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Pennsylvania Medical Marijuana Act 16

Pennsylvania updated the status of the medical marijuana program. The final regulations for the grower/processors, dispensaries and laboratories have been published and the links are below.

The state breaks the program down into two phases, but for now are only giving details about Phase 1, allowing licenses for only 12 grower/processors and 27 dispensaries (down from the original 25 grower/processor and 50 dispensary permits). Each dispensary can still have up to 3 locations from the single permit, and  there is mention that the second and third locations must be in different counties than the first dispensary. See the map with the link as to the locations of the permits that will be available as the state was broken down into 6 regions and population density is a factor.  

The applications for permits will be available 1/17/17, with applications accepted 2/20 - 3/20/17.   The DOH is saying that the applications will all be reviewed in 90 days and that they are still intending to keep the goal date of early 2018 for PA grown medical cannabis to be provide for PA medical marijuana eligible adults through PA dispensaries.

  • A physician who is properly registered is able to issue medical marijuana certifications/cards to patients at their practice. (4 hour training class required)
  • Dispensaries must have a physician or pharmacist there at all times (for other locations an NP or PA maybe be onsite). (4 hour training class required)
  • Medical marijuana can be dispensed in pills, oils, topical forms, and vaporization.  
  • Medical Marijuana cannot be smoked or used recreationally in Pennsylvania
  • “Edibles” are not legal in Pennsylvania
  • Does not allow for home cultivation
  • A patient or caregiver can only receive a 30 day supply of medical marijuana at one time.
  • MMJ products sold in Pennsylvania must be analyzed for THC (tetrahydrocannabinol) and CBD (cannabidiol) content.  
  • Through the Safe Harbor program, eligible patients in PA with the appropriate physician support already have the ability to apply.  By mid -August over 53 letters were approved.
  • MMJ is approved for 17 medical conditions including Severe chronic or intractable pain of neuropathic origin or severe chronic or intractable pain in which conventional therapeutic intervention and opiate therapy is contraindicated or ineffective

Highlights of OTHER STATES  Medical Marijuana Programs

  • Pharmacists or physicians required for dispensing include: Minnesota, New York and Connecticut
  • Connecticut House bill 5450  - Protects nurses from any criminal or civil penalties who may need to administer medical marijuana to qualified patients in the hospital.
  • Maine Originally limited to hospice and SNF but recently signed and amended inpatient hospital use and  Permits and protects medical professionals who may need to administer medical marijuana to applicable individuals in the hospital from any criminal or civil penalties.

For the complete Medical Marijuana Act 16 here 

Grower/Processor Regulations: here

Dispensary Regulations: here

Lab regulations: here
 
Map of Grower Processor / Dispensary Locations: here

Technician Bill

For the first time in ten years there is progress on passage of a pharmacy technician bill in both the House and Senate in Pennsylvania.  The core of both bills will require:

  • technician registration with the board
  • passage of a Board approved technician training program ( grandfather clause for current pharmacy technicians)
  • A high school diploma 
  • A minimum age of 17

The House bill has been passed and referred to the Senate: click here
The Senate Bill is similar to the house bill and is now being addressed: click here

ASHP has a policy statement on advancing the role of Pharmacy Technicians and enhancing their qualifications in order to achieve the Pharmacy Practice Model Initiative (PPMI).
 ASHP supports:

  • state’s mandating licensure (not registration) of technicians
  • completion of an accredited technician training program 
    Pharmacy Technician Training (0702) Source: Council on Education and Workforce Development To support the goal that pharmacy technicians entering the pharmacy workforce have completed an ASHP-accredited program of training; further, To encourage expansion of PTAC accredited pharmacy technician training programs. (NOTE: Starting in 2014 technician training program accreditation is a joint initiative by ACPE and ASHP who have formed PTAC: Pharmacy Technician Accreditation Council
  • Passing a technician certification exam (PTCB). 

Unfortunately, Pennsylvania lags far behind other states in regulations or standards for Pharmacy Technicians.  The Emily Jerry foundation, following the death of Emily Jerry due to an IV compounding error contributed to by a pharmacy technician with minimal training, has been advocating for state practice laws that mandate training and competency assessment of technicians.  Pennsylvania is one of 4 states where there is no legal oversight of pharmacy technicians leading to a grade of 0 (not even an F). See state map and grades here

So the situation we face, what position PSHP should take on the Senate Bill?  Possible positions include: 

  1. Oppose the bill and advocate that the bill must mandate both completion of an accredited training program and technician certification consistent with ASHP policy. 
  2. Support the bill as proposed as a good first step (knowing that more stringent requirements are likely to lead to opposition by community pharmacy groups and kill the bill and work with the State board of Pharmacy). 

Before taking a position on this issue, PSHP values your opinion on these bills, your thoughts about technician training and certification and other important pending legislation. 

What is going on in PENNSYLVANIA to Stem the Prescription Drug ABUSE EPIDEMIC?

On April 6, 2016, a few hundred pharmacists converged in the State Capitol on Harrisburg to support legislation related to the practice of pharmacy.  While the pharmacists had many topics they wanted to discuss with our legislators, on topic most government officials wanted to discuss with pharmacists was the prescription drug abuse epidemic.  Dr. Racheal Levine, the physician general for the state of Pennsylvania, and Mr. Jason Snyder, the Director of Communications for the Administration on Drug and Alcohol Abuse, both met separately with a large congregation of pharmacists from the Pennsylvania Pharmacist Association to discuss three different methods that the state is employing to reduce opioid abuse.  
To read more link to the full article….

Prescription Drug Monitoring Program 
Click here

Biosimilar legislation
Click here

 

Other Issues of Concern

Intern hours: While the number of intern hours in PA that must be obtained outside the pharmacy curriculum has been reduced to 500 (still 1500 total) PSHP continues to seek an exemption for residents enrolled in an ASCP accredited residency program. 

Updates on current laws:  The PA Board is finalizing regs on collaborative practice (Law was passed several years ago). The Board continues to work on compounding regulations and have largely embraced the recommendations made by the joint PPA-PSHP task force that provided comments to the Board in 2013.

Draft Compounding Regulations

Draft Pharmacy Act General Revisions. 

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