Compounding Pharmacies / FWA

- Compound Requirements

         - Must be for medications for specific patients, for a specific condition, for a specific       prescription

         - Compounding in bulk for multiple patients before prescriptions are received is manufacturing!

- Limits

         - Patients will probably not know

         - Prescriber will not know unless they have a commercial arrangement with the pharmacy

         - Health Plans will only know when doing analysis of medication utilization

         - PBMs will only know when doing analysis of medication utilization

- What are compounds?

         - Injectables with custom ingredients and dosing

         - Oral tabs/caps with non-manufactured ingredients

         - Oral liquids for custom dosing

         - Topical medications in different bases for better absorption or non-allergic

- What are compounding pharmacies?

         - Regulated by State laws

         - Rationale:

                  - Children’s medications

                  - Allergic modifications

                  - Dosing modifications

                  - Mixing injectables

                  - Animal treatments

                  - Misc.

- Limits on compounding

         - PBM restrictions on medications currently manufactured

         - State oversight

         - Lack of absorption or effectiveness

- FWA

         - Small % of total  dispensing

         - Physician prescribing for custom medications with a commercial motive

         - Pharmacists dispensing/manufacturing for multiple patients for custom medications with a commercial motive

         - Sterility problems

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Gender Bias in Medicine and Drug Research

1. Women 51% of population, but few women in clinical research

2. Sex is based on reproductive organs and functions assigned by chromosomes

     - Gender is self-representation in response to socials institutions shaped by       environment and experience

     - Action: Education, research, workforce development

3. Medical Biases against women

     - Heart failure – Australia: women < men to receive recommended treatment for heart       failure

     - Alzheimer’s Disease – women perform better than men in early stages

     - Medical trials – women excluded

          - 8 Rx in US withdrawn between 1997-2001 for less safe and effective

          - Until early 1990’s women excluded from biomedical studies

          - Example:

               - Women:  ASA reduced risk of stroke, but not MI

               - Men:  ASA reduces risk of MI, but not stroke

     - CPR dummies – U of Penn (2018) women less likely to receive CPR

     - Endometriosis – 1/10  women wait > 7 years for diagnosis

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All About Vaccines with special guest Dr. Mark Walberg

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Vaping

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AI in Healthcare

Disclaimer – PP develops, innovates and utilizes AI for our clients

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 1. Quality of prescription drugs

    a. Health Canada responsible for efficacy and safety of drugs marketed in Canada

    b. Health Canada operates under the Food and Drugs Act and regulatory mandate under the Food and Drug Regulations

    c. Most drugs are not manufactured in Canada 

    d. There is no parity between drugs available without a prescription in US vs. Canada

2. Availability of prescription drugs

    a. US Rx received in Canadian pharmacy must be approved by a Canadian physician prior to it being filled – cosigning

    b. Canada Health Act – drugs administered in Canadian hospitals are approved at no cost to patients

    c. Employers cover many Canadians and their families

    d. Drug Shortages Canada – 

         i. Website for reporting drug shortages and discontinuations in Canada

         ii. Drug sellers must report that they cannot meet demand

3. Cost considerations

    a. Canada

         i. Most prescription drugs are imported

         ii. Government places price ceilings on Brand name medications imported into Canada

    b. Canadian internet pharmacies are suspect

    c. Bricks and mortar pharmacies are same as US

4. Opportunity Savings

    a. HIS Markit study – Abilify costs 87% less and Xarelto costs 60% less

    b. Concerns that manufacturers will increase prices for drugs in US and Canada

5. State Plans

    a. Florida

    b. Vermont

6. Trump’s Plan

    a. States, individual pharmacies, wholesalers can write proposals and submit for federal approval

    b. Exclusions – biologics, medications created from living organisms

    c. FDA would work with manufacturers to bring drugs made in foreign factories to the US (e.g., insulin)

7. Arguments Against – PhRMA

    a. Counterfeit, dangerous medications

    b. Canada drug market too small

    c. Canada doesn’t have an unlimited supply of medications

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1. Indigent / Homeless Population

     a. No address

     b. No phone

     c. No income, or no money for health care

     d. No transportation

     e. No time management

     f. Information varies dependent on associations

     g. Information sharing is variable and frequently based on incorrect concerns, false conversations, etc.

2. Health Care Issues

     a. Poor diet

     b. Poor exercise program

     c. Lack of follow up on relatively trivial problems that result in major complications

     d. Poor historians

     e. Frequently comorbid

     f. Frequently have behavioral health problems

     g. Inconsistent adherence – office visits, obtaining labs, picking up drugs

3. Medication Issues

     a. Can’t afford copays

     b. Frequently don’t have a watch for scheduling medication

     c. Medications cannot be evaluated as the patient may not be available to identify side effects, etc.

     d. Patients frequently cannot obtain labs to use for medication management

     e. Adherence is a problem, especially if they stop taking the medications due to side effects, etc.

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  Travel Health:

1. What are the most common health issues travelers may encounter?

       a. Travelers diarrhea

       b. In terms of “things that will kill you”, most travelers die from pre-existing medical conditions (MI) or accidents (specifically MVA)

2. Mentioned vaccines, are there other vaccines people will need to consider besides those for GI bugs?

       a. Yellow fever… basically a mosquito-borne disease that destroys your liver and has a very high fatality rate. Found in South America (Amazon) and Sub-Saharan Africa. Mosquitoes bite during the day and can also carry dengue, chikungunya and zika… so still have to prevent mosquito bites.

       b. Japanese encephalitis… similar to West Nile, it causes neurological symptoms. Found in Southeast Asia, mostly in rural parts. Need to have a travel health advisor assess whether or not you should get it.

       c. Rabies… fairly expensive, but lifesaving if bit by a rabid animal.

       d. All the routine vaccines you thought you didn’t need… Tdap, meningitis, polio, MMRV and FLU! (because it looks like malaria and you will be treated as such in tropical countries)

3. What about malaria?

       a. Parasitic disease that lays dormant for weeks to months and can result in death in 24-48 hours without treatment

       b. Mosquitos bite at night so need modern housing or a bed net

       c. Medication are typically taken before travel, while traveling and up to one month after

4. Anything else?

       a. Lots of other things to consider… altitude sickness, other parasites (even those you can get from bathing in contaminated water like lakes and rivers), jet lag, etc.

       b. Best to consult someone certified in travel health or tropical medicine… so they will have passed a competency exam

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Devices Used in Therapeutics

1. Types of devices used for TESTING / MONITORING and At-Home Test Kits discussed in this talk –

     a. Blood Glucose monitors

     b. Blood pressure monitors

     c. Prothrombin Blood Coagulation monitors

     d. Pregnancy test kits

     e. and others

2. FDA Medical Device Classes

     a. Class I = low to moderate risk to patient

          i. 47% of devices

          ii. 95% exempt

          iii. Examples = Enema kits, elastic bandages, manual stethoscopes, and bedpans

     b. Class II = moderate or high risk to patient

          i. 43% of devices (most devices)

          ii. Examples = powered wheelchairs, some pregnancy tests kits

     c. Class III = high risk to patients

          i. 10% of devices

          ii. Examples = Implantable pacemakers, breast implants

     d. FDA Regulatory Requirements

          i. FDA Registration  (21 CFR Part 807)

          ii. Medical Device Listing

          iii. Premarket Notification 510(k) OR Premarket Approval (PMA)

     iv. Investigational Device Exemption (IDE) for clinical studies

               1. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

     v. Quality System (QS) regulation

     vi. Labeling requirements

     vii. Medical Device Reporting (MDR)

3. Over-the-Counter use Tests

     a. Regulation by the FDA in the In Vitro Test Database (IVD) Over-the-Counter Database

     b. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm

4. QS by FDA approved home and Lab Tests, laboratory validation

     a.  https://www.fda.gov/industry/regulated-products/medical-device-overview

     b. https://www.pharmacytimes.com/publications/issue/2013/september2013/at-home-test-and-monitor-kits

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 Beliefs:

1. Cold temperatures bring on cold/flu

2. Going outside with wet hair gives you a cold

3. The flu shot causes the flu

4. Coffee Can Stunt Childhood Development

5. Cracking Knuckles Leads to Arthritis

6. Starve a Fever, Feed a Cold

7. Gluten is Bad

8. Sitting is the New Smoking

9. Eating chocolate gives you acne.

10. Walking around barefoot on a cold floor will give you varicose veins

11. Sugar causes hyperactivity in children.

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