의약품의 표시기재 현황과 개선방안 -주사제 및 PTP 경구제를 중심으로- (Description Status of Medical Supplies And Methods for Improving Description - Focusing On Injections and PTPs -)

서지정보

· 발행기관 : 한국병원약사회
· 수록지 정보 : 병원약사회지 / 24권 / 3호 / 226 ~ 233페이지
· 저자명 : 김정현, 홍수연, 전은용, 이후경, 인용원, 손기호

초록

Medical information descriptions for direct containers are meant to foster the safe and effective use of medicine, and the guidelines for their formulation are stipulated in the relevant pharmaceutical affairs laws. However, legally, all information except the name of the product and manufacturing company is omittable in cases in which the size of the container is not sufficient for the inclusion of information. This shortage of description results in mistakes in the preparation of medicine, and also contributes to difficulties in medicine management. These problems constitute the motivation for the writing of this paper. First, we have assessed the current status of information description for both injection and PTP products. We have also proposed a few hypothetical solutions for the problems described above.
Our investigation was conducted with 192 types of vial and ampule injection products and 195 types of PTP product, all of which were prescribed at the Samsung Medical Center. For those products, we assessed the external packaging and direct containers, to determine whether they described the following 6 items: the names of the elements of the medicine, the product name, the manufacturing company, the expiration date, and the manufacturing sequence number.
In our investigation, it was shown that in the external packaging of the injection products, the description of all items was included at a rate of 100%, but complete descriptions were observed in only 68.5% (200 types of product) of the direct containers. Among the examined direct containers, the rate at which the expiration date was included was lower than that for the others products: 96.6% (169 over 175 products) for vials and 51.3% (60 over 117 products) for ampules.
For PTP, the description rate of all items was 100% for all items in the case of external packaging, whereas it was 59.5% (116 products) in the case of direct containers, and only 6.2% (12 products) when the medicine was packaged in single tablets. The rates at which the names of elements, product name, and elemental contents were included were 71.8% (140 products), 100% (195 products), and 86.2% (168 products), respectively, for PTP. In particular, all three items were described in only 37.4% of cases in which the medicine was packaged in the form of a single tablet (73 products).
In conclusion, the description rate is currently quite good for the items, which are mandatorily specified in the pharmaceutical affairs law, but is not as good for the items that may be omitted in exceptional cases. Therefore, it is necessary to consider whether these omissions are acceptable or unacceptable on a case-by-case basis. Even though direct containers and packages are small, it is imperative that the six items specified in this research be included on those packages, so that the safety and management of the medicine can be guaranteed. In this manner, we can ensure safe and effective medicine usage. To this end, it is also necessary that the government and associated organizations be continuously reminded of these problems, and finally, that the current laws in this regard be amended.

영어초록

Medical information descriptions for direct containers are meant to foster the safe and effective use of medicine, and the guidelines for their formulation are stipulated in the relevant pharmaceutical affairs laws. However, legally, all information except the name of the product and manufacturing company is omittable in cases in which the size of the container is not sufficient for the inclusion of information. This shortage of description results in mistakes in the preparation of medicine, and also contributes to difficulties in medicine management. These problems constitute the motivation for the writing of this paper. First, we have assessed the current status of information description for both injection and PTP products. We have also proposed a few hypothetical solutions for the problems described above.
Our investigation was conducted with 192 types of vial and ampule injection products and 195 types of PTP product, all of which were prescribed at the Samsung Medical Center. For those products, we assessed the external packaging and direct containers, to determine whether they described the following 6 items: the names of the elements of the medicine, the product name, the manufacturing company, the expiration date, and the manufacturing sequence number.
In our investigation, it was shown that in the external packaging of the injection products, the description of all items was included at a rate of 100%, but complete descriptions were observed in only 68.5% (200 types of product) of the direct containers. Among the examined direct containers, the rate at which the expiration date was included was lower than that for the others products: 96.6% (169 over 175 products) for vials and 51.3% (60 over 117 products) for ampules.
For PTP, the description rate of all items was 100% for all items in the case of external packaging, whereas it was 59.5% (116 products) in the case of direct containers, and only 6.2% (12 products) when the medicine was packaged in single tablets. The rates at which the names of elements, product name, and elemental contents were included were 71.8% (140 products), 100% (195 products), and 86.2% (168 products), respectively, for PTP. In particular, all three items were described in only 37.4% of cases in which the medicine was packaged in the form of a single tablet (73 products).
In conclusion, the description rate is currently quite good for the items, which are mandatorily specified in the pharmaceutical affairs law, but is not as good for the items that may be omitted in exceptional cases. Therefore, it is necessary to consider whether these omissions are acceptable or unacceptable on a case-by-case basis. Even though direct containers and packages are small, it is imperative that the six items specified in this research be included on those packages, so that the safety and management of the medicine can be guaranteed. In this manner, we can ensure safe and effective medicine usage. To this end, it is also necessary that the government and associated organizations be continuously reminded of these problems, and finally, that the current laws in this regard be amended.

참고자료

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