Transcript Technology & Automation in Pharmacy Practice PHCL 311

Pharmaceutical Industry
Part I & II
PHCL 311
Hadeel Al-Kofide M.Sc
Topics to be covered today..
• Introduction
• Jobs opportunities in pharmaceutical industry
• History
• Definitions
• Types of interactions with industry profession
• Guidance to interactions with industry professions
• Other careers in pharmaceutical industry
• Market Leaders in Pharmaceutical Industry
• Deciding if pharmaceutical industry is suitable for you
Why Study Pharmaceutical Industry
“We are all members of the pharmaceutical industry – we either
prescribe drugs, or take them ourselves. We need to learn to
work together.”
Introduction
• The pharmaceutical industry develops, produces, & markets
medicinal drugs
• Pharmaceutical companies can deal in generic &/or brand
medications
• They are subject to a variety of laws & regulations regarding
the patenting, testing & marketing of drugs
Jobs Opportunities in Pharmaceutical
Industry
It includes many job opportunities of pharmacists:
• Drug discovery
• Sales
• Manufacturing
• Regulatory
• Marketing
• Project management
• Medical information
• Health outcomes research
• Product development
• Legal
• Quality assurance
• Information technology
• Training & development
• Scientific communications
Jobs Opportunities in Pharmaceutical
Industry
History
• The earliest drugstores date back to the Middle Ages
• The first known drugstore was opened by Arabian pharmacists
in Baghdad in & many more soon began operating throughout
the medieval Islamic world & eventually medieval Europe
• By the 19th century, many of the drug stores in Europe &
North America had eventually developed into larger
pharmaceutical companies
History
• Most of today's major pharmaceutical companies were
founded in the late 19th & early 20th centuries
• Key discoveries of the 1920s & 1930s, such as insulin &
penicillin, became mass-manufactured & distributed
• Switzerland, Germany & Italy had particularly strong
industries, with the UK, US, Belgium & the Netherlands
following suit
Definitions
• Clinical research professionals • PhRAM
• Drug safety professionals
• Pharmaceutical company
• Medical or drug information
• Pharmaceutical products
specialists
• Pharmaceutical sales
representative (PSRs)
• Detailing
• Drug discovery
• Drug development
• Pharmacovigilence
Definitions
Clinical Research Professionals
• Responsible for the oversight of clinical trials
• Include clinical research monitors & administrators
• These two could be separated so the research monitors visit the
site to complete data verification, & administrators will act as
the link external to internal team members
Definitions
Drug Safety Professionals
• Monitor serious adverse events & respond to Medwatch
• Responsible for global safety surveillance
• Also responsible for post-marketing surveillance
Definitions
Medical or Drug Information Specialists
• Will address specific questions by patients & health care
professionals that require review of data on file or address
topics not directly related to the marketing mission
Definitions
Pharmaceutical Sales Representative (PSRs)
• Have the primary responsibility of reaching out to providers &
prescribers within a defined area
• These professionals deliver the marketing message for
pharmaceutical products based on training received by the
pharmaceutical manufacturer
Definitions
PhRMA
• Pharmaceutical Research & Manufacturers of America
• Non-profit association that represents leading research based
pharmaceutical & biotechnology companies
Definitions
Pharmaceutical Company
• Manufacturer or sponsor
• The company who develops, manufacturers & supplies
medication for patients
Definitions
Pharmaceutical Products
• Drug therapies developed by pharmaceutical companies
• Also called pharmaceuticals
Definitions
Detailing
• Occurs when a PSR meets with a health care practitioner to
deliver their marketing message & provide product details
Definitions
Medical Liaisons (MLs)
• A healthcare consulting professional who is employed by
pharmaceutical, biotechnology, medical device, & managed
care companies
• The ML is a person who can communicate high scientific
concepts, yet balance clinical objectives with business
opportunities
• Have the responsibility to build relationship with key health
practitioners (i.e. leaders)
Definitions
Drug Discovery
• The process by which potential drugs are discovered
• In the past most drugs have been discovered by isolating the
active ingredient from traditional remedies
• Modern technology focus on understanding metabolic
pathways related to disease state or pathogen, & manipulating
these pathways using molecular biology or biochemistry
• A great deal of early-stage drug discovery has traditionally
been carried out by universities & research institutions
Definitions
Drug Development
• Refers to activities undertaken after a compound is identified
as a potential drug in order to establish its suitability as a
medication
• Objectives of drug development are to determine appropriate
formulation & dosing, as well as to establish safety
• Research in these areas generally includes a combination of in
vitro studies, in vivo studies, & clinical trials
Definitions
Pharmacovigilence
• Also called safety surveillance
• The monitoring of adverse events for a pharmaceutical product
Types of Interactions With Industry
Professionals
Types of Interactions With Industry
Professionals
• Each of the roles described previously in pharmaceutical
industry serve two function:
Business
operations
Product
development
Pharmaceutical
Industry
Types of Interactions With Industry
Professionals
• Interactions between industry professions & other part of the
medical field usually is related to the business part of the
industry
Focusing on Pharmaceutical care
representatives
Types of Interactions With Industry
Professionals
• PSR & health care practitioners
• PSR & pharmacy/therapeutic committee
Interactions
PSR & Health Care Professionals
• Goal of PSR: marketing & sale of pharmaceuticals to legal
prescribers
• PSR will need to interact with professionals in regular basis so
they must convey information in appropriate manner so
basic communication skills are essential
• Other essential skills companies look for when employing a
PSR
Interactions
PSR & Health Care Professionals
• Other essential skills companies look for when employing a
PSR:
 Patience
 Diligence
 Ability to understand basic medical & pharmaceutical
terminology
 Organization skills
 Acceptable appearance
 Ability to accept criticism & deal with it appropriately
Interactions
PSR & Health Care Professionals
• During interaction with professionals the PSR offer the latest
marketing information about their products
• Product information is usually distributed in the form of:
 Brochures
 Medical literature reprints
 Multimedia presentations
Interactions
PSR & Health Care Professionals
• The health professional expect certain information from the
PSR about a certain pharmaceutical product which include:
 Indication
 Therapeutic benefits
 Safety data
 Comparative data with new or old drugs
 Price
Interactions
PSR & Health Care Professionals
• A study was conducted to determine if the physician received
these information, the results showed that most of sale
representatives focused on indication & giving less
information in regard to drug safety, comparable efficacy &
cost
• Pharmacists working in the hospital can help physicians in
providing additional information in case PSR did not cover all
the aspects
Interactions
PSR & Health Care Professionals
• PSR may also distribute drug samples
• Drug sample: a package containing a limited quantity of
pharmaceutical product sufficient to evaluate clinical response,
distributed to authorized health care practitioners free of
charge & for patients for treatment
Interactions
PSR & Health Care Professionals
• Positives & negatives of drug samples:
Positives
Negatives
Treatment option for some
patient
Poor drug control including
incorrect labeling & packaging
Opportunity to experience a
new product for a physician
Access to prescription drugs by
inappropriate personnel
Convenience
Encouragement of poor
prescription practices
Interactions
PSR & Pharmacy/Therapeutic Committee
• Sale representatives may be asked to provide information upon
request to address specific concerns of the P&T committee
• Formulary adoption of a particular drug is extremely valuable
to the PSR
Interactions
Medical Liaisons & Thought Leaders
• MLs deliver medical education message as opposed to
marketing message
• MLs share scientific information about drug products with
PSR & instruct them on key points
• They may give presentation to practitioners
• MLs have extensive medical background allowing them to
have more information about a product
Interactions
Pharmaceutical Marketing & Patients
• Companies tend to use DTC (Direct To Consumer)
advertisements
• This makes patient demand the new medication, leading to
increase profit
• Pharmacists specially community pharmacists can help
educate the patient if he has any question regarding a drug he
saw in an advertisement
Guidance Interactions With Industry
Professionals
Guidance Interactions With Industry
Professionals
• Institutional policies & procedures
• PhRMA code
• Food & drug administration (FDA)
• Others
Guidance on Interactions
Institutional Policies & Procedures
• Health institutes generally have policies & procedures related
to the activities of PSR within their facility
• ASHP published a guideline for pharmacists for the activity of
PSR
• Each hospital can have its own policy & procedure
Guidance on Interactions
PhRMA
• In 2002 the PhRMA adopted a code for pharmaceutical
manufacturers as related to marketing interactions with health
care professionals, & specifically the gifts & gratuities given
to health care professionals
• The Code attempts to ensure that all interactions focused on
informing healthcare professionals about products, providing
scientific & educational information, & supporting medical
research & education
Guidance on Interactions
PhRMA
• Key points of PhRMA code:
Category
Guidance
General
interactions
The interactions should focus on providing medical
educational information
Entertainment
Should not be included in interactions, except if there is a
venue related to proving scientific information
Continuing
education
Sponsors can provide support for conferences but not
individual participants. Sponsors should not be involved
specifically with the content
Gifts
Gifts with personal benefit only are not allowed. Items for
health care of patients are allowed if less than 100 $. Example
of allowed gifts include office pens, notepads & anatomical
models
Guidance on Interactions
FDA
• In addition to its expected role in drug development the FDA
regulate direct to consumer advertising
• They mandate that these advertisements portray a fair balance
for medications this include the major risk of the product
Other Career Areas in Pharmaceutical
Industry
Other Career Areas in Pharmaceutical
Industry
• Clinical research administrators
• Clinical or product development professional
• Drug discovery professionals
• Health outcome professionals
• Project management
• Quality assurance professional
• Regulatory professional
• Scientific communications professionals
Drug Discovery Professionals
• Professionals who are involved in early stages of molecular
& chemical identification
• They usually require more specific skills in areas including but
not limited to:
 Organic & medicinal chemistry
 Pharmacology
 Pharmaceutics
 Pharmacogenomics…
Health Outcome Professionals
• They are professionals who utilize pharmacoeconomic
backgrounds to create models & studies to investigate the
benefits of a given pharmaceutical product
• May be involved in:
 Phase IV post-marketing studies
 Discuss economic considerations at their institute
 Or utilize this information when making formulary
decisions
Quality Assurance Professional
• They are different than quality control professionals
(quality control professionals test chemical products &
evaluate manufacturing processes)
• Quality assurance professionals work with:
 Clinical development
 Training & development
 Regulatory components of the company
To assure that
business
operations
function at an
acceptable level of
quality
Regulatory Professionals
• Interact with regulatory agencies throughout the world
• Unlike legal department, regulatory professionals are more
likely to have science & medical backgrounds
• They must have an understating of the medical environment &
how a product might position it self in the market
• They must be able to communicate scientific & medical
information to regulators to support positive product approval
Summary
•
Pharmaceutical industry carries different career pathways for
pharmacists & open new work ideas
•
The relationship between the industry & healthcare
professionals is mostly done through marketing or advertising
agents
•
This relationship has its own guidance & protocol to prevent
bias
Thank you