Assessment of "look-alike" packaging designs related to medication errors using information technology.

This study aimed to assess the similarity among press-through pack (PTP) sheets of pharmaceutical products in Japan. The appearance of PTPs was assessed using a pharmaceutical design database (PDD) of 2,750 pharmaceutical tablets comprising approximately 40 % of the 6,840 products marketed in Japan. Package sheet color (Sc), tablet color (Tc), character color (Cc), sheet line color (SLc), and upper color (Uc) were used to evaluate the uniformity of PTP sheet design. To assess the risk of misidentification, 1,000 prescriptions for 82,273 cancer patients were retrieved from 21,026,742 records in the claims database of the Japan Medical Data Center Co. Ltd., Tokyo, Japan. The most frequent PTP sheet colors for 143 drugs were Sc (silver), Tc (white), Cc (blue), SLc (none), and Uc (silver). The prescribing pattern of 1000 randomly chosen prescriptions was analyzed. Database records of prescriptions without tablets (n = 69), including only one PTP tablet (n = 292), and those with lack of PDD prescription data (n = 388) were excluded. Eventually, 236 prescriptions were evaluated. Fourteen prescriptions (5.9%) had PTP sheets with five matching elements and 29 had with four matching elements (12.3%). This novel PDD database for information technology concept easily identified similar PTP sheets involved in prescriptions dispensed in 18 % of evaluated cancer patients. The concept seems to be applicable for preventing look-alike dispensing errors.

Comparative quality tests of two types of sustained release preparation of isosorbide dinitrate.

Two commercial sustained release preparations of isosorbide dinitrate (ISDN), capsules (preparation A) and tablets (preparation B), were tested for content uniformity and dissolution pattern. The deviations in contents of the single doses from the declared content ranged from -7.7% to +9.7% which conformed to the standard (+/- 15%) of the Japanese Pharmacopeia X (JP X). Dissolution tests were performed using the rotating basket method described in JP X. The dissolution medium were No. 1 and 2 solutions (pH 1.2 and 6.8, respectively) specified in JP X disintegration test, and 0.05 M phosphate buffer solutions (pH 3.0 and 5.0). The dissolution patterns of both preparations were independent on the pH of the medium. However, there was a marked difference between the dissolution rates of the two: after 8 hr of the test, the rates of preparation A were 85-89%, but those of preparation B were only 42-50%. From preparation A a somewhat constant release of ISDN continued until the 6 hr. ISDN was determined by the HPLC method.