spacer
home > pmps > autumn 2013 > get with the programme
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Get With the Programme

With increasing complexities including less tolerance for risk, long timelines, rigorous regulations and growing costs, it has never been more difficult, expensive or time-consuming to develop safe, effective medications. Nevertheless, over the last four years, the number of registered clinical trials has more than doubled (1), and as of June 2013 there were nearly 150,000 trials registered with the Food and Drug Administration (FDA), creating an even greater need for improved efficiencies across drug development.

This puts a premium on accurate results and that, in turn, makes it even more important to make sure that patients are adherent to their medications – taking them on time and in the right way.

However, patient medication adherence remains inconsistent – and has been that way for decades. For long-term chronic illnesses, studies show that as many as 50 per cent of patients are non-adherent.

Trial Challenges

Non-adherence is a serious challenge, whether a patient is taking a medication as part of a clinical trial or in the clinical setting. But the implication of nonadherence in trials is far greater than just one individual, since reliable data is needed to determine the safety and efficacy of the medication.

The fact is, we are all human. We make mistakes. Patients in clinical trials skip doses, stop taking their medications and misunderstand instructions. And they do not always tell the trial staff – either because they want to please the study team or because they are concerned about being dropped from the study altogether.

Education, proper motivation and awareness can help. Trial organisers and physicians are using these techniques, but they also need to understand what is actually happening in the trial population so they can intervene when needed. In the past, researchers had no way to tell.

Electronic Monitoring

Researchers, pharmaceutical companies and governments alike agree that the use of electronic monitoring methods change the picture by supplying a more data-focused approach, allowing for objective, accurate, real-time reporting. In fact, the FDA recently issued draft guidance encouraging the use of packaging as a necessary part of a broader adherence strategy, noting that practices such as the implementation of ‘smart bottles’ to monitor patient medication adherence and encourage better performance (when needed) have become standard.

One of the most commonly used electronic monitoring methods are Medication Event Monitoring System (MEMS) Caps. These caps keep track of actual dosage and feed the data to a server for analysis and predictive modelling, differentiating non-adherent patients from nonresponders. The information is provided in real-time so trial organisers can intervene, giving them the opportunity to improve communications through education, motivation and awareness.

Simply showing patients how they are taking their medication can change behaviour. A recent study found that providing patients with feedback about their own adherence patterns makes more of a difference in behaviour than any other kind of intervention – increasing adherence levels by nearly 20 per cent (5). Electronic monitoring methods can help make that kind of feedback possible.

Improving Adherence

MEMS Caps have been used by hundreds of thousands of patients in studies, which show that tracking patient dosing histories leads to more accurate trial results, can prove a predictor of the medication’s actions, gives researchers improved statistical power without increasing costs or stretching timelines, and results in long-term risk reduction for both patients and brands.

Implementation of programmes like these represents a shift in the practice of drug development, and ultimately has the potential to impact patient health by enabling optimised trial outcomes. Learnings from these programmes – especially around patient intervention and education – can also be used to determine how to best develop and incorporate adherence solutions in clinical care.

Patient Behaviour

Improving medication adherence is complex and involves changing patient behaviour, which requires a deep understanding of patients’ adherence barriers and underlying reasons for not taking their medication (which can include forgetfulness, side-effects, lack of perceived need for treatment, or lack of control). Although every patient is different, the analysis of data from MEMS Caps can identify consistent trends and patterns that can be used to educate pharmacists, physicians and pharmaceutical manufacturers on how, when and why their patients do or do not take their medication.

Given the complexity of behaviour change and the patterns, barriers and underlying reasons for medication non-adherence, studies show that a multi-disciplinary approach is most effective. Pharmacy programmes, disease management and customer relations management are among the many solutions proven to combat poor medication adherence. However, of all the options available, medication packaging is uniquely effective as one of the last opportunities to educate patients about how to take their medications safely and effectively.

Packaging Solutions

Recent studies have demonstrated that packaging designed to promote patient adherence can significantly improve patient medication adherence in the clinical setting. In fact, a first-of-its-kind study, conducted by Venebio, found that when used alone, Shellpak medication adherence packaging demonstrated a setting. But the implication of nonadherence in trials is far greater than just one individual, since reliable data is needed to determine the safety and efficacy of the medication. The fact is, we are all human. We make mistakes. Patients in clinical trials skip doses, stop taking their medications and misunderstand instructions. And they do not always tell the trial staff – either because they want to please the study team or because they are concerned about being dropped from the study altogether. Education, proper motivation and awareness can help. Trial organisers and physicians are using these techniques, but they also need to understand what is actually happening in the trial population so they can intervene when needed. In the past, researchers had no way to tell. Electronic Monitoring Researchers, pharmaceutical companies and governments alike statistically significant impact over vials, improving adherence and persistence for long-term daily medications (6).

Medication adherence packaging can be used to help intervene and educate in several ways – not least by saving pharmacists’ time that can be spent with patients. For example, pharmacists who receive pre-filled adherence packages spend less time counting, verifying and dispensing pills, freeing time to counsel patients, helping to explain the purpose of their medication, how to take it properly and answer any questions they may have.

Adherence packaging can also provide improved package billboard space. Unlike round vials, the open, flat space on blister packaging provides room for readable medication information, patient education and links to other programmes. For example, a QR code or website on the package could link to other adherence resources, such as disease management websites, auto-refill programmes, mobile apps or loyalty systems.

Conclusion

Whether in the clinical setting or clinical trials, one thing is certain – patient medication adherence is an ongoing challenge. We know that end-to-end solutions that take a multifaceted approach are the best way to combat this problem across the drug lifecycle. Over the next few years, continued input from patients and providers will be needed to determine how best to improve upon these existing solutions to continue advancing patient outcomes.

References
1. Visit: www.clinicaltrial.gov
2. Vrijens et al, BJCP, 2012
3. World Health Organization, Adherence to long-term therapies: evidence for action, 2003. Visit: www.who.int/chp/ knowledge/publications/adherence_ full_report.pdf
4. D’Angio R, Improving patient adherence through health behavior change, BCG analysis: Harris interactive survey, 2002. Visit: www.nmmra.org/resources/ download.php?id=1315
5. Demonceau et al, Drugs, April 2013
6. Zedler BK et al, A pharmacoepidemiologic analysis of the impact of calendar packaging on adherence to self-administered medications for long-term use, Clin Ther, 2011


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

About the aurther

Bernard Vrijens, PhD, is Chief Science Officer at MeadWestvaco Healthcare. He was General Manager of the AARDEX Group, prior to AARDEX becoming part of MWV Healthcare in 2012. Aardex solutions, including MEMS Caps, are widely recognised as the goldstandard method for compiling and analysing drug dosing histories. Bernard is also Associate Professor of Biostatistics at the University of Liège, Belgium. He is co-author of two book chapters, more than 30 peerreviewed scientific papers, and named as inventor on two patents. Bernard is also a founding member and Managing Director of the European Society for Patient Adherence, Compliance and Persistence.

spacer
Bernard Vrijens
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Mr Turhan Ozen Chief Cargo Officer at Turkish Airlines elected to the International Air Cargo Association (TIACA) Committee

Turhan Ozen, serving as Chief Cargo Officer at the global brand Turkish Airlines, was elected to the International Air Cargo Association (TIACA) Committee, the joint voice of the industry that aims to enhance the air cargo profile with intensive efforts towards the global standards.
More info >>

White Papers

RSSL introduces same-day mycoplasma testing service in UK

RSSL

Reading Scientific Services Ltd (RSSL), a leading provider of scientific and technical solutions to the global biopharmaceutical, pharmaceutical, and biopharmaceutical sectors, has introduced the United Kingdom’s first same-day mycoplasma testing service for manufacturers of biologic medicines.
More info >>

 
Industry Events

CPhI & P-MEC China

18-20 June 2019, SNIEC, Shanghai, China

CPhI & P-MEC China 2019 is your gateway to successfully grow your business at the 2nd largest pharma market in the world. Whether you are looking for sourcing new business or getting the latest market insight, this is your one-stop shop pharmaceutical platform in Asia.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement