Methods for providing an easily comprehendible risk rating for pharmaceutical products
View Patent ↗The invention relates to a method for assigning a risk rating to a medical product. The method includes assessing one or more threats associated with the medical product; assessing the level of experience with the medical product; and assigning a risk rating for the medical product to provide an indication of risk associated with the medical product. The method may be implemented as a webpage. For example, a new contraceptive may be assigned a risk rating of yellow for the general treatment population. This risk rating allows consumers to make an informed choice between different products on the basis of benefit versus risk, and help patients decide what steps they may wish to take to minimize their risk if they choose to take the new drug.
1. A method implemented on a computer system for assigning a risk rating to a medical product, the method comprising:
using the computer system programmed with an algorithm for assessing one or more threats associated with the medical product, wherein assessing one or more threats associated with the medical product includes determining a probability of the threat occurring, and using the value of the probability of the threat occurring to determine and assign a threat value to the threat and storing the threat value on a readable medium, and wherein determining the probability of one or more threats occurring comprises pooling the probability of multiple threats occurring to give a pooled probability and assigning a single probability value for the pooled probability of the multiple threats;
using the computer system programmed with an algorithm for assessing the level of experience with the medical product, wherein assessing the level of experience with the medical product includes assessing the level of experience with the medical product based on a level of usage of the product, assigning an experience value to the level of experience, and storing the experience value on a readable medium, wherein the level of usage of the medical product comprises years on the market, number of prescriptions, number of patients studied during the clinical trials, number of patients taking the product, and number of countries in which the product has been approved and marketed; and
using the computer system programmed with an algorithm for assigning a risk rating for the medical product to provide an indication of risk associated with the medical product, wherein the risk rating for the medical product is assigned based on the threat value and experience value and the computer system is programmed to display the resulting risk rating on a display.
2. The method of claim 1 , wherein assigning a risk rating to the medical product comprises using the risk rating algorithm programmed on the computer system to assign a risk rating to one or more of a pharmaceutical product, a biologic product, and a medical device.
3. The method of claim 1 , wherein assessing one or more threats further comprises assessing the severity of the threat.
4. The method of claim 3 , wherein assessing the severity of the threat comprises assessing one or more of a risk of permanent disability, death, and serious adverse event.
5. The method of claim 1 , wherein assessing one or more threats further comprises assessing the potential population affected by the threat.
6. The method of claim 5 , wherein assessing the potential population affected by the threat further comprises assessing a percentage of the population to which the threat applies.
7. The method of claim 5 , wherein assessing the one or more threats further comprises one or more of determining the population to which the threat applies, determining whether the population at risk as a result of the threat can be identified in advance, and determining an indicator of usage of a second medical product for which there is an interaction with the first medical product.
8. The method of claim 1 , further comprising pooling the assessment of each threat.
9. The method of claim 1 , further comprising determining whether the medical product is an orphan product.
10. The method of claim 1 , wherein assigning the risk rating comprises assigning a gradated rating having at least three grades.
11. The method of claim 10 , wherein assigning the three grades comprises assigning a gradated rating having three symbols.
12. The method of claim 1 , wherein the method uses the algorithm for assessing one or more threats programmed on the computer system to assess more than one threat.
13. The method of claim 1 , wherein assigning a risk rating further comprises using software programmed on the computer system to provide and display guidance associated with the risk rating.
14. The method of claim 1 , wherein the method for assigning a risk rating to a medical product is implemented on a webpage.
15. A webpage for providing a risk rating for a medical product, the webpage configured to:
receive input relating to a medical product; and
display a risk rating for the medical product;
the webpage including software instructions programmed on a computer system for processing the input relating to the medical product to retrieve data relating to an assessment of one or more threats associated with the medical product wherein assessing one or more threats comprising determining a probability of the threat occurring, retrieve data relating to an assessment of the level of experience with the medical product based on a level of usage of the product, wherein the level of usage of the medical product comprises years on the market, number of prescriptions, number of patients studied during the clinical trials, number of patients taking the product, and number of countries in which the product has been approved and marketed, and assign a risk rating for the medical product to provide an indication of risk associated with the medical product, the risk rating being based on the threats associated with the medical product and the level of experience with the medical product,
wherein determining the probability of one or more threats comprises an assessment of the probability of multiple threat occurring to give a pooled probability.
16. The webpage of claim 15 , wherein the medical product comprises one or more of a pharmaceutical product, a biologic product, and a medical device.
17. The webpage of claim 15 , wherein the assessment of one or more threats further comprises an assessment of the severity of the threat.
18. The webpage of claim 17 , wherein the assessment of the severity of the threat comprises an assessment of one or more of a risk of permanent disability, death, and serious adverse event.
19. The webpage of claim 15 , wherein the assessment of one or more threats further comprises an assessment of the potential population affected by the threat.
20. The webpage of claim 15 , wherein the risk rating comprises at least three grades.
21. The webpage of claim 20 , wherein the three grades comprise three symbols.
22. The webpage of claim 15 , wherein the webpage is programmed with software instructions for retrieving data relating to an assessment of more than one threat.
23. The webpage of claim 15 , wherein assigning a risk rating further comprises providing guidance associated with the risk rating.
24. The webpage of claim 19 , wherein assessing the potential population affected by the threat further comprises assessing a percentage of the population to which the threat applies.
25. The webpage of claim 15 , wherein assessing the one or more threats further comprises one or more of determining the population to which the threat applies, determining whether the population at risk as a result of the threat can be identified in advance, and determining an indicator of usage of a second medical product for which there is an interaction with the first medical product.
26. The webpage of claim 15 , further comprising determining whether the medical product is an orphan product.
27. The webpage of claim 15 , wherein the webpage is displayed on a screen.