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Medical Devices
- BP meters, blood glucose monitors
- The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:
- Establishment registration,
- Medical Device Listing,
- Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
- Investigational Device Exemption (IDE) for clinical studies.
- MEDICAL Devices
- Diagnostic equipment includes medical imaging machines, used to aid in diagnosis. Examples are ultrasound and MRI machines, PET and CT scanners, and x-ray machines. Treatment equipment includes infusion pumps, medical lasers and LASIK surgical machines.
- Home Use Devices
- Safety & Efficacy
- Medical devices that are authorized by the FDA for over-the-counter purchase that are not otherwise restricted and are appropriately described and labeled, such as:
- Adhesive bandages
- Crutches
- Eyeglass frames
- Otoscopes
- Personal Sound Amplification Products (PSAPs)
- Sharps containers
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What you need to know about Healthcare in 2020.
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Topic: Washing Hands
- Goal – Prevention of infections and spreading disease
- How – water 100 degF or 38 degC, soap (?) for 20 seconds
- When
- Preparing food
- Using toilet or changing a diaper
- Blowing nose, coughing, sneezing
- Treat wounds or caring for a sick person
- Handling garbage
- Handling pets and their food
- Hand Sanitizer
- Must have >= 60% alcohol
- Antibacterial sanitizer is OK when hands are not dirty
- Antibiotic resistance
- Global health threat
- Need standard treatment guidelines
- Misuse and overuse of antibiotics
- Use hand washing prevention
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Update on HIV/AIDS
Main Points:
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Childhood Issues
• Storage
o Keep out of reach
o Products not prescriptions
o Child-resistant packaging
• Safety
o Administer as prescribed or labeled
o Use dosing device (teaspoon, tablespoon, measuring cup, etc.)
o Write clear instructions to caregivers
o Share info with babysitters, family, friends
• Destruction
o Clean out used or expired medications
o Put in sealable bag and bring to pharmacies
• Safe Administration
o Teach about always given by adult
o Rx not candy
o Drug use – storage, read drug label and facts, follow dosing instructions
• Poisoning
o Have Poison Help number by phone (1-800-222-1222)
o 24/7/365
o How to take Rx and how to treat poisoning
• Special cases
o Childhood obesity
o Injury
o Lice
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Compliance – Easy to talk about, but hard to do!
o Drug Compliance – definition
o Same as compliance with doctor visits, lab draws, device use, BP measurements, BG measurements
o Take medications as prescribed by your doctor
o The best drug taken for the right reasons is no good, if it is not taken
o Education is primary method
o History
o A problem for decades
o No general solution
o Unintentional non-adherence
o https://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-12-98
o 62% forgot
o 37% ran out of medications
o 23% careless about taking medications
o Barriers
o Why?
o Low perceived need
o Affordability
o Worse self-rated health
o Youth
o Prescriber/Pharmacists
o Cost
o Self-reporting
o Time to track pill counts
o Refill messages
o Time for education
o Scheduling
o 1-2x/day > 3-4x/day
o Devices
o Memory
o Calendars
o Automation – tops of medication bottles, app alerts
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Statistics
o >30 million people in US, 1 in 4 don’t know they have it
o 84 million US adults have prediabetes, and 90% don’t know they have it
o 7th leading cause of death in US
o Type 2 diabetes accounts for 90% to 95% of all diagnosed cases
o # of adults diagnosed with diabetes has doubled with age and overweight/obese
Risk factors
o Overweight
o >= 45 y/o
o Parent, brother, or sister with T2D
o Physically active < 3x/week
o Gestational diabetes (diabetes w/pregnancy) or given birth to baby weighing > 9 pounds
o African Americans, Hispanic/Latino Americans, American Indians, Alaska Natives, Pacific Islanders, and some Asian Americans have higher risk for prediabetes and T2M
Leading cause of in 2019
o Chronic kidney disease
o Lower-limb amputations
o Adult-onset blindness
Risk Factors -- independent
o Diet
o Over-weight
o Lack of exercise
o Smoking – 30-40% more likely to develop type 2 diabetes than non-smokers
o Non-compliance with medications, weight loss, diet
Medications
o Large armamentarium of drugs
o Look for A1c lowering
o Risk factors are independent and can still cause end-organ disease
o Compliance with monitoring blood sugar – proxy for end-organ disease
o Compliance with medication
o Compliance with Insulin is approximately 50% across US
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Topic: Care Transitions
What are care transitions?
-Acute to home or chronic care/step down
-Example: Hospital to home
Concern
-Don’t want patient to return to the hospital within 30 days for same problem
- Medicare refusal to pay for certain conditions to promote prevention
Issues
-Understand discharge orders
-Comply with discharge orders
-Drug coordination from pre-hospital, to in hospital, or post-hospital regimen
-Labs and services to follow up
Examples
-Pneumonia & Serious infections – injectable to oral antibiotic, antibiotics compliance, monitor for symptoms (temperature, swelling, pain, GI symptoms, dizzy/confused, etc.)
-Heart Failure – monitor weight everyday, comply with medicines
-COPD/Emphysema – arrange for O2, use FiO2 to expand vital capacity, correct use of inhalers
-Asthma – correct use of inhalers
-Heart Attack – BP, lipid, ACEI regimen of medications – promote compliance
-DVT – transition from injectable-to-oral anticoagulants – promote compliance, alert notification if bleed
-Pain management – CDC recommendations
Support
-Nurse case managers
-Pharmacists
-Home – rest, anabolic diet, hydration
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Value & Ethics in Drug Pricing
1. What is the argument between high prices and value?
2. How is value determined?
a. ICER
b. NICE
c. Cochran Reviews
3. How is pricing determined?
4. What is the ethical question?
a. Support prescription and prescriber’s plan
b. 20% of standard Rx are for off-label
c. 50% of cancer treatment is off-label or unapproved
5. Actions to bridge value to price
a. Value-based purchasing
b. Non-inferiority trials
c. Objective review of the literature
d. Committee reviews, e.g., tumor boards, P&T Committees
6. Outstanding question
a. Cost vs. affordability
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Outline for OTC Talk
What are OTC’s?
How should they be used?
Cost-Benefit
Information Resource
Request OTC Formulary: https://www.123formbuilder.com/form-4856229/
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