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

Patients Overestimate Their Adherence in Clinical Trials

According to Dr. Dorothy L. Smith, President and CEO of McLean-based Consumer Health Information Corporation (CHIC), "Research shows that many patients are overestimating their adherence and not providing the study investigators with honest self-reports. The study design may be flawless, but if the patient does not understand the medication instructions and is not motivated to take the study medications as prescribed, the results of the clinical trial might be flawed." She asked: "Could this be part of the reason for the unexpectedly high adverse drug reactions and deaths that have made recent headlines and resulted in numerous post-marketing dilemmas?"

The main reason that patients over-report their usage is because they do not want to disappoint their doctors. Failure to report the patient's adherence has a huge impact on study results. Data on the efficacy of the study could be misinterpreted or the dose required to provide a desired effect overestimated.

Smith urged the pharmaceutical industry and clinical pharmacists to take the time to ensure that patients understand all information they need when participating in a clinical trial, by developing consent documents written in plain language, explaining how to take the study medications and use any device correctly, and the need to be honest with the study investigators regarding any problems they are having taking the medication.

Patients in clinical trials need to understand how important their study results are to the general population who will be taking the medication in the future.

Reported in Medical News Today

Monthly Reports to Patients Significantly Improved Medication Adherence

Adults who received renal transplants greatly improved their adherence to medication when they were sent computer reports that showed them when and how often they took their daily medications.

For the first time, researchers used a continuous self-improvement intervention approach that involved providing transplant recipients with monthly feedback, including reports on their adherence.

This program also included two methods of nurse support: a clinical nurse specialist worked with transplant patients to identify ways to improve the patient's compliance; a clinical nurse specialist practiced attentive listening and support to the patient.

After 1 month, the mean medication adherence score for the continuous self-improvement intervention group was significantly higher than the attention-control group's mean medication adherence score (P = .03).

Medication adherence remained fairly stable in the continuous self-improvement group, even at the six-month mark.

To read more go to: Computerised Pill-Taking Reports

Mobile Healthcare Will Help Cell Phone Subscriptions Hit 5B This Year

Mobile healthcare via cell phone use is one of the primary reasons why cell phone subscriptions worldwide will hit 5 billion this year. International Telecommunication Union (ITU) Secretary-General Dr. Hamadoun Toure, who is attending the Mobile World Congress this week in Barcelona, Spain, believes that seemingly small features like medical appointment reminders have helped to better quality in developing nations.

"Even the simplest, low-end phone can do so much to improve healthcare in the developing world," Toure said, according to cnet. He also believes that SMS messages that help to instruct patients on how and when to take medications, have made a huge impact." It's such a simple thing to do, and yet it saves millions of dollars--and can help improve and even save the lives of millions of people," he said.

For more information go to CNET

iReminder Publishes White Paper on U.S. and International HPV Vaccine Adherence Programs

iReminder has released a white paper on global compliance and reminder programs for the HPV vaccine.

iReminder's HPV Vaccination Compliance white paper provides guidance to pharmaceutical brand managers, managed care organizations, and Immunization Information Systems. The white paper includes best practices employed to help patients complete the three-dose HPV vaccinations. Many of these practices also are effective for a wide range of adherence programs.

Market data for Merck's GARDASIL® and GlaxoSmithKline's CERVARIX® are included, as well as an overview of the pipeline for HPV vaccines. Compliance programs in the U.S., UK, Scotland, Switzerland, Finland, Germany and Australia are described in detail.

To get the full white paper go to: http://www.ireminder.com/whitepaper.php.

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Specialized Support Programs Can Increase Treatment Adherence and Persistence for People with Multiple Sclerosis

A new study shows that multiple sclerosis (MS) patients enrolled in a seven-month disease therapy management (DTM) program show greater adherence to injectable MS medications and treatment persistence than patients who receive injectable MS medications through a community pharmacy.

In addition, the percentage of DTM patients who reported an MS relapse decreased by more than a third at the end of the program.

Among the key study findings was that the DTM group had significantly greater persistence on therapy (220 days) compared with the two control groups (specialty pharmacy, 188 days; and retail pharmacy, 177 days), and a lower medication discontinuation rate (7.7 percent vs. 21.8 percent for specialty pharmacy and 28.2 percent for retail pharmacy).

To read about the study go to: Managed Care

Factors for High Retention in Pediatric Clinical Trials

The Correction of Myopia Evaluation Trial (COMET), a randomized, multicenter clinical trial of myopia progression in children, had an exceptionally high retention rate of 98.5% (462/469) at three years of follow-up. They evaluated and compared the reasons for COMET's high retention rate according to participating families and clinical center staff. The questionnaire evaluated study features in four categories: staff characteristics, operational aspects, specific study elements, and incentives.

Features that appealed to 90% or more families and promoted continued study participation included staff attributes such as friendliness, responsiveness and encouragement, and aspects pertaining to standard of care such as completeness of eye exam, quality of eye care and free eyeglasses.

Staff tended to underestimate the importance of the following features for retention: seeing the same staff at each visit, appointment reminders, center location, newsletters, commitment to the study, being part of a nationwide study, length of the study, association with a college of optometry, completeness of eye exam, and eye drops.

The findings highlight the importance of intangible factors such as staff attributes and participants' study commitment in maintaining high retention rates, and the usefulness of surveying both families and staff.

This paper was published in Clinical Trials, Vol. 2, No. 5, 443-452 (2005)