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So far ConsortiEX has created 38 blog entries.

New & Noteworthy – CSP Order Module

See the ConsortiEX EXchange Order Module  in Pharmacy Purchasing & Products New & Noteworthy   ConsortiEX offers Enterprise Resource Planning (ERP) applications to collect, integrate, compare, and share sterile product compounding data, which facilitates the tracking of every ingredient and batch within the organization. EXchange Orders supports the hub-and-spoke approach of insourcing compounding sterile preparations (CSPs), allowing health systems’ affiliate locations to order IV admixtures from a central pharmacy location. The EXchange Orders Module interfaces with Assure-Trak IV Workflow Management, enabling users to achieve high-volume production of CSPs and streamline cost efficiencies while establishing quality control.  

October 20th, 2017|503A, 503B, Compounding, ConsortiEX, IV Workflow|

Unpacking USP 800

Healthcare workers who handle hazardous drugs, such as those used to treat cancer, are exposed to harmful chemicals that can pose some serious health risks: infertility, spontaneous abortions, congenital malformations, cancer, immune disorders—and the list goes on. Since 1994, more than 100 studies related to hazardous drug handling from organizations including the Oncology Nurses Society, American Society of Clinical Oncology, and Occupational Safety and Health Administration have documented evidence that the work environment can become contaminated with hazardous drugs when these materials are handled without adequate precautions.  Until now, there hasn’t been an authoritative  standard for how spaces that store, prepare, transport, or administer hazardous drugs, including pharmacies, hospitals, patient treatment clinics, and physician’s practice facilities, should be designed to minimize this risk. The United States Pharmacopeial (USP) Convention’s Chapter 800, “Hazardous Drugs—Handling in Healthcare Settings,” changes all of that. Released in February 2016, USP 800 provides guidance for personnel handling hazardous drugs, including the use of personal protective [...]

October 18th, 2017|503A, 503B, Compounding, Industry, USP|

Compounding Pharmacy Market Demands and New FDA Regulations

Since the early 1960s, medication compounding is the significant function of the pharmacist. However, the role of the pharmacist is quickly changing from compounding medications to dispersing already compounded medications.   What is Compounding Pharmacy? Pharmacy compounding is the art and science of medication preparation for patients. It involves the process of preparing a medication for a patient in the right quantity and dosage. It consists of the mixing of various ingredients that comprises a prescription in the order and format prescribed by a medical practitioner or doctor. Compound medications are often done by a licensed pharmacy, licensed medical practitioner. Often they are produced by an outsourcing company, under the supervision of a licensed pharmacist or medical practitioner.   Read the full article: checkbiotech.org

October 17th, 2017|FDA|

Formulary Considerations: The Past, Present, and Future

IN THE 1940s, when health system formularies were created, they were simply a current list of medications stocked in the pharmacy, along with some related information about each drug.1 In the 1980s, the clinical and economic value of well-controlled and managed formularies were highlighted.2 Today, Pharmacy and Therapeutic (P&T) committees are considered a critical tool for healthcare organizations to ensure safe, appropriate, and cost-effective use of pharmaceuticals for patient care. A guideline on P&T committees and formulary systems, developed by the American Society of Health-System Pharmacists, summarizes the best practices and techniques that should be implemented for optimal formulary system management.1 Policies and procedures for procuring, dispensing, administering, and appropriate utilization of medications are also included in the formulary management process.   Readthe full article: ajmc.com

October 16th, 2017|503A, 503B, Compounding, Industry, IV Workflow, USP|

Five Blockchain Use Cases for Healthcare Payers, Providers

The distributed ledger methodology known as blockchain is piquing interest in the healthcare industry as organizations search for more secure and trusted strategies for managing big data. By decentralizing ownership of key data sets, yet increasing the strength of permissioned sharing protocols, blockchain proponents hope to create an interoperable, patient-centered big data ecosystem that prioritizes accuracy, timeliness, and shared-decision making. Providers are eager to invest in this vision, which could be game-changing for payers, patients, and their clinicians.  Interest in blockchain-based tools is strong, with 68 percent of payers and 12 percent of providers planning on at least one blockchain implementation by the end of 2018, according to a recent Black Book poll. Early use cases for blockchain have included the creation of a truly longitudinal health record controlled entirely by the individual and a more robust patient matching and identification system that improves patient safety while eliminating administrative pain points. But as blockchain gains ground among health data management experts, the [...]

October 11th, 2017|DSCSA|

Big Pharma Turns to Blockchain to Track Meds

No more counterfeits? The pharma industry may be on the verge of solving a longtime problem: How to stop a flow of stolen or counterfeit pills entering the supply chain and trickling down to patients. The answer comes in the form of blockchain technology, a form of software that runs across multiple computers, and creates a tamper-proof, indelible record of transactions. On Thursday, a group of companies announced the MediLedger Project, which is creating blockchain tools to manage pharmaceutical supply chains. The group, which includes drug giants Genentech and Pfizer, has already completed a successful pilot program to track medicines. If the project meets its goals, everyone from drug makers to wholesalers to hospitals will be recording drug deliveries on a blockchain. What this means in practice is that, at each step of the distribution process, a network of computers will vouch for the provenance and authenticity of a drug shipment—making it harder for thieves to unload stolen medications, or for counterfeiters [...]

October 10th, 2017|DSCSA, Industry|

FDA Seeks Higher Production Standards for Compounded Drugs

The FDA understands the importance of access to compounded drugs, and is committed to supporting access to these drugs under "high production standards," according to a recently-released statement from FDA Commissioner Scott Gottlieb, MD. The Drug Quality and Security Act (DQSA) provides a pivotal foundation for achieving these goals, by working with outsourcing facilities to meet regulatory standards, Gottlieb explained in the statement. The FDA has posted a new report that provides a list of the drugs that entities registered as outsourcing facilities have produced. The first report list includes compounded drug products that outsourcing facilities reportedly produced between December 2016 and May 2017.   Read the full article: specialtypharmacytimes.com

October 5th, 2017|Compounding, DQSA, FDA|

Securing the Supply Chain with Molecular Tagging

Earlier this summer, the FDA extended the Product Identifier Requirement under the Drug Supply Chain Security Act (DSCSA) to November 2018. The legislation applies to manufacturers, packagers, distributors and all others involved in the production and delivery of pharmaceuticals. At last year’s Pharmaceutical Traceability Forum, Applied DNA Sciences polled key executives and leaders about serialization and anti-counterfeiting in the pharmaceutical industry. Drug Discovery & Development spoke with Bob Miglani, chief of business development, about the survey as well as how the Long Island-based company’s molecular tagging technology provides security and authentication to help pharmaceutical companies identify, target, track and trace products throughout the supply chain. Read the full article: dddmag.com

October 4th, 2017|DSCSA, Industry|

Closed-System Transfer Devices: Important Considerations for Pharmacists

Closed-system transfer devices (CSTDs) mechanically prohibit the transfer of environmental contaminants into a system and the escape of hazardous drugs or vapor concentrations outside the system. Although the first CSTD was approved in the United States in 1998, several products are currently available, including those with widely varying design characteristics. Because of these design differences, CSTDs are not a monolithic category of products. One of the most important differences is the method of preventing release of hazardous drugs from each device. Although some devices rely on a carbon filter to limit the escape of hazardous drug vapors, others are mechanically closed. Still, other differences in products may affect real-world use, including the nature of connections. Some devices rely on a needle-free connector, whereas others rely on a needle-based connector between a drug and vials or intravenous bags.   Read the full article: pharmacytimes.com

October 4th, 2017|Compounding, DQSA, Industry, USP|

Gottlieb Supports Compounded Drugs

On Sept. 26, 2017, FDA Commissioner Scott Gottlieb, MD, made a statement regarding the agency’s efforts to ensure available and safe compounded drugs. The agency is continuing its commitment to oversee drug compounders and is providing resources to these companies in the hopes of promoting safer products. Compounded drugs, while not approved by FDA, provide therapies to healthcare providers and patients that might not otherwise be available. These medications, however, come with the potential for contamination if improperly manufactured. “Supporting access to compounded drugs made under high production standards involves helping new outsourcing facilities as they strive to develop expertise in compounding medicines under current good manufacturing practice standards,” Gottlieb said in the statement. Facilities registered with FDA under section 503B of the Food, Drug, and Cosmetics Act are regulated by FDA and must comply with current good manufacturing practices. In the past few years, FDA has increased their effort to inspect these facilities, resulting in a variety of warning letters [...]

October 3rd, 2017|503A, 503B, Compounding, DQSA, FDA, Industry|
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