involving 70-plus compounded products . One of the most serious recent events was in 2011 , when more than 200 patients contracted fungal meningitis after receiving methylPREDNISolone acetate injection prepared by a compounding pharmacy that was contaminated with Exserohilum ( a brown-black mold ) and Aspergillus species . The compounding pharmacy in this case was not registered with the FDA and was being investigated for crossing the line into full-scale manufacturing by taking bulk orders for methylPREDNISolone without proof of individual prescriptions and shipping large batches of drugs nationwide , a practice the FDA had previously warned the company about regarding other drugs .
As the ECRI report ( 2024 ) notes , “ Errors made during the compounding of injectable medications can have severe — sometimes deadly — consequences if they are not detected before the drug is administered to the patient . Unfortunately , such errors are exceedingly difficult for nurses or others who administer the preparations to detect . Consequently , errors that are not caught before the preparation leaves the pharmacy have a high likelihood of reaching the patient .”
While accurate compounding is important for all preparations , the ECRI report ( 2024 ) emphasizes that “ Injectable preparations are of particular concern because of their need to be sterile , the frequency with which compounding is required , the opportunities for error , and the potential for significant harm . Errors can include using incorrect or expired ingredients ( e . g ., medications , diluents ), using an incorrect dose or concentration , using an incorrect volume , or mislabeling the medication .”
Both ECRI and the ISMP recommend that pharmacy departments implement technological safeguards — like workflow management systems — to minimize opportunities for human error in the sterile compounding process . These systems offer a range of capabilities ( such as bar coding or gravimetric analysis ) both to help prevent errors during the manual steps in the process and to help catch errors before they reach the patient .
The ISMP ’ s Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding Technology were developed to help healthcare facilities identify best practices to support safe use of technology and automation in sterile compounding and to recommend best practices associated with sterile compounding when technology cannot be used .
Environmental harm from patient care
In 2022 , ECRI included supply chain shortfalls as posing risks to patient care as its No . 2 hazard on the list . While so many essential articles of personal protective equipment ( PPE ) as well as cleaning and disinfectant products were nearly impossible to procure during the COVID-19 pandemic , this year , a different supply chain concern – the medical waste stream — makes the 2024 list .
The healthcare sector is one of the largest contributors to the national waste stream , but this was greatly exacerbated by the COVID-19 pandemic . As Lee , et al . ( 2022 ) report , “ The increased volume of plastic waste due to COVID-19-related practices has significant ramifications that pose challenges with respect to ensuring a sustainable environment . Penga , et al . predicted that 193 countries worldwide would generate an additional 8.4 million tons of plastic waste due to COVID-19-related activities , a 10 percent increase from the baseline since the World Health Organization ( WHO ) declared the disease a global pandemic in March 2020 . Of the additional plastic waste generated during the pandemic , approximately 87.4 percent was discharged from healthcare institutions , including PPE ( such as masks , sanitary gloves , and face shields ), online packaging materials ( due to