Prescribers weigh-in on proposed label rule


A survey co-released by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that 8-in-10 healthcare providers have serious concerns about a proposed Food and Drug Administration rule on generic drug labeling.

A random phone survey of 150 physicians, 150 physician assistants and 150 pharmacists conducted by Fairleigh Dickinson Universi-ty’s PublicMind on behalf of GPhA found strong reservations about many of the rule’s key provisions among all three groups.

The study comes as the FDA considers more than 100 responses to its controversial proposed rule, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” which would dramatically alter the current regulations to allow generic medicine manufacturers to change their safety labels without prior FDA review and without immediate access to the drug’s complete safety data

“Doctors, physician assistants and pharmacists are on the frontlines of health care in America, and large majorities said that provisions of the proposed rule would create confusion, take up essential time and impact their likelihood to prescribe generic drugs,” said Ralph Neas, president and CEO of the GPhA. “Most importantly, 81% of those surveyed believe FDA approval should be required prior to generic drug safety label changes.”

“The proposed rule raises significant concerns for practicing pharmacists, particularly in regard to patient confusion and effective risk counseling,” added Thomas Menighan, EVP and CEO of the American Pharmacists Association. “Pharmacists devote a great deal of time to counseling patients on appropriate medication use, and as the survey indicates, 67% of pharmacists asked are concerned that they will not have sufficient time to effectively address issues created by this proposed regulation.”

Other key findings of the study include:

  • 79% of physicians, pharmacists and physician assistants say they have heard “nothing” about the proposed rule;
  • 76% of prescribers and dispensers say their patients would be at least “somewhat confused” by the proposed changes, which would allow multiple safety labels for the same drug; 53% said it would be “very’ confusing even for themselves;
  • 71% anticipate the new rule would increase the amount of time they need to spend with patients reviewing patient history and the new labels;
  • 68% believe they would not have the time required to keep current with the labeling changes; and
  • 77% are at least “somewhat concerned” the proposed new rule could impact legal liabilities; even more pronounced among pharmacists (85%).


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Curating the life science data cloud


As lifetime earnings for pharmaceuticals decrease, commercialization expenses increase and payers tighten their belts on reimbursement, life science companies will be faced with shrinking margins over the next few years. In order to maintain basic operating margin levels and continue investing in research and development at current levels, life science manufacturers will be forced to reduce costs by more than $35 billion by 2017, according to results from a new survey of 70 life science organizations from the IMS Institute for Healthcare Informatics.

In order to produce cost savings and keep their businesses operationally efficient in the advent of change, IMS suggests in its new report, “Riding the Information Technology Wave in Life Sciences: Priorities, Pitfalls and Promise,” that the most reasonable approach is to adopt a strategy based on data integration and cloud-based technologies. To preserve operating margins, drug manufacturers need to incorporate new technologies and streamline the transfer and curation of data both internally and externally.

To offset rising expenditures, companies already have begun to reduce their marketing teams, outsource some of their in-house functions and adjust their drug development strategies to focus on specialty medications and therapies associated with smaller patient populations, noted the report. “We believe the large global pharmaceutical companies have more restructuring to undertake to remove costs from their business operations,” noted Murray Aitken, executive director of the IMS Institute for Healthcare Informatics. “Further efforts are needed to bring efficiencies to the commercial operations of life sciences companies.”

The authors of the report explained that the best use of the new, more efficiently packaged data housed on the cloud would be to inform future campaigns and improve multichannel marketing operations, track audience engagement and feedback through social media-based applications and patient mobile apps, and run commercial operations applications, such as those used by sales teams. Rather than spend money to produce and store company data, manufacturers could run these company functions through cloud-based applications. In addition, according to IMS, “companies typically experience a minimum of 20% to 30% on operating costs and lower total cost of ownership when moving their infrastructure to the cloud.”

Although pharmaceutical manufacturers have historically been resistant to the uptake of social and mobile applications, the report stated there is a new willingness to shift to the cloud, as cloud companies are improving compliance and becoming more sensitive to HIPAA-related issues. Plus, 74% of respondents reported a high or greater level of need to derive insights and value from data, particularly from specialty patient populations.

The report predicted that cloud-based technologies would contribute to better coordination across departments and would save time that would normally be wasted on data reconciliation; however, there could be some potential risks associated with the use of this technology, including security breaches, the intellectual property issues surrounding ownership of the data and/or the loss of control of the data, the report suggested. In addition, while the report noted that there may be a large cost associated with switching data from a “legacy” system, it does not address the costs associated with training employees on the new technology.

While the report contended “healthcare-specific data models with standardized fields are needed to merge and share patient electronic medical records,” there also could be some instances where companies don’t want to share what they consider to be proprietary data. Some pharmaceutical manufacturers don’t necessarily want competing companies to know which fields they are capturing within their forms, and some clinicians could argue that there is no such thing as a “standard” field in data collection, especially as it relates to complex medications that fall into the specialty or oncology category.

However, IMS’ Aitken predicted the adoption of integrated systems will allow for the “democratization of analysis,” and will help manufacturers make assessments and conclusions about the success or relative failure of a drug launch and its marketing activities.

“The healthcare industry is beginning to speak the language of real-world evidence,” Aitken said. “We think this is a significant step forward in helping life science companies not only understand how their products are being used but, more importantly, how they should and can be used to lower costs, as well as achieve improved patient outcomes.”


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Automation helps improve outcomes, provides faster, cheaper Rx services

BY Richard Monks

With community pharmacies being called on to provide a wider range of services, drug stores across the country are adapting new technologies to ensure that they can meet the evolving needs of their patients and strengthen their role in the nation’s healthcare system.

Chronic patients may only see their primary care physician a handful of times per year, but they see their pharmacists two to three times a month, on average.

Healthcare experts say that this frequent access to patients creates a huge opportunity for pharmacists to become central players in patients’ care. However, they note, it also creates a need to make pharmacies more efficient.

With a growing number of pharmacists providing such services as medication therapy management and immunizations, and the prescription-filling process becoming increasingly complex, those in the industry say there is a heightened need for speed and the ability to ensure that the various systems employed in a typical community pharmacy work together.

“There’s so many steps in filling a prescription,” said Miranda Rochol, VP product and strategy at Healthcare Data Solutions, a supplier of real-time prescriber verification services. “It can be a challenge to integrate all of the different systems.”

Healthcare Data Solutions is among a handful of technology providers that continues to tweak its offering to meet pharmacies’ changing needs. For instance, Rochol said, the company’s technology runs more than 70 different validations in a matter of milliseconds to ensure that a physician is authorized to prescribe a certain class of drugs.

The system, she said, helps eliminate prescribing errors and the related fines that fall on the backs of pharmacies when these errors occur.

While the changing role of the pharmacist is dictating that community pharmacies employ a wider range of systems, automation and counting technology remains at the heart of most pharmacies’ operations.

According to a report released this spring by the market research group BCC Research, the worldwide market for pharmacy automation is expected to grow by nearly 9% a year over the next five years to nearly $4.9 billion in 2018.

Technology providers say that adding more functionality to automation systems will be crucial in ensuring that these systems continue to play a central role in pharmacies’ technology strategies. Systems to promote adherence and compliance, and those that monitor patients in their ambulatory settings, will continue to become more prominent in pharmacies, with automation also taking on added significance.

Automation, technology providers contend, will continue to improve dispensing safety and efficiency, and will be at the center of pharmacies’ efforts to provide the high-touch and personal care that patients and providers are demanding.

Most suppliers have already embarked on expanding the functionality of their systems to meet the changing needs of pharmacies and patients.

Over the past year, for example, ScriptPro has continued to add functionality to its automation systems, including the use of biometrics to ensure that only authorized pharmacy staff handle prescriptions, as well as QR bar codes on prescription labels that help patients manage refills and make communicating with their pharmacy easier.

For several years, technology proponents and public health officials have touted sophisticated pharmacy technology as a critical component in reining in healthcare spending. Among the most-often mentioned ways to control costs are the increased use of electronic prescribing and electronic health records. Both technologies have been expanding across the healthcare spectrum in recent years, with industry insiders and government regulators saying the technologies hold great promise for driving down healthcare costs going forward.

Surescripts, the nation’s largest health information network, reported that it routed more than 1 billion electronic prescriptions last year. Nearly three-quarters of the nation’s office-based physicians and 9870 of the chain pharmacies across the country have adapted e-prescribing. Usage among independents last year increased by 1170, according to Surescripts.

While slower to become part of pharmacies’ everyday operating routines, electronic health records got a boost earlier this year when Walgreens, CVS Caremark, Kroger, Rite Aid and Safeway pledged to support the Blue Button initiative, a public-private partnership between healthcare providers and the federal government that seeks to give people greater access to their electronic health information in order to help them manage their care.

Technology suppliers also have been working to broaden the use of electronic health records.

Last month, QS/1 rolled out its ESI Rx History interface. The company said the medication reconciliation program enables pharmacies to instantly retrieve a patient’s medication history through QS/1’s PowerLine.

“Using ESI Rx History allows pharmacies to add their patient’s information to the database,” said Michael Ziegler, QS/1’s marketing and analyst senior manager. “If the patient ever is admitted to a hospital, this will give doctors immediate access to the most current medications the patient is taking.”

The debut of the new interface came less than a week after QS/1’s introduction of a new tool to help pharmacists provide better care.

Through a partnership with VUCA Health, QS/1 is offering a variety of services, including on-demand prescription-specific videos, to engage patients and strengthen customer relationships.

The technology allows pharmacies to print QR codes on prescription labels linking patients to VUCA Health videos that review prescription safety, provide alerts to a medication’s possible side effects and detail ways to limit reactions.


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