Bibliographic record
Abstract
Several months have passed since news broke of a horrific compounding tragedy at the New England Compounding Center (NECC) in Framingham, Massachusetts. An outbreak of fungal meningitis in fall 2012 was traced to contaminated methylprednisolone acetate prepared by the NECC. According to the US Centers for Disease Control and Prevention (CDC), as of May 11, 2013, 55 deaths and a total case count of 741 had been attributed to the contamination, and the numbers continue to rise. Patients who received medications from this pharmacy have also experienced paraspinal, spinal, and peripheral joint infections. The Institute for Safe Medication Practices (ISMP) has compiled a list of selected compounding misadventures since the 1990s. For legal reasons, many compounding misadventures never become public, but the US Food and Drug Administration (FDA) has been actively inspecting compounding pharmacies with a history or suspicion of large-scale compounding or quality concerns. Compounding problems are not isolated to the United States. Recently, more than 1200 cancer patients in Ontario and New Brunswick received chemotherapy solutions with concentrations below labelled specifications. It appears that jurisdictional issues regarding proper oversight of this operation and others were similar to the problems identified in relation to the NECC event. It is time to face our naivete and our occasional arrogance about safe compounding practices. We must learn from these events and take measures to ensure that we are doing everything possible to protect patients and reduce the risk of improperly compounded sterile preparations. On a personal level, I have been profoundly affected by the NECC event, and I continue to be perplexed by the actions of some of my colleagues who somehow still believe that the principles of contamination control and robust quality systems don’t apply to them. As a pharmacist and a potential future patient, I ask, “What are you doing for your present-day and future patients in light of these recent issues?” Whether you agree or disagree with United States Pharmacopeia (USP) Chapter and other USP chapters critical to compounding or the Pharmaceutical Inspection Cooperation Scheme’s compounding guide, the message couldn’t be clearer. Business as usual is no longer acceptable. We must embrace standards and guidelines that incorporate evidencebased science and best practices that have been vetted through public comment and review cycles. More specifically, it is time to perform risk assessments of the compounding methods used in our own pharmacies, so that inherent risks can be identified and mitigated through detailed policies and procedures, robust training programs and quality systems. Pharmacy staff members must know not only what is expected of them as they prepare sterile dosage forms, but also why they are expected to do these things. We must move away from the pure apprenticeship model of training and instead deploy methods and procedures that establish a solid foundation for quality work practices that will prevent compounding errors. Pharmacy practitioners are increasingly challenged to prepare compounded sterile dosage forms that are not commercially available, at times using nonsterile active pharmaceutical ingredients. Handling and transforming these components into appropriate sterile dosage forms may require greater experience and expertise than a particular pharmacy possesses. In such cases, we must take these limitations into account and recognize the risks they pose to our patients. In particular, only robust and validated procedures should be used. We have the responsibility to ensure that any compounded preparation is what it is expected to be and, to the degree possible, to ensure and measure its sterility. Conversely, if we don’t have the requisite expertise, we should not undertake these activities. Historically, pharmacists compounded medications in a “just in time” manner. However, current distribution models require that more compounded sterile preparations be stored at room temperature, prompting the desire for longer beyond-use dating. The sterility tests described in USP Chapter
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; both teacher heads agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".