a community pharmacy was filling medications using the incorrect PHN. The doctor then called the PharmaNet Help Desk to find out where the medications on the record were being filled and followed up by calling both pharmacies involved. It was then discovered that one of the pharmacies inadvertently downloaded the incorrect patient information when setting up a local record for one of their new nursing home patients. Case Study #2 A pharmacist called the College to request that medications be transferred from an incorrect patient’s profile to the correct one. Upon review of both patients’ information, it was discovered that both PHNs belonged to the same patient. When the patient first visited the pharmacy, a pharmacist searched for the PHN, but they did not have the correct spelling of the patient’s name. When the search came back empty, he assumed that person did not have a PHN and therefore created a new one. As a result of having 2 PHNs, this patient’s medication history was incomplete on both records. The pharmacist then called the Help Desk to request PHNs be merged. Verifying PHNs help keep patients safe In the above cases, the medication record was incomplete and incorrect and this can ultimately impact patient care. When the PHN is not verified prior to dispensing medication, and when the PharmaNet record is not reviewed regularly, errors such as these get overlooked and this can have a negative outcome.
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