FDA wants more clinical trial data before approving Forest, Gedeon Richter psychiatric drug
NEW YORK — The Food and Drug Administration has declined to approve an experimental drug for schizophrenia and bipolar disorder developed by Forest Labs and Gedeon Richter, a Hungarian drug company, the two said Thursday.
The companies said the FDA issued a complete-response letter for cariprazine. The agency issues a complete-response letter when it has finished reviewing an application but issues remain that preclude final approval. In the letter, the FDA acknowledged the drug’s efficacy, but wanted more clinical trial data.
"Given the complex pharmacokinetics and metabolism of cariprazine, we believe this request was made to better define the optimal dosing regimen to maintain the demonstrated efficacy, while minimizing the potential for the development of adverse events generally associated with this class of drug," Forest Research Institute president Marco Taglietti said.
Report: Expanding role of pharmacists in Canada can reduce burden of chronic illness
MONTREAL — Expanding the role of pharmacists can help reduce the burden of chronic illness on patients and potentially save Canada’s system an estimated $1.4 billion to $1.9 billion over three years. That’s according to the recent Pharmaprix/Shoppers Drug Mart Sustainable Solutions Report: A Focus on Managing Complex Chronic Diseases.
Like the United States, the increasing prevalence of complex chronic diseases is one of the most important health issues facing Canadians, making prevention and management a key priority for governments.
"Pharmacists already provide advice to patients that take medication to treat chronic conditions, but they can do so much more," stated Denis Roy, senior director, professional affairs at Pharmaprix. "Governments have identified chronic disease as an immense challenge and they are investing significant dollars in prevention and treatment of these illnesses; using pharmacists more effectively can help achieve the goal of improving care for Quebecers and Canadians, while at the same time reducing costs and creating more access to the healthcare system."
The report also includes survey data showing support from physicians and patients who want pharmacists to play a bigger role in healthcare delivery.
Such complex chronic diseases as arthritis, hypertension, diabetes, cancer, asthma and chronic obstructive pulmonary disease impact 37% of Canadians and are a factor in 70% of deaths. In Quebec, a little more than half of the population older than 12 years suffers from at least one chronic disease. Some risk factors for chronic diseases like age and genetics can’t be helped, while others are controllable like diet, exercise or tobacco use. In 2011, the associated medical costs for individuals with these complex chronic diseases were estimated at $42 billion, or 21% of total healthcare spending. This figure is expected to rise to $53 billion by 2015.
How Pharmacists Can Make A Difference
The Pharmaprix/Shoppers Drug Mart report includes a set of three steps governments can take to facilitate pharmacists playing a more substantial role in the management of chronic diseases. These include: enabling pharmacists to develop and manage patient care plans; allowing pharmacists to make prescription renewals and adaptations for specific drug classes; and improving electronic infrastructure and information-sharing between pharmacists and physicians.
Similar measures were outlined in a plan entitled, 9,000 Points of Care: Improving Access to Affordable Healthcare, released by Canada’s broader pharmacy community. That plan estimated between $1.4 billion and $1.9 billion would be saved over three years by expanding the role of pharmacists in managing chronic diseases. It is also estimated that 1.3 million emergency room visits and 500,000 hospitalizations could be avoided, freeing up to 6.3 million hours of physician time.
"Patients with chronic illnesses such as diabetes stand to benefit significantly by having access to pharmacists that can help them reach their health target, such as providing monthly feedback and support regarding their blood glucose results," Roy said. "In Quebec, four Type 2-diabetics out of 10 are at risk of developing serious complications because they do not reach their treatment goals. Pharmacists see these patients more frequently than any other healthcare professional, and they should be considered by the healthcare system as medication managers that can help diabetics stay away from the hospital."
Enabling pharmacists to develop and manage patient care plans involving lifestyle management tips and one-on-one or group counseling is one instance of how pharmacists can improve the patient experience while also saving physician time and healthcare dollars, the company stated.
An example of this type of program is the "Diabetes Care from Head to Toe" campaign, developed to help people control their diabetes. It also helps those with diabetes work with a pharmacist to monitor their blood sugar levels and medication over time to prevent complications that range from stroke to foot ulcers and include target organ damage in the eye, kidney and heart.
According to Diabetes Quebec, more than 760,000 Quebecers are affected with the disease. From this number, more than 250,000 have uncontrolled diabetes. What’s more, at least 200,000 Quebecers are unaware they have diabetes.
Physicians and Canadians Support Pharmacists’ Expanded Role
As part of the Sustainable Solutions report, national surveys were conducted of general practitioners and Canadians to determine their views on the role of pharmacists. It found 88% of doctors say they would be open to having more support from other healthcare professionals to help manage care for their patients with such chronic conditions as arthritis, diabetes or hypertension.
Almost a third of family physicians (31%) agree an expanded role for pharmacists will result in patients getting improved management of their chronic diseases. And 40% say patients will get quicker access to some services. Physicians agree that an expanded role for pharmacists can benefit the healthcare system as a whole in ways such as increasing patient adherence with medications (63%), reducing hospital re-admissions because of pharmacists conducting drug reviews (50%) and patients getting ongoing lifestyle and disease counseling from pharmacists (39%).
Canadians also want pharmacists to help them better manage their chronic conditions and would make use of their services. The vast majority of Canadians (94%) agree pharmacists can play an important role in helping people with chronic conditions manage their health, and 87% would like pharmacists to help make sure they take their medication as prescribed. The company noted that research from the Canadian Association of Chain Drug Stores and the Canadian Pharmacists Association reported similar findings.
NACDS emphasizes pharmacy’s collaborative role in curbing Rx abuse, diversion
ARLINGTON, Va. — The National Association of Chain Drug Stores has announced that in lead-up to a hearing of the Subcommittee on Health of the U.S. House of Representatives Committee on Energy and Commerce, it has submitted a statement emphasizing the important collaborative role that pharmacy plays in helping to ensure that prescription medications are used appropriately and that local communities are safe. The association also offered recommendations to better integrate prescription drug monitoring programs into pharmacies nationwide.
According to NACDS, the statement underscores that the association and the chain pharmacy industry are committed to partnering with federal and state agencies, law enforcement agencies, policymakers, and others to work on viable strategies to prevent prescription drug abuse, such as prescription drug monitoring programs.
“Our members are engaged daily in activities with the goal of preventing drug abuse,” NACDS said in the statement. “Pharmacies submit information on the controlled substances they dispense. This includes information on the patient, prescribed drug dosage and quantity and the prescriber. This information allows the state to conduct confidential reviews to determine any patterns of potential abuse or diversion.”
“While most individuals take prescription medications responsibly, we recognize that the potential exists for controlled substances to be diverted and abused. Most states now utilize PDMPs as a tool to curb controlled substance abuse. Chain pharmacies work with state PDMPs in all states that have them,” NACDS said in its statement.
NACDS recommended workable solutions to ensure PDMPs be appropriately designed so they are not administratively burdensome or disruptive to patient care in the pharmacy. In addition, NACDS emphasized the importance of consistency of reporting requirements to improve interstate operability; providing sufficient time for pharmacies to comply with the PDMP integration requirements; the establishment of a national aggregated controlled substance database as opposed to a patchwork of state databases; and expanding and accelerating the use of electronic prescribing for controlled substances.
“E-prescribing holds great promise to generate a robust database of real-time information that could be used by DEA, state enforcement officers, pharmacies, insurers, wholesalers and other partners to assist with the proactive identification of prescription drug abuse,” NACDS said in its statement.
In reiterating its support for legislation that would reauthorize the National All-Schedules Prescription Electronic Reporting Act, NACDS concluded, “We are committed to the health and welfare of our patients and the communities they call home. We believe that PDMPs are critical tools in combating prescription drug abuse and we encourage providing resources to ensure the viability of PDMPs.”