Multi-state Outbreak of Burkholderia cepacia Infections
Update July 8, 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 firstname.lastname@example.org. Members of the media should contact the CDC Media Office at email@example.com.
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.
- 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
- 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.”
Dear ASHP Member:
Have you voted in ASHP's 2016 Election?
This is an important opportunity for you to participate and select ASHP's leaders.
Voting for the ASHP 2016 Election is open until 12:00 midnight, July 28, 2016.
Your ballot has been customized for you. It contains only the names of the candidates for whom you are allowed to vote. Remember, Section members are only allowed to vote in the one section previously designated as their primary section.
To vote, you will need your Election Validation Number and your ASHP I.D.
2016 ISHP ANNUAL FALL MEETING &
60th ANNIVERSARY CELEBRATION
MARK YOUR CALENDARS TO JOIN YOUR COLLEAGUES!
September 23rd - 25th, 2016
Sun Valley, Idaho
Registration will Open in August, but you can book your discounted room today!
CDC reports increase in HPV-associated cancer incidence
Morbidity and Mortality Weekly Report (07/07/16) Vol. 65, No. 26, P. 661 Viens, Laura J.; Henley, S. Jane; Watson, Meg; et al.
Nearly 39,000 human papillomavirus (HPV)-associated cancers were diagnosed annually from 2008 through 2012, up from 33,369 cases seen from 2004 to 2008, according to CDC. For the study, CDC used data from population-based cancer registries that participate in its National Program of Cancer Registries and the National Cancer Institute's Surveillance, Epidemiology, and End Results program. CDC found that approximately 23,000 of the HPV-associated cases were among females. Cervical carcinomas and oropharyngeal squamous cell cancers were the most common HPV-associated cancers diagnosed. Rates of all HPV-associated cancers varied widely by state, with 7.5 per 100,000 persons in Utah and 14.7 per 100,000 in Kentucky. CDC noted, however, that many states with overall HPV-associated cancer rates that were higher than the U.S. rate of 11.7 per 100,000 were in the U.S. Census Southern region. An estimated 79% of the HPV-associated cancers were attributable to HPV. Of those cases, 80% were attributable to HPV types 16 and 18, which can be prevented with the bivalent, quadrivalent, and 9-valent HPV vaccines, and 12% were attributable to five additional HPV types (31, 33, 45, 52, 58) that can be prevented by the 9-valent HPV vaccine. CDC also stressed the importance of regular cervical cancer screening in women, to detect pre-cancerous lesions before they develop into cancer.
New Antimicrobial Stewardship Standard Issued by The Joint Commission
BETHESDA, 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-GastautFollowing 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
August 3-4, 2016
Location: Boise TBD
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
Meeting website will launch
on July 14, 2016
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 July 15, 2016 - JVN