Insights and updates from Gates Healthcare Associates
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OUT OF THE GATES


Compounding pharmacy is back in the news in a big way. Another lengthy NECC trial has started here in Boston, where prosecutors have charged the supervisory pharmacist for his role in the tragic meningitis outbreak -- which started five years ago this month.


Meanwhile, the FDA is ramping up regulation of outsourcing facilities, the category of compounder ("503B") that voluntarily registers with the agency and must meet more stringent CGMP requirements. According to this recent news story, along with this statement from FDA Commissioner Scott Gottlieb, the agency aims to encourage more compounders to register, mainly by adjusting the agency's enforcement priorities based on size and riskiness.

The rub, as always, with any new federal guidance for our profession will be how it relates to -- or conflicts with -- the authority of state boards of pharmacy, particularly when it comes to patient-specific prescriptions.

Gates Healthcare Senior Associate Ken Speidel, RPh, PharmD, recently focused on these and other issues related to the Drug Quality and Security Act during a recent webinar hosted by Medisca. In the days ahead, our entire team will be closely monitoring these developments and continuing to advise our clients on how to best navigate the regulatory waters as they meet the needs of their providers and patients.

Best wishes.

Sincerely,
Ernest P. Gates Jr., RPh, FASCP, FIACP, FACA
President, Gates Healthcare Associates

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Caring for Our Seniors

Gates Healthcare is excited to provide expert guidance to those caring for our senior citizens. Through a new specialized service, long term care clients such as pharmacies and skilled nursing facilities will benefit from subject matter experts in the areas of compliance, reimbursement and safety.

Our team will lead clients through the increasingly complex regulatory and reimbursement landscape, offering simple and actionable solutions that empower clients to remain focused on their essential work of caring for seniors. Among the services are:
  • Billing & Reimbursement - Medicare parts A and D, state Medicaid, managed care
  • Payment Integrity - Pharmacy pricing and fees, cost-effective therapy
  • Clinical Services - Therapeutic interchange, formulary compliance, drug utilization, clinical programs (anticoagulant, diabetes, pain)
  • Quality Assurance - CMS compliance
  • Pharmacy - Management, medications, infusion, electronic medical records, automated dispensing systems, nursing, education 
  • Regulatory & Legislative Issues - FDA, DEA, CMS, Board of Pharmacy
  • Contract Negotiation
 
Denise Frank Honored by Minn. Pharmacist Group

DENISE FRANK
Denise M. Frank, RPh, an Associate with Gates Healthcare Associates, has received special recognition by the Minnesota Pharmacists Association.

The group awarded her the Bowl of Hygeia at its recent annual meeting. The award recognizes pharmacists who possess outstanding records of civic leadership in their communities.

"It was unexpected and I am both thrilled and humbled by this recognition by my peers," said Frank, who is a licensed pharmacist in Minnesota.

Frank joined the Gates Healthcare team of expert consultants in early 2017. She is a longtime pharmacist and training specialist in the areas of pharmacy practice, compounding, community pharmacy accreditation and operation compliance, medication therapy management, and regulatory compliance. She previously served as the accreditation and inspection services manager for the National Association of Boards of Pharmacy.
Healthy Headlines .....................................................

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Below are several news stories on compounding and other pharmacy-related topics. Click on the headlines for more:

Proposed Drug Law Raises of Another Compounding Tragedy

Doctors Tells of Patient Deaths in NECC Meningitis Outbreak

CNN Will Limit Opioid Prescriptions to Seven Days

Amazon Reportedly Talking to Pharmacy Benefit Managers

UCLA's Compounding Pharmacy Faces Sanctions

COMPOUNDING SOPs
Gates Healthcare Associates has everything a compounder needs for SOPs - Standard Operating Procedure manuals for sterile, non-sterile and hazardous drug compounding.

Our SOP templates, developed by Gates Healthcare Senior Associate Joe Cabaleiro, RPh, can be customized for a particular pharmacy's practice and scope of services.

STAY CONNECTED:
Gates Healthcare Associates is a pharmaceutical and healthcare consulting firm that provides extensive clinical, programmatic, and regulatory knowledge and insight to an array of organizations nationally and abroad. We help our clients confront and overcome challenges and obstacles to growth, positioning them for long-term business success.

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