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This comprehensive overview covers the cost-effectiveness of prescription drug therapy for insurance companies and healthcare providers. It explores the pharmaceutical industry, including drug development, administration, interactions, regulations, patents, generics, pharmacology, drug wholesaler practices, institutional pharmacy purchasing, pharmaceutical R&D costs, new drug timelines, drug composition, therapy benefits, utilization review, formularies, brand strategy, promotion, and pharmacogenomics.
Typology: Summaries
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Pharmaceuticals are arguably the most socially important healthcare product. Pharmaceutical development is a big-risk undertaking, in which many promising leads prove disappointing.
The regions with the highest pharmaceutical sales are the U.S., Western Europe, and Japan. The U.S. accounts for about 50% of the world's pharmaceutical revenues.
Population growth and increased life expectancies have fueled recent growth in the pharmaceutical industry.
According to the manual, partnerships between pharmaceutical companies and genomic companies will not prove immediately profitable.
Prescription drug therapy is cost-effective for insurance companies and healthcare providers. The high price of healthcare is not explained by the high price of medicines.
Direct-to-consumer (DTC) advertising is one of the oldest and most effective pharmaceutical marketing techniques.
The number of districts in a region is influenced by the region's population.
An example of the regionalization of healthcare delivery systems is the different prescription reimbursement policies in California and Florida.
The regional manager is not the heart of pharmaceutical sales. Most district managers (DMs) did start as representatives. A typical district has 8 to 12 territories.
Comparative selling is the most effective method for grabbing market share. Pharmaceutical representatives do not mainly visit pharmacies. It usually takes more than 1-2 calls to a physician before they commit to prescribing a product.
The pharmacist may dispense a product other than what the physician prescribed.
Employers are considered 'payers' according to Chapter 12 of the manual.
According to the manual, researching and developing novel drugs defines 'ethical pharmaceutical companies'.
The continued investment in R&D by the pharmaceutical industry has not resulted in a disappointing number of new drugs being approved and in development.
Thanks to modern medicines, people newly diagnosed with HIV are expected to live another 50 years. The average American lifespan has increased by almost 30 years since
Clinical Trials and Drug Development
A treatment group is a group of patients assigned to receive a specified treatment.
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.
'Asymptomatic' means not exhibiting signs or symptoms.
Physiology denotes the study of bodily functions (as opposed to structures).
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.
Most of the body's required vitamins must be taken in from outside the body.
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.
Placebo effects can lead to withdrawal symptoms.
On average, only about 5 out of 4,000 drugs studied in the laboratory are eventually studied in people.
Sublingual drugs are absorbed directly and almost immediately into the bloodstream.
Three of the seven rights of drug administration are the right patient, right drug, and right dose.
Pro-drugs are administered in an inactive form, which is metabolized into an active form.
The kidney of an 85-year-old person excretes drugs only around 50% as efficiently as that of a 35-year-old person. The normal age-related decrease in kidney function can help doctors determine an appropriate dosage based solely on a person's age.
Caplets are shaped like capsules and have film coatings to aid in swallowing, differentiating them from tablets.
The legend 'Caution: federal law prohibits dispensing without a prescription' is found on the label of all prescription drugs.
Drugs that are metabolized by N-acetyl transferase tend to reach higher blood levels and remain in the body longer for slow acetylators. About 50% of the people in the U.S. are 'slow acetylators'.
Drug-drug interactions are not always harmful. Smoking decreases the effectiveness of some drugs.
Interactions with drugs are a concern for dietary supplements, despite them not being classified as drugs.
The 'magic bullet' concept, as phrased by Ehrlich, does not exist. An ideal drug would be aimed precisely at a disease site and would not harm healthy tissues.
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.
Between 3% and 7% of hospital admissions in the United States are estimated to be for the treatment of adverse drug reactions. There is no universal scale for quantifying the severity of an adverse drug reaction. Noncompliance is a serious public health concern because it increases the cost of medical care.
Pharmaceutical Regulations and Patents
Companies can be granted patents for drugs, manufacturing processes, and new uses of existing drugs. Drugs' trade names are often unrelated to their intended use.
Generic drugs are usually equivalent in quality to the brand-name drugs for which they are marketed as equivalents. Generic drugs account for about 20% of the total pharmaceutical market. Biologics do not cause immune responses, which is an incorrect statement. 'Large molecule' products are developed and manufactured through biological processes, not chemical processes.
Agonists are drugs that attract or bind to cell receptors in order to mimic or enhance activities by endogenous chemical messengers.
The mechanism of action denotes how an active pharmaceutical ingredient (API) works in the body. Binders cement the active and inert components together to maintain cohesive portions.
'BID' denotes twice a day. 'PRN' denotes 'as needed'.
Differences in inactive ingredients can cause patients' different reactions to brand-name and generic drugs.
Not all cells have a nucleus. The patient's genetic makeup, age, body size, use of other drugs and dietary supplements, other conditions or diseases, and whether the patient takes the drug properly can all affect drug response. Drug reactions are not predictable because they can occur after a person has been previously exposed to the drug one or more times without any allergic reactions.
The typical relationship between a drug's site of administration and site of action is that they are usually somewhat removed from each other. Cmax refers to the peak plasma concentration on a measuring curve. Pharmacoprocesses is not a main concept in clinical pharmacology.
'Transfugal' is not a route of drug administration. Intradermal drugs are delivered by injection under the skin. An example of intravenous drug delivery is an injection of anesthetic directly into the bloodstream. The major organs of the gastrointestinal system are the mouth, esophagus, stomach, liver, pancreas, gallbladder, small intestine, and large intestine.
Pharmaceutical Distribution and Pricing
National account managers (NAMs) are normally responsible for selling to distributors.
Secondary drug wholesale distributors sometimes buy their drugs directly from manufacturers. Large chain pharmacies are allowed to buy directly from drug manufacturers by FDA law. Three companies account for nearly 90% of all drug wholesale sales. Manufacturer-direct sales bypass the need for intermediary distributors. A group purchasing organization (GPO) is an entity consisting of two or more hospitals or other healthcare entities that negotiates contracts on behalf of its members.
Drugs dispensed by institutional pharmacies are, on average, 3 times larger than those dispensed by retail pharmacies.
Brokerage sales, dock-to-dock sales, and drop shipments are all types of non-stock sales. Rebates are another term for 'after-market arrangements'.
The PDMA is not the Prescription Drug Manufacturers Association, but rather the Prescription Drug Marketing Act.
An independent drug store is a company that owns and operates three or fewer pharmacies.
Drug Labeling and Intellectual Property
The usual dosage range is covered in the 'indications and usage' section of a drug's package insert information. Drug labels must include indications and usage information, as well as contraindications. The 'description' section of a drug's package insert information should include the drug's proprietary name and the established name.
Exclusivity gives exclusive marketing rights, is granted by the FDA, and can run concurrently with a patent or not.
The key difference between exclusivity and a patent is that exclusivity is only granted upon the drug's FDA approval. For an invention to be worthy of patent protection, it must be novel, useful, and not obvious.
A generic drug is bioequivalent to the originator brand-name drug in dosage, strength, safety, and quality. The FDA's criteria for equivalency do not require the drugs to contain identical amounts of the same inactive ingredients. A generic drug is bioequivalent to the originator brand-name drug in dosage, strength, safety, and quality. The 'Approved Drug Products with Therapeutic Equivalence' list is generally considered the most reliable source of information on therapeutically equivalent drug products. 'AA' is an Orange Book rating. Biological equivalents are chemical equivalents which, when administered in the same amounts, will provide the same biological or physiological availability as measured by blood and urine levels. A generic drug is 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. Generic substitution denotes the dispensing of an unbranded generic product for the product prescribed. The duration of a patent challenge is 180 days.
Pharmaceutical Sampling Practices
The more visibility you can give your drug, the more likely it will be prescribed, similar to how a grocery store shelf displays products. Pharmaceutical representatives do typically store and secure their own drug samples. Sampling is sometimes the most important factor in a pharmaceutical rep's success. The FDA approves storage conditions for drug products. Pharmaceutical representatives must always record the amount of drug samples left and obtain a signature for that amount. The sale, purchase, or trade or offer to sell, purchase, or trade prescription drug samples is prohibited by Section 503 of the Federal Food, Drug, and Cosmetic Act, as amended by the Prescription Drug Marketing Act. The federal government does regulate the drug sampling for a pharmaceutical representative. Donating or selling prescription drug samples is not permitted by Section 503 of the Federal Food, Drug and Cosmetic Act. The United States Pharmacopoeial Convention issues monographs that define how drugs should be stored and what variance is allowed in their stated contents. Storage conditions for drug products are based on information supplied by the manufacturer.
Medications are usually affected by changes in temperature, light, humidity, and other environmental factors. Degraded drugs can sometimes still be used when the amount of remaining drug has not fallen lower than 85-90% of that stated on the label. Drug recalls are almost always negotiated with the FDA beforehand.
Electronic prescribing systems can help improve problems such as patients 'doctor-shopping' for controlled substances, pharmacists misreading prescriptions, and physicians wasting time calling pharmacies.
Pharmaceutical Research and Development
If you receive a shipment from your employer and notice that there are twice as many samples as what is posted on the packing slip, you should call your sales manager to inform them of the mistake and ask for instructions.
The area of pharmaceutical R&D that has seen the largest cost increases is clinical trials.
On average, it takes 10-15 years for a new drug to be developed, from the discovery of the initial compound to FDA approval.
The Pharmaceutical Research and Manufacturers of America (PhRMA) is an industry-based regulatory agency, run mainly by the companies themselves.
Several factors have complicated the pharmaceutical R&D process:
An intensive regulatory process Growing demand in the medical community for more complex data about pharmaceuticals The increasing number of procedures in Phase III trials
The landmark FDA Modernization Act of 1997 was a major step forward in enabling safe and effective new drugs and biologics to be made available sooner to patients.
According to the manual, a market-based system is the best way to deliver healthcare.
Increased pharmaceutical price controls would stifle innovation in the U.S. healthcare system.
None of the following sectors invest a greater percentage of sales in research than the biotech sector: aerospace, communications, or electronics.
The intent of these acts was to hasten the commercialization of technologies that otherwise might not be used.
The G10 medicines group recently reported that there is poor collaboration between publicly- and privately-funded research concerns in the European Union (EU).
The aim of preclinical pharmacological studies is to obtain data on the safety and effectiveness of the lead compound.
Toxicity information in preclinical studies helps provide confidence about a drug's safety.
Pharmacological studies using animals are regulated under good laboratory practice.
Drugs administered to patients do not only contain active pharmaceutical ingredients (APIs).
The drug's vesicles do not affect a drug's ability to permeate membranes.
Lipid-soluble drugs can usually pass through cell membranes.
Weak acid drugs are generally absorbed by the stomach more quickly than weak basic drugs.
Rectal administration does 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.
A drug's lipid-solubility, polarity, and the vascular nature of the drug's target tissue all affect its distribution to target tissues.
The term 'transdermal' means 'to apply the drug on the skin surface'.
Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug.
According to NIH ethical guidelines, the most important criteria in selecting subjects for clinical studies is the scientific objectives.
The statement that the members of the IRB/IEC must be experts in the topic of study is incorrect.
Phase I and IV trials are often open label, but phase II and III are double- blinded or at least blinded.
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.
A case-control study is an observational study that first identifies a group of subjects with a certain disease and a control group without the disease, and then looks back in time (e.g. via chart reviews) to find exposure to risk factors.
The mean is the sum of all observations divided by the number of observations.
Incidence is a measure that describes the number of new events that occur during a specified period of time in a population at risk for the event (e.g. lung infections per year).
The standard error of the mean is a measure used to describe the variability of the population mean.
Validity denotes the extent to which a test actually measures what it is supposed to be measuring, or what we think it is measuring.
Kaplan-Meier analysis and Cox proportional hazards analysis are methods of survival analysis.
The methods section of a clinical paper describes subjects' entry and exclusion criteria.
The document that sets out how a trial is to be conducted (i.e., the study's general design and operating features) is called the inclusion criteria.
Geographic variations are not one of the ethical constraints that must be considered when designing and performing clinical trials.
Large molecule drugs are mainly protein-based drugs that develop in biological systems such as living cells, while small molecule drugs are not.
Vaccines are not types of 'small molecule drugs'.
Attenuated vaccines are less expensive to prepare than inactivated vaccines.
Toxoids are derived from the toxins secreted by a pathogens.
The estimated annual death toll for malaria is 1.5 to 3.5 million people.
There are more red blood cells than white blood cells for the same volume in the human body.
From the 1930's to the 1980's, insulin was primarily obtained from porcine and bovine extracts.
Interferons, interleukins, and monokines are types of cytokines.
Blood glucose is not a type of hormone.
In vitro gene therapy is a basic technique in which patients' genetically faulted tissues are removed, loaded with normal genes in vectors, and returned to the patients' bodies.
Pluripotent stem cells can develop into many cell types, but not a new individual.
Leukemia is a condition in which the bone marrow is unable to produce functional white blood cells to fight infection.
Retroviruses are a type of vector used in gene therapy.
Semipotent is not a type of stem cell.
Insulin is not a way in which traditional vaccines are prepared.
Effective drug therapy is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life.
DUR programs have traditionally been used to ensure the appropriate, safe, and effective use of prescription drugs, but are increasingly shifting their focus to minimizing costs.
DUR programs involve retrospective monitoring of physicians' prescribing patterns.
A formulary is a list of prescription drugs approved by insurance coverage.
The history of drug formularies in the U.S. extends back to the American Revolution.
All of the following are types of formularies: - A closed three-tier formulary in which generic drugs are listed on Tier 1 - A five-tier formulary that is supplemented by a step therapy program - An open formulary that places few restrictions on coverage or access
The repeal of Hatch-Waxman is not a recent formulary trend.
The Hatch-Waxman Act made it easier for generic manufacturers to compete with R&D companies.
Opportunity cost is the value of a sacrificed alternative.
The three primary entities that fund pharmaceuticals are employers, the government (Medicare and Medicaid), and individuals.
A company's medical liaison would not be a member of a P&T committee.
The statement that "Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan" and that "pharmaceutical companies are more interested in acquiring and exploiting another's brand than in acquiring another's R&D and sales and marketing assets" is false.
Ideally, brand strategy development for a new drug should begin during Phase II clinical trials.
An example of an 'expressive' value is "I own a BMW because I want people to know that I'm a serious driving enthusiast".
'Uniqueness' is an example of a 'functional' value.
It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify.
To be competitive, pharmaceutical brands must be distinctive, possessing defining characteristics that are perceived by customers to be unique, attractive and relevant to their needs.
With the global need for new drugs, pharmaceutical brand names are subject to regulatory approval.
DTC advertising has become an essential marketing tactic for both large and small brands over the last few decades.
Doctors' personal experiences and their patients' unique situations most strongly influence physicians' prescribing habits.
Pharmaceutical companies spend less on promotional activities than on R&D.
A brand that treats a very common chronic condition would be most well- served by mass-market print and TV ads.
Saliva is the least commonly analyzed fluid for conducting a medical diagnostic test.
The statement that "gold standard' testing achieves the greatest results among the diagnostic testing measurements" and that "gold standards provide the best understanding of what is happening to a patient so cost is not a factor when deciding to run these tests routinely" is false.
Every diagnostic test has some risk, such as the possibility of injury during the test or the need for further testing if the results are abnormal.
Urine is not commonly used for examination to check abnormalities of chromosomes, genes (including DNA) or both in genetic testing.
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) uses small needle sensors (electrodes) to record the electrical activity in selected muscles and peripheral nerves during rest.
Wearable and implantable test technologies currently in development will allow for constant monitoring of body chemistry and collection of previously inaccessible data.
Diagnostic tests are used to detect, confirm, or rule out the presence of a disease or medical condition, not to provide a single purpose for scientific analysis.
Many diagnostic tests are considered to be of a general therapeutic nature and are not specified.
The most sensitive screening tool to detect osteoporosis, a disorder characterized by fragile, weak bones due to a drop in bone mass and increased risk of fracture, is not the arthrocentesis diagnostic test.
Diarrhea is not a sign of a nervous system disorder.
The electroencephalogram (EEG or brain wave test) is a non-invasive procedure used to detect and record brain wave activity.
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.
Companies use prescriber data to conduct research.
Under the PhRMA Code, the following are acceptable: - Modest meals for staff members attending educational events - Providing modest meals to staff members attending educational events
The following would not be acceptable: - Gifts that are only given to doctors with high prescribing volumes
The PhRMA Code on interactions with healthcare professionals is only voluntary and not mandatory.
Pens and clipboards designed to be used by patients in doctors' offices would not be considered acceptable promotional items under the PhRMA Code.
An anatomical model valued under $100 is an example of an acceptable patient education item under the PhRMA Code.
Pharmaceutical Industry Regulations and
Practices
The PhRMA (Pharmaceutical Research and Manufacturers of America) Code does not permit a company to provide entertainment or recreational activities to healthcare practitioners under any circumstances. The only exceptions are:
When the activity is intended to facilitate informational exchange. When the practitioner is acting as a bona fide advisory board consultant. When the practitioner is providing a legitimate service to the company.
Under the PhRMA Code, a company may sponsor a lunch at a 3-day conference, but only if the lunch is clearly separate from the CME (Continuing Medical Education) portion of the conference.
The Office of Inspector General (OIG) is an arm of the Department of Health and Human Services that investigates regulatory infractions, provides compliance advice, and brings enforcement actions.
It is false that it is illegal to ask receptionists for personal information about clients, such as home phone numbers, birthdays, or hobbies.
The primary goals or functions of the P&T (Pharmacy and Therapeutics) committee do not include educating sales representatives on legal and ethical guidelines for professional behavior.
One major challenge facing family medicine is managed care policies eroding patient-doctor relationships.
According to the manual, family physicians diagnose and treat approximately 95% of the patients they see, as opposed to referring them to specialists.
The steps on the product adoption continuum are: awareness, evaluation, and adoption.
Drug therapy is a type of somatic psychiatric treatment.
The last 10 minutes of each hour is usually not the best time to make office visits to psychiatrists, as they are usually on their way to the hospital at that time.
Drug Utilization Review (DUR) is an MCO's (Managed Care Organization's) practice of monitoring prescribing patterns.
The focus of the short call protocol is beginning with a specific patient type.
The Medical Science Liaison (MSL) is someone employed by a pharmaceutical company who builds relationships with thought leaders and acts as an informational resource.
MSLs typically have graduate-level science degrees.
Companies typically judge the MSL team's contributions based on return on education.
'Pull through' programs involve sales representatives more than 'push through' programs.
The types of 'pull through' programs include adherence/persistency, educational support, and therapeutic intervention.
It is false that pharmaceutical sales reps, who mostly work out of their homes, do not need to work well in a team environment.
The most likely reason a doctor would lack interest in one of your clinical studies is that they do not like the way you are presenting it.
Effective methods for researching the 65+ market include being a Medicare Part D information resource, knowing the physician-payer mix, and taking advantage of partnership programs.
When a physician visits your hospital display, you should not begin the conversation by asking "Can I help you?"
One of the rules is to focus on their agenda, not your own.
It is true that side effects that might be considered minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies for specialty care products.
It is true that in some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician.
Blockbuster drugs typically have sales of just under $10 million annually, while orphan drugs treat rare conditions.
The greatest challenge for a generic drug manufacturer is often to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug.
Most calls and visits to physicians' offices (excluding waiting and driving time) are relatively short in duration.
Countering attack is not a step in managing rumors.
According to the text, staying focused is considered "going to the next level".
One of the primary job responsibilities of a retail pharmacist is dispensing pharmaceuticals.
Pharmaceutical companies and representatives do not categorize their patients, but rather their customers.
The Medicare Prescription Improvement & Modernization Act introduced Medicare Part D as a relatively new prescription drug benefit.
A pathogen is a disease producer.
White blood cells play the most prominent role in fighting infection and disease.
A receptor is a structure that generally resides on a cell surface (or in the cytoplasm) and causes a biological change or activity when stimulated.
Renal pertains to the kidneys.
Gene mapping is the practice of locating genes on a chromosome.
Pharmacogenomics is the field most concerned with drug effects due to slight genetic differences.
The United States federal government is referred to as the USG.
IDN stands for Integrated Delivery Network.
Small molecule refers to drugs that are non-biological (i.e., chemical) in nature.
The medical abbreviation that denotes 'hour' is H.
Pharmacology is the study of drugs' beneficial and toxic effects on living cells, tissues, and organisms.
Organs are specialized cells and tissues that work together to perform a specific body function for a common purpose.
The mechanism of action is the method by which a medication produces its therapeutic effects.
Plasma is the fluid portion of the blood.
An allergy is an extreme sensitivity and reaction to a foreign substance, including medications.
Central Nervous System (CNS) agents are used as analgesics, anesthetics, and anti-convulsants.
Cholinergic agonists work by mimicking the actions of acetylcholine.
Fibrinolytics are therapeutic agents used to promote blood clot formation.
Protein inhibitors are not a type of gastrointestinal agents.
Patients with weakened immune systems are most likely to receive immune globulins.
Iron's primary function in the body is carrying oxygen.
Antimetabolites are not a type of anti-infectant.
Entry-level resumes are more likely to begin with the education section than the experience section.
Targeted cover letters are always tailored to specific companies.