Synergy Medical's SynMed Ultra
PHARMACY

High-tech tools, systems elevate pharmacy

BY David Salazar

Increasingly, pharmacies are turning to automation as a way to increase efficiency and free up their pharmacists — employing everything from lower-cost, in-store automation to sophisticated robotics systems that help make central fill operations more efficient and reduce dispensing costs.

(To view the full Category Review, click here.)

“We’re striving to help [our customers] reposition their pharmacists so they can work at the high end of their credentials, which leads directly into helping them reap the rewards of their intense focus on delivering patient-facing care,” Innovation COO Tom Boyer told Drug Store News.

The increased need for efficiency in pharmacy is expected to continue, with Transparency Market Research projecting that in 2018, the pharmacy automation systems market will hit $7.8 billion, compared with the market’s $4.7 billion value in 2011.

In the past year, Innovation expanded its offerings for high-volume central fill pharmacies, unveiling its RxCollect robotic collation technology and showcasing what it deems as the next generation of our workforce, cobots, which are flexible and adaptable robots that work alongside humans, at its Pharmacy Operations Symposium, co-hosted with Binghamton University’s Watson Institute for Systems Excellence.

The company also is piloting a digital shelving solution with robotic back-end fulfillment that can improve efficiency and improve inventory management, and is collaborating with leading chains on a reduced-footprint, will-call solution that would make prescriptions accessible via kiosk or drive-through, as well as behind the counter.

“Last year we introduced the RxCollect technology for high-volume central fill sites,” Innovation EVP global business development Doyle Jensen told DSN. “This year we’ll continue our efforts with digital shelving technology, along with new will call and storage and retrieval systems.”

Alongside the interest in improving pharmacy efficiency has come increased pressure on pharmacies to deliver on patient outcomes, with adherence taking precedence in the metrics by which pharmacies are judged. For a growing number of pharmacies, automation plays a central role in improving adherence.

Synergy Medical has been playing an important part in this trend with proven and reliable technology for blister card automation. The company completed the first installation of its in-store robot in 2008, and in the ensuing years, the company’s blister card automation has grown to service 200,000 lives. “We see adherence packaging as a natural extension to medication synchronization; it is the final step to closing the patient adherence loop,” said Synergy Medical’s senior director of sales, North America, Mark Rinker.

Rinker said the company is committed to being an innovative leader in this space, and is expecting to launch a new solution this year that has its eye toward high-volume and central fill pharmacies, the SynMed Ultra. The company also is continuing its focus on accuracy and efficiency with additional tools to increase capacity, traceability and improve pharmacy workflow.

“Synergy Medical’s 11 engineers are continuously working to upgrade the technology, allowing SynMed to interface with virtually every software system, and to fill [more than] 30 different types of blister cards,” the company told DSN. “Already, Synergy Medical’s software team has released [more than] 80 updates of SynSoft, continuous improvements that were mainly inspired by customer feedback.”

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CHPA's Chip Davis
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Touting the benefits of generics: Q&A with GPhA’s Chip Davis

BY David Salazar

Generics continue to grow as a proportion of the total prescriptions dispensed every year, and as that number has grown, so have the savings that generics bring to the healthcare system. The Generic Pharmaceutical Association has been front and center, touting the benefits that generics bring for lawmakers, payers and, most importantly, patients. Drug Store News spoke with GPhA president and CEO Chip Davis about the organization’s efforts in 2016 and plans for the remainder of 2017.

DSN: With 2016 in the rearview mirror, what are some of the biggest legislative victories for the generics industry last year? 

Chip Davis: Generic drug and biosimilar manufacturers are pleased to see momentum for the bipartisan CREATES Act. This bill is a widely supported effort that would stop brand drug companies from blocking generic drug competition. While there is much debate on the drivers of high health costs, experts agree that one solution is to encourage pharmaceutical competition from generic drugs.

DSN: With the passage of the 21st Century Cures Act last year, what elements were good for the industry, and what work is left to do on elements that were left out?

Davis: GPhA recognizes this bill is a bipartisan achievement that should spur innovation and benefit patients. Notably, the package includes important funding to support the Comprehensive Addiction and Recovery, [or] CARA, Act, which will help address the public health crisis surrounding prescription drug abuse. We urge Congress to expeditiously pass this bill.

While the 21st Century Cures Act … does not include provisions GPhA supports to increase prescription drug pricing competition, we will continue working with Congress to find solutions to rising drug costs that bring safe and effective generic drugs to market more quickly and ensure more patients and payers have access to them. Toward that end, GPhA will continue to support and seek enactment of the bipartisan CREATES Act, sponsored by Sens. Grassley, Lee, Leahy, and Klobuchar, and the FAST Generics Act, sponsored by Reps. Stivers and Welch.

DSN: You recently wrote a letter to then-President-elect Donald Trump — what are the key policy prescriptions that the GPhA would like to see a focus on as his administration gets started?

Davis:  Generic and biosimilar medicines are a ready-made solution to high drug costs. Unleashing the full potential of these medicines will require a bipartisan effort that includes patients, pharmacists, doctors, payers, supply chain partners and others, who rely on access to safe, effective and more affordable medicines. It is important that policymakers pursue patient-centric and market-based solutions that enhance competition and expedite generic market entry to bring down prices and improve patient access to medicines.

Generic drugs are 89% of prescriptions dispensed in the United States, but are only 27% of total drug costs, according to the GPhA/Quintiles IMS Institute Generic Drug Savings and Access report. This means hundreds of billions in annual savings for our healthcare system, a foundation to build upon, not to inhibit or put at risk.

To that end, GPhA supports five policy prescriptions that would increase competition and make safe, effective and more affordable medicines more accessible to all Americans:

1. Promote timely access to quality affordable generic drugs that meet high standards of a streamlined development and approval process.

2. Create policies that recognize the different economic dynamics of the brand and generic markets.

3. Ensure an intellectual-property framework that balances the need for innovation and robust generic competition.

4. Stop some brand companies from blocking or delaying generic drug development.

5. Increase utilization of affordable generics across all patient populations.

DSN: One of the pieces of legislation GPhA has championed is the Creating and Restoring Equal Access to Equivalent Samples, or CREATES, Act — given the recent report on drug pricing from the Senate Committee on Aging that called for better access to samples for generics makers, do you see 2017 as a more fruitful year for the legislation, and how could it help speed up generics development?

Momentum for the bill continues to build, and we look forward to timely re-introduction during the next Congress. There is widespread support from all corners of the pharmaceutical supply chain, patient groups, health professionals, payers and others interested in ensuring access to more affordable medicine.

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New final FDA guidance begins to clear path for more biosimilars

BY David Salazar

As 2016 drew to a close, the Food and Drug Administration gave a gift of sorts to drug makers looking to submit to the agency an application for approval of a biosimilar drug when it issued its final guidance, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”

(To view the full Category Review, click here.)

The finalized guidance follows the draft guidance the agency issued in May 2014.

“Clinical pharmacology studies build upon the foundation of comparative analytical studies and normally are a critical part of demonstrating that there are no clinically meaningful differences between the proposed biosimilar product and the reference,” the guidance said. “These studies can be instrumental in addressing residual uncertainty in biosimilarity assessments, and also can inform the need for and design of any necessary subsequent clinical studies to address remaining uncertainties.”

The finalized guidance came a little more than three months after the FDA published its performance goals for fiscal years 2018 through 2022 under the Bioisimilar User Fee Act II, and it is one of five finalized guidances pertaining to biosimilars that the agency has published. And while the guidances that have been released have outlined important underpinnings of the path to approval, the industry is still waiting for the agency to resolve an important question with a forthcoming guidance, namely interchangeability.

QuintilesIMS predicts that in the next 10 years, biosimilars — whose prices are about 10% to 15% less than those of the original biologics — will generate healthcare spend savings ranging from $44 billion and $250 billion. As more approvals roll in for biosimilars — currently five biosimilars have been approved and three have launched — and some 50 biosimilars sit in the pipeline, one of the largest barriers that biosimilars face, besides patent litigation, is that of interchangeability.

“Until there’s clarity on what it takes to have that interchangeable status,… interchangeability will be a major determinant of a biosimilars’ potential and the ability for payers and providers to use these drugs as a source of competition,” Numerof & Associations research analyst Michael Kuchenreuther told Drug Store News.

In January, the FDA issued a draft guidance on interchangeability of biologic products that is accepting comments on it until March 18 for stakeholders who want their input to be considered before a final guidance is issued, which the agency has said it will issue by the end of 2017.

In the meantime, five biosimilars have been approved — Sandoz’s Zarxio (filgrastim-sndz), a biosimilar of Neupogen (filgrastim); Pfizer’s Inflectra (infliximabdyyb), a Remicade (infliximab) biosimilar; Basaglar, an insulin glargine biosimilar that challenges Sanofi’s Lantus; Erelzi (etancercept-szzs), an Enbrel (etancercept) biosimilar; and Amjevita (adalimumab), a biosimilar of Humira.

By 2021, QuintilesIMS projects that one to two additional insulin biosimilars will be approved, as well as one to two additional infliximab copies, seven to 10 biosimilars of adalimumab, one to two ranibizumab copies, one to four additional biosimilars of filgrastim, one to two of epoetin alfa, three to four of bevacizumab and two to three each of rituximab, trastuzumab and pefilgrastim.

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