Investigational drugs and radioactive substances will act as a base policy to put foundations for a research hospital or a nuclear medicine department. The policy is multidisciplinary and affect multiple departments in the hospital.
As usual with most of the policies sample posted here, there is some default data that should be listed in the policy header and footer. Below are some of the info that you need to include in your Pharmacy Investigational Drugs and Radioactive Substances Policy header:
- Hospital name, obviously.
- Pharmacy department operational policy and procedure, this header just to notify the reader that the following policy belongs to which department.
- Policy code or Number, for filing/indexing purposes.
- Edition Number, same purpose as above.
- Title of the policy, in our case; it would be pharmacy investigational drugs and radioactive substances.
- Important dates [date reviewed, approved date, effective date and due for review date].
- Applies to [department] in this case it should be pharmacy department
- And last but not least, you’ll mention the nature of the policy, whether it’s going to be multidisciplinary or department specific. (Multidisciplinary policy)
Investigational Drugs and Radioactive Substances
Definitions
- Investigational drug is a drug not yet introduced in the market and not yet approved by FDA.
- Radioactive substances are materials used for diagnosis or therapy in a tracer with no pharmacological effect.
Purpose
To prohibit the circulation and promotion of investigational drugs and to govern the use of radioactive substances by nuclear medicine department.
Policy
- The use of investigational substances is prohibited as per regulations.
- Handling of radioactive substances are restricted only for the use of nuclear medicine department.
Procedures and responsibilities
- P&T committee: display or any other promotional activities for investigational substances are prohibited.
- Nuclear medicine department:
- Investigational & radioactive substances should not be dispensed to the patient.
- Radioactive substances are restricted only for the use of nuclear medicine department (refer to the nuclear medicine department policy and procedure).
You’re almost done and pharmacy investigational drugs and radioactive substances policy is almost ready, what’s remaining is just few basic policy layout filling.
- References.
- Revisions: Revised as per timescale.
- Distribution: Here you should mentioned where this policy will be sent, and which departments will get a notification for it; for our current Pharmacy Investigational Drugs and Radioactive Substances Policy we are going to sent it to:
- Chairperson of P&T committee.
- Nuclear medicine department.
- Pharmacy department.
- Signed originals is maintained in manual 81 indexing office.
The policy is now finished, and it’s time to get proper signatures, whether your hospital is implementing an electronic signatures, or manual sign and stamp.
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