Method of assessing and managing risks associated with a pharmaceutical product
First Claim
1. A method for assessing and managing risks associated with utilizing a pharmaceutical product comprising:
- identifying, characterizing and ranking adverse events caused by using the pharmaceutical product;
identifying a medication-use process associated with a pharmaceutical product;
identifying potential failure modes where the medication use process will not be adequate to protect patients from experiencing adverse side effects;
quantifying the potential effect of said failure mode to create a pharmaceutical hazard score, wherein said hazard score considers the severity and frequency of occurrence of the effects of said failure;
conducting a logical hazard assessment of said failure modes found to have a high hazard score to evaluate the need to mitigate the effect of said failure modes; and
designing a risk management intervention program to manage said adverse events.
5 Assignments
0 Petitions
Accused Products
Abstract
A method for identifying and assessing risks associated with a pharmaceutical product. The method comprises identifying adverse events caused by a pharmaceutical product, identifying the failure modes in the process of using said pharmaceutical product that exposes patients to said adverse events, quantifying the potential effects of said failure modes to conduct a hazard assessment for purposes of evaluating the need to mitigate the failure mode, and designing a risk management program to manage the adverse events. In addition, the present invention includes a method for creating effective interventions for use in mitigating the risk of the pharmaceutical product. Such method includes the creation of educational materials which are continually evaluated and revised to achieve an expected level of effectiveness on a target audience.
-
Citations
57 Claims
-
1. A method for assessing and managing risks associated with utilizing a pharmaceutical product comprising:
-
identifying, characterizing and ranking adverse events caused by using the pharmaceutical product;
identifying a medication-use process associated with a pharmaceutical product;
identifying potential failure modes where the medication use process will not be adequate to protect patients from experiencing adverse side effects;
quantifying the potential effect of said failure mode to create a pharmaceutical hazard score, wherein said hazard score considers the severity and frequency of occurrence of the effects of said failure;
conducting a logical hazard assessment of said failure modes found to have a high hazard score to evaluate the need to mitigate the effect of said failure modes; and
designing a risk management intervention program to manage said adverse events. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
-
-
43. A method for creating educational materials for use in mitigating the risks of a pharmaceutical product comprising:
-
compiling a database of educational components wherein said components are useful in providing information regarding the risks of a pharmaceutical product or procedures to mitigate said risks;
selecting a plurality of said components from said database to create an educational tool kit wherein the components are selected based on the expected effectiveness of said component in managing the identified risks of the pharmaceutical product;
tailoring interventions to assure implementation by other end users;
designing a dissemination plan for distributing the educational materials to a target audience;
implementing the dissemination plan through forums and venues, such as learning labs, virtual learning forums, and preceptorships;
evaluating the expected impact of the educational tool kit on the target audience; and
adding, deleting, or modifying the selected components to achieve a desired expected impact. - View Dependent Claims (44, 45, 46, 47, 48, 49, 50)
-
-
51. A system comprising:
-
a logic configured to identify, characterize and rank adverse events caused by using a pharmaceutical product;
identify a medication use process associated with the pharmaceutical product;
identify potential failure modes of the medication use process;
quantify the potential effect of said failure modes to create a pharmaceutical hazard score, wherein said hazard score considers the severity and frequency of occurrence of the effects of said failure modes;
conduct a logical hazard assessment of said failure modes found to have a high hazard score to evaluate the need to mitigate the effect of said failure modes; and
design a risk management program to manage said adverse events.
-
-
52. A system comprising:
-
a processor;
a memory operably connected to the processor, where the processor can access the memory;
a logic operably connected to the processor, where the logic is configured to;
identify, characterize and rank adverse events caused by using a pharmaceutical product;
identify a medication use process for the pharmaceutical product;
identify potential failure modes of the medication use process;
quantify the potential effect of said failure modes to create a pharmaceutical hazard score, wherein said hazard score considers the severity and frequency of occurrence of the effects of said failure modes;
conduct a logical hazard assessment of said failure modes found to have a high hazard score to evaluate the need to mitigate the effect of said failure modes; and
design a risk management program to manage said adverse events wherein said risk management program comprises control measures to reduce the incidence and consequences of said failure modes.
-
-
53. A computer-readable medium storing processor executable instructions operable to perform a method, the method comprising:
-
identifying adverse events caused by using a pharmaceutical product;
identifying a medication use process for the pharmaceutical product;
identifying potential failure modes of the medication use process;
quantifying the potential effect of said failure modes to create a pharmaceutical hazard score, wherein said hazard score considers the severity and frequency of occurrence of the effects of said failure modes;
conducting a logical hazard assessment of said failure modes found to have a high hazard score to evaluate the need to mitigate the effect of said failure modes; and
designing a risk management program to manage said adverse events wherein said risk management program comprises control measures to reduce the incidence and consequences of said failure modes.
-
-
54. A system comprising:
-
a means for identifying adverse events caused by using a pharmaceutical product;
a means for identifying a medication use process for the pharmaceutical product;
a means for identifying potential failure modes of the medication use process;
a means for quantifying the potential effect of said failure modes to create a pharmaceutical hazard score, wherein said hazard score considers the severity and frequency of occurrence of the effects of said failure modes;
a means for conducting a logical hazard assessment of said failure modes found to have a high hazard score to evaluate the need to mitigate the effect of said failure modes; and
a means for designing a risk management program to manage said adverse events wherein said risk management program comprises control measures to reduce the incidence and consequences of said failure modes. a means for measuring, evaluating and reporting the effectiveness of a risk management program.
-
-
55. A pharmaceutical product risk assessment and management kit comprising:
one or more intervention components, wherein said one or more intervention components are selected for inclusion in said pharmaceutical product risk assessment and management kit by a pharmaceutical product risk assessment and management method. - View Dependent Claims (56)
-
57. A pharmaceutical product hazard scoring chart comprising:
-
a first column of a pharmaceutical severity scale; and
a second column of a pharmaceutical frequency of occurrence scale;
wherein a pharmaceutical hazard score is the product of said first column and said second column.
-
Specification