Counseling Points Multiple Sclerosis - Spring 2015 - 10
Table 3. Recommendations for Managing Treatment Safety in MS
* Selection and timing of treatment should be a shared decision between the healthcare provider and the person with
MS, based on individual assessment of disease risk, likelihood of treatment efficacy (benefit) and short- and long-term
adverse effects (risk).
* Communication of known or possible risks/benefits should be objective, understandable for the patient, and
* The safety profile should take into account risk minimization plans proposed by regulatory agencies.
* Only pivotal clinical trials and several years of prescription use can determine the safety profile of a treatment.
Documents used to inform patients must be periodically reviewed in this view of new perceptions or evidence of risk
* Healthcare professionals and patients should be involved in the spontaneous reporting process of adverse events to
regulators in the course of prescription use of treatments.
* Implementation of international long-term follow-up, cohort databases or registries should be required for all new
* Risk minimization over time should be based on transparent information provided by regulators and manufacturers
that is provided on a timely basis to health care professionals and patients.
Adapted with permission from: Clanet MC, Wolinsky JS, Ashton RJ, et al. Risk evaluation and monitoring in multiple sclerosis therapeutics. Mult Scler.
have any questions about their medications. This
is usually not because they understand everything
about the treatment-they simply don't know
enough about the medication to ask the right
turnarounds. An analysis by Cohen and colleagues
from Tufts University Medical School describes
barriers related to reimbursement and diagnostic tests as "bottlenecks" that keep patients from
getting the treatments prescribed for them. 51
Many MS nurses have made a 3-month followup appointment and/or MRI appointment for a
patient who was started on a new therapy, only to
find that the person had not yet begun using the
new agent within that time period. Is a 6-month
follow-up time period more realistic? Some
nurses recommend that the patient return in 6
months, regardless of whether a therapy has been
started, to determine whether and why a delay
has occurred. Some practices use automated software systems such as Covermymeds.com to help
streamline prior authorization paperwork.52
Patients often answer "No"
when asked if they have any
questions about their medications.
They may not know enough about
the medication to be able to ask the
right kinds questions.
kinds of questions. 50 In addition, patients may
sense that the nurse or other healthcare provider
doesn't have time to answer all of their questions.
Effect of Reimbursement and Prior
Authorization on Monitoring Needs
As most healthcare providers know, prior authorization systems do not necessarily promote quick
New and emerging therapies will continue to
have a major impact on the treatment of MS.