2016 ISHP ANNUAL FALL MEETING & 60th ANNIVERSARY CELEBRATION
"The Future of Pharmacy Practice: Provider Status and Collaborative Practice"
September 23rd - 25th, 2016
Sun Valley, Idaho
Book Room Your Room at the ISHP Negotiated Rate...
Do You Know an Exceptional Pharmacist or Pharmacy Technician?
Nominate your well deserving colleagues for one of the ISHP's Annual Awards:
2016 Pharmacist of the Year
2016 Pharmacy Technician of the Year
ISHP 2016 Poster Competition
Planning to Present a Poster at the 2016 ISHP Annual Fall Meeting? Review and Complete the application provided below.
Mylan Offers Discounts on EpiPen After Clinton Criticism
(Reuters, 25 August 2016) - Mylan NV said on Thursday it would reduce the out-of-pocket cost of its severe allergy treatment EpiPen through a discount program, a day after Democratic Presidential candidate Hillary Clinton joined lawmakers in criticizing the drug's high price. The company, which did not lower the drug's list price, said it would reduce the patient cost of EpiPen through the use of a savings card, which will cover up to $300 of EpiPen 2-Pak. Price of the product, acquired in 2007, has zoomed to $600 from $100 in 2008. For patients previously paying the full list price, the card effectively reduces their out-of-pocket cost exposure by 50 percent, Mylan said. The company said it is also doubling the eligibility for its patient assistance program, which will eliminate out-of-pocket costs for uninsured and under-insured patients and families. Clinton on Wednesday called on Mylan to voluntarily drop the price of EpiPen. Clinton's comments came after a bipartisan group of lawmakers called for investigations into the price increase of EpiPens, which are preloaded injections of epinephrine (adrenaline) that people use if they are having a dangerous allergic reaction that could result in death, if untreated. On Wednesday, Republican Senator Susan Collins and Democratic Senator Claire McCaskill requested that Mylan provide a briefing to explain the price change.
A group of lawmakers said on Wednesday that they had written to the U.S. Food and Drug Administration to ask about its approval process for alternatives to the EpiPen. The comments from Clinton and lawmakers sent biotech stocks spiraling down on Wednesday, similar to the slump last fall when Clinton had first criticized the high cost of drugs. Clinton admonished Valeant Pharmaceuticals International Inc , which raised the price of a heart drug. In March, she released a campaign ad vowing to target the company.
Clinton also criticized Turing Pharmaceuticals when public ire rose after it decided to raise the price of an antiviral medication commonly used by AIDS patients and pregnant women to $750 from $13.50 a tablet. Turing was then led by Martin Shkreli, who became the poster child for the issue of soaring prices for prescription medications. He later stepped down as CEO of Turing.
Vitamin K antagonists’
risks and benefits in the oldest patients
Use of vitamin K antagonists in patients aged 90 years or older was associated with a slight increase in the risk of bleeding compared with patients in their 70s. The risk of thrombosis was higher in patients in their 90s and 80s compared with those in their 70s, according to results of a matched cohort study published online in JAMA Internal Medicine.
Kooistra, HA et al. Risk of bleeding and thrombosis in patients 70 years or older using vitamin K antagonists.JAMA Intern Med. 2016;[Epub ahead of print].Gout: DASH Diet Lowers Serum Uric AcidThe DASH diet lowers elevated serum uric acid levels to almost the same extent as pharmacological preparations in individuals at risk for gout, a large intervention trial indicates. "The DASH diet is a well-known diet for blood pressure, a condition common in 75% of gout patients, so we wanted to see if it could be effective for uric acid in addition to blood pressure, as using the same diet for the two conditions would be advantageous for patients with gout,"stated Stephen Juraschek, MD, PhD, from Johns Hopkins University School of Medicine, Baltimore, Maryland."And we showed that the DASH diet can lower uric acid by 1.3 mg/dL in adults with an elevated uric acid, an effect similar to that of medication, where allopurinol, for example, the first-line urate-lowering medication, lowers uric acid by about 2 to 3 mg/dL."The study was published online August 14 in Arthritis and Rheumatology.Multi-state Outbreak of Burkholderia cepacia Infections
Update August 19, 2016
At this time, CDC and FDA are continuing to investigate this issue. Additional updates will be posted as they become available.
Update August 10, 2016
FDA released an updated statement including a voluntary recall of all of liquid productsmanufactured by PharmaTech and distributed by: Rugby, Major, Bayshore, Metron, Centurion, and Virtus.
This issue remains under investigation. In addition to the above recall of all liquid products manufactured by PharmaTech, both FDA and CDC continue to recommend that clinicians and patients not use any brand of liquid docusate sodium product as a stool softener or for any other medical purpose.
To date, CDC has confirmed 60 cases from 8 states.
Update July 14, 2016
CDC continues to work with FDA, health departments and multiple healthcare facilities to investigate a multi-state outbreak of infections caused byBurkholderia cepacia complex (also known as “B. cepacia complex”). At this time, CDC continues to recommend that clinicians not use any liquid docusate product as a stool softener or for any other medical purpose. This recommendation is now expanded to all patient populations. If an oral liquid docusate stool softener is medically necessary, alternative medicines should be used.
CDC urges healthcare providers and laboratories to remain on alert for infections caused by B. cepacia complex occurring among non-cystic fibrosis (CF) patients and should inform infection prevention staff immediately when these infections are identified. In addition, although infections caused by B. cepaciacomplex are known to occur among patients with CF, any clusters of such infections should be reported. Cases and clusters should be reported to state or local public health authorities.
Facilities that identify infections caused by B. cepacia complex among non-CF patients or clusters of these infections among CF patients should sequester and save all docusate products used in the facility.
To date, 47 B. cepacia complex cases have been confirmed by molecular typing to match one of two outbreak strain types identified from healthcare facilities in five states. Reports of possible cases from additional states are currently being investigated. CDC has confirmed that two samples of unused oral liquid docusate product received from one of the affected hospitals have tested positive for B. cepacia complex. Further testing is being conducted to determine if bacteria from these samples match the outbreak strains. FDA is currently testing multiple liquid docusate products that are epidemiologically linked to reported B. cepacia complex cases. To date, CDC has confirmed one product as having B. cepacia complexgrowth; however, because of epidemiologic links, CDC is concerned about potential contamination of multiple liquid docusate products, pending FDA’s ongoing investigation of shared ingredients in the products in question.
(Updated July 14, 2016)
At this time, CDC and FDA continue to actively investigate this issue. CDC has confirmed 53 cases from 5 states. All recommendations detailed in the last update stand. We will provide an update to this announcement soon. Please direct questions to email@example.com. Members of the media should contact the CDC Media Office at firstname.lastname@example.org.
For the latest info, please click HERE
Starting August 1, FDA inspectors will make a preliminary assessment of whether pharmacies are in compliance with 503A before applying 503B standards in “Form FDA-483” investigations and will not include observations in its Form-483 based “solely” on FDA’s good manufacturing practice (CGMP) requirements under 503B, unless it appears that pharmacies are compounding drugs that do not qualify for the 503A exemptions.
HealthDay (7/11) reports several common operations can slightly increase a patient’s risk of becoming addicted to opioids, according to a new study published in JAMA Internal Medicine. Researchers examined the number of opioid prescriptions patients filled before and after 11 common operations in order to determine how many patients became addicted to opioids following surgery. MedPage Today (7/11, Fiore) reports the 11 procedures that the study focused on were: “total knee arthroplasty, total hip arthroplasty, laparoscopic cholecystectomy, open cholecystectomy, laparoscopic appendectomy, open appendectomy, cesarean delivery, functional endoscopic sinus surgery [FESS], cataract surgery, transurethral prostate resection [TURP], and simple mastectomy.” Researchers found that some of the procedures, including total knee arthroplasty, laparoscopic cholecystectomy [gall bladder removal], and cesarean delivery, increased patients’ risk for becoming addicted to opioids, while there was no increased risk of opioid addiction for patients who underwent “cataract surgery, laparoscopic appendectomy, FESS, and TURP.” HCP Live (7/11, Scott) points out that the study found that the patients who underwent the surgeries in question showed “only a slightly elevated risk of becoming addicted to opioids compared to that of the population as a whole.” Dr. Eric Sun of Stanford University said, “While we found that surgical patients are at an increased risk for chronic opioid use, the overall risk for chronic opioid use remains low among these patients, at less than 0.5 percent for most of the procedures we examined.”
- The FDA notice is effective August 1 (and does not apply to current or past inspections).
- Going forward, FDA will need inspectional evidence regarding section 503A to be reviewed, prior to the close of an inspection, and to be taken into consideration in decisions about what to include in any Form FDA-483.
- FDA acknowledges that “because a Form FDA-483 does not represent a final Agency determination regarding a firm’s compliance, formerly, FDA investigators have been identifying deviations from drug production practices on Forms FDA-483 that could lead to quality problems without regard to whether the observations related to CGMP deficiencies or other deficiencies …”
- FDA intends to continue to inspect compounding facilities and to take action, as appropriate, when the agency identifies violations of Federal law that could put patients at risk.
Common Surgeries May Raise Risk for Opoid Dependence
New Antimicrobial Stewardship Standard Issued by The Joint CommissionBETHESDA, MD 27 Jun 2016—The Joint Commission on June 22 issued a prepublication version of the new antimicrobial stewardship standard for hospitals, critical access hospitals, and nursing care centers and stated that it becomes effective January 1.
This new medication management standard has eight so-called elements of performance. One of these requires accredited healthcare organizations to have an "antimicrobial stewardship multidisciplinary team" and, when available in the healthcare setting, at least one pharmacist on that team.
Click HERE to view the pre-publication
Topline Results Positive for Cannabidiol in Lennox-Gastaut
Following release in March of positive topline results from a phase 3 trial of an investigational cannabidiol product (Epidiolex, GW Pharmaceuticals) in patients with Dravet syndrome, GW Pharmaceuticals has now announced more positive results, this time from a phase 3 study in patients with Lennox-Gastaut syndrome (LGS).
Like Dravet syndrome, LGS is a rare and severe form of epilepsy that begins in infancy or early childhood. Epidiolex is a liquid formulation of pure plant-derived cannabidiol, a nonpsychoactive component of the cannabis plant. Read the news release HERE.
|IN THE LITERATURE||ANNOUNCEMENTS||FUTURE CE EVENTS|
Idaho Board of Pharmacy Board Meeting
October 26th - 27th, 2016
Location: Boise - Idaho Capitol
For additional information on times and locations, click HERE.
ASHP Midyear Clinical Meeting
Las Vegas, NV
December 4 - 8, 2016
Click HERE for more info
NABP teams with ACPE for paperless CPE records. Go to the NABP Web site here to set up your e-profile and obtain your unique pharmacist identifier number.
The Idaho Society of Health-System Pharmacists is the only state pharmacy association in Idaho that is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.
Apply for a Research Grant The Idaho Pharmacy Research and Education Foundation (IPREF) was established by ISHP and has a small fund to support pharmacy research. For more, click here.
Drug Shortages For the latest news on Drug Shortages check out ASHP's site for updated news on the issues you care about most.
Vaccine Refresher www.cdc.gov/vaccines/default.htm
Last updated August 24, 2016 - JVN