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KRS Global Biotechnology Outside the Hood
The deadly, multistate meningitis outbreak our country is currently dealing with brings much needed scrutiny to the compounding pharmacy business. The scale of the outbreak makes it the worst among a series of fatal or harmful infections and overdoses linked to compounding pharmacies in the U. For example, in , more than patients died after the S.
Up until now, there have been adverse events involving 71 compounded products in the past 2 decades, many with devastating outcomes.
encouraged by USP to support dating periods exceeding 30 days.3 It is clearly the responsibility of compounding personnel to assure that any data used to determine BUDs of preparations is applied consistently and is sufficiently conservative to protect the patient receiving the preparation.
Results of our survey on drug storage, stability, compatibility, and beyond use dating March 22, ISMP would like to thank the practitioners, mostly pharmacy directors and managers, staff pharmacists, clinical pharmacists, and medication safety pharmacists, who responded to our recent survey on drug storage, stability, and beyond use dating of injectable drugs. We conducted the survey to learn more about what resources pharmacists rely on to guide drug storage, stability, and beyond use dating.
We were specifically interested in learning about conditions that may result in unnecessary waste of drugs during the ongoing drug shortage crisis or waste of very expensive medications given the ever rising cost associated with healthcare. CMS is reviewing this matter further. We are hoping the results of our survey, as described below, provide CMS with some baseline information to support its review process. About a quarter of respondents reported that, upon request, manufacturers never or rarely provide newer in-house data on extended beyond use dating that differs from the package insert.
Numerous respondents also noted that a conflict of interest may exist for the drug company regarding additional drug testing or acknowledgment of external testing related to storage, stability, compatibility, and beyond use dating. They remarked that, once a drug has been approved, the company may have little incentive to conduct additional testing on its products because the results may lead to required, costly labeling package insert changes and a reduction in sales if the beyond use dating is extended.
FDA considers this a practice-related issue.
U.S. v. TIGHE
Compounding is the ancient art of pharmacy. Once manufactured medications became widely available, pharmacists stopped compounding until recently. Why, you might ask? Other good medications are discontinued simply because of lack of profit to the manufacturer. Many physicians seek customized and unique formulations for their patients in vain. Pharmaceutical medications can treat most of the people.
Assuming physical stability, can I apply extended dating to a CSP that is mixed in a class 5 hood inside a class 7 clean room under the new USP > chapter guidelines?
Both the amplitude- and the phase-modulation of the modes are anti-correlated in V The other three stars show, however, quite diverse modulation properties of the radial modes. We find no evidence of an influence of the radial modes and their modulations on each other. The only common features are that both modes are modulated in each Blazhko RRd star, the rapid phase change either positive or negative is connected to the amplitude minimum of the respective mode a typical feature of Blazhko stars , and that the amplitude and amplitude variation of the fundamental mode are larger than or the same as for V99 those of the overtone mode.
The modulations of the F and 1O modes of V13 are anticorrelated; no connection between the modulation properties of the modes in the other stars is evident. Standard image High-resolution image Export PowerPoint slide The phase differences of the maxima of the overtone mode and the nearest maxima of the fundamental mode are plotted in the bottom panels of Figure 1. As the period ratios do not equal 3: Although the phase variation of the modes perturbs these cycle lengths for some extent, both the phase-difference plots in Figure 1 and the dt values given in Table 1 suggest that the modulation periods are not in connection with the cycle lengths of the onset of similar, close-resonance conditions.
As its overtone mode is strongly phase modulated, the temporal period ratio is even larger than 3:
Read ASHP Discussion Guide on USP Chapter Compounding Sterile Preparations
Therefore, there was no enforcement and likewise, little monetary support for pharmacists and pharmacies wanting to improve their sterile compounding processes. Even with the emphasis on best practices, two national surveys conducted by ASHP in and , found few changes in sterile compounding practices. In , the U. Supreme Court ruled section A unconstitutional, creating a void of federal regulation for the pharmacy profession and the FDA.
USP requires that personnel must be trained and their knowledge and skills verified through testing at least annually at the skill level appropriate to their compounding duties. However, because extending dating, by definition, makes a preparation high-risk, personnel who perform the batch-preparation of CSPs must receive additional training and technique verification at least semi-annually.
Closed but untaped mL bottles have a shelf life of 4 years. Closed but untaped mL bottles have a shelf life of 21 months. Transpiration loss occurs mainly around the cap circumference and not through the container walls. There is no difference between the transpiration loss of water versus hydrochloric or nitric acid aqueous solutions.
The shelf life can be accurately predicted from the ratio of the cap circumference to the surface area of the solution exposed just below the head space. Transpiration loss is linear with time. Typically, Inorganic Ventures stock items have an average shelf life of years. Some have a shelf life exceeding a decade. The cap circumference to volume ratio predicts a shelf life of up to one year. NIST has reinforced this fact, stating, “The limit on the validation period is due to transpiration of the solution
Summary of USP for Compounding Sterile Preparations
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Five Appendices — shall vs. Pharmacopeia USP is to provide the practice standards to help ensure that compounded sterile preparations are of high quality, and is for the pre-administration phase of sterile preparations. It describes the CSP requirements guidelines, USP procedures and compliance for CSPs and sets the standards that apply to all settings in which sterile preparations are compounded.
Adherence to will reduce the potential for contamination caused by unclean environment, pharmacist error, lack of quality control, incorrect beyond-use dating and other factors. The standard applies to anyone who prepares CSPs and all places where they are prepared. CSPs include drugs, nutrients, biologics, diagnostics and radiopharmaceuticals. The guideline requires environmental controls to include a separate area for compounding that meets a definite level of cleanliness, and monitoring to guarantee that control is maintained.
While the Board cannot definitely say that pharmacists will face disciplinary action for the failure to follow USP , the possibility does exist.
Meningitis cases spotlight broken system
Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration FDA or action by a state board of pharmacy, the world of compounding is rapidly changing, and many pharmacies are turning to subcontractors for their regulatory needs. But, by doing so, they may be risking more than they realize. Sterility Testing One area where many pharmacies have turned to subcontractors is sterility testing.
USP > Risk Levels Ingredient: CSP Relationship Risk Level Example One to One () Low-Risk Compounding • Reconstitution and transfer of a 1 gram vial of cefazolin.
Some of the most common issues for healthcare providers today include: PharMEDium was among the first entities to voluntarily register with the U. The company works with hospitals and ambulatory surgery centers to promote patient safety while easing the supply chain burden to ensure hospitals and surgery centers have the drugs they need. Since the passage of the Drug Quality and Security Act in November , the FDA has been charged with federal oversight of sterile compounding facilities and conducts rigorous inspections.
The Drug Quality and Security Act eliminated the patchwork of state laws and provided clear oversight to regulatory bodies. Prior to the federal law passage, regulatory bodies at the state level licensed facilities to compound medications.
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Medically reviewed on Jun 11, by L. Anderson, PharmD Patients often have questions about drug expiration dates: Can I safely take a medication if it has reached the drug expiration date? Are there recommendations about the best way to store my medications? Which drugs should never be used past their expiration date?
Compounding for Phase 1 Investigational Studies: USP General Chapter is currently being developed to provide guidance on compounding investigational preparations for phase 1 clinical studies. The chapter will describe considerations such as training, facilities, equipment and components, release testing, quality assurance, quality control and documentation for compounding investigational .
In particular, pharmacists must offer to discuss the unique drug therapy regimen of each Medicaid recipient when filling prescriptions for them. Such discussions must include matters that are significant in the professional judgment of the pharmacist. The information that a pharmacist may discuss with a patient is found in the enumerated list below. Name and description of the medication. Dosage form, dosage, route of administration, and duration of drug therapy.
Special directions and precautions for preparation, administration, and use by the patient. Common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered. Techniques for self-monitoring of drug therapy. Action to be taken in the event of a missed dose. Under OBRA , Medicaid pharmacy providers also must make reasonable efforts to obtain, record, and maintain certain information on Medicaid patients.
This information, including pharmacist comments relevant to patient therapy, would be considered reasonable if an impartial observer could review the documentation and understand what has occurred in the past, including what the pharmacist told the patient, information discovered about the patient, and what the pharmacist thought of the patient’s drug therapy.
Information that would be included in documented information are listed below. Name, address, and telephone number. Comprehensive list of medications and relevant devices.