MSK-Derm Health and Society Flashcards
Describe the steps in the drug approval process
- Drug is developed
- Animals are tested
- Investigational New Drug (IND) appliction submitted to the FDA
- Phase 1 clinical trial: Safety
- 20-80 people
- Healthy volunteers
- Phase 2 clinical trial: Effectiveness
- 100’s of people
- Patients with a certain disese or condition
- Compare new drug to placebo or current treatment
- Phase 3 clinical trial: Additional info
- Continue to study safety and efficacy
- Study in different popultions
- Study effects of other drugs
- Review Meeting
- NDA application
- Application reviewed
- Drug labeling
- Facility inspection
- Phase 4 (post-marketing) clinical trial
List some strategies for decreasing out of pocket medication costs for patients
GOTMeDS
- Generics
- Order in bulk
- Therapeutic alternatives
- OTC, cheaper meds in the same class
- Medication review
- Remove unnecessary medications
- Discount drugs
- Splitting pills
- Prescribe higher dose and advise patients to split pills
What is the difference between pharma and biotech?
- Pharma
- Large companies w/shareholder financing
- Usually small molecule druge
- Biotech
- Smaller companies
- Role of venture capital
- Generally higher molecular weight products made with or from live cells/organisms
What happened 20 years ago that may have contributed to the current opioid epidemic?
- FDA approved the first long-acting/extended release opioid (oxycontin)
- Consensus statements supported the use of opioids for non-cancer pain
- Accredidation mandates for monitoring and addressing pain
- Patient satisfaction surveys: “Did your doctor do everything they could to manage your pain?”
- Did not mandate opioid prescription, but mandate in conjunction with consensus statemetnets + availability -> increased prescription
____ of the population age 16 years and older had proficient health literacy
12% of the population age 16 years and older had proficient health literacy
- This highlights the need for patient-education as a part of care
What is conservative prescribing?
Descrbe the strategies
Do not prescribe unnecessary medications
- Think beyond drugs
- Practice strategic prescribing
- Maintain awarenes and vigalence regarding adverse effects
- Be skeptical and cautious of new drugs
- Work with patients to establish a deliberative shared agenda
- Consider long-term, broad effects of a treatment course
Especially impoartant in elderly patients
Respecting a patient’s customs and language preferenes is an example of which quadrant of the patient-centered education model?
Cultural respect
What was the sunshine act?
The act that mandated that pharmaceutical industry payments to physicians be disclosed to the public
What is the 340B discount program?
A program to increase access to medications for low-income hospitals and communities
- Drug manufacturer cells outpatient drugs to 340B hospitals at discount prices
- Only hostpitals with high volumes of low-income patients, or serve rural areas qualify
- Low incompe patients get the medication free or at a reduced cost
- Insured patients pay their normal copay
The hospital saves money by buying the drugs at the discounted price from the manufacturer
Which region of the United States has the highest rates of benzodiazepine use in conjunction with opioids?
The South
Which state has the death rate due to opioid overdose?
West Virginia
Which states had the highest use of high-dose opioid pain relievers?
Delaware, Tenessee, Nevada
What may lead to high variability between opioid prescription rates by state/region?
Lack of consensus on indications for use
What are the 5 key points from the 2011 IOM briefing pain management?
- Heighten awareness about pain and its health consequences
- Emphasize the prevention of pain
- Improve pain assessment and management in the delivery of healthcare and financing programs of the fed. govt
- Use public health communication strategies to inform patients on how to manage their own pain
- Address disparities in the experience of pain among subgroups of Americans
Which state has the highest rates for opioid prescriptions? Which state has the lowest?
Highest – Alabama
Lowest – Hawaii
What are the quadrants of the patient-centered education model?
- Cultural Respect
- Health Literacy
- Patient-Provider Partnership
- IOM 6 aims
- Safe
- Effective
- Efficient
- Timely
- Patient-centered
- Equitable
E Wojciechowski, L Rosen. Case Review: Journey for Developing a Patient-Centered Education Model. The Internet Journal of Advanced Nursing Practice. 2018 Volume 17 Number 1.
