FDA Offers New Guidelines in Tylenol Dosing

By: Victor Sun Pharm D.

Acetaminophen (Tylenol) is one of the most commonly used pain relievers in America today. Copiously used over the counter for minor pains, it is one of the main ingredients found in prescription pain medications such as Percocet, Vicodin and Tylenol with codeine.

Acetaminophen over-dosage is one of the most common and severe forms of overdose. The maximum recommended dose for acetaminophen is 3000mg a day for the average adult. Patients who exceed this dosage, experience overdose symptoms starting with nausea and vomiting, fatigue, abdominal pain and ultimately liver failure if left untreated. Overdoses are common because acetaminophen is so prevalent in combination pain and cold medications. Unaware patients taking one or two extra strength Tylenols as needed, along with a prescription strength pain medication containing acetaminophen, easily reach 3000mg a day.

Since Jan 14, 2014 the US Food and Drug Administration has urged health care providers to stop prescribing medications with more than 325mg of acetaminophen. The FDA has concluded that the benefits of using more than 325 mg of acetaminophen in drugs like Percocet and Vicodin are few. Studies supporting the use of higher strength acetaminophen, such as 500mg and 650mg in prescription products, have only shown to be marginally more effective at pain relief as compared to formulations with strengths of 325mg. The FDA has concluded that the benefits of a higher dose formulation do not outweigh the risks of liver damage from acetaminophen overdose.

Back in 2011 the FDA requested drug manufacturers to reduce the amount of acetaminophen in their products, with half of the manufacturers complying and already producing products with low strength of acetaminophen. Products such as Vicodin now come in strength of 5mg/300mg, 7.5mg/300mg and 10mg/300mg offering similar pain relief with lower risks. Healthcare professionals are strongly encouraged to prescribe these new products to help avoid acetaminophen overdoses in patients.

Patients who are taking prescription strength painkillers such as Percocet or Vicodin should avoid taking more than one acetaminophen product at a time. Patients should also avoid drinking alcohol while taking acetaminophen, as alcohol can exacerbate damage to the liver.

In general, Tylenol and products containing acetaminophen are safe to use. This is why the FDA has allowed higher strength of the drug to stay over the counter. But as a precautionary measure, patients should be aware that taking more acetaminophen than the liver can handle is dangerous and such drugs should be taken with caution.

FDA Approves New Hard-to-Abuse Opioid

By: Ankur Dave, RPh, Director of Clinical Services and Quality Assurance

On Thursday November 20th, 2014 the FDA approved the first hard-to-abuse version of hydrocodone. Branded as Hyslinga ER by Purdue Pharma, the painkiller is indicated for patients with severe, round-the-clock pain that cannot be controlled with alternative treatments. Current dosing recommendations are listed as once daily but may be subject to change once more studies are done.

According to the FDA, Hysingla ER contains properties that will reduce the abuse of the drug if chewed, crushed, snorted, or injected. The medication, which is difficult to break or dissolve, also forms a viscous hydrogel, making it difficult to prepare for injections. However when taken orally these medications can still be abused.

The goal is to limit the various ways in which people abuse opioids. As Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research states, “Although the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the United States.”

The company expects to launch the new product in the United States early in 2015 in multiple dosage strengths between 20 mg and 120 mg to be taken once every 24 hours. Unlike many other hydrocodone formulations, Hysingla ER will not contain any acetaminophen, which is a leading cause of acute liver failure in the US, according to Purdue.

Understanding Refractory GERD

Less than half of patients prescribed a PPI for GERD are taking it properly. PPIs should be taken 30 minutes before breakfast to maximize acid inhibition and, even, though there is no direct evidence that proper dosing can improve symptoms, most authorities emphasize the need to ensure proper dosing, especially in those with refractory GERD.

When the once daily dose of PPI’s is not successful, many doctors decide to double it, with new evidence suggesting that thirty percent of patients respond well to the BID schedule. After two or three months, many patients can return to the once a day dosing schedule.

If patients are still non-responsive, some lifestyle modifications may be suggested, such as losing weight and avoiding late night meals. Augmenting PPI therapy with over the counter antacids or adding H2 antagonists may also help.


Specialty RX has earned The Joint Commission’s Gold Seal of Approval® for accreditation by demonstrating compliance with The Joint Commission’s national standards for health care quality and safety in home care. The accreditation award recognizes Specialty RX’s dedication to continuous compliance with The Joint Commission’s state-of-the art standards.

Specialty RX underwent a rigorous unannounced on-site survey where a team of Joint Commission expert surveyors evaluated Specialty RX for compliance with standards of care specific to the medication needs of patients.

“With Joint Commission accreditation, we are making a significant investment in quality on a day-to-day basis from the top down. Joint Commission accreditation provides us a framework to take our company to the next level and helps create a culture of excellence,” says Joe Kubulak, Specialty RX VP of Operations & RPh in Charge. “Achieving Joint Commission accreditation is a major step toward maintaining excellence and continually improving the care we provide.”

Founded in 1951, The Joint Commission seeks to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value. The Joint Commission evaluates and accredits more than 20,000 health care organizations and programs in the United States, including more than 10,600 hospitals and home care organizations, and more than 6,600 other health care organizations that provide long term care, behavioral health care, laboratory and ambulatory care services. The Joint Commission also certifies more than 2,400 disease-specific care programs such as stroke, heart failure, joint replacement and stroke rehabilitation, and 400 health care staffing services. An independent, not-for-profit organization, The Joint Commission is the nation’s oldest and largest standards-setting and accrediting body in health care. Learn more about The Joint Commission at www.jointcommission.org.

Upcoming Event: Specialty RX CEU Seminar

The Specialty RX CEU SeminarThe Specialty RX invites Administrators and Directors of Nursing to a CEU Seminar on Wednesday, June 26, 2013 at The Waterford on the Bay Senior Living.

The seminar will feature speakers Lydia Restivo RN, C.D.O.N.A & Ruth West RN, BS on the topic of “THE SPINNING WHEEL OF REHAB: Where Does A Restorative Nursing Program Fit In?”

· Approved for 6 LNHA CEUs by NAB
· No Admission Fee
· Reservations Required
· Kosher Breakfast & Lunch
· Health Care Vendor Exhibits
· Valet Parking

For more information about this event, please call Signature Events at 917-327-8261 or email info@signatureeventsny.com
To register, please fill out the registration form online at www.signatureeventsny.com or fax the completed form to 718-799-1041.

Specialty RX Steps Up to Sandy to Ensure an Uninterrupted Continuum of Care


The Perfect Pharmacy During the Perfect Storm

Specialty RX, a leading Long-Term Care Pharmacy, was the only LTC pharmacy that operated FULL TIME, at full capacity, throughout the Tristate during the recent Hurricane despite the acute flooding in many areas.

Specialty RX’s storm operations involved the use of commercial generators, drivers stationed in South Jersey, Brooklyn and Long Island as far out as the Hamptons, and even the rental of 10 SUVs in order to reach everyone everywhere. To ensure pharmacists on call and 24-hour coverage, Specialty RX had staff sleep over at company headquarters from Sunday through Wednesday. With other area pharmacies unable to fill their orders due to flooding and power outages, Specialty RX stepped in and shouldered their deliveries for them.

When client facilities were forced to evacuate – Specialty RX made sure to follow all patients & residents to their temporary relocation, continuously servicing all their pharmaceutical needs. Specialty RX personnel even assisted in the evacuation process of three Rockaway facilities.
It was a remarkable team effort. Personnel from all departments pitched in to replace those unable to get to work, with Human Resources Managers packing meds on the floor to ensure uninterrupted delivery.