FDA panel recommends approval for experimental Gilead HIV drug
FOSTER CITY, Calif. — Gilead Sciences scored a second favorable Food and Drug Administration expert panel vote as the FDA’s Antiviral Drugs Advisory Committee recommended on Friday that the regulatory agency approve an experimental drug designed to treat HIV.
Gilead announced that the FDA panel voted 13-1 to support approval of the Quad (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate) for HIV-1 infection in adults that have not received previous treatments. The FDA isn’t required to follow advisory committee votes when deciding whether to approve a drug, but usually does.
The treatment is designed as a once-daily regimen that combines four HIV drugs in one pill. The FDA’s recommendation is based on results of two phase-3 clinical trials indicating that the Quad demonstrated non-inferiority to Gilead’s Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) and a regimen containing Truvada (tenofovir disoproxil fumarate) and Bristol-Myers Squibb’s Reyataz (atazanavir) boosted with Abbott’s Norvir (ritonavir).
The news closely follows the advisory committee’s recommendation that the FDA approve Gilead’s Truvada for pre-exposure prophylaxis, or PrEP, in which HIV-negative patients take the drug daily to reduce their risk of infection.
The benefits of e-prescribing beyond achieving meaningful use
E-prescribing owes a debt of gratitude to meaningful use. Without the Office of the National Coordinator’s inclusion of the capability as a core measure, enabling physician technologies may not have taken off with such vigor. But where MU’s e-prescribing requirements — such as two-way transmissions, complete active medication lists and formulary information — leave off, real innovation — characterized by real-time transactions, automated requests and responses, and Intelligent Routing like Emdeon provides — begins with many valuable benefits for providers, pharmacies and patients.
For one, it establishes a connectivity platform between physicians and pharmacists that simplifies and enhances collaboration to enhance patient safety. It also can reduce paperwork and the associated inefficiencies and inaccuracies that may flow from reliance on handwritten notes. And new technologies are designed to add transparency to drug pricing, allowing clinicians to search for cheaper alternatives at the patient’s request. But beyond these well-known advantages, technology developers are responding to healthcare’s emerging drivers, including interoperability and patient-centered care models, by integrating new capabilities into existing e-prescribing platforms.
Among this new set of functionality is e-prescribing for controlled substances. Eleven percent of all prescriptions are for controlled substances, but until just recently, the Drug Enforcement Administration prohibited EPCS, for fear it that it couldn’t be adequately monitored. Now, with additional security controls — including passwords, biometrics and secure tokens that fit smoothly within physician workflow — the DEA believes that EPCS creates a safer portal for prescribing and dispensing controlled substances than manual processes, protecting both doctors and pharmacies.
E-prescribing also provides additional patient safety measures. According to a 2007 study published in the Journal of the American Medical Informatics Association, more than 1,000,000 serious drug errors occur in U.S. hospitals annually. E-prescribing technology can allow providers to see prescription histories and reconcile medications at the point of care through a medication reconciliation module available as a component of many e-prescribing tools. Enabled e-prescribing systems can capture up to 95 percent of patient medication information, far more than the approximately 70 percent typically revealed during patient interviews.
Prescription monitoring program features also are being incorporated into e-prescribing modules. This capability is designed to lower instances of drug diversions and enable patient compliance by preventing physicians from ordering controlled substances they are not legally permitted to prescribe or a patient is not eligible to receive.
Finally, e-prescribing is becoming a significant component of patient engagement programs, helping to involve individuals in the prescription process. When a physician submits an order, the system may automatically send an email, text or voice message to the patient confirming the order and pharmacy destination. This also provides a conduit for the pharmacy to communicate with patients by notifying them when the prescription is ready, for example, adding a new level of convenience.
E-prescribing capabilities outlined by MU requirements can create a safer environment for patients by reducing errors and promoting medication compliance. And pharmacists and clinicians will spend less time following up on handwriting interpretations or prior authorization requirements. But beyond MU, e-prescribing will continue to be the technology of the future, enabled with advanced capabilities for managing prescription risks, leading to more appropriate and potentially cost-effective prescribing decisions.
Senior director of clinical services, pharmacy services division
Lathe Bigler serves as Emdeon’s senior director of clinical services for the pharmacy services division. His focus on developing layers of competitive advantage and increasing market growth are instrumental in Emdeon’s advancement in the exchange of electronic prescriptions and other clinical information. Bigler has more than 15 years of experience in the healthcare and information technology fields, and has held roles in marketing, product management, business development and industry relations with such corporations as NDC Health, Midmark Diagnostics, DrFirst and AltaPoint Data Systems. Bigler has a bachelor’s degree in marketing and business administration.
NACDS applauds enactment of Alabama PBM audit legislation
ALEXANDRIA, Va. — A law that will establish standards in the pharmacy audit process conducted by pharmacy benefit managers in the state of Alabama has received the applause of the National Association of Chain Drug Stores.
NACDS on Friday offered its appreciation for the enactment of the Pharmacy Audit Integrity Act by Alabama governor Robert Bentley.
Among its provisions, SB 383 establishes uniform standards for the auditing of pharmacy records and includes requiring two weeks written notice of an audit. The law also requires audits that involve clinical or professional judgment be conducted in consultation with a pharmacist and establishes an appeals process.
“We thank Governor Bentley for signing this important pro-patient, pro-pharmacy legislation to curb tactics used by some PBMs that take away from the important business of improving patient health and making healthcare delivery more efficient and cost-effective,” NACDS president and CEO Steve Anderson said. “We thank the Alabama Pharmacy Association for their leadership in helping to ensure transparency in the PBM audit process.”
NACDS has endorsed federal legislation that seeks to preserve pharmacy choice for patients and takes additional steps to prevent threats to pharmacy patient care. The bipartisan Pharmacy Competition and Consumer Choice Act — S. 1058 and H.R. 1971, sponsored by Sen. Mark Pryor, D-Ark., and Rep. Cathy McMorris Rodgers, R-Wash., respectively — includes provisions requiring transparency by PBMs in pharmacy audits.