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
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.