What does an agent do?

1. treat all parties fair

2. set guidelines for interactions with suppilers

3. No conflicts of interest

4. Code of conduct

- obtain the best value for the organization

including: clinical outcomes, quaility, not necessarily the cheapest and total cost

- establishes guidelines for facility access, how outside vendors interact with staff

- describes process for presenting business opportunities

- potential conflicts of interest (requires disclosed statement)

- describes penalities for violation

- addresses what is acceptable for gifts

-Tier 2 Suppliers: raw products

-Tier 1 Manufacturer: finished product

-Broker

-Distributor

-Hospital

-Inventory

- Internal Distribution System

-Physician

-Nurse

- Patient

- outsourcing

- offshoring

- outsourcing offshore

- Outsourcing is a contract for a specific function of business to an outside firm

- Offshoring is when a US company moves a specific function or component abroad

- May increase prices to poor synergies

- if relationship is terminated it may cost more to bring back home

- different tax structure in other countries

- challenges with other governments

- poor infrastructure

- intellectual property theft

- unstable political climates

- quality problems

China (43%)

India (34%)

- Allows buyers to aggregate purchases to a single vendor rather than hundreds.

-Consolidates and streamlines purchasing process

- reduces the cost of doing business

- reduce the on-hand inventory

- eliminates waste as new technology is brought in

- manages inventory levels

- tracks usage

- generates orders to replenish product

- reduces stock keeping units

- drives better pricing through increased volume and commitment

- Products, equipment, and services

 - determining requirements/specifications

- estimating contract value

- qualification of the vendors.

- Its a product evaluation

- It includes... evaluation criteria, measuring clinical outcome, acceptability vs preference, summary and recommendation

- We look at not only the cost but the total value a product brings as related to quality of outcome and the total cost.

- compared to the current cost

- projected cost over the duration of contract term

- total cost of purchase/ownership: including associated costs and reimbursment, contribution to the bottom line

- labor impact

- Price

- specification

- utilization/volume

- commitment

- market share

- clearly defining requirements that will get the job done

- need vs want

- acceptability vs preference (focus on acceptability)

- fitting the right product with the right need

-The frequency of use, the needed volume.

- It helps to eliminate waste and prevents redundancy

- commitment to purchase: contract term, firm pricing periods

- scope of contract: products, contract prices

- Performance & service levels

What contracts do dealers have?

- they have multiple contracts

- they assign the account to a specific contract pricing

- they report back sales by account to manufacturer

What are 3 strategies drug companies use to improve their drug discovery economics?

1. Improved Research techinques

2. Perform research and development in other countries

3. Leave the risky research to small biotech companies

- combinatorial chemistry

- genomics

- pharmacogenomics

- expansion of drug trial settings

- mergers & acquisitions

- partnering

- The process of machines creating thousands of molecules by mixing & matching chemical building blocks

- A "hit" occurs when a molecule reacts with the disease in the right way.

In combinatorial chemistry, the machines can only work with liquids. What kind of problems does this cause?          

- the solution breaks down the compound

- the compound settles, so the sample drawn is useless.

- also the molecules formed are too large for humans

- The machines lack intellectual creativity and intuition

- failed to create a FDA approved drug through the end of 2002.

What is Lipinski’s rule and why was it developed?

- Lipinski's rule is a list of complex technical traits that make it hard for humans to absorb

- It was developed to optimize results of machine made drugs

- People are surviving longer with serious illnesses and have more need for symptom relief.

- Some problems with this are lack of research staff, structure, bias, and ethics

What might drug companies due to help decrease the rising debt?

Where are there a significant number of patent increases? Which is emerging as a key pharmaceutical market and has increased RD?

- In China, India, and Korea

- China

- invest more in research

- understand and demonstrate the value of their product

- lower the cost of distribution

- provide value-added services to customers

What are the major changes forecasted by PricewaterhouseCoopers?

- Blockbuster sale model will disappear and replaced by integrated packages of medicines and services

- compliance monitoring will become more prevalent

- shift from treatment to prevention

- new technologies will drive R&D

- shift from made to forecast drugs to made to order therapies

- direct to consumer distribution channels will diminish the role of wholesalers

What is pharmacogenomics? Is it financially worthwhile?

- the science of understanding the relationship between an individuals genetic make-up and their response to drug treatment

What are the new FDA rules for drug labels?

- summary of important information at the top

- table of contents section

- new section on how physicians can counsel patients

- prescribing information made more prominent

- inclusion of data that won FDA approval

- Communication with the public: drug safety newsletter, consumer education

- Creation of drug safety over sight board

- Fact sheet and press release

- collaboration on research outside of competition

- the goal is to find genetic predictors of serious but rare diseases.

- the side effects are rare and any one company doesnt have enough cases to determine risk factors

What is GIVE and what is its purpose?

- generic initiative for value and efficiency

- increase the number and variety of products available for patients and providers

How are insurance companies addressing rising health care costs?

- increased cost sharing by the patients: higher deductibles, copays, and premiums

- modified benefit offerings: increased prior authorization for medical procedures and drugs

What is the mission of PhRMA?

What are some challenges for Michigan Medicaid?

- Budget deficits

- enrollement tracks with unemployment rate

- aging MI population- long term care

- increased focus on biologics

- increased pressure from employers for options to cut healthcare costs

List and describe the different types of rebates

Basic Rebate: 15% of the AWP

Price Inflation Rebate: equal to the full amount by which AWP increases

Generic Rebate: flat 11% of the AWP

MI Medicaid Supplemental Rebate 

What are the steps in the medication process?

- Prescribe

- Dispense

- Administer

-Monitor

-Assess

What medical instrument causes the most harm in the health care setting?

How many preventable errors are there in a year? How much do these increase costs?

- 1.5 million adverse drug reactions a year

- 3.5 Billion in extra costs

- Prescribing 56%

- Administration 34%

- Transcription 6%

-Dispensing 4%

1. Incomplete patient information

2. Administration Errors

3. Prescribing Errors: illegible handwriting

4.Lack of communication between caregivers

5. Drug interactions, allergies

Why the disparity in the US health care system?

- fragmented health care system: no sharing of health care information

- most medical information is still paper based

- Technology has focused on billing systems and registration systems

Who/What is influencing the change in automating the medication process?

- Government Incentives

- Leap Frog Group: large corporations

- Joint Commission: national patient safety goals

-HIPAA: standardized data exchange and privacy

- $$$$$: ADE are expensive

What are the Joint Commission’s national patient safety goals?

- increase accuracy of patient identification

- increase communication between caregivers

- increase safety of medication use

What are the barriers to implementation of computerized health care systems?

- high cost in a low margin environment

- Healthcare IT expenditures are only 5% of the yearly budget, and average 20%

- Reluctance to change

- Industry standards are lacking: Barcodes and data interoperability

What are some problems with existing medication process?

- Complete patient information is not available

- orders are incorrect

- Time lag in transmission of orders

- Need to transcribe paper based drug orders

- physicians are often unaware of plan preferences or the costs of what they prescribe

- increased legibility

- standardization

- Drug/drug or drug/allergy checking

- Rules and alerts

When computerized physician ordering systems are used what is the rate decrease in ADEs?

81%

- Physician malpractice insurance agencies are willing to reduce premiums to pay for the system

How can we fix dispensing errors?

- pharmacist verfication

- use of online drug database

- Automation of dispensing process

- Point of Care Solution: Barcodes

- Verification of the 5 rights:

Right patient

right drug

right dose

right route

right time

What are the barriers to barcodes?

- non standard symbology

- expense

- process change

- lack of industry prepared bar coded package

- barcoding small UD packages

What are the benefits of bar coding medication administration?

- improved accuracy and patient safety

- increased documentation efficiency

- increased charge capture accuracy

- enhanced pharmacy nursing communication

What is the benefit of telemedicine?

- exchange health information and provide health care services across geographic barriers

- helpful in a shortage of intensive care specialists

- potential to increase access to larger numbers of patients

What is the assess portion in the medication process?

What are the benefits of E-prescribing?

- reduces medication errors

- avoid the costs of adverse drug events

- savings in prescribing and dispensing time

What is personalized medicine?

- direct relevance of genetics to human disease and drug metabolism

- clinical action will be decided based on phenotypic and genotypic

- the most visited health care facility by patients

-  a lot of patient interaction

- exciting new areas for pharmacists

- career path can go in many directions

- the rising health care costs

- the competition for resources and work load

- hiring the right people

- the evolving role of the community pharmacist

- increased drug promotion: direct to consumer advertising

- New drugs: more new drugs are on the market

-Medicare Part D: increased accessibility to prescription drugs by seniors

-The aging population

- Demand is greater than supply

- demand may increase with more pharmacists going into part time positions

- demand may also increase with the increased availability of professional opportunities for pharmacists outside the traditional setting

- increased drug utilization: eldery 65+ increased use, increased access to prescription drugs

- cost of specialty pharmaceuticals: new biotech drugs

- fragmented healthcare system

- Technological Innovation

- pay and benefits

- management

- working conditions