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21 Cards in this Set

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What storage temperature is considered "cold"?
Cold may not exceed 8ºC (46ºF)

Refrigerator is a cold place between 2º-8ºC (36º-46ºF)
What entities require storage temperatures to be in the monographs?
FDA or USP

Must be cognizant of temperature specifications
What storage temperature is considered "cool"?
Cool is between 8º-15ºC (46º-59ºF)
What storage temperature is considered "warm"?
Warm is between 30º-40ºC (86º-104ºF)
What storage temperature is considered "excessive heat"?
Excessive heat above 40ºC (104ºF)
What is "room temperature"?
Relates to temp. of a work area

Controlled room temperature 20º-25ºC (68º-77ºF)

Mean kinetic temp may not exceed 25ºC
What is a "container"?
Unit dose package container with dosages for a particular patient

Unit dose container in a single-unit container that is defined by the USP-NF and used administration directly from the container (but is NOT used as a single parenteral dose)
What is a "well-closed container"?
A container that protects the contents from extraneous solids and form loss under ordinary/ customary handling, shipment, storage, and distribution conditions
Who does VA law indicate that records belong to?
Records are property of health care professionals who maintain records

May not disclose records without permission under HIPAA rules

Provider has to approve the removal of records from his office unless the records are subpoenaed

You have to get permission from the patient before you can disclose any information
- Exemptions are allowed under HIPAA laws
- You can disclose aggregate data that has "de-identified" patient information
Under what conditions is disclosing of information allowed under HIPAA?
Sale of medical practice or pharmacy
- Upon written consent of the patient, parent/guardian, or authorized person to oversee the child's care
- You may collect fees
- May defend the provider or provider's employees against accusations of wrongful conduct
- Situations of child abuse/ serious threats to public health and safety
- When necessary to care for the patient
- Waiver of a right to privacy by patient
- To 3rd parties for purposes of reimbursement
- Some cases of substance abuse
- For purposes of collecting organ and tissue donations
Whe can copies of medical records be given, and under what circumstances?
Must have written, signed, and dated form from the requester
- Must state the nature of the request
- Evidence of that the person requesting the info is authorized to receive it
- Photocopies or other duplicates must be accepted by the requester
The provider must act within 15 days and do one of the following
- Furnish copies to the requester
- Inform requester tha records do not exist
- Provider info regarding where records can be found if not held by the provider
- Deny the request
May not be provided if a physician or clinical psychologist provides in writing that turning over the information will injure the pt's health
- Records denied for this reason can be subject to review by another physican or clinical psychologist selected by the requester
When and what patient records are admissible in judicial proceedings?
Copies of medical records and other records or patient pr physician records are considered sufficient as the original records

Both parties' attorneys and patient must have access to a subpoena requesting that the documents be compelled

The requesting party may be responsible for copying fees

The patient must provide a signature authorizing the release of his medical records
Do records have to be given out for minors?
Minors separated from their parents may receive a consent authority form
- A judge responsible for the custody of that child
- Directors of social services or designees for minors as established by law enforcement or judges
- Executives of state institutions or agencies qualified to receive and care for minors
- Qualified emergency personnel at the scene of an emergency or accident
--This includes licensed health care professionals or the hospital UNLESS the minor is over 14 years old and is physically able to consent to treatment
When are minors considered adults?
Receipt of care to treat VD or any infectious or contagious disease that has to be reported to the State Board of Health

Medical or health servies related to birth control, pregnancy or family planning, except for surgical sterilization

medical or health care services for outpatient care, treatment or rehab for substance abuse, or mental or emotional disturbance

Any minor who is married

Pregnany minor is able to make medical decisions for both her and her baby

Individuals age 17 for blood donation
What legal issues face pharmacists - regarding "gray areas of the law" --responsibility of pharmacists are as healthcare professionals
Origins and implementation of laws and regulations

Laws and regulations are promulgated out of a paternalist view that without a certain provision, the public would be harmed
(paternalistic view = FDA makes decisions on behalf of patient because they can't make decisions for themselves)

Determined answers related to laws is not black and white; it is based upon "Notions of fairness", Custom or history, Politics, and Balance between conflicting societal interests
Pharmacists, pharmacies and commerce involving rx and non-rx drugs regulated based on the “market failure” approach to law
What is "Market Place Failure"?
The market does not always act to promote behaviors that maximize outcomes for public - so the government steps in to regulate
What are reasons for regulation of pharmacists and drugs?
Publics goods that the market will not otherwise produce
- Probably not the case for many drugs - bus is for vaccines and orphan drugs

Controlling externalities because the public does not fully understand the risk of using a drug
(such as antibiotic overuse or the overuse of any Rx drug)

Information asymmetry that the public doesn't understand the need for or use for a drug unless they are informed by a trained individual who understands drug therapy

The court system fills the gaps between legislation and regulations - it can change the interpretations based on the public's sentiment
Who determines when a health care professional has failed to live up to the public trust?
The Courts and juries
What is tort law?
A fancy word for civil wrongs vs. criminal wrongs

It is based on state law and common law

Inadvertent vs. intentional torts:
- negligence is most common
- intentional means the person must know or should know the risks involved to the other person
What is "malpractice"?
Professional version of negligence

A plaintiff, or person bringing the case, must prove elements of negligence through:
- duty - i.e. dispense an Rx correctly
- breach - of a duty
- cause - harm casued by the RPh?
- harm - caused by the RPh?

Defendant can respond with either a guilty plea, a motion for summary judgment, or affirmative defense
Who is Richard Courtney, MO Pharmacist?
The guy who billed far more cancer drugs to the insurance company than what Eli Lilly had distributed to him - and he also diluted chemo drugs

In 2002 he was ordered to pay $2 billion to a cancer patient for intentionally diluting drugs

The cause of action - federal prosecution for misbranding an dadulteration of chemo drugs

He admitted reason because of greed