Key Health Care Issues Impacting Pharmacy

Many critical health care issues at the federal and state levels will impact health-system pharmacists. Attendees at ASHP 2016 Summer Meetings & Exhibition were updated on some of the key issues facing pharmacists during a session that included speakers from ASHP’s regulatory affairs and government relations.

Opioid Misuse Prevention

The opioid abuse epidemic has garnered a lot of attention on Capitol Hill. Opioid prescriptions have increased 175% in the past 20 years. Emergency department visits due to nonmedical use of opioids more than doubled between 2006 and 2010. The National Drug Institute estimates the overall cost of opioid abuse is $700 billion annually, according to Christopher Topoleski, BA, director, federal regulatory affairs, ASHP. 

In March, the Senate voted 94 to 1 to pass the Comprehensive Addiction and Recovery Act (CARA), which ASHP supported. This legislation would provide for additional education, treatment, monitoring, and other resources to address the opioid abuse and heroin epidemic currently facing the nation. Two months later the House passed a bipartisan package of bills to fight America’s growing epidemic of painkiller abuse and heroin addiction with a near unanimous 400 to 5 vote.

“The House and Senate need to get together on these two bills and try and figure out their differences since the bills are not identical,” Mr Topoleski said during the session.

Opioid abuse legislation is also being passed at the state level. More than 42 states have laws that address access to naloxone to treat opioid overdoses, and 49 states have prescription drug monitoring programs (PDMPs), reported Nicholas Gentile, BA, director, ASHP’s state grassroots advocacy and political action.

Massachusetts passed a comprehensive law on opioid abuse in March. It calls for 7-day supply for all minors and first-time prescriptions, requires physicians to check PDMP every time they prescribe an addictive opioid, and allows patients to request physicians to prescribe less than the normal amount and pharmacies to provide less than the full amount. Maine is another state to recently pass comprehensive opioid abuse legislation. The legislation places several statewide limitations on opioids, including a 7-day prescription limit on new opioid prescriptions for acute pain, and a 30-day prescription limit for chronic pain. Additionally, prescribers must deliver all opioid prescriptions electronically or apply for a waiver if they are unable to do so.

Because pharmacists are on the frontlines, Mr Gentile encouraged attendees to be involved in opioid misuse prevention efforts occurring in their state.

Regulation Needed to Protect Drug Consumers

The speakers also addressed the recent spikes in generic drug prices, a topic that has been the focus of several hearings in Congress and investigations. The US Health Department of Health & Human Services is examining the impact on federal programs. Furthermore, federal prosecutors are investigating manufacturers, seeking documentation on how companies price their products, said Mr Topoleski. “There may not necessarily be illegal activity but just because you can do something with pricing doesn’t mean ethically you should do it,” he added.

At the state level, in 2015, 8 states proposed drug company transparency legislation in response to drug price spikes; none of the legislative efforts were successful, said Mr Gentile. However, in June, Vermont was the first state to pass a law on this issue. The law requires state officials to identify 15 drugs for which “significant health care dollars spent” and where wholesale acquisition prices rose by 50% or more over the previous 5-year period. Alternatively, they must identify list prices for 15 drugs that rose more than 15% over the last 12 months. Once the drugs are identified, Mr Gentile said the state’s office of the attorney general will contact these drug companies to provide justification for the increase.

On the regulatory side, track-and-trace requirement developed by the FDA to identify counterfeit, diverted, or stolen products is still ongoing. This provision is part of the Drug Supply Chain Security Act (DSCSA) of 2013. The FDA convened a 2-day public meeting in April to discuss track-and-trace pilot projects with participants from all levels of the supply chain. Jillanne Schulte, JD, director, government relations division, ASHP, said the meeting really focused on what track-and-trace pilot projects will look like. “I think the FDA’s main focus for the next foreseeable future will be in getting the big skeleton of track-and-trace in place to make sure everyone is starting to get up to speed so we know what the system will look like and what the building blocks are.”

ASHP will continue engaging with the FDA as it continues to implement the provisions of DSCSA that are key to pharmacy, she said.—Eileen Koutnik-Fotopoulos