Side Effects & Risk Management

Side Effect And Risk Management Patient Information

Patients need to be able to recognize the early warning signs of side effects and the appropriate actions to take.  They need this information in language they can understand that is non-frightening.  They need to know how to manage minor side effects and what to do if they develop early warning signs of more serious or life-threatening adverse reactions.

Side effects are the #1 concern of patients:

Side effects

• Patients decide not to fill initial prescription

A fear of developing side effects is one of the most common reasons that patients decide not to fill the initial prescription. 10 – 20% of patients decide in the doctor’s office they are not going to fill the prescription. Between 50% – 75% of patients do not tell the physician.

• Patients decide not to refill prescriptions

Side effects can develop after the patient has taken a few doses of a medication.  Research has reported that up to 75% – 85% of patients decide to drop out of therapy at the end of the first year. Fear of side effects and a lack of understanding how to manage side effects are two of the major reasons patients drop out of treatment.

Consumer Health Information Corporation has 30 years of experience in developing patient information on side effect management.  Our team of health professionals know the types of questions patients ask and how to respond because of their years of counseling patients and answering their questions about side effects.

We have expertise in developing wording that is evidence-based, accurate yet non-frightening and practical.  We know how to develop side effect management information for patients that will be acceptable to FDA and still understandable to patients.

All side effect management information is translated to the Grade 6-8 level so that patients are able to understand “the words”. Even more important, all medical terminology regarding specific side effects are translated into symptoms that patients will be able to recognize. For example, many patients do not know how to recognize the early warning signs of jaundice.  We provide patients with symptoms they will be able to recognize.

Because of our medical and pharmacy experience, our team knows how to develop side effect management information this is 100% accurate, practical and non-frightening.  Research has shown that patients who know how to recognize the early signs and symptoms of side effects and how to manage them are less likely to drop out of therapy because of fear.

Areas of Service

We have worked with medical, regulatory, and marketing teams on major blockbuster products to develop side effect management information for patients in the following:

  • FDA-approved patient labeling including side effect recognition and risk management
  • Customized side effect management materials for product launches, health professional counseling tools
  • Patient counseling tools for health professionals on side effect management
  • Informed Consent documents for clinical trials
  • REMS patient information
  • Smart phone apps and patient portals