PHARMACY

CVS Pharmacy debuts ScriptPath Prescription Schedule

BY David Salazar

WOONSOCKET, R.I. — CVS Pharmacy’s latest initiative is making medication management easier for patients with multiple prescriptions. The company has debuted the ScriptPath Prescription Schedule, which shows all of a patient’s current prescription information in one place. The schedule features easy-to-understand icons that indicated when a patient should take a medication and how much should be taken in each dose.

The ScriptPath Prescription Schedule looks to meet the needs of the 50% of patients who report confusion about how and when to take their medications, as well as patients with complex prescription regimens. With the initiative, patients with five or more medications will automatically receive counseling from the pharmacist about their medication and be given a ScriptPath Prescription Schedule, and any patient or their caregiver can request one. In addition to meeting patient needs, the initiative is bringing patients more touch points with pharmacists, CVS Pharmacy EVP pharmacy services Kevin Hourican told Drug Store News.

“We are a pharmacy innovation company, our purpose is to help people on their path to better health. We know there's tremendous confusion out there … [and] our pharmacists want to do this kind of work,” Hourican said. “We want to be able to holistically understand the patient's medication regimen and more importantly, help the patient understand their medication regimen and counsel them on the medication they're taking and the front-store products they're taking to go along with it.”

Hourican said that in its beta stage, pharmacists helped counsel 50,000 patients who were taking their medications at the wrong time within the larger population of patients counseled. And with it now live in CVS Pharmacy's  more than 9,700 retail pharmacy locations, the patient population that will automatically receive counseling is roughly 9 million patients. 

The information for the ScriptPath Prescription Schedule is generated through a robust clinical engine that uses prescriber instructions to provide dosage and interval information and reconcile dosing times across a patient’s medication regimen. It also can understand prescriptions in English s and Spanish. CVS Pharmacy also has planned a 2018 roll out of a new prescription label, designed by the mind behind Target’s ClearRx prescription packaging system and inventor and lead designer of the ScriptPath system Deborah Adler, who ensured all elements of the ScriptPath system easy to read and understand, as well as developed clear icons and intuitive layout for the system.

“What’s really great about this project is it's a marriage of really crisp design voice that Deborah brings to the table and the deep clinical, innovative pharmacy technology that only CVS can bring forward,” Hourican told Drug Store News. “The marriage of the two together is what makes this project exciting to us, and we think our customers and patients are going to react to it in a favorable way.”

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PHARMACY

Lupin gets FDA nod for generic Acticlate

BY David Salazar

SILVER SPRING, Md. — The Food and Drug Administration has approved Lupin’s generic of Acticlate (doxycycline hyclate) tablets. The drug is indicated to treat infections caused by various micro-organisms and as an adjunctive therapy for severe acne.

Lupin’s generic will be available in 75- and 150-mg dosage strengths. The product had U.S. sales of roughly $253 million for the 12 months ended June 2017, according to QuintilesIMS data.

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FDA unveils efforts to speed complex generic approval

BY David Salazar

SILVER SPRING, Md. — As it continues to expand on its Drug Competition Action Plan, the Food and Drug Administration has outlined new efforts to make it easier for manufacturers to bring complex generics to market. In a post on the FDA’s blog, commissioner Dr. Scott Gottlieb noted that in many instances complex drugs — which include drugs with complex active ingredients and complex drug-device combination products — do not have generic competitors for various reasons.

“The new policies we’re announcing today are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs,” Gottlieb wrote. “This focus is critical because, first and foremost, these drug products provide important therapies to patients. They are also becoming increasingly significant to the economic health of the generic drug industry. Being able to ‘genericize’ a complex drug can be a high-value opportunity for a generic drug maker that helps underwrite the costs of other generic applications.”

Among the efforts is a draft guidance to assist manufacturers submitting abbreviated new drug applications for complex generics in creating and submitting preliminary requirements. The draft guidance is designed to give the FDA the ability to give better advice to sponsors looking to enter the complex generics space.

“These meetings will allow for enhanced communication between generic drug applicants and FDA early in the generic drug development process, allowing for more efficient generic drug development, review, and approval pathways. We’ve found from analyzing our new drug program, that early and better meetings between FDA and sponsors can improve development timelines. We want to bring these same types of opportunities to developers of complex generics."

The agency also is issuing another draft guidance to help manufacturers determine when submission of an ANDA for peptides — compounds made up of 40 or fewer amino acids, which constitute a number of branded medicines that don’t currently have generic competition despite having lost exclusivity — would be appropriate. Gottlieb said that the draft guidance would help ensure that the risk of an immune responsive from a generic due to impurities will not differ from the reference drug.

“We’re doing all of this without sacrificing the scientific rigor of the process one bit,” Gottlieb wrote. “A central aspect of our approach, and our efforts to spur innovation and generic competition, is focused on adopting more rigorous and sophisticated science, including sophisticated quantitative methods and computational modeling, in drug development, evaluation and review.”

Gottlieb said the agency would be releasing more policies to spur complex drug competition, and that it would be doing more than releasing guidances. In the next year, he said the FDA would be looking to identify gaps in science and develop more tools aimed at better clinical endpoint testing, particularly for complex drugs that can’t be measured through typical bioequivalence methods or that don’t have an efficient or convincing bioequivalence test method. It also will hold scientific workshops around quantitative modeling approaches, among other opportunities for complex drug development, in the hope that they will speed product development and keep development costs down while improving patient access.

“Our announcements today are part of a broader effort by the administration to address the high and rising cost of drugs and in the coming months, we’ll advance other policies aimed at enabling generic competition to complex drugs,” Gottlieb said. 

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