The responsibility for prescribing rests with the prescriber. As the prescriber, you are best placed to determine the needs of the patient and to monitor the outcome of therapy.
You also have an added responsibility to ensure the patient has been given appropriate information about the medicine and the supply under this access program and for obtaining the patients informed consent prior to treatment. Please feel free to use this example patient consent form.
The following information at least should be explained to the patient:
- The amount of medicine that will be provided under this program and any limits and/or costs that may apply (e.g. such as hospital or pharmacy dispensing fees).
- The supply of the dug is only guaranteed until such time that the medicine is reimbursed by the Australian Pharmaceutical Benefits scheme (PBS), New Zealand Pharmaceutical Management Agency (PHARMAC) or approved for use on a hospital formulary – whichever is appropriate.
- This prescription product is only to be provided to patients who are otherwise unable to afford treatment themselves. You agree to an audit of this supply at the discretion of Merck Healthcare. You agree not to sell or otherwise charge the patient for obtaining the medicine under this access program.
- Merck is committed to the ongoing safety surveillance of our products to ensure timely detection of new risks that could impact on our products’ benefit-risk profiles. Timely signal detection allows us to develop effective risk mitigation measures to ensure patient safety.
Adverse Reaction and Product Complaint Reporting
In order to help us monitor the safety of our products, we strongly encourage all healthcare professionals to report any adverse reactions occurring in their patients to the Merck Patient Safety department. Safety information that we collect and monitor include:
- All serious and non-serious adverse reactions, even if already listed in the Product Information and/or considered not to be caused by a Merck product
- All pregnancy and breastfeeding exposure to a Merck product
- Any lack of therapeutic efficacy (including any progression, exacerbation or relapse of an existing disease)
- Incidences of overdose, abuse, misuse or off-label use
- Any type of medication error (for example, prescribing, dispensing and administration errors)
- Occupational exposure
To report an adverse reaction, please email ICSR_ANZ@merckgroup.com or call 1800 633 463 (toll-free - australia) or 0800 426 252 (toll-free – new zealand)
In some instances, our Merck Patient Safety department may follow-up with you for further information to ensure that we have the most accurate and comprehensive information available for our internal medical evaluation. If you do not wish to be further contacted after submitting an adverse reaction report, please inform us at the time of reporting.
If you wish to report a technical product complaint with or without an associated adverse reaction, please use the above contact details.
Use of patient data collected in this system:
Patient information, including patient medical information, is collected to enable assessment of the patient’s eligibility with starting the nominated drug treatment in accordance with the Product Information. Patient names are only used for facilitating delivery of product to the nominated pharmacy and for enrolling the patient into a Patient Support Program (PSP) associated with the medicine. All patient information is stored securely in encrypted password protected systems. These systems may be located within Australia and/or outside Australia, but only in countries that have similar privacy laws/regulations and expectations as in ANZ. At all times adherence to the Australian Privacy Principles will be maintained.
Deidentified and aggregated (i.e. pooled) information may be used by Merck to evaluate the program and may be written up in a medical journal. The reports or abstracts will not identify any individual patient or healthcare professional.
If you have any questions about how Merck handles personal and sensitive data, please feel free to email the Privacy Officer at Merck (Australia):