Medication Adherence Updates: Review of US REMS Regulation and Compliance

Wednesday, July 7, 2010

Review of US REMS Regulation and Compliance

In iReminder's latest white paper we review FDA Risk Evaluation and Mitigation Strategies (REMS) and Elements to Assure Safe Use (ETASU) programs. The review covers strengths and challenges of existing implementations, as well as emerging best practices.

The white paper, called A Review of US REMS Regulation and Compliance, is available online for download.

The white paper provides an analysis of key developments in REMS compliance and implementations. Recommendations on compliance programs include:

Automated IVR, email and SMS messages to patients to remind them of upcoming laboratory testing and refill dates
Automated alerts to HCP and pharmacies when patients report that they will not comply with laboratory testing or refill pick ups
Automated distribution and printing of Medication Guides at the pharmacy and HCP office
Online access for:
- Pharmacies to determine certification status of HCPs
- Prescribers to determine certification status of pharmacies
- Wholesalers to determine certification status of pharmacies
- HCP and pharmacy training and certification
Online storage of HCP and Patient Agreement documentation

0 comments:

Post a Comment

Clinical Trials Stats

A growing trend of constant trial delays can cost a company up to $8 million each day their product is not on the market.
More than 35% of patients do not understand the informed consent documents because they are not written in plain language.
It is estimated that up to 30% of patients in clinical trials dump study drugs.
Only 6 percent of clinical trials are completed on time, and 72 percent of trials run over schedule by more than one month.
Recent NIH data indicates that just 4% of the U.S. population has participated in clinical trials
Within 3 years, up to 65% of FDA-regulated clinical trials will be conducted outside of the U.S.
In clinical trials just a 20% decrease in patient adherence requires a 50% increase in sample size to maintain equivalent power.

iReminder

iReminder, LLC is a healthcare technology company focused on increasing medication adherence and persistence. Marketed to companies in the healthcare sector, iReminder delivers customizable reminders and coaching messages to patients by phone, email and SMS text in the U.S. and internationally -- in any language and alphabet. iReminder offers an SaaS (software-as-a-service) model. Its technology is scalable to hundreds of thousands. For more information, visit iReminder.com or call 877-326-3293.

Med Adherence Stats

Better adherence to antihypertensive treatment alone could prevent 89,000 premature deaths in the United States annually.
People who are prescribed self-administered medications typically take less than half the prescribed doses.
People ages 45-54 years old are most likely to be non-compliant with their doctor’s advice
Medication non-adherence is responsible for up to 33% to 69% of medication-related hospital admissions.
The New England Healthcare Institute estimates that $290 billion in healthcare costs could be avoided if medication adherence were improved.
Of the 3 billion medication prescriptions issued each year in the US, 12% are never picked up by the patient and 40% are not taken correctly
UnitedHealthcare also looked at whether breast-cancer patients were compliant with their medication. It found that 38% weren't filling prescriptions for their aromatase inhibitors, drugs that stop the estrogen production that can feed certain cancers.
49% of consumers who look online for pharmaceutical information are interested in email or text reminders for prescriptions/refills
A one month pilot proved that by using SMS-based appointment reminders, Kaiser was able to save $150 per appointment, their no-show cost, which equated to a total cost savings of over $275,000 at a single clinic.
A study of California healthcare noted that 24.5% of blacks reported putting off filling a prescription, compared with 14.9% of whites, 10.8% of Hispanics and 6.1% of Asian-Americans.
Among patients with diabetes, those with lower levels of adherence have nearly twice the total annual healthcare costs of those with high levels of adherence ($16,498 versus $8,886).
Chronic diseases are estimated to constitute 75% of overall healthcare costs.
In one survey, of those who don't take pills they're supposed to, 79 percent said they simply forgot.
Adherence-related spending by brands runs 8-15% of overall marketing spending.
29% of Americans stop taking their medicine before it runs out.

Medication Adherence Updates

Wednesday, July 7, 2010

Review of US REMS Regulation and Compliance

0 comments:

Post a Comment

Clinical Trials Stats

iReminder

iReminder Links

Medication Adherence News

Blog Archive

Med Adherence Stats

Labels

Contributors

Medication Adherence Updates

Wednesday, July 7, 2010

Review of US REMS Regulation and Compliance

0 comments:

Post a Comment

Clinical Trials Stats

iReminder

iReminder Links

Medication Adherence News

Blog Archive

Med Adherence Stats

Subscribe

Labels

Contributors