The Abuse Deterrent Opioid Ecosystem

I've said it before and I'll say it again, addressing opioid abuse and addiction isn't just a formulation problem ... it's a systems problem.


Consider Utah Attorney General Sean Reyes' op-ed on opioid abuse (A smart way to counter prescription drug deaths). There are a few things that need to be added – and amended.


The vast majority of patients using non-abuse deterrent opioids do so safely and as directed. A subset, approximately four percent, abuse. And government statistics show that 78.5% of those who abuse prescription pain medication did not obtain the drugs from a physician in the first place.


Should non-abuse deterrent opioids ultimately disappear from the marketplace? Absolutely. But removing an entire category of generic products when there are no generic abuse deterrent alternatives not only does eradicate the abuse and addiction problem (since even abuse deterrent opioids can be abused) but punishes the millions of Americans who need opioids to address their chronic pain. Insurance companies are not ready to regularly reimburse for new, abuse deterrent formulations – despite steep discounting by manufacturers. The numbers are staggering -- 240,120,330 non-ADF generic opioids were prescribed in 2015 (nearly a quarter of a billion tablets) versus 5,068,398 branded opioids with ADF properties.


Further, payers often implement barriers to the use of branded, on-label non-opioid medicines, relegating these treatments to second line options. 52% of patients diagnosed with osteoarthritis receive an opioid pain medicine as first line treatment as do 43% of patients diagnosed with fibromyalgia and 42% of patients with diabetic peripheral neuropathy even though there are FDA-approved, non-opioid medicines specifically designed and labeled to treat these conditions.


Payers should step up to the public health plate and do the right thing right now.


Should the FDA, as General Reyes suggests, “… commit to following recommendations made by its advisory committees?” No. That is not the role they play. FDA Advisory Committees advise. It is (and should remain) up to the experts at the FDA to make the final decision. Ultimate responsibility must always reside with the regulator. (The FDA advisory committee that reviewed the controversial opioid Zohydro voted 11-2 that there was no evidence to suggest it had greater abuse or addiction potential than any other opioid.) 


Most importantly, a smart public health strategy would be a robust effort to better educate physicians on appropriate prescribing – something the FDA has been calling for regularly. Today the agency announced it will require short-acting opioid pain medications to carry a boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. It’s a good next step – but an even better one would be working with patients, caregivers, and physicians on better use of 21st century technologies (apps, social media, etc.) for tracking and measuring patient understanding and therapeutic outcomes. of safety info perhaps?  Promoting "safe use” can (indeed must) take many forms.


Peter J. Pitts

Chief Regulatory Officer

Adherent Health, LLC

Chairman, MHL Standards & Practices Committee

Safe Use App-ens

Late last year the FDA announced it’s “Safe Use of Drugs” Program. The theory behind the concept of safe use is that drugs can be made “safer” through patient education. A medical product “used as directed” is “safer.”

As former FDA Deputy Commissioner Joshua Sharfstein said, “The aim of the Safe Use Initiative is to identify specific preventable problems related to medication use and identify specific metrics that can measure progress; and to do it all by developing collaborations.”

Patient education is one thing – how to deliver that information is something else. And in the 21st century that means smart phones, tablets, and … mobile apps.

Consider the value of HIPAA-compliant Mobile Health Library (MHL) and the patient user experience.

For one prescription medicine (anonymous here due to client confidentiality), physicians who prescribed the drug also “prescribed” a brand-specific Patient Support App from Mobile Health Library – with important results.

After an initial test period, 4,062 distinct content engagement experiences by 1,200 patients (who received the brand-specific app at time of prescription) interactions with educational content related to Brand Safety Information ranked highest (42%) followed by educational content “about brand” (30%) and educational content “about condition/diagnosis” (28%). 

Per Sharfstein, “Partnerships will be important in the Safe Use Initiative. Clearly the clinical community is an important partner. Pharmacies have a very important role. Insurers should be engaged as they have the access to patients and know what is being prescribed. Pharmaceutical companies also have a vested interest in seeing their medicines used well.”

When it comes to making safe use a reality – mind the MHL app.

Peter J. Pitts

Chief Regulatory Officer

Adherent Health, LLC

Chairman, MHL Standards & Practices Committee

How to make pharma Rx support apps better? Get REAL.

Most Pharma Patient Apps:  Maybe not so good

I’m certainly not the first to describe the generally woeful nature of most patient apps developed for prescription medicines by manufacturers.  Pharmaceutical companies have a lot of apps in the market, and have been making apps for a long time, but their apps aren’t seeing downloads and usage on par with the apps from other industries.”

So what are the specifics?

Approximately two-thirds of apps published by the pharmaceutical industry are only in iOS/Apple device format.  In a world where over 50 percent of the population is using Android and Kindle Fire based devices?  Why?  Colleagues report that many iOS app pilots never quite make it to being full iOS/Google Play/Amazon app store commitments, often due to a lack of meaningful app performance metrics, and changes in marketing management.

Since most existing pharma patient support apps are rarely used (and often quickly deleted), what do prescribers and patients really want?

Privacy. Few Rx patient support apps are privacy protected, are HIPPA-compliant, or even have privacy policies.  When surveyed in late 2012, a SERMO recruited multi-specialty physician panel (results depicted below) reported that patient privacy protection was among the most important patient app benefits desired.

Adherence. Affordability. Education. Feedback. A simple review of pharma app offerings finds that very few apps have most of the attributes that patients, nurses, and their physicians want.   Some patient apps are not for patient support at all, but are reconstituted DTC acquisition mobile websites that offer little if any app-specific functionality or patient support services (Xarelto Patient Center as one example). Some apps remind for dosing or patch rotation (PatchMate, Exelon).  Some apps support planning and tracking of injection sites (Copaxone iTracker).  Some include access to copay savings cards and coupons. Many support some type of branded or unbranded education.   But very few support feedback of patient-reported outcomes. On this very timely topic, recent announcements by Biogen Idec and Novartis preview an emerging reimbursement strategy, with new “table stakes” that include real-world tracking, monitoring, and demonstration of Rx safe-use and outcomes-attainment. 

Biogen Idec recently announced the use and potential expansion of FitBit strategies to track physical activity rates for MS patients taking their MS brands.   Biogen Idec CEO George Scangos says he’s confident his company will be able to provide useful information to doctors, who can then “hopefully intervene earlier, and that should save the payers money and should result in better outcomes for patients.”

Novartis CEO Joe Jimenez went a step further during a speech in November 2014.   As reported by Reuters, “Jimenez is convinced remote monitoring technology will play a central role in this respect, both to help healthcare systems check if patients are improving and also to protect companies that need to ensure they are not penalized for a drug failing if a patient does not take his or her medicine.”  Said Jimenez, "It doesn't mean we will own the technologies, but it does mean the technologies will play an important role in the management of disease." 

For too many in the pharma industry, unfortunately “patient-engagement” still means direct marketing, patient acquisition and website clicks. As more payers become hungry for “real-world” outcomes-attainment tracking of specific pharmaceutical brands, industry Rx Patient Apps must more measurably support medication safe use and health outcomes attainment.  With such apps now having a seat at the reimbursement table, helping to re-define what “preferred” formulary medications really means.


Rob Dhoble

President, Adherent Health LLC


Safe-Use? It’s All About The Base

The joke inside the FDA is that the Brief Summary is like the Holy Roman Empire – neither brief nor a summary. Funny for the FDA – and an important jump-starter for a serious question – how can safety information be more user-friendly . To quote one of my favorite doctors, Dr. Seuss, “Sometimes the questions are complicated and the answers are simple." If it’s all about safe-use, to paraphrase some pop culture, it’s all about the base for both the FDA and pharmaceutical marketers.

The theory behind safe-use is that the best way to make any drug safer, it to ensure it is used as directed. That means putting that information in places and formats that are most accessible to patients. And in 2015 that means mobile apps. New user data from Mobile Health Library (MHL) confirms that, when Important Safety Information (ISI) is made mobile-friendly, it’s regularly accessed by on-treatment patients.

Consider one year’s worth of data for MHL’s patient support app for generic Exemestane. Of all the engagement activities available to the user, “Side Effects & Safety” rank first (at 28%), followed by “Savings & Refills" (16%), “About Condition" (15%), “About Exemestane” (14%), and “Dosing Reminder” (13%).  And the safe-use numbers for branded medicines are even higher. For one medicine (a branded epilepsy treatment), patients are accessing the Med Guide at 90%+ rates.



If it’s about giving the patients what they want – then it needs to be about giving them safety information in the ways they want it. When it comes to safety, it’s time for both the FDA and Big Pharma to start saying “App-y New Year.”

Peter J. Pitts

 Chief Regulatory Officer 

Thinking about apps? Think about your bathroom.

According to an article in Fierce Pharma, “Big Pharma has plenty of apps up for grabs, with companies like Sanofi, Boehringer Ingelheim and Johnson & Johnson rolling out flashy new products to pique consumers' interest. But as it turns out, not too many consumers are downloading them.”


Stand-alone pharma “…apps aren't appealing to the masses. Nearly half of pharma companies are only targeting local markets, distributing their apps in 3 or fewer countries. Drugmakers also tend to build their app portfolios around specific products, rather than tailoring their approaches to fit popular demand. The app market for health tracking, weight loss and fitness management is booming, and pharma companies that cash in on the trend could stand to benefit the most …”.

Here’s another way to look at it, consider your bathroom. How many medicine cabinets do you have? Answer: one. Now think about apps. Why would you want one app for every medicine you take? Wouldn’t one “medicine cabinet” app with all your medicines in it make better sense. One app with information on all your medicines’ safety information, dosing reminders, educational materials, even co-pay cards – and interactive communications with all your various healthcare professionals.

Now think about your weather app. Do you have a different app for every city? Of course not. You have one app with every city you're interested in. Same idea.

That’s the Mobile Health Library value proposition – one health app per patient, not one stand-alone app for every medication. Just like LinkedIn, Facebook, and Yelp.

Peter J. Pitts                                                                                                                                                         Chief Regulatory Officer

The complete Fierce Pharma story can be found here:

It’s an MHL App-ening!

The Food and Drug Administration has ruled that some products of health IT are not the same as medical devices and thus not subject to healthcare regulations. This according to the agency’s April publication of a framework

According to the Federal Times:

The FDA declaration goes even further, noting that even IT products that straddle the line still will be exempt. “For most health IT products that may be considered devices, FDA does not intend to focus its oversight on them,” said Bakul Patel, senior policy advisor for the FDA’s Center for Devices and Radiological Health.


Mobile Medical App is a category of mobile apps defined by FDA as “apps that consist of features of a regulated medical device by using attachments, sensors, or other such methods”.

Some examples of mobile apps that fall in this category include:

  • Mobile apps that connect to medical devices to control them or to display, store, analyze or transmit patient specific medical device data.
  • Mobile apps that transform a mobile platform with device functionality by using attachments, display screens, or sensors.
  • Mobile apps that perform patient specific analysis and provide patient specific diagnosis or treatment recommendations.
  • Mobile apps that use patient specific parameters to calculate dosage or create dosage plans for radiation therapy

Classification of Mobile Medical Apps:

Mobile medical apps have been classified into 3 categories:

Class I: No FDA review required and are considered least risky. For such devices, as long as they meet FDA-set standards they are ready to be marketed.

Class II: They are considered to be moderately risky. This category of devices requires the manufacturer to file pre-market notification. Pre-market notification means that the device manufacturers will be required to notify FDA of their intent to market a medical device at least 90 days in advance.

Class III: They are considered to be highly risky and will be under FDA scanner. Class III devices will need premarket approval. This is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. They may be defined as apps that support human life, play a critical role in preventing impairment of human health, or which presents a potential risk of illness or injury. These devices almost always must be approved by FDA before they are allowed in the market, and typically rely on the evidences obtained through clinical testing (i.e. on humans) to prove that they are safe and effective.

Mobile apps, entities, activities not under purview of FDA regulation

Examples under this category include:

  • Entities that distribute mobile apps such “iTunes App store” or the “Google Play store,” are not considered as medical device distributors by FDA
  • Mobile apps developed solely for non-clinical research, teaching or analysis and not introduced into commercial distribution
  • Mobile apps that are essential e-copies of medical textbooks and reference material
  • Mobile apps used for provider or patient medical training and education
  • Mobile apps used to automate operations in a healthcare setting and not for use in the diagnosis or treatment of disease (i.e., (i.e., dosing reminders, scan-to-refill, e-diaries, sign-and‐send e-forms, and multi- language options)

Mobile apps that function as an electronic health record (EHR) system or personal health record system.


Peter J. Pitts, Ph.D.

Chief Regulatory Officer

EFPIA Goes Mobile

According to the European Federation of Pharmaceutical Industries and Associations new “Manifesto for an Integrated Life Sciences Strategy in Europe,” drug manufacturers in Europe are missing out on opportunities for growth and patient outreach because they are failing to understand the value and potential of mobile health applications.

Per EFPIA’s director general Richard Bergström, “This is going in the direction of better patient compliance, adherence and motivation as well as an emphasis on health literacy and mobile apps … We need to find a way to unlock both the perceived and real regulatory hurdles, because I am not sure that the regulatory barriers are that high, and I think we are just being held back by conservatism.”

Bergström’s views are supported by the EU’s executive European Commission, which launched a Green Paper and consultation on mHealth in April this year. Its purpose is to examine existing barriers and issues related to mHealth deployment and help identify the right way forward to unlock its potential inside the 28-nation system.

Peter J. Pitts, Ph.D.

Chief Regulatory Officer

- See more at:

"Wiggle" my Aunt Fanny

OPDP reminds us that it's not the platform -- it's the content. (Or in this case, the lack thereof.) 

According to an article in Medical Marketing & Media,

The latest proof that the FDA is not giving social media outreach wiggle room, even though communications guidelines are not due out until this summer, is an untitled letter to Institute Biochimique and US partner Akrimax Pharmaceuticals over a Facebook page for its hypothyroidism drug Tirosint.

Not so fast MM&M.

It seems that, per OPDP, the Facebook page failed to “communicate risk information” and omitted material facts.

There should never be “wiggle room” for that. Not ever – especially for a drug with a boxed warning.

“Wiggle Room?” Hardly.

How about “proper oversight?”


Well done, OPDP.

AB Fab

California Assemblywoman Susan A. Bonilla has partnered with the California Pharmacists Association and the California Healthcare Institute to introduce legislation (AB 2418) that improves the process for medical patients to obtain their prescription drugs and follow their doctor's instructions on taking their medications.

"Poor medication adherence costs the US health system $290 billion dollars in other health care expenditures, such as emergency room visits and unnecessary physician office visits," said Jon Roth, Chief Executive Officer for the California Pharmacists Association. "Assembly member Bonilla's legislation will go a long way to improving medication adherence by allowing patients to receive their medication in a way that is most convenient to them and all those medications to be synchronized with all their other drugs, resulting in the best chance for a patient to successfully complete all of their prescriptions."

Specifically, this bill:

  • Allows patients to opt out of their health plan’s mandatory mail order program if they prefer to obtain their prescription drugs from a community pharmacy.
  • Streamlines prescription medications by placing the patient’s medications on the same refill schedule.
  • Allows patients who run out of prescription eye medications because of accidental spillage or who use more than 70% of their eye drops to be eligible for an early refill.

Pharmacy programs seem to be the best way forward, and there’s hard data to back that up. Case in point – the successful Appointment-Based Model program being used at Thrifty White, a Midwest chain of pharmacies. (For more information on the Thrifty White program, see the article, Adherence and persistence associated with an appointment-based medication synchronization program, from the December 2013 edition of the Journal of the American Pharmacists Association

By creating processes that support and improve patient access to medications; patients experience better health outcomes and improved quality of life. Patients who pick up their medications at their local pharmacy have the opportunity to talk with their pharmacist about how to properly take their medications and to understand the positive benefits of taking their medications.

Peter J. Pitts, Ph.D.

Chief Regulatory Officer

As I See It: Small is the new Big

Small is the new Big.

It's fast becoming an n of 1 world, where every disease is an orphan disease and success is measured by individual outcomes rather than large population studies such as CATIE or ALLHAT or the multitude of programs being funded by PCORI.

Small is the new Big means we must also think differently about pharmacovigilance. While we must continue to capture adverse event data, we must also strive to capture Substandard Pharmaceutical Events (SPEs). SPEs occur when a product does not perform as expected—perhaps because of API or excipient issues. SPEs can arise because of an issue related to therapeutic interchangeability. When it comes to 21st-century pharmacovigilance, we have to both broaden and narrow our views about bioequivalence to the patient level. Small is the new Big.

When it comes to drug development, adaptive clinical trials and companion diagnostics further define the urgency of small-scale thinking.  Demonstrating outcomes on an n of 1 level is crucial not just for 21st century healthcare technology assessment but also for physician pay-for-performance measures and the benefit of actual patients.

There's a lot of lip service paid to the comment that “the era of the blockbuster is over.” Now consider that statement from the perspective of another industry­—in the 21st century would you rather be Blockbuster or Netflix?

Small is the new Big. That means a focus on individual patient outcomes, which means a focus on the individual patient rather than the general population and on long-term care rather than short-term cost.

And it's about time.


Peter J. Pitts, Ph.D.

Chief Regulatory Officer

The Medium is the Medicine

When it comes to medication adherence, is knowledge power? Or is that even the right question. Perhaps patients, and healthcare professionals (and payers and regulators) also need to learn how to share knowledge. When it comes to medication adherence in the 21st century, the medium is the medicine.

Are package inserts, hard copy med guides, brochures and “starter packages” still the best way to make important healthcare information “sticky?” Were they ever? Will the tried-and-true ways enhance safe use or drive positive therapeutic outcomes? Or do today’s patients (also known as consumers) want their healthcare intelligence the same way they’re getting enlightenment and orientation on all the other things they want and need to know about the daily details of their lives? In short, on tablets and smart phones.

Is there an app for that?  


Peter J. Pitts, Ph.D.

Chief Regulatory Officer