Fact-finding Survey of GS1 Data Bar Labeling of Ethical Drugs in Hospital Pharmacy Departments

Securing the safety of medical services by preventing health damage and serious accidents due to mix-ups of ethical drugs is one of the important health care policies of our country. Causes of mixups of ethical drugs include similarities of the names, appearances of drugs and shapes, and printing colors of their packages. Notifications calling for attention to these causes have been issued by the MHLW, and measures to prevent medical accidents related to similarities of names and appearances have been taken [1-4].


Introduction
Securing the safety of medical services by preventing health damage and serious accidents due to mix-ups of ethical drugs is one of the important health care policies of our country. Causes of mixups of ethical drugs include similarities of the names, appearances of drugs and shapes, and printing colors of their packages.
Notifications calling for attention to these causes have been issued by the MHLW, and measures to prevent medical accidents related to similarities of names and appearances have been taken [1][2][3][4].
In addition, to prevent medical accidents due to mix-ups of ethical drugs, a new measure to identify ethical drugs mechanically and automatically without dependence on human judgment was suggested to be necessary, and thorough implementation of safety management in handling drugs through drug management using 2-dimensional codes and IC tags, establishment of databases for the evaluation of similarities of drug names and appearances, and clarification of conditions of prescription of drugs that need particular caution in handling, such as anticancer drugs, was demanded [5]. Numerous measures and education of medical workers for the prevention of mix-ups of ethical drugs have also been attempted overseas, but the patients' safety has not been fully protected [6][7][8][9], and the use of a medication management system using bar codes is recommended in countries such as the United States [6,[9][10][11].

Abstract
In Japan, JAN codes were used for the packaging of ethical drugs, but in September 2006, the MHLW issued "Guidelines for implementation of bar-code labeling of ethical drugs" for mechanical checking of drugs using GS1 Data Bar to prevent mix-ups and to ensure the traceability of ethical drugs.
In Japan, tablets and capsules of ethical drugs are mostly delivered to patients, particularly outpatients, in PTP or SP. In the present survey, the printing conditions of GS1 DataBar on PTP or SP of oral tablets and capsules, and on the containers and labels of external preparations were investigated.
The height and width of GS1 DataBars were most frequently 3 mm and 19 mm, respectively, regardless of the size of the PTP sheet itself. The color of GS1 DataBars was most frequently black, and the background was most frequently white.
For drugs for internal use, improvements in printing technology have led to the increased diversity of the design of labeling with GS1 DataBars and preservation of the original design image. For drugs for external use, however, how to overcome the "smallness of the printing area" and "unique shape of the dosage form" is an important challenge for the future.
In Japan, JAN codes were used for the packaging of ethical drugs, but in September 2006, the MHLW issued "Guidelines for implementation of bar-code labeling of ethical drugs" for mechanical checking of drugs using GS1 DataBar to prevent mix-ups and to

Materials and Methods
The study protocol was reviewed and approved by the institutional review boards of the participating institutions.

Surveyed Drugs
The state of GS1 DataBar labeling of drugs for internal and external use dispensed at Saiseikai Yokohamashi Tobu Hospital was surveyed during the period of June 26-August 6, 2017. Saiseikai Yokohamashi Tobu Hospital is a core hospital providing emergency medical service in the northern area of Yokohama City (population in the area: 1,570,303 persons [14]). The items to be surveyed were determined using the report by Sato et al. [15] as a reference. printed perpendicularly to the drug name and those expressed as "multiple" on counting, details were described in the space for the printing pattern. The substrate of printing of GS1 DataBars was classified as "aluminum", "plastic", or "paper", and it was classified as "paper" when a paper sticker on which a GS1 DataBar was printed was attached to an ointment tube, etc.
Concerning drugs for external use, the position of printing of GS1 DataBars was classified as follows by the dosage form: In tubed ointments, the position was classified into front, back, and side by defining the surface on which the drug name was indicated as front.

Holder of marketing authorization
Printing method: The printing method on the PTP sheet was classified as "endless" or "pitch".

Results and Discussion
The height and width of GS1 DataBars were most frequently 3 mm and 19 mm, respectively, regardless of the size of the PTP sheet itself (Tables 1-3), (Figure 1).     (Table 5).       Concerning repeated printing, boxing, and whitening of the background of GS1 DataBars, the pitch method was used for all drugs for external use, and repeated printing was not observed (0/144). GS1 DataBars were boxed in 6.9% (10/144) and were highlighted with a white background in 16.7% (24/144). The color of GS1 DataBars was most often black and the background was most often white (Table 10, 11). The position of GS1 DataBars on drugs for external use is shown in Figure 3.   In the report by Sato et al. [15], the "height of GS1 DataBars" was most frequently 2 mm, but it was most frequently 3 mm in our present survey. Other differences from their report [15] were that the background color of GS1 DataBars was most frequently white, and that there were wider variations in the printing color of GS1 DataBars and background color. For ophthalmic/nasal/ear solutions and bottled ointments, the position of GS1 DataBar was classified as "left of the drug name", "right of the drug name", or "back of the drug name". It was most often "back of the drug name" for ophthalmic/nasal/ear solutions but "right of the drug name" for bottled ointments. These two dosage forms differed markedly in "size of printing area".
For aerosol preparations, the position of GS1 DataBars was most frequently "on the inhalation device alone" and "on both the inhalation device and can" but was "on the can alone" in none of the preparations examined. For suppositories, GS1 DataBars were mostly prepared separately as a sticker inside or outside the individual package to be attached at the time of dispensation. These two dosage forms had a "unique shape specific to the dosage form" as a common characteristic. In particular, for suppositories, if the GS1 DataBar is printed on each preparation, it is curved along its shape. As a curved GS1 DataBar leads to reading errors, they are considered to be attached according to the amount used. However, this labeling method is not considered optimal because it increases the complexity of the dispensing procedure.
For drugs for internal use, improvements in printing technology have led to the increased diversity of the design of labeling with GS1 DataBars and preservation of the original design image. For drugs for external use, however, how to overcome the "smallness of the printing area" and "unique shape of the dosage form" is an important challenge for the future. Under the present circumstances of labeling with GS1 DataBars, we will evaluate the viewpoint from which pharmacists, who are using GS1 DataBars in actual practice, rate the designs of drugs and how they perceive the present designs to make package designs including GS1 DataBars more convenient for use in medical practice.

Conclusion
The current state of labeling of PTP sheets with GS1 DataBars used in medical practice was surveyed. The use of GS1 DataBars in the field of traceability and medical safety is also expected to progress further in Japan. The end users of drugs are patients who consume drugs by an analogue action of "taking drugs". It is important to evaluate the state of use of GS1 DataBars and package designs of drugs by reflecting on the viewpoints of both pharmacists and patients.