1.  Nutrition

2. ADR

3.  MMIC

4.  Infectious disease

1.  Physicians (one-chair)

2.  Pharmacits (one-secretary, usually director of pharmacy)

3.  Nurses

4.  Administration

5.  Quality improvement managers

6.  Others (dietary, respiratory, radiology, lab)--Appointed by medical staff

P&T Specifics:

1.  Who makes up the majority of voting members?

2.  Addresses what (7)

1.  Physicians

2.  Forumlary management; biologics; contrast agents; alternative meds; safety issues; quality improvement; policy and procedures

*Members should always disclose conflicts of interest and interaction with sales reps is governed by policies 

Focus of Committee

1.  According to ASHP

2.  What government body must they comply with

3.  Selection of medications based on (4)

1.  Evaluate, educate, communicate, advise

2.  Joint Commission

3.  Evidence based:  efficacy, multiple indications, strength of study, needs of institution

Safe:  ADRs, Food interactions, Inc safety but more expensive, setting use specifics

Cost-effective

Ethical, legal, improve QOL, meets values of institution

1.  Monitor and trend

2.  Identify areas to improve or eliminate ADR

3.  Educate on reporting

4.  Support Medwatch

1.  Monitoring and trend

2.  Predict and prevent

3.  Educate

4.  Report to ISMP

Continually updated list of medicaitons and related information, representing the clinical judgement of pharmacists, physicians, and other experts in the diagnosis and/or treatment of disease and promotion of health

ASHP

Individual New Drug Reviews

FDA Treatment Potnetial classifications (3)

1.  P - Priority Review

2.  S - Standard Review

3.  O - Orphan Designation

Individual New Drug Review

FDA Chemical Types (8)

1.  New molecular entity

2.  New derivative

3.  New formulation

4.  New combination

5.  Already marketed, new manufacturer

6.  Alread marketed, new drug use

7, Marketed drug w/o approved NDA

8.  OTC Switch

1.  Generic substitution

2.  Therapeutic interchange

3.  Guidelines/Criteria fo ruse

1.  Brand/Generic

2.  FDA approval information

3.  Pharmacology/MOA

4.  Indications (approved and unapproved)

5.  Dosage forms

6.  PK considerations

7.  Special populations

8,  Comparative information to similar agents

9.  Pivotal clinical trials

10.  Safety assessment

11.  Cost evaluation

Formulary Rating

1.  Crteria based (4)

2.  3 nonformulary considerations

1.  Disease process; Age, Physician; Concomitant medicaitons

2.  Special order; use own medications; not available "in-house)

1.  Define therapeutic interchange

2.  3 things to take into account when selecting one

1.  Exchange of medications in same clas or indication

2.  Safety; cost savings; shelf space

1.  Policies

2.  Collaborations with key associates and members

3.  Subcommittees of P&T may be developed to address specific drugs and drug classses

4.  Communication b/t other committees.  

Conflict definition

1.  Traditional are usually?

2.  Less contentious way to define

1.  Negative in nature

2.  An apportunity to understand and respond to the concerns of others

Benefits of conflict

1.  What would be a benefit of disagreements about data or strategies

2.  When could not raising an issue prove dangerous for us as pharmacists

3.  What do managers need to create in their workplace culture?

1.  Can force teams to critically analyze assumptions

2.  Medication safety issues

3.  All members feel free to express their opinions knowing that they will be considered thoughtfully and respectfully

1.  Workloads heavier than normal

2.  New colleages or a new manager

3.  New work or procedures required

4.  Pharmacy understaffed

5.  Noise levels higher than normal

6.  Pts, supervisors, colleagus more demanding than normal

7.  Scheduling disagreement

8.  Inadequate understanding of job dutites

9.  Impression that pharmacist makes money, but technician does the work

10.  After a mediation error has occured.  

1.  Personalities

2.  Communication styles

3.  Decision making preferences

4.  Work approaches 

1.  Individual perceptions:  race, ethnicity, gender, sexuality, impressions of other party

2.  Opinions

3.  LIfe experiences 

1.  "What happened?" conversation

2.  Feelings conversation

3.  Identifity conversation

People usually have default method for responding to conflict

1.  Approach linked to personal level of __ and __

1.  Assertiveness

2.  Cooperativeness

Thomas-Kilmann Conflict Mode Instrument

5 management styles and the result of each

1.  Avoidance:  Lose/Lose

2.  Accommodation:  Lose/Win

3.  Compromise:  Lose/Lose

4.  Competing:  Win/Lose

5.  Collaboration:  Win/Win

*Individuals tend to favor the mode they are most comfortable with

Resolving competing interests can benefit from advanced preparation:

1.  Conflict resoluation pre-work includes (5)

1.  Analyzing your own interest and those of others

2.  Defining your desired outcome

3.  Considering natural points of agreement and intersection b/t your ineterests and others

4.  Listing factors that might derail the conversation and developing strategies to keep on track

5.  Paying attention to timing 

1.  Identify the problem

2.  Identify all possible solutions

3.  Decide which solution is best

4.  Determine how to implement the solution

5.  Assess the outcome of the solution 

1.  Collaborative conflict resolution is difficult b/c it requires (2)

2.  Although not easy, why is collaboraiton preferred

1.  Time and effort from all parties; Sensitivity to the needs and feelings of others

2.  Focuses energy on attacking a problem instead of individuals.  

Group sessions for managing conflict

1.  A ___ facilitator is helpful

2.  The facilitator should remind participants to separate ___ from ___ b/c ___ makes it easier to develop potential options

1.  Neutral

2.  Interests from Positions

Interests 

1.  Ground rules for communication are established

2.  All parties are expected to voice their desired outcomes

3.  All parties are committed to resolving issue under discussion

1.  Spend extra time assessing participant needs/concerns

2.  Restating of the ground rules 

3.  Seek common ground early

4.  Allow various levels of negotiation

5.  Whenever possible, constitute subgroups with members who are not traditionally aligned

6.  Be sensitive to group and individual dynamics (ensure all parties get to express themselves)

7.  Be sensitive to role as facilitator and remain neutral

1.  Establish conflict protocols

2.  Equip employees with tools and confidence to manage conflict

3.  Screen for conflict competence during hiring and promotion

4.  Refuse to hear arguments until parties have exhausted attempts to reach their own consensus

5.  Establish conflict escalation protocol

6.  Make conflict resoluation process transparent

1.  Ask questions rather than express opinions

2.  Ask for advice and concerns before making decisions

3.  Expect staff to express opinions and reward individuals for doing so

4.  Hold meetings in which one person is designated as devil's advocate

5.  Ask staff to provide list of pros and cons for various options

6.  Be open to feedback

1.  Discuss each others persepectives

2.  Acknowledge how you might have contributed to conflict

3.  Let people talk

4.  Consider interest rather than position

5.  Collect data to understand prospective

6.  Establish objective standards for making decisions

7.  Partner in problem solving

1.  What happened from your perspective

2.  May I share how I see things?

1.  I'm interested in your view of what happened.

2.  Tell me more about that

Let's work together to propse some potential solutions

Why don't we make a list of possible options and then rewivew the pros and cons of each

Florence Nightingale

1.  War surved in

2.  First real example of a __ nurse

3.  Established what

4.  Separated ___ from ___

5.  Established what 2 levels of nursing

6.  Her nursing text was titled

1.  Crimea

2.  Trained

3.  Nursing curriculum

4.  Education from service

5.  Staff and Administrators

6.  Notes on Nursing

Civil War Nursing

1.  WHere did nurses come from and what did this lead to the recognition of need of

2.  First 4 schools of nursing in what US cities

.  1.  Volunteer citizens which indicated need for trained nurses

2.  Boston; New Haven; New York; Philadelphia

Early Nursing Education

1.  Began where?

2.  Standardized curriculum?

3.  Role of students

4.  Location of first professional (BSN) program

1.  Hospitals

2.  No

3.  Cheap labor

4.  University of Minnesota

Nursing Milestones Early 1900s

1.  1900

2.  1903

3.  1911

4.  1912

1.  Am Journal of Nursing

2.  First state requirement for licensure (NC)

3.  Am Nurses Assn (ANA)

4.  Naiotnal League of Nursing Education (NLN)

1918 Army School of Nursing

Nurses drafted

WWII Nursing

1.   What act created US Cadet Nurse Corp

2.  What rank did nurses have

3.  Desegregation?

1.  Bolton Act

2.  Nurses commissioned as officers

3.  Yes

1.  Cap

2.  Pinning

3.  Uniforms

Nursing Diploma Program

1.  Length

2.  Affiliated with?

3.  Where do grads work

3.  Growing or shrinking

1.  2-3 yrs

2.  Hospital

3.  Hospital or Inpt facility

4.  Shrinking

Associate Degree Nursing (ADN)

1.  Length

2.  Location

3.  Popular with what students

4.  Focus

5.  Where grads work

1.  2 yrs

2.  Community colleges

3.  Older students

4.  Technical skill/pt care

5.  Hospitals or other "structured" nursing facilities

BSN

1.  Length

2.  Base of curriculum compaed with diploma and ADN

3.  Entry point for

4.  Required for (2)

1.  4 yrs

2.  Broader

3.  Professional nursing practice

4.  School nursing; Admission to graduate programs

1.  Health Science Core

2.  Science and Math

3.  Psychology

4.  Liberal Learning Outcome (Comm, Ethics, Math, Creativity)

5.  Nursing Science

1.  High School Graduate

2  Graduate from accredited school of nursing (Diploma, ADN, BSN)

3.  Pass NCLEX

Licensure Continued

1.  Conferred by who?

2.  Must be licenced in

3.  How often does WV license have to be renewed?

1.  State

2.  State of practice, although some states have compact whereby your license is good in multiple states

3.  Annual

1.  Member of healthcare team

2.  Provide patient care

3.  Provide patient educaiton

4.  Manage patient care

5.  Patient advocate

1.  Board that regulates nursing in WV

2.  What 2 aspects does it regulate?

1.  WV Board of Examiners for Registered Professional Nurses

2.  Nursing education programs

Nursing Practice (Licensure)

1.  Advanced Pracice Nursing (APRN with MSN or higher)

2.  Doctorate Nurse Practice (DNP)

3.  Doctor of Philosophy (PhD)

APRN

Define

1.  Nurse Practitioner (NP):  Prescriptive authroity

2.  Clinical Nurse Specialist (CNS):  Consultation, research, educaiton, administration

3.  Certified Nurse Midwife (CNM):  well-woman OBGYN and low risk

4.  Certified Registered Nurse Anethetiss (CRNA):  Oldest; adminsiter anesthetics under variety of settings

Certification of Advanced Practice Nurses

1.  Does it add to legal scope?

DNP

1.  What occurs in 2015

2.  Define what DNP allows nurses to do

1.  Qualification for ARNP will mandate DNP

2.  Impact practice at the highest level, through practice expertise and the use of evidence to lead organizational and policy change

**Prepares nurse for 1 of 4 ARNP roles

1.  Clear link b/t higher levels of nursing eduaiton and positive pt outcomes

2.  REcognition of overall increase in complexity of pt care today

3.  Critical need for increased quality and pt safety

4.  Need to increase doctoral educaiton, clincially prepared nursing faculty

1.  Organizational and Systems Leadership

2.  Clinical Scholarship

3.  Analytical Methods for Evidence Based Practice

4.  Information/Systems Technology

5.  Healthcare policy/advocacy

Ph.D. Nursing

1.  Why?

Prescriptive Authority for APRN

1.  Do all states allow some form?

2.  IN WV what 4 branches must they be licenced under

3.  Other requirements beyond certification

1.  Yes (may be independent, collaborative, suprvised)

2.  CRNA, CNM, Clinical Nurse Specialist; CNP

3.  Pharmacology undergrade and at least 45 hrs of grad level pharm; documentation of use of pharamcology in clinical practice; evidence of 15 advanced pharm hrs within 2 yrs prior to application for authrity; collaborative practice with UNENCUMBERED MD

Prescriptive Authority APRN

1.  WV prescribing schedules

2.  Must file ___ Registrations with BOE

3.  What certification must be maintained

4.  # of hrs of approved pharm education prior to renewal

1.  C III-V

2.  DEA b/c the board maintains DEA #s

3.  Active, uninterrupted national certification

4.  8 hrs of approved BOE coursework

1.  C I/II

2.  Antineoplastics

3.  Radio-pharamceuticals

4.  General anesthetics

5.  MAO inhibitors (unless colab with psychiatrist)

6.  CIII Limited to 72 hr w/o refill

Prescriptive Exclusions APRN Con't

1.  C IV/V rules

2.  Phenothiazine limited to

3.  Non-controlled antipsychotics and sedative limited to

1.  Up to 90 day supply w/ 1 refill...script expires in 6 months with following exeptions:

2.  30 days non-refillable

3.  90 days...no more than 1 refill and shall expire in 6 months

Information Required on Prescription Form (7)

1.  Name, address, phone # of prescribing nurse

2.  Name, DOB, address of pt

3.  Date of script

4.  Full name of drug, dose, route, directions

5.  Number of refills

6.  DEA when required

7.  Prescriptive authority number issued by BOE

1.  Formulary development and management

2.  Pharmacy networks

3.  Generic substitution

4.  Rebates and discounts

5.  Clinical and trend management programs

6.  Electronic claims processing 

1.  Employers/other 3rd party payers pay insurers who pay PBMs

2.  Employers/other part payers pay PBMs directly

3.  Pts pay insurers who pay PBMs

1.  Federal government

2.  State and local government

3.  Employwers

4.  Unions

5.  HMOs

6.  Insurance companies (BCBS)

7.  Other 3rd party plan administrators

1.  2 top PBMs

2.  3 other PBMs

1.  Medco/Express Scripts (60% all mail order); CVS/Caremark

2.  Wellpoint pharmacy

PharmaCare

MedImpact

Ideal situation is provide access to needed medications while controlling costs

Reality:  controlling short term costs rather than long-term total healthcare costs

1.  Increased drug utilization:  Moral hazard (insurance induced demand); DTC advertising; Marketing to health care practitioners; New therapies

2.  Increased drug prices:  Older, less expensive drugs replaced by newer more expensive drugs

1.  Control utilization:  pt cost-sharing (copay); Pt and health professional educaiton; formularies and other restrictions/incentives

2.  Control prices:  manufacturer prices (rebates); pharmacy reimbursement

1.  Formulaires

2.  Disease management programs

3.  Three-tier copayments

4.  Mail order

Formularies (Express Scripts)

1.  Therapeutic Assessment Committee (TAC)

2.  Value Assessment Committee (VAC)

1.  Composed of clinical pharmacists and medical director and examines clinical evidence for recommendations

2.  Assesses cost-benefit of optional drugs and makes formulary recommendation

Disease/Case Mangement Programs

1.  Goal

2.  Who is often primary service provider for this type of program?

1.  To manage high risk patient populations to reduce costs b/c 1-5% of sickest chronic pts can generate 25-50% of costs

2.  Nurses:  encourage educaiton and compliance

Tiered Copayments

1.  What are the usual tiers (4)

2.  3 things it accomplishes

1.  Generic; Preferred brand; Non-preferred brand; Specialty

2.  Steers pts toward preferred drugs increasing rebates

Makes pts share cost of more expensive drugs

Gives pts access to drugs not on preferred list

Mail Order

1.  Reimbursement rates compared with community pharmacies

2.  2 employer options

3.  Does it decrease costs when PBMS own their own mail order pharmacy?

4.  3 challenges for community pharmacy

1.  Lower

2.  Mandatory or optional (usually incentivized)

3.  Yes

4.  TAkes away business; hard to screen for DDIs if pt gets part from mail and part from community; community pharmacies may be asked to counsel for mail medications

1.  Define pricing "spread"

2.  Findings of JAPhA Study

1.  The difference b/t what the PBM pays the pharamcy for the drug ingredient cost portion of a prescription and what the PBM charges the employer for the drug ingredient cost of the same prescription

2.  Mean price spread was $12.29 but wasw even higher for generic drugs than brand name drugs

1.  Improper therapeutic substitution

2.  Improper disclosure/sharing of manufacturer rebates

3.  Improper payments to plans to persuade them to switch PBMs

4.  Antistrust violoations (common amongst pharmacists)

5.  Defrauding of pts

1.  According toe GAO, do PBMs reduce drug cost?

2.  What was the primary source of revenue for PBMS when they came on the market?

3.  What is it now (4)?

1.  Yes

2.  Revenue from administrative fees (ie, fee for each script processed)

3.  Mix of admin fees, rebates/other payments from manufacturers, "spread" differences, feeds for other services (disease management)

1.  Full disclosure of rebates obtained from pharmaceutical manufacturers...some models even require that rebates be passed along to the plans

2.  Elimination of the "spread"

1.  Define PBM rebates

2.  Paid to who?

3.  2 effects

1.  Money from pharmaeeutical manufacturers to PBMs in exchange for formulary/PDL inclusion...volume discount

2.  Federal and State Programs

3.  Reduces plan costs; Lowers copays for members

1.  Pharmacy has a valuable product, but most savings come from?

2.  What can ensure that medications are used correctly and that patients actually get better?

1.  Effective medicaiton use

2.  Patient counseling

1.  What is one of pharmacies largest investments?

2.  Purchasing is what

1.  Inventory

2.  An asset management process that merits focused attention and forethought

1.  75% of overall pharmacy business expenses may be accounted for by what?

2.  What does this practically mean given a constant sales level?

1.  Cost of goods sold (COGS)

2.  Profits can potentially incrase or decrease by 15% for every 1% change in COGS

1.  Right products

2.  Right quantity

3.  Right time

4.  Right price

5.  Right vendor

1.  Personal observations

2.  Scanning media and press

3.  Knowledge of prescribing habits of local physicians

4.  Product movement reports, statements from insurance claims, DURs

5.  Your expectations or those of your organization

6.  Organizational factors such as preferred practice, mission, space restricitons, and budget

1.  Procurement costs

2.  Storage, maintenance, delivery

3.  Third-party patyments

Right Quantity

1.  Want to avoid?

2.  Define:  Stock depth

3.  Equation for stock depth

1.  "Out of stock" incidents...but also don't want too much which could go bad

2.  The quantity at which you may be reasonably certain the item will be available when needed...AKA:  Reorder point

3.  = (review time + lead time) x avg demand + safety stock

Right Time to Order

1.  Variables to consider

2.  What does having safety stock increase?

3.  INventory carrying/holding cost includes what 3 things?

4.  Define Just in time purchasing

1.  All factors in stock depth formulation and inventory investment

2.  Carrying costs assocaited with inventory

3.  Capital costs; Storage costs; Cost of risk

4.  As the last unit of an item sells, the next unit arrives before it is needed

Right Price

1.  4 components

1.  Product purchase price

2.  COGS

3.  Carrying Cost

4.  Procurement costs (personnel time)

Procurement Costs

1.  What can lower this?

2.  4 tools to minimize

1.  More efficient purchasing

2.  Quantity discount

Cash discount

Product bundling

Minimum purchasing 

Reduction in price for prompt payment

Right Vendor

1.  2 major types of vendors

2.  Things to consider when choosing a vendor (7)

1.  Full-service wholesalers

Buying groups that are cooperative organizations used by smaller organizations to increase buying power by combining orders

2.  Delivery schedule; Frequency of out-of-stock situations; breadth of merchandise lines and assortments; assistance with product placement and floor layout; Available technology and other services; Returned goods policies; financing and credit terms and options

Economic Order Quantity (EOQ)

1.  Define

2.  Equation

1.  Ideal time for purchases occurs at point where total costs are minimized because procurement and carrying costs are equal and this is referred to as EOC

2.  = SQRT (2DP/CI)

D = demand in units; P = procurement cost $; C = unit cost to business $; I = inventory carrying cost (% of investment in inventory, may be estimated to include capital costs, storage, insurance, taxes, other risks)

1.  Submit order

2.  Reconcile what is payed for and what is recieved

3.  Inspect products for damage and short expiration dates

4.  Products should be stocked properly

5.  Rotate inventory

Visual Inventory Control Method

1.  Define process

2.  Good and bad about it

1.  Visually observing number of units in inventory and comparing them with a prescribed list of how many units should be carried (stock depth)...ordering more when below desired number

2.  Good is that it is informal, convenient, and inexpensive

Bad:  Lesss effective with greater error potential

Periodic Inventory Control Method

1.  DEfine

2.  Good and Bad

1.  Stock counts at intervals defined by policy, and compares the number on hand to predefined minimums (determined stock depth)

2.  Good:  Allows for some basic analysis

Bad:  May require more time than visual method; measures only a single time point...not continuous

Perpetual Inventory Control Method

1.  Define

2.  Good and Bad

1.  Monitor inventory constantly using technology

2.  Good:  can generate a report at any moment; provides most accurate and comprehensive picture of both units and actual financial investment in inventory

Bad:  None listed

Inventory Turnover Rate (ITOR)

1.  Definition

2.  Calculation

1.  The rate at which supply of an item is exhausted and replaced

2.  ITOR = COGS/Average Inventory

Average Inventory = (beginning inventory + ending enventory) / 2

1.  Reduced investment in inventory, freeing cash for other services/activities

2.  Increased retun on inventory investment

3.  Possible out-of-stock situations (if ITOR is too high)

Variabiliyt in inventory

1.  Define Pareto's law in pharmacy context

Managing Returns

1.  Usual grace period from wholesalers

2.  Source of information for returned goods policies

1.  48 hrs

2.  Red Book

Unclaimed Prescriptions

1.  Define

2.  Can cause higher what

1.  Any prescription "that has been presented in a pharmacy...for which a patient does not wait or return to pick up the prescription, arrange to have it picked up for him/her, or have it delivered"

2.  Inventory/associated costs

Monitoring Shrinkage

1.  What counts don't match that might be result of shrinkage

2.  Define shrinkage

1.  Shelf count and record count

2.  When items are lost, stolen, or misplaced...potential cause for inventory cost as a percentage of sales to increase...can be interanal or external theft

1.  Background checks

2.  Clear employee purchases through register by manager or another worker

3.  Cosigning purchases for another employee

4.  Package inspections

5.  Stricktly controlled access to inventory storage areas

6.  Provide personal storage (eg lockers) areas for employees

1.  Pharmacy layout plan

2.  Adequate lighting

3.  Security cameras/mirrors

4.  Avoid obstructive fixtures/displays

5.  Place cash register/sales clerk near front door

6.  Pay attention

1.  Bar coding

2.  Point-of-sale scanners (utilized as perpetual inventory monitor)

3.  RFID

4.  Online applicaitons

5.  Inventory management software

Shortages

1.  Causes (6)

2.  What is key in managing them

1.  Raw materials, delayed production, company mergers, recalls, market shifts, incrased demand

2.  Communication

1.  Merchanidising is?

2.  Define Planogram

1.  Visual selling

2.  Merchandising blueprint that designates stock levels, product positions, and number of product facings

1.  Shelf space and shelf facing have prime tenants

2.  Positioning a product next to a leading seller in a product category increases it sales

3.  Best shelf position is b/t waist and eye level

4.  Most eyes (and sales) anchor to the right

5.  Shelf sign in front of a product increases sales

6.  Clustering simialr producs enhances visibility and eases selection

1.  Increased # of Rx's

2.  Price increase

3.  Shift to higher cost drugs 

1.  Neurology, mental health, pain

2.  Endocrine and diabetes

3.  Cardiovascular

4.  Oncology

5.  Musculokeletal and rheumatology

6.  Respiratory

7.  Anti-infective

1.  Advocates for pharmaceutical industry insist costs justified for what 3 reasons

2.  How much does it cost to bring to market?

1.  R&D; Tremendous value medicataions; High risk of industry

2.  $802 million

Samples

Sales rep contact

DTCA

Journal Ads

1.  Presentabilty/appearance

2.  Outgoing personality

3.  Excellent interpersonal skills

4.  Education and certificataion

Representative Taloring approach..what do do with the following clinican types

1.  Friendly

2.  Skeptical

3.  High prescriber

4.  Prefers competing product

5.  Refuses to see rep

1.  Frame interactions as gesture of friendship

2.  Use literature, humility, and appeal to their "high intellect"

3.  Make best effort to establish personal connection, best gifts

4.  Find out why, try to capture a niche

5.  Try to work through staff to get useful informaiton

1.  Acknowledgement of relative status (valueable time)

2.  Find out what is know

3.  Drop some knowledge on them

4.  Provider resistance

5.  Reinforce role (compliments/sympathy)

6.  Closure:  ensure opportunity for return, gifts, obligation

1.  Sell product

2.  Inform and educate professionals

3.  Gather information:  use of product within organization; use of competitors products by organization; local treatment policies

1.  Appeal to authority

2.  Bandwagon effect

3.  Appeal to pity

4.  Red herring appeal

Sold to industry for decades so they can link prescripting data with physician identifiers (16% of AMA revenue)

Physicians can "opt-out" of this if they choose, but few know that they can do so...also must be renewed every 3 yrs and manufaturers have 90 days to comply after the person opts out

Off-label or Extralabel: estimated hospital pts on at least 1 off-label drug

1.  Can reps pitch them

Topomax

1.  __ out of 10 scripts not for epiliepsy

1.  No up-to-date S/E or clinical research on products

2.  Potential for sever negative S/E

3.  Heightens chance for future physician malpractice suit from pt

4.  Off labe means it is not FDA approved

1.  Influsence prescribint habits/get pts on meds

2.  Representative access

1.  Source of meds for indigent

2.  Reduced pt cost

3.  Provided can test efficacy and tolerability before committing to long-term use

4.  Prescribed can gain experience with product

5.  Can start thearpy immediately

1.  Loss of pharmacist review

2.  Clinician unfamiliarity increases chance of med errors

3.  Labeling/documentation often lacking

4.  Storage concerns

5.  Estmated that only 1/2 reach pt

6.  Ethical concerns with personal use

7.  Only branded expensive drugs are sampled increasing overall cose of healthcare

*82% of sample users had health insurance the entire year!!!

1.  Percieved influence of reps you compared with other physicians

2.  What size gift needs to be given to influence behavior?

1.  You think you aren't, but other sare

2.  Any size gift imposses a sense of indebtedness and obligation to reciprocate

**Most physicians believe they are not influenced by rep visits...but they are!

1.  Takes samples out of practice

2.  Permits better ADE screening

3.  Allow for better pt instructions