Cost-Effectiveness of Prescription Drugs, Summaries of Nursing

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Pharmaceutical Development and

Regulation

Pharmaceutical Industry Overview

Importance of Pharmaceuticals

Pharmaceuticals are arguably the most socially important healthcare product. Pharmaceutical development is a high-risk undertaking, in which many promising leads prove disappointing.

Geographical Regions of Pharmaceutical Sales

The U.S., Western Europe, and Japan are the regions with the highest pharmaceutical sales. The U.S. accounts for about 50% of the world's pharmaceutical revenues.

Factors Driving Industry Growth

Population growth and increased life expectancies have fueled recent growth in the pharmaceutical industry. Increased international standardization and regulation have also contributed to industry growth.

Relationship between Pharmaceutical Companies and

Genomic Research

Partnerships between pharmaceutical companies and genomic research companies will prove profitable, as pharmaceutical companies have a strong interest in these collaborations.

Cost-Effectiveness of Prescription Drugs

Prescription drug therapy is generally cost-effective for insurance companies and healthcare providers. The high price of healthcare is not solely explained by the high price of medicines.

Pharmaceutical Marketing Techniques

Direct-to-consumer (DTC) advertising is one of the oldest and least effective pharmaceutical marketing techniques.

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Regionalization of Healthcare Delivery Systems

Differences in prescription reimbursement policies between regions (e.g., California and Florida) are an example of the regionalization of healthcare delivery systems.

Pharmaceutical Sales Team Structure

The Regional Manager is the heart of a pharmaceutical sales team. Most District Managers (DMs) started as representatives. A typical district has 8 to 12 territories.

Effective Market Share Strategies

Comparative selling is the most effective method for grabbing market share, rather than criticizing the competition, using PowerPoint presentations, or questioning doctors' choices.

Pharmaceutical Sales and Distribution

Physician-Pharmacist Interactions

Pharmaceutical representatives mainly visit physicians, not pharmacies. It usually takes more than 1-2 calls to a physician before they commit to prescribing a product. Pharmacists may sometimes dispense a product other than what the physician prescribed.

Payers in the Pharmaceutical Industry

Employers, patients, and physicians are considered 'payers' in the pharmaceutical industry, according to the manual.

Ethical Pharmaceutical Companies

Ethical pharmaceutical companies are those that research and develop novel drugs, rather than those that simply manufacture generics or donate a specified proportion of their revenue.

Pharmaceutical R&D Challenges

One of the most disappointing results of the pharmaceutical industry's continued investment in R&D is the few new drugs being approved and in development.

Advancements in Medical Treatment

Thanks to modern medicines, people newly diagnosed with HIV are expected to live another 20 years.

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The average American lifespan has increased by almost 30 years since

Clinical Trial Terminology

A clinical trial is a group of patients assigned to receive a specified treatment. The main difference between a blinded and double-blinded study is that in a double-blinded study, neither the study staff nor the study participants know which subjects are in the experimental group and which are in the control.

Adverse Drug Reactions

Exhibiting atypical signs or symptoms that were not indicated in the product packaging is an example of an adverse drug reaction.

Pharmacology Fundamentals

Definition of a Drug

In its broadest definition, a drug is any substance that produces a physical or psychological change in the body. The Federal Food, Drug and Cosmetic Act (FFDCA) defines a drug as any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or a substance other than food intended to affect the structure or function of the body.

Vitamins and the Body

Most of the body's required vitamins must be taken in from outside the body.

Pharmacokinetics and ADME Testing

ADME testing measures the rate at which the body absorbs the drug, distributes it to the organs necessary to produce the desired effect, metabolizes it into waste material and then excretes it from the body. ADME testing is primarily used in the field of pharmacokinetics.

Placebos

Placebo effects can lead to withdrawal symptoms. Placebos can be distinguished from drugs because they do not lead to withdrawal symptoms.

Drug Development and Testing

On average, only about 5 of 4,000 drugs studied in the laboratory are eventually studied in people.

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Routes of Drug Administration

Sublingual drugs are absorbed directly and almost immediately into the bloodstream. The three rights of drug administration are the right patient, the right drug, and the right dose.

Pharmacokinetic Factors

Pro-drugs are administered in an inactive form, which is metabolized into an active form. The normal age-related decrease in kidney function can help doctors determine an appropriate dosage based solely on a person's age.

Dosage Forms

Caplets are shaped like capsules and have film coatings to aid in swallowing. The legend "Caution: Federal Law prohibits dispensing without a prescription" is found on the label of all prescription drugs.

Pharmacology Concepts

Acetylation and Drug Metabolism

About 50% of people in the U.S. are 'slow acetylators'.

Drug-Drug Interactions

Duplication can involve two drugs with the same effect intensifying each other's therapeutic effects without any serious side effects. Smoking decreases the effectiveness of some drugs.

Dietary Supplements

Dietary supplements are regulated as foods, and interactions with drugs are a concern.

Drug Resistance and Tolerance

Tolerance refers to a person's diminished response to a drug after repeated use, while resistance applies to microorganisms' or 'cancer' cells' abilities to withstand drug effects.

Adverse Drug Reactions

Between 3% and 7% of hospital admissions in the United States are estimated to be for treatment of adverse drug reactions. There is no universal scale for quantifying the severity of an adverse drug reaction.

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Pharmaceutical Patents and Generics

Companies can be granted patents for the drug itself, the method of delivering and releasing the drug into the bloodstream, and the way the drug is made. Legally, bioequivalence of different versions of a drug can vary by up to 20%.

Biologics

Biologics are also called "large molecule" drugs, are derived from living materials, and can cause immune responses. Vaccines are a type of biologic.

Pharmacodynamics

Agonists are drugs that attract or bind to cell receptors in order to mimic or enhance activities by endogenous chemical messengers.

What is the medical abbreviation for 'as

needed'?

Possible answers:

i. BID ii. PRN iii. PSN iv. QID

The correct answer is ii. PRN , which stands for "pro re nata" meaning "as needed" in Latin.

Which components might cause patients'

different reactions to brand name and generic

drugs?

Possible answers:

i. differences in active ingredients ii. differences in inactive ingredients iii. differences in both active and inactive ingredients iv. Patients' reactions to a brand name and generic drugs are equivalent.

The correct answer is iii. differences in both active and inactive ingredients. Differences in the active and inactive ingredients between brand name and generic drugs can lead to different patient reactions.

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All cells have a nucleus.

Possible answers:

i. TRUE ii. FALSE

The correct answer is i. TRUE. All cells, with the exception of red blood cells, have a nucleus.

Which of the following does NOT affect drug

response?

Possible answers:

i. the patient's genetic makeup, age, body size, and use of other drugs and dietary supplements. ii. the patient's other conditions or diseases. iii. whether or not the patient takes the drug properly iv. All of these factors influence drug response.

The correct answer is iv. All of these factors influence drug response. All of the listed factors can affect a patient's response to a drug.

Drug reactions are predictable because they

do not occur after a person has been

previously exposed to the drug one or more

times without any allergic reactions.

Possible answers:

i. TRUE ii. FALSE

The correct answer is ii. FALSE. Drug reactions are not always predictable, as they can occur even after previous exposure without any allergic reactions.

What is the typical relationship between a

drug's site of administration and site of

action?

Possible answers:

i. They are usually somewhat removed from each other. ii. They are usually the same site. iii. They should not be the same site for economic reasons. iv. They should not be the same site for safety reasons.

The correct answer is i. They are usually somewhat removed from each other. The site of drug administration and the site of action are typically different locations in the body.

Which of the following is the time of peak

plasma concentration on a measuring curve?

Possible answers:

i. an abbreviation for the maximum concentration of white blood cells ii. the time of peak plasma concentration on a measuring curve iii. the time interval within which a given dose of a drug is expected to have a therapeutic effect iv. the peak plasma concentration on a measuring curve

The correct answer is ii. the time of peak plasma concentration on a measuring curve.

Which of the following is NOT a main concept

in clinical pharmacology?

Possible answers:

i. Drug Distribution and Elimination ii. Pharmacodynamics iii. Pharmacokinetics iv. Pharmacoprocesses

The correct answer is iv. Pharmacoprocesses. Pharmacoprocesses is not a main concept in clinical pharmacology.

Which of the following is NOT a route of drug

administration?

Possible answers:

i. buccal ii. Intramuscular iii. sublingual iv. transfugal

The correct answer is iv. transfugal. Transfugal is not a recognized route of drug administration.

What is an example of intravenous drug

delivery?

Possible answers:

i. a subcutaneous insulin injection ii. a transdermal nicotine patch iii. an injection of anesthetic directly into the bloodstream iv. any type of pre- surgery anesthetic

The correct answer is iii. an injection of anesthetic directly into the bloodstream. Intravenous drug delivery involves administering a drug directly into the bloodstream.

What are the major organs of the

gastrointestinal system?

Possible answers:

i. the heart, the blood vessels, and the blood ii. the lymph nodes and lymph vessels iii. the mouth, esophagus, stomach, liver, pancreas, gallbladder, small and large intestines iv. the nasal passages, the trachea, the diaphragm, and the lungs

The correct answer is iii. the mouth, esophagus, stomach, liver, pancreas, gallbladder, small and large intestines. These are the major organs that make up the gastrointestinal system.

Who is normally responsible for selling to

distributors?

Possible answers:

i. Floaters ii. Local Territory Representatives iii. NAMs iv. Pharmacy Benefit Managers

The correct answer is ii. Local Territory Representatives. Local territory representatives are typically responsible for selling directly to distributors.

How often do secondary drug wholesale

distributors buy their drugs directly from

manufactures?

Possible answers:

i. always ii. almost always iii. sometimes iv. never

The correct answer is iii. sometimes. Secondary drug wholesale distributors do not always buy directly from manufacturers.

By FDA law, large chain pharmacies are not

allowed to buy directly from drug

manufactures.

Possible answers:

i. TRUE ii. FALSE

The correct answer is i. TRUE. Large chain pharmacies are prohibited by FDA law from buying directly from drug manufacturers.

Only 3 companies account for nearly 90% of

all drug wholesale sales.

Possible answers:

i. TRUE ii. FALSE

The correct answer is i. TRUE. A small number of companies dominate the drug wholesale distribution market.

What type of sale bypasses the need for

intermediary distributors?

Possible answers:

i. brokerage sales ii. drop shipment sales iii. integrated delivery network sales iv. manufacturer-direct sales

The correct answer is iv. manufacturer-direct sales. Manufacturer-direct sales bypass the need for intermediary distributors.

What is a group purchasing organization

(GPO)?

Possible answers:

i. a company that owns and operates 3 or fewer pharmacies ii. a wholesaler that obtains drugs from manufacturers and delivers them directly to pharmacists' warehouses iii. an entity consisting of two or more hospitals or other health care entities that negotiates contracts on behalf of its members iv. any distributor of a prescription drug that conducts at least 22 transactions every 2 years

The correct answer is iii. an entity consisting of two or more hospitals or other health care entities that negotiates contracts on behalf of its

members. A GPO is an organization that negotiates contracts on behalf of its member healthcare providers.

Prescriptions dispensed by mail-order

pharmacies are, on average, around 3 times

larger than those dispensed by retail

pharmacies.

Possible answers:

i. 3 times smaller ii. just slightly smaller iii. 3 times larger iv. 10 times larger

The correct answer is iii. 3 times larger. Prescriptions from mail-order pharmacies are typically larger on average compared to those from retail pharmacies.

What is another term for rebates?

Possible answers:

i. after-market arrangements ii. in-state arrangements iii. mail-order arrangements iv. sell-side arrangements

The correct answer is i. after-market arrangements. Rebates are also referred to as after-market arrangements.

The PDMA is the Prescription Drug

Manufacturers Association.

Possible answers:

i. TRUE ii. FALSE

The correct answer is ii. FALSE. PDMA stands for Prescription Drug Marketing Act, not the Prescription Drug Manufacturers Association.

A company that owns and operates three or

fewer pharmacies is an.

Possible answers:

i. authorized distributor ii. drug store iii. in-state wholesaler iv. independent

The correct answer is iv. independent. A company that owns and operates three or fewer pharmacies is considered an independent pharmacy.

Which section of a drug's package insert

information covers the usual dosage range?

Possible answers:

i. clinical pharmacology ii. contraindications iii. description iv. and usage

The correct answer is iv. and usage. The dosage and usage information is typically covered in this section of a drug's package insert.

Drug labels must include indications, usage

information, and contraindications.

Possible answers:

i. TRUE ii. FALSE

The correct answer is i. TRUE. Drug labels are required to include indications, usage information, and contraindications.

What should be included in the 'description'

section of a drug's package insert

information?

Possible answers:

i. the drug's proprietary name and the established name ii. the indications iii. the mechanism of action iv. warnings

The correct answer is i. the drug's proprietary name and the established name. The description section typically includes the drug's proprietary and established names.

Exclusivity gives exclusive , is granted by the

FDA, and can run concurrently with a patent

or not.

Possible answers:

i. marketing rights ii. research work iii. trademark assignment iv. values

The correct answer is i. marketing rights. Exclusivity grants the holder exclusive marketing rights for a drug, which is granted by the FDA.

What differentiates exclusivity from a patent?

Possible answers:

i. Exclusivity can be granted at any time during a drug's lifespan. ii. Exclusivity can encompass a wide range of claims, whereas patents do not. iii. Exclusivity is only granted upon the drug's FDA approval. iv. Exclusivity typically lasts longer than patents.

The correct answer is iv. Exclusivity typically lasts longer than patents. Exclusivity and patents have different durations, with exclusivity often lasting longer.

What is required of an invention for it to be

worthy of patent protection?

Possible answers:

i. It must be novel, useful, and not obvious. ii. It must have been on the market for at least 3 months. iii. It must have competitors. iv. all of these

The correct answer is i. It must be novel, useful, and not obvious. These are the key requirements for an invention to be eligible for patent protection.

A generic drug is to the originator brand-

name drug in dosage, strength, safety, and

quality.

Possible answers:

i. bioequivalent ii. biophysical iii. different iv. similar

The correct answer is i. bioequivalent. Generic drugs must be bioequivalent to the brand-name drug in terms of dosage, strength, safety, and quality.

Which of the following is NOT required by the

FDA's Criteria for Equivalency?

Possible answers:

i. The drugs are adequately labeled. ii. The drugs contain identical amounts of the same active ingredients. iii. The drugs contain identical amounts of the same inactive ingredients. iv. The drugs involve the same dosage form and route of administration.

The correct answer is iii. The drugs contain identical amounts of the same inactive ingredients. This is not a requirement for FDA equivalency criteria.

A generic drug is to the originator brand-

name drug in dosage, strength, safety, and

quality.

Possible answers:

i. bioequivalent ii. biophysical iii. different iv. similar

The correct answer is i. bioequivalent. Generic drugs must be bioequivalent to the brand-name drug in terms of dosage, strength, safety, and quality.

What list is generally considered the most

reliable source of information on

therapeutically equivalent drug products?

Possible answers:

i. 'International Council on Harmonization (ICH) Handbook' ii. "Approved Drug Products with Therapeutic Equivalence" iii. The Blue Book iv. The Red Book

The correct answer is ii. "Approved Drug Products with Therapeutic Equivalence" , also known as the Orange Book, which is considered the most reliable source for information on therapeutically equivalent drug products.

Which of the following is an Orange Book

rating?

Possible answers:

i. AA ii. B iii. CZ

The correct answer is i. AA. The Orange Book uses rating codes like AA to indicate therapeutic equivalence.

What is the term for chemical equivalents

which, when administered in the same

amounts, will provide the same biological or

physiological availability as measured by

blood and urine levels?

Possible answers:

i. biological equivalents ii. branded generics iii. therapeutic equivalents

The correct answer is iii. therapeutic equivalents. This term refers to drugs that are chemically equivalent and provide the same biological availability.

What term denotes a drug that is identical or

bioequivalent to the originator brand-name

drug in dosage form, safety, strength, route,

quality, performance, characteristics, and

intended use?

Possible answers:

i. generic ii. OTC iii. therapeutic alternative iv. vector-based

The correct answer is i. generic. This term refers to a drug that is identical or bioequivalent to the brand-name drug.

What term denotes the dispensing of an

unbranded generic product for the product

prescribed?

Possible answers:

i. chemical substitution ii. generic substitution iii. pharmaceutical license iv. Pharmacist's license

The correct answer is ii. generic substitution. This term refers to the dispensing of a generic drug instead of the branded product that was prescribed.

How is a drug sample closet or cabinet like a

grocery store shelf?

Possible answers:

i. Drug sample closets are like grocery store shelves in all these ways. ii. The generic products are usually kept on the top shelf. The more expensive products are always kept on the top shelf. The more visibility you can give your drug, the more likely that it will be prescribed.

The correct answer is i. Drug sample closets are like grocery store shelves in all these ways. The arrangement and visibility of products in a drug sample closet is similar to how products are displayed on grocery store shelves.

Pharmaceutical representatives do not

typically store and secure their own drug

samples.

Possible answers:

i. TRUE ii. FALSE

The correct answer is i. TRUE. Pharmaceutical representatives do not typically store and secure their own drug samples.

Sampling is sometimes the most important

factor in a pharmaceutical rep's success.

Possible answers:

i. TRUE ii. FALSE

The correct answer is i. TRUE. Providing drug samples can be a critical factor in a pharmaceutical representative's success.

The FDA approves storage conditions for drug

products.

Possible answers:

i. TRUE ii. FALSE

The correct answer is i. TRUE. The FDA does approve the storage conditions for drug products.

Pharmaceutical representatives must always

record the amount of drug samples left and

obtain a signature for that amount.

Possible answers:

i. TRUE ii. FALSE

The correct answer is i. TRUE. Pharmaceutical representatives are required to record the amount of drug samples left and obtain a signature.

What is prohibited by Section 503 of the

Federal Food, Drug and Cosmetic Act, as

amended by the Prescription Drug Marketing

Act?

Possible answers:

i. pharmaceutical companies providing research results directly to consumers ii. the purchase of another company's drug research without written permission from the FDA iii. the sale of pharmaceutical products to more than 8 different therapeutic classes iv. the sale, purchase, or trade or offer to sell, purchase, or trade prescription drug samples

The correct answer is iv. the sale, purchase, or trade or offer to sell, purchase, or trade prescription drug samples. This is prohibited by Section 503 of the Act.

The federal government does not regulate the

drug sampling for a pharmaceutical

representative.

Possible answers:

i. FALSE ii. TRUE

The correct answer is ii. TRUE. The federal government does regulate drug sampling for pharmaceutical representatives.

Which of the following is permitted by Section

503 of the Federal Food, Drug and Cosmetic

Act?

Possible answers:

i. hospitals donating their prescription drug coupons to qualified charitable organizationss ii. hospitals donating their prescription drug samples to qualified charitable organizationss iii. hospitals selling their prescription drug samples to qualified charitable organizations at reduced costs iv. none of these

The correct answer is ii. hospitals donating their prescription drug samples to qualified charitable organizationss. This is permitted under Section 503 of the Act.

Which entity issues monographs that define

how drugs should be stored, and what

variance is allowed in their stated contents?

Possible answers:

i. FDA ii. Federal Food, Drug and Cosmetic Act iii. International Council on Harmonization (ICH) iv. United States Pharmacopoeial Convention

The correct answer is iv. United States Pharmacopoeial Convention. This organization issues monographs on drug storage and content requirements.

Storage conditions for drug products are

based on information supplied by the

manufacturer.

Possible answers:

i. TRUE ii. FALSE

The correct answer is i.

The EU Pharmaceutical Industry and

Preclinical Pharmacological Studies

The EU Pharmaceutical Industry

The EU pharmaceutical industry has surpassed the US pharmaceutical industry due to increased price controls in the US. The EU should continue to discourage links between private and public research facilities, as there is poor collaboration between publicly- and privately-funded research centers.

Preclinical Pharmacological Studies

Aim of Preclinical Studies

The aim of preclinical pharmacological studies is to obtain data on the safety and effectiveness of the lead compound.

Toxicity Information

Toxicity information in preclinical studies helps provide confidence about a drug's safety.

Regulation of Pharmacological Studies

Pharmacological studies using animals are regulated under Good Laboratory Practice.

Reasons for Containing Only APIs

Drugs administered to patients only contain active pharmaceutical ingredients (APIs) for reasons of safety and economics.

Drug Permeation

The drug's chemical composition, polarity, and vesicles do not affect a drug's ability to permeate membranes. Lipid-soluble drugs can usually pass through cell membranes, the blood-brain barrier, and the gastrointestinal tract.

Absorption of Weak Acid Drugs

Weak acid drugs are generally absorbed by the stomach more slowly than weak basic drugs.

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Routes of Administration

Intravenous administration, rectal administration, and transdermal administration do not completely bypass the liver. Intravenous drug dosages are easier to control than drugs administered transdermally because the entire dose is available in the bloodstream to be distributed to the target site.

Factors Affecting Drug Distribution

A drug's lipid-solubility, polarity, and the vascular nature of the drug's target tissue affect its distribution to target tissues.

Medical Terminology

"Transdermal" means to apply the drug on the skin surface.

Carcinogenicity Studies

Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug.

Clinical Studies and Statistical Concepts

Ethical Guidelines for Clinical Studies

According to NIH ethical guidelines, the most important criteria in selecting subjects for clinical studies is relative risk.

Institutional Review Board (IRB)

The members of the IRB/IEC do not have to be experts in the topic of the study. The IRB/IEC acts as a third party to oversee the welfare of the trial subjects and has the right to stop a trial or require that procedures and methods be changed.

Blinding in Clinical Trials

All clinical trials are blinded except for Phase I and IV trials, which are often open label, while Phase II and III trials are double-blinded or at least blinded.

Measuring Drug Effects

If it is not possible to measure the direct effects of a drug, surrogate markers such as blood pressure and cholesterol levels are used instead.

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Types of Observational Studies

A case-control study first identifies a group of subjects with a certain disease and a control group without the disease, and then looks to back in time to find exposure to risk factors.

Measures of Central Tendency and Variability

The mean is the sum of all observations divided by the number of observations. The standard deviation and standard error of the mean describe the variability of the population mean.

Validity and Reliability

Validity denotes the extent to which a test actually measures what it is supposed to be measuring. Kaplan-Meier analysis and Cox proportional hazards analysis are methods of survival analysis.

Clinical Paper Sections

The methods section of a clinical paper describes subjects' entry and exclusion criteria.

Clinical Trial Documents

The protocol sets out how a trial is to be conducted, including the study's general design and operating features.

Biologics and Advanced Therapies

Differences between Small and Large Molecule Drugs

Large molecule drugs are mainly protein-based drugs that develop in biological systems such as living cells, while small molecule drugs are synthesized using chemical reactions.

Vaccines

Vaccine development focuses on how to reduce virulence while retaining the ability to produce immunity. Attenuated vaccines have the advantage of not reverting to virulence over inactivated vaccines.

Immune System Components

Antigenic components in vaccines are obtained from or derived from the pathogen.

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Malaria

The estimated annual death toll for malaria is 300,000 to 500,000 people.

Blood Cells

There are more red blood cells than white blood cells for the same volume in the human body.

Insulin Production

Insulin was primarily obtained from recombinant biopharmaceutical processes from the 1930s to the 1980s.

Cytokines and Hormones

Cytokines include interferons, interleukins, and monokines. Hormones include amino acid derivatives, polypeptides, and steroids, but not blood glucose.

Gene Therapy Techniques

In situ gene therapy involves removing patients' genetically faulted tissues, loading them with normal genes in vectors, and returning them to the patients' bodies.

Stem Cells

Multipotent stem cells can develop into a broader range of cell types than pluripotent or totipotent cells. Leukemia is a condition in which the stem cells in the bone marrow malfunction and produce an excessive number of immature white blood cells.

Gene Therapy Vectors

Retroviruses are types of vectors used in gene therapy.

Traditional Vaccine Preparation

Traditional vaccines can be prepared using attenuated, inactivated, or toxoid methods.

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Pharmaceutical Management and Marketing

Drug Utilization Review (DUR) Programs

DUR programs involve retrospective monitoring of physicians' prescribing patterns and are increasingly popular, expected to be used by almost 90% of HMOs in the coming years.

Formularies

A formulary is a list of prescription drugs approved by insurance coverage. Formulary types include closed three-tier, five-tier supplemented by step therapy, and open with few restrictions.

Hatch-Waxman Act

The Hatch-Waxman Act made it easier for generic manufacturers to compete with R&D companies.

Opportunity Cost

Opportunity cost is the value of a sacrificed alternative.

Pharmaceutical Funding

The three primary entities that fund pharmaceuticals are employers, the government (Medicare and Medicaid), and individuals.

Pharmacy and Therapeutics (P&T) Committees

P&T committees typically include a company's medical liaison, attending physicians, and the physician who heads the surgery department.

Managed Care Organizations

Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan.

Pharmaceutical Branding and Marketing

Brand Strategy Development

Ideally, brand strategy development for a new drug should begin during Phase II clinical trials.

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Brand Values

'Expressive' brand values relate to how a brand makes the customer feel, while 'functional' brand values relate to the brand's practical attributes.

Pharmaceutical Branding

Pharmaceutical companies rarely explore, develop, and promote expressive values with which patients might identify. To be competitive, pharmaceutical brands must be distinctive, possessing defining characteristics perceived by customers as unique, attractive, and relevant to their needs.

Regulatory Approval of Brand Names

Pharmaceutical brand names are subject to regulatory approval.

Direct-to-Consumer (DTC) Advertising

DTC advertising has become an essential marketing tactic for both large and small pharmaceutical brands.

Factors Influencing Physicians' Prescribing

Habits

Factors that Influence Physicians' Prescribing Habits

Doctors' personal experiences and their patients' unique situations Direct-to-consumer (DTC) advertising Other types of pharmaceutical marketing

Pharmaceutical Companies' Spending

Pharmaceutical companies spend more on promotional activities than on research and development (R&D).

Pharmaceutical Marketing Strategies

Appropriate Targets for Mass-Market Advertising

A brand that treats a very common chronic condition A very expensive brand

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Diagnostic Testing

Commonly Analyzed Fluids for Medical Diagnostic Tests

Blood Urine Fluid that surrounds the spinal cord

Characteristics of 'Gold Standard' Testing

'Gold standard' testing provides the best understanding of a patient's condition, and cost is not a factor when deciding to run these tests routinely.

Risks Associated with Diagnostic Tests

Every diagnostic test has some risk, which may be the possibility of injury during the test or the need for further testing if the results are abnormal.

Genetic Testing

Urine is not commonly used as the cell material for genetic testing to check for abnormalities of chromosomes, genes (including DNA), or both.

Bone Marrow Aspiration and Biopsy

The bottom bone of the foot is not one of the four common test sites for bone marrow aspiration and biopsy.

Osteoporosis Diagnosis and Monitoring

DEXA is the only method that may be used to make a definitive diagnosis of osteoporosis and to monitor the response to treatment.

Electromyography (EMG)

Electromyography (EMG) uses small needle sensors (electrodes) to record the electrical activity in selected muscles and peripheral nerves during rest.

Wearable and Implantable Test Technologies

Wearable and implantable test technologies currently in development will allow for constant monitoring of body chemistry and collection of previously inaccessible data.

Purposes of Diagnostic Tests

Diagnostic tests are used to detect, confirm, or rule out the presence of a disease or medical condition, and they are performed for a variety of

reasons, such as screening, evaluating the severity of a disorder, and monitoring the response to treatment.

Neurodiagnostic Tests

Neurodiagnostic tests are mostly based on the central nervous system (brain or spinal cord) and can be used to detect signs of nervous system disorders, such as chronic headaches, seizures, and dizziness.

Electroencephalogram (EEG)

The Electroencephalogram (EEG or brain wave test) is a non-invasive procedure used to detect and record brain wave cell activity.

Coronary Angiogram

A coronary angiogram is obtained by injecting an iodine-based dye or other contrast agent into the bloodstream and taking x-rays of the coronary arteries.

Pharmaceutical Marketing Practices

Use of Prescriber Data

Companies use prescriber data to conduct research, identify individual patients who the physician should speak with about the product, and identify patients who can be added to targeted mailing lists.

Acceptable Practices under the PhRMA Code

Modest meals during recreational events at which some educational information is exchanged Modest meals for staff members attending educational events

Unacceptable Practices under the PhRMA Code

Cash for a meal if the food at an educational event has run out, regardless of the source of the cash Gifts that are only given to doctors with high prescribing volumes

Promotional Items under the PhRMA Code

Acceptable promotional items include journal subscriptions, medical textbooks, and patient education items valued under $100, such as an anatomical model.

Sponsorship of Educational Events under the PhRMA Code

The PhRMA Code permits a company to sponsor a lunch at a 3-day conference if part of it includes an educational program for which attendees