Question

14) Discuss the clinical phases of investigational drug studies. (2 points) 15) The home health nurse is visiting a patient who was discharged from the hospital last night. The patient did not have the time to get their prescriptions filled. The home health nurse is reviewing the prescriptions and one of them reads: "Timolol (Timoptic) two drops AD daily at night.” What action should the nurse take and why? What patient teaching should you provide about timolol? (2 points)

Answer 1

Ans) Clinical trial phases:

Phase Primary goal

Phase I Testing of drug on healthy volunteers for safety; involves testing multiple doses (dose-ranging)

Phase II Testing of drug on patients to assess efficacy and side effects

Phase III Testing of drug on patients to assess efficacy, effectiveness and safety

Phase IV trial is also known as postmarketing surveillance trial, or informally as a confirmatory trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold (e.g. after approval under the FDA Accelerated Approval Program). Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials).

15) Before using timolol eye drops or gel-forming solution, tell your doctor and pharmacist if you are allergic to timolol, beta blockers, or any other drugs.

- You should know that your vision may be blurred during your treatment with timolol gel-forming solution. Avoid rubbing your eyes even if your vision is blurred.