Development and Implementation of an Ultraviolet-Dye-Based Qualification Procedure for Hand Washing and Disinfection to Improve Quality Assurance of Pharmacy Preparations and Compounding, Especially in Cleanrooms: A Pilot Study

Author:

Knol Catharina W. J.12ORCID,Stob Paul H.2,Woerdenbag Herman J.1ORCID

Affiliation:

1. Department of Pharmaceutical Technology and Biopharmacy, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands

2. Fagron Sterile Services Nederland, Dieselstraat 3, 7903 AR Hoogeveen, The Netherlands

Abstract

Even though, nowadays, most medicines are manufactured industrially, patients may have medical needs that can only be met by a tailor-made approach. This requires the availability of pharmacy preparations made under Good Manufacturing Practice (GMP) conditions. An efficient hand hygiene practice is essential herewith, especially if sterile products that are prepared in a cleanroom are concerned. The effectiveness of hand washing and hand disinfection procedures greatly relies on adequate training. We carried out an observational cross-sectional pilot study aimed at optimizing hand hygiene training with objective and measurable quality assessments using an ultraviolet (UV) dye. Practical acceptance criteria for qualifying personnel through this method were set and evaluated. In total, 25 GMP-qualified cleanroom operators washed and disinfected their hands with UV dye hand wash lotion and UV dye hand alcohol, respectively. To obtain a proof-of-concept, the results were judged based on adherence to the WHO six-step protocol and associated acceptance criteria. Commonly missed areas were brought to light, and the influence of procedure duration was investigated. UV-dye-based assessments appeared to be more valuable in hand disinfection than in hand washing. In both procedures, the back of the hands and the thumbs were frequently missed. This underpins the need for enhanced and repeated education on hand washing and disinfection. Additionally, a dry skin gave rise to extra cleaning challenges. From this pharmacy practice pilot study with a focus on pharmaceutical product care, it may be concluded that the application of UV-dye-based assessments offers valuable insights for pharmacists to optimize hand hygiene, thereby increasing the safety of tailor-made medicines and on-site preparations.

Publisher

MDPI AG

Reference64 articles.

1. Council of Europe (2023, September 26). Resolution CM/Res(2016)1 on Quality and Safety Assurance Requirements for Medicinal Products Prepared in Pharmacies for the Special Needs of Patients. Available online: https://search.coe.int/cm/Pages/result_details.aspx?ObjectID=090000168065c132.

2. Le Brun, P., Crauste-Manciet, S., Krämer, I., Smith, J., and Woerdenbag, H. (2023). Practical Pharmaceutics. An International Guideline for the Preparation, Care and Use of Medicinal Products, Springer Nature Switzerland. [2nd ed.].

3. World Health Organization, and International Pharmaceutical Federation (2023, September 26). WHO Technical Report Series, No. 961, 2011, Annex 8 Joint FIP/WHO Guidelines on Good Pharmacy Practice: Standards for Quality of Pharmacy Services 2011. Available online: https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/distribution/trs961-annex8-fipwhoguidelinesgoodpharmacypractice.pdf.

4. Pharmaceutical compounding: A history, regulatory overview, and systematic review of compounding errors;Watson;J. Med. Toxicol.,2021

5. European Association of Hospital Pharmacists (2023, September 26). EAHP Position Paper on Pharmacy Preparations and Compounding, Making a Difference in Medication by Delivering Tailor-Made Medicines for the Benefit of Patients. Adopted October 2020. Available online: https://www.eahp.eu/sites/default/files/eahp_position_paper_on_pharmacy_preparations_and_compounding_october_2020.pdf.

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