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Disclaimer to the On-line Edition
This Manual has been designed for use in the NICU at London Health Sciences Centre (LHSC), London, Ontario, Canada, and represents clinical practice at this institution. The information contained within the Manual may not be applicable to other centres. If users of this Manual are not familiar with a drug, it is recommended that the official monograph be consulted before it is prescribed and administered. Any user of this information is advised that the contributors, Editor and LHSC are not responsible for any errors or omissions, and / or any consequences arising from the use of the information in this Manual.

IMMUNIZATION

The following is taken from Bill 52 "An act to amend the Health Protection and Promotion Act, 1983", which received Royal Assent on May 21, 1987.

Section 37a Subsection 2 and 3

(2)A physician or other person authorized to administer an immunizing agent shall, before administering it to a patient, inform the patient, or where the patient is not competent to consent, the person authorized to consent on the patient's behalf, of benefits or possible adverse reactions to it and of the importance of reporting to a physician forthwith any reaction that might be a reportable event.

(3)A physician or person registered under Part IV (nursing) or VI (pharmacy) of the Health Disciplines Act who, while providing professional services to a person, recognizes the presence of a reportable event and forms the opinion that it may be related to the administration of an immunizing agent shall, within seven days after recognizing the reportable event, report thereon to the medical officer of health of the health unit where the professional services are provided.

Individual monographs on Diphtheria toxoid, Haemophilus b Conjugated Vaccine, Pertussis Vaccine, Poliomyelitis Vaccine and Tetanus Toxoid can be found in this manual.

Diphtheria ToxoidTetanus Toxoid
Poliomyelitis VaccinePertussis Vaccine

DIPHTHERIA TOXOID

  1. BENEFITS

    Diphtheria most often occurs as membranous nasopharyngitis and/or laryngotracheitis which may lead to airway obstruction. Less commonly the disease manifests as cutaneous or chronic ear infections. Life threatening complications include heart failure from myocarditis and paralysis from the effects of diphtheria toxin. The case fatality rate is approximately 10%.

    Diphtheria toxoid prevents disease in most completely immunized individuals and results in milder illness in the few who get the disease. Immunization does not prevent carriage of toxigenic strains so that it is important to continue routine boosters throughout childhood and adult life in order to prevent disease.

  2. ADVERSE REACTIONS

    Slight fever, local pain, redness, and/or swelling at the injection site occasionally occur. Sterile abscesses rarely occur after use of absorbed vaccines containing diphtheria toxoid, most often because of inadvertent subcutaneous rather than intramuscular injection. In children over 7 years of age and in adults, a reduced dose of diphtheria toxoid must be used in order to minimize adverse reactions.

  3. MATERIAL RISKS

    Convulsions compatible with simple febrile seizures may rarely occur after diphtheria toxoid in association with high fever. Such convulsions are not associated with brain damage or an increased risk of subsequent epilepsy.

    Systemic allergic reactions (anaphylaxis, urticaria, bronchospasm, laryngospasm, angioneurotic edema) are rare. In children over 7 years of age, a reduced dose of diphtheria toxoid must be used in order to minimize adverse reactions.

  4. REPORTABLE EVENTS

    Fever greater than 40.5oC; convulsions; or systemic allergic reactions occurring within 72 hours of vaccination. Other neurologic events occurring within 15 days of vaccination.

TETANUS TOXOID

  1. BENEFITS

    Tetanus (lockjaw) is a neurological disease with severe muscular spasms caused by the neurotoxin produced by Clostridium tetani in a contaminated wound. The case fatality rate is approximately 60%. The majority of cases in Canada occur after wounds so trivial that medical attention was not sought.

    Tetanus toxoid is virtually 100% effective in preventing tetanus in fully immunized individuals. However, because tetanus spores are widely distributed throughout the environment and the bacteria are commonly found in the intestinal tracts of humans and animals, routine boosters every 10 years for life are necessary to maintain protective immunity.

  2. ADVERSE REACTIONS

    Slight fever, local pain, redness, and/or swelling at the injection sight occasionally occur. Sterile abscesses rarely occur after use of adsorbed vaccines containing tetanus toxoid, most often because of inadvertent subcutaneous rather than intramuscular injection.

    Severe local reactions, with marked swelling, redness, pain and tenderness, usually accompanied by fever, malaise, and myalgia may occur in persons who have received an excessive number of boosters of tetanus toxoid.

  3. MATERIAL RISKS

    Convulsions compatible with simple febrile seizures may rarely occur after tetanus toxoid in association with high fever. Such convulsions are not associated with brain damage or an increased risk of subsequent epilepsy.

    Systemic allergic reactions (anaphylaxis, urticaria, bronchospasm, laryngospasm, angioneurotic edema) are rare.

  4. REPORTABLE EVENTS

    Fever greater than 40.5oC; convulsions; or system allergic reactions occurring within 72 hours of vaccination. Other neurologic events occurring within 15 days of vaccination.

POLIOMYELITIS VACCINE

  1. BENEFITS

    Although most infections with poliovirus manifest as asymptomatic or non-specific febrile illnesses, the infection may lead to paralytic disease or death as a result of damage to lower motor neurons.

    Two types of vaccine are available, both of which are trivalent formulations containing types 1, 2 and 3 poliovirus: the inactivated poliovirus vaccine (IPV) which is administered by injection and the live, attenuated oral poliovirus vaccine (OPV). Both vaccines prevent paralytic disease in over 95% of recipients.

  2. ADVERSE REACTIONS

    No serious side effects of currently available IPV have been documented.

  3. MATERIAL RISKS

    Because IPV contains trace amounts of streptomycin and neomycin, systemic allergic reactions in individuals sensitive to these antibiotics are possible, but are extremely rare.

    The use of OPV has been associated with paralytic disease in both recipients of the vaccine and in their contacts. The risk of such disease is significantly increased in infants with severe immunodeficiency disorders. However, in none of the 14 such cases reported in the USA between 1973 and 1984 was the diagnosis of immune deficiency known prior to administration of OPV.

    The risk of paralytic disease after receipt of the first dose of OPV is estimated to be one in 1.2 million doses distributed. The risk after subsequent doses is 1 % of this rate. The risk of vaccine-associated paralytic disease in contacts is l per l.0 million doses distributed. An alternative method of calculating risk, based on the number of children born per year, i.e. the population likely to be both susceptible and exposed to OPV, results in an estimated rate of one vaccine-associated case per 391,000 children born in the USA between 1973 through 1984.

  4. REPORTABLE EVENTS

    Systemic allergic reactions. Paralytic disease occurring within 4 weeks of administration of OPV.

PERTUSSIS VACCINE

  1. BENEFITS

    Pertussis (whooping cough) is a bacterial infection of the respiratory tract resulting in severe coughing spells (paroxysms), often followed by an inspiratory whoop and vomiting. The paroxysmal stage lasts 2-4 weeks. The total duration of illness in uncomplicated cases is 6-10 weeks. Complications include apneic spells, seizures, pneumonia, encephalopathy, and death. Complications are much more common in the first year of life; the frequencies of pneumonia, seizures, and encephalopathy in young infants hospitalized with pertussis are 20%, 2.5%, and 0.5% respectively. At least half of those who develop pertussis encephalopathy sustain permanent brain damage.

    Pertussis is prevented in over 80% of children who have received at least 3 doses of vaccine and is milder in vaccinated children who do become ill.

  2. ADVERSE REACTIONS

    Common minor reactions to pertussis vaccine include:

    fever 38oC47%
    local redness 2.4 cm7%
    swelling 2.4 cm9%
    pain at injection site51%
    drowsiness32%
    fretfulness53%
    anorexia21%
    vomiting6%

    The incidence and height of fever can be significantly reduced by administration of acetaminophen (15 mg/kg/dose) at the time of vaccination and every 4 hours thereafter as necessary. Fussiness is also significantly reduced. Such treatment has less effect on local reactions.

    Sterile abscesses may occur at a rate of 1 per 100,000 doses, most often as the result of inadvertent subcutaneous injection of adsorbed vaccine.

  3. MATERIAL RISKS

    Uncommon, but severe reactions occurring within 48 - 72 hours of vaccination include:

    persistent, inconsolable crying 3 hr.1%
    convulsions1 in 1750 doses
    hypotonic-hyporesponsive state1 in 1750 cases
    encephalopathy1 in 140,000 doses
    permanent brain damage1 in 310,000 doses

    The risk of encephalopathy and brain damage temporally associated with pertussis vaccine is under on-going study and is probably significantly less than the above figures, which are based on the U.K. Childhood Encephalopathy Study. On-going surveillance of adverse reactions to DPT in Alberta has resulted in an estimate of the same order of magnitude as the British study.

    Administration of pertussis vaccine has not been shown to result in an increased risk of sudden infant death syndrome, infantile spasms, or Reye's syndrome.

    There may be an increased risk of convulsions in a child with a history of previous seizure or with a history of seizures in parents or siblings. Such convulsions almost always occur in association with high fever and do not increase the risk of brain damage or subsequent epilepsy. The incidence of such seizures associated with fever can probably be reduced by the use of prophylactic acetaminophen as discussed above.

  4. REPORTABLE EVENTS

    Major reactions occurring within 72 hours of vaccination, including: convulsion, hypotonic-hyporesponsive state, fever greater than 40.5oC, persistent crying over 3 hours, encephalopathy, and/or systemic allergic reaction.

    THE NATIONAL ADVISORY COMMITTEE ON IMMUNIZATION (NACI) HAS MADE NEW RECOMMENDATIONS REGARDING PERTUSSIS IMMUNIZATION. "CONTRAINDICATIONS AND INDICATIONS" HAVE BEEN DIVIDED INTO "ABSOLUTE", "RELATIVE" AND "DEFERRED". PLEASE SEE CANADA COMMUNICABLE DISEASE REPORT 1993 (30 MARCH); 19-6: 41-44.

RECOMMENDED ROUTINE IMMUNIZATION SCHEDULE*-July 1997

INFANTS BEGINNING SERIES IN EARLY INFANCY

AGE
VACCINE
2 monthscDPT Polio* + Act-HIB
4 monthscDPT Polio* + Act-HIB
6 monthscDPT Polio* + Act-HIB
after 1st birthdayMMR
18 monthscDPT Polio* + Act-HIB
4-6 yearscDPT Polio*
MMR
12 yearsHepatitis B (3 doses)
12-14 yearsTD Polio

SOURCE: Ontario Ministry of Health, Public Health Branch, July 1997

*cDPT refers to 'component' pertussis, an acellular pertussis vaccine composed of 5 purified pertussis antigens. This is present in DPT Polio Adsorbed vaccine - QUADRACEL(R)

** CONSULT ONTARIO MINISTRY OF HEALTH GUIDELINES FOR IMMUNIZATION SCHEDULES FOR CHILDREN WHO WERE NOT IMMUNIZED IN EARLY INFANCY.

TO AVOID CONFUSION PLEASE ENSURE THAT THE FULL NAME OF THE VACCINE IS INDICATED WHEN ORDERS ARE WRITTEN

Dose

  1. cDPT Polio* +Act-Hib
    • 0.5 mL IM, after reconstitution with Connaught's DPT Polio adsorbed vaccine

    • Act-HIB(R) is supplied as a lyophilized powder. It may be reconstitued with Connaught's DPT Polio Adsorbed vaccine (which is sold under the trade name QUADRACEL(R) as follows:

      1. Shake the ampoule (DPT Polio Adsorbed vaccine - QUADRACEL(R)) well uniformly distribute the suspension before withdrawing the contents.
      2. Inject all of the DPT Polio Adsorbed vaccine - QUADRACEL(R)into the vial of Act-Hib(R) (ie. the lyophilized powder)
      3. Swirl the vial until a cloudy, uniform suspension results. Avoid foaming.
  2. Where there is a contraindication to the Pertussis Vaccine, or if dosage is deferred, then give:
    1. Diphtheria Tetanus (DT) 0.5 mL IM
    2. Poliomyelitis Vaccine

      Inactivated Polio Vaccine 0.5 mL SC

    3. Haemophilus b Conjugated Vaccine (Act-HIB(R))

      0.5 mL IM*

      * Reconstitute with diluent that is provided.

FOR PHARMACY USE

  1. Polio - Code: OCEAN
  2. DPTP - Code: DALE
  3. DT - Code: PEAT
  4. Act-HIB(R) - Code: TALL

References

  1. Information for parents on adsorbed vaccines and infectious diseases (based on recommendations by the National Advisory Committee on Immunization) Connaught Laboratories, Willowdale, Ontario.
  2. Pasut G: Revised Polio Immunization Schedule, Ontario Ministry of Health Memorandum, Jan 9, 1990.
  3. Schabas R: Introduction of Enhanced Inactivated Polio Vaccine in Ontario, Memorandum, Ontario Ministry of Health, 5 April, 1993.
  4. Hanson R, Browne G, Fasher B et al : Cisapride-induced prolonged QT interval:too much of a good thing (Letter). The Journal of Pediatrics 1997; 130 : 164-166.
  5. Haemophilus b Conjugate Vaccine, Product Monograph, Pasteur Merieux Connaught, Rhone-Poulenc Group, May 1997.

Updated: February 2000




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