Brief Description: On May 30, 2018, the Right to Try law was enacted. The Right to Try law expands patient access to investigational drugs from the Compassionate Care Program. A physician can request access to an investigational drug from the manufacturer, if the patient has a terminal illness, has exhausted all approved treatments and is not eligible for a clinical trial. Drugs must have completed a Phase I trial, but unlike the Compassionate Care Program, Right to Try does not require FDA review, the FDA does not make recommendations on dosing or collect ADR data. Manufacturers can charge for manufacturing cost, shipping, reporting and IRB approval. Manufacturers are required to report at least annually on use of Right to Try for their drug development pipeline on their web site. They must also provide data on ADRs with the experimental treatment. The FDA has stated the agency will support Right to Try but has not published guidance on the program. It is very likely that Right to Try will increase use of investigational drugs outside of clinical trials. Patients with terminal illnesses or their families that are researching alternate treatments, will probably become more aggressive in their request for a new treatment. The Pharmaceutical Pipeline Tracker has information on safety, efficacy, route of administration and dosing frequency. Prescribe Right will continue to monitor developments in Right to Try and add information to the database to support health care professionals that need to discuss an investigational therapy with patients or with other providers.
Actors– Hospital pharmacists with P&T committee investigational drug update responsibilities.
Preconditions– The generic drug name or research code to which a physician has requested access. A subscription to the Pharmaceutical Pipeline Tracker.
Basic Flow– At any computer, laptop, or mobile device open a web browser and enter www.prescriberight.com in the search field then hit the enter key on the keyboard. The Home page opens. On the command line hover over “Pharmaceutical Pipeline Tracker” to reveal the drop-down menu. Click on “Access the Tracker” on the drop-down menu. Then begin entering the investigational drug name in the search box next to the Single Drug Search button. A scrollable word wheel appears from which to choose the drug for which you wish to see its monograph which provides access to that drug’s data elements: generic name, brand name (if available), pharma company, research code, indication, drug class, route, PDUFA Date (if available), FDA and EU status. Statements on efficacy and safety are present. Published research studies (if available) are accessible via URL links to PubMed.
Alternate Flows– In addition to the Single Drug Search capabilities as described above, search buttons are present for a search of all investigational drugs with the same indication as the previously searched individual investigational drug (See USE CASE – Monitoring Investigational Drugs by Indication). Similarly, one could search for all drugs within the same Drug Class or Therapeutic Category (i.e. oncology). Clicking on any drug name takes the user to that drug’s individual monograph containing the following data elements: generic name, brand name (if available), pharma company, research code, indication, drug class, route, PDUFA Date (if available), FDA and EU status. Statements on efficacy and safety are present. Published research studies (if available) are accessible via URL links to PubMed. Click on the back arrow returns to the list of drugs for continued study of the category.
Exception Flows– User Name and Passwords must be spelled correctly. Begin searches by typing the first letters of the search word in the Single Drug search box, then choose from the word wheel list and click on the appropriate drug name, then click on the blue Single Drug Search button.
Post Conditions– Users will have a roadmap on the information needed to prepare a report to Physician(s), P&T Committee and any individual departments seeking drug utilization recommendations. The Pharmaceutical Pipeline Tracker has information on safety, efficacy, route of administration and dosing frequency for investigational drugs. Prescribe Right will continue to monitor developments in Right to Try.
Actors– Hospital pharmacists with P&T committee investigational drug update responsibilities.
Preconditions– The generic drug name or research code to which a physician has requested access. A subscription to the Pharmaceutical Pipeline Tracker.
Basic Flow– At any computer, laptop, or mobile device open a web browser and enter www.prescriberight.com in the search field then hit the enter key on the keyboard. The Home page opens. On the command line hover over “Pharmaceutical Pipeline Tracker” to reveal the drop-down menu. Click on “Access the Tracker” on the drop-down menu. Then begin entering the investigational drug name in the search box next to the Single Drug Search button. A scrollable word wheel appears from which to choose the drug for which you wish to see its monograph which provides access to that drug’s data elements: generic name, brand name (if available), pharma company, research code, indication, drug class, route, PDUFA Date (if available), FDA and EU status. Statements on efficacy and safety are present. Published research studies (if available) are accessible via URL links to PubMed.
Alternate Flows– In addition to the Single Drug Search capabilities as described above, search buttons are present for a search of all investigational drugs with the same indication as the previously searched individual investigational drug (See USE CASE – Monitoring Investigational Drugs by Indication). Similarly, one could search for all drugs within the same Drug Class or Therapeutic Category (i.e. oncology). Clicking on any drug name takes the user to that drug’s individual monograph containing the following data elements: generic name, brand name (if available), pharma company, research code, indication, drug class, route, PDUFA Date (if available), FDA and EU status. Statements on efficacy and safety are present. Published research studies (if available) are accessible via URL links to PubMed. Click on the back arrow returns to the list of drugs for continued study of the category.
Exception Flows– User Name and Passwords must be spelled correctly. Begin searches by typing the first letters of the search word in the Single Drug search box, then choose from the word wheel list and click on the appropriate drug name, then click on the blue Single Drug Search button.
Post Conditions– Users will have a roadmap on the information needed to prepare a report to Physician(s), P&T Committee and any individual departments seeking drug utilization recommendations. The Pharmaceutical Pipeline Tracker has information on safety, efficacy, route of administration and dosing frequency for investigational drugs. Prescribe Right will continue to monitor developments in Right to Try.
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