Mitch G. Sobel, RPh, MAS, FASHP

I wish to thank everyone for all of the kind words and support extended towards me from the NJSHP Board and membership. It is an honor and privilege to serve as your President for the second time. I would like to share some insights from the House of Delegates Session at the ASHP Summer meeting in Denver, Colorado. Rob Adamson, Russ Lazarro, Carlo Lupano, and me represented NJSHP and submitted some recommendations and amending language for ASHP policy consideration:

• Amending language for policy statement regarding medical marijuana. Requested that ASHP provide guidance and clarification regarding the DEA classification and legal issues involved with the handling, dispensing, and distribution of marijuana by pharmacists. Many state and Board of Pharmacy regulations may contradict Federal rules and guidelines concerning medical marijuana use. This contradiction places many pharmacists at risk for litigation under their respective states’ law.
• Recommendation for clinical practice policy regarding human genome transfer therapy. Requested that ASHP provide clinical practice guidelines regarding the new field of human genome transfer therapy.
• Recommendation for increased pharmacist to patient ratio. Requested ASHP advocate increasing the number of pharmacists and pharmacy technicians per patient to support the pharmacy practice model initiative (PPMI).
• Recommendation for pharmacy technician licensure and continuing education requirements. Requested ASHP advocate that pharmacy technicians are licensed in a manner similar to pharmacists. This includes a national standard of testing, training, and continuing education requirements.

We received numerous positive comments about our New Jersey Delegation’s contributions to the ASHP House of Delegates Caucuses and Sessions. I was very proud and humbled to be a part of such a dynamic team.

The big topic of ASHP for the week was the Pharmacy Practice Model Initiative. To summarize, this initiative advocates the advanced practice of pharmacists at the patients’ bedside by utilizing education, technology, and pharmacy technicians. This is a focused shift of moving from a distributive practice model to a clinical and cognitive practice model. Specifically, the ultimate goal is to establish the pharmacist as a direct care provider and integral part of the medical team. Pharmacy leaders must insert their pharmacy staff into medical teams and committees to provide value and impact patient care as a vital team member. This leadership has to commit to education and developing our future leaders of our profession. It is so important to build relationships with healthcare providers so that they understand and support our pharmacy practice initiatives and goals. Hospitals have a nurse, physician, and even environmental service workers on every patient care area. It’s time that a pharmacist should be stationed on every patient care area. We must advocate, market, and justify this expectation and not rest until our profession’s value is seen and our voices are heard. Together we can change the course of our practice and make the pharmacy practice model initiative a reality. For more information regarding the PPMI, please log on to www.ashp.org

By the time you get to read this article July 1st may have come and gone, as well as another delay in the start of New Jersey’s Medical Marijuana Program.

Last year the New Jersey Delegation to the American Society of Health-system Pharmacists (ASHP) asked the Board of Directors to consider the current policy in light of NJ’s pending implementation.

As it turns out, a year has gone by and nothing yet has happened in New Jersey.

As a reminder, New Jersey’s program, unlike the rest of the country, is the most restrictive. It requires a standing patient-prescriber relationship, specific diagnosis and limits on the amount a patient can obtain, the maximum concentration of Medical marijuana, 10%, etc.

Unlike the rest of the country where programs are extremely loose and not as specific, the NJ program even had a follow-up quality portion to get feedback and data on efficacy.

It may all be in vein at this point because the current new governor is holding off on approval and implementation of the program.

The true stumbling block for NJ pharmacists, and practice sites is the legality over the procurement, storage and dispensing, since Marijuana, other than the FDA approved product Marinol is: a) not FDA approved, b) classified as a Schedule I Controlled Dangerous Substance, and c) lacks evidence based literature to support its efficacy and use.

The situation was recently made worse by the fact that the State Attorney General was officially asked if they would prosecute anyone handling Medical marijuana, which in essence means no one can do anything until the State Attorney General weighs in on that decision.

Hence, the ASHP did not endorse the use of medical marijuana for anything other than research purposes and did state that the DEA should reclassify medical marijuana as a schedule II.

Most of the delegates at the ASHP House felt that NJ new law might pass as research since follow-up on efficacy is part of the State’s requirement, that in reality that might be a stretch.

So, the current status of medical marijuana use in the state leaves hospitals, pharmacies and especially pharmacists in a quandary as how to handle a patient who arrives with their own supply of medical marijuana, even if the state final approves and starts the program.

More too come! Thanks!

Register for free at pharmacypracticenews.com to search for the article Pharmacists’ Role in Medical Marijuana Remains a Bit Hazy ~ ASHP House of Delegates vote may yield more direction by Charlotte Huff

NEW JERSEY SOCIETY OF HEALTH-SYSTEM PHARMACISTS 2012 ANNUAL MEETING/EXHIBITION & INSTALLATION DINNER
FRIDAY, APRIL 20, 2012

HILTON EAST BRUNSWICK
3 TOWER CENTER BLVD.
EAST BRUNSWICK, NEW JERSEY
(732) 828-2000

PLEASE MARK YOUR CALENDAR!

North Central Chapter
July 20, 2011
Topic: HIV
Location: Wallace Auditorium at Overlook Hospital
99 Beauvoir Avenue
Summit, NJ
Time: TBA
Speaker: Saira Choudry, PharmD

August 2011
Topic: Astma
Location: Wallace Auditorium at Overlook Hospital
99 Beauvoir Avenue
Summit, NJ
Time: TBA
Speaker: Sonia Patel, PharmD, BCPS
Hunterdon Medical Center

ASHP and the ASHP Research and Education Foundation are launching a PPMI Webinar Journal Club which will offer CE credits. There will be monthly webinars from July-November 2011 which will support the implementation of PPMI. Registration is now open for the July webinar, and future registration links will be posted in the webinar section of the PPMI Website.

The webinars will include a 15- to 20-minute discussion of the article followed by a moderated discussion. This continuing pharmacy education (CPE) activity is designed for pharmacists and pharmacy technicians who work in hospitals. There is no charge for participating in the webinars. More information can be found on the PPMI Website.

Registration Web Link

Celebrate your hard work and dedication in your pharmacy career! Share your accomplishments with NJSHP! Our monthly Newsbriefs is an excellent opportunity to provide education and information about your contributions to the practice of pharmacy. Your story can be an inspiration to others! So don’t be shy. To submit your contribution, please contact Stella Williams at 609-936-2205 or email at swilliam@njha.com. We’d love to hear from you!

Get into the Society Spirit and order your state pin today. State pins can be ordered easily through the NJSHP website.

Cheryl A. Thompson BETHESDA, MD 14 June 2011 — Bedford Laboratories, distributor of drugs manufactured by Ben Venue Laboratories Inc., on Monday issued a public notice about the company's eight-week-old recall of indomethacin for injection lot 1948138.

The recall, the company said, is occurring because sample vials in the lot contained more than the allowable amounts of particulates equal to or greater than 10 µm or 25 µm or both.

These particulates have been identified as "active drug substance," the company added.

Indomethacin for injection contains indomethacin sodium. The labeling states that the drug is administered to premature infants to close a hemodynamically significant patent ductus arteriosus.

Bedford said it notified its wholesalers and distributors on April 19 about the recall.

Read More

Influential Researcher and Author Honored
6/14/2011 BETHESDA, Md. —The American Society of Health-System Pharmacists (ASHP) has named Lawrence A. Trissel, FASHP, an honorary member of the Society for his sustained contributions to health-system pharmacy practice and dedicated service to the organization. Trissel will receive the honor today during ASHP’s Summer Meeting in Denver.

Trissel is a noted leader in health-system pharmacy, researcher, and author. He is best known for authoring the Handbook on Injectable Drugs through 16 editions, Lawrence Trissel is also author of the vast Trissel’s 2 Clinical Pharmaceutics Database, the largest electronic database of its kind ever assembled. Additionally, he is the author of Stability of Compounded Formulations, Calcium and Phosphate Compatibility in Parenteral Nutrition, Stability-Indicating HPLC Methods for Drug Analysis, and Trissel’s Tables of Physical Compatibility, among others.

Read More

Lauded for Her Landmark Research
6/14/2011 BETHESDA, Md. — The American Society of Health-System Pharmacists (ASHP) today honored Marie A. Chisholm-Burns, Pharm.D., M.P.H., FCCP, FASHP, with the ASHP Board of Directors Award of Excellence in recognition of her landmark research analysis published in 2010 demonstrating the positive impact of pharmacists-provided direct patient care on patient outcomes.

Chisholm-Burns is professor and head of the department of pharmacy practice and science at The University of Arizona (UA) College of Pharmacy. She also has joint appointments as professor in the department of surgery at The UA College of Medicine and the division of health promotion sciences at The UA College of Public Health.

Read More

Cheryl A. Thompson BETHESDA, MD 13 June 2011 — FDA on June 10 approved the marketing of ezogabine, or Potiga, as add-on therapy for the treatment of partial seizures in adults.

The agency said the drug is the first neuronal potassium-channel opener developed for the treatment of epilepsy.

Valeant Pharmaceuticals International Inc. and GlaxoSmithKline, which collaborated to get FDA's approval of ezogabine, said the new product will likely be available in pharmacies by year's end.

The companies said FDA has recommended ezogabine for regulation as a controlled substance.

As yet, the Drug Enforcement Administration, which has the authority to schedule ezogabine, has not commented publicly on the issue.

Once the Drug Enforcement Administration completes is decision-making process, the companies said, Potiga's prescribing information and medication guide will be available.

Read More

The American Society of Health-System Pharmacists (ASHP) has released the results of the National Survey of Pharmacy Practice in Hospital Settings: Prescribing and Transcribing 2010. A randomized sample of 1,968 pharmacy directors at general and children's medical-surgical hospitals participated in the annual survey. Based on their responses, survey authors found that the role of pharmacists in healthcare continues to expand. As study author and ASHP vice president Douglas J. Scheckelhoff explains “Throughout the survey, there is significant evidence that pharmacists’ unique expertise is sought after and valued by other healthcare providers. This includes the increase in hospitals providing 24-hour review of medication orders by pharmacists and the growing ways that pharmacists provide leadership in the medication-use system.” Specific findings include that 60 percent of pharmacy directors say P&T committees are highly effective at "increasing safety," and that significantly more prescribers accept pharmacist recommendations regarding antibiotic use (55.5% in 2001; 94% in 2010), pain management (65% in 2001; 98.9% in 2010), dosage adjustment (72.7% in 2001; 99.3% in 2010), and anticoagulation therapy (73.2% in 2001; 98% in 2010). They also found that many more pharmacists are providing advice through consultations at hospitals in areas including dosage adjustment (88.1% in 2001; 98.1% in 2010), drug information (91.9% in 2001; 98.1% in 2010), pharmacokinetics (76.9% in 2001; 90.6% in 2010), antibiotics (78.8% in 2001; 83.8% in 2010), and anticoagulation (33.8% in 2001; 64.8% in 2010). The full results of the survey can be found in the American Journal of Health-System Pharmacy at http://www.ajhp.org/content/68/8/669.abstract

The FDA has announced safety label changes for simvastatin (Zocor), simvastatin/niacin (Simcor), and simvastatin/ezetimibe (Vytorin) because the highest approved dose--80 milligram (mg)--has been associated with an elevated risk of myopathy, particularly during the first 12 months of use. Based on this finding, the agency recommends that simvastatin 80 mg be used only in patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity. It should not be prescribed to new patients. There are also new contraindications and dose limitations for when simvastatin is taken with certain other medications. The full list of these new limitations can be found at www.fda.gov/Drugs/DrugSafety/ucm256581.htm#Simvastatin_Dose_Limitations

The Everest Institute has introduced a new pharmacy technician education program at its campus in Tigard, Oregon that will begin on June 28. The 720-hour program provides both technical and practical training on pharmacy calculations, drug distribution systems, and preparation of sterile dosage forms. The program also includes an externship of 160 hours, which prepares the student for the actual work setting. Upon completion of this program, the graduate will be fully prepared to take the national pharmacy technician certification exam offered by the Pharmacy Technician Certification Board (PTCB).

A shortage of medications for a variety of illnesses has hospitals searching for substitutes to prevent patient harm, but delays in treatments have occurred in some cases. The problem of short supplies or even unavailable medicines is not new, but it is getting significantly worse, with the number of shortages tripling over the past five years to 211 medications. While some of those shortages from last year have been resolved, another 89 drug shortages have occurred in the first three months of 2011, according to the University of Utah's Drug Information Service, which tracks shortages for the American Society of Health System Pharmacists.

An FDA advisory panel has recommended that dosing for children's acetaminophen (Tylenol) be changed so that it is based on weight instead of age. The panel also recommended that a standard label be used for all products and that any age-associated weight tables be updated to indicate the rise in the average weight of children in the past 20 years.

Seminole State College in Oklahoma began offering a Pharmacy Technician Certification on June 7 that will run through Aug. 2. The 50-hour course is designed to prepare students for the Pharmacy Technicians Certification Board (PTCB) exam. Course content includes medical terminology specific to the pharmacy, reading and interpreting prescriptions and defining drugs by generic and brand names. Students will learn dosage calculations, I.V. flow rates, drug compounding, dose conversions, dispensing of prescriptions, inventory control, billing and reimbursement.

Representatives from FDA have an article appearing in today's NEJM to discuss the FDA Final Rule on IND safety reporting. This article provides further color on the FDA's thinking behind the Rule. For further information go tohttp://healthpolicyandreform.nejm.org/?p=14665&query=home

A recent study has found that longer emergency department (ED) wait times may be associated with more patient deaths and hospital admissions. The study authors found that the longer the patient stayed in the ED waiting room, the more at risk he or she was for an adverse event. "For every extra hour of mean length of stay in an emergency department, in similar patients at the time of presentation, there is an association with increased seven day mortality and admission to hospital in those who are discharged home or leave without being seen," they said. "Waiting times have important implications for patients who attend emergency departments, most of whom go home after their visit." However, patients who left without being seen were not associated with adverse events.

Malignant hyperthermia (MH), although an uncommon condition, can present in an ambulatory surgery center (ASC) utilizing general anesthesia, and patient safety protocols should include preparation for managing this condition. Blue Chip Surgical Partners Vice President of Operations Regina E. Dolsen, RN, BSN, MA, recommends several measures to help manage MH. Facilities should have a properly stocked MH cart or kit, with the required and non-expired drugs (dantrolene), equipment, supplies, and forms, immediately accessible for all operating rooms. Organizations should also have organizational protocols for treating patients with known history of MH and a point person to be responsible for MH preparation. When preparing for an MH event, Dolsen says, "It should be a hands-on drill. It should include the mixing of the dantrolene and physically preparing it." An education and training program for new employees should include updated training tools and time for questions and answers. In addition, facilities should provide a role for the consulting pharmacist in training or keeping protocols current, and should clearly define the role and responsibility of anesthesia. The cart or an otherwise designated area should have visual aides that review the steps for recognizing the situation and providing immediate treatment. Institutions should also be aware of the MH Hotline, which provides medical professionals with access to MH experts around the clock. During an MH event, there should also be concise forms to use as well as specific transfer protocols and methods for cost-effective management of supplies and medications.

When cleaning up after a serious storm, there is a high risk of injury. Although swift first aid is usually sufficient for preventing infection in small wounds, medical care should be sought for more serious cuts or wounds because of the threat of tetanus. The Chattanooga-Hamilton County Health Department in Tennessee notes that immunization is one of the best ways to prevent tetanus, as is the use of protective gear such as heavy gloves and sturdy shoes when handling storm debris. Adults and children should receive a routine tetanus vaccination every 10 years. Cuts or puncture wounds should be cleaned with soap and water, and a healthcare provider may need to be consulted. Healthcare providers, immunizing pharmacists, and all local health departments usually offer tetanus vaccines.