Current Status of Depackaging and Dispensing of Proton Pump Inhibitor Injections in 288 Hospitals and the Impact on Drug Quality
Objective To investigate the depackaging status of Proton Pump Inhibitors(PPIs)for Injection in hospitals and the impact on drug quality.Methods The differences in the storage conditions of PPIs for Injection in the 2010,2015,and 2020 editions of the Chinese Pharmacopoeia,and those in the drug instructions of PPIs for Injection searched from the official websites of the National Medical Products Administration(NMPA),the Food and Drug Administration(FDA),and the European Medicines Agency(EMA)were compared.A questionnaire was designed by"Questionnaire Star"and distributed to 288 third-class,second-class,below second-class hospitals in 30 provinces(96 cities)in China to investigate the current depackaging and storage status of PPIs for Injection in hospitals.The color changes in Omeprazole Sodium for Injection after light exposed were observed,and the content of omeprazole under light exposed after depackaging was determined by the high-performance liquid chromatography-mass spectrometry(HPLC-MS)method.Results Chinese Pharmacopoeia requires that PPIs should be shielded from light or stored in a cool and dark place.Among the drug instructions of PPIs for Injection in the domestic market,90.59%of the instructions require shading storage,and 9.41%require avoiding light.The original-patented Omeprazole Sodium for Injection is required to be used within 24 h under general indoor light conditions after depackaging.In the FDA and EMA,Omeprazole Sodium for Injection and Esomeprazole Sodium for Injection are required to be used immediately after depackaging in the instructions for storage.A total of 408 survey questionnaires were collected,of which 356 were valid,with an effective rate of 87.25%.Among them,the proportion of third-class hospitals was the highest(68.54%),the surveyed personnel were mainly pharmacists(64.89%),76.69%of them have worked for more than 10 years,and only 48.03%of them have received training on the storage mangement of shading drugs.The depackaging rates of PPIs for Injections in pharmacy,during transportation,and in the ward were 43.75%,52.78%,and 79.86%,respectively;PPIs for Injections stored without shading after depackaging accounted for 35.71%,82.24%,and 77.83%,respectively;the duration from depackaging to use of PPIs for Injections was mainly 3-5 d(45.14%).The surface of Omeprazole Sodium for Injection turned yellow within 24 h under general indoor light conditions after depackaging,and gradually deepened with the extension of lighting time.The RSD of omeprazole concentration after 30 d of light exposed was 6.67%(>5%),and the content decreased by 12.30%after 16 d of light exposed compared to 1 d of light exposed.Conclusion Early depackaging of PPIs for Injections and unmasked storage after depackaging are common in all aspects of drug circulation in hospitals,which reduces the drug content.It is recommended that relevant departments should establish a management system for the depackaging of PPIs for Injections,which should be used immediately and stored in dark after depackaging.
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