Chain Drug Review, July 9, 2018

56 Chain Drug Review July 9 2018 RX News Technology Can Advance a 21st Century Regulatory Process By Dean Erhardt The NEW YORK Driven by the 21st Century Cures Act Food and Drug Administration Commissioner Scott Gottlieb has publicly stated a goal of moving the FDA into the new century by creating a regulatory process that is modern and efficient It doesnt seem all that long ago about 1992 that the Prescription Drug User Fee Act PDUFA was passed allowing the FDA to collect fees from drug manufacturers to fund the new drug approval process PDUFA must be reauthorized every five years Upon the latest renewal this included the Food and Drug Administration Reauthorization Act FDARA which incorporates the reauthorization of PDUFA through September 2022 According to the FDA website PDUFA VI will provide for the continued timely review of new drug and biologic license applications However there is prevailing cynicism in the market regarding the FDAs commitment to a timely review process given the long delays and date changes imposed on companies by PDUFA According to Commissioner Gottliebs blog the stated goal that should be welcomed in every corner of the industry is To advance this progress its key that the FDA adopt a regulatory approach to these technologies thats as innovative and nimble as the opportunities that were tasked with evaluating Clearly the FDA is tasked with significant responsibility and the need for pharmaceuticals to go through a stringent review process that ensures safe and effective medications should not be underestimated That said the industry should be receptive to a streamlined process that leverages current technology such as artificial intelligence and computer simulation These technology innovations could possibly bend the cost curve if the cost of clinical trials could be at least in some cases materially impacted The FDA is not the only stakeholder interested in improving the approval process In May The Wall Street Journal asked Are Big Clinical Trials Relevant Researchers Disagree This was not a prompt to debate the merits of one pathway versus another What is evident is that smaller nimble trials that are tailored to a patients genetic makeup should Lower the cost of getting a product to market Lower the price and therefore the cost to the health care system by enabling lower cost vis à vis lower overall investment cost Of course as manufacturers go through the FDA approval process the clinical trial is not the only investment requirement As one would imagine companies particularly new companies have other significant costs during their commercialization process such as setting up their distribution program attaining state licensing staffing a commercial organization which may include a substantial salesforce developing clinical education programs and many other activities A delay in the approval process impacts all of these areas and can cost many millions to a manufacturer outside of the actual FDA approval process In addition FDA delays can force manufacturers to make significant layoffs only to hire again later The FDA and other regulatory bodies might also look beyond drugs and biologics to devices and e health products that are approved via the 510K process Many of these products are highly innovative and bring unique solutions in such high profile disease states as opioid dependency and substance use disorder The products while not drugs can also address significant diseases that are underserved today in some cases with no potential for negative impact i e side effects One example might be gammaCore manufactured by electroCore which initially was approved for the acute treatment of pain associated with episodic cluster headache in adult patients also known as the suicide headache This product has subsequently attained approval for the acute treatment of pain associated with migraine headache in adult patients albeit using neuromodulation these products are therapeutic just like medicines While discussing issues that require regulatory approval it may also be time for the Centers for Medicare and Medicaid Services CMS to look at how to reimburse for some of these products Finally it is encouraging to witness the development of the agency known as the Oncology Center of Excellence This organization holds promise not only to accelerate treatment options but also to encourage manufacturers to invest in cures for ultra orphan diseases such as diffuse intrinsic pontine glioma DIPG a type of brain cancer that primarily affects children and leaves them with almost no hope This serves as an example of a disease where there has been no significant innovative therapy since the 1960s With a more innovative approach to drug development perhaps more can be done for these types of diseases without having to break the bank in order to get a product to market Realistically our world is changing at a record pace largely driven by technology Now it is incumbent upon the FDA and others to challenge themselves to create a regulatory approach thats as innovative and nimble as the opportunities that were tasked with evaluating as Gottlieb called for The other option is for the industry to simply stay the course and continue to outpace the regulatory environment This will require spending unnecessary time and money and potentially delay life saving options for patients everywhere Dean Erhardt is chief executive officer of D2 Consulting Rx Can Boost Numbers of Vaccinations From 55 Dean Erhardt Opioids on the Decline posed prescription limits according the Avaleres data which show declines in every state but Idaho in 2017 States have been wrestling with the opioid issue for years with varying degrees of success said Kelly Brantley vice president at Avalere Limiting the supply of opioids such as through fill limits is gaining traction as part of a broader set of strategies being tested by states as they continue to confront the opioid crisis she said Twenty two states have now enacted opioid fill limits that restrict the quantity of opioids a physician can prescribe to an individual patient over a specific time frame As Congress considers sweeping legislative initiatives to address this epidemic state governments are continuing to advance solutions within their own states Clara Soh a director at Avalere said in a statement For its part the Food and Drug Administration is committed to addressing the crisis on all fronts with a significant focus on decreasing exposure to opioids and preventing new addiction by taking steps to encourage more appropriate prescribing supporting treatment of those with opioid use disorder and promoting development of improved as well as lower cost forms of medication assisted treatment fostering the development of novel pain treatment therapies that may not be as addictive as opioids and opioids more resistant to abuse and misuse and taking action against those who contribute to the illegal importation and sale of opioid products The agency will also continue to evaluate how drugs on the market are used in both medical and illicit settings and take regulatory action where needed WASHINGTON States that passed laws setting limits on opioid prescriptions experienced the steepest declines in the number of prescription opioids sold in 2017 according to Avalere Health The firm said its research suggests that sales of prescription opioids declined 11 in 2017 from a year earlier The biggest declines were in the seven states Connecticut Maine Massachusetts New York Pennsylvania Rhode Island and Vermont where legislators took action in 2016 limiting opioid prescriptions to a three to 14 day supply or limiting the morphine milligram equivalent MME amount of medication that could be prescribed Avalere said The biggest decline was in Maine where sales of prescription opioids were down nearly 25 from 2016 levels Prescription opioid supplies are declining even in states that have not im States with laws limiting opioid prescribing amounts Work with your workflow Pharmacists are busy As pharmacies look for ways to improve immunization rates it is important to take pharmacist workflow into account Is it possible to determine eligibility and indication for each patient by checking the clinical guidelines for that particular vaccination the payers requirements for reimbursement the patients medical history and your local immunization registry for the patients history Yes Is that something that a busy pharmacist has time to do while a patient is waiting in the store Not likely Pharmacies can leverage technology to streamline the identification of eligible patients but ensuring this technology does not break the pharmacists workflow is critical to success As health care in the United States continues to shift to lower cost highervalue settings of care the pharmacy has the potential to play a pivotal role in addressing stagnant adult immunization rates by leveraging their access to patients who need vaccinations and are already in their store on a regular basis By implementing proven best practices pharmacies can make a significant impact on public health and move the needle on adult immunization rates John King is chief executive officer of OmniSYS a technology company that helps pharmacies and pharmaceutical manufacturers drive growth by engaging patients competing on value and distinguishing their brands Pharmacists Help Adherence Rates in the Elderly pharmacy in promoting adherence reviewed existing knowledge of pharmacy programs and services capability for boosting adherence in this growing patient population Pharmacists have a key role in monitoring and improving patient adherence to medicines both as a single profession as well as within a multidisciplinary patient centered collaborative team commented Parisa Aslani professor in medicines use optimization at the University of Sydney School of Pharmacy in Australia and signs of cognitive impairment allowing them to adjust the way in which they communicate with patients and the actions they take Its important for medication regimens to be convenient and as far as possible undemanding Aslani remarked It is imperative to develop and implement interventions that address the individual needs of patients she said adding that it is vital for such interventions to have long term sustainability THE HAGUE Netherlands Pharmacist interventions can significantly improve medication adherence in the elderly a new report from the International Pharmaceutical Federation FIP has found Services including counseling with prescription refills dosage administration aids and reminder systems are among interventions that improve adherence for seniors with chronic conditions the study says The authors of the report Use of medicines by the elderly The role of lead author of the report Elderly patients are at particular risk for nonadherence because they often take several medicines for multiple conditions and taking these medicines properly can be a challenge especially for those with declining cognitive function or mobility and manual dexterity issues The authors point out that mild or early cognitive decline can go unnoticed by health professionals and recommend that pharmacists be given training to prevent them from missing