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Pharmacy rules
Bill that aims to tweak pharmacy rules would cut costs

02/15/18
By Ryan Lessard news@hippopress.com



 Lawmakers are pushing a couple bills that aim to push back on Board of Pharmacy rules that might have unintentionally affected the affordability of and access to critical treatments.

 
Infusions
Sen. Andy Sanborn, a Republican from Bedford, has drafted an amendment that would clarify the definition of compounding prescription drugs in the hopes of carving out an exception for infusion medications that were bunched in with new, strict safety regulations. 
As written, Sanborn said, the Board of Pharmacy rules, which came out in 2016, make New Hampshire an “outlier” compared to any other state. 
They were written in reaction to the fungal meningitis outbreak in 2012 that originated from a drug compounding facility in Framingham, Massachusetts. Hundreds were sickened and more than 70 died from the infections.
In an effort to prevent such things from happening in New Hampshire, Sanborn said, the board cast a wide net by requiring stringent safety equipment not just for the compounding of drugs, but also for the reconstituting of single powder drugs with saline solution to be used in IVs, infusions or injections.
Therein lies the rub. According to Sanborn, the requirements are a step backward in efforts to reduce costs over the past 20 years, as providers have moved more toward an out-of-hospital or in-home model when it comes to regular infusion medications.
An example of this is the drug Remicade, which is administered for a number of ailments including Crohn’s disease.
“Because of the expense of the drug, you could only get an infusion in a hospital setting. And, in general, the cost of a single infusion, which you need to get about every six to eight weeks … is $18,000 to $25,000 true cost, depending on which hospital you go to in New Hampshire,” Sanborn said.
Alternatively, getting that drug from a local infusion company, which can reconstitute and administer the drug in a patient’s home, can cost between $2,500 and $3,000.
 
Getting the memo
After the board changed the rules, however, nobody seemed to have gotten the memo, according to Sanborn.
“So they wrote everybody up, fined them all and issued them cease and desist letters,” Sanborn said.
This happened in early November last year.
Mike Bullek, administrator and chief of compliance on the Board of Pharmacy, said they investigated eight different sites in the state for not following the new rules. 
Bullek said the board supports Sanborn’s efforts to redefine compounding, but he hopes the language still ensures the practice of reconstitution follows some basic cleanliness guidelines like using sterile gloves and wiping containers with alcohol.
“You want to be able to help the patient out on the cost end of things, but you also want to make sure it is mixed in an aseptic manner,” Bullek said.
He also said the board used national guidelines as a template when they wrote the rules but those standards have since eased up.
While he appreciates the need for safety when it comes to compound drugs, Sanborn thinks reconstituted infusions should not fall under that category. For one thing, the company in Framingham that caused the multi-state outbreak six years ago did not follow existing safety protocols, he said, and the infusion drugs are much safer. 
Remicade, for example, has zero recorded adverse events, despite there being 150 million doses sold worldwide. 
The amendment was attached to an unrelated bill, but the bill moved forward without the amendment. Sanborn said he plans to attach it to a different bill in the next couple of weeks. 





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