Botulism – Guide for Healthcare Professionals Includes information on obtaining anti-toxin

This information requires knowledgeable interpretation and is intended primarily for use by healthcare workers and facilities/organizations providing healthcare including pharmacies, hospitals, long-term care facilities, community-based healthcare service providers and pre-hospital emergency services.

Botulism is a neuroparalytic disease caused by a nerve toxin that is produced by the bacterium Clostridium botulinum. There are three main kinds of botulism: Foodborne, Wound and Intestinal (infant and adult).

Symptoms

Foodborne

Initially, symptoms of foodborne botulism may include vomiting and/or diarrhea followed by one or more of: ptosis (drooping of eyelids), visual disturbance, dilated and fixed pupils, dysphagia (difficulty in swallowing), dry mouth and dysphonia (difficulty speaking). These symptoms may extend to a descending symmetrical flaccid paralysis in an alert afebrile person. Constipation is a common symptom later in presentation. The case-fatality rate is approximately 5-10%.

Wound

Wound botulism symptoms are similar to foodborne symptoms (except there is no vomiting and/or diarrhea). The presence of a wound is also useful to note.

Intestinal (“infant botulism” and “adult colonization”)

Intestinal botulism affects infants under one year of age almost exclusively, but can affect adults who have altered gastro-intestinal anatomy and microflora. The earliest and most frequently observed symptom of infant botulism is constipation followed by lethargy, poor feeding, ptosis, difficulty swallowing, hypotonia, and generalized weakness (floppy baby) including a weak cry. The symptoms observed in adults are similar to foodborne botulism.

Mode of Transmission

Foodborne botulism is a severe intoxication resulting from ingestion of preformed toxin present in contaminated food. Wound botulism cases may result from contamination of wounds by soil or gravel, or injection of illicit intravenous drugs. Intestinal botulism results from ingestion of C. botulinum spores that then germinate in the colon, rather than by ingestion of preformed toxin.

Botulinum toxins could be used in bioterrorism. Although the greatest threat may be via aerosol use, the more common threat may be via its use in food and drink.

Incubation Period

In foodborne botulism, symptoms generally begin 12 to 36 hours after eating a contaminated food, but can also occur as early as six hours or as late as 10 days. The incubation period of wound botulism is longer, averaging about 10 days. The incubation period of intestinal botulism is unknown.

Diagnosis

Diagnosis of foodborne botulism is made by demonstration of botulinum toxin in serum, stool  gastric aspirate or incriminated food, or isolation of C. botulinum from stool or gastric aspirate. Identification of organisms in a suspected food is helpful but not diagnostic because C. botulinum spores are ubiquitous. The diagnosis may be accepted in a person with the clinical syndrome who had consumed a food item incriminated in a laboratory confirmed case. Wound botulism is diagnosed by detection of toxin in serum or by positive wound culture. The diagnosis of intestinal botulism is established by identification of C. botulinum organisms and/or toxin in a patient's feces or autopsy specimens. Differential diagnoses of botulism include Guillain-Barré syndrome, stroke, and myasthenia gravis.

What Should I Do If I Suspect a Botulism Case?

Complete all of the following 5 steps:

Step 1 - For ADULT BOTULISM cases, obtain equine botulism antitoxin from the Ministry of Health and Long-Term Care.

For INFANT BOTULISM cases, refer to the following section in Step 1.

During Work Hours (8:30am - 4:30pm Monday to Friday):
Call the Infectious Diseases Policy and Programs Section at (416) 327-7392 and request to speak with a staff member.

After-Hours, Weekends and Holidays:
Call the Spills Action Centre at (416) 325-3000 or 1-800-268-6060 and request to speak with the Public Health Division staff on-call.

Please provide Ministry of Health and Long- Term Care staff with :

1. the name of the physician to which the antitoxin should be sent
2. the address to which the antitoxin should be sent
3. the physician's contact telephone number
4. the name of the health unit in which the hospital is located

One vial of bivalent Type A&B and one vial of monovalent Type E botulinum antitoxin should be administered as soon as possible. Ministry staff will arrange for the shipment of one vial of Type A&B and one vial of Type E. A product monograph and directions for administration will be included with the product.

Ministry staff will advise the Ontario Government Pharmaceutical and Medical Supply Services (OGPMSS) in York Region of the authorization. The physician's information (i.e., name, address, and phone number) will be provided to OGPMSS. OGPMSS will prepare for the delivery of the Type A&B and Type E botulinum antitoxin.

For INFANT BOTULISM cases, obtain infant botulism antitoxin.

BabyBIG® is a human-derived botulism antitoxin indicated in the treatment of infant botulism for babies up to one year of age. It is deemed to be safer than horse-derived antitoxin because there are lower rates of hypersensitivity reactions and serum sickness associated with its administration.

The Ministry of Health and Long-Term Care will pay the USA $45,300.00 fee for the product, as well as the transportation cost from California.

• The producers of BabyBIG® do not permit pre-orders of their product; therefore, the attending physician must place a request with Health Canada for the Special Access Programme (SAP) to gain access.
• The physician must complete the Special Access Request Form (attached) and fax it to the SAP immediately (fax: (613) 941-3194). To avoid delays, all sections of the form must be completed accurately and it is recommended to follow-up with a phone call to the SAP office at (613) 941-2108.
• If the case presents on a weeknight, weekend or holiday, the SAP on-call officer can be reached by telephone at (613) 941-2108 (press 0). The attending physician should be prepared to provide the information required on the Special Access Request Form (see attached) to the on-call officer and then follow-up on the next business day with a copy of the completed form.

The SAP will then authorize the California Department of Health Services to ship the BabyBIG® to the hospital.

For further information on the Special Access Programme, please consult their website :
Special Access Request Form A

For additional information on BabyBIG®, contact the Infant Botulism Treatment and Prevention Program at (510) 231-7600.

Additional information can be obtained at Infant Botulism Treatment and Prevention Program

Step 2 - Notify the Botulism Reference Service for Canada.

Call the Botulism Reference Service to :

• discuss the clinical presentation of the suspect case in order to support the diagnosis
• obtain advice on the appropriate submission of laboratory specimens (see step 3) prior to administering treatment.

Call the Botulism Reference Service office during working hours at (613) 957-0902 or the after-hours cell phone at (613) 296-1139.

Step 3 - Obtain the appropriate laboratory specimens and forward the specimens to the Botulism Reference Service for Canada in Ottawa.

A good case history should be obtained to support the diagnosis. Suspect food and clinical specimens should be sent to the Botulism Reference Service in Ottawa.

Prior to sending the specimens, physicians must call the Botulism Reference Service office at (613) 957-0902.

After-hours, call the Botulism Reference Service cell phone at (613) 296-1139 to make arrangements for transporting clinical specimens for laboratory analysis.

Specimens may include leftovers or unopened containers of food. When commercial foods are involved, it is important to retrieve the label, the manufacturer's lot number, and codes embossed on the can or package. Suitable clinical specimens for analyses include fecal samples (approximately 10 g) or enema fluid, gastric contents (adjusted to approximately a pH of 6.0 with 1N NaOH, if possible) and serum (from 20 ml of blood collected before administration of antitoxin). When infant botulism is suspected, the essential material for analysis is the infant's feces. If necessary, soiled parts of diapers may be submitted.

Specimens should be handled according to routine practices and additional precautions, and packaged for transport to the Botulism Reference Service. For safe shipment, the specimens must be in a watertight primary receptacle, in a watertight secondary container, with sufficient absorbent material between the two containers to absorb the entire contents of the primary receptacle. The preferred method of preserving the material during shipment is by cooling rather than freezing, i.e. by including commercial cooling packs in the parcel. In urgent cases, the parcels are picked up immediately upon arrival.

Samples should be sent by courier (not Canada Post) to :
Dr. John W. Austin or Mr. Greg Sanders
Botulism Reference Service
Health Canada
Room D457, Sir Frederick G. Banting Building
Building 22, Tunney’s Pasture, PL2204E
251 Sir Frederick Banting Driveway
Ottawa, ON
K1A 0K9
Telephone: (613) 957-0902
Fax: (613) 941-0280

Treatment

Serum should be collected to identify the specific toxin before antitoxin is administered, but antitoxin should not be withheld pending test results. One vial of bivalent Type A&B and one vial of monovalent Type E botulinum antitoxin should be administered as soon as possible.

(Note that the liquid volume per vial may vary, however, the number of units of antitoxin is constant). Attempts may be made to remove contaminated food still in the gut by inducing vomiting or by using enemas.

For all types of botulism, accessibility to respiratory support is essential. For wound botulism, in addition to antitoxin, the wound should be debrided and/or drainage established, and appropriate antibiotics (e.g. penicillin) administered.

Once flaccid paralysis occurs, it cannot be reversed by administration of antitoxin. Antitoxin neutralizes circulating toxin (i.e., neurotoxin that is not already bound to neurons). Advice on the most up-to-date treatment should be sought from a clinical expert.

Step 4 - Call your local health unit immediately.

Botulism is a Reportable Disease in Ontario under the Health Protection and Promotion Act and must be reported immediately to the local medical officer of health by telephone. The disease should be reported even if it is only suspected and has not yet been confirmed. The Health Unit should be also advised if a food item is the suspected source of the illness.

Step 5 - Provide Patient Information

After treatment with equine-origin antitoxin, please contact the Ministry of Health and Long- Term Care during work hours (call (416) 327- 7392) and request to speak with staff from the Infectious Diseases Policy and Programs Section and provide the following information: patient initials, date of birth, sex, indication for use, dosage, quantity used and date administered. This information will be provided to the Health Canada Special Access Programme for the purpose of obtaining equine botulinum antitoxin for future use.

References

Please note that this information is subject to change. The following sources contain additional information :

1. Heymann, D. "Control of Communicable Diseases Manual". 18th Edition. 2004. American Public Health Association: Washington D.C.
2. Health Canada, Canada Communicable Disease Report Volume 22-21, 1 November 1996 available at Canada's Communicable Disease Report 1996
3. Public Health Agency of Canada website: Public Health Agency of Canada Botulism Fact Sheet
4. Centers for Disease Control and Prevention website : Centers for Disease Control and Prevention website

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