[Clinical Preparations: Status Quo and Challenges in the Future]

Area of Science:

• Pharmacy practice and drug formulation.
• Hospital pharmacy and quality control.

Background:

• Clinical preparations are essential for drug therapy and commercialization.
• The 2012 Japanese Society of Hospital Pharmacists guidelines aimed to enhance safety and utility.
• Current practices lack standardized expiration dating and adequate informed consent for clinical preparations.

Purpose of the Study:

• To address safety and quality concerns with clinical preparations.
• To highlight deficiencies in current guidelines and practices.
• To propose the development of a new procedural manual for clinical preparations.

Main Methods:

• Review of existing guidelines and reported issues with clinical preparations.
• Analysis of challenges in determining expiration dates and obtaining informed consent.
• Discussion of safety measures and relief strategies for clinical preparations.

Main Results:

• Inadequate determination of expiration dates for most clinical preparations.
• Insufficient acquisition of informed consent for the use of clinical preparations.
• Reported incidents including underfilled prescriptions and overdoses following guideline release.

Conclusions:

• Existing guidelines require updates to ensure the safety and quality of clinical preparations.
• A new procedural manual is necessary to standardize practices and mitigate risks.
• Enhanced pharmacist expertise and procedural adherence are critical for safe clinical preparation dispensing.