Princess Health and WellCare provides twist-on naloxone nasal atomizers for free, encourages those who know addicts to have naloxone on hand. Princessiccia

Princess Health and WellCare provides twist-on naloxone nasal atomizers for free, encourages those who know addicts to have naloxone on hand. Princessiccia

drug abuse drug treatment drug use health insurance heroin pharmacists

Gusty 15:15 Add Comment

WellCare of Kentucky and the Kentucky Pharmacists Association have teamed up to provide 1000 twist-on naloxone nasal atomizers for free, in hopes of making it easier for people to administer the drug.

Dr. Paul Kensicki

"We believe this will make it easier, and less intimidating, for people with no medical background to administer it in an emergency situation," Paul Kensicki, medical director of behavioral health at WellCare of Kentucky, said in op-ed released by Wellcare.

WellCare will provide the atomizers to pharmacists, who will then distribute them to Medicaid recipients and individuals with no insurance coverage.

Kentucky's 2015 anti-heroin law allows pharmacists to dispense naloxone (brand name Narcan), a drug that can reverse the effects of a heroin overdose, without a prescription.Traditionally, the drug has been given as an injection, but the atomizer transforms the syringe to allow it to be administered as a nasal spray.

Naloxone immediately reverses the effects of an opioid overdose by physiologically blocking the effects of the drug. It has no side effects and cannot be abused. "It�s nothing short of a miracle drug," Kensicki writes. "It can absolutely save a life."

More than 1,000 Kentuckians die each year from drug overdoses, with more than 200 of these deaths from heroin. It has become a more common cause of death than car accidents in Kentucky.

"People who know someone who is using opioids, such as a spouse, parent or a roommate, should have naloxone readily available in case they discover an overdose in progress," Kensicki writes.

He notes that patients may be at the most risk of an overdose during recovery, because if they relapse their bodies aren't able to process the same amount of the drug they had been accustomed to before trying to quit.

"Making naloxone available does not mean it is �okay� to use heroin, and we are certainly not removing all the risks of addiction," Kensicki writes. "But we are giving friends and families a tool they can use to help save their loved ones in emergency situations � buying people the time they need to fight their addiction."

Princess Health and Legislature's many health bills include some with life-saving potential, better prevention, greater access and help for children. Princessiccia

Princess Health and Legislature's many health bills include some with life-saving potential, better prevention, greater access and help for children. Princessiccia

assisted living autism cancer drugs General Assembly health care access influenza legislation legislature pharmaceuticals pharmacies pharmacists physician assistants smoking state government

Gusty 13:57 Add Comment

By Melissa Patrick
Kentucky Health News

One paragraph in this story was incorrect and has been stricken.

FRANKFORT, Ky. -- Kentucky legislators have all but ended their regular session without agreeing on a budget, but were able to pass a wide range of health bills that await Gov. Matt Bevin's signature or veto.

Legislators can still pass more bills, including a budget, when they return for one day, April 12, and reconsider any bills the governor vetoes (except the budget, if one passes that day).

Many of the health bills deal with regulation, such as which agency oversees home medical equipment and licensing rules for physicians. Others, like SB 211, sponsored by Sen. Alice Forgy Kerr, R-Lexington, establish a special day to encourage research for amytrophic lateral sclerosis by officially naming Feb. 21 "ALS Awareness Day."

But several others will impact the daily lives of Kentuckians, directly or indirectly. Some have the potential to save lives.

Senate Bill 33, sponsored by Sen. Max Wise, R-Campbellsville, requires every Kentucky high-school student to receive compression-only CPR training. "Each year nearly 424,000 people have sudden cardiac arrest outside of the hospital and only 10 percent of those victims survive," Wise said at a Jan. 13 Senate Health and Welfare Committee meeting. "Yet when a CPR trained bystander is near, they can double or triple these victims survival rate."

Another bill with life-saving potential would let Kentuckians take time off work to be "living donors" or donate bone marrow without the risk of losing jobs or income. House Bill 19, sponsored by Rep. Ron Crimm, R-Louisville, requires paid leave of absence for such reasons, and offsets this cost to the employer with tax credits.

(An amendment to this bill, illustrating how legislation gets passed in unusual ways during the closing days, would allow Lexington to impose an additional 2.5 percent hotel-room tax to improve its convention center.)

A minor housekeeping bill had an important health amendment attached to it that mandates assisted-living communities to provide residents with educational information about the flu by Sept 1 of each year. SB 22 is sponsored by Sen. Ralph Alvarado, R-Winchester. The CDC estimates that between 80 and 90 percent of seasonal flu-related deaths occur in people over 65.

Colon cancer, which kills more than 850 Kentuckians a year, remained in the spotlight with passage of HB115, sponsored by Rep. Tom Burch, D-Louisville. It would expand eligibility for screenings to age-eligible, under-insured Kentuckians, or uninsured persons deemed at high risk for the disease. This bill is aimed at the 7 percent of Kentuckians who have remained uninsured since the state expanded Medicaid under federal health reform, and those who have insurance but can't afford deductibles or co-payments.

Other bills intended to create better access to care for Kentuckians would expand the duties of advanced practice registered nurses (SB114); decrease the oversight of physician's assistants (SB154); create a pilot program to study telehealth and how it's paid for (HB 95); and better define who can perform administrative duties in pharmacies (HB 527).

Children: "Noah's Law," or SB 193, sponsored by Alvarado, mandates the coverage of amino-acid-based formulas for eosinophilic esophagitis and other digestive disorders. It will have an impact on more than 200 Kentucky families. It is called "Noah's Law" after 9-year-old Noah Greenhill of Pike County who suffers from the disease, which requires him to get this formula through a feeding tube four times a day because of severe food allergies, at a daily cost of more than $40. This bill has already been signed by the governor and took effect immediately.

HB148, sponsored by Rep. Linda Belcher, D-Shepherdsville, allows day-care centers to be able to obtain and store epinephrine auto-injectors for emergency use. This bill was amended to include "participating places of worship" as a location that newborns up to 30 days old can be left without threat of prosecution to the parent or family member who leaves them there.

The latest Centers for Disease Control and Prevention study found that one in 68 of the nation's children have autism, and Kentucky legislators passed two bills this session to address their needs. SB 185, sponsored by Sen. Julie Raque Adams, R-Louisville, creates the Office of Autism and guidelines for an Advisory Council on Autism Spectrum Disorders. This bill has already been signed by the governor. HB 100, sponsored by House Minority Leader Rep. Jeff Hoover, R-Jamestown, requires insurers to maintain a website to provide information for filing claims on autism coverage and make autism-benefit liaisons available to facilitate communications with policyholders.

Big bills: One of the high-profile health bills that passed this session is SB20, sponsored by Alvarado, which creates a third-party appeals process for providers to appeal denied Medicaid claims. Alvarado has said that 20 percent of Medicaid claims are denied, compared to the national average of around 6 percent. He suggest that bringing this bill will help bring these numbers more in line with each other and thus will encourage more providers to participate in Medicaid.

A bill that will eventually increase accessibility to drugs made from living tissues that are very expensive, but also very effective, also passed. SB 134, sponsored by Alvarado, would allow pharmacists to substitute a less-expensive "interchangeable biosimilar" drug for its name-brand "biologic" one, even though the U.S. Food and Drug Administration hasn't approved these interchangeables yet. Humira and Remicade for arthritis, and Enbrel for psoriasis, are a few of the most common biologics on the market.

Another bill is aimed to help small-town pharmacies stay competitive with chains. SB 117, sponsored by Wise, allows the state Insurance Department to regulate pharmacy benefit managers, like Express Scripts, much like insurance companies. It would also provide an appeal mechanism to resolve pricing disputes between pharmacies and PBMs. The state has more than 500 independent pharmacists that will be affected by this law.

Bigger issues: Health officials say the single most important thing that Kentucky can do to improve the state's health at no cost is to pass a statewide smoking ban for workplaces. Rep. Susan Westrom, D-Lexington, filed a smoke-free bill late in the session that didn't even get a hearing in committee, despite having passed the House last year. Bevin opposes a statewide ban.

Adams and Alvarado filed a bill to require insurance companies to pay for all evidence-based smoking cessation treatments in hopes of decreasing the state's smoking rate, but it was filed late in the session and only brought up for discussion.

Democratic Rep. David Watkins, a retired physician from Henderson, filed three bills to decrease smoking in the state: one to increase the cigarette tax, one to raise the legal age for buying tobacco products to to 21, and one to require retail outlets to conceal tobacco products until a customer requests them. All were to no avail.

Rep. Darryl Owens, D-Louisville, filed bills to continue the Kynect health-insurance exchange and the state's current expansion of the federal-state Medicaid program. The bills passed mostly among party lines in the House, but the Senate has not voted on them as Senate President Robert Stivers said he would if the House did.

Princess Health and Full House has Senate bill to regulate how druggists dispense 'biosimilar' medication that hasn't even been approved by FDA . Princessiccia

Princess Health and Full House has Senate bill to regulate how druggists dispense 'biosimilar' medication that hasn't even been approved by FDA . Princessiccia

food and drug administration generic drugs legislation lobbying lobbyists pharmacists

Gusty 11:39 Add Comment

Update: SB 134 passed the state House 96-0 March 23 with a floor amendment that allows communication by fax, telephone, electronic transmissions or other prevailing means by the pharmacist to the provider to suffice as notice. The bill now awaits concurrence.  

Brand-name drugs called "biologics," because they are made from living tissues, have no competition from "interchangeable biosimilar" products in the U.S. because no interchangeable products have been approved by the U.S. Food and Drug Administration. But that hasn't stopped the drug industry and Kentucky lawmakers from moving a bill to regulate how pharmacists could dispense these drugs if and when they are approved.

"This bill allows Kentucky pharmacists the ability to dispense safe and less expensive biological medications by allowing substitution of interchangeable biosimilars," Sen. Ralph Alvarado, R-Winchester, told the House Health and Welfare committee, which approved it March 17.

Current law does not allow these substitutions without advanced approval from the prescriber, Alvarado said. "This bill removes that hurdle."

The most contentious part of Senate Bill 134 has been its requirement that pharmacists must notify prescribers when they make this substitution, which advocates say is necessary because there are slight variations between the drugs.

Alvarado, also a physician, said the notification comes down to a "safety mandate," noting that if the patient had a "bad outcome" while on one of these medications, it is important for the provider to know exactly what medication the patient is taking.

Democratic Rep. David Watkins, a retired physician from Henderson, voted for the bill and supported the provider notification requirement.

"We're not talking about generics where you have exactly ideal medications, you are talking about biosimilars . . . which would be in some instances different molecules and have some different aspects," Watkins said. " I think that not notifying my office would be a gross disservice to my patients."

But the pharmacists disagree, and want substitution of interchangeable biosimilars to be handled the same way as generic medications, with the prescriber able to place a note on the prescription that says "do not substitute," said Bob Oakley, chairman of the Kentucky Pharmacists Association.

Oakley told the committee that while pharmacists support automatic substitution of an interchangable biosimilar for the name-brand biologic, they do not support notification. "Therefore, we are here to ask that we just keep it simple and keep it seamless," he said.

Rep. Addia Wuchner, R-Florence, said the bill had accommodations to make notification manageable for pharmacists, and asked Oakley what their real problem was. He replied, "It just adds more work to . . . their busy day."

But the pharmacists' lobby has cited other reasons. KPhA Executive Director Bob McFalls told James McNair of the Kentucky Center for Investigative Reporting, "Prescriber notification requirements have shown to increase costs for the health-care system overall" since they cause more brand-name drugs to be dispensed.

SB 134 passed the Senate 36-1 March 2, with Republican Sen. Jimmy Higdon, the majority whip from Lebanon, the only one voting against it. Higdon had submitted several floor amendments to modify the notification requirements, but withdrew them before the final vote.

Higdon told McNair that he didn't understand the urgency to pass this bill, noting that its passage would have no immediate effect.

�It�s the kind of bill that should be discussed,� Higdon said. �This whole thing is very complicated and futuristic, and a lot of people are talking to us about passing this. I just want to err on the side of caution. It doesn�t need to be fast-tracked. We need to do it right.�

Higdon was referring to the many lobbyists hired by pharmaceutical manufacturers that have descended on Kentucky in support of this bill.

"At least nine drug companies and groups have stated an interest in the Senate bill, according to the Kentucky Legislative Ethics Commission, McNair reports. "The number of registered lobbyists hired by pharmaceuticals employers has nearly doubled, from 46 in 2011 to 83 today. Their annual spending has more than doubled, to $824,196 in 2015."

The bill now resides in the House. Speaker Pro Tem Jody Richards, D-Bowling Green, has filed a floor amendment to remove the notification requirements.

About biologics and biosimilars

While conventional medications are made from pure chemical substances and can be easily replicated, biologics are made from living tissues and each batch varies slightly from the last, according to the FDA. That's why these products can't be called generics, which are chemcially identical.

The most common biologics are Humira and Remicade for arthritis and Enbrel for psoriasis. They are very expensive and can cost thousands of dollars each month.

"Express Scripts, the pharmacy benefits manager, estimates that while biologics accounted for only 1 percent of all prescriptions in 2014, they accounted for 32 percent of all prescription-drug spending," McNair reports.

Biosimilars are medications that are "highly similar" to already FDA-approved biological products. To date, only one of these, Zarxio, used for certain cancer patients, has been approved by the FDA, but it was not designated as interchangeable. According to the Regulatory Affairs Professional Society, six biosimilars have applied for FDA approval.

Interchangeable biosimilars are expected to produce the same clinical results in any given patient as it's "highly similar" biologic. To date, no interchangeable biosimilar medications have been approved by the FDA. When appoved, Alvarado suggested that they will cost up to 40 percent less than the biologics.

Kentucky is home to the North American distribution hubs for Amgen, Genentech and Johnson and Johnson and is the primary distribution point for many of the biologics (and soon to be biosimilars) in the U.S., according to an e-mail from RunSwitch PR.

Princess Health and Meds-for-meth bill drew record lobbying expenses, not even including radio and newspaper ad campaigns.Princessiccia

Princess Health and Meds-for-meth bill drew record lobbying expenses, not even including radio and newspaper ad campaigns.Princessiccia

advertising allergies drug abuse drug companies drugs legislation legislature meth methamphetamine pharmaceuticals pharmacies pharmacists pseudoephedrine state government

Gusty 05:14 Add Comment

Makers of over-the-counter drugs spent more than any lobbying interest ever had during a single Kentucky legislative session in their effort to defeat a bill requiring prescriptions for the key ingredient in methamphetamine, Bill Estep reports for the Lexington Herald-Leader.

"The Consumer Healthcare Products Association spent $457,053 on lobbying activities in the first three months of this year's legislative session, according to reports filed with the state Legislative Ethics Commission," Estep writes. "The group's lobbying effort was so dominant that it spent more than the next five groups combined in that period, January through March, according to spending reports."

And the figure doesn't even included hundreds of thousands of dollars that the trade group spent on radio and newspaper campaigns, because the lobby-reporting requirements do not apply to messages aimed only at the general public. The group did report spending on "a phone-bank operation to put people in contact with legislators to voice concerns about legislation to require a prescription for medicine containing pseudoephedrine, which is now available over the counter," Estep writes.

Read more here: http://www.kentucky.com/2012/04/30/2170495/makers-of-cold-medicines-set-new.html#storylink=cpy

The efforts, dating back to 2010, were partly successful. The legislature passed a bill "that will require a doctor's prescription for pseudoephedrine, but only after someone has bought 24 grams of the medicine a year," Estep notes. "A 48-count box of the generic medicine with 30-milligram pills contains 1.44 grams of pseudoephedrine. The bill excludes limits on gel caps and liquid pseudoephedrine." (Read more)

The lobbying effort wasn't only about Kentucky. The makers of Sudafed and other pseudoephedrine preparations are trying to stave off similar efforts in other states, and viewed Kentucky as a sort of firewall after seeing prescription-only laws pass in Oregon and Mississippi.

Read more here: http://www.kentucky.com/2012/04/30/2170495/makers-of-cold-medicines-set-new.html#storylink=cpy

Read more here: http://www.kentucky.com/2012/04/30/2170495/makers-of-cold-medicines-set-new.html#storylink=cpy

Princess Health and Campbellsville pharmacists have mixed views about meds-for-meth bill; a good example of localizing a statewide issue.Princessiccia

Princess Health and Campbellsville pharmacists have mixed views about meds-for-meth bill; a good example of localizing a statewide issue.Princessiccia

health journalism methamphetamine pharmacists pseudoephedrine state government; General Assembly

Gusty 15:43 Add Comment

Pharmacists have mixed opinions about a bill that would require a prescription to purchase pseudoephedrine after a monthly or yearly limit has been reached, reports Calen McKinney for the Central Kentucky News Journal in Campbellsville. (Photo by McKinney)

The drug is the key ingredient used to make methamphetamine. Last week the Senate approved a bill that would limit non-prescription individuals' purchases to 7.2 grams per month and 24 grams per year.

Tresa Phillips at Nation's Medicines in Campbellsville told McKinney she feels the system in place now � an instant computer tracking system called MethCheck � is working. "I'm not sure that a new law is going to make a big difference," she said, adding that a person who is buying the drug already has to show state-issued identification.

However, Jay Eastridge at Eastridge-Phelps Pharmacy applauded the move. "It sort of restricts pseudoephedrine getting into the wrong hands," he said. "I wholeheartedly support the bill." Eastridge said pharmacists have become "gatekeepers" in the face of the meth epidemic and "it's just painful to watch" people coming in "from one drug store to the next seeing what they can get."

Ed Baise of the Medicine Centre agreed that pharmacists have "become the police" when it comes to limiting pseudoephedrine. But he said the drug should be put in a class of its own and pharmacists should be responsible for controlling purchases. Baise pointed out allergy sufferers could be inconvenienced by the bill. "This may help some," he said, "but it's not gonna solve the problem." (Read more)