Devices are typically used by the patient to administer a specialty drug. In some cases the physician or nurse may use or insert the device.
- Offered in various forms, devices can be used for monitoring a condition or a biologic marker (like glucose blood testing), pumps and respiratory inhalers, and patient-used auto-injectors (like insulin or migraine drugs).
- They can be used in combination with micro-technology delivery systems (similar to insulin pens, mini-pumps and transdermal patches used today).
- They often have unique or specific patent protection for use with one drug or may be used by a class of drugs (respiratory inhalers, oncology related patch products).
- They can be used by the patient, the clinical provider or in a hospital/clinic setting for infusion, administration or refilling of the drug.
- Specific and complex diagnostic clinical tests are created during the development of certain specialty drugs and prior to the drug entering the market for general use.
- Many of the clinical or diagnostic tests now include gene-based elements of a test beyond typical molecular or traditional blood and urine testing.
- Most often used to determine the need for as well as efficacy of the drug for certain patients such as oncology, rheumatology, and infectious disease.
- Other important diagnostics include genomics and genetic testing:
- To date genetic tests have been developed for thousands of diseases and it is common to see an increasing numbers of biomarker and genetic tests enter the market prior to or at-launch of many biologic drugs.
- Laboratory diagnostics and biomarkers (e.g. traceable substance that is introduced into an organism as a means to examine organ function and other aspects of health) for drug dosing and delivery application are covered under the medical benefit.
- Most tests look at single genes and are used to diagnose rare genetic disorders, including rare inherited mutations of otherwise protective genes. Providers can now specialize in educating patients about their genetic results and the role of genomics in personalized care to include drug product selection.
- A growing number of tests are being developed to look at multiple genes that may increase or decrease a person’s risk of common diseases, such as cancer or diabetes.
- These tests and the use of other genomic technologies have the potential to help prevent common disease and improve the health of individuals and populations. For example, predictive gene tests may be used to help determine the risk of developing common diseases, and pharmacogenetic testing may be used to help identify genetic variations that can influence a person’s response to one or more medicines.
- Specially trained pharmacists can assist physicians in the use of drugs based from pharmacogenetics results. Learn more about genetic testing