Pharmacybrands Final Algorithm for Dukoral Supply May 2012

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Training Material, Dukoral What is Dukoral? Dukoral is an inactivated oral vaccine, consisting of killed whole-cell Vibrio cholera O1 of several strains (Inaba and Ogawa serotypes, classical and El Tor biotypes) and purified recombinant cholera B subunit (WC/rBS). What is Dukoral used for? Dukoral is indicated for active immunisation for cholera of adults and children from 2 years of age with an ongoing or anticipated epidemic or who will be spending an extended period of time in areas in which cholera infection is a risk. Dukoral is also indicated for active immunisation of adults and children from 2 years of age who will be visiting areas posing a great risk of diarrhoeal illness caused by Enterotoxigenic Escherichia coli (ETEC). The heat-labile toxin of ETEC (which causes diarrhoea) is similar to cholera toxin – that’s why Dukoral works for prevention of both cholera and ETEC. The World Health Organisation states “vaccination against cholera and ETEC should be recommended to at-risk travellers.”[1] ETEC ETEC is the most common cause of diarrhoea in visitors to developing and tropical countries. Countries with higher prevalence include Mexico, Central America, Latin America, Africa (excluding South Africa), India, Nepal and The Middle East. South East Asia has low prevalence of ETEC. There are other causes of travellers’ diarrhoea, and Dukoral is not 100% effective, so ensure consumers are aware of the need for good hygiene practices regardless of whether or not they take Dukoral (see below). Travellers’ diarrhoea affects 40-90% of travellers depending on their destination.[2-4] While generally mild and self-limiting, it is inconvenient and risk is highest in those with chronic conditions, young children, elderly and those who cannot compensate fluid loss such as travellers to high altitudes.[4] Enterotoxigenic E coli (ETEC) is the most common cause of diarrhoea in visitors to developing and tropical countries,[2, 5] responsible for nearly half of all cases of travellers’ diarrhoea.[6] There is regional variability in frequency of causes of travellers’ diarrhoea, for example ETEC is thought to be more common in Latin America than Southeast Asia, but data collection varies between studies and some information is old, from the 1970s.[7] Transmission of ETEC is usually from contaminated food and water, and infection occurs 10 hours to 3 days after exposure, typically causing profuse watery diarrhoea sometimes with low grade fever, abdominal cramping and/or vomiting.[8, 9] While ETEC diarrhoea commonly lasts 4 to 6 days, one study in Nepal found 19% of travellers and expatriates suffered for more than 14 days with ETEC diarrhoea.[4] There are variants of ETEC: the more common heat-labile toxin producing ETEC (which Dukoral protects against)[4] causes an estimated 10 million cases of travellers’ diarrhoea each year;[1] the heat-stable toxin producing ETEC is less common; and some strains produce both toxins[9]. Copyright Pharmacybrands May 2012 Community Pharmacy Dukoral training material.
Dukoral provides protection against the heat-labile toxin-producing ETEC through anti-toxin immunity rather than through antibodies against bacterial cells; this protection starts 7 days after the second dose.[4] Dukoral provides short-term protection against ETEC diarrhoea of around 50% regardless of what toxin is produced, and this efficacy rate increases if only heat-labile toxin producing strains are included.[4] The Committee to Advise on Tropical Medicine and Travel in Canada suggests the following points for appropriate usage.[10] Because 25-50% of travellers’ diarrhoea is caused by ETEC bacteria, the protection by the vaccine is approximately 50%, and using the vaccine has the potential to give a false sense of security (and possibly be less strict on food and water hygiene), using this vaccine for travellers’ diarrhoea cannot be routinely recommended for most travellers. Therefore the decision as to whether or not to use Dukoral depends on the individual circumstances. Those at higher risk are: People with increased risk of serious consequences from travellers’ diarrhoea because of their chronic illness, such as chronic renal failure, congestive heart failure, insulin-dependent diabetes mellitus, inflammatory bowel disease People with increased risk of getting travellers’ diarrhoea, such as young children (over age of 2 years), or those with low gastric acid (e.g. on proton pump inhibitors) People who are immunosuppressed People with a history of repeated severe travellers’ diarrhoea People for whom travellers’ diarrhoea will be particularly difficult to manage, e.g. business travellers, elite athletes. Although not specifically mentioned by the Canadians, trampers in remote areas of developing countries are another logical at-risk group, For these people travellers’ diarrhoea in a developing country is likely to cause considerable discomfort and difficulty in adhering to their travel plans; 30% of Western travellers with travellers’ diarrhoea are confined to their room and 40% have to change their scheduled activities.[4] Travellers’ diarrhoea is a risk factor for irritable bowel syndrome,[5, 11] and can lead to chronic reactive arthritis.[5] Treatment of travellers’ diarrhoea is usually rehydration with an antidiarrhoeal if necessary; in some cases antimicrobial treatment is recommended.[12] Antimicrobial treatment of ETEC is becoming more difficult due to resistance; resistance to tetracyclines, cotrimoxazole and ampicillin is high and resistance is occurring even with the quinolones which are currently the preferred antimicrobial treatment for travellers’ diarrhoea.[8] In diarrhoea with frequent watery stools oral antibiotics (and other medication) may be poorly absorbed due to rapid intestinal transit.[2] Important points to reiterate with the consumer: Dukoral only reduces the risk of diarrhoea from ETEC and cholera. Good hygiene (see below) remains vital. Refer to the doctor 4-6 weeks before travel to ensure routine vaccinations are up-to-date and travel vaccinations and/or malarial prophylaxis are covered. See www.who.int/ith/en/ or http://wwwnc.cdc.gov/travel/page/vaccinations.htm for latest travel vaccination requirements. Copyright Pharmacybrands May 2012 Community Pharmacy Dukoral training material.
Page 1: Algorithm for Dukoral Supply Has th
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Page 7 and 8: The UK prescribing information[17]

Pharmacybrands Final Algorithm for Dukoral Supply May 2012

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