Princess Health and Adults 62-85 are often taking combinations of drug or dietary supplements that could be deadly; risk nearly doubled in 5 years. Princessiccia

Princess Health and Adults 62-85 are often taking combinations of drug or dietary supplements that could be deadly; risk nearly doubled in 5 years. Princessiccia

alternative medicine generic drugs over-the-counter medicine pharmaceuticals prescription drugs research

Gusty 06:53 Add Comment

Update: 4/4/16, This story has been updated to reflect that the study says the number of adults using at least five prescription drugs a day has increased and not the average older American is using at least five prescription drugs a day.

The number of older Americans at risk of potentially life-threatening drug interactions almost doubled between 2005 and 2011, according to a study from the University of Illinois at Chicago.

"One in six older adults now regularly use potentially deadly combinations of prescription and over-the-counter medications and dietary supplements, a two-fold increase over a five year period," says the release.

More than half the potentially deadly interactions involved a non-prescription medication or dietary supplement such as a vitamin. The study found that older adults have increased their use of vitamins and supplements, despite limited evidence of their clinical benefit.

The study, published in JAMA Internal Medicine, examined changes in medication use in more than 2,000 adults aged 62 to 85 between 2005 and 2011.

Fifteen potentially life-threatening drug combinations of the most commonly used medications and supplements were identified, and the study found nearly 15 percent of older adults in 2011 used at least one of these dangerous combinations, up from 8 percent in 2005.

The study found that older adults have grown more fond of non-prescription medications and supplements: 63.7 percent of older adults used them in 2011, up from 51.8 percent in 2005. Older adults using at least five prescription medications increased to 35.8 percent from 30.6 percent in the same time period.

The most common life-threatening interaction identified by the study was cholesterol-lowering drugs (statins), drugs used to prevent blood clots (anti-platelet drugs) and omega-3 fish oil supplements.

�Many older patients seeking to improve their cardiovascular health are also regularly using interacting drug combinations that may worsen cardiovascular risk,� one of the researchers said in a news release.

The researchers encourage health-care providers to carefully consider adverse effects of combining prescription and nonprescription medications when treating older adults, and to counsel patients about the risks. Older adults should also ask their pharmacists about potential drug interactions.

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 Conway, other AGs ask FDA to require generic prescription pain pills to be abuse-resistant, tamper-resistant.Princessiccia

Princess Health and Conway, other AGs ask FDA to require generic prescription pain pills to be abuse-resistant, tamper-resistant.Princessiccia

attorney general drug abuse drug companies food and drug administration generic drugs prescription drug abuse prescription drugs

Gusty 14:47 Add Comment

Generic versions of popular pain relievers must be made harder to abuse, in order to curb prescription drug abuse that is epidemic in many states, Attorney General Jack Conway and 47 other attorneys general said in a letter sent to federal officials Monday.

The National Association of Attorneys General letter encourages the Food and Drug Administration to adopt standards requiring manufacturers and marketers of generic prescription painkillers to develop tamper- and abuse-resistant versions of their products, because the attorneys general are concerned that non-medical users are shifting to non-tamper-resistant formulations of generic opioids.

�Prescription drug abuse is an epidemic that kills more than 1,000 Kentuckians each year,� Conway, who co-chairs NAAG�s Substance Committee, said in a news release. �The development of tamper-resistant and abuse-deterrent opioid drug products is a valuable aid to the law enforcement, legislative and public awareness initiatives many of us have implemented in our states to combat prescription drug abuse.�

Prescription drugs can be deadly when abused, and fatal drug overdoses are now the leading cause of death due to unintentional injury in the United States and Kentucky, exceeding even motor vehicle deaths, according to the Centers for Disease Control and Prevention. Federal data show that U.S. drug overdose deaths totaled 38,329 in 2010, rising for the 11th straight year, and accidental deaths involving addictive prescription drugs overshadow deaths from illicit narcotics.

In Kentucky, the number of drug-overdose deaths in Kentucky rose a staggering 296 percent from 2000 to 2010, according to the Kentucky Injury Prevention and Research Center. Kentucky is one of the most medicated states in the country, and has the sixth highest overdose rate. Last year, 220 million doses of the highly addictive painkiller hydrocodone were dispensed in the state -- that�s 51 doses for every man, woman and child in the state, says the AG release.

The news release from Conway's office said he led the effort to reach out to the FDA, along with Attorneys General Luther Strange of Alabama, Pam Bondi of Florida and Roy Cooper of North Carolina. Click here to read the letter; for a news release, click here.