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A federal judge...tossed the convictions of a co-owner and former employee of a Massachusetts compounding pharmacy accused of conspiring to help it evade regulatory oversight before its drugs caused a deadly 2012 fungal meningitis outbreak...U.S. District Judge Richard Stearns in Boston ruled that New England Compounding Center co-owner Gregory Conigliaro and former employee Sharon Carter did not have fair warning their actions could subject them to prosecution...Jurors convicted Conigliaro and Carter of conspiring to defraud the U.S. Food and Drug Administration by misleading it into thinking NECC was operating like a conventional pharmacy and not like a drug manufacturer...State-regulated compounding pharmacies produce customized drugs pursuant to patient-specific prescriptions to address individual needs. But prosecutors said NECC was actually a drug manufacturer making medications in bulk...READ MORE

Board Members
Leo Basch, PharmD, RPh, Las Vegas
Robert Sullivan, Reno
Jason Penrod, PharmD, RPh, Reno
Kevin Desmond, RPh, Reno
Wayne Mitchell, PharmD, RPh, Carson City
Melissa Shake, PharmD, RPh, Las Vegas
Jade Jacobo, PharmD, JD, RPh, Las Vegas

Retirement of the Executive Secretary
- Larry L. Pinson, PharmD, RPh

New Reno Office -
985 Damonte Ranch Parkway, Suite 206, Reno, NV 89521.

Board Member Update

Nevada Medicaid Initiates Antibiotics Prior Authorization Criteria - Nevada Department of Health and Human Services

National Pharmacy Compliance News

Final Guidance Documents Address FDA Policies Related to DSCSA

First FDA-Approved Drug Containing Extract From Cannabis Plant to Be Placed in Schedule V

ASHP Guidelines Provide Recommendations for Preventing Patient Harm From Medication Errors

FDA’s Final Guidance Documents Address Compounding and Repackaging of Radiopharmaceuticals

Pharmacy Toolkit Encourages Conversations With Patients About Prescription Opioids

Biosimilars Added to FIP’s Policy on Pharmacists’ Right to Substitute a Medication

FDA Offers CE Course on Reducing Hypoglycemic Events in Patients With Type 2 Diabetes - Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemic Events in Patients with Type 2 Diabetes

The Food and Drug Administration last week warned that differences in how drugmakers and compounders label the strength of injectable drugs may lead to dangerous dosing errors..."Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently,"...For small volume parenteral drugs and biologics, FDA recommends that strength per total volume be the primary and most prominent expression of strength, followed by strength per milliliter enclosed by parentheses...two recent MedWatch reports cited medication errors that led to patients overdosing on compounded injectables that featured strength per milliliter more prominently on the labels than the strength per total volume...Such mix-ups could be avoided...if compounders were to follow the same labeling conventions as traditional drugmakers, though FDA does not review the labels of compounded drugs before they are sold.

With the recent deaths of Spade and Bourdain, health care professionals are also concerned about suicide contagion, a phenomenon in which high-profile suicides influence patients to attempt or committ suicide themselves...pharmacists can play a key role in preventing suicide...pharmacists are ideally situated to assist those in need because of their frequent interactions with patients and access to medical records...However, pharmacists are often unprepared to properly respond to signs of suicide risk, as very few pharmacy schools incorporate suicide prevention courses into their curricula...here are 5 ways pharmacists can help patients who are contemplating suicide...

1. Identify at-risk patients.
2. Monitor medication use and mental health.
3. Collaborate with the health care team.
4. Refer to suicide prevention resources.
5. Be encouraging and empathetic.

The Dutch hospital (Erasmus Medical Center in Rotterdam) has been offering it (lutetium octreotate) to patients for more than a decade at 16,000 euros ($18,000) for one course of treatments. Drug firm Novartis, which in 2018 acquired rights to sell it in Europe, is asking more than five times that for its proprietary version, Lutathera...Thomasa (Emar Thomasa) is part of a protest against high drug prices launched by an unlikely group of rebels: Dutch pharmacies...Amsterdam’s University Medical Center (UMC) and the Transvaal Pharmacy in The Hague - have vowed to bypass drug company products and make treatments for a handful of rare diseases themselves, exercising their right to “compound” medicines...Drug companies have raised concerns about the safety of compounded medicines that have not been approved by European regulators. But the specialized compounding pharmacies, which have on-site laboratories, have been backed by the Dutch government as part of efforts to tame rapidly rising medicine costs...READ MORE

Today we’re updating some of our proposed policies related to these outsourcing facilities. Among our goals is to make it more feasible for compounding pharmacies to become outsourcing facilities...ottlieb said the FDA’s aim for this guidance is to recognize the differences in drug production between outsourcing facilities and conventional drug manufacturers. The guidance is intended to provide clarity on quality assurance, maintaining suitable facilities, sterility, stability testing, and beyond-use or expiration dates for products that don’t go through the FDA drug approval process...This revised draft guidance includes...revisions related to release testing, stability testing and beyond-use dating, as well as policies that differentiate between the production of sterile and non-sterile drug products...

Medical errors of all kinds, including medication errors, are now the third highest cause of death in the United States and may be responsible for 10% of all deaths in the country, according to a 2016 study by Johns Hopkins Medicine. According to the National Academy of Medicine, preventable medication errors harm 1.5 million Americans annually and cost hospitals an additional $3.5 billion each year...“I think the problem is becoming worse because this is a complex medical system that we have,”...Strategies to prevent medication errors in recent years include a move to electronic prescribing and adding barcodes to drug products. But experts say these efforts have not eliminated the need for vigilance among pharmacists, technicians, and other healthcare professionals in the community and hospital setting. Here’s more on the actions pharmacists need to take to avoid some of the most common medication errors.

• Processing Errors
• Dosage Errors
• Care Transition Errors
• Alert Fatigue Errors
• Other Errors
• Technology on the Horizon

Endo International Plc said...the U.S. health regulator has decided...not to include blood pressure treatment vasopressin in its list of drugs that can be used in compounding, in a boost to the drugmaker that makes the only FDA-approved version of the product...The company had sued the Food and Drug Administration in October 2017, alleging that the agency had improperly authorized the bulk compounding of hundreds of drugs, including “essentially a copy” of Endo’s Vasostrict...The agency’s decision renders the sale of compounded products containing vasopressin unlawful, unless manufactured using an FDA-approved product, Endo said...READ MORE

What I’m(Michael Hogue, president-elect of the American Pharmacists Association) hearing from these recent graduates, as well as from seasoned pharmacists, is:

• Public and private payers are looking to pay the lowest price for prescription drugs;
• The community pharmacy business model no longer supports sufficient staffing, leaving little time for patient care, and in some cases jeopardizing patient safety;
• Pharmacists, now largely employed by a corporate entity rather than through private practice, feel they have little control over their practice environment and professional judgment;
• The number of pharmacists in many markets is leading to fear among some of losing their jobs or experiencing lower wages if they do not meet productivity metrics as more technical tasks are delegated to technicians;
• Full-time employment is sometimes hard to come by as a pharmacist; and
• Young pharmacists have tremendous personal debt from college.

The American Pharmacists Association...adopted a policy on the pharmacist workplace environment and patient safety. The policies serve not only as guiding statements and principles for the profession, but are frequently referenced when key policy and legal decisions are at play. In addition...APhA board of trustees has incorporated pharmacist well-being initiatives as core to our strategic plan. Among other efforts, we are building tangible resources to assist individual pharmacists with practice challenges, professional satisfaction, recognition and personal well-being...APhA is working with other professional organizations and employers to seek legislative changes at the state and national levels that will result in recognition of pharmacists as providers of care. Coupled with changes that remove unnecessary barriers to the use of technologies and technicians, this will lead to new opportunities for the patient care we are capable of providing, allowing the business model to shift.

Pharmacy owners who ask themselves the following 5 questions on a weekly basis will find that this exercise helps them create the pharmacies that they want, ones that matter in their communities and ones that help create lifestyles that benefit their families.

1. Is what got me where I am today going to get me where I want to go tomorrow?
2. Have I differentiated myself in the marketplace?
3. Am I organizing my time, effort, and other resources around winning strategies and great marketing to build the future I want, or am I still clinging to the status quo, which is based on yesterday’s breadwinners and today’s mistakes?
4. Am I focusing each hour of every single working day on those few activities that contribute the most to increasing cash flow and profits?
5. What do potential patients value most that they are not finding from me and are seeking from my competitors?