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News & Press: PSHP News

President's Letter - October 2019

Friday, October 25, 2019  
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Hello Fellow Pharmacy Colleagues - 

Being involved with the Pennsylvania Society of Health-System Pharmacists is an exciting way to quench my thirst for up to date knowledge on regulatory compliance, mechanisms to advance pharmacy practice initiatives and staying current on hot clinical topics!  Looking forward, the coming year will bring great for networking and knowledge at the Annual Assembly in King of Prussia this coming week.  I personally am incredibly grateful for the opportunities to advocate on behalf of hospital pharmacy and patients from my past years on the legislative committee and the PSHP Board, and now as joining the ranks of some awesome hospital pharmacists that have come before me!

Tuesday was the Pennsylvania Board of Pharmacy Meeting in Harrisburg, and two major topics discussed were mandatory electronic prescribing of controlled substances and the Pennsylvania Board of Pharmacy’s response to USP’s delay of Chapter <797> and <795> implementation, enforcement of USP 800. 

Electronic Prescribing of Controlled Substance (EPCS)

The Pennsylvania Department of Health is going live with the mandatory implementation of electronic prescribing of controlled substances (Schedule II – V) effective October 24, 2019. Per Act 96 (passed into law in Oct of 2018), all practitioners must comply by electronically sending prescriptions for controlled substances directly to pharmacies.  There are exceptions for a patient, for example patients enrolled in a hospice program or residing in a nursing home or residential health care facility, periods of unplanned technology down time.  There is also ability for practitioners to apply for a waiver for delayed implementation, such as prescribers without an electronic medical record.    The Department of Health’s website (which was just update in Sept 2019) is a good source of specifics.  Additionally, an FAQ from the commonwealth is attached.  

The Board of Pharmacy is making it clear that pharmacists are not the regulators, and cannot deny filling a controlled substance to patients based solely to the presentation of a paper prescription.  It is expected for pharmacists to continue to scrutinize paper prescriptions for fraud, and act accordingly if fraud is suspected.  It is not expected for pharmacists to report prescriber or to request information as to if a prescriber has a waiver. 

The Department of Health intends to audit practitioners with administrative penalties of $100 per violation for the first – 10th violations and moving up to $250 per violation thereafter with a max of $5,000 per year.  However, this shall not be reported by the DOH to the practitioner’s appropriate licensing board and shall not be considered disciplinary action.

Department of Health Website on Electronic Prescribing of Controlled Substance (EPCS)

Delay of USP <797> <795> Implementation, effects on USP <800> Enforcement

Today the pharmacist board members, board secretary and legal counsel had a powerful conversation about the US Pharmacopeia’s September 23rd announcement of the postponement of the implementation date of the revised Chapters <797> - Sterile Compounding, <795> - Non-Sterile Compounding and <825> Radiopharmaceuticals and what effects it has on the PA’s new compounding regulations implementation and enforcement.

For those of you wondering why USP delayed implementation, it did so through following its own bylaws on appeal processes.  The new versions proposed significant revisions to the beyond use dating of both compounded sterile preparations (CSPs) as well as non-sterile compounded preparations (NSCPs).  Some organizations (such as the International Association of Compounding Pharmacy and others) have expressed disagreement on the level of scientific evidence surrounding the new shortened BUDs as well as changes to the allowance to extend BUDs.

At home in Pennsylvania, the Compounding Regulations were finalized in April of this year.  The specific wording reads:

27.601. Compounding of preparations.

The compounding of sterile and nonsterile preparations shall be done in accordance with section 503a of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. § 353a), Federal regulations promulgated thereunder, and the current version of the USP chapters governing compounding.

The authors of the regulation intended this to allow for Pennsylvania pharmacists to follow the most up to date versions of USP’s applicable compounding chapters, as USP is written by a panel of experts and under goes a rigorous peer review and public comment process, and is continuously updated.  Thus the PA compounding regulations are flexible and allow inspectors to survey for and enforce the current posted versions of USP <797> (2008) and <795> (2014) today, and then when new versions are approved and implemented, the board can begin enforcing the future them. 

The next question discussed, with input from Board Prosecution Liaison was “Where does the enforcement of USP 800 stand?”

Per the US Pharmacopeia website:

General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings is not subject to any pending appeals and will become official on December 1, 2019. During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendially applicable. USP encourages utilization of <800> in the interest of advancing public health” 

The purposed new versions of USP <797> and <795> directly reference USP 800 for the respective sterile and non-sterile compounding of Hazardous Drugs, while the current versions do not mention USP <800>.

Since PA Compounding Regulations are currently reflecting to and enforcing the current versions of USP <797> and <795>, and neither of these versions mention USP 800, at this time the BOP inspectors will not be enforcing USP 800. 

However, Board Inspectors do care about informational chapters and it would be expected that if they notice issues concerning healthcare worker exposure to hazardous drugs, they would share such information with the pharmacy being inspected.  (Unofficially, board inspectors may likely take notice of facilities’ stage of working towards compliance with USP 800 for future risk-based inspections schedules)

USP Chapter 800 is currently informational only, but these practices are critical to worker safety and are in concert with the National Institute for Occupational Safety and Health (NIOSH) Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Setting and OSHA’s Controlling Occupational Exposure to Hazardous Drugs.

Controlling Occupational Exposure to Hazardous Drugs - US Department of Labor

Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings - CDC

Thanks for reading about exciting topics happening in Pennsylvania.  And I look forward to seeing you at the Annual Assembly in King of Prussia in October!


Christine Roussel, PharmD, BCOP

Incoming PSHP President 


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