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Are institutional recommendations and guidelines good for patients?
By Mike Wokasch
It depends on the level of scrutiny and expertise applied by the prescribing physician in assessing the information used to support the recommendations and guidelines. Institutional assessments are most helpful when driven by clinically meaningful patient benefits resulting from comprehensive reviews of clinical data by therapeutic area experts — assuming they are unbiased with no conflicts of interest. This is a rather idealistic perspective when you consider most clinical data are from trials designed for regulatory approval and do not necessarily performed to reflect real-world clinical practice or typical patients.
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Last week's survey: Will medication reconciliation improve hospital readmission rates?
CPPA releases community pharmacy practice accreditation standards
The Center for Pharmacy Practice Accreditation released the approved consensus-based standards for community pharmacy practice accreditation. The standards consist of three domains that outline specific requirements a practice will need to meet to receive accreditation. The standards include an interpretive narrative to provide additional detail regarding how a practice will be evaluated for accreditation.
Certifying organizations with a certification process approved by DEA
In the March 26 Federal Register, the DEA published the attached notice regarding qualified certifying organizations’ certification processes for electronic prescription or pharmacy applications to be verified and certified as meeting the requirements of 21 CFR Part 1311. The notice indicates the following:
Certifying organizations with a certification process approved by DEA pursuant to 21 CFR 1311.300(e)
“… the Interim Final Rule provides that, as an alternative to the audit requirements of 21 CFR 1311.300(a) through (d), an electronic prescription or pharmacy application may be verified and certified as meeting the requirements of 21 CFR Part 1311 by a certifying organization whose certification process has been approved by DEA. The preamble to the Interim Final Rule further indicated that, once a qualified certifying organization’s certification process has been approved by DEA in accordance with 21 CFR 1311.300(e), such information will be posted on DEA’s Web site. 75 FR 16243 (March 31, 2010). On January 18, 2013, DEA approved the certification processes developed by Global Sage Group, LLC, and by iBeta, LLC. iBeta’s certification process was previously approved by DEA but only with regard to the certification of the application’s biometrics subsystem, including its interfaces. 77 FR 45688 (August 1, 2012). This approval for iBeta’s certification process is expanded to include the entire certification process.”
A list of qualified certifying organizations with a certification process that has been approved by DEA is posted on the DEA Office of Diversion Control website.
Please refer to the Federal Register notice for further details.
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Collaboration for Improvement in Patient Outcomes
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Date: Saturday, April 27
Location: Banner Desert Medical Center
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Friday, May 3
Geriatric Pharmacy Roundtable: A Focus on Geriatric Pharmacotherapy
Midwestern University College of Pharmacy Glendale
2013 Arizona Pharmacy Association Annual Convention & Trade Show
Watch your mailbox for complete information about the 2013 Arizona Pharmacy Association Annual Convention & Trade Show, June 27-30 at the Westin La Paloma in Tucson, Ariz.
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Pharmacists reach patients with illustrations, less jargon
Half of patients in the United States don't understand the health information they receive, according to an estimate by the American Medical Association. The average American reads at an eighth-grade level, whereas most healthcare information, including labels on prescriptions, is written for college graduates.
AAN: Doctors miss some FDA drug alerts
American Academy of Neurology via MedPage Today
The Food and Drug Administration's drug alerts on antiepileptic drugs may not be reaching healthcare professionals, and even if they do, physicians may not retain or act on that information, researchers reported. An online survey of American Academy of Neurology members showed that roughly 20 percent of healthcare professionals caring for epilepsy patients were not aware of major electronically reported FDA drug safety warnings for antiepileptic medicines, such as valproate, according to Sarah Bell of the Johns Hopkins University in Baltimore and colleagues.
Dual antiplatelet therapy: A phone call away from near-perfect adherence
Many patients struggle with adherence to their drug regimen, and compliance can be especially difficult for patients who have had an acute coronary syndrome event and are placed on five or more new medications. Some of these patients are discharged on the same day they are admitted and either do not receive drug counseling or are in no condition to understand the drug counseling they are offered. Poor adherence to dual antiplatelet therapy — missing more than five days of treatment — increases the risk of stent thrombosis and death. Small delays and temporary interruptions in therapy can also have dire consequences.
OhioHealth uses team approach to tame drug shortage
Pharmacy Practice News
Before a shortage of potassium phosphate products hit the OhioHealth health system in March 2011, the member hospitals had been "acting in silos" to manage scarcities. However, things changed after they realized they only had a two-week supply of potassium phosphate and an indefinite shortage resolution date ahead of them. As Lorrie Burns, one of OhioHealth's medication safety pharmacists, explained during a recent Institute for Safe Medication Practices webinar, the health system quickly moved to a collaborative and proactive approach.
CMS cuts reimbursement for diabetes test supplies
American Pharmacists Association
Community pharmacies can expect a two-step cut in Medicare reimbursement for diabetes testing supplies. CMS is decreasing the fee schedule amounts for retail DTS to the current mail-service fee schedule amounts April 1, and then further reducing reimbursement to the national mail-service program single payment amounts July 1. Together, the two imminent cuts add up to 72 percent, according to CMS' fact sheet and news release issued Jan. 30.
Missed last week's issue? See which articles your colleagues read most.
Drug shortages erode the quality and increase the cost of cancer care
Medical News Today
A national survey of health professionals showed that drug shortages are taking a heavy toll on cancer patients, forcing treatment changes and delays that for some patients meant worse outcomes, more therapy-related complications and higher costs.
1st US state biosimilars bill becomes law
Virginia has become the first U.S. state to introduce legislation governing the substitution of biosimilar drugs for prescribed biologics. Brand-name drugmakers have welcomed the law as "a model" for all U.S. states, but the generics industry has attacked it for pre-empting FDA guidance.
CVS Pharmacy wants workers' health information, or they'll pay a fine
A new policy by CVS Pharmacy requires every one of its nearly 200,000 employees who use its health plan to submit their weight, body fat, glucose levels and other vitals or pay a monthly fine. Employees who agree to this testing will see no change in their health insurance rates, but those who refuse will have to pay an extra $50 per month — or $600 per year — for the company's health insurance program. All employees have until May 1, 2014, to make an appointment with a doctor and record their vitals.
Pharmacist: Medication crackdown hurts patients
At least one pharmacy in Tucson, Ariz., is facing a limited supply of Oxycontin and Percocet. The Medicine Shoppe said its distributor Cardinal Health recently notified them that they had reached their threshold, "they told me that they noticed a spike in October and November of last year so they cut me off on March 18. It doesn't make any sense to me," said Deborah Van Sant, a pharmacist who owns the midtown pharmacy.
Computerized drug-order systems lead to millions fewer hospital medication errors
Use of computerized provider-order entry systems in hospitals helped avert more than 17 million medication errors per year in U.S. hospitals as of 2008, according to the results of a recent study published in the Journal of the American Medical Informatics Association. The study drew on surveys carried out by the American Hospital Association and the American Society of Health-System Pharmacists, as well as a review of previously published studies.
State AGs pressure FDA for abuse-resistant generic pain drugs
Pharmacy Practice News
State attorneys general have joined forces to urge the FDA to mandate more difficult-to-abuse versions of prescription pain medications — specifically, generic opioid analgesics. In a letter dated March 11 to the FDA, the group of 48 state attorneys general asked the agency to adopt drug development standards outlining how manufacturers of generic prescription painkillers should develop abuse- and tamper-resistant versions of the analgesics.
Inhaler approved for cystic fibrosis patients
The TOBI Podhaler — tobramycin inhalation powder — has been approved by the FDA to treat cystic fibrosis patients infected with Pseudomonas aeruginosa, a bacterium that can damage the lungs.
Botulism treatment approved for biodefense and emergency use
American Society of Health-System Pharmacists
Cangene Corporation of Winnipeg, Canada, recently announced the approval of Botulism Antitoxin Heptavalent for the treatment of naturally occurring botulism and for use as a biodefense agent. The horse-serum-derived antitoxin neutralizes all seven known serotypes of botulinum nerve toxin — types A, B, C, D, E, F and G — and was developed through a contract with the Biomedical Advanced Research and Development Authority. By 2018, a total of 200,000 doses of the product will be delivered to the Strategic National Stockpile, according to the company.
Biogen wins EU backing for big new MS drug hope
European regulators have recommended approval of two new multiple sclerosis pills from Biogen Idec and Sanofi, both of which are expected to become major sellers. The recent decision by the European Medicines Agency was particularly significant for Biogen, since the U.S. biotech company is still awaiting a verdict on Tecfidera, or BG-12, in the United States.
AzPA Pharmacy Flash
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Disclaimer: The AzPA Pharmacy Flash is a weekly roundup of articles of interest to pharmacists and pharmacy professionals. This email may contain an advertisement of AzPA and/or third party products and services. Opinions expressed in these articles do not necessarily reflect the views of AzPA or its advertising partners. The AzPA Pharmacy Flash is compiled by MultiBriefs, a division of MultiView, Inc. Factual errors are the responsibility of the listed publication.
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