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Pharmacy Administration 2
Pharm Ad Test 2 Material
212
Pharmacology
Professional
03/09/2010

Additional Pharmacology Flashcards

 


 

Cards

Term
Hospitals after the Civil War
Definition

  1. Hospitals were no longer places to go and die.
  2. New technologies were introduced.
  3. Aseptic and antiseptic techniques were introduced. Hygiene improved tremendously.
  4.  Surgical procedures advanced
  5.  Nursing grew

Term
5 Historical Phases in the development of Hospitals
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

Term
PHASE 1: Early Hospitals TIME FRAME: Pre 1870
Definition
  •    Early in the nineteenth century, most Americans saw the hospital as a place that protected the rest of the community from the sick.  (Quarantine)
  •  In the 1800s and before, people saw the hospital as a place where people went to die.  
  •   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
Term

PHASE 2:  First period of rapid growth

TIME FRAME:   1870 - 1910

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.

Term

PHASE 3:  Period of Consolidation     

TIME FRAME:   1910 - 1945

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.
Term
Flexner's Recommendations
Definition

  1. Reducing the number of medical schools from 155 to 31 university schools committed to medical research and academic excellence.
  2. Medical school admission requirements should include at least two   years of college with preparation in biology, chemistry, and physics.
  3. Medical schools should obtain strong financial support for modern labs and hospital facilities.
  4. Medical schools should emphasize the scientific method and time in the laboratory and clinic.
  5. Original research should be a core activity of medical schools.
  6. Medical schools should have a large staff of full time professors in clinical and scientific departments

Term

PHASE 4: Second period of rapid growth        

TIME FRAME:   1945 - 1980

Definition
There was a tremendous increase in hospital:
1. services, 
2. costs, 
3. technology
  • There was a modest expansion in the number of hospitals. 
  • The Hospital Survey and Construction Act of 1946 (Hill-Burton Act)
  • The increased breadth and intensity of hospital care was also fueled by:
  • The rapid growth of insurance to pay for care.
  • The rapid growth of Medicare and Medicaid to pay for care.

 

Term
The Hospital Survey and Construction Act of 1946 (the Hill-Burton Act)
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.

Term

PHASE 5: The current period of consolidation

TIME FRAME:   1980 - Present

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

Term
Horizontal integration
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

Term
Vertical integration
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.

Term
Managed care organizations cost containment mechanisms
Definition

1. Prior approvals for drugs

2. Second opinions from physicians

3. Contracting with hospitals that charge lower prices for their services

Term
Charges
Definition

Prices for services that are set by the hospital: 

1. Room and board

2. Services provided (ex. meals)

3. Medicines

Term
Cost
Definition
The price that is negotiated between the hospital and third-party payers
Term
Retrospective payment
Definition
Reimbursement on the basis of cost or charges
Term
Prosepective Payment System of 1983
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.
Term
Diagnosis Related Groups (DRGs)
Definition

 This is a system to classify hospital cases into one of almost 750 different groups Based on:

 

  1.  Clinical diagnosis
  2. Whether it’s a surgical procedure
  3. Age
  4. Sex
  5. Presence of complications
  6. Other clinical information

·      examples include:

 

  •           Pneumonia, Heart failure, C-section, Hip/knee replacement

     

Term
DRG weight
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.
Term
How much does a hospital get reimbursed for a patient’s stay when he or she is admitted under a particular DRG?
Definition

TOTAL REIMBURSEMENT = DRG WEIGHT x REIMBURSEMENT AMOUNT

Term
The Reimbursement Amount is affected By:
Definition

  1. Location of the hospital (rural or urban)
  2. Teaching status (Teaching gets more than non-teaching)
  3. Amount of care provided to low-income patients

Term
Exclusions from DRG system
Definition

  1. Rehabilitation facilities         
  2. Psychiatric facilities
  3. Children’s hospitals 
  4. Cancer hospitals
  5. Long-term care facilities/hospitals
  6. Rehabilitation and psychiatric units in the hospitals   
  7. Home-health agencies
  8. Hospices
  9. Hospital-outpatient facilities
  10. Skilled nursing facilities

Term

Balanced Budget Act (BBA) of 1997

established prospective payment for: 

Definition

 

  1. Long-term care facilities/hospitals
  2. Rehabilitation and psychiatric units in the hospitals   
  3. Home health agencies         
  4. Hospices                
  5. Hospital outpatient facilities 
  6. Skilled nursing facilities       

 

 

  • Separate prospective care is used for reimbursing care at each of these facilities.

 

Term
The Balanced Budget Act of 1997
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. 

  •   In response to backlash
  • The Balanced Budget Refinement Act in 1999 restored $8.4 billion to Medicare reimbursements.
  • The Benefits and Improvement Protection Act (BIPA) in 2000 restored another $11.5 billion in Medicare reimbursements.
Term

Differences between the Retrospective Payment System (charges and costs) and the Prospective Payment System

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.

Term

Impact of the Prospective Payment System

Definition
  1. Decreases in the number of inpatient admissions and length of stay.
  2. Increases in post-hospital use of services (nursing home care, home health care etc)
  3. Unbundling of services
  4. DRG code Creep
  5. Dumping
Term
Fraud
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
Term
Unbundling
Definition
To separate out services included in the DRG and have them done somewhere else in your healthcare system.
Term
DRG Code Creep
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.
Term
Dumping
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.
Term

Short-term HOSPITALS and long-term hospitals

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

Term

General hospitals and specialty hospitals

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.

Term

Public hospitals and private hospitals

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.

Term
Not-for-profit hospitals and for-profit (investor-owned) hospitals
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.

Term

Community hospitals and non-community hospitals

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

Term
Teaching hospitals and non-teaching hospitals
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.

Term

Independent and multi-hospital system

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. 

Term
Statistics and Trends about Hospital in last Decade
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.
Term
Hospitals have a governing body that can be one of two types
Definition

  1. Board of directors --> in “for profit” hospital
  2. Board of trustees --> in a “non profit” hospital

Term
Purposes of the board of directors/board of trustees
Definition


  1. To establish the mission and goals of the hospital.
  2. They are going to develop hospital policies.

Term

The board of directors/board of trustees has primary authority and control of the hospital and delegates duties to two other groups

Definition

  1. Hospital Administration or Management Team
  2.   Medical Stall or Professional Staff Organization

Term

 

Hospital Administration or Management Team

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

Term

 

Medical Staff or Professional Staff Organization

Definition

Has its own organizational chart and bylaws of operation. 

 

Divided by specialty.  Some specialties may include:

  1.             Internal medicine
  2.             Surgery
  3.             Pediatrics
  4.             Obstetrics/gynecology
  5.             Psychiatry
  6.             Pathology
  7.             Radiology
  8.             Anesthesiology

Term

There are three ways a physician can work for a hospital:

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.

Term
Joint Commission
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

Term
Joint Commission also accredits:
Definition

  1. Ambulatory Care Centers
  2.  Behavioral Health Care Facilities
  3. Critical Access Hospitals
  4. Home Health Care Organizations
  5.  Laboratory Services
  6. Long Term Care Facilities
  7. Office Based Surgery Facilities

Term
Section 1 Accreditation Standards
Definition

covers patient, client or resident-focused functions that relate directly to the provision of care, treatment and services: 

 

  1.  Ethics, rights and responsibilities
  2. Provision of care, treatment and services
  3. Medication Management
  4. Surveillance, prevention and control of infection

Term
Section 2 accreditation standards
Definition

contains organization functions that are vital to the organization’s ability to provide high-quality care, treatment, and services:

  1.       Improving organization performance
  2.       Leadership (they evaluate the leaders)
  3.       Management of the environment of care
  4.       Management of Human Resources
  5.       Management of Information (monitor HIPAA)
  6.       Medical staff and nursing services

Term
The importance of the Joint Commissio accreditation being voluntary.
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.

Term
Pharmacy Director
Definition

  1. Oversees personnel and human resources issues (hiring, firing, performance appraisal)
  2. Manages the hospital’s drug budget
  3. Set quality standards for the department
  4. Evaluate policies and procedures
  5. Implementing new programs
  6. Ensures compliance with Joint Commission, department of public health, and board of pharmacy

Term
Pharmacists
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

Term

Staff and Other Support Personnel

Definition

1. Technicians

2. Interns

3. Stock Technicians

4. Administrative assistants

5. Purchasers

Term

The drug distribution responsibilities of the hospital pharmacy

Definition

  1. Floor-stock distribution – older method
  2.   Unit-dose distribution – the current accepted method

Term
Floor-Stock Distribution
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.

Term
Unit-Dose Distribution
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

Term

Non-distributive responsibilities of the hospital pharmacy

Definition
  1. Drug Therapy Monitoring
  2. In-Service Education
  3. Drug Information Services
  4. Specialized Clinical Pharmacy Services
  5. Adverse Drug Reaction Monitoring
  6. Medication Utilization Evaluations
  7. Formulary Development
  8. Therapeutic Substitution
  9. Purchasing and Inventory
Term
Therapeutic Substitution
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.
Term
Pharmacy and Therapeutics (P&T) Committee
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.
Term

 

Multidisciplinary Care

 

Definition

Many different professionals, somewhat independent of each other, working for the good of the patient. (not really working together though) 

Term
Interdisciplinary Care
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] 

Term
MD
Definition
medical doctor
Term
DO
Definition
Doctor of osteopathy
Term
OD
Definition
Doctor of Optometry
Term
DC
Definition
Doctor of Chiropractic
Term
DPM
Definition
Doctor of Podiatric Care
Term
DDS
Definition
Doctor of Dental Surgery
Term
DMD
Definition
Doctor of Dental Medicine
Term
Physicians – MD or DO
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)!!!

Term
Optometrist - OD
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

Term
Chiropractors - DC
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

Term

Podiatrists - DPM

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

Term
Dentists – DDS or DMD
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)

Term
Nurses – LPN, LVN
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

Term
Nurses – RN
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)

Term
Social Workers
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

 

Term
Medical and Public Health social workers
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)

 

Term
Mental Health and Substance Abuse Social Workers
Definition
assess and treat individuals with mental illness or substance abuse problems
Term

Psychologists

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

Term
Dietitians/Nutritionists
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

Term
Occupational Therapist
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

Term
Physical Therapist
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

Term
Recreational Therapists
Definition

Provide treatment services and recreation activities to individuals with disabilities or illness
Education – bachelor’s degree
23,300 in 2008

Term
Respiratory Therapist
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

 

Term
Six forces to examine the competitive intensity
Definition

  1. Threat of New Entrants
  2. Rivalry Among Existing Firms
  3. Threat of Substituted Products
  4. Bargaining Power of Buyers
  5. Relative Power of Stakeholders
  6. Bargaining Power of Suppliers

Term
Threat of New Entrants
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) 

 

Term
Rivalry among existing firms
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

 

Term
Threat of Substitute Products
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) 

 

Term
Bargaining Power of Buyers
Definition

 

  1. Customer Consolidation
  2. Managed Care and third party payers

 

Term
Relative Power of Stakeholders (Government)
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

 

Term
Bargaining Power of Suppliers
Definition
Not as significant in Pharmaceutical industry
Term
Current Issues Facing the Pharmaceutical Industry
Definition

 

*Reimportation of drugs from Canada, Mexico and other countries
*Lack of new compounds by big pharma
*Biosimilars
*Healthcare reform

 

Term
Healthcare Reform Summary
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

 

Term
Moral hazard of health insurance
Definition

 

  • This is the effect of Health insurance increasing utilization.
  • 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. 
  • 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

 

Term
Managed Care
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) 

Term

 

1999-2003 Growth Factor of National Health Expenditures 

 

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) 

 

Term

 

2004 – 2007 Growth Factors in Health Expenditures 

 

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

 

Term

 

2008 Growth Factors in National Health Expenditures

 

Definition
The economy sucks! Thats why it dropped! 
Term

 

2009-2019 Growth Factors of National Health Expenditures

 

Definition

There is growth because:

 

  • Baby boomers will start getting Medicare coverage

    Baby boomers (a large cohort of people) will have more sicknesses and ailments that will make the period interesting.

    Technological innovations will also contribute to cost growth

 

Term
Gross Domestic Product
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

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?

 

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

 

Term
Why was there a sudden increase in National Growth in Retail Prescription Drug Spending in 2006??
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

 

Term
What is QUALITY? 
Definition

it means the reduction of preventable errors and reduced variability in evidence-based best practices

Term
Paradoxes of the U.S. Healthcare System
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.

Term
MHSS Organization
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. 

Term
Dr. Benjamin Rush
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
Term
Dorthea Dix
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. 

Term
Mental Health Act of 1946
Definition
Created the NIMH
Term

Mental Health Study Act of 1955

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*

Term
Community Mental Health Center Act of 1963
Definition

  • Funded construction and staffing of community mental health centers (CMHC) (no longer has to be State Hospitals (whitfield) or large facilities) 

Term
Medicaid/ Medicare in 1965
Definition
Provided financial resources so that institutions could be depopulated and transferred to other LTC facilities or care
Term
ECA
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. 
Term
NCS
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. 

Term

The four sectors of the Mental Health System

Definition

  1. Specialty Mental Health Sector
  2. The general medical/ primary care sector
  3. The Human Services Sector
  4. The Voluntary Support Services Sector

Term
Specialty Mental Health Sector
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

Term
The general/ primary care sector
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

Term
The Human Services Sector
Definition

  •  
    • The human services sector consists of social welfare, criminal justice, educational, religious, and charitable services. 

Term
The Voluntary Network Sector
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. 

Term
Public Sector
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)   

Term
Private Sector
Definition

  • refers both to services directly operated by private agencies
  • Financed through private agencies (employer-based-insurance) 

Term
Financing the MHSS
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 

Term
Impact of Managed Care
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). 

Term
Important Factors in Mental Health Service Delivery
Definition

1. Mental Health Parity Act
2. Mental Health Parity and Addiction Equity Act

3. Stigma
4. Prevention
5. Entry into treatment 

Term
Mental Health Parity Act (MHPA) 
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.

  1.  

                                                               i.      For example, in 1975, MS’s annual cap on mental health expenditures was $1,000.

Term
Mental Health Parity and Addiction Equity Act
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.  

Term
Role Of Pharmacist in Mental Health Services
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. 

Term
What is Hospice Care? 
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

Term
Hospice Philosophy
Definition

  1. Dying is a natural part of the life cycle
  2. Belief that we each have the right to die pain-free and with dignity. 
  3. Practitioners seek not to hasten nor postpone death but instead provide comfort and supportive care while the patient's illness runs its course. 
  4. Emphasis is not on death and dying but on living each day until the death comes
  5. Not only the patient receives care but the family does as well. 

Term

Role of Hospice Programs

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. 

Term
Palliative Care (definition by WHO)
Definition

  The active total care of patients whose disease is not responsive to curative treatment.

Term
Palliative Care (Oxford Textbook) 
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. 

Term
Interdisciplinary Approach to Hospice Care
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: 

  1. Medical Director
  2. Attending/ Primary Physician 
  3. Nursing Care
  4. Home Health Aides
  5. Social Services
  6. Chaplains or other counselors
  7. Volunteers
  8. Bereavement Care 
  9. Pharmacists 

Term
Medical Director
Definition

Duties:

  1. Refer and recruit patient admissions
  2. Educate on hospice and EOL care to medical community
  3. Coordinates care with attending physicians
  4. Leads interdisciplinary team
  5. Admissions, certifications, re-certifications,
  6. 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. 

Term
Attending/ Primary Physician
Definition

This is the patient’s designated physician for medical care

Duties:

  1. Certifies patient’s prognosis
  2. Continues ongoing medical care/consultation for patient’s disease state and symptoms after hospice admission
  3. Signs death certificate 

Term
Nursing Care
Definition

Clinical Coordinators, Admission nurses, Case Managers (RN), LPN ,Triage Team


Duties:

  1. Provide medical care to a patient two-three times/week
  2. Assess and monitor patient’s condition
  3. Consult with MD on patient’s plan of care
  4. Coordinate medication use/education
  5. Coordinate other necessary supportive care (DME, medical supplies, etc.

Term
Home Health Aides 
Definition

Duties: Assist patients with transfers, bathing, eating, etc. Provide support to family/caregivers to address their needs 

Term
Social Services
Definition

Duties: Counseling and supportive services Assist in preparation of end of life (i.e. legal issues, vacations, funeral arrangements, etc.) 

Term
Chaplains and Counselors
Definition

Duties: Life review/counseling Prayers and spiritual services for any religion 

Term
Volunteers
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. 

Term
Bereavement Care
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.) 

Term
Pharmacists Role in Hospice
Definition

  1. Assessing the appropriateness of medication orders and ensuring the timely provision of effective medications for symptom control.
  2. Counseling and education the hospice team about medication therapy
  3. Ensuring that patients and caregivers understand and follow the directions provided with medications.
  4. Providing efficient mechanisms for extemporaneous compounding of nonstandard dosage forms.
  5. Addressing financial concerns (we can get meds generic and can work with social workers and manufacturers)
  6. Ensuring safe and legal disposal of all medications after death.
  7. Establishing and maintaining effective communication with regulatory and licensing agencies

Term
Dame Cicely Saunders
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 

Term
Medicare Hospice Benefit
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

Term
Services Covered under the MHB
Definition

                    Physician

                    Nursing Care

                    Home health aide

                    Chaplain

                    Social Work

                    Bereavement

                    Medical equipment and supplies

                    Medications

                    Volunteer

                    • PT, OT, ST, and/or dietary counseling 

Term
Services NOT covered by MHB
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 

Term
Eligibility for MHB
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. 

Term
Payment for MHB
Definition

 


  1. Admission certification
  2. Re-Certification
    1. Two 90-day periods followed by unlimited 60-day periods. (Its open ended if you don’t die within your 6 months)
    2. 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. 

 

Term
Barriers to Hospice Care
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

Term
Ambulatory Care 
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. 

Term
Reasons for an Increase in Ambulatory Care Visits.
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

Term
Goal of Ambulatory Care
Definition

Increases in ambulatory care = decreases in health care costs 

Term
Factors affecting Utilization of Ambulatory care
Definition

  1. Access
  2. 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) 

Term
Health Disparities 
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.) 

Term
Types of Care 
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

Term
Primary Care
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). 

Term
Who Provides Primary Care? 
Definition

  1.      Physicians (general, family, pediatrics, etc.)
  2.          Nurse Practitioners (NP)
  3.        Physician assistants (PA)

Term
Primary Care Settings 
Definition

 

 

  •     Private practice

 

¡  Usually multiple physicians, and not just one person at a clinic (dominant form of primary care.

 

  •     Managed 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 

 

Term
Preventive Care
Definition

A form of primary care

  1. Health promotion (providing resources and get word out about things from flu shots, etc)
  2. 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. 

Term
Coordination of Needed Services 
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. 

 

Term
Telemedicine 
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. 

Term
Trends in Health care affecting Ambulatory Services
Definition

  1. 1.    Attention to improving health care for Americans living with chronic diseases
  2. 2.    Continuing emphasis on medication safety
  3. 3.    Greater emphasis on emergency preparedness and bioterrorism

Term
Role of Pharmacist in an Ambulatory Care Setting
Definition

  1. Patient Education
  2. Pharmacotherapeutic interventions
  3. Medication Management
  4. Screening and early detection
  5. Health promotion and disease prevention

Term
Pharmacotherapeutic Interventions Regarding Ambulatory Care
Definition

 

  • Identify and prevent drug related problems 
  • Establish Treatment goals and outcomes
  • Make a pharmacy care plan
    • Initiate
    • Modify
    • Discontinue
    • Monitor Drug therapy

 

Term
Medication Therapy Management Services 
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

Term
Pharmacists involvement in preventive care services
Definition

  1. Screening and Early detection
  2. Health Promotion and Health Disease Prevention

Term
Complementary and Alternative Medicine
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.

Term
Value and Results of Pharmacists work in Ambulatory Care
Definition

  1. Decrease in Hospital rates
  2. Decrease in Drug Rates
  3. Increase in quality of care
  •  
    • Increased adherence
    • Increased outcome of treatment
    • Fewer Adverse Drug Events 

Term
Delta Health Alliance 
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. 

Term
Major reasons that have been cited for slow development of clinical pharmacy services 
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

Term
Opportunities of Pharmacist Involvement in Ambulatory Care
Definition

 

 

  1. Help with patient satisfaction
  2. Impact on long term outcomes
  3. Quality of Care
  4. Disease Management Protocols with Doctors
  5. Involvement on multidisciplinary teams
  6. Certifications
  7. MTMS
  8. Mississippi-based Health Initiatives
  9. Community pharmacy residency

 

 

Term
Challenges of Pharmacists Involvement in Ambulatory Care
Definition

 

 

  1. Dynamics in the Health care team
    • Stepping on someones shoes
  2. The publics perception of pharmacy
    • Cognitive services not top of mind
  3. How will the know of your services?
    • Marketing!
    • Make your scope of practice known to patents

 

 

Term
Hematopoietic Growth Factors
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

Term
Epoetin alpha 
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. 
Term
Darbepoetin alpha
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. 
Term

Methoxy-PEG-epoetin-beta

(PEG=polyethylene glycol) 

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 
Term
Hematide 
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

 

Term
Filgrastim
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

 

Term
Pegfilgrastim
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

 

Term
Sargramostim
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. 

 

Term
Plerixafor
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.

  •  

    Term
    Infliximab
    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

    Term
    Anakinra
    Definition

    Trade Name: Kineret

    Type: recombinant IL-1 protein

    Mechanism of Action: IL-1 receptor antagonist

    Indications: Rheumatoid arthritis 

    Approval: 2001

     

    Term
    Adalimumab
    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

     

     

    Term
    Efalizumab
    Definition

    Trade Name: Raptiva

    Type: ---

    Mechanism of Action: ----

    Indications: WITHDRAWN FROM MARKET

    Approval: 2003

     

    Term
    Etanercept
    Definition

    Trade Name: Enbrel

    Type: Infusion Protein

    Mechanism of Action: TNF-alpha blocker

    Indications: Rheumatoid Arthritis; Plaque Psoriasis; Psoriatic Arthritis; Ankylosing SpondlyitisJuvenile 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. 

     

    Term
    Alefacept
    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 

    Term
    Abatacept
    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.

     

    Term
    Certrolizumab pegol
    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!)
    • Administered SC (monthly dosing after initial therapy)

    Term
    Golimumab
    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

    Term
    Ustekinumab 
    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)

    Term
    Tocilizumab
    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

    Term
    Muromonab-CD3
    Definition

    Trade Name: Orthoclone OKT3

    Type: Murine Mab (Anti- CD3 Mab) 

    Target: T-cell CD3 receptor

    Indications: Transplant Rejection

    Approved: 1986

    Additional Info: 

    Term
    Daclizumab
    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

     

    Term
    Basiliximab
    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
    Term
    Palivizumab
    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

     

     

    Term
    Ranibizumab
    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)
    Term
    Natalizumab
    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

     

    Term
    Anti-thymocyte Globulin (ATG) 
    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.

     

    Term
    Prednisone
    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: 

     

    Term
    Methylprednisone
    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: 


     

    Term
    Tacrolimus
    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: 

     

    Term
    Sirolimus
    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: 

     

    Term
    Microphenolate Mofetil 
    Definition

    Trade Name: Cellcept

    Type: Small Molecule

    Target: Blocks purine synthesis and T-cell proliferation

    Indications: Maintenance therapy for transplant patients 

    Approved: -- 

    Additional Info: 

     

    Term
    Glatiramer Acetate
    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: 

     

    Term
    Albuterol
    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.

     

     

    Term
    Fluticasone
    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.

     

     

    Term
    Zafirlukast and Montelukast
    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 

     

    Term
    Salmeterol and Formeterol
    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

     

     

    Term
    Cromolyn Sodium or Nedocromil Sodium
    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

     

     

    Term
    Omalizumab
    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

     

    Term
    Pegaptanib Sodium
    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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