Term
Hospitals after the Civil War |
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Definition
- Hospitals were no longer places to go and die.
- New technologies were introduced.
- Aseptic and antiseptic techniques were introduced. Hygiene improved tremendously.
- Surgical procedures advanced
- Nursing grew
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Term
5 Historical Phases in the development of Hospitals |
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Definition
PHASE 1: Early Hospitals
TIME FRAME: Pre 1870
PHASE 2: First period of rapid growth
TIME FRAME: 1870 - 1910
PHASE 3: Period of Consolidation
TIME FRAME: 1910 - 1945
PHASE 4: Second period of rapid growth
TIME FRAME: 1945 - 1980
PHASE 5: The current period of consolidation
TIME FRAME: 1980 - Present
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Term
PHASE 1: Early Hospitals TIME FRAME: Pre 1870 |
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Definition
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Early in the nineteenth century, most Americans saw the hospital as a place that protected the rest of the community from the sick. (Quarantine)
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In the 1800s and before, people saw the hospital as a place where people went to die.
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Hospitals were places for the poor with little to no family ties could go for care; they were charity hospitals.
- But after the Civil War, hospitals grew at a rapid pace and the charitable mission of the hospital began to change
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Term
PHASE 2: First period of rapid growth
TIME FRAME: 1870 - 1910
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Definition
· Hospitals evolved from 1870 to 1910 as science and technology moved ahead. They evolved into local workshops for physicians treating all classes of patients.
· By 1873, there were an estimated 178 hospitals in the U.S.; by 1909, there were more than 4300 hospitals in the U.S. |
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Term
PHASE 3: Period of Consolidation
TIME FRAME: 1910 - 1945
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Definition
- Few hospitals are built
- Started as Proprietary schools for profit and not rigorous curriculum or lab
- In 1910the Flexner Report is released and schools become more focused on teaching and research centers and this report caused structural changes in the hospital.
- Abraham Flexner conducts a survey of 155 medical schools
- John Hopkins was used as a model because it was the first school to offer a 4 year degree.
- Flexner made recommendations that changed the way schools were run.
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Term
Flexner's Recommendations |
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Definition
- Reducing the number of medical schools from 155 to 31 university schools committed to medical research and academic excellence.
- Medical school admission requirements should include at least two years of college with preparation in biology, chemistry, and physics.
- Medical schools should obtain strong financial support for modern labs and hospital facilities.
- Medical schools should emphasize the scientific method and time in the laboratory and clinic.
- Original research should be a core activity of medical schools.
- Medical schools should have a large staff of full time professors in clinical and scientific departments
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Term
PHASE 4: Second period of rapid growth
TIME FRAME: 1945 - 1980
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Definition
There was a tremendous increase in hospital:
1. services,
2. costs,
3. technology
- There was a modest expansion in the number of hospitals.
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The Hospital Survey and Construction Act of 1946 (Hill-Burton Act)
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The increased breadth and intensity of hospital care was also fueled by:
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The rapid growth of insurance to pay for care.
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The rapid growth of Medicare and Medicaid to pay for care.
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Term
The Hospital Survey and Construction Act of 1946 (the Hill-Burton Act) |
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Definition
1. created federal funding sources to build new hospitals, expand and renovate facilities, increase bed capacity, and add emerging technology.
2. During the Act’s existence, about 15% of hospital construction was funded through Hill-Burton funds.
3. The Act was killed in 1974 as a result of having too many hospital beds. |
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Term
PHASE 5: The current period of consolidation
TIME FRAME: 1980 - Present
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Definition
· The second period of rapid growth starts slowing down.
· Changes in hospital payment systems changed hospital behavior and structure.
· The number of hospitals has decreased as hospitals merged with each other.
· Competition became fierce as hospitals began advertising and developed new services and programs.
· A host of new services were added that were not traditional inpatient care.
- Also, managed care organizations are more strongly depending on cost containment mechanisms |
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Term
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Definition
Two of the same types of facilities join together, usually for efficiency.
Competition became fierce as hospitals began advertising and developed new services and programs |
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Term
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Definition
Joining of different firms, usually for service expansion.
9 Hospitals could now offer different services such as rehabilitation services, home health care, outpatient
services, and nursing homes. |
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Term
Managed care organizations cost containment mechanisms |
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Definition
1. Prior approvals for drugs
2. Second opinions from physicians
3. Contracting with hospitals that charge lower prices for their services |
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Term
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Definition
Prices for services that are set by the hospital:
1. Room and board
2. Services provided (ex. meals)
3. Medicines |
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Term
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Definition
The price that is negotiated between the hospital and third-party payers |
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Term
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Definition
Reimbursement on the basis of cost or charges |
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Term
Prosepective Payment System of 1983 |
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Definition
a method by Medicare to control increases in spending, and once enacted it made diagnosis-related groups (DRGs) the basis of payment for inpatient hospital services for Medicare patients. |
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Term
Diagnosis Related Groups (DRGs) |
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Definition
This is a system to classify hospital cases into one of almost 750 different groups Based on:
- Clinical diagnosis
- Whether it’s a surgical procedure
- Age
- Sex
- Presence of complications
- Other clinical information
· examples include:
- Pneumonia, Heart failure, C-section, Hip/knee replacement
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Term
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Definition
The value assigned to each DRG patient, which is based on the average resources used to treat medicare patients in that treatment group. A heart transplant has the highest DRG. |
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Term
How much does a hospital get reimbursed for a patient’s stay when he or she is admitted under a particular DRG? |
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Definition
TOTAL REIMBURSEMENT = DRG WEIGHT x REIMBURSEMENT AMOUNT
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Term
The Reimbursement Amount is affected By: |
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Definition
- Location of the hospital (rural or urban)
- Teaching status (Teaching gets more than non-teaching)
- Amount of care provided to low-income patients
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Term
Exclusions from DRG system |
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Definition
- Rehabilitation facilities
- Psychiatric facilities
- Children’s hospitals
- Cancer hospitals
- Long-term care facilities/hospitals
- Rehabilitation and psychiatric units in the hospitals
- Home-health agencies
- Hospices
- Hospital-outpatient facilities
- Skilled nursing facilities
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Term
Balanced Budget Act (BBA) of 1997
established prospective payment for: |
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Definition
- Long-term care facilities/hospitals
- Rehabilitation and psychiatric units in the hospitals
- Home health agencies
- Hospices
- Hospital outpatient facilities
- Skilled nursing facilities
- Separate prospective care is used for reimbursing care at each of these facilities.
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Term
The Balanced Budget Act of 1997 |
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Definition
This act was also designed to reduce Medicare reimbursements to hospitals, physicians, home health agencies and skilled nursing facilities by $115 billion from 1998-2002.
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In response to backlash
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The Balanced Budget Refinement Act in 1999 restored $8.4 billion to Medicare reimbursements.
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The Benefits and Improvement Protection Act (BIPA) in 2000 restored another $11.5 billion in Medicare reimbursements.
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Term
Differences between the Retrospective Payment System (charges and costs) and the Prospective Payment System
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Definition
- With PPS, payments are determined in advance and are fixed.
- With PPS, the unit of payment changed from per day to per admission.
- With PPS, payment rates are independent of each hospital’s own cost experience.
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Term
Impact of the Prospective Payment System
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Definition
- Decreases in the number of inpatient admissions and length of stay.
- Increases in post-hospital use of services (nursing home care, home health care etc)
- Unbundling of services
- DRG code Creep
- Dumping
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Term
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Definition
Shifting part of a patient’s treatment to another setting outside of the health system while still receiving DRG payments for an entire admission |
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Term
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Definition
To separate out services included in the DRG and have them done somewhere else in your healthcare system. |
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Term
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Definition
Reclassification of patients into higher-weighted DRG's. No one is sure how hospitals do this but physcians and administrators are educated how to do this if a given patient may have an "uncertain" diagnosis and they can be brought to a new DRG weight so more money can be made. |
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Term
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Definition
Practice of trying to shift severely ill patients to other institutions. Highly ill patients cost more to keep and occupy beds that new patients can be put in. |
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Term
Short-term HOSPITALS and long-term hospitals
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Definition
· Hospitals are classified as short-term if the average length of stay is less than 30 days.
· Most hospitals are short-term.
· Short-term hospitals are also called acute-care hospitals.
Average lengths of stay for long term facilities are 30 days or more |
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Term
General hospitals and specialty hospitals
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Definition
· General hospitals provide a variety of services, including general medical and surgical services, obstetric services, etc.
· Specialty hospitals concentrate on one disease like psychiatric diseases, cancer, or tuberculosis, or one segment of the population such as children or veterans.
· Most hospitals are general hospitals. |
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Term
Public hospitals and private hospitals
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Definition
· Public hospitals are owned agencies of the federal, state, and local governments.
· Federal hospitals are usually designed for special beneficiaries: American Indians, veterans, military personnel,
· Many states operate psychiatric treatment facilities. These would be state-run, specialty hospitals.
· Local governments like counties can also own and run hospitals.
· State and local hospitals are noted for their efforts in handling uncompensated cases.
· Private hospitals can be either non-profit or investor-owned. |
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Term
Not-for-profit hospitals and for-profit (investor-owned) hospitals |
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Definition
· For-profit hospitals have to distribute some of their profits to investors while non-profits have no investors that they must pay dividends to; there is nobody to distribute the “profits” to. |
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Term
Community hospitals and non-community hospitals
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Definition
· Community hospitals include all nonfederal, short-term general and some specialty hospitals that are available to the public.
· Non-community hospitals are not open to the general public.
They include federal hospitals for military personnel and Veterans Affairs hospitals |
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Term
Teaching hospitals and non-teaching hospitals |
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Definition
· Teaching hospitals may be expressly associated with a medical school or may have an affiliation with a medical school.
· Teaching hospitals serve as sites for physician residencies.
· Teaching hospitals perform a lot of uncompensated care and a large percentage of tertiary or highly complex services. |
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Term
Independent and multi-hospital system
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Definition
· Hospitals are part of a multi-hospital system when they are either leased under contract by another hospital or are legally incorporated by or under the direction of a board that determines the control of two or more hospitals. |
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Term
Statistics and Trends about Hospital in last Decade |
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Definition
- Outpatient visits increased
- decrease in length of stay has to do with the prospective payment system
- Hospital closures were largely a response to a massive transformation in the delivery of patient care. More outpatient care, decrease in length of stay, and hospital mergers.
- Most hospitals are non-government, not for profit.
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Term
Hospitals have a governing body that can be one of two types |
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Definition
- Board of directors --> in “for profit” hospital
- Board of trustees --> in a “non profit” hospital
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Term
Purposes of the board of directors/board of trustees |
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Definition
- To establish the mission and goals of the hospital.
- They are going to develop hospital policies.
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Term
The board of directors/board of trustees has primary authority and control of the hospital and delegates duties to two other groups |
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Definition
- Hospital Administration or Management Team
- Medical Stall or Professional Staff Organization
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Term
Hospital Administration or Management Team
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Definition
· The hospital administration or management team implements the policies of the board.
· The hospital administration or management team includes a hospital administrator or CEO
· Although it varies from hospital to hospital, there might be Vice Presidents for:
**Finance
**Planning and Marketing
**Nursing
**Professional Services – looks over pharmacy, physical therapy, respiratory therapy. They look over all profressional services.
**Support Services – laundry, security, powerplant (non professional)
**Human Resource Management |
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Term
Medical Staff or Professional Staff Organization
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Definition
Has its own organizational chart and bylaws of operation.
Divided by specialty. Some specialties may include:
- Internal medicine
- Surgery
- Pediatrics
- Obstetrics/gynecology
- Psychiatry
- Pathology
- Radiology
- Anesthesiology
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Term
There are three ways a physician can work for a hospital: |
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Definition
- Physician can be a private practitioner who is not an employee of the hospital. This is the most common type of doctors at a hospital. They are just allowed to use the hospital for admitting and treating their patients. They have an office elsewhere.
- Physician can be a full time employee of a hospital. They probably have a salary and the hospital will provide them an office. Less common.
- Some physicians maintain their own private practices outside of the hospital, but receive a part-time salary from the hospital for administrative work. Least common. They may be the chief of a service, but they have their own private practice.
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Term
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Definition
This is a non-governmental body that has its purpose to set standards for hospitals and healthcare facilities and subsequently accredit hospitals and other healthcare facilities based upon those standards
Evaluatie in an on-site survey that occurs unannounced in a time frame between every 18-39 months. Make sure you are always prepared since you never know when they are coming |
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Term
Joint Commission also accredits: |
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Definition
- Ambulatory Care Centers
- Behavioral Health Care Facilities
- Critical Access Hospitals
- Home Health Care Organizations
- Laboratory Services
- Long Term Care Facilities
- Office Based Surgery Facilities
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Term
Section 1 Accreditation Standards |
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Definition
covers patient, client or resident-focused functions that relate directly to the provision of care, treatment and services:
- Ethics, rights and responsibilities
- Provision of care, treatment and services
- Medication Management
- Surveillance, prevention and control of infection
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Term
Section 2 accreditation standards |
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Definition
contains organization functions that are vital to the organization’s ability to provide high-quality care, treatment, and services:
- Improving organization performance
- Leadership (they evaluate the leaders)
- Management of the environment of care
- Management of Human Resources
- Management of Information (monitor HIPAA)
- Medical staff and nursing services
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Term
The importance of the Joint Commissio accreditation being voluntary. |
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Definition
1. First, the Centers for Medicare and Medicaid Services (CMS) allows Joint Commission Accreditation to be an alternative to a specific Medicare/Medicaid approval. The way in which this works is: In order for a health care organization to participate in and receive payment from the Medicare or Medicaid programs, it must be certified as such by the CMS. In some cases, CMS can take Joint Commission accreditation for this approval instead.
2. Accreditation status also influences managed care contract decisions as many insurance carriers consider this accreditation in making reimbursement decisions. Many insurance plans limit their payments to accredited hospitals.
3. It may also fulfill state licensure requirements. Many states rely in whole or in part on Joint Commission accreditation in granting certification and/or licensure. |
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Term
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Definition
- Oversees personnel and human resources issues (hiring, firing, performance appraisal)
- Manages the hospital’s drug budget
- Set quality standards for the department
- Evaluate policies and procedures
- Implementing new programs
- Ensures compliance with Joint Commission, department of public health, and board of pharmacy
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Term
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Definition
1. Staff Pharmacists- in-pharmacy duties like checking medications.
2. Clinical Pharmacists - on the floor doing counseling
3. Charge Pharmacists - floor manager of sorts |
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Term
Staff and Other Support Personnel |
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Definition
1. Technicians
2. Interns
3. Stock Technicians
4. Administrative assistants
5. Purchasers |
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Term
The drug distribution responsibilities of the hospital pharmacy
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Definition
- Floor-stock distribution – older method
- Unit-dose distribution – the current accepted method
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Term
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Definition
Floor stock distribution involves supplying the nursing staff with a pre determined number of dosage forms, which are stored in a separate drug room in each nursing unit. Nurses then dispense the medications based on physician’s orders.
WHAT IS THE PROBLEM WITH THIS TYPE OF DRUG DISTRIBUTION SYSTEM?
- Pharmacists can’t review the doctor’s order for the patient.
- Pharmacists can’t review patient’s profile. No idea if there are drug interactions going on or anything.
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Term
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Definition
· As orders come to pharmacy throughout the day for patients, the pharmacist enter the orders into the computer, a Medication Administration Record (MAR) for the patient and all of their medications is created
· That day’s worth of medication is filled by the pharmacist and is taken up to the floor either by delivery, or a tube system or some other method.
· Through the night, the technicians will print the MARs for the patients and fill patient cassettes of all the medication they will need for the next day, and the pharmacist will check it and place in the patient’s drug cassette whereby itis delivered first thing in the morning (or some other time during the day).
Just like the name of the distribution method suggests, the drugs are packaged in unit doses |
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Term
Non-distributive responsibilities of the hospital pharmacy
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Definition
- Drug Therapy Monitoring
- In-Service Education
- Drug Information Services
- Specialized Clinical Pharmacy Services
- Adverse Drug Reaction Monitoring
- Medication Utilization Evaluations
- Formulary Development
- Therapeutic Substitution
- Purchasing and Inventory
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Term
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Definition
the practice of dispensing a drug product containing different therapeutic moeity but that is of the same pharmacological or therapeutic class that can be expected to have similar therapeutic effects when administered to patients in therapeutically equivalent doses. |
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Term
Pharmacy and Therapeutics (P&T) Committee |
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Definition
Usually acts on behalf of the medical staff by developing the arrangements for therapeutic substitution in a hospital. The arrangment usually reflects the preferred products as included in the institutions protocols and formulary. |
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Term
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Definition
Many different professionals, somewhat independent of each other, working for the good of the patient. (not really working together though) |
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Term
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Definition
Many different professionals working together for the good of the patient, communicating effectively among themselves and with the patient (and caregivers) [team based approach] |
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Term
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Definition
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Term
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Definition
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Term
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Definition
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Term
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Definition
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Term
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Definition
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Term
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Definition
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Term
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Definition
Doctor of Dental Medicine |
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Term
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Definition
•Diagnose illnesses and prescribe and administer treatments for patients suffering from injury or disease.
•Unlimited scope of practice
•Allopathic vs. Osteopathic (vs. Homeopathic?)
•Education
–Undergraduate education – 3+ yrs. premed (most students have at least a 4 yr bachelor's degree)
–Medical school – 4 yrs. (called undergraduate medical education)
•In 2008, 129 accredited medical schools leading to the M.D. and 25 accredited schools leading to the D.O.
–Internship, residency, fellowship – 3-8 yrs. (called graduate medical education)
–10-16 years total (post high school)!!!
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Term
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Definition
•Examine people’s eyes to diagnose vision problems and eye diseases and prescribe some treatments
•Prescribe eyeglasses, contact lenses, and sometimes medications (State dependent)
•Education
–3+ yrs. preoptometric (most students have 4 yr bachelor’s degree)
–4 yrs. optometry school (Doctor of Optometry)
•In 2009, there were 19 accredited colleges of optometry in the U.S. and 1 in Puerto Rico
–1 yr. residency for specialization
•About 35,000 practicing in 2008
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Term
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Definition
•Diagnose and treat health problems associated with the body’s muscular, nervous, and skeletal systems, especially the spine
•Do not prescribe drugs or perform surgery
•Do make referrals, recommend lifestyle changes, make adjustments, and perform therapies with water, light, massage, ultrasound, electric, and heat
•Education
–2+ yrs. pre-chiro, moving toward 4 yr. bachelor’s
–4 yrs. chiropractic college
•In 2009, there were 16 accredited chiropractic programs in the U.S.
•About 49,000 practicing in 2008
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Term
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Definition
•Diagnose and treat disorders, diseases, and injuries of the foot and lower leg to keep this part of the body working properly
•Practice limited to the foot
–Prescribe drugs
–Make referrals
–Fit orthotics and design casts and shoes
•Education
–Usually 4 yr. bachelor’s degree
–4 yrs. College of podiatric medicine
•In 2008, there were 8 accredited colleges of podiatric medicine in the U.S.
–2-4 yrs. Residency
•About 12,000 practicing in 2008
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Term
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Definition
•Diagnose, prevent, and treat problems with teeth and mouth tissue
•Prescribe medications and perform procedures (surgical and nonsurgical)
•Specialties
–Orthodontists, oral and maxillofacial surgeons, oral and maxillofacial radiologists, pediatric dentists, periodontists, prosthodontists, endodontists, public health, and oral pathologists
•Education
–2+ yrs. Predental (most students have 4 yr bachelor’s degree)
–4 yrs. Dental school
•In 2008, there were 57 accredited dental schools in the U.S.
–Post graduate training by 15% of DDS/DMD (specialists)
•About 142,000 practicing in 2008 (almost all dentists work in private practice, most as solo practitioners)
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Term
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Definition
•Licensed Practical Nurse and Licensed Vocational Nurse
•Care for the sick, injured, convalescent, and disabled under the direction of physicians or registered nurses
•Most work in hospitals and nursing facilities
•Provide bedside care, take vital signs, aid with personal hygiene, collect samples, administer medications, and perform routine lab tests
•Education
–High school or equivalent
–1 year program in high school, vocational/technical school, community or junior colleges, universities, or hospitals
•Many such programs in the U.S.
•About 754,000 practicing in 2008
–Decline in hospitals, average growth in in nursing facilities, fast growth in outpatient and home health settings
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Term
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Definition
•Registered Nurse
•Promotes health, prevents disease, and helps patients cope with illness
•Nurses assist physicians, administer medications, and develop care plans
•Education
–2-4 yrs. Associate degree, or diploma program, bachelor’s degree
•Many such programs are available in the U.S. (there are relatively few diploma programs and the number is decreasing)
•Advance Practice Nurse
–Nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife
–Have prescriptive authority in most jurisdictions and in some jurisdictions may practice independently without physician collaboration or supervision
–Education
•2 yrs. Graduate education, usually Master’s (note that the standard for qualification to be an advanced practice nurse is shifting to that of a Doctor of Nursing Practice (DNP) by 2015)
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Term
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Definition
•Assist people by helping them cope with issues in their everyday lives, deal with their relationships, and solve personal and family problems.
•Education – Bachelor’s degree minimum (some have MSW, DSW, or PhD)
642,000 in 2008 (not all of these are involved in health care
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Term
Medical and Public Health social workers |
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Definition
–Psychosocial support to individuals, families, or vulnerable populations coping with chronic, acute, or terminal illnesses, such as Alzheimer's disease, cancer, or AIDS; may run support groups
–Discharge planning
–Interdisciplinary teams (i.e., geriatric or organ transplant)
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Term
Mental Health and Substance Abuse Social Workers |
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Definition
assess and treat individuals with mental illness or substance abuse problems |
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Term
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Definition
•Help mentally and emotionally disturbed patients adjust to life and help medical and surgical patients deal with illness or injury
•Education
–Specialist degree (e.g., EdS), Master’s, PhD, or PsyD education
–A doctoral degree (e.g., PhD, PsyD) usually is required for independent practice as a psychologist
–4 yrs. Undergraduate
–2-7 yrs. Graduate
•170,200 in 2008
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Term
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Definition
•Plan food and nutrition programs and supervise the preparation and serving of meals
•Education
–4 yrs. Bachelor’s degree (at least)
•60,300 in 2008
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Term
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Definition
•Help people improve the ability to perform tasks for daily living and working
–Education – bachelor’s degree (Note: Beginning in 2007 master’s degree or higher is required as entry-level degree)
–104,500 in 2008
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Term
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Definition
•Help restore function, improve mobility, relieve pain, and prevent or limit permanent physical disabilities from illness or injury
–Education – Master’s degree, Doctor of Physical Therapy (DPT) (DPT is now the most common degree granted)
–185,500 in 2008
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Term
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Definition
•Provide treatment services and recreation activities to individuals with disabilities or illness
–Education – bachelor’s degree
–23,300 in 2008
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Term
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Definition
•Evaluate, treat, and care for patients with breathing or cardiopulmonary disorders
–Education – associate’s degree or four-year baccalaureate degree
–105,900 in 2008
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Term
Six forces to examine the competitive intensity |
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Definition
- Threat of New Entrants
- Rivalry Among Existing Firms
- Threat of Substituted Products
- Bargaining Power of Buyers
- Relative Power of Stakeholders
- Bargaining Power of Suppliers
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Term
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Definition
**Barriers to entry:
----Product differentiation
----Patent protection
----Capital requirements - R & D
•(If you are a small company, and you don’t have R &D then you won’t survive. You have to have the appropriate finances)
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Term
Rivalry among existing firms |
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Definition
----Rate of industry growth (Implies more players in the market and if there are more players in the market then competition is higher)
----Number of competitors
----Success of biotech products and firms
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Term
Threat of Substitute Products |
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Definition
----Generic substitution (Cardizem is substituted with diltaizem)
----Therapeutic substitution/therapeutic interchange (Drugs in same class is a therapeutic substitution like antihistamines, such as Claritin for Allegra)
----Rx to OTC switch (omeprazole to prilosec OTC)
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Term
Bargaining Power of Buyers |
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Definition
- Customer Consolidation
- Managed Care and third party payers
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Term
Relative Power of Stakeholders (Government) |
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Definition
----Orphan Drug Act of 1983 (ex: Addison’s disease or cancer subtype disease. Less than 200,000 people have to be infected with a disease. The companies who make these drugs got funding and tax breaks)
----Drug Price Competition and Patent Term Restoration Act of 1984 (Waxman-Hatch Amendments) (Generic boom after this law)
----The Omnibus Budget Reconciliation Act of 1990 (allowed for discounts to medicaid. Same law that required patient counseling for medicaid patients)
----The Prescription Drug User Fee Act (PDUFA) of 1992
----The Food and Drug Administration Modernization Act (FDAMA) of 1997
----Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003
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Term
Bargaining Power of Suppliers |
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Definition
Not as significant in Pharmaceutical industry |
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Term
Current Issues Facing the Pharmaceutical Industry |
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Definition
*Reimportation of drugs from Canada, Mexico and other countries
*Lack of new compounds by big pharma
*Biosimilars
*Healthcare reform
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Term
Healthcare Reform Summary |
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Definition
*Expands coverage and provides subsidies
*Medicare Payroll tax on “Cadillac plans”
*Medicare
*Closes the Medicare prescription drug "donut hole" by 2020. Seniors who hit the donut hole by 2010 will receive a $250 rebate.
*Beginning in 2011, seniors in the gap will receive a 50 percent discount on brand name drugs. The bill also includes $500 billion in Medicare cuts over the next decade.
*Expands Medicaid coverage
*Insurance reform – cannot deny coverage for preexisting conditions
*Abortion – insurance not required to cover it
*Individual mandate – should have insurance by 2014
*Employers with >50 employees required to provide health insurance
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Term
Moral hazard of health insurance |
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Definition
- This is the effect of Health insurance increasing utilization.
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This is important in the Factors Contributing the Growth Rate of National Health Expenditures
during 1960s- 1980 and 1980-1993
- •When we remove out of pocket costs consideration from decision making then more people are going to utilize health care. During this time period more people had coverage and had the ability to utilize healthcare. So more and more people were insulated from costs, and the government involvement in 1960 was a big contributor to this.
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•The medical technology was more expensive, the more things we could diagnose and treat that were never thought of increased, the drug discovery increased.
•The 1970s were characterized by high levels of inflation explains some of the high % of growth of health costs.
•When there are more people, we spend more on health care. We had a huge population growth during this period.
•People, relative to 30s and 40s, are living longer than they had before which gave a large aged population
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Term
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Definition
- (increases in this type of care cause drop in growth rate)
- Important in the 1994-1998 growth rate of national health expenditures
– more and more people begin to move to managed care programs. (Managed care was associated with drug utilization and working with providers to limit price increases. They do this by restrict people’s choices. Employers wanted to lower the costs of the health insurance they were having to pay. US auto-manufacturers also had a hard time because they were having to pay the growing healthcare expenditures. Managed care began to help do this by moving people into these programs that reduced price and utilization of healthcare) |
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Term
1999-2003 Growth Factor of National Health Expenditures
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Definition
•Managed care is not used as much.
•When choices are restricted of Americans, there is a managed care backlash. People were choosing jobs with less healthcare restrictions. Employers were looking for people (not a big unemployment rate) and had a hard time filling jobs if they had a bad healthcare plan.
•There was a good economy during this period. In a good economy, State governments get more money from income taxes. The governments get more money then they budget for and they spend their money. They expanded Medicaid eligibility at this time, so more people could be covered. The people who didn’t have coverage in the 1960’s-80s now have more possibility of care through state programs. (remember Medicare is a federally funded program)
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Term
2004 – 2007 Growth Factors in Health Expenditures
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Definition
•Growth goes down again because employer has more power than employee and starts enacting cost control mechanisms.
Some states after expanding Medicaid, then contracted Medicaid which put more people on uninsured list
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Term
2008 Growth Factors in National Health Expenditures
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Definition
The economy sucks! Thats why it dropped! |
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Term
2009-2019 Growth Factors of National Health Expenditures
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Definition
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Term
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Definition
Definition: the amount of all the goods and services that are produced within a defined geographic area (a country). As more of our dollars go to healthcare we have less money to go to other goods and services.
Lower periods of growth, then there is a huge portion of the GDP spent on healthcare. The large growth in 2009 represents the largest 1 year increase in GDP reflecting severity of recession and lack of economic growth (numerator grows, denominator doesn’t). If you are spending the majority of your income on healthcare then you don’t have the money to contribute to other things |
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Term
•Why is it that we have seen a precipitous drop in the growth of retail drug spending in the period from 1999 until today?
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Definition
•GENERICS – They are less expensive, so the growth in dollars is less.
•increase in tiered copayment benefit plans – insurance have more tightly controlled plans that force people to take generic drugs.
•changes in the types of drugs used – not just generics for brand names but therapeutic substitution of a different drug that has the same mechanism of action that is less expensive.
•decrease in the number and type of new drugs introduced – Not as many billion dollar products hit the market.
safety concerns – There were several drugs that had large media coverage and showed that maybe there is not a pill for every illness and that there are good medications but some do more harm than good
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Term
Why was there a sudden increase in National Growth in Retail Prescription Drug Spending in 2006?? |
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Definition
•Increased use of prescription drugs, (Medicare Part D), new indications for existing drugs, strong growth in several therapeutic classes, and increased use of specialty drugs. Prior to 2006, the elderly didn’t have coverage for prescription drugs unless they had private insurance, on the graph we have an increase in drug usage because of this.
•lower rebates from drug manufacturers, and
changes in the therapeutic mix of drugs
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Term
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Definition
it means the reduction of preventable errors and reduced variability in evidence-based best practices |
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Term
Paradoxes of the U.S. Healthcare System |
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Definition
•We have the most advanced technology and spend the most money per capita, but have a very high rate of medical errors and do not favorably compare with other countries in gross measures of health status.
•There are significant gaps in who has access to health care.
•Other examples:
–The majority of people suffering from high blood pressure are unaware that they have the condition (many people with diabetes are unaware or not in treatment).
–The majority of people coping with depression do not receive the types of medicines known to be effective.
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Term
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Definition
The U.S. mental health service system is complex and connects many sectors (public–private, specialty–general health, health–social welfare, housing, criminal justice, and education). As a result, care may become organizationally fragmented, creating barriers to access. The system is also financed from many funding streams, adding to the complexity, given sometimes competing incentives between funding sources.
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Term
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Definition
The father of American Psychiatry. The first person to recognize mental illness as a disease and not a demonic possession and he advocated for Treatment. This marks the beginning of the Moral Movement of Mental Health |
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Term
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Definition
A long time advocate for treatment of the mentally ill. She would approach legislators with goal to create asylums. She wanted them to be a safe haven where they could be together and thus protect the public. Funding was given, but they were large and understaffed so counseling and treatment was minimal or poor, and the people admitted were rarely allowed to leave. (“Mental Health Prisons”) Dorthea Dix also tried to capture the amount of people in the US via a census to figure out how many people suffered from a mental illness. |
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Term
Mental Health Act of 1946 |
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Definition
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Term
Mental Health Study Act of 1955
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Definition
- Joint commission on Mental Illness and Health, Action for Mental Health. (This act allowed for the discovery of drugs and helped the pharmaceutical industry realize there was a market for mental health so they created drugs to sell.
*Post WWII, mental disorders became more treatable with medications, which fostered more optimism toward treatment and prevention*
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Term
Community Mental Health Center Act of 1963 |
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Definition
- Funded construction and staffing of community mental health centers (CMHC) (no longer has to be State Hospitals (whitfield) or large facilities)
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Term
Medicaid/ Medicare in 1965 |
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Definition
Provided financial resources so that institutions could be depopulated and transferred to other LTC facilities or care |
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Term
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Definition
NIMH Epidemiologic Catchment Area Survey (cluster sample of people from 5 regions and they wanted to enumerate the people with illness and see what types of illnesses did they have) (1980-1985). The first real attempt to enumerate disease and describe mental health on a broader scale and continue what was done in 1955. |
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Term
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Definition
National Comorbidity Survey (1990-1992) – Another large study (3rd since 1955) that adhered to the World Health Organization and so we could compare internationally. We have more mental illness than other industrialized nations.
NCS – Replication (2005) – used DSM 4 criteria to enumerate and gather data, consistent with WHO criteria, and it acts as a mental health census so we could figure out where to allocate our resources.
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Term
The four sectors of the Mental Health System
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Definition
- Specialty Mental Health Sector
- The general medical/ primary care sector
- The Human Services Sector
- The Voluntary Support Services Sector
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Term
Specialty Mental Health Sector |
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Definition
- Specialty mental health services include services provided by specialized mental health professionals (psychologists, psychiatric nurses, psychiatrists, and psychiatric social workers) and the specialized offices, facilities, and agencies in which they work.
- Specialty services were designed expressly for provision of mental health services
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Term
The general/ primary care sector |
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Definition
- The general medical/primary care sector consists of health care professionals (family physicians, nurse practitioners, internists, pediatricians, etc) and the settings (offices , clinics, and hospitals) in which they work.
- These settings were designed for the full range of health care services, including, but not specialized for, the delivery of mental health services
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Term
The Human Services Sector |
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Definition
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- The human services sector consists of social welfare, criminal justice, educational, religious, and charitable services.
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Term
The Voluntary Network Sector |
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Definition
-
- The voluntary support network refers to self-help groups and organizations.
- These are groups devoted to education, communication, and support, all of which extend beyond formal treatment.
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Term
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Definition
- Refers both to services directly operated by government agencies (e.g. state and county mental hospitals) and
- to services financed with government resources (e.g. Medicaid, Medicare)
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Term
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Definition
- refers both to services directly operated by private agencies
- Financed through private agencies (employer-based-insurance)
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Term
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Definition
- History of insurance and mental health care
- Believed to result in high costs
- Catastrophic care guaranteed by public mental health system
- Traditional forces at play in insurance (moral hazard and adverse selection) may have been exaggerated. Impact of managed care
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Term
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Definition
- Cost controls
- Lowered fees, reduction in utilization (fewer hospital stays and less time in mental health services) and shifting to ambulatory setting.
- Managed behavioral health care organizations (MBHOs).
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Term
Important Factors in Mental Health Service Delivery |
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Definition
1. Mental Health Parity Act 2. Mental Health Parity and Addiction Equity Act
3. Stigma 4. Prevention 5. Entry into treatment |
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Term
Mental Health Parity Act (MHPA) |
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Definition
signed into law in 1996, requires that annual or lifetime dollar limits on mental health benefits be no lower than any such dollar limits for medical and surgical benefits offered by a group health plan or health insurance issuer offering coverage in connection with a group health plan.
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i. For example, in 1975, MS’s annual cap on mental health expenditures was $1,000.
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Term
Mental Health Parity and Addiction Equity Act |
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Definition
is a federal law that provides participants who already have benefits under mental health coverall parity with benefits limitations under their medical/surgical coverage. |
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Term
Role Of Pharmacist in Mental Health Services |
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Definition
- “Some feel embarrassed, helpless, frightened, powerless, uncomfortable, or self-protective when working with patients with mental disorders.”
- Pharmacists frequently interact with a wide variety of patients with mental, cognitive, and emotional disorders.
- Pharmacists must acquire the knowledge and interpersonal skills, including observation, to interact effectively with these patients.
- Familiarity with the MMSE
- Familiarity with local services and state services for mental illness and addictive disorders.
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Term
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Definition
A model for quality, compassionate care at the end of life. Involves a team-oriented approach to expert medical care, pain management, emotional, and spiritual support expressly tailored to patient’s needs and wishes |
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Term
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Definition
- Dying is a natural part of the life cycle
- Belief that we each have the right to die pain-free and with dignity.
- Practitioners seek not to hasten nor postpone death but instead provide comfort and supportive care while the patient's illness runs its course.
- Emphasis is not on death and dying but on living each day until the death comes
- Not only the patient receives care but the family does as well.
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Term
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Definition
o Provide comprehensive palliative care to terminally ill patients and supportive services to their families and significant others, 24 hours a day, seven days a week, in both home and facility based settings.
o With physician oversight, the patient and family receive physical, social, spiritual, and emotional care during the later stages of the patient’s illness, during the dying process, and during the family’s bereavement period. Hospice doesn’t stop for family after patient is buried.
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Term
Palliative Care (definition by WHO) |
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Definition
The active total care of patients whose disease is not responsive to curative treatment.
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Term
Palliative Care (Oxford Textbook) |
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Definition
The management of patients with active, progressive, far advanced disease for whom the prognosis is limited and the focus of care is the quality of life. |
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Term
Interdisciplinary Approach to Hospice Care |
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Definition
The team works together to provide the patient/family with support and guidance as they confront common challenges associated with dying.
Team Members include:
- Medical Director
- Attending/ Primary Physician
- Nursing Care
- Home Health Aides
- Social Services
- Chaplains or other counselors
- Volunteers
- Bereavement Care
- Pharmacists
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Term
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Definition
Duties:
- Refer and recruit patient admissions
- Educate on hospice and EOL care to medical community
- Coordinates care with attending physicians
- Leads interdisciplinary team
- Admissions, certifications, re-certifications,
- EOL pain and deaths
The Role of the administrator depends on the given facility and the full time vs part time responsibilities of their job.
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Term
Attending/ Primary Physician |
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Definition
This is the patient’s designated physician for medical care
Duties:
- Certifies patient’s prognosis
- Continues ongoing medical care/consultation for patient’s disease state and symptoms after hospice admission
- Signs death certificate
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Term
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Definition
Clinical Coordinators, Admission nurses, Case Managers (RN), LPN ,Triage Team
Duties:
- Provide medical care to a patient two-three times/week
- Assess and monitor patient’s condition
- Consult with MD on patient’s plan of care
- Coordinate medication use/education
- Coordinate other necessary supportive care (DME, medical supplies, etc.
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Term
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Definition
Duties: Assist patients with transfers, bathing, eating, etc. Provide support to family/caregivers to address their needs
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Term
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Definition
Duties: Counseling and supportive services Assist in preparation of end of life (i.e. legal issues, vacations, funeral arrangements, etc.)
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Term
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Definition
Duties: Life review/counseling Prayers and spiritual services for any religion
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Term
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Definition
Duties Trained community persons to assist families in their time of need Provide support in any possible way Grocery shopping, respite hours, transportation, etc.
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Term
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Definition
Duties: Support services to friends and family after the patient’s death for up to one year.
- Bereavement support is provided by various disciplines depending on the hospice (i.e. social work, chaplains, psychologist, etc.)
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Term
Pharmacists Role in Hospice |
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Definition
- Assessing the appropriateness of medication orders and ensuring the timely provision of effective medications for symptom control.
- Counseling and education the hospice team about medication therapy
- Ensuring that patients and caregivers understand and follow the directions provided with medications.
- Providing efficient mechanisms for extemporaneous compounding of nonstandard dosage forms.
- Addressing financial concerns (we can get meds generic and can work with social workers and manufacturers)
- Ensuring safe and legal disposal of all medications after death.
- Establishing and maintaining effective communication with regulatory and licensing agencies
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Term
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Definition
· introduced hospice to the US in the late 1960s.
o The first hospice was founded in 1967 by Dame Cicely Saunders, a British physician. Saint Christopher Hospice of London
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Term
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Definition
Reserving such services for terminally ill Medicare beneficiaries with life expectancies < 6 months. How many hospice patients? 963,000 are expected to die while in hospice, about 38% of deaths
- Designed to meet the unique needs of those who have a terminal illness, providing them and their loved ones with special support and services not otherwise covered by Medicare.
- Under MHB, beneficiaries elect to receive non-curative treatment and services for their terminal illness by waiving the standard Medicare benefits for treatment of a terminal illness (meaning they would not pay for chemotherapy or something like that once they agree to Hospice. You can still have Medicare just don’t file for that terminal illness so all the other things a patient is on can still be paid for (high BP, etc))
- However, the beneficiary may continue to access standard Medicare benefits for treatment of conditions unrelated to terminal illnesses
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Term
Services Covered under the MHB |
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Definition
• Physician
• Nursing Care
• Home health aide
• Chaplain
• Social Work
• Bereavement
• Medical equipment and supplies
• Medications
• Volunteer
• • PT, OT, ST, and/or dietary counseling
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Term
Services NOT covered by MHB |
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Definition
- Services for conditions unrelated to the terminal illness.
- Services for the terminal diagnosis that are not called for in the hospice care plan or arranged by hospice.
- Room and board in a facility.
- in-patient care and respite care can be covered if deemed necessary by hospice team
- Hospice care from another provider (other than one associated with your hospice team).
• Drugs intended to cure disease.
• Care in an emergency room, inpatient facility care, or ambulance transportation, unless it’s either arranged by your hospice medical team or is unrelated to your terminal illness
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Term
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Definition
1. Certified by the patient’s primary physician and hospice medical director that the patient is terminally ill and has a life expectancy of six months or less.
2. Sign a statement choosing hospice care using the MHB, rather than curative treatment and standard Medicare covered benefits for their terminal illness.
3. Enroll in a medicare approved hospice program.
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Term
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Definition
- Admission certification
- Re-Certification
- Two 90-day periods followed by unlimited 60-day periods. (Its open ended if you don’t die within your 6 months)
- The patient must demonstrate disease progression or decline from terminal illness to be re-certified (continue eligibility for MHB). (If they have no health decline or no tumor growth or whatever, then they may lose hospice if they will live for years. If there is some sort of progression of decline then they usually stay)
i. The patient MAY be discharged if they do not continue to meet eligibility requirements.
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Term
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Definition
- Other patients are referred to hospice only in the final days of their lives
- Some dying patients never get referred to hospice
- Only 38% of patients die with hospice care.
- Length of stay ~3 weeks nationally, more than a third of patients spend less than seven days enrolled in hospice
- Difficulties with prognosis
- Inability to accurately predict prognosis Limited public awareness
- Cultural differences and barriers contribute to an inequitable distribution of hospice services
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Term
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Definition
health care provided to non-institutionalized patients. “Outpatient” care, usually on an appointment basis.
Inpatient – hospital, overnight, surgery, more
Outpatient – private doctors, less invasive surgery, physical therapy or rehab, primary care from a pharmacy clinic. |
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Term
Reasons for an Increase in Ambulatory Care Visits. |
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Definition
1. Rapid growth of managed care
2. Greater emphasis on shortened hospital stays/ more outpatient care.
3. Drugs sparing hospital visits because they are OTC (statins, anti-hyperlipidemics, antibiotics)
4. Technology has increased
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Term
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Definition
Increases in ambulatory care = decreases in health care costs |
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Term
Factors affecting Utilization of Ambulatory care |
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Definition
- Access
- Insurance status (people with no health insurance won't go to health clinics because they can't afford it so they go to expensive emergency rooms)
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Term
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Definition
- Differences in access for different minority populations, income brackets, and women.
- Disparities lead to differences in deaths from heart disease, cancer, stroke and diabetes (the 4 top killers), as well as other illnesses.
- “ HRSA (Health Resources and Services Administration – responsible for improving access) envisions optimal health for all, supported by a health care system that assures access to comprehensive, culturally competent, quality care.”
(Remember that cultural competence improves care because of language barriers, being aware of different disease risks of different population.)
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Term
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Definition
Primary care = medical care oriented toward the routine needs of patients (diagnosis, treatment of common illnesses, etc.)
Secondary care = routine hospitalization and specialized outpatient care
Tertiary care = complex services provided in inpatient hospital facilities
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Term
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Definition
- · "ambulatory care” not equal to primary care
- · Primary care is one type of ambulatory care
o Patients principle source of general outpatient medical care
o Generally a longitudinal relationship
- · “Accessible” (in theory), located in the community settings.
- · “First stop” for most personal health care needs
- · Integrates/coordinates other needed services (via referrals, etc).
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Term
Who Provides Primary Care? |
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Definition
- Physicians (general, family, pediatrics, etc.)
- Nurse Practitioners (NP)
- Physician assistants (PA)
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Term
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Definition
¡ Usually multiple physicians, and not just one person at a clinic (dominant form of primary care.
¡ HMOs (Health maintenance organizations)
¡ PPOs (preferred provider organizations
- Hospital clinics and outpatient centers
¡ EX: anticoagulation clinics
¡ Diabetes/ metabolic clinics
¡ Dialysis units
¡ Chemotherapy centers
- Emergency rooms and “urgent care” centers
¡ Some patients use the ER as their “family physician”. This impact is that they are being charged a LOT more to go to the ER. People without insurance usually do this because they aren’t sick a lot but probably do not know that the costs could be 10x more.
- Free Clinics
- Certain governmental facilities
¡ County health Departments
¡ AHECS (Area Health Education Centers)
¡ Indian Health Services (A branch of the Public Health Service)
¡ Veterans Affairs medical Centers
¡ School health clinics
¡ Prison Health Services
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Term
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Definition
A form of primary care
- Health promotion (providing resources and get word out about things from flu shots, etc)
- Disease prevention
Primary prevention (population-based care)
- Restaurant Inspection
- Elimination of cancer causing environmental pollutants
- Smoking bans, etc
Preventive health services (direct patient care)
- Immunization
- Screening and early detection, etc.
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Term
Coordination of Needed Services |
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Definition
**Patient Centered focus for care
**Integrated health care team
**Safety, quality, all play a role in service selection and implementation
**Primary care occurs in the community setting.
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Term
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Definition
Safe, high quality ambulatory care may require information management and coordination across multiple settings, especially for patients with chronic illnesses. (AHRQ, 2007). AHECs in the rural US often include a telemedicine component. (contacting a specialist via video technology or something like that so they can see the wound or just for advice that allows for quicker, more affordable patient care.)
AHEC = Area Health Education Center, these centers have telemedicine components.
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Term
Trends in Health care affecting Ambulatory Services |
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Definition
- 1. Attention to improving health care for Americans living with chronic diseases
- 2. Continuing emphasis on medication safety
- 3. Greater emphasis on emergency preparedness and bioterrorism
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Term
Role of Pharmacist in an Ambulatory Care Setting |
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Definition
- Patient Education
- Pharmacotherapeutic interventions
- Medication Management
- Screening and early detection
- Health promotion and disease prevention
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Term
Pharmacotherapeutic Interventions Regarding Ambulatory Care |
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Definition
- Identify and prevent drug related problems
- Establish Treatment goals and outcomes
- Make a pharmacy care plan
- Initiate
- Modify
- Discontinue
- Monitor Drug therapy
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Term
Medication Therapy Management Services |
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Definition
Paid for by Medicare part D
- A distinct service or group of services that optimize therapeutic outcomes for individual pts
- Independent of, but can occur in conjunction with, the provision of a medication product
- Encompasses a broad range of professional activities and responsibilities within the licensed pharmacist’s, or other qualified health care provider’s, scope of practice
- Includes:
- comprehensive medication review (brown bag)
- prescriber consultation,
- patient compliance consultation and education,
- monitoring
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Term
Pharmacists involvement in preventive care services |
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Definition
- Screening and Early detection
- Health Promotion and Health Disease Prevention
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Term
Complementary and Alternative Medicine |
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Definition
- Approaches to health care that are outside the realm of conventional medicine as practiced in the U.S.
- Complementary = used together with conventional medicine
- Alternative = used in place of conventional medicine
- Integrative = combines mainstream therapies and CAM therapies for which there is some scientific evidence of safety and efficacy.
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Term
Value and Results of Pharmacists work in Ambulatory Care |
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Definition
- Decrease in Hospital rates
- Decrease in Drug Rates
- Increase in quality of care
-
- Increased adherence
- Increased outcome of treatment
- Fewer Adverse Drug Events
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Term
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Definition
l 40 funded projects to provide health care to Delta region counties in MS, among them:
l Delta Pharmacy Patient Care Management Services
o To improve medication use and health outcomes in the Medicaid population of targeted areas and evaluate the efficiency of Pharmacy Management Services on medication adherence and disease management
l Delta Infant Mortality Elimination (DIME)
l Rural Tele-Emergency/ Tele Stroke:
o To improve timely treatment of stroke victims.
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Term
Major reasons that have been cited for slow development of clinical pharmacy services |
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Definition
- Lack of reimbursement and other incentive
- Pharmacists’ attitudes
- Lack (at times) of a cohesive professional vision and message.
- History of limited support (by schools of pharmacy) for clinical services in community pharmacy settings.
- Lack of “change agents,” leaders who can make the difference
- Public perception
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Term
Opportunities of Pharmacist Involvement in Ambulatory Care |
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Definition
- Help with patient satisfaction
- Impact on long term outcomes
- Quality of Care
- Disease Management Protocols with Doctors
- Involvement on multidisciplinary teams
- Certifications
- MTMS
- Mississippi-based Health Initiatives
- Community pharmacy residency
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Term
Challenges of Pharmacists Involvement in Ambulatory Care |
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Definition
- Dynamics in the Health care team
- Stepping on someones shoes
- The publics perception of pharmacy
- Cognitive services not top of mind
- How will the know of your services?
- Make your scope of practice known to patents
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Term
Hematopoietic Growth Factors |
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Definition
1. ESA [Erythropoietin Stimulating Agent]
2. G- CSF [Granulocyte Colongy Stimulating Factor]
3. GM-CSF [Gronulocyte Macrophage Colony Stimulating Factor]
4. Small Molecule antagonist of CXCR4 |
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Term
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Definition
- Trade Name: Epogen or Procrit
- Type: ESA
- Function: Stimulates Erythropoeisis (rhEPO)
- Approval Use: Anemia, chronic kidney disease or chronic renal failure, adjunct to chemotherapy, preoperative preparation
Extra Info:
•Black box warnings: (risk of serious cardiovascular and thromboembolic events)…
•Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered EPO to target higher versus lower hemoglobin levels in clinical studies.
•Adjust the ESA dose to maintain the lowest hemoglobin level necessary to avoid the need for blood transfusions.
•Monitor patients’ hemoglobin levels to ensure they do not exceed 12 g/ dL. (Normal = 12-17 g/dL)
•Understand that ESAs are given to decrease the chances of receiving transfusions.
•Understand that ESAs should not be given to treat the symptoms of anemia, including shortness of breath, dizziness, fatigue, low energy, or poor quality of life. |
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Term
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Definition
- Trade name:Aranesp
- Type: ESA
- Function: Stimulates erythropoiesis, longer half life (glycosylated- 2 additional N-linked oligosaccharide chains)
- Major Use:Anemia, chronic kidney disease or chronic renal failure, adjunct to chemotherapy, preoperative preparation
Extra Info:
•Black box warnings: (risk of serious cardiovascular and thromboembolicevents)…
•Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered EPO to target higher versus lower hemoglobin levels in clinical studies.
•Adjust the ESA dose to maintain the lowest hemoglobin level necessary to avoid the need for blood transfusions.
•Monitor patients’ hemoglobin levels to ensure they do not exceed 12 g/ dL. (Normal = 12-17 g/dL)
•Understand that ESAs are given to decrease the chances of receiving transfusions.
•Understand that ESAs should not be given to treat the symptoms of anemia, including shortness of breath, dizziness, fatigue, low energy, or poor quality of life. |
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Term
Methoxy-PEG-epoetin-beta
(PEG=polyethylene glycol) |
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Definition
- Trade name: Micera
- Type: ESA
- Function: stimulates erythropoiesis, longer half life (134 hours) (PEGylated- PEG enhances the stability of the protein). Continuous erythropoietin receptor activator.
- Major Use:Anemia, chronic kidney disease or chronic renal failure, adjunct to chemotherapy, preoperative preparation. Usually given for anemia in chronic kidney disease though.
- Not approved in the US
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Term
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Definition
- Trade name: Affymax
- Type: ESA
- Function: Same, non-rhEPO PEGylated synthetic dimeric peptide
- Major Use: In phase III clinical trials to treat anemia in patients with chronic renal failure.
- Hematide™ (Affymax) is a synthetic dimeric peptide-based ESA which is being evaluated for the treatment of anemia in patients with chronic renal failure. It may enter market in 2011
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Term
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Definition
- Trade name: Neupogen
- Type: G-CSF (recombinant - human derived)
- Function: stimulates neutrophil proliferation, differentiation, and migration.
- Major Use: Neutropenia in AIDS or post-chemotherapy or bone-marrow transplantation; severe neutropenia
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Term
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Definition
- Trade name:Neulasta
- Type: G-CSF [A covalently linked analog of recombinant G-CSF (filgrastim) and monomethoxypolyethylene glycol (PEG)]
- Function:Stimulates neutrophil proliferation, differentiation, and migration, but has a longer half life than neupogen
- Major Use: Neutropenia in AIDS or post-chemotherapy or bone-marrow transplantation; severe neutropenia
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Term
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Definition
- Trade name:Leukine
- Type: GM-CSF (recombinant)
- Function:Stimulates proliferation and differentiation of neutrophils, eosinophils, and monocytes
- Major Use: Following induction chemotherapy in older adults with acute myelogenous leukemia (AML). Before and/or after peripheral blood stem cell transplantation. Mobilizes progenitor cells and helps with myeloid reconstitution after transplant. Protects against infections because it accelerates myeloid recovery, including increases in the number and activity of neutrophils (bacteria protection), monocytes/macrophages (fungi/virus protection) and myeloid-derived dendritic cells (virus protection). These three key cells provide protection from multiple pathogens
- This drug shortens the time it takes neutrophils to recover while significantly reducing the number of deaths that would result from infections.
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Term
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Definition
Trade name: Mozobil
Type: small molecule antagonist of CXCR4
Function: Stem Cell Mobilizer
Major Use: In combination with G-CSF to mobilize HSCs (hematopoetic stem cells) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.
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Term
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Definition
Trade Name: Remicade
Type: Chimeric Mab
Mechanism of Action: TNF-alpha blocker
Indications: Rheumatoid Arthritis; Plaque Psoriasis; Crohn’s Disease; Psoriatic Arthritis; Ankylosing Spondlyitis; UC-Ulcerative colitis
Apporoved: 1998
Other Info:
- 1st in class Mab for RA
- Given by IV injection
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Term
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Definition
Trade Name: Kineret
Type: recombinant IL-1 protein
Mechanism of Action: IL-1 receptor antagonist
Indications: Rheumatoid arthritis
Approval: 2001
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Term
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Definition
Trade Name: Humira
Type: Human Mab
Mechanism of Action: TNF-alpha blocker
Indications: Rheumatoid Arthritis; Plaque Psoriasis; Crohn’s Disease; Psoriatic Arthritis; Ankylosing Spondlyitis; Juvenile Idopathic Arthritis.
Approval: 2002
Other Info:
- 1st fully Human Mab
- Taken by injection
- Half life about 10 -20 days
- Pre-filled and pre-measured syringe containing 40 mg (0.8 mL) or… Humira pen
- No mixing, no measuring, no filling
- Usually injected once every two weeks
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Term
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Definition
Trade Name: Raptiva
Type: ---
Mechanism of Action: ----
Indications: WITHDRAWN FROM MARKET
Approval: 2003
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Term
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Definition
Trade Name: Enbrel
Type: Infusion Protein
Mechanism of Action: TNF-alpha blocker
Indications: Rheumatoid Arthritis; Plaque Psoriasis; Psoriatic Arthritis; Ankylosing Spondlyitis; Juvenile IdopathicArthritis
Approval: 2003
Other Info:
- Half life is 3- 5 days
- This fusion protein is made up of the Fc portion of IgG, and a TNF-a receptor portion (mimics the action of TNF-a receptors on cell surface) , and blocks action of soluble TNF-a.
- Administered using 25-50mg in a sureclick prefilled autoinjector.
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Term
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Definition
Trade Name: Amevive
Type: Fusion Protein
Mechanism of Action: Blocks CD-2 on memory T cells
Indications: plaque psoriasis
Approval: 2003
Other Info:
•Memory T cells (CD4+) are also a predominant cell type in the psoriatic plaque.
•Alefacept is a fusion protein consisting of the first extracellular domain of LFA-3 (lymphocyte function–associated antigen 3) fused to the hinge CH2 and CH3 sequences of human IgG1.
•Alefacept binds to CD2 receptors on memory T -cells, and leads to the inhibition of T cell co-stimulation and a reversible reduction of memory T cells
•Consequently inhibits the inflammatory process.
•Additionally, alefacept binds to Fc receptor on natural killer cells and macrophages, resulting in T cell apoptosis (programmed cell death).
Alefacept has a slow onset of action, peaking approximately 18 weeks after the first injection of a 12-week course.
It is associated with long remissions without the need for maintenance therapy
Its efficacy improves with subsequent courses
it has a high safety profile.
Administered IV or IM
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Term
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Definition
Trade Name: Orencia
Type: Fusion Protein
Mechanism of Action: Blocks CD 80/86 on APC
Indications: Juvenile Idiopathic Arthritis and Rheumatoid Arthritis
Approval: 2005
Other Info:
•T-cell activation requires several interactions between a T-cell receptor and antigen presenting cell (APC) of which one of the most important is the interaction between CD28 and CD80/CD86.
- The expression of CTLA4 is up-regulated on the T cell following activation. Binding of CTLA4 to CD80/CD86 provides a control signal that enhances T-cell activation.
- •Abatacept interrupts the interaction between CD80/CD86 and CD28 or CTLA4, prevents T-cell activation and its effects in RA.
- •Overall, this results in the inhibition of downstream effects of TNF-a and other inflammatory cytokines.
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Term
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Definition
Trade Name: Cimzia
Type: Humanized Mab + PEG - NO-Fc
Mechanism of Action: TNF alpha blocker
Indications: Chronn's Disease, Rheumatoid Arthritis
Approval: 2008
Other Info:
- Cimzia is a humanized Mab that does not contain the Fc portion (only the Fab portion and a segment (CH1) linked to PEG!)
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Administered SC (monthly dosing after initial therapy)
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Term
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Definition
Trade Name: Simponi
Type: Human Mab
Mechanism of Action: TNF-alpha Blocker
Indications: Ankylosing Spodylitis, Psoriatic Arthritis, Rheumatoid Arthritis
Approval: 2009
Other Info:
•Simponi is the first anti TNF-a blocker that offers an effective once-monthly treatment option.
•Dose of Simponi is 50 mg by SC injection once a month (self administered)
SmartJect autoinjector |
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Term
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Definition
Trade Name: Stelara
Type: Human Mab
Mechanism of Action: IL-12 and IL-23 blocker
Indications: Plaque Psoriasis
Approval: 2009
Other Info:
- Dual mechanism of action
- SC every 12 weeks
- Blocks IL-12 and IL-23 cytokines from binding to respective IL receptors on surface of T-cells.
- Prevents T-cell signalling (Th1 and Th17 pathways)
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Term
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Definition
Trade Name: Actemra
Type: Humanized Mab
Mechanism of Action: IL-6 receptor antagonist
Indications: Rheumatoid Arthritis
Approval: 2010
other Info:
- IL-6 is essential for regulation of the immune process; however, overproduction of the cytokine leads to inflammation and disease (RA, CD, etc.)
- As a result, the cytokine must be regulated to control both the magnitude and duration of response.
- •Actemra is an IL-6 RECEPTOR blocker. Does not directly block the cytokine IL-6, but competes for binding on IL-6R
- •Administered IV
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Term
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Definition
Trade Name: Orthoclone OKT3
Type: Murine Mab (Anti- CD3 Mab)
Target: T-cell CD3 receptor
Indications: Transplant Rejection
Approved: 1986
Additional Info: |
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Term
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Definition
Trade Name: Zenapax
Type: Humanized Mab (anti-IL 2 rMab)
Target: IL-2 receptor
Indications: Transplant Rejection
Approved: 1997
Additional Info:
•Bind specifically to IL-2 receptor alpha-subunit on surface of activated T-cells.
•Competitively inhibits IL-2 activation of T-cells, a critical pathway in the cellular immune response in transplant rejection.
•Indicated for induction therapy in patients receiving kidney transplants; used in conjunction with cyclosporine and corticosteroids.
•Similar in efficacy and safety
•IV administration
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Term
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Definition
Trade Name: Simulect
Type: Chimeric (anti IL-2 rMab)
Target: IL-2 receptor
Indications: Transplant Rejection
Approved: 1998
Additional Info:
•Bind specifically to IL-2 receptor alpha-subunit on surface of activated T-cells.
•Competitively inhibits IL-2 activation of T-cells, a critical pathway in the cellular immune response in transplant rejection.
•Indicated for induction therapy in patients receiving kidney transplants; used in conjunction with cyclosporine and corticosteroids.
•Similar in efficacy and safety
•IV administration
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Term
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Definition
Trade Name: Synagis
Type: Humanized Mab
Target: epitome of the F protein of RSV (epitome means short arm)
Indications: Respiratory Syncytial Virus (RSV)
Approved: 1998
Additional Info:
- Palivizumab is a IgG1k MAb (humanized) composed of human (95%) and murine (5%) antibody sequences, with a MWT of 148 kDa.
- Directed to an epitope of the F protein of respiratory syncytial virus (RSV).
- Exhibits neutralizing and fusion-inhibitory activity against RSV.
- Indicated for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease.
- Administered Intramuscularly (IM)
- Protects infants for 30 days/dose
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Term
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Definition
Trade Name: Lucentis
Type: Humanized Mab
Target: VEGF (Vascular endothelial growth factor -stimulates growth of new blood vessels)
Indications: Age related Macular Degeneration
Approved: 2006
Additional Info:
- •Intravitreal injection once a month (inject the eye!)
- •Cost about 24k per year
- •Efficacy demonstrated in clinical trials vs. sham or PDT (photodynamic therapy)
- -Unlike bevacizumab, the parent molecule from which it is derived, it is an Ig with a molecular weight of 150 kD, ranibizumab is approximately 33% the weight and size, allowing it to pass through the retina and reach the sub-retinal space where neovascularization occurs.
- A key difference between pegaptanib and ranibizumabis the number of VEGF-A isoforms each can bind and inhibit. With a binding site at the end of a string of 165 amino acids, pegaptanib easily binds VEGF-Aisoform 165, but not the shorter isoforms 110 and 121. With a more proximal binding site, ranibizumabis able to bind and inhibit all three VEGF-A isoforms. (So lucentis has the ability to knock out otherisoforms giving it a better clinical profile)
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Term
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Definition
Trade Name: Tysabri
Type: Humanized Mab
Target: T-cell VLA4 receptor
Indications: Multiple Sclerosis
Approved: 2006
Additional Info:
- is the first alpha-4 antagonist in the new selective adhesion molecule (SAM) inhibitor class. (It blocks T-cells from entering and gaining access to CNS) The drug is designed to inhibit the migration of T-cells into chronically inflamed tissue of the CNS where they may cause or maintain inflammation.
- Natalizumab works by blocking the T-cell surface integrin and preventing immune cells from migrating through blood vessels in the brain to areas of inflammation.
- Indicated for treatment of RRMS (relapsing remitting multiple sclerosis), slow progression of disease and reduce flare-ups associated with MS.
- Also indicated for Crohn’s Disease!! Patients with moderately to severely active CD with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α.
- Interaction between the integrin a4b1 and vascular cell adhesion molecule 1 (VCAM1), which is blocked by natalizumab, is important in the entry of leukocytes, including T cells, into the central nervous system. These cells are thought to contribute to the damage of the myelin sheath and possibly the axon through several complex mechanisms. The damage is specific to a protective barrier around the neurons, it won’t be wide spread
- Natalizumab therapy increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. This is a fatal condition in the brain.
- Was removed from the market because of PML but returned in 2006 with new standards from FDA.
- Because of the risk of PML, TYSABRI® is available only through a special restricted distribution program called the TOUCH™ Prescribing Program. (part of restriction imposed on the drug when it re-entered the market by the FDA)
- Under the TOUCH™ Prescribing Program, only prescribers, infusion centers, and pharmacies associated with infusion centers registered with the program are able to prescribe, distribute, or infuse the product.
- In addition, TYSABRI® must be administered only to patients who are enrolled in and meet all the conditions of the TOUCH™ Prescribing Program
- Cost (12 infusions/year) 30k per year
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Term
Anti-thymocyte Globulin (ATG) |
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Definition
Trade Name: Thymoglobulin
Type: Pab (polyclonal antibody)
Target: Ig mediated T-cell Depletion by an unknown mechanism
Indications: Induction Therapy of Transplant Patients (immediate, profound immunosuppression for approximately 2 weeks post transplant)
Approved: --
Additional Info:
- It is a purified IgG –based polyclonals obtained by immunization of rabbits with human thymocytes.
- This immunosuppressive product contains cytotoxic antibodies directed against antigens expressed on human T-lymphocytes.
- In patients, T-cell depletion is usually observed within a day from initiating Thymoglobulin therapy.
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Term
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Definition
Trade Name: Prednisone
Type: small molecule (corticosteroid)
Target: Suppress release of IL-1 and IL-6 from APC’s
(this prevents Tc-cell activation and APC communication)
[they inhibit NK-beta activation and inflammatory cytokine production]
Indications: Maintenance therapy for transplant patients (reduce the immune system's ability to recognize and reject the foreign organ or tissue, while limiting toxicity. This is a lifelong therapy tailored for each patient)
Approved
Additional Info:
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Term
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Definition
Trade Name: Methyl-Prednisone
Type: small molecule (corticosteroid)
Target: Suppress release of IL-1 and IL-6 from APC’s (this prevents Tc-cell activation and APC communication)
[they inhibit NK-beta activation and inflammatory cytokine production] Indications: Maintenance therapy for transplant patients (reduce the immune system's ability to recognize and reject the foreign organ or tissue, while limiting toxicity. This is a lifelong therapy tailored for each patient)
Approved
Additional Info:
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Term
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Definition
Trade Name: Prograf
Type: Small Molecule (calcineurin inhibitor...cyclosporine is another but it isn't used much at all)
Target: Inhibits calcineurin, Blocks production of IL-2 from T-cells.
Indications: Maintenance Therapy for Transplant patients
Approved
Additional Info:
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Term
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Definition
Trade Name: Rapamune
Type: Small Molecule (mTOR inhibitor)
Target: Inhibits mTOR; Blocks IL-2-driven T-cell proliferation
Indications: Induction Therapy for Transplant Patients
Approved --
Additional Info:
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Term
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Definition
Trade Name: Cellcept
Type: Small Molecule
Target: Blocks purine synthesis and T-cell proliferation
Indications: Maintenance therapy for transplant patients
Approved: --
Additional Info:
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Term
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Definition
Trade Name: Copaxone
Type: It composed of acetate salts (L-glutamic acid, L-glysine, L-tyrosine, L- lysine)
Target:
•GA is believed to activate T-cells, and thesse GA-specific activated T-cells enter CNS and release ANTIINFLAMMATORY cytokines IL-10 and TGF-b (tumor growth factor beta). They are both involved in the production of anti-inflammatory mediators.
•IL-10 is a potent regulatory cytokine in autoimmunity that inhibits Th1 cells and macrophage activation .
•TGF-b- suppresses cytotoxic T cell response, production of TNF as well as other factors that contribute to myelin damage .
•Hence, the ability of GA-specific infiltrating T-cells to express and induce the formation and release of these potent modulating cytokines may contribute to its therapeutic activity
Indications: Treatment of Multiple Sclerosis
Approved
Additional Info:
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Term
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Definition
Trade Name: Proventil, Ventolin, Proair
Type:
- b2-agonists (Short acting)
Target:
- Causes relaxation of the bronchial smooth muscles through stimulation of beta-2-adrenergic receptors.
Indications:
- Bronchodilators (b2-agonists) are the best choice for relieving sudden attacks of asthma and for preventing attacks from being triggered by exercise. THey workTo prevent asthma symptoms while exercising
- As the main treatment for mild intermittent asthma. These medications also are used to relieve sudden asthma symptoms. They do not control the inflammation
Approved: --
Additional Info:
- Acts mainly in lung cells and have little effect on other organs, such as the heart.
- Start acting within minutes, increasing airflow and making it easier to breathe. Good for four to six hours.
- They may be taken orally, inhaled, or injected.
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Term
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Definition
Trade Name: Flovent
Type: long term anti-asthmatic medication
Target:
- Corticosteroids resemble natural body hormones which reduce inflammation in the bronchial tubes. They also decrease the mucus made by the bronchial tubes and make breathing easier. (They are meant to block inflammation. Certain steroids can block events very early in T cell activation on a transcription level.)
Indications:
- When steroids are taken by inhalation for a long period, asthma attacks become less frequent as the airways become less sensitive to allergens
Approved
Additional Info:
- Usually administered by Metered Dose Inhalers (MDI) or Dry Powder Inhalers (DPI). Used in combination with other medications.
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Term
Zafirlukast and Montelukast |
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Definition
Trade Name: Montelukast - Singulair
Type: Leukotriene Modifiers
Target:
- inhibit leukotriene receptors, resulting in the reduction of leukotriene-induced bronchoconstriction.
- They work by counteracting leukotrienes, substances released in the lung that cause the air passages to constrict and promote mucus secretion. Leukotriene pathway modifiers improve lung function and decrease asthma symptoms
Indications: Asthma (work on inflammation side of the disease)
Approved: --
Additional Info: Can be used in combination with steroids
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Term
Salmeterol and Formeterol |
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Definition
Trade Name: --
Type: Both are Long-acting b2-agonists (bronchodilators)
Target: : relax smooth muscle in the bronchial tubes, allowing the tubes to remain open longer and making breathing easier. Prevent the late phase of bronchoconstriction induced by allergen exposure.
Indications: long term treatment of bronchospasm during asthma
Approved: --
Additional Info:
- Long-acting inhaled b2-agonists are indicated for use only by people who are also taking inhaled corticosteroids. They may be used in the following situations:
- To treat moderate persistent and severe persistent asthma
- In combination with an inhaled corticosteroid, because they enhance steroids anti-inflammatory action for controlling asthma and preventing asthma attacks
- These work well to control asthma during exercise and while sleeping
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Term
Cromolyn Sodium or Nedocromil Sodium |
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Definition
Trade Name: --
Type: Mast Cell Stabilizer
Target:
- Target Mast Cells
- These medications can prevent attacks when given before exercise or when exposure to an allergen cannot be avoided. Regular use of cromolyn improves lung function and the ability to exercise. Peak expiratory flow rates are improved, and the need for short-acting b2-agonists is decreased.
Indications: Long term care of asthma
Approved
Additional Info:
- Initially used in children as a long term treatment to prevent asthma attacks.
- These are safe drugs but are expensive, and must be taken regularly even if there are no symptoms!
- These medications have few side effects but many patients complain of the taste. Nausea, vomiting, and diarrhea occur, as seen in other medications, but these symptoms are rare
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Term
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Definition
Trade Name: Xolair
Type: Monoclonal Antibody (Humanized Mab that binds to IgE)
Target: This is an anti-IgE antibody. An antibody that inhibits an antibody. Inhibits the amount of IgE binding to Mast cells, basophils, and eosinophils. It binds to IgE which decreases the cell bound IgE in blood, decreases expression of high affinity receptors, decreases the release of soluble mediators, thus it decreases inflammation and asthma symptoms.
Indications:Moderate/severe allergic asthma whose symptoms not controlled by inhaled steroids. You have to have been on inhaled steroids before you go on this biologic product. It is not used for actute attacks but should be used prophylacticallybecause you can’t wait until T-cells are produced.
Extra Info:
- Not used for acute attacks.
- 150 to 375 mg SC/ every 2 to 4 weeks (Not self-injectable)
- Expensive: $10k to 12k per year
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Term
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Definition
Trade Name: Macugen
Target:anti-VEGF inhibitor approved by the FDA
Indication: the treatment of Wet Age-Related Macular Degeneration. ("wet" means there is abnormal growth or development of vasculature in the eye that causes a degradation of visual acuity )
Additional Info:
- Aptamers are RNA or DNA molecules selected in vitro from vast populations of random sequence that recognize specific ligands. They fold up into unique 3-D structures, allowing them to bind specifically to proteins, like VEGF.
- Binding to VEGF prevents angiogenesis, or stimulation of blood vessel formation and prevention of vascular permeability (leaky vessels), in WET but not DRY macular degeneration.
- A key difference between pegaptanib and ranibizumab is the number of VEGF-A isoforms each can bind and inhibit. With a binding site at the end of a string of 165 amino acids, pegaptanib easily binds VEGF-A isoform 165, but not the shorter isoforms 110 and 121. With a more proximal binding site, ranibizumab is able to bind and inhibit all three VEGF-A isoforms. (So lucentis has the ability to knock out other isoforms giving it a better clinical profile)
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