Medicines/pharmaceuticalsof animal originV3.0 November 2020Medicines/pharmaceuticals of animal origin - This guideline providesinformation for all clinical staff within Hospital and Health Services (HHS) onbest practice for avoidance of issues related to animal products.

Medicines/pharmaceuticals of animal origin - V3.0 November 2020Published by the State of Queensland (Queensland Health), November 2020This document is licensed under a Creative Commons Attribution 3.0 Australia licence.To view a copy of this licence, visit State of Queensland (Queensland Health) 2020You are free to copy, communicate and adapt the work, as long as you attribute the State of Queensland(Queensland Health).For more information contact:Medication Services Queensland, Queensland Health, GPO Box 48, Brisbane QLD 4001,email [email protected] electronic version of this document is available at data/assets/pdf file/0024/147507/qh-gdl-954.pdfDisclaimer:The content presented in this publication is distributed by the Queensland Government asan information source only. The State of Queensland makes no statements, representationsor warranties about the accuracy, completeness or reliability of any information containedin this publication. The State of Queensland disclaims all responsibility and all liability(including without limitation for liability in negligence) for all expenses, losses, damagesand costs you might incur as a result of the information being inaccurate or incomplete inany way, and for any reason reliance was placed on such information.Medicines/pharmaceuticals of animal origin - V3.0 November 2020Page 2

Table of Contents1 Purpose42 Scope43 Background44 Religious restrictions54.1 Organisations consulted:75 Resources76 Appendices9Appendix A - Porcine (Pig) productsAppendix B - Bovine (Cow) products911Bovine – Manufacture includes exposure to bovine materials “Bovine-Indirect14Appendix C Chinese Hamster Ovary (CHO) cellsAppendix D - Murine (mouse)Appendix E - Equine (Horse)Appendix F - Egg/ChickenAppendix G – Other AnimalsAppendix H - Excipients that may be of animal origin1721252629317 References328 Approval339 Version Control33Medicines/pharmaceuticals of animal origin - V3.0 November 2020Page 3

1 PurposeThis guideline provides information for clinicians to assist patients wishing to avoid animalproduct, to make informed decisions about their treatment/care.2 ScopePeople with food allergies or intolerances, or who want to avoid animal products forreligious, cultural or secular reasons may want to know about the origin/source of drugs andexcipients contained within their medicines, to enable them to make a fully informeddecision about their treatment. This wish is supported by the Australian Charter ofHealthcare Rights which states that ‘patients have a right to have their culture, identity,beliefs and choices recognised and respected’. This document provides information forclinicians to assist patients in making this choice.This guideline provides information for all clinicians involved in the medicines managementcycle within Hospital and Health Services (HHS). While the information contained in thetables of products in the appendices is compiled from the best information available, itshould not be regarded as fully comprehensive. Information on enteral and infant feeds (andmany herbal and complimentary medicines) is not included in this document. Please refer toa dietitian for advice on enteral/infant feed composition.3 BackgroundPerson-centred care is the gold standard approach to healthcare delivery and has beenshown to improve the safety and quality of health care, improve patient outcomes andexperience, and improve the performance of health service organisations1. For this reason,healthcare professionals must take into consideration patients’ patients’ religious beliefsand lifestyles when prescribing and administering medicines.2Many different medicines and vaccines, or specific formulations of a medicine such astablets, capsules, creams or mixtures contain animal products or are animal derived. Forexample, gelatin is a partially hydrolysed collagen which is usually bovine (beef) or porcine(pig) in origin. Gelatin is used in making capsule shells and is one of many types ofstabilisers added to pharmaceutical products such as vaccines.3 Heparin, an injectableanticoagulant, is prepared from a porcine source. Further examples of pharmaceuticalproducts known to be of animal origin are listed in the appendicesSeveral of the world’s most prominent religions have objected to the use of certain animalderived products, including Muslim, Hindu, Christian, Jewish and Buddhist faiths (see table1). A growing number of individuals are also increasingly restricting their consumption anduse of animal-derived products for ethical reasons such as animal welfare and objections tothe intentional killing of animals, environmental concerns and perceived health benefits,However, neither religious nor secular groups are homogeneous in their views on the use ofMedicines/pharmaceuticals of animal origin - V3.0 November 2020Page 4

animal-derived products used in their care. Consequently, there is considerable diversity ofopinion, and membership of a particular group does not necessarily dictate an individual’sconvictions4. However, informing patients about the origins of their proposed medication (ifanimal derived and no suitable synthetic alterative exists) will assist them in makinginformed decisions regarding their treatment.2 There may be provisions within variousreligious groups to provide some form of dispensation, depending on the nature of the needfor treatment.NB All medicines must undergo testing in non-human animals before they can proceed to testing inhumans in order to gain a product license13.4 Religious restrictionsTable 1 Religious restrictionsReligionCountries where widelypracticed (relevant toQueensland)RestrictionsBuddhismTibet, Bhutan, India, Nepal, SriLanka, Burma, Thailand, Laos,Cambodia, Malaysia, Vietnam, China,Bangladesh, Korea, Japan,Singapore, parts of Russia.For some vegetarian Buddhists - allanimal products prohibitedhowever, no fixed rules.HinduismIndia, Nepal, Bangladesh, Indonesia,Pakistan, Sri Lanka, Philippines, Fiji,UK, Mauritius, Bhutan, South Africa,Burma, SingaporeFor majority who are vegetarian –all animal products including eggprohibitedFor those who are not vegetarian,restrictions still include bovine*and porcine productsIslamIndonesia, India, Pakistan,Bangladesh, Egypt, Turkey, Iran,Nigeria, Ethiopia, Afghanistan,Sudan, Iraq, Malaysia, Tanzania,Somalia, Cote d’Ivoire, Congo,Philippines, Sierra Leone, Thailand,Eritrea, LebanonPorcine products prohibitedAll animal products not killed inthe prescribed ritualistic way(halal) prohibitedProducts containing alcoholprohibitedPlease note gelatin iscontentious**Medicines/pharmaceuticals of animal origin - V3.0 November 2020Page 5

ReligionCountries where widelypracticed (relevant toQueensland)Abstain from blood products e.g.blood transfusions.Jehovah’switnessesA 24 hours a dayservice forclinicians treatingJehovah’sWitnesses isavailable. Thenumber can befound via the‘Contacts’ Buttonon their siteJudaismRestrictions[The use of fractions derived from theAustralia, USA, Mexico, Brazil andmany other countries (240 in total)primary components of blood is notabsolutely prohibited see – religious andethical position medical therapy]Queensland Blood Managementprovide information on consentand refusal see: consent-refusalMany HHSs have procedures forrefusal of blood products.USA, Israel, France, Canada, UK,Russia, Argentina, Ukraine, Braziland South AfricaAll porcine and shellfish productsprohibitedOther rules about animal productsthat can be ingested: land animals must bemammals which chew their cudand have cloven hooves birds of prey are prohibited fish must have fins and scales non-fish seafood is prohibitede.g. shellfish meat and milk (any dairy)cannot be mixedObservers only consume kosherproducts – complex set of rulesSeventh DayAdventistSikhAustralia, USA, South America, someAfrican countriesSome abstain from meat, but eggsare permissible.India, Pakistan, Malaysia, Singapore,Fiji, New Zealand, USA and UKFor some who are vegetarian – allanimal products including eggprohibitedFor those who are not vegetarian,restrictions still include bovine andporcine productsAll animal products from halalsources prohibitedProducts containing alcoholprohibited.Adapted from Multicultural Clinical Support Resource Folder- Health and Religion available at data/assets/pdf file/0025/158740/8mcrs hlth relgn.pdf accessed 03/08/2020Medicines/pharmaceuticals of animal origin - V3.0 November 2020Page 6

4.1 Organisations consulted: Buddhist Council of Queensland (President) Hindu Society of Queensland (President) Brisbane Sikh Temple (President) Seventh-day Adventist Church South Queensland (President) Jehovah’s witnesses Hospital Information Services International Office The Islamic Council of Queensland (Secretary) Vegan Australia Queensland Jewish Board of Deputies Incorporated5 ResourcesA United Kingdom publication titled “Drugs of porcine origin and their clinical alternatives An introductory guide” 2 (written in 2004, accessed 26/08/2020) gives further information ondrugs of porcine origin and is available at: atives Booklet.pdfA Canadian question and answer document produced by the Alberta Health Services –Calgary provides healthcare professionals with an introduction to the religious and culturalissues associated with drugs of animal origin and the need for informed choice in amulticultural society.5 This document, titled “Medications derived from animals andculturally diverse patients” is available he Vegan society (England and Wales) has two blogs about medication:Is my medication vegan? available at: cation-vegan and What vegans should know pre-operatively available t-vegans-should-know-pre-operativelyThe manufacturer’s Product Information (PI) gives details on the composition of themedicine (i.e. listing the active and inactive constituents/ingredients) and provides someform of description on how the medicine is produced (e.g. whether manufacture of theproduct included exposure to animal derived materials). Also, Consumer MedicineInformation (CMI) leaflets are available for most prescription medicines which enablepatients to check the medicine’s ingredients. However, these leaflets are produced in Englishonly, so further assistance may be needed.There appears to be no consistently practical way of identifying whether the gelatin inproducts has come from beef or pork. This information is not always stated inmanufacturers’ PI or CMI leaflets but may be important for Jewish, Muslim and Hindu peoplewho may want to avoid even traces of these particular animal products. If patients areconcerned about whether the drug or excipients within their medicine are of animal origin,Medicines/pharmaceuticals of animal origin - V3.0 November 2020Page 7

they could seek the information from their pharmacist or doctor who can check themedicine's PI or CMI. Alternatively, patients can call the National Prescribing Services (NPS)Medicines Line (1300 888 763)6 or contact the Medical Information Department of thepharmaceutical company that makes the medicine7.For further clarification, the patient could seek guidance from their religious organisation.Medicines/pharmaceuticals of animal origin - V3.0 November 2020Page 8

6 AppendicesAppendix A - Porcine (Pig) productsProduct nameGeneric nameTherapeutic omboticsderived from porcineintestinal mucosaCreonPancrelipaseDigestivesupplements andcholelitholyticsPancreatic extract(porcine)Creon Micro Entericcoated granulesPancrelipaseDigestivesupplements andcholelitholyticsPancreatic extract(porcine)CurosurfPoractant alfaRespiratory agentnatural porcine psin (porcine)Anticoagulantpig mucosaEthical NutrientsDigestion uman)Immunoglobulinporcine parvovirus(PPV) as a model forhuman parvovirusB19Heparin sodiuminjectionHeparin sodiumAnticoagulantPorcine mucousHeparinised salineHeparin sodiumAnticoagulantPorcine mucousHeparinised salineinjectionHeparin sodiumAnticoagulantPorcine mucousImogam RabiesPasteurizedRabies immuneglobulin (human)Rabies immuneglobulin (human)Porcinepseudorabies viruswas selected tomodel hepatitis Bvirus and herpesvirusM-M-R II Powder forinjectionMeasles, mumps andrubella virus vaccineliveVaccinePorcine gelatinObizurSusoctocog alfaHaemostatic agentPorcine sequenceMedicines/pharmaceuticals of animal origin - V3.0 November 2020Page 9

Product nameGeneric nameTherapeutic classCommentOrgaranDanaparoidHaemostatic agentFrom animal mucosa(Porcine)Panzytrat 25000Amylase, creatic extract(porcine)Prothrombinex-VFHuman prothrombincomplexHaemostatic agentHeparin, porcineProQuadMeasles, Mumps,Rubella and VaricellaVirus Vaccine LiveVaccinehydrolysed porcinegelatinRotarixHuman rotavirus liveattenuated vaccineVaccineContains porcinecircovirus type 1(PCV-1)RotaTeqRotavirus vaccinelive oral pentavalentVaccineporcine circoviruses(PCV) 1 and 2Varivax RefrigeratedPowder for injectionLive varicella vaccine.Vaccinehydrolysed porcinegelatinZostavaxZoster virus vaccineliveVaccinehydrolysed porcinegelatinAppendices A to G compiled from reference 9Medicines/pharmaceuticals of animal origin - V3.0 November 2020Page 10

Appendix B - Bovine (Cow) productsProd

best practice for avoidance of issues related to animal products. Medicines/pharmaceuticals of animal origin V3.0 November 2020 . Medicines/pharmaceuticals of animal origin - V3.0 November 2020 Page 2. Medicines/pharmaceuticals of animal origin - V3.0 November 2020. Published by the State of Queensland (Queensland Health), November 2020 This document is licensed under a Creative