Thursday, April 26, 2018
Public Policy
The main function  of the Public Policy Council is to monitor all legislative activities with potential impact on institutional pharmacy practice, and to coordinate the release of all publicity pertaining to the Society.

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October 2017

v NJSHP and FDU video has over 2291 views. A second, longer video has not yet been published.

v Nancy and I have been asked to be on a NJ State Subcommittee working on mandating Pharmacy Technician Certification, which would start with the next license renewal, 2018.

v Information from the ASHP State affiliate conference call on 9/20/17:

·       Roll call: Valley Residents gave their names

·       Legislative

o   There is an ASHP representative on the hill

o   House is in recess

o   Senate is working on Cassidy Graham Repeal and Replace Bill

§  Two republicans (Rand Paul and Susan Collins) will not be voting for bill

§  Two other undecided republicans

o   Must address CHIP reauthorization in next 10-12 days

§  HR592 is the provider status bill out on the hill at this time

§  Unsure if HR592 is attached to the CHIP bill

·       Updates on Federal Regulatory side

o   FDA has leaked to trade press a document for 503 “light” category for cGMPs

o   FDA is deciding is they will allow 503a to register as 503b for office use compounding

o   CMS has released an RFI to crowdsource and determine a new direction for their post-ACA alternative payment models

·       State Provider Status Update

o   A lot of organizations are on recess

o   Alaska – created a dedicated provider status with prescriptive authority task force

o   Oregon – Formulary committee now requires pharmacists, including community pharmacists. Secretary of State wrote to the Oregon BOP to ask them about Diabetic inclusions

o   Ohio – working on provider status bill with 2 other pharmacist state organizations

o   Idaho – going through a rules rewrite, adding items that pharmacists will be able to prescribe

·       White bagging and brown bagging

o   North Dakota wants to use the group as a sounding board for discussion

§  Express Script was looking for ASHP support for regulations on specialty medications

§  Issue that even larger hospitals are having problems becoming accredited dispensers of specialty drugs in infusion centers

§  Brown bagging is when the specialty drug is sent to the patient, white bagging is when it is sent to the infusion center

§  Want to discourage PBMs from being able to block infusion pharmacies from being able to stock specialty drugs

§  Caller from NJ – one hospital sent a letter to patients saying that if patients brought their own specialty medication in, they would no longer be able to service them at their infusion center after January 1st 2018. Regulatory risk is too great. Cold chain status is unknown; no information on product pedigree, yet the infusion center is the final dispenser and becomes liable for that medication that was in the patient’s possession (after having it mailed directly to them). Very problematic as far as track and trade.

§  No news about this issue from the national level

·       Open Forum

o   California legislation on drug pricing

§  Going to governor to be signed

§  Deals with rate of increase of prices and information about price increase timing

§  Bill is based on concept that through more transparency, you operate on a concept of public shaming. Check if there is a valid, publicly acceptable reason for an increase on drug pricing

§  Bill has 3 parts:

·       Require manufacturers to supply information to health plans, government, and insurance companies about price increases on a quarterly basis and before any increases

·       Designates how to figure out if bill had any impact on pricing – insurance companies must supply information to the government

§  October 15th cutoff for governor to veto before it becomes law

§  Similar to bill that Vermont passed last year – transparency of pricing bill

§  Limited enforcement ability on the pharmaceutical companies ($1,000 a day fine for not posting pricing reports)

§  Warning – drug companies might try to turn this bill around on hospitals and retail pharmacies by  encouraging their transparency

·       State Regional Call will be moved to mid-Nov and mid-Dec due to Midyear and the holidays

o   Probably Tues/Wed or Wed/Thurs

·       Next call Wed Oct 25th at 4pm EST

v Pharmacists apply for pre-approval by the NJ BOP for “Collaborative Practice” is still very much lacking. Of the 18,000 pharmacists in the state, as of this morning, only 57 have been approved. We need a plan. I’ve been to FDU to speak to the staff there and have given two ACPE program about this.

Respectfully submitted,

Carlo Lupano, RPh, MBA, CCP, FASHP 

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Public Policy Forum
Governor Signs new NO FLUSHING Act
Governor Signs new NO FLUSHING Act

A new Bill and joint resolution was recently signed by the Governor which prohibits health care facilities from discharging prescription medications into sewer or septic systems in certain circumstances.

This new standard notes that every health care facility shall establish and implement a policy, procedure, plan, or practice that prohibits the health care facility and any employee, staff person, contractor, or other person under the direction or supervision of the health care facility from discharging, disposing of, flushing, pouring, or emptying any unused prescription medication into a public wastewater collection system or a septic system.

The exceptions or allowable times that items may be “flushed” are as follows:

    • Non-prescription medication
    • an intravenous solution containing only dextrose, saline, sterile water, or electrolytes, or a combination
    • pursuant to the product insert, product label, product packaging, or prescription:

(1) the dose of prescription medication is to be partially wasted prior to administration of the medication per physician order;

(2) the prescription medication is a controlled substance as defined by federal law, rule or regulation; or

(3) the prescription medication is not deemed hazardous by the United States Environmental Protection Agency or the National Institute of Occupational Safety and Health, in the Centers for Disease Control and Prevention within the United States, Department of Health and Human Services

This act shall take effect on the 210th day after the date of enactment

For additional details please see:

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