The American Pharmacy Staff's Experiences and Opinions of Generic Drug Substitution

 
 
The American Pharmacy Staff's Experiences and Opinions of Generic Drug Substitution
The American Pharmacy Staff’s
 Experiences and Opinions of
 Generic Drug Substitution
- A Study in California




Figure 1. In the United States, medications are dispensed in bottles with labels (1).




Naffe Nguyen
Institutionen för farmaci, Uppsala universitet
Examensarbete i samhällsfarmaci, HT‐2010
30 Högskolepoäng
Handledare: Sofia Kälvemark‐Sporrong
The American Pharmacy Staff's Experiences and Opinions of Generic Drug Substitution
Abstract
Introduction: Generic drug substitution is a common trend in the world including the United States,
with a purpose to save the health care system money. Still, American studies have shown that the
patients and doctors prefer brand name drugs. Furthermore, problems with the American health
insurance companies’ policies cause problems for the patient and the pharmacy, when it comes to
generic drug substitution.

Aim: To investigate the American pharmacy staff’s experiences and opinions of generic drug
substitution in California.

Methods: Semi‐structured, face‐to‐face interviews were conducted until saturation.

Results: According to the interviewed pharmacy staff, the pharmacies’ computer system is defaulted
to always substitute brand name drugs to generic drugs. The system’s main purpose was perceived
as to save money. The interviewees mention problems with health insurance companies and poor
communication with the doctors’ offices. This causes patients’ confusion which leads to a poorer
drug treatment. The pharmacists and the doctors are acknowledged to play important roles to
prevent these problems with additional counseling. Some suggestions to the existing problems were
made, but further studies are needed.

Conclusions: The study found that the patients’ confusion can be helped by additional counseling
from the pharmacist and the doctors, more information from authorities and more responsibility
from the patients’ side to stay proactive about their medication. The problems with the health
insurance companies were not easy to be solved, since most of the incentives are financial.




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The American Pharmacy Staff's Experiences and Opinions of Generic Drug Substitution
Innehåll
Abstract ................................................................................................................................................... 2
Abbreviations .......................................................................................................................................... 5
Background .............................................................................................................................................. 6
   Definition of Generic Drug .................................................................................................................. 6
   The Pharmaceutical Bodies in the United States ................................................................................ 6
   American Pharmacy Staff .................................................................................................................... 7
       The Pharmacist ................................................................................................................................ 7
       The Pharmacy technician ................................................................................................................ 8
       Pharmacy aides ............................................................................................................................... 9
   The American Health Insurance System and Generic Substitution .................................................... 9
       Medicare and Medicaid................................................................................................................... 9
       Medi‐Cal .......................................................................................................................................... 9
       The Third Party Plans and Generic Drugs ...................................................................................... 10
   History of Generic Drugs in the United States .................................................................................. 10
       The Establishment of Medicare and Medicaid .............................................................................. 10
       Computerization of Pharmacies .................................................................................................... 10
       Drug Price Competition and Patent Term Restoration Act of 1984 .............................................. 11
       Legislations .................................................................................................................................... 11
   How Generic Drugs Enter the Market ............................................................................................... 12
       Before sending ANDA to the FDA .................................................................................................. 12
       The Review .................................................................................................................................... 13
       The Pricing of Generic Drugs ......................................................................................................... 13
   Trends of Generic Substitution in the United States......................................................................... 13
   Patient’s view on generic drugs ........................................................................................................ 14
       How to increase the generic drugs usage amongst patients ........................................................ 15
   The Pharmacist and Generic Substitution ......................................................................................... 15
Aim ........................................................................................................................................................ 17
Method .................................................................................................................................................. 17
   Qualitative interviews ....................................................................................................................... 17
       Sample selection and study population ........................................................................................ 17
       Interview setting............................................................................................................................ 18
       Data Collection .............................................................................................................................. 18
       Data Analysis ................................................................................................................................. 18


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The American Pharmacy Staff's Experiences and Opinions of Generic Drug Substitution
Results ................................................................................................................................................... 20
   From prescription to dispensing ....................................................................................................... 20
   Results from the data analysis .......................................................................................................... 21
       1.      The system in general............................................................................................................ 22
       2.      The problems ......................................................................................................................... 25
       3.      The economical aspect .......................................................................................................... 29
       4.      The pharmacy staff ................................................................................................................ 31
       5.      The Patients ........................................................................................................................... 37
Discussion .............................................................................................................................................. 39
   Methodological considerations ......................................................................................................... 42
Conclusion ............................................................................................................................................. 44
Future studies ........................................................................................................................................ 44
Acknowledgements ............................................................................................................................... 45
References ............................................................................................................................................. 46
Appendix 1: Interview guide ................................................................................................................. 50
Appendix 2: Informant Consent Form, page 1 ...................................................................................... 51
Appendix 2: Informant consent form, page 2 ....................................................................................... 52
Appendix 3: Example of prescription in the U.S. ................................................................................... 53
Appendix 4: Data from the interviews .................................................................................................. 54




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Abbreviations
In this thesis these following abbreviations are used frequently:

ANDA                         Abbreviated New Drug Application. An application submitted to the FDA
                             when a generic company wants to manufacture and market a generic
                             drug.

DAW                          Dispensed as written. A term used the doctor puts on the prescription
                             to prevent it from being substituted

DEA‐number                   Drug Enforcement Administration number. All health care providers
                             who can write prescriptions are provided with this number as an
                             identification tool to track the prescription to the prescriber.

FDA                          Food and Drug Administration. An authority responsible for
                             implementing and enforcing the federal Food, Drug and Cosmetic Act.

NDA                          New Drug Application. An application submitted to the FDA when a
                             pioneer company wants to manufacture and market a new drug.

PA                           Prior authorization. The procedure when the pharmacy or the doctor’s
                             office sends an application to the health insurance company in order to
                             get their patient’s medication (that is not on the insurance company’s
                             formulary) covered by the insurance company.




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Background
Generic drug substitution is a common practice all around the world in order to save money for the
patients and the whole health system (2)(3). But the pharmaceutical setting in the United States is a
complex system with many components and the generic drug substitution is a phenomenon that
demands the interaction of all the components, such as the regulatory authorizations,
pharmaceutical companies, pharmacies, the patients, and the health insurance companies.

Definition of Generic Drug
When the expiry date of the drug patent by the innovator company has expired, a generic drug can
be manufactured without a license and this pharmaceutical product is intended to be
interchangeable with the innovator product (4). Per se there is neither law nor regulation in the U.S.
that contains a definition of a generic drug. Dr Roger Williams proposed a definition that has been
adopted by the Food and Drug Administration (5). Generic drugs are “copies of brand‐name drugs
and are the same as those brand name drugs in dosage form, safety, strength, route of
administration, quality, performance characteristics and intended use”. Furthermore, FDA states that
“all generic drugs approved by FDA have the same high quality, strength, purity and stability as
brand‐name drugs “(4). A brand name drug or a proprietary drug is the drug first manufactured by
the innovator company and its name is reserved only for its owners (6).

The Pharmaceutical Bodies in the United States
The Food and Drug Administration is responsible for implementing and enforcing the federal Food,
Drug and Cosmetic Act. The FDA is an agency of the U.S. Department of Health and Human Services.
It has six product centers, one research center, and two offices. (7). The responsibilities consist of
control and prevention of adulteration of food, drugs and cosmetics moving in interstate commerce.
The FDA also sets label requirements, standards for investigational drug studies and marketing new
drug products, amongst other tasks. They also compile information about adverse drug reactions (8).

The responsibility for regulation of pharmacy practice within the state lies with The State Board of
Pharmacy, which is a State Government’s Agency. This means that every state has its own board. To
practice pharmacy and provide pharmacy services in the state, institutions and community
pharmacies must obtain licenses from the board. The state boards publicize regulations that affect
drug dispensing and control. For some states, the state board of health licenses the hospital
pharmacy on their own. In other words, there are different classes of pharmacy license, including
retail, hospital and nuclear pharmacy (8).

The American Pharmaceutical Association (APha) is the voluntary, national professional society of
pharmacists. It was the first‐established national professional society of pharmacists, founded in
1852. It includes several other organizations that represent pharmacists by type of practice, interests
and location (8). The APha is the largest association for pharmacists in the U.S., having more than
60 000 pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians and
others in this profession. It provides a forum for discussion, building consensus and policy setting for
the pharmacy profession (9).




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American Pharmacy Staff
Compared to the Swedish system which has pharmacists, prescriptionists and pharmacy technicians,
the pharmacy staff in the United States consists of pharmacists (Doctor of Pharmacy) and pharmacy
technicians. In some pharmacies there are pharmacist aides (10). Table 1 shows a brief review over
the different pharmacy positions.

Table 1. Review over the different pharmacy positions.

              Pharmacist                   Pharmacy technician                Pharmacy aide

Education     Pharm.D.                     No standard education              None
              2 years specific studies     On‐set training                    High school diploma
                                                                              preferred
              4 years pharmacy school      Informal technician programs:
                                           college, hospital, organizations
              1‐2 years fellowship
              (optional)



Licensure     Exams: NAPLEX and MPJE       High school diploma                None
              Hours of pharmacy            No criminal records                Skills needed:
              experience
                                           Must be registered with State      Experience with:
              Age requirements             Board of Pharmacy                  cashier, customer
                                                                              service, inventory
              No criminal records          National certification exam



Job         Delegation and                Prescription preparation            Answering telephone
description supervision                                                       calls
                                          Provide customer service
             Counseling                                                       Stocking shelves cashier
                                          Administrative duties within a
             Distribute prescription      pharmacy                            Prepare insurance
             drugs                                                            forms
             Monitoring the progress                                          Maintain patient
             of patients                                                      profiles



The Pharmacist
The majority of pharmacists work in community pharmacies, such as in retail, healthcare or in a
hospital. In a pharmacy, pharmacists distribute prescription drugs, advise patients and physicians,
and monitor the progress of patients. Pharmacists are responsible for every filled prescription’s
accuracy, in other words they delegate the prescription‐filling and administrative tasks, and supervise
their completion. (10)

The education and licensure
To become a pharmacist, one must generally earn a Doctor of Pharmacy (Pharm.D.) degree from an
accredited college or school of pharmacy and pass examinations to obtain a license. The Bachelor of



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Pharmacy degree has been replaced by the The Pharm.D program. The Pharm.D. programs generally
take 4 years to complete. (10)

Important changes in pharmacy education have occurred over the last century, the Doctor of
Pharmacy degree is now the sole professional degree for entry into practice. Over the last 40 years
the pharmacy education system has devoted resources to transform product oriented curriculum to
a patient‐centered focus one. The pharmacotherapeutic component and the patient communication
and physical assessments have increased significantly. Early and consistent exposure to patients and
practice settings is now an expectation of the Pharm.D. programs, and is an important difference
from the Swedish pharmacist education (11).

To be able to practice as a pharmacist, a license is required in all the States of America. After the
Pharm.D. degree is obtained, the individual must pass a series of examinations. All States require the
NAPLEX, North American Pharmacist Licensure Exam, which tests pharmacy knowledge and skills
(10). The Students generally perform very well on the NAPLEX. National exam pass rates in 2009 for
first‐time candidates were 97.5 % (11). Some states also require the MPJE, Multistate Pharmacy
Jurisprudence Exam, whilst some have their own pharmacy law exam. The exams are administrated
by the NABP, National Association of Boards of Pharmacy. Furthermore, before a license can be
obtained, every jurisdiction requires a specific number of hours of experience in practice setting. (10)
For example to be licensed as a pharmacist in California where this study will take place, you must:
      Fill the age requirement: 18 years of age
      Have obtained a B.S in Pharmacy or a Pharm.D. degree from a accredited college of
         pharmacy program.
      Have completed 1500 intern experience hours or have a verified pharmacist licensure in
         another State for at least one year.
      Have passed the NAPLEX and the CPJE, California Practice Standards and Jurisprudence
         Examination (12).

 The Pharmacy technician
Pharmacy technicians assist the pharmacists in prescription preparation, provide customer service,
and help with the administrative duties within a pharmacy. Depending on State rules, pharmacy
technicians have various responsibilities. Questions regarding prescriptions or drug information are
always referred to the pharmacist (10).

Education and licensure
There are no standard education requirements for pharmacy technician, but some States require a
high school diploma. Most technicians receive informal on‐the‐set training, which can range from 3‐
12 months. Formal technician programs range from 6 months to 2 years and are available through
community colleges, hospitals, military and a variety of organizations. Most states require that
pharmacy technicians must be registered with the State Board of Pharmacy. The Pharmacy
Technician Certification Board and the Institute for the Certification of Pharmacy Technicians
manages the national certification examinations. High school diploma and no felony convictions are
required for applicants to be able to take either exam. Recertification must be done every 2 years
and requires 20 hours of continuing education within that 2‐year period. Education hours can be
earned from different sources, such as colleges, training programs and pharmacy associations. (10)



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Pharmacy aides
Pharmacy aides have administrative duties, including answering telephone calls, stocking shelves and
work as a cashier. Pharmacy aides also prepare insurance forms and maintain patient profiles. There
are no formal requirements for pharmacy aides with experience operating a cash register, customer
service and managing inventory. Pharmacy aides receive informal on‐the‐job training that lasts less
than 3 months. (10)



The American Health Insurance System and Generic Substitution
Another important component in the American pharmaceutical setting is the health insurance
companies. The American health insurance market offers a wide diversity of health plans and
insurance coverage. Health plans offer all types of coverage options related to various premium
schemes. If a consumer does not know if he will get a disease, basic health coverage will be chosen.
The customer may also have access to it through an employer or a public insurance plan, most
consumers pay premiums or social taxes to get partial coverage. However, pharmaceuticals are often
not covered or only partially covered by insurance. Therefore large discrepancy in total cost for
medications often exists among consumers (13). To understand the health insurance issues with
generic substitution it is important to understand what the federal and states’ insurance program are
and how they work.

Medicare and Medicaid
Medicare is a federal insurance program and the medical bills are paid from trust funds which those
covered have paid to. Primarily, it serves patients over 65, whatever their income and young disabled
people and dialysis patients. Medicare is basically the same everywhere in the U.S. Medicaid is an
assistance program to Medicare that serves low‐income people of every age. The medical bills are
paid from federal, state and local tax funds. Usually, no part of costs for covered medical expenses is
paid by the patients, but a small co‐payment is sometimes required. Medicaid is a federal‐state
program and varies from state to state. It is run by state and local governments within federal
guidelines (14). This thesis will focus on California’s health insurance system. California’s Medicaid
program is called Medi‐Cal (15).

Medicare Part D, Prescription Drug Program makes prescription drug coverage available to all
Medicare beneficiaries. (15). Medicare Part D provides prescription drug benefits for a total of $310
deductible, after the patient spent $310, the patient mus pay 25% of the cost of his/her prescriptions
until the cost of all the medication in a year reaches $2,830. After that the patient is stuck with 100 %
of the bill until the total cost of the medications hits 6,440. This gap when Medicare does not cover
anything of the patient’s prescription is known as the Medicare doughnut hole (16).

Medi­Cal
Medi‐Cal is the public health insurance program which provides health care services for low‐income
individuals, such as families with children, seniors, people with disabilities, pregnant women, and low
income persons with specific diseases. It is financed equally by the State and the federal government.
If some medications are not covered by Medi‐Cal, the pharmacy can submit a prior authorization to
ask Medi‐Cal for permission to fill the prescription (15). About how a PA works in detail, see From



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Prescription to Dispensing in the Results section. Medi‐Cal has a formulary the “Medi‐Cal List of
Contract Drugs”.


The Third Party Plans and Generic Drugs
Third party drug insurance coverage has grown rapidly in the United States since 1990 and patients
with health insurance coverage tend to have an increased consumption of medical services. In recent
years, third party insurers are attempting to control the increasing drug expenditures in a couple of
ways, one has been to guide the use to preferred drugs on the insurers’ formulary. Another way was
to charge consumers a low copayment for a generic drug and higher for a brand drug. Varying the
copayments between generic and brand name drug still mean that the costumers. The third party
payers began to negotiate with the brand drug manufacturer offering them a spot on the formulary
in return for price discounts. To a brand manufacturer, being excluded from the formulary can result
in a loss of market share. This way the third party payers have power of the exclusion to hold down
drug prices and make the demand for prescription medications more price elastic (17).


A study from 2005, the generic utilization rate among the uninsured respondents exceeded the rate
for those respondents with employer coverage. But the overall utilization rate of generics was higher
after the implementation of Part D (18). Among Part D enrollees, the generic use rose from 50% to
63% in 2007. The Prescription Drug Program’s aggressive use of financial incentives may have been
one of the contributors. Although, nearly 31 % of the elderly remain in employer‐sponsored plans in
2006 and little is known about their generic use after the start of Medicare Part D. There is even less
information about the generic use among the Medicare beneficiaries who lack prescription drug
coverage (19). A new study from 2010 shows that a greater use of generic medicines can help the
States afford the cost of implementing expanded Medicaid coverage under new health care reform
laws. Data from the Centers for Medicare and Medicaid Services show that each two percentage
point increase in generic use in Medicaid saves the system an additional one billion dollars (20).



History of Generic Drugs in the United States
The Establishment of Medicare and Medicaid
In 1965, the establishment of Medicare and Medicaid changed the pharmaceutical landscape in
many ways. Medicare brought millions of new prescriptions into community pharmacies but along
with the new system problems with paperwork, reimbursement hassles and regulations came (21).
The growing of third party programs and the high cost of prescription drugs stimulated government
agencies to study cost‐decreasing approaches, such as generic substitution (21).

Computerization of Pharmacies
In the late 1970’s the computers entered the prescription departments across the United States.
Even though the early computer system’s high cost and low power, it offered pharmacists a solution
for dealing with the piling paperwork in the pharmacy’s back rooms. In the 1980’s the computers
became more sophisticated and soon pharmacists could check for drug interactions and have patient
profiles. This improvement led to the current situation where a safe and fast generic substitution can



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be done, since pharmacists no longer had to handle paperwork and instead had all the information
about the patient, the drugs and the health insurance in one place (21).

Drug Price Competition and Patent Term Restoration Act of 1984
In Sweden the regulations for generic drug substitution was conducted in October 2002, so in
comparison to Sweden the U.S. has a much longer experience with generic drugs (22). In the U.S.,
President Ronald Reagan signed the Act of 1984, into law in 1984.

There are two parts of the 1984 law. Part I of the new law gave the FDA authority to accept
Abbreviated New Drug Applications (ANDA) for approval of marketing of generic drugs. Part II
authorizes extension of the patent terms for approved new drugs. The two parts of the law are
supposed to give a balance between encouraging competition, and innovation and research (23).This
led to large potential gains in two economical perspectives. First, it reduces the clinical studies to
support the generic drug’s version’s safety and efficacy. Second, it lower prices significantly to
patients and other third‐part payers. (24)

To conclude, the historic changes of The Drug Price Competition and Patent Term Restoration Act of
1984 were designed to:

    1.   Speed up the federal approval process of generic drugs
    2.   Make therapeutically equivalent generic drugs more available to patients by reduced costs.
    3.   Eliminate the costly and ethically questionable need of animal and human clinical trials.
    4.   Assure the continuing research and development of new drugs through incentives as periods
         of market exclusivity and patent term restoration

The FDA has during the last 27 years approved more than 5000 generic drug products, in a variety of
classes of drugs, for marketing in the United States. (23)

Legislations
In the 1970’s the APha advocated and argued for the repealing of anti‐substitution laws. Together
with the consumer movement in the 1970s secured the repeal of these laws. Cost savings came
slowly, as pharmacists were in the beginning reluctant to substitution (21).

The state anti‐substitution laws that prohibits pharmacists from deviate from the physician’s brand
name prescriptions has been revoked (24). All states in the U.S. have laws about generic substitution
to one degree or another. Some states are called "positive formulary" states, which means that the
state list generics that can be substituted, and there are states with "negative formulary", which list
drugs that cannot be substituted. There are also states that have nether a positive nor a negative
formulary and where pharmacists are permitted to perform generic substitution as long as the drugs
are pharmaceutically equivalent. In some states the Orange Book1 is required when substituting,
however that does not apply to California where this study is taking place. Figure 1 identifies which
laws that applies in which state.




1
 An FDA publication that lists drug products and contains indications as to whether generic versions of medications are
considered to be "equivalent" to the brand name drugs. But the only drugs listed in this book are those that have been
approved by the FDA with a NDA, so there are no drugs from before FDA on the list (2).

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Figure 2. The different generic substitution laws that applies to different states. California is abbreviated CA(25).




How Generic Drugs Enter the Market
There are two types of drug manufacturers: Pioneer firms and generic firms. The first category does
the research and development of new drugs and bring them to market. To legally manufacture and
market new products in the United States, the pioneer company must send a New Drug Application
(NDA) to the FDA and get it approved. The second type of firm is the generic or imitator firm. To be
able to manufacture the generic drug, it needs to submit an Abbreviated New Drug Applications
(ANDA) to the FDA (8).

Before sending ANDA to the FDA
After a submission and approval of an ANDA, a generic drug product can be marketed. When a
generic firm files an ANDA to the FDA it must certify that:

    a) The patent of the brand name drug has expired or
    b) The patent of the brand name drug will expire on a particular date and the generic company
       does not seek to market its generic product before that date or
    c) The patient for the brand‐name drug is invalid or will be infringed (17).

The ANDA contains information to show that:

    1.   Conditions of use prescribed, recommended or suggested in the labeling approved
    2.   The labeling proposed for the new drug is the same as for the already approved
    3.   The active substance is the same as that of the innovator drug
    4.   The dosage forms, the strengths and the routes of administration are the same


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5. It is bioequivalent to the innovator drug (23).

An acceptable ANDA must also contain a description of the composition and the components of the
dosage form to be marketed, a brief statement about the manufacturer location, the name and
address of the supplier of all the ingredients and authorization to inspect the facility when requested
(23).

The Review
The ANDA review that leads to an approval takes about 15‐24 months. The variation in time to
approval occurs because the firm’s applications are different in quality and because the FDA is an
unpredictable bureaucracy, according to O’Donell (8). The review is carried out by pharmacists,
physicians, chemists, biopharmaceutical scientists, and others. In addition, the FDA also uses
scientific and technical expertise of scientists through its Pharmaceutical Sciences Drug Advisory
Committee. The reviewers tasks are to:

    1. Evaluate the labeling, chemistry, manufacturing and controls for the active ingredient(s),
       excipients, final dosage form and in vivo bioequivalence data and in vitro dissolution data
    2. Inspect and audit of all facilities involved in the manufacturing, testing, packaging, and
       controling of the drug.
    3. Inspect the facility conducting bioequivalence study and auditing of the bioequivalence study
       (23).

The Pricing of Generic Drugs
In the U.S., the lowest prescription drug prices are negotiated by the Department of Veteran Affairs
and the Department of Defense. The general pattern of pricing is consistent with the heterogeneity
across purchaser groups in buying power and also prescribing patterns. The American costumers are
typically paying on average the highest brand prices and among the lowest for generic drugs. The
interpretation of this phenomenon is that by charging U.S customers higher prices, pharmaceutical
companies can sell abroad to a more price‐sensitive customer at lower prices and thereby expand
worldwide access to drugs but still recoup large fixed research and development costs from their U.S.
sales. (26)

Trends of Generic Substitution in the United States
Pharmaceutical expenditures grew rapidly in the last decades and are estimated to total
approximately 10 % of the United States’ health care costs. In 1984 19% of all prescriptions filled in
the United States were generic, whilst in 2001 the percentage of generic prescriptions was 47% (27).
In the past it was possible that pharmacists were inadequately compliant to the generic substitution
laws, but in 1997 generic substitution by pharmacists averaged 96 %. There are a number of reasons
why it has generic substitution has increased. One is the influence of third party payers, who often
use various incentives to promote generic products to pharmacists in order to contain drug
expenditures. Suh expresses some concern about the generics’ rising prices, which is because several
generic manufacturers have raised the prices on specific items (3).

Paul Bisaro, Chairman of Generic Pharmaceutical Association’s Board of Directors stated in a press
release that “Generic pharmaceuticals continue to be one of the best buys in health care /…/ While
prices for name brand prescriptions continue to rise year after year, generic prices have remained
generally unchanged and in some cases have even declined as more competition enters the market”

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(20). The cost of the generic drug is approximately 70 % of the branded product, when there is only
one generic product available for the brand drug. But, when more than five generic versions are
available, the cost is only 30 % of the brand product’s price and the more generic products, the lower
the prices are (5). According to another study by Suh, generic drugs usually enter the market at a
price 25 % less than of the brand name drugs. Within 1 year the price tends to reduce to 45% lower
and within 3 years 75 % lower than the brand name drug (3).

A new study of today’s prescription drug utilization found that dispensing generic drugs saved the
American health care system 139.6 billion in 2009 alone and more than 824 billion dollars over the
past decade. The Generic Pharmaceutical who commissioned the study noted that even greater
savings could be achieved in future years. This could be accomplished by increasing the funding of
FDA’s Office of Generic Drugs to ensure timely review and approval of new generic drugs, facilitate
access to affordable generic biological medicines and allow generic manufacturers to bring generics
to market sooner(20). Furthermore, with the new health insurance reform by president Obama,
there will be 10 billion dollars fees over ten years on the brand pharmaceutical industry. The plan is
to close the Medicare so‐called “doughnut hole”, ensuring the older patients not to skip or cut back
on needed medication (28).

The trends of generic drug usage depend also on the prescribers’ willingness to allow generic drug
substitution. The opportunity for generic drug use did not exist for approximately 38 % of the
prescription orders in 2002(29). Prescribers used the brand name drug for 82 % of prescription
orders allowing generic drugs options (29). The reasons why physicians may prefer and prescribe
brand names are various. It can be simply as brand names are often more memorable or evocative
and easier to pronounce than generic names. Many physicians may be unaware of new generic
products or are only familiar with the brand drug. Another reason might be that physicians are not
aware of the strict controls of generic drugs by the FDA and believe them to be not as effective as
brand name drugs (30).

Although the use of generic drugs is widespread there are still problems with generic drug
substitution. During many of years monitoring patients’ pharmacokinetics, it was discovered that
when switching from one type of drug distribution as intravenous to another, like oral, no dose
adjustment was done. Intravenous and oral are two different types of drug distribution well known
to have different bioavailability. Both pharmacists and physicians are responsible for not making any
serious harmful substitution. Unnecessary substitution for economic motives that cause the patients
adverse effects will end up costing the health care system more in other ways, like greater use of
system resources (31).



Patient’s view on generic drugs
American patients believe in two things about drugs. On one hand they believe that “more is better”
which makes them consume more medications, but on the other hand there is a growing doubt
amongst patients about the safety, necessity and efficacy of drugs. There is also a general demand
for “the strongest medicines possible” which can influence the request of a higher priced brand
name drug over a generic one. For some patients, there is a perception that generic drugs are not as
effective as the brand name drug. Brand name drugs are also perceived as an insurance of quality


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and a status marker (32). Although, a majority of the patients have mixed emotions towards generic
drugs, there has been a fairly stable positive attitude across the years and from studies reviewed, 40‐
60% of the patients have positive attitudes. But this does not necessarily translate to an increased
use of generic drugs. In a study done in Florida, 66% of the older respondents rejected generic
alternatives and believed that the lower priced generics were less effective. This applied to the low‐
income respondents too (33).

Does the patient’s background affect their opinions about generic drugs? Some studies have indeed
confirmed that customers’ views of generic drugs are affected by their demographic and
socioeconomics characteristics; such as age, gender, ethnicity, income, education level, and
chronicity of the medical condition. Generally low‐income and less educated customers had less
knowledge and more negative attitudes towards generic drugs. There was also mistrust in this
customer group. When it comes to age, some studies found that older customers had no trust in
generic drugs, but other studies indicated that young consumers were more negative. One may
conclude that there are consumers in all ages that are conscious about the brand names and are
suspicious about generic drugs (34). Drug product characteristics, such as price, perceived quality and
effectiveness, and manufacturer, too have influence on consumers’ attitude of generic drugs. Also,
consultation with other health care professionals, for example a physician, influences the consumers’
preference for generic drugs (35). Furthermore knowledge and past experiences with generic
products (groceries, over the counter‐products) are important factors that can influence the
consumer’s attitude. For chronically ill patients, the more risky and serious the medical condition is
perceived, the less likely he or she would choose a generic drug for the medical treatment (33).

A study affirmed that a particular country’s pharmaceutical reimbursement system implemented has
an effect on consumer’s use of generic drugs. A brand name drug is preferred if a third party pays for
the medication or if there were no co‐payments differences between a brand name and a generic
drug(36). The customers were more interested in generic drugs when the difference in co‐payment
increased. Financial motivation is a strong predictor of the preference of a generic drug and potential
savings by consumers is the main reason for choosing the lower‐priced generic drug (37).

How to increase the generic drugs usage amongst patients
Hassali et al. suggest a couple of actions that can be taken to change the consumers negative
attitudes towards generic drugs. Researchers should consider studying the consumer’s decision‐
making processes. Also, the communication between patients and health care professionals about
the equivalency of brand name and generic drugs should improve. Finally, mass educational efforts
to increase the consumers’ knowledge about generics should be directed to encourage them to be
active in managing their medical conditions. This will help those with low levels of literacy to
overcome their misconception about generic drugs (33). In the American consumer driven healthcare
system, there are difficulty to navigate through complex benefit plans and identify the most cost‐
effective options. There should be educational campaigns that enhance the patient‐physician and
patient‐pharmacist communication about generic drugs to improve comfort for those discussions.
(38)

The Pharmacist and Generic Substitution
Prescribers and pharmacists are the agents for the patients and insurers when making decisions
about generic drug substitution. Studies showed that the pharmacists are highly trusted amongst


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health care professionals and the patients are satisfied with the pharmacists’ services (29). The
pharmacists have expressed some concerns about the fact that they have to constantly seek the
physician’s authorization to revise the prescription from brand name drugs to generic drugs. This
might affect their relationship with the physician. Both pharmacists and physicians are cautious
when they have the opportunity to perform a generic substitution; they wish to avoid potential legal
liability (3).

It is confirmed that pharmacists have an important role in generic drug substitution as they
substituted 84 % of prescriptions that allowed substitution. This suggests that generic substitution
has increased significantly since 1975, when the estimated rate was 2 % (29). Although, despite the
legal and professional expectations of pharmacists‐patients’ interactions, studies shows patient
counseling rates between 33‐74% (39). The lack of communication between pharmacists and
patients is a reason for the low client expectations of pharmacist consultation services. Clients expect
pharmacists to be prescription drug supplier rather than a counselor regarding medications (40).

Although the pharmacist perform many substitution, one study indicated that the majority of the
asked pharmacists thought that original brand medicines were of higher quality and 50 % of the
pharmacists stated that generic and brand name drugs are equally effective. A lot of them reported
concerns regarding the generic substitution and suggested actions like advertising campaigns, patient
pamphlets and distinct packing for generic medicines (2). Another concern for pharmacist is the
frequent switching of generic manufacturers (3). In another study, when asking about profitability in
the pharmacy, only 11 % of the responding pharmacists believed it increased profit whereas 89 % felt
profits were decreased because of greater time explaining frequent medication changes to patients.
A majority (68 %) also stated that profit of generic drugs was less so it is necessary to increase sales
volume in the pharmacy (2).




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Aim
The aim of this thesis is to investigate the American pharmacy staff’s experience and opinions of
generic drug substitution, more specific in Northern California. In order to do so, a detailed review of
the American pharmacy system and its components was done.


Method
Initially, to gain more background information about the pharmaceutical setting and the generic
drugs situation in the U.S., a literature search was done. The literature search was performed with
Uppsala University’s Samsök function which resulted in articles from multiple search engines such as
Oxford Journals, PubMed, Science Direct, Springerlink and Web of Science. Also, Google Scholar was
used to attain articles. Furthermore, American and international authorities’ web pages, including
FDA, WHO and BLS, were used to gain basic background information about the pharmaceutical
situation, such as guidelines, regulation and definitions, in the U.S. According to Kvale, it is essential
to have a theoretical understanding for the phenomena one wants to study before it is studied (41).

Qualitative interviews
Qualitative interviews were conducted to collect the data needed. This method has the potential to
not only answer the specific questions, but also reveal the implicit information (41). The use of
qualitative research methods is rising in health services and health policy research. It’s consistent
with the development in the social sciences and the need for more in‐depth understanding of
naturalistic settings and the complexity of social change. The pharmacy is in a naturalistic setting and
there have been many rapid changes. (42)The study’s aim was to explore and therefore the
interviews were as open and semi‐structured as possible (43) . The interviewer followed an interview
guide (Appendix 1) with planned questions, but followed up the interviewees’ answers and
comments to get new perspectives on the phenomena.

Sample selection and study population
All participation in this study was voluntary and the interviewees were promised confidentiality. The
interviewees were found by using snowball sampling. After scheduling the interviews by phone, the
author met the interviewees for a face‐to‐face interview.

All of the interviews were conducted in October‐November 2010. In total, 13 interviews were
conducted. Of the 13 interviewees, nine of them were pharmacists and four were pharmacy
technicians. The pharmacy staff’s work experience, age, sex and background tried to be taken in
consideration, when choosing interviewees. To gain heterogeneity in age was hard, since most of the
author’s contacts were in the same age, and when they recommended their friends they too were in
that age. The interviewees’ age ranged from 23 to 55 and the average age was 34,5. The same
problem applied to the interviewees work experience, most interviewees work experience had three
to five years of experience, only two interviewees had a >25 years of experience. Their average
working experience in pharmacy practice was 8 years, and the range was three to 28 years.

Heterogeneity in sex and background was obtained, seven interviewees were females and 6 were
males. Caucasians, Asians, Latinos and Indian‐Americans were represented in the study population.
The sampling continued along with the analysis until the author decided that saturation was
achieved.


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Interview setting
The pharmacies visited were located in Northern California: Sacramento (seven interviews), Citrus
Heights (four interviews), Vacaville (one interview) and Elk Grove (one interview). To truly
understand the content of a study, the interviewer should be in the environment where the studied
phenomena are taking place (41). According to Wibeck it is important that the interviewees are
comfortable with the surroundings so it is important for the interviewer to be flexible with the choice
of interview setting (44). The majority of the interviews were conducted in the pharmacies’ offices or
empty lunch rooms, where privacy and confidentiality could be kept. But a couple of pharmacists
were busy or were the only pharmacist working in the pharmacy and the interview had to be carried
out in the pharmacy, while working with prescriptions or handling costumers. Some interviewees
preferred to do the interview while working in the pharmacy. This led to interviews with a lot of
distraction and pauses. The interviewer had to stop the recorder and repeat the question to re‐
discover the thread again. One interview was carried out at a coffee shop because the pharmacist’s
pharmacy was too far away to be visited, although it was in a quiet and empty area of the coffee
shop.

Data Collection
The interviews were conducted by the author on pharmacists and pharmacy technician in retail
pharmacies in Sacramento and nearby communities in Northern California, USA. Every interview was
opened by a presentation of the study and the author/interviewer. The interviewees then had a
chance to ask questions. A written consent form (Appendix 2) was read and signed by all the
interviewees before the interview was conducted. Interviewees have to be informed and give their
consent to avoid any problems in the future for both the interviewer and the interviewees (41). The
Face‐to‐face interviews were conducted with an interview guide (Appendix 1) and all interviews were
recorded digitally. The interviews average length was 26 minutes, ranging from 12 to 53 minutes.

Kvale states that a “pilot study” should be done in the first stage of any data gathering, in order to
gain experience (41). After the first interview with a pharmacy technician the author sent the
transcribed interview to her supervisor for advices and recommendations. After the three first
interviews, the author revised the questions after consulting with the supervisor. The interview guide
was revised one more time after four more interviews.

The study was supposed to explore the retail pharmacy’s experience with generic drugs, but one
interview was made with a hospital pharmacy pharmacist to learn about the differences in retail and
hospital pharmacies and the hospital staff’s experiences. Since the generic drug system and generic
drug substitution worked the same way, no emphasize was made on the hospital pharmacies’ system
in this study.

Data Analysis
The recordings were transcribed verbatim by the author into text to be further analyzed. The analysis
of the study was a content analysis with editing approaches (45). Qualitative studies are
characterized by the simultaneous collection and analysis of the data (43). The data, in this case the
interviews, were analyzed to shape the ongoing data gathering. The advantage of this qualitative
content analysis is that the researcher can go back and refine questions, develop hypothesis and
pursue questions and problems that may emerge. Qualitative research uses categories to explain and
describe social phenomena. The categories will be based on the writer’s interpretation of the
patterns and meanings of the result and are obtained gradually from the data (46).

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Research has shown that the use of more than one analyst can improve the consistency or reliability
(41) (46). However, other research states the opposite (46). In this thesis the author analyzed and
categorized the data independently and the result was audited and discussed with the supervisor.

Initially the data in this study the transcription of the interviews were read and reread to indentify
and index categories. This was particular sentences, phrases or words the respondents gave. The
different decoding was compared and categorized; by other words the different sequences had
different etiquettes. The codes were then compared to see a pattern (44). The author wrote all the
relevant phrases and word in an extensive mind map. A mind map was chosen because of its
flexibility to use both writing and drawing. The phrases or words that belonged together were moved
to the same area of the page, the areas circled and these circles formed the categories. A total
number of five categories were found.




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Results
By interviewing the pharmacy staff an overall picture of the procedure at the retail pharmacies was
achieved. This first section describes the whole work process in the pharmacy with emphasize on
generic drug substitution and the next section will present the results from the interviews.

From prescription to dispensing
Like many other countries, there are a couple of ways for a physician to write the patient a
prescription in the U.S. The doctor can write a paper prescription for the patient to drop off at the
pharmacy or the doctor can call or fax in a prescription by himself or through a nurse. The doctor can
also send an electronic prescription to the pharmacy, but it is still very rare at retail pharmacies.

At the pharmacy, the pharmacy technician is the first staff member the patient meets. The pharmacy
technician receives the prescription and if the patient is new with the pharmacy, their date of birth
and address has to be registered into the patient system. When the prescription is a dropped off
prescription the technician verifies the patient’s name, date of birth, date of prescription,
prescriber’s signature, health insurance documents and check if the prescription has a DAW –
dispensed as written. For example if the prescription is for a brand, a DAW prevents the pharmacist
from switching it to the generic, even if the health insurance covers the generic. If there is no DAW,
then the computer system always default the brand name medication to a generic medication.

When the prescription gets to the pharmacy, the technician scans the prescription in. They start by
checking the prescription’s date, if it’s a new medication for the patient, the name of the drug, the
direction, notes from the doctor and finally if it is covered by the patient’s insurance company. The
system automatically checks the doctor’s DEA‐number to identify and verify the right doctor.

Then the technician types the prescription into the computer system and after it has been reviewed
by the pharmacist, the pill counter dispenses a bottle with the right label and right amount of pills.
Almost every medication is dispensed in the pharmacies’ dispensing bottles, rarely in their original
packaging. The next step for the technician is to check the medication’s label, count the pills and sign
the bottle. All the patient’s prescriptions are put in the same basket and for the pharmacist’s last
verification check. The pharmacist counts, matches the pills to the database and does the last
checking of the medication before the medicine and the information leaflet about the drug is
dispensed to the patient. If the prescription is called in by telephone, only a pharmacist or a
pharmacist intern can take the call and write it as a new prescription, then the prescription is
scanned into the computer system and typed up by the pharmacy technician, in order to be filled.

When the patient picks up his/her medication they have to show their ID and health insurance card.
For the verification the cashier usually ask for the patients’ phone number or address. They pay to
the cashier, who is usually a pharmacy technician or a pharmacy aide. If the patient has any
questions regarding the medication they are referred to the pharmacist in the counseling window.

Every insurance company, including the state insurance Medi‐Cal has its own formulary. A formulary
is a list of approved drugs that will give the patients the lowest co‐pay. This list can change every
year, every six months or even every month. If the patient’s insurance company’s formulary doesn’t
cover for the medication the patient request or the doctor prescribed, the patient has to either pay
higher co‐pay or out of pocket. This can in many cases be very costly. If the patient however has a
reason for wanting that specific medication that is not covered the pharmacy can contact the

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doctor’s office and tell them to do a PA – prior authorization. This means that the doctor’s office
sends the insurance company a medical justification (why the patient cannot take medication on
formulary, patients’ allergies) and a list of drugs in the same class that the patient already tried but
did not work for the patient. Then the patient has to wait for a response from the health insurance
company.

If the patient is on Medi‐Cal there is a different system to do a PA. The pharmacist requests
information about the patient and an approval for the substitution from the doctor and then the
pharmacist sends the information (the same as for private insurance companies) to Medi‐Cal
electronically.

To conclude, the generic drug substitution is a common phenomenon in the pharmacies, but the
procedure is complex with its many components.

Results from the data analysis
The analysis of the data resulted in five main categories.

1. The system in general
   a) Why generic drugs are common in the U.S.
   b) The changes over time
   c) The lack of mandatory information to the patients
2. The problems
   a) Problems at the pharmacy
      i) The lack of generics
   b) Problems at the doctor’s office
      i) Communication issues
      ii) “Dispensed as written”
      iii) The nurses
   c) Problems with the health insurance company
      i) The prior authorization
      ii) The changing formularies
      iii) Medi‐Cal
3. The economical aspects
   a) Savings for the patient
   b) The pharmacy’s profit
   c) The health insurance company’s profit
4. The pharmacy staff
   a) Opinions and knowledge of generic drug substitution
      i) Generic and brand name drugs are “exactly the same”
      ii) The most common questions from the patients
   b) The pharmacist’s role
      i) The importance of counseling
      ii) The patients responsibility
      iii) Other ways to inform patients
      iv) The pharmacist’s education about generic drugs
   c) The pharmacy technician’s role


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