Canadian Immunization Guide
Seventh Edition - 2006

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Part 1
General Guidelines

National Guidelines for Immunization Practices

Preamble

The current edition of the Guide contains many examples of the effectiveness of provincial/territorial childhood immunization programs in Canada as carried out by both private and public providers. These include elimination of wild-type poliovirus and a decrease of over 95% in the incidence of Haemophilus influenzae type b and measles infections. To guarantee continued success it is essential that policy makers, program administrators and providers work together, proactively, to plan, conduct and regularly review immunization programs. Furthermore, several challenges remain, such as continued documented occurrences of "missed opportunities for immunization"; subgroups of Canadians with lower than optimal vaccine coverage; evidence of incorrect handling and storage of vaccine by providers; wide variations in the reporting of adverse events following immunization; and evidence that there is insufficient communication regarding the risks and benefits of vaccines.

Accordingly, the National Advisory Committee on Immunization (NACI) has developed guidelines for immunization practices applicable to both public and private systems of vaccine delivery. The guidelines that follow resulted from extensive consultation with provincial/territorial health authorities; medical, nursing, public health and hospital organizations; and individual providers and child advocacy groups. The original guidelines (Canadian Immunization Guide, 6^th edition) were officially endorsed by the Canadian Paediatric Society, Advisory Committee on Epidemiology, College of Family Physicians of Canada, Canadian Medical Association, Canadian Nurses Association, Aboriginal Nurses Association of Canada, Society of Obstetricians and Gynaecologists of Canada and the Canadian Public Health Association. They have been slightly modified for this edition.

The guidelines are deliberately broad, far-reaching and rigorous. They define the most desirable immunization practices that health care providers can use to assess their own current practices and identify areas of excellence as well as deficiency. It is recognized that some of the guidelines require involvement of the provinces and territories (e.g., regarding the need to track immunizations and audit coverage levels). Furthermore, some providers/programs may not have the funds necessary to fully implement the guidelines immediately. In such cases the guidelines can act as a tool to clarify immunization needs and to facilitate obtaining additional resources in order to achieve national goals and targets.

The following terms have been used throughout:

• Provider : any individual, nurse or physician qualified to give a vaccine
• Regular provider : individual usually responsible for a given child's vaccinations
• Child/children : the individuals (infancy to adolescence) being considered for immunization
• Recipient : the individual being considered for immunization
• Parent : the individual(s) legally responsible for the child

These guidelines are recommended for use by all health professionals in the public and private sector who administer vaccines to or manage immunization services for Canadians. Although some guidelines will be more directly applicable to one or other setting, all providers and local health officials should collaborate in their efforts to ensure that there are high coverage rates throughout the community and thus achieve and maintain the highest possible degree of community protection against vaccine-preventable diseases.

Guideline 1
Immunization services should be readily available.

Immunization services should be responsive to the needs of vaccine recipients. When feasible, providers should schedule immunization appointments in conjunction with appointments for other health services. Newborn infants should have the first immunization appointment arranged as soon as possible after birth. Immunization services, whether public health clinics or physicians' offices, should be available during the week and at hours that are convenient for working parents. Public sector services should be available on working days, as well as during some other hours (e.g., weekends, evenings, early mornings or lunch hours).

Guideline 2
There should be no barriers or unnecessary prerequisites to the receipt of vaccines.

While appointment systems facilitate clinic planning and avoid unnecessarily long waits, appointment-only systems may act as barriers to the receipt of vaccines. People who appear on an unscheduled basis for vaccination, particularly those in hard-to-reach populations, should be accommodated when possible. Such recipients should be rapidly and efficiently screened without requiring other comprehensive health services.

A reliable decision to vaccinate an adult or a child can be based exclusively on the information elicited from the recipient or from the child's parent, and on the provider's observations and judgment about the health of the potential vaccine recipient at the time. At a minimum, this includes questioning the patient or the child's parent about:

• the recipient's current state of health;
• potential contraindications;
• reactions to previous vaccinations.

Policies and protocols should be developed and implemented so that the administration of vaccine does not depend on individual written orders or on a referral from a primary care provider.

Guideline 3
Providers should use all clinical opportunities to screen for needed vaccines and, when indicated, to vaccinate.

Each encounter with a health care provider, including those encounters that occur during hospitalization, is an opportunity to review the immunization status and, if indicated, administer needed vaccines. Physicians should consider the immunization status at every visit and offer immunization service as a routine part of that care or encourage attendance at the appropriate public health or physician clinic. At each hospital admission the vaccination record should be reviewed and, before discharge from the hospital, patients should receive the vaccines for which they are eligible by age or health status. The patient's current immunization provider should be informed about the vaccines administered in hospital. However, successful implementation requires significant improvements in record-keeping of immunization histories (see Guideline 8).

Home care or public health nurses should use home visits as an opportunity to immunize both adults and children who are home-bound or otherwise unable to access immunization services.

Guideline 4
Providers should educate parents and adult vaccine recipients in general terms about immunization.

Providers should educate people in a culturally sensitive way, preferably in their own language, about the importance of vaccination, the diseases that vaccines prevent, the recommended immunization schedules, the need to receive vaccines at recommended ages and the importance of them bringing their or their child's vaccination record to every health care visit.

Parents and adult recipients should be encouraged to take responsibility for ensuring that they or their child complete the full series. Providers should answer all questions recipients may have and provide appropriate educational materials at suitable reading levels, preferably in the patient's preferred language. Providers should familiarize themselves with information on immunization provided by the appropriate health departments as well as by other sources.

Guideline 5
Providers should inform patients and parents in specific terms about the risks and benefits of vaccines that they or their child are to receive.

Information pamphlets about routine vaccines are available from ministries of health in many provinces and territories, and also from the Canadian Paediatric Society. Such pamphlets are helpful in answering many questions that patients and parents may have about immunization, and they facilitate informed consent. Providers should document in the medical record that they have asked the patients and parents if they have any questions and should ensure that satisfactory answers to any questions were given.

Guideline 6
Providers should recommend deferral or withholding of vaccines for true contraindications only.

There are very few true contraindications to vaccination according to current Canadian guidelines, and providers must be aware of them. Accepting conditions that are not true contraindications often results in the needless deferral of indicated vaccines. Minimal acceptable screening procedures for precautions and contraindications include asking questions to elicit a history of possible adverse events following prior vaccinations and determining any existing precautions or contraindications.

Guideline 7
Providers should administer all vaccine doses for which a recipient is eligible at the time of each visit.

Available evidence indicates that most routine vaccines can be administered at the same visit, safely and effectively, including multiple injections. Some vaccines are provided in a combination format whereby more than one is given in a single injection, and others require separate injections. Unless the package insert specifically allows, vaccines should never be mixed in the same syringe.

Guideline 8
Providers should ensure that all vaccinations are accurately and completely recorded.

8.1	Data to be recorded in the patient's record at the time of vaccination For each vaccine administered the minimum data to be recorded in the patient's record should include the name of the vaccine, the date (day, month and year) and route of administration, the anatomical site, the name of the vaccine manufacturer, the lot number, and the name and title of the person administering the vaccine.
8.2	Updating and maintaining the personal vaccination record All providers should encourage recipients or parents to maintain a copy of their own or their child's personal vaccination record card and present it at each health care visit so that it can be updated. If a patient or parent fails to bring the card, the provider should ensure that adequate information is given so that the recipient/parent can update the card with the name(s) of the vaccine(s), the date, the provider and the facility.
8.3	Documentation for vaccines given by other providers Providers should facilitate the transfer of information in the vaccination record to other providers and to appropriate agencies in accordance with requirements. When a provider who does not routinely vaccinate or care for an individual administers a vaccine to that individual, the regular provider should be informed.
8.4	All provinces/territories should develop and maintain electronic immunization registries.

Guideline 9
Providers should maintain easily retrievable summaries of the vaccination records to facilitate age-appropriate vaccination.

Providers should maintain separate or easily retrievable summaries of vaccination records to facilitate assessment of coverage as well as the identification and recall of patients, especially children, who are delayed in the recommended immunization schedule. In addition, immunization files should be sorted periodically and inactive records placed into a separate file. Providers should indicate in their records, or in an appropriately identified place, all primary care services that each patient receives in order to facilitate scheduling with other services.

Guideline 10
Providers should report clinically significant adverse events following vaccination - promptly, accurately and completely.

All individuals who are immunized should be given instructions for post-immunization care. Prompt reporting of adverse events following vaccination is essential to guarantee vaccine safety, allowing for timely corrective action when needed, and to keep information regarding vaccine risk-benefit and contraindications up to date.

Providers should instruct parents to inform them of adverse events following vaccination. Providers should report all clinically significant events to the local public health authority, regardless of whether they believe the events are caused by the vaccine or not. Providers should fully document the adverse event in the medical record at the time of the event or as soon as possible thereafter. At each immunization visit, information should be sought regarding serious adverse events that may have occurred following previous vaccinations.

Guideline 11
Providers should report all cases of vaccine-preventable diseases as required under provincial and territorial legislation.

Providers should know the provincial/territorial requirements for communicable disease reporting. Reporting of vaccine-preventable diseases (VPD) is essential for the ongoing evaluation of the effectiveness of immunization programs, to facilitate public health investigation of vaccine failure and to facilitate appropriate medical investigation of a patient's failure to respond to a vaccine that has been appropriately administered. Provincial data systems for VPD should be linked to electronic immunization registries.

Guideline 12
Providers should adhere to appropriate procedures for vaccine management.

Vaccines must be handled and stored as recommended in manufacturers' package inserts. The temperatures at which vaccines are transported and stored should be monitored according to provincial/territorial guidelines. Vaccines must not be administered after their expiry date, and vaccines that have undergone a breach in the cold chain should not be used without appropriate consultation.

Providers should report usage, wastage, loss and inventory as required by provincial, territorial or local public health authorities.

Providers should be familiar with published national and local guidelines for vaccine storage and handling. Providers must ensure that any office staff designated to handle vaccines are also familiar with the guidelines.

Guideline 13
Providers should maintain up-to-date, easily retrievable protocols at all locations where vaccines are administered.

Providers administering vaccines should maintain a protocol that, at a minimum, discusses the appropriate vaccine dosage, vaccine contraindications, the recommended sites and techniques of vaccine administration, as well as possible adverse events and their emergency management. The Canadian Immunization Guide and updates, along with package inserts, can serve as references for the development of protocols. Such protocols should specify the necessary emergency equipment, drugs (including dosage), and personnel to manage safely and competently any medical emergency arising after administration of a vaccine. All providers should be familiar with the content of these protocols, their location, and how to follow them.

Guideline 14
Providers should be properly trained and maintain ongoing education regarding current immunization recommendations.

Vaccines must be administered only by properly trained persons who are recognized as qualified in their specific jurisdiction. Training and ongoing education should be based on current guidelines and the recommendations of NACI and provincial and territorial ministries of health, the National Guidelines for Immunization Practices, and other sources of information on immunization.

Guideline 15
Immunization errors should be reported by providers to their local jurisdiction.

Immunization errors and related incidents should be monitored as a patient safety issue. All immunization errors should be reported by the vaccine provider to the agency or local sector that assumes accountability for the quality of immunization programs. Immunization errors commonly include an error in vaccine type, dose, site, route, person, time or schedule.

Immunization-related incidents include a range of events, such as needle injury caused by failed restraint of children, immunization without consent, or fainting with a fall resulting in injury. Methods to detect immunization errors or incidents may include provider self-reporting, direct observation or record audits. Decreasing immunization errors requires an accurate system of error reporting in an open environment that focuses on positive reinforcement rather than punitive action. Activities to prevent immunization error in an agency or organization are a better barometer of quality than the error rate alone. Publishing or sharing information about immunization errors is a first step towards an immunization quality-improvement program that strives to reduce the incidence of errors. Immunization errors can be effectively reduced by systematically identifying, eliminating or minimizing both human and system related factors.

Guideline 16
Providers should operate a tracking system.

A tracking system should generate reminders of upcoming vaccinations as well as recalls for individuals who are overdue for their vaccinations. A system may be manual or automated, and may include mailed or telephone messages. All providers should identify, for additional intensive tracking efforts, patients considered at high risk of failing to complete the immunization series on schedule (e.g., children who start their series late or children who fall behind schedule).

Guideline 17
Audits should be conducted in all immunization clinics to assess the quality of immunization records and assess immunization coverage levels.

In both public and private sectors, an audit of immunization services should include assessment of all or a random sample of immunization records to assess the quality of documentation and to determine the immunization coverage level (e.g., the per centage of 2-year-old children who are up to date). The results of the audit should be discussed by providers as part of their ongoing quality assurance reviews and used to develop solutions to the problems identified.

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