【國際醫藥新聞分享】動物用人藥?


Assistant-in-Charge: Lily Yang (楊家瑜)
Member-in-Team: Candice (許育瑄), Angela Chiang (江媚如)
Article Reference: Pharm大鏡
Pubilshed Date of Article: 22nd September 2018

Original Article:

2012年12月底,新竹縣衛生局至台裕藥廠稽查,發現其違法供應人類用藥給動物醫院,引發藥廠提供人用藥物給獸醫診療機構恐違反現行藥事法之爭議,導致藥商停止供應人用藥物給動物診療機構,致使寵物恐將面臨無藥可醫治的情形,引起飼主恐慌,因此獸醫師提出開放動物使用人藥的訴求,但究竟人用藥物能否開放給動物使用呢?

近年來,人藥是否開放給動物使用這個議題討論度日益增高,獸醫不斷爭取開放人藥品項給貓狗等動物使用,中華民國獸醫師公會全國聯合會理事長陳培中表示:「即使是在動物用藥開發品項最多的美國,就有高達 7成是使用人用藥物,主因就是動物用藥數量過少,不符成本。」而動物用藥成本居高不下的原因在於動物用藥市場大幅小於人用藥物市場,藥廠研發和生產成本皆高,所以動物用藥品項不多、產量也不高,所造成的結果就是,這些小額數量的藥物並無法完全負荷動物疾病所需的治療,使得動物面臨無藥可用的狀況。因此,獸醫方認為使用人用藥物勢在必行。

然而藥師基於藥學專業知識,對獸醫的訴求提出疑慮:人用藥物是否能直接使用於動物?人用藥開發雖前期採用動物試驗,但後續的研發,包含賦形劑使用或治療指數等等,皆是基於”人”為主體做研究,經由人體臨床數據及嚴謹的科學證據為基礎才能核准上市。動物與人之生理機制、作用機轉不同,直接將人用藥物施與動物上,是否反倒會造成動物危害?

對此,獸醫方做出的回應,一為動物用藥實為不足,若碰到緊急狀況,讓獸醫師在本有人用藥物可以救治的情況下,卻因法令限縮動物醫療權利,只能眼睜睜看著動物受苦、甚至喪命;再者,國外例如美國、歐盟、日本等,均准許獸醫師使用人用藥品診治動物,行之有年,既然國外並未造成太大的問題,那台灣應可嘗試跟進國際腳步。

為此,政府召開數場公聽會,聽取獸醫與藥師雙方意見後,農委會依據動保法,擬出《人用藥品用於犬貓及非經濟動物之使用管理辦法》草案,內容包括自2015年至今獸醫界提出開放使用895項藥物,在與食藥署開會討論後,於2018年5月已審核通過597項,獸醫師可以直接使用。

從原先的200多項,到2018年的近600項藥物,獸醫持續要求開放更多品項。中華民國保護動物協會祕書長黃慶榮:「若國內改成明文規定禁用藥物的話,才能夠真正解決獸醫缺藥的問題」。因現行方法為正面表列,列出「可以」使用的藥物,永遠列不完所需的藥物。獸醫的訴求為全面開放人用藥物,希望改用反面表列,將規定改為「禁用」的品項,列出不可使用於動物,或開放會對社會造成危害性等的品項,才能避免動物的醫療權利受到限縮。

對於獸醫師增加開放品項的訴求,藥師並不十分贊同,那為什麼藥師不贊同開放更多的品項呢?原因在於藥事法目標在規範人用藥品之審核及管理,提供人類安全使用,但基於保護動物立場,係在無動物用藥可用情況下,才例外准許獸醫師於審慎評估下使用人用藥品。藥師擔心一旦開放越來越多品項,藥物例如抗生素或管制藥品容易流出、釀成氾濫。以美國為例,美國的動物用藥與人藥都是由同一個管理單位-FDA管理,不論是動物用藥還是人藥皆用同一個標準,然而國內動物用藥是由農委會管理,人藥是由衛福部管理,管理單位不同,管理標準也不一樣,因此若要開放人藥給獸醫醫療機構,應該比照國外方法,統一單位、統一標準管理,且必須要有嚴格的流向、回收的管控,否則未來這一部份將會產生極大的法律漏洞。

除了管理上的問題,調劑權也具有爭議。調劑是屬於藥師的專業與權利,但在動物用藥這項領域不一定比獸醫師更了解使用藥物上的注意事項,那藥師應該把這部分的調劑權讓給獸醫?還是要在藥學系課程中納入動物用藥的知識呢?抑或是直接創立一個新職業「獸藥師」?不論走哪一步都有後續衍生的種種狀況需要去解決。現如今獸醫持續在爭取開放更多品項,讓動物在用藥方面可以有更多的保障;藥師也必須在可能引發藥物流向問題下,為人民的用藥作更嚴格的把關。這個議題未來還有待更多的討論,以求達成雙方的共識,創造雙贏局面。

Translation of Article:

The Public Health Bureau of Hsinchu county inspected a case that Tai-Yu pharmaceutical factory has
been illegally supplying veterinary clinics with human medical products in late December 2012, which triggered the controversy of whether pharmaceutical factories can provide veterinary clinics with human medical products and whether it might violate the Pharmaceutical Affairs Law. Therefore, Tai-Yu pharmaceutical factory has stopped supplying human medicinal products to veterinary clinics, which cause panic among the owners worrying about their pets may face the situation of medicine insufficiency. As a result, veterinarians have requested for the permission to use human medical products on animals. But should human medical products be used in animals?

Recently, the issue of whether human medical products can be used in animals has been highly discussed and veterinarians have been striving for the permission. The board director of Taiwan Veterinary Medical Association indicated that even in the United States, where the animal medicine have been developed the most, human medical products still account for 70 percent in verterinary clinics. The market of animal medicinal product is considerably smaller than human. As a result, the cost of research and production are high, leading to less variety of animal medicinal products. Consequently, animals may face medicine insufficiency due to the inadequent amounts of animal medicine for all the treatments. Therefore, veterinarians consider the use of human medical products as a solution to this situation.

However, based on their professional knowledge, pharmacists doubt the veterinarians’ statement. Although in the early phase of developing drugs, the animal trials are implemented, the later processes, including the use of excipients and the experienments on therapeutic index, are still human-based. Medicine are only approved after being supported by convincing clinical data and rigorous scientific proof. Considering the difference between the mechanisms of human and animals, the possible harm of the human medicine to the animals remains unknown.

In response to this concern, veterinarians state that animal medicines are surely insufficient. Because of the restricted law, we can do nothing but watch animals suffering or dying when there is an emergency, even if some human medicinal products can be applicated to save them. Furthermore, countries such as the United States, Japan and organizations such as the European Union, have allowed veterinarians to prescribe human medicinal products on animals for many years. Since there are no huge problems occurs in these countries, Taiwan should try to follow up.

The government has held several public hearings upon this issue. After taking advices from both veterinarians and pharmacists, the Council of Agriculture drafted the Implementation of the Management of Human Medicines Use on Cats, Dogs, and Non-Economic Animals based on the Animal Protection Law. Until May 2018, 597 out of 895 kinds of medicines requested the government approval now can be prescribed to the animals by the veterinarians after discussions with the TFDA since 2015.

Veterinarians have been continuously requesting more drug approvals from the government from 200 kinds in the beginning to about 600 kinds in 2018. The secretary-general of APA, Xing-Rong Huang, mentioned: “Only if the law clearly states the banned medicines, could we solve the problem of the deficiency in animal medicines.” Since the present law is positive listings, with only the approved medicines listed, it is impossible to list all the required medicines. Veterinarians’ appeal is to access all human medicines and use negative listings in the law, which lists the medicines that cannot be applicated in animals or will cause damage to the society. In this way, the veterinans can prevent the right of medical treatment in animals from being abridged.

However, pharmacists do not fully agree on the appeal by the veterinarians. Currently, the Pharmaceutical Affairs Law aims to regulate the approval and management of human medicines, in order to hold promise for drug safety. Only when facing a shortage of animal medicines, can veterinarians applicate human medicine after giving full consideration based on animal protection. Pharmacists worried that once more drugs being approved, drugs such as antibiotics or controlled drugs may easily be released and abused. Take the United States as an example, animal medicines and human medicines are both under the management of FDA, regulated by the same standards. Whereas, in Taiwan, animal medicines are regulated by the Council of Agriculture and human medicines are regulated by the Ministry of Health and Welfare with different standards applied. Therefore, if veterinary clinics were to applicate human medicines in the future, the regulations and the executive departments should be united like other countries do. Also, a strict management on the flow and recycle of drugs should be performed, or these issues will cause a huge loophole in the laws.

Besides the concerns about management, the dispensing rights are also controversial. Dispensing rights are the power in pharmacists, but pharmacists may not understand as many precautions as veterinarians do in the application of animal medicines. In this case, rather should pharmacists turn over the right of dispensing to veterinarians, or include the application of animal medicines in pharmacy education, or establish the “veterinary pharmacist”. Whatever solutions choosed in the future, there are still derivative issues needed to be solved.

Nowadays, veterinarians are continuously requesting for more approvals from the government in order to guarantee the medication safety on animals, and pharmacists should keep close tabs on the raising problems of the drugs flow. In an attempt to reach a consensus on both sides and to create a win-win situation, the issue is remained to be discussed further in the future.

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