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

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

2 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.

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

3 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

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

4 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

5 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.

6 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).

7 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. 2 years specific studies 4 years pharmacy school 1‐2 years fellowship (optional) No standard education On‐set training Informal technician programs: college, hospital, organizations None High school diploma preferred Licensure Exams: NAPLEX and MPJE Hours of pharmacy experience Age requirements No criminal records High school diploma No criminal records Must be registered with State Board of Pharmacy National certification exam None Skills needed: Experience with: cashier, customer service, inventory Job description Delegation and supervision Counseling Distribute prescription drugs Monitoring the progress of patients Prescription preparation Provide customer service Administrative duties within a pharmacy Answering telephone calls Stocking shelves cashier Prepare insurance forms Maintain patient 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

8 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)

9 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

10 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

11 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).

12 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

13 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”

14 (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

15 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

16 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).

17 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.

18 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).

19 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.

20 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

21 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

22 i) No patient counseling 5. The patients a) Pain and psychiatric medication b) The side effects c) The lack of societal promotion for generic drugs 1. The system in general The majority of the interviewed pharmacy staff emphasized how common generic drugs are in the American pharmaceutical setting. Most of the respondents used the expression “defaulted in the system” when talking about generic drugs. Well, our system in Walgreens, our system is set up to default, to default generics on all medications that is not documented as a DAW – dispensed as written. The only time we would keep it as a brand is when preferred by the costumer.

[P1]2 Why generic drugs are common in the U.S.

To prove how common generics are in the pharmacy system, one interviewee showed a monitor with statistics with the usage percentage of generic drugs over total amount of prescriptions in the pharmacy. The retail pharmacies are monitored to get reports on how much brand versus dispensed generics that every pharmacy dispenses. The average percentages of generics dispensed over all dispensed prescriptions were at all the pharmacies in the study over 90 %. One pharmacist showed the monitor over the whole district of Sacramento’s pharmacies and stated that a percentage of lower than 95 % was rare.

If too much brand drug medication is dispensed, the pharmacy manager will be warned and the staff can be retrained. Even though many respondents agreed on that patients prefer brand, it is still the generic drugs that are dispensed in a very large quantity. “You see, this is our usage of generics, every store is higher than 90%, so I don’t think generics are a problem.” [P4] Most respondents state that even though the patient request the brand, the pharmacist who is counseling always try to convince the patient to accept the generic drug. One reason is that the generic drugs are more or less always available on the pharmacy shelves.

The patient will get their medication on‐site without any time‐consuming special orders or prior authorization and they can avoid any delay of their drug treatment. This will lead to an overall more efficient drug treatment for the patient.

The most essential reason, according to the respondents, for the patient to stay on the generic drug is that in most cases generic drugs are always covered by the insurance companies’ formularies. If the medication is on the formulary, the patients are only required to pay the cheapest co‐pay. From a practical point of view this means the least work for all the parties, the patient, the pharmacy, the doctor and the health insurance company. According to some respondents, this is what the patient request and asks for when they drop off their prescription at the pharmacy. “So a lot of time when the patient gets a prescription they want to make sure that the generic exist because the co‐payment can be so different.

A lot of them there is a 5 dollar 2 P1 = Interviewee number 1 (see appendix 4 for data about the interviewees)

23 copayment on generics and 35 dollar on brand, and if you have 10‐15 prescriptions a month it’s really important.” [P4] The doctors can, according to the respondents, prescribe either brand name drugs or generic drugs. From the respondents experience the majority of prescriptions have a brand name drug. This can be of many reasons. The doctor may prefer and believe in the brand name drug or brand name medications in general. Furthermore respondents explain situations when the doctors simply forget or does not know the generic name. There have also been occasions when the doctors are unaware of the existence of a generic product.

In some cases, doctors generally stay with the brands. The respondents gave examples of thyroid medication and anticoagulants.

The doctors can also educate the patients more about generics, suggested some respondents. If the patients hear about generic drugs both at the doctors’ office and the pharmacy, they might accept it faster and not be confused and upset at the pharmacy. “They could definitely tell their patients they might get generics. But sometimes that’s what (the brand name drug) the doctor’s have a t the office or that’s what they want for the patients…” [P10] A more controversial reason is that doctors receive incentives from pharmaceutical companies to prescribe more brand name drugs. Many respondents were agreed on that there is “something going on behind the scene” and that doctors’ office get many benefits for prescribing brand name drugs.

The pharmaceutical companies’ representatives also leave pre‐printed prescription forms for the brand name drug, to encourage the doctors to prescribe their product, according to respondents who have seen the preprinted forms. But according to the state of California, the preprinted phrase “do not substitute” is not valid unless there are initials or the signature of the doctor next to it. “Brand name companies also makes “pre‐printed prescription forms” so the doctor doesn’t have to remember the names, just sign! Even a lot of them says “don’t substitute”” [P13) The changes over time Respondents with many years of experience points out how many more generic drug companies there are now compared to 20 years ago.

They experienced that the numbers of many generic companies is the biggest difference comparing today to 20 years ago. New generic drugs keeps showing up on the insurance companies’ formularies and coming in to the pharmacy continuously and it is hard for both pharmacy staff and patients to keep track of new generic drugs. Sometimes the pharmacists were surprised about a new generic drug that has been ordered to the pharmacy without their notice.

“Of course when I just started as a pharmacist although there were some generics available, most people still received the brand name, and as it more and more progressed more and more generic drugs became available.”[P12] When interviewing the older pharmacists with many years of experience, they claimed that the biggest difference from today’s generic drugs to the ones 20‐30 years ago is their quality. The generic drugs back then were, according to the respondents, poor in quality. One respondent state that he

24 experienced that the quality control from the FDA has improved considerately over the years.

Also, many respondents point out that there are many generic drugs made by foreign manufacturers. “In the early 80’s, the quality control for generics were… You could get bottles of pills for patients that were “oh here you go, powder!” (laughter). As time has gone on there are more and more generic manufacturer in foreign countries. But overall the quality and quality control has improved. “ [P13] The respondents with many years of work experience also states that along with the increasing numbers of generic companies and insurance companies, the work load for pharmacists at the pharmacy has increased.

One example is the insurance companies’ formularies, before the few numbers of insurance companies sent the printed out formularies to the pharmacies and the pharmacy staff could physically look it up for the patients. Today there are over 50 insurance companies and each one of them has their own formulary that updates every month to six month. But to the respondents’ relief, the computerization of the pharmacy has facilitated for the pharmacy staff substantially; the formularies for example are emailed out to the pharmacies. Some respondents claimed that a couple of decades ago it was more common for the pharmacist to ask their patients if they prefer brand name or generic drug when they dropped off the prescription.

Back then most patients received brand drug medication. Today’s computer system automatically default the drug name to a generic drug name. Furthermore, there were more counseling to explain the differences back in the days.

The lack of mandatory notification to the patients California’s state law states that the pharmacy can choose to perform a generic drug substitution if there are generic drugs available. The only exceptions are when the patient demands the brand drug for various reasons or if the doctor has signed “do not substitute” or “dispense as written”. The pharmacies’ computer system automatically default a prescribed medication to the generic version of it, unless there is a comment from the doctor or refusal from the patient. Even when the prescription is called in by phone and typed out by the pharmacy staff, the brand name drug always automatically switches to a generic name drug.

“Well, the way it works with our computer system and when practicing pharmacy is that generic medicin is dispensed unless stated that brand name is required so it is defaulted to generics…” [P4] As seen in Figure 2 under The History of Generic Drugs in the U.S., California is a state where patients consent and notification about the generic substitution is mandatory. But almost all of the respondents claim that they rarely inform the patient about that their medication has gone through the generic substitution. In general the pharmacist informs the patient when information is requested, as many respondents stated.

Some respondents claim that the patients are very familiar with generic drugs and that the patients do not request the information from the pharmacist. Other respondents explain that they only inform about the substitution when it is a new patient, a new generic drugs has entered the market, mainly when there has been a change for the patient. “We usually don’t (inform the patient . But most patients understand the generic and the brand name. They understand it very well” [P2]

25 One pharmacist experienced that the patients are not even aware of the generic substitution. “Interviewer: Do patients know that their medications always get automatically substituted to a generic? P11: No, I don’t think so. When they get the medication, they always wonder why it’s a different name.” [P11] Some respondents state that patients have poor information about generic drugs and that information from the pharmacist should be provided for them every time they pick up the prescription.

“If things get to busy it (counseling) doesn’t happen every time, then the patient usually call and say “this time my pill is yellow, last time it was purple”, so it is hard to convince them that it is the same medication.

So it’s better to address it before they get it.”[P12] 2. The problems According to the respondents, usually the problems with generic drug substitution start when there is a change in the system. For example when the patient want brand name drug instead of generic drug which is the action that emerges problems with the insurance, the prior authorization, patients’ co‐pay rises, patient confusion, the failed drug treatments and so on.

Problems at the pharmacy – the lack of generic drugs When interviewing the pharmacy staff about their experience with generic drugs, the general opinion about generic drugs is that the whole American system is very familiar to generic drugs and therefore there are few problems. Some respondents claimed that generic drugs are released to the market to slow and that many patients are asking for generic drugs, knowing that the price and their co‐pay will decrease when a generic drug enters the market. Respondents claim that generic drug company and the pharmacy are in general slow to get the generic drugs to the pharmacy and into the computer system.

Sometimes the pharmacy staff or patient hears about a generic drug for some medication, but it takes month before it actually shows up on the shelves of the pharmacy. That is an issue that can be improved, according to the respondents.

“(Pharmacy chain store name) is very fast to get new generics out to the store, I’ve worked for other companies that are very slow and patient get very angry when it’s not available.” [P13] Some pharmacists agree on that 17 years for the brand name manufacturer to release patent are too long and for the patients’ good it should be released earlier. But they also stated that it is a subject for the FDA to decide on. Problems at the doctors’ office Communication issues One problem that comes up frequently is the communication or more likely lack of communication with doctor’s office. When the author asks about doctors’ office in the interviews, many respondents make very bothered face expressions to show their disapproval.

According to them, the doctor’s office is a very busy place and any issues that goes through there are very time‐consuming. One

26 respondent states that the most doctors’ offices usually need more organizational skills (P9). But in general, most respondents point out a very good relationship with the doctor’s offices. “There are many problems. We do make calls and send out faxes, sometimes it doesn’t get passed down from the nurse or the doctor, and sometimes they get disregarded. Sometimes faxes get turned away so / I know they’re busy as well but more organizational skills would be better.” [P9] “Dispensed as written” According to the respondents, the doctors listen to their patients and respect their requests. As one respondent expressed it “the last decision lies with the patient” (P5).

The doctor has to comply with the patient’s request, because in the end it is the patient who is paying for their medication. Some respondents state that some doctors can be very specific and very keen on signing for DAW or “no substitution”. Pharmacist also explained that some DAW can also be signed by mistake. If the pharmacist goes into the patient’s profile and discover that the patient’s always been on generics and the prescription says brand name and DAW, the pharmacist usually calls the doctor to make sure he prescribed the right medication. Many times it can be the doctor who made a mistake, then the doctors’ office must fax over a new prescription for the patient.

The nurses Another issue that reveals when discussing problems with doctors’ offices is nurses. Many respondents express that nurses are sometimes not authorized to make the decision for the patient, but still do it because of different reasons. Some nurses are too self‐confident, whilst other are just too busy to talk to the doctor first.

“Interviewer: I talked to other and they mentioned nurses… (P11 rolls her eyes and laughs) why did you make that face? P11: No! Because some of the nurses think they know their patients and deny you (a PA) no matter what. Then you have to tell the patients to talk to their doctor, that we already talked to the nurse and we can’t do anything more from our end.” (P11) Some respondents have experienced nurses telling them that the doctors’ office does not do any prior authorizations and that the patient has to contact the doctor for a new prescription. Most respondents believe that this leads to many inconveniences for some patients who need their medication immediately.

One respondent commented that emergency rooms never do PA but if it is a primary care doctor’s office denying the patient a PA for a brand name drugs then the best patient care is certainly not given.

“I had a couple of situations when the nurses say “we don’t do prior authorizations”. Sometimes that’s not ok when some things are needed immediately. Sometimes if it’s just maintenance medication the patient can just go in and get a new prescription. But that’s not in the patient’s best interest. “ [P9] But most respondents emphasize that overall the pharmacy has a very good relationship with the doctors’ offices and the problems that are existing are hard to solve.

27 Problems with the health insurance companies The prior authorization When a patient chooses brand name drug instead of the defaulted generic drug, a couple of problems for the patient emerge.

Most insurance companies’ formularies cover for generic drugs only and if the patient requests the brand because of their preference for brand or allergy to the generic drug, the pharmacy has to do a prior authorization. Even thought the insurance company approves the prior authorization, the patient still needs to pay the insurance company’s higher co‐ pay for generic drugs, because the drug is non‐formulary. If the patient is insured by the private insurance company, the pharmacy has to call or fax the doctors’ office to request the doctor to do a prior authorization with the insurance company.

The pharmacy then has no responsibility for the procedure; it is up to the doctors’ office to send the insurance company the medical justification (why the patient needs the brand) and the information about the patient.

“ I send the doctor a fax and say “this medication is not approved and we need to have a prior authorization, please call this insurance number”. Doctors, if they do that, then the insurance company or the doctor calls you and then you call the patient.“ [11] Even if the pharmacy has no responsibility for a PA performed for a private insured patient, some respondents still experience some problems. The patient usually calls the pharmacy, not the doctor, to check up the process and it is the pharmacy that has to explain the procedure. This increases the work load for the pharmacy and it is the pharmacy that has to receive the patient’s anger and frustration.

One reason for this is the fact that it is hard to contact the doctors’ office. If a prior authorization needs to be done for a patient insured by Medi‐Cal, the state plan, the pharmacy takes care of the process. The pharmacist has to log on Medi‐Cal and send an electronic request, with the justification for why the patient needs the brand and a list of all the medication the patient has tried but could not take. This part does not take long time, most respondents’ experiences are 1‐3 days. But if the pharmacy get a rejection, which can be because of not enough information about the patient or invalid reason for not wanting the generic and, it takes an addition of 3 days until Medi‐Cal reviews it again.

The patient has to contact the pharmacy every day to see if they are approved or not, which also increase the work load at the pharmacy. Most respondents state that a PA can be very time consuming, but that there is no way to get around this problem or simplify the matter. Since the insurance companies more and less always have generic drugs on their formulary, a patient who wants a brand name drug will always have to comply with these rules. One respondent experienced that putting a note from the pharmacist in the PA, telling the administrator to speed up the process for the sake of the patient, could sometimes speed up the process.

“When I send a electronic PA I can indicate “please speed up the patient, the patient is in need of medication”. I can put in a comment there, so whoever is reviewing understands it’s stressed. But that’s all you can do.” [P11] The changing formularies One respondent states: “Life would be much easier if there was one universal formulary” [5]. This sums up what most respondents thought about the health insurance companies’ formularies. The pharmacy staff’s biggest issue is the health care insurance companies. As mentioned earlier, the

28 pharmacy encounters problems with insurance companies when performing a PA for the patients, but there are other problems. All the insurance companies have different formularies with the drugs they “prefer” and the drugs on the formulary has the lowest co‐pay. If the patient requests any drugs not on the formulary or want their old drug manufacturer instead of the one on the formulary, it will cost them higher co‐pay. However, it is impossible for the pharmacies to keep themselves updated with the formularies, the formularies can change every year, every six months and even every month.

Most respondents agreed on that they had more knowledge about the Medi‐Cal’s formulary, because they handled it more than other formularies. The confusion for the patient comes unfortunately at the pharmacy when the patient picks up the drug and discovers much higher co‐pay. “Most of the time the pharmacists have no idea when the formulary got changed or what drugs are included in the formulary for some insurance company, we don’t know until we encounter the drug and the insurance reject it, so we don’t need to keep up with the insurance company.” [P2] “There’s no way we can memorize the formularies, they’re all different and they’re all changing.

So all we do is when we fill the old insurance and then we see if it covers or not. Except for Medi‐Cal, Medi‐Cal we know more about.” [P10] Manufacturers who are competing with each other for the treasured spot on the insurance companies’ formularies, that the generic drug on the formulary switches manufacturers every month. This is a source for further patient confusion. When the formulary changes, the pharmacists are obligated to offer their patients the cheapest co‐pay, the patient can get a generic drug with a different manufacturer from now and then and of course that confuses them. “In the past patients generally stayed on one manufacturer.

But there’s so much competition now, so there are multiple manufacturer so because of that when our computer system sees that there is a cheaper manufacturer, they’ll send us the cheaper one. So let’s say we always get manufacturer A, for some reason manufacturer B is cheaper, so automatically it switch.” [P7] When discussing this problem most respondents stated that they try to keep the patient on the same manufacturer even when the formulary changes, but it is not always possible. Sometimes the patient’s manufacturer’s drug is not available in the pharmacy and needs to be ordered. “Just for customer service level we try to keep the manufacturer the same, because it’s better customer service, especially our older patients, we don’t want them to go home every month with different pill, colour or shape of Fluoxetin.” [P4] Even pharmacists expressed that they also felt confusion when a new generic drugs is ordered to the pharmacy, of which they have never heard of.

“But sometimes I don’t even know a generic is available until it comes into my pharmacy or it get substituted and you’re like “oh wow, is this available [ P11]

29 Medi­Cal The state insurance Medi‐Cal’s formulary is a very valuable formulary to be on for the pharmaceutical companies, since many patients are insured with Medi‐Cal. Med‐Cal has however many brand name drugs on their formulary, which means that the co‐pay for these drugs is higher for the patient. This also leads to many problems for the pharmacy. When other insurance companies prefer generic drugs the pharmacy orders and stock mostly generic drugs, but Medi‐Cal prefers the brand name drug, the pharmacy needs to do a special order for the patient because brand name drugs are very rare on the pharmacy shelves.

Consequently this leads to longer wait for the patients to start their drug treatment and more expensive drugs for both patients and the pharmacy.

“Yes the state program Medi‐Cal, a lot of times even for a simple antibiotics, like a mixture antibiotics suspension they want it to be brand. If it’s a baby and you don’t have the brand name available in the pharmacy then we have to delay the treatment for the baby, that’s where the problem starts.” [P3] Also, the pharmacy has to pay for these drugs but if the patients chose not to pick up these drugs just end up on the pharmacy’s shelves. The respondents also complain about the requirement to always be updated and to remember to order these brand name drugs for the Medi‐Cal patients. 3. The economical aspect “In America, it’s all about money!” [P2] The quotation above sums up all the problems and benefits of the generic drug system in America.

All of the respondents mentioned profit as the motive for the generic substitution. The respondents were all in one way or another discussing profit, profit for the patient, the pharmacy, and the health insurance company.

“Well if they (the patients) want brand then both pharmacy and insurance company will lose, cause the insurance company has to pay much more money for the brand and the pharmacy makes less money for brand, so both sides don’t want that to occur. “ [P4] Table 2. A summary of the financial incentives from generic drugs for patient, pharmacy and health insurance company. Who saves money on generic drugs? How? Patient Patient pays less co‐pay for generic drug (if it is on the insurance companies formulary) Patient with many prescriptions reaches the “doughnut hole” slower Pharmacy Pharmacy pays less to buy generic drugs Pharmacy loses money if brand drugs are stocked but not sold Health insurance company Insurance company pay more for a brand drug, even if the patient’s co‐pay is higher than for generic drugs

30 Savings for the patients Generic drugs are in most cases substantially cheaper than brand name drugs and as mentioned before, today most insurance companies have generic drugs on their formularies. The patients get to pay the lowest co‐pay if they choose a generic drug instead of the brand name. “The insurance prefer the generics. Usually when the brand is dispensed, it’s usually 3‐4 times the amount of the generics.” [P1] In general, all respondents agreed on the fact that the majority of their patients are on generic drugs. But when the patient’s preference was discussed different answers were given.

The respondents experienced that the majority of the patients prefer brand, but that there were some patients who prefer generic drugs. But comparing all answers it came down to one conclusion summed up well by one respondent: “Patients prefer brand, but they cannot afford it!” [P11] One issue that repeatedly comes up when discussing profit for the patient is the problem with the “Medicare doughnut hole”. Patients have to start paying out of pocket when their prescriptions cost more than 310 dollars every year and until they reach the 6,640 dollars‐limit. Many respondents have experienced that this “doughnut hole” leads to that patients “spread out” their medications.

Instead of taking 2 pills every day, the patient tries to save on their medication by taking only 1 pill every day. This is obviously a big problem for the patient’s drug treatment and health condition. This usually applies for patients with multiple prescriptions and who cannot afford paying out of pocket. If the patients taking the generic drug with a co‐pay of 1 dollar they might reach the doughnut hole eventually, but with a 3 dollars co‐pay for brand name drugs, the doughnut hole will get reached 3 times faster. So even if the patients had different preferences, most of them accept the generic substitution because of financial reasons.

This means also that patients with allergic reactions to generic drugs and needs brand name drugs reach the doughnut hole faster. “I say an example, if you get the brand name Klor‐Con, usually the part D, the brand is 3.30 dollars, generics are 1.10. Some people get only the brand but some of them have a higher amount of prescriptions /…/ and the dough nut hole will be reached within 6 months. And when the dough nut hole is reached then you have to pay the co‐pay which is super high…” [P1] Profit for the pharmacy When asked about the pharmacists’ role in the generic drug substitution, all respondents had different answers.

Some respondents answered that the role of the pharmacist is to save patients money. Other respondents emphasize that the pharmacy is also responsible for the pharmacy’s profit and with generic drug substitution, the profit increase.

“We do from a business standpoint put an emphasize on generics too because our profit for generics can be 2 or 3 times more…” [P4] The same reason generic drugs are cheaper for patient applies on the pharmacy. Generic drugs’ prices are substantially lower than brand name drugs and the pharmacy makes a bigger profit by buying generic drugs for the pharmacy. Also the brand name drugs have a higher probability to

31 remain on the shelf, since fewer insurance companies have brand name drugs on their formularies. If the drugs never get picked up by patients, it will eventually expire and be thrown in the garbage.

Profit for the health insurance company In California’s economical crisis with budget cuts the health insurance companies decreases the drugs on the formularies and covers for fewer. Many of the interviewed pharmacists have that experience, especially the respondents with many years of experience. According to the respondents, the health insurance companies decide whether the patients should choose generic drugs or brand name drugs. One of the respondents stated: “In the US, the insurance company holds the key, not the pharmacist, not the patient, not the doctor” [P2] Depending on what the insurance companies decide to put on their formulary, the pharmacy and the patient has to comply with it, if they want to save money on their medications.

One economical aspect important for patients on Medi‐Cal is the fact that the state insurance has many brands on their formulary. This is an issue very hard to understand for the patient and the pharmacy, according to the respondents. Medi‐Cal is the insurance for the financial weak patients, why would they have expensive brand medication on their formularies? Some respondents have no answer to that question. Some respondents stated that the highest reimbursement rate from the pharmaceutical companies to the health insurance companies will give them the spot on the formularies. Brand name drug companies are constantly fighting for their more expensive brand name drug to be on the formularies in order to keep the market share from the generic brand companies.

One respondent expressed it: “It’s usually the reimbursement rates, the amount they get from the manufacturer will change and if they find there’s another company that pays them more for each prescription, they change to that. There’s a constant battle between the pharmaceutical companies and the insurance. And they go back and forth and in the end it affects the patients.” [P10] One respondent explained why Medi‐Cal is a big problem for the profit of the pharmacies and the patients: Medi‐Cal is a consistent problem, we have to remember to order brand name drugs for only Medi‐Cal patients which is kind of frustrating.

They’re very expensive and then they sit in our inventory and sometimes Medi‐Cal changes their mind and then we’ll be left with brand name products on the shelves. [10] 4. The pharmacy staff Opinions and knowledge of generic drug substitution When interviewing the pharmacy staff about their opinions about generic drugs, all of them were very positive towards generic drugs. Some opinions from the pharmacy staff about generic drugs that came up were:

32 “I think they’re awesome! It’s cheaper for the consumer, cheaper to make and cheaper to keep in stock and on the shelves.” [P5] “I think it’s great! The system we have here, generics is a much better option. If I think of my own insurances I would rather have generics, because I know I have other bills when I go to the doctor. In the American system it pays to stay with the generics.” [10] “I use them and I didn’t have any problems. It’s less expensive and just as effective.” [12] Some respondents, when discussing their own opinions and experience about their own medications, claim that if the price difference is small, they rather go for the brand name drug.

If there is a big difference in the co‐pay, they would pick the generic drug. Some over the counter‐drugs most respondents claimed that since there is a small small difference, they rather go for the brand name drug Tylenol instead of the generic drug made by Walgreens. One respondent expressed her experience as follow: “…For myself, maybe marketing got to me too, I guess I would pay Tylenol rather than Walgreens generics. But that’s for OTC, for prescription drugs, I feel the generics have better quality. Somehow in my mind OTC products don’t have the same quality… I don’t know why, maybe it’s because prescription drugs are more expensive? And brand drugs are much more expensive compared to buying OTC when the price differences aren’t that much.

[P9] Although the pharmacists and the pharmacy technicians are educated in the differences of generic drugs and brand name drugs, there were still some respondents who expressed their disbelief in some generic drugs. One respondent claimed that she tried not to put her patients on a new generic drug that just entered the market. But as one of the respondents expressed it, the pharmacy staff has to believe in the good of generic drugs or else it is hard for them to work in a pharmacy convincing the patient to use generic drugs.

“Also I believe that if you don’t believe in generic then you don’t belong in retail pharmacies.” [P4] No questions were asked about the pharmacy staff’s knowledge about generic drugs. But in the analysis it was discovered that most of the respondents, especially pharmacists, were trying to explain the differences between the generic drug and the brand name drug. Some respondents mention the differences in for example inactive ingredients or that brand drug is substantially more expensive because of the research behind it by the brand name manufacturer. But the most common phrase used among pharmacy staff when describing generic drugs and brand name drugs is “they are exactly the same”.

This is according to the respondents, also the information they give the patient. “I think they’re great and… hopefully everything goes generics eventually, it saves the customers a lot of money and it works exactly the same.” [P11] “So we automatically switch over to the generic, as long as we educate the patient that they are identical to each other.” [P7]

33 Generic and brand name drugs are “exactly the same” When asking the pharmacy staff if they thought they needed more education or training about generic drugs, most respondents were agreed on that they were enough educated to handle the patients’ questions. The main opinion among the respondents was that both patients and pharmacy staff were knowledgeable enough about generic drugs. “I think it’s fine the way it is. In the pharmacy we’re always able to talk to the pharmacist, in that area in particular it’s fine. The pharmacist can always talk to the doctor…” [P10] “I guess we could refresh our memories with brand names because we only use generics all the time.

But I think that’s all. We’re pretty good with generic drugs” [P9] The most common questions from the patients The questions about generic drugs that the pharmacy staff most frequently receives are:  Do the brand name drug and generic drug have the same effect on my condition?  Is there a big price difference?

 Is it the same active ingredients? According to the respondents, patients rarely ask more scientific questions about the difference between generic drugs and the brand name drugs. This may be because the patients are very accustomed to generic drugs and have the knowledge about the differences already or that many patients simply do not have time to ask questions when visiting the pharmacy. The main thing pharmacy staff needs to know to be able to perform the substitution, according to the respondents is what to substitute to. This information can be found in the computer system at the pharmacy “My job is to always say that they’re (the generic drugs and the brand name drug) the same and equivalent, that’s my job as a pharmacist.” [P3] “You have to tell them that they get a generic.

You are the source that tells them that it’s as good as the brand and a lot of people have that question (laughter). They rely on you to tell them the truth.” [P13] The pharmacist’s role The pharmacists are the key roles in the generic substitution, according to the respondents. Generally the patients want reassurance from the pharmacy that the generic drug is as good as the brand name drug when they get substituted. The pharmacist has the authority and education to give time reassurance and advices about their medication. The respondents were agreed on that the pharmacists’ role in the generic substitution is to give the patient the best medication to the best price.

“I think my main role is to try to get the best medication at the best price for the patient to increase drug compliance.” [P9]

34 The patients have confidence in their doctor and the pharmacist, they are the patients’ only source of information when it comes to generic drugs, according to the respondents. The respondents are aware of how much confidence the patients have in them. “A lot of surveys show that pharmacist is one of the most trusted professions.” [P13] The importance of patient counseling When it comes to the question if the patients received enough information about their generic drug, there were different responses.

Most respondents stated that they only inform the patient about the substitution or explain the generic drugs when information is requested by the patient and that is enough for the patient. But some respondents believed that this is not resulting in a good patient care and there are many patients confused about their generic drugs. One respondent believes that the lack of counseling is because of a busy pharmacy or when the patients pick up their refill prescription, the pharmacist assumes that the patient already received the information before. Still, he emphasized that it is important to do the counseling even with patients who come in for their refills.

“They (the patients) surely need more education. You do your best to talk to everybody when they get their prescription. I try to ask patients on refills, even if they got counseled the first time they may not remember it / We have computers we can provide detailed information fast. A store like this can get very busy but it’s very important to pharmacists to keep their patients educated.” [P13] The same respondent also stressed how important it is to do the counseling right at the pharmacy when the patient is picking up the prescription, because it is easier for the pharmacist to explain the generic substitution on site.

When the patient gets home and discovered that the medication’s name is not the same as on the prescription their doctor gave them or that their pill looks different this time, it will only lead to more work load for the pharmacy when receiving an angry or confused phone call.

According to most pharmacists interviewed, the patient’s sources of information about generic drugs are the doctors’ offices or the pharmacies. Many respondents agreed on that there are not much information from the FDA or the society to reduce the patient confusion. Also, the generic companies are not marketing their products, the respondents agreed on that they have not seen advertisement about generic drugs, there are only ones for brand name drugs. But it is unclear if the FDA prohibits generic drug advertisement or if there has been none made. However, the respondents suggested action to improve patients’ knowledge like more advertisement from the FDA or the pharmaceutical companies.

“Most of the advertisements are from the brand manufacturer. I haven’t seen a advertisement from a generic manufacturer. So I actually don’t know if there’s none that have been approved by the FDA or that the generic manufacturers just don’t advertise. Maybe the FDA think that the public will get confused instead of informing.” [P11]

35 The patients responsibility Some respondents were also pointing out the fact that the patients too have responsibility for staying updated with their health insurance company about their medications. According to respondents, some patients come to or call the pharmacy and have a very little knowledge about their health insurance company’s policy and the pharmacy get blamed or yelled at by these angry or confused patients.

“… The patient needs to be more active and keep themselves informed about their insurance. There are some people who don’t even know who they are insured through. They just have a card but they don’t care to look up the company.” [P9] Most respondents agreed on that the insurance companies have some responsibility in informing the patient too, but some respondents stated that the insurance companies use too complicated terms for the patient to understand. The patient just ends up not reading or listening to their insurance companies information.

“So the (health insurance) companies maybe should be more active about informing the patients and the patients need to be more proactive about their medications. A lot of problems can be avoided if they just knew what they get. But there’s a lot of fancy talk when the insurance companies talk to the patients and I think they can get lost. A lot of technical terms, if I wouldn’t be working in pharmacies, I would be confused.” [P9] Other ways to inform patients However, there are other ways than counseling for the pharmacy to inform the patient. The pharmacy staff explains that all generic drug prescriptions receive a label on the information pamphlet which come with the pill bottle.

This solution is used in all the interviewed pharmacies and helps noticing and informing the patients when they receive a generic drug instead of a brand name drug or when they receive another generic manufacturer.

“Well, once a manufacturer switch we have a label that says “the pills may look different, but it’s the same medication”.” [P8, hospital pharmacy] “But when the doctor’s writes for a brand and it gets switched to generics, the label itself has to say “this is a generics of this”. That’s mandatory. If it’s a new prescription I have to come out to tell them that it is a generic.” [P11] The pharmacist’s education about generic drugs The pharmacists interviewed state that they first and foremost learned about generic drug substitution in pharmacy school. Most pharmacy schools give emphasis to teach about the active ingredients and more commonly generic drug names rather than brand names.

Some pharmacists stated that for some medications they only know the generic drug names. In addition, the pharmacists always have access to the pharmacy computer system that can help them find the right generic drug to substitute and the information about the drug.

Most respondents state that the continuing education help them keep updated about the latest news on new generic drugs and other not covered anymore by the insurance. The continuing

36 education is mandatory, but after it is done the only thing the pharmacist needs to do is to “check a box” on a webpage proving that he or she has completed it. The continuing education consists basically of professional magazines and the pharmacy staff can choose to do it online or at their homes. The pharmacy staff might get surprise audits, but one respondent mean that the continuing education is for one’s own good and audits happened rarely now in times of budget cuts.

The pharmacy technician’s role According to respondents, pharmacy technician is the link between the patient and the pharmacist. The pharmacy staff the patient usually encounters first and most frequent at the pharmacy is the pharmacy technician. Most interviewed pharmacy technician went to trait school for a couple of months one respondent only did the board test to be certified pharmacy technician, so when asking about their knowledge in generic drugs most of the respondents claim they were educated about it in the pharmacy by the pharmacist. Some of them used the computer system a lot to learn about generics.

“I usually get educated by the pharmacist. Like a rejection, when something is not covered, brand or generics, I inform them what drug it is, they tell me what it is used for and what class it runs /…/ But it also educates me when I look into the drug info on what it’s used for, that’s pretty neat our system has that information. The pharmacist plays a lot of key roles cause I’m always asking them.” [P1] No patient counseling But as a pharmacy technician, they cannot do any counseling for the patient and all further questions about the generic substitution have to be referred to the pharmacist.

If the patient asks the pharmacy technician if the generic drug and the brand name drug are the same, most of the pharmacy technician interviewed answers the patient with a yes, while some of them refers the patient directly to the pharmacist.

“If it’s a question about the generics and how well they work, I would just automatically refer it to the pharmacist. Cause I don’t feel comfortable to do any type of counseling.” [P5] When it comes to the generic substitution, the main thing a pharmacy technician does is informing the patient about the about the drug, although only basic information that can be found in the drug information part in the computer system and refer the patient to the pharmacist or their physician for the rest of the questions.

“We pharm techs cant, here in the States we cannot counsel people, of course we can do it for certain medication that we see every day , basic facts, like how do you use it, stuff like that.

But 9 out of 10 times we’re not supposed to, just for our safety and for the patients’ safety. Pharmacist go to school to be able to answer those questions…” [P6] When asking the pharmacy technicians if they need more education or training about generic drugs, most of them think that it is the pharmacists’ task to handle the questions, since they have been to school for many years.

37 “That’s the pharmacist job and I think it should stay that way. They have the big picture about patient’s health situation, diabetes and so on. Pharm tech don’t have that background knowledge for that type of questions. I think that’s fine.” [P10] However, some responding pharmacists point out that the pharmacy technician can learn about generics from their experience and answer some questions if they know the answer. “Once I explain it to the technician, the technician can answer the questions from the costumer. Most of the time we will refer them to the pharmacist, but the pharmacy team, they have a lot of knowledge about it (generic drugs), since they also need to pass certain exams to become technician.” [P3] 5.

The Patients All respondents agreed on that their experience is that majority of the American patients are positive towards generic drugs.

I don’t think we get a great deal of problem. There is a small percentage that want brand. I think they believe that the quality is there and they don’t get a bad drug. Years ago, there were a lot of those questions. But now for the most part, they accept it. [P13] Only a very small number of patients insist on getting the brand name drug, according to the respondents. However, the patients who disbelieve in generic drugs are often comparing medication to everyday objects like groceries or clothes.

“It’s interesting, there are definitely a lot of people who thinks in terms of (generic drugs) as a grocery item, where the brand may taste better or is a better product, that somehow the generics doesn’t work as well or doesn’t contain as much active ingredient or has other effects than brand name.”[P12] Pain and psychiatric medication This phenomenon applies mostly to drugs where the effect is subjective to the patient, like psychiatric medications and pain medications.

It is hard for the patient and the pharmacy to distinguish between the lack of the generic drug’s effect or that the patients are experiencing placebo. The respondents also pointed at the fact that especially some pain medications are well‐ known for being abused and sold on the black market, which is a big problem in the U.S. “Pain medications are very pricey and sometimes I feel like they’re (the patients) selling it. Pain is very subjective, based on yourself, so when they take the brand medication they think it works great and the generics feels like they don’t work as good or it takes too long to kick in.” [P11] The side effects Many respondents have patients who complain about their generic drug giving them an upset stomach, nausea or that the drug has no effect.

It is unclear if these symptoms are actually signs of the generic drug’s side effect or if the patient is experiencing common side effects for that type of drug.

38 “A lot of costumers say it (the generic drug) upset their stomach or they get nauseated, but I guess a majority of the medications, a lot of them cause nausea, and it’s not much of a difference if it’s a generic or brand.” [P1] No specific pattern in patient preference of generic drugs The patients base their opinions on the information they receive from the doctors and the pharmacists, according to the respondents. Some respondents claimed that the patients’ opinions also get affected by the media. When asked if the respondents have seen some patterns in the patients preference in generic drugs, when it comes to patient background, there are many different answers.

Older patients or older female patients are by far the most common answers to that question. According to the respondents elderly patients have difficulties adapting to the new drugs because they have been on their old brand name drug for such a long period of time. The patient types who prefer brand name drugs, mentioned by the respondents, are:  Older patients  Older, female patients  Female patients  Younger generations who educated themselves  Uneducated people  Wealthy people  Caucasians, Indian and Hispanic The respondents emphasized that mostly it was the patient group of older or older female patients who were the most reluctant to generic drugs.

Big differences in ethnicities or education level were not seen, according to the respondents. Pharmacies which had many low‐income patients insured my Medi‐Cal, were not experiencing many patients who were willing to pay more to get the brand name drugs.

The lack of societal promotion for generic drugs Another issue that might affect the patients’ attitude towards generic drugs is the lack of marketing for generic drugs. According to the respondents, there are few, if any, advertisements for generic drugs whilst there are many for brand name drugs. This could result in the patients’ insecurity and confusion when they experience the pharmacist informing about their generic drugs. “Author: What can have affected their opinions? P10: I think the marketing. They think that brand is the only thing that works for them. Even if you tell them that it’s the research and the name you pay for, in their mind they just feel like the company that created it, it’s the company that’s making it right.

They feel like the generics are fake.” [P10] Most respondents agreed on that patients need more information about generic drugs from society, and first and foremost the information should come from the FDA, who the patients have confidence in.

“I think the FDA should do it (giving out more information), I mean if the generics manufacturer would do it, people would think it would be for their benefit. I think the FDA should go out and inform the people about the generics benefits.” [P10]

39 Discussion This study explored the pharmacy staff’s experiences with generic drug substitution in California and their opinions about generic drugs and the whole system behind it. When the author presented this study to the interviewees, some of them did not understand the purpose of this study. They meant that Americans are very accustomed to the idea of generic drug substitution and that there are no problems with the system.

As the quality of the generic drugs have improved over the years today’s pharmacists experienced that generic drug substitution is defaulted in the American pharmacy system, according to the interviewed pharmacists. The study confirmed that generic drugs were substituted to a very high percentage of total prescriptions dispensed. The same issue is discussed in a study by Suh which shows a generic drug dispensing percentage of 96 % in American pharmacies in 1997 (3). Generic drugs are indeed commonly dispensed in the U.S.(27) so the respondents were at first reluctant about discussing problems.

But the more interviews that were made, more problems with the system emerged.

The California state law requires the pharmacist to have the patient’s consent or notify the patient when doing the generic substitution (25). But according to the interviewees, information to the patients was only provided when the patients ask for it. This is an important reason for why patients still get confused when being dispensed generic drugs. The pharmacists who are responsible for counseling had different experience about this issue. Some respondents stated that their counseling was enough to meet the patients’ demand whilst some interviewees agreed on that the patients need more counseling and information about generic drugs.

Some of the respondents claimed that some patients were not even aware of the automatic generic drug substitution and this results in confused patients’ telephone calls and an increase in work load for the pharmacy. A recent study has shown that the pharmacists’ counseling rate at 33‐74 % (47) and some studies showed that some patients see the pharmacist as a dispenser not a consultant (40). This problem could be solved by increasing pharmacists’ counseling. The pharmacists need to be more active in counseling patients when there is a change in the patients’ prescription (change from brand name to generic drug, change of manufacturer, etc.).

The fact that pharmacists are a profession that patients have confidence in has been showed in other studies (39) and is confirmed by the pharmacy in this study. Since the pharmacists are one of the major information sources they should provide the patients with more information to decrease the existing patient confusion about generic drugs. In the U.S. the prescriber is allowed to prescribe either brand name drug or generic drug for the patient, also when the prescriber writes the prescription he or she can choose to sign the prescription as a DAW – dispensed as written. In this case the drug on the prescription cannot be substituted to a generic drug or vice versa.

The brand name drugs prescription automatically get defaulted to a generic drug in the computer system if there is no DAW. This system has its advantage; it saves time for pharmacy staff to manually substitute which is practical since generic drugs are so common. But on the other hand, the pharmacy staff needs to be alert on informing the patient about the substitution. If the pharmacy staff just makes it a habit to always inform new patients about the substitution, a lot of patient confusion may be avoided. The pharmacy staff interviewed also suggested more information to the patient by other sources.

The majority of the respondents thought that the FDA offered too little information about generic drugs and that a national authority as the FDA should take responsibility to do more advertisement

40 and provide more information about generic drug substitution, since generic drugs are profitable for both patients and the whole health care society. This type of information was also suggested in another study (2). In the U.S., only pharmacists are allowed to counsel the patients (25). But some interviewed pharmacist claim that if the pharmacy technician has a lot of experience about generic drugs and have counseled with the pharmacist in advance, they can answer the questions about equivalency from the patients. Most interviewed pharmacy technicians state that they prefer to refer the patients to the pharmacist, because the pharmacists have the education and knowledge to answer the patients more correctly.

The respondents consider themselves very well educated in generic drugs and that the 15 hours continuing education every year is enough to answer the patients’ questions. They claim that the patients do not demand any scientific or specific information. But when providing the patients with information the pharmacists often refer to brand name drugs and generic drugs as “exactly the same”. The majority of the respondents were very positive to generic drugs and when discussing their opinions most of them used the phrases similar to “generic drugs and brand name drugs are exactly the same”. According to the respondents, that is what they tell the patients too.

This may cause some problems for the patients if the pharmacist ensures them that the different manufacturers’ drugs are exactly the same and then they experience side effects from the inactive ingredients in the generic drugs. This could lead to the patients’ confidence in the pharmacist decreasing. The pharmacist should explain for the patients the differences between brand name and generic drugs, to avoid patients’ confusion and mistrust. The phrase “generic drugs and brand name drugs are exactly the same” may not be suitable to use when counseling the patient. According to most respondents and other studies, a majority of the doctors prescribe the brand name drug, because of familiarity or a higher trust in brand name drugs (29).

This is also confirmed in a recent study from 2010 (30). The respondents had no suggestions about how to change the doctors’ prescribing patterns. Although, most of them agreed on that the doctors’ should offer more information about the generic drug substitution to the patients, so confusion and anger can be avoided at the pharmacy, where they usually hear of generic drugs the first time. According to the respondents and other studies, the patients have great confidence in doctors (47). Another problem discussed was the nurses’ role at the doctors’ offices. Some respondents experienced the nurses were acting out of their authorization rights for example approving an override of the DAW without counseling the doctor or deny prior authorization.

But further research about the nurses roles should be done before any conclusion can be made.

A big problem that emerged when discussing the pharmacies’ and the doctors’ relationships, was the communication problem with the doctors’ offices. These problems usually occur when the patient prefer brand of different reasons and a prior authorization needs to be made for the patient. The doctors’ office is a very busy place and any issues involving contacting the doctor takes time and adds more delay to the patients’ drug treatment. This obviously causes a series of problem for the pharmacy and the patient but the respondents have no suggestions how to solve this problem. As of today, the prior authorization to the health insurance companies (except Medi‐Cal where the pharmacy handles the PA), is required to go through the doctor’s office.

According to the respondents, it would require some national or state law that facilitates it or change it so that the pharmacy handles all the PA’s. But most respondents did not think the problems were enough

41 troubling to even suggest actions to that length. To be able to draw a conclusion if this should be changed to give patients a better service, further studies need to be made. The health insurance companies and the pharmaceutical companies constantly battling about the reimbursement rates, affects the service provided at the pharmacy and in the end the patients’ drug treatment. Some formularies change almost every month due to new reimbursement rate and a new manufacturer on the formulary. This causes confusion at the pharmacy which cannot keep their staff updated with all the health insurance companies’ formularies because of current workload.

Different manufacturer also means different size, color or shape of the pills which naturally causes confusion for the patients. The respondents could not see any solution to this problem. The respondents state that sometimes they keep the patients on the same manufacturer even if the co‐pay for the patient is higher to satisfy the patient. The insurance companies should have a maximum amount of times the formulary can be changed every year. This would lead to a more updated pharmacy staff and a less confused patient.

According to the respondents, the health insurance companies hold the key. Patients and pharmacy have to comply with the formularies of the insurance companies. If for example Medi‐Cal put a brand name drug on the formulary, the patients have to accept the brand name drug for the lowest co‐pay (despite what drug they used before) and the pharmacy needs to remember ordering it for the Medi‐ Cal patients, if not the patients will have to wait for their drug treatment. There are more than 50 insurance companies in the U.S. and according to the respondents some insurance companies change their formulary as often as every month.

The pharmacists’ concern over the constant switch of manufacturer has been expressed in other studies as well(3). This causes a lot of confusion for the patient and the pharmacy. One respondent suggested one universal formulary for all the insurance companies, but that would be almost impossible to put into action. The manufacturer that pays the insurance companies the highest reimbursement rate gets the spot on the insurance companies’ formulary and it is according to the respondents, a constant battle.

Although most of the respondents claimed that the majority of the patients were positive to generic drugs and studies confirm this (33), the pharmacies still experience patients who do not accept generic drugs and demand brand name drugs. But since most insurance companies only cover for generic, these patients have to pay higher co‐pay when choosing a brand name drug, therefore in the end they choose generic drugs. There a couple of reasons why patients want brand name drugs. The patients have a tendency to compare generic drugs to generic products in grocery or clothe stores and think of the generic drug as a fake or lower quality drug, according to the respondents.

This pattern that the patient prefers the brand name drug because they think it is superior to the generic drug is shown in other studies too(32). Although the respondents points out that older patients and older female patients have a tendency to prefer brands, but there are no clear patterns. More attention should be given to the older patients, to make sure that they understand the generic drug substitution. Also no differences between high‐educated and low‐educated patients, or different ethnicities were found in this study, which was stated to exist in other studies(34). According to the respondents, this misunderstanding and confusion can be helped by providing the patients with more information about generic drugs, as mentioned before.

In Sweden, there are studies suggesting improved medication packages with a bigger focus on the name of the active ingredients to prevent patients’ confusion(48), while in the U.S. this problem does

42 not exist, according to the respondents. The pharmacies are dispensing information pamphlets and medication bottles from the pill dispenser, both with a label that say for example “X is a generic drug for Y”. Although, the respondents and other studies (33) emphasize that it is furthermore the patient responsibility to read the information provided by the pharmacy or their insurance company.

For example, much of the confusion at the pharmacy cashier when the patient receives a new generic drug by a new manufacturer with a new price can be avoided if the patient read the information the insurance companies send out now and then.

The insurance companies’ formularies hold the key to what drug the pharmacy has on the shelf and what drug the patient, according to the respondents. Generic drugs are, as mentioned above, defaulted into the system, so most patients choose the generic drug. But even though the insurance companies’ formularies prefer generic drugs because it is cost‐saving for the patient, this cause problems for the patients who are allergic to generic drugs and need the brand name drug. In this case the patients need a prior authorization from the insurance company to get the brand name drug and if it gets approved the patient has to pay a higher co‐pay for the brand name drug.

This will consequently lead to the feared doughnut hole, when the patients’ prescriptions must be partly or later fully payed out of pocket. To avoid paying out of pocket, many patients spread out or skip their medication which can lead to an ineffective drug treatment and worse health condition. One of the coming health insurance reform’s purposes is to cover for the doughnut hole. This may solve the problem of spreading out their medications for the patients who need to be on brand name drug. But the insurance companies’ formularies are hard to change, since they are affected of the reimbursement rates of the pharmaceutical companies who are driven by profit.

Another interesting issue when it comes to the health insurance companies is that Medi‐Cal, which is the public health insurance for low‐income patients, have brand name drugs on the their formulary. This causes many problems for the pharmacy and the patients. The pharmacy needs to order expensive brand name drug to the pharmacy and if they because of some reasons do not, the patients will have to wait and delay their treatment. According to most respondents this is a result of “behind the scenes” actions and financial incentives by the pharmaceutical companies. The pharmaceutical company with the highest reimbursement rate will be on the insurance company formulary.

According to the respondents, Medi‐Cal should be an institution promoting and working for the patients and the public health and not to gain profit. Nevertheless, this is the responding pharmacists’ opinions and the author did not find any studies that confirm these finding so further studies should be made to investigate this issue.

To summarize, most respondents agreed on that generic drug substitution defaulted into their systems and a very common issue but that there are some problems with the American pharmacy system. However, the problems are widespread and include too many parties for any simple improving actions. Methodological considerations Doing a qualitative study about a complex system as the American pharmaceutical system demands a detailed knowledge of the subject. After the literature search the author was fairly knowledgeable about the components of the pharmaceutical system involving generic drug substitution.

To be able to plan and conduct qualitative interviews, the author also did research on interviewing and analyzing techniques. But the fact that the author/interviewer has no experience or training in this

43 field of expertise should be taken in consideration. According to Kvale, the researcher’s interests and expectations influence the research process. Other factors that can affect the outcomes of the interviews are the interviewer’s knowledge, sensitivity, empathy, behavior and appearance (41). Wibeck stresses how important it is for the interviewees to feel secured with the surroundings (44), but the author/interviewer experienced that pharmacy staff in the pharmacies visited was too busy to have time to participate in the interviews in their workplace. Many interviewees preferred to remain in the pharmacy working while answering the questions and some of these interviews were informative but unfortunately most of them contained a lot of distractions.

The interviews conducted after work hours at coffee‐shops or for those who did the interviews on their lunch break in the lunch rooms were much more informative and the interviewee had time to elaborate their answers. Conducting interviews on the work‐site may also have affected the interviewees to keep a “professional” attitude towards the subject of the interview. A common problem with qualitative interviews is that there are too few interviewees for the researcher to generalize the result and come to any conclusion. Kvale proposes a number of approximately 15±10 interviews (41). But studies have shown that qualitative studies need to focus on fewer cases to in detail investigate a specific pattern and logic in that system or model (42).

After 13 interviews, the author/interviewer experienced that the interviewees’ responses did not contain additional new information and that a deep understanding for the system was achieved. One problem experienced by the author/interviewer was the culture and language barrier. This does not have to be a disadvantage, since a researcher outside of the system can discover issues that the one in it might not, by for example asking more detailed questions. Mostly, the interviewer and the interviewees understood each other well. But some questions had to be rephrased to after the pilot study so the interviewees could understand what the question was asking for.

Although, the author/interviewer had good English skills, the interpretation of the respondents’ answers might be different if the interviews were conducted by a person who has English as a native tongue. The sample selection was in many ways heterogeneous (in for example sex, background, ethnicity), but also homogenous since most of the participants worked for the same pharmacy chain. Since the author’s contacts recommended friends or old co‐workers, naturally most of them worked for the same company. Only three interviews were conducted at other pharmacy chains; a grocery store pharmacy, a private pharmacy and a hospital pharmacy.

But interviews at different pharmacy chains and after consulting the interviewees, it was clear that the system of substituting brand name drugs for generic drugs is universal in the United States, so interviewing different pharmacy chains would with high probability give the same result. Although, more heterogeneity when it comes to age or years of work experience should have been considered.

One problem that emerged when the interview guide was revised a few times to explore new findings was that the interview guide may have ended up being biased by the new knowledge. The author wanted to explore the new knowledge and this may have affected the interview guide’s shifting focus on new subjects. This might have led to neglecting of findings that would have emerged if the old interview guide was kept. But, on the other hand, qualitative methods are supposed to give more understanding of a phenomenon and hence further elaboration of the focus, and therefore the interview‐guide, can be relevant.

44 Ideally the analysis should be carried out by multiple analysts (49), but due to time constraint the analysis of the data and the categorization was carried out by the author independently. The results were audited by the supervisor. This result may not be generalized to the rest of the American pharmacist population or even in the whole California. This is a study conducted in California, where the laws and situation of the state can have affected the generic drug situation. The respondents who had been working in other states claimed that even if the generic drug substitution was different from state to state, generic drugs and generic drug substitution is defaulted into the pharmaceutical settings all over the United States.

Conclusion The main findings in this study are:  In the United States generic drug substitution is a very common phenomenon and the pharmaceutical setting with patients, doctors and pharmacy staff are all very accustomed to generic drugs and the substitution, according to the respondents.  Although generic drug substitution is common, the interviewees state that there is still confusion among the patients regarding many issues concerning generic drugs. Most of these issues can be solved by more information from the FDA and more counseling from the pharmacist and the doctor. A particular focus should be on older patients, according to respondents.

 The responding pharmacy staff emphasize that the patients need to take responsibility for their own medical treatment and stay updated about their insurance policies and drugs. This would spare the patient (and the pharmacy) many moments of anger and confusion.  The many problems with health insurance companies’ formularies and communication problems with the doctors’ offices are too widespread to be solved easily, according to many respondents. Also, many problems with the American pharmacy system have their origin in financial incentives, which make them hard to ignore and change in a money‐driven economy like the United States’.

Future studies Some suggestions for future studies are:  More observation studies to confirm and/or compliment the current findings.  Investigate Medi‐Cal’s role in the generic substitution and incentives to put brand name drugs on their formularies and hence complicating matters for pharmacy staff and the patients’ drug treatment.  Look into the possibility for authorities as FDA to practice some control the insurance companies formularies, preventing monthly updates or even one universal formulary for the state or all the states.

 Explore why the advertisement and information about generic drugs is limited and if there is any solution to this issue.

45 Acknowledgements My sincere thanks go out to my study participants for making time for me in your busy schedules. You are the ones that made this study possible. Thank you, my old pharmacist colleagues at the Walgreens pharmacy at Arden Way, Sacramento for sharing your knowledge and contacts, this study would have been hard to accomplish without your support. Sofia Kälvemark‐Sporrong, I am very grateful to have had you as my supervisor. You have been encouraging me through this whole project and always coming with inspiring ideas and your guidance was always one phone call or email away.

Thank you, Erica Olsson for your inspiring discussions, enthusiastic encouragement and review of manuscripts.

A special thank you goes out to my family and friends for believing in me and supporting me in every way.

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50 Appendix 1: Interview guide Name: Age: Pharmacy position: Education: Years of experience at pharmacies: Experience  General: Tell me your general experiences of generic drug substitution. o Walk me through the whole process at your pharmacy?(only the first interviews)  Pharmacist: What would you say is the pharmacist/pharm. tech’s role in the substitution?  Physician: What kind of problems may occur in the communication between doctor’s office and pharmacy? o What kind of arrangement would you suggest to overcome the difficulties? o Prior authorization  Health insurance: Do you experience practical difficulties when doing the substitution?  Patients: What have you experienced is the patients’ attitude towards generic drugs in general?

o What can have affected their opinions about generic drugs?  Does the patient always get the same manufacturer? Lack of consistency?  Have you experienced that generic substitution and the use of generic drugs affect the patient’s drug treatment? – effects/non‐effects, compliance Opinions  What do you think of generic drugs and generic drug substitutions, in general?  Do you feel that brand name drugs have higher quality/effectiveness?  What do you think are the biggest advantages with generic drugs? – price?  What do you think are the biggest disadvantages generic drugs? – confusion, disruption in treatment?

 Patient confusion – if the patient say brand name instead of generic ‐ what can you do? Knowledge  What kind of education or training did you get about generic drug substitution? – drug information, patient communication  What are the most common questions you get about generics? o What do you think the pharmacy staff needs to know about generic drugs to do the substitution? o What actions would you suggest to make pharmacy staff more knowledgeable in this area?

51 Appendix 2: Informant Consent Form, page 1 To the pharmacist/pharmacy technician it may concern, My name is Naffe Nguyen and I am a pharmacist student from Uppsala University, Sweden.

This semester I am writing my master thesis about the The American Pharmacy Staff’s Views and Experiences regarding Generic Drugs. I am currently in the U.S. to do interviews to gather information for my thesis and I would be much grateful and honored if you could participate in an interview. I would like to emphasize that participation in this interview is 100% voluntary and you can anytime change your mind about your participation.

The interview will take 30‐60 minutes and will be recorded digitally. All data gathered will be strictly confidential. Parts of the interview will be presented as a result of the thesis, but your name and other personal information will not be appearing in this thesis. If you have any questions about your participation, you are welcomed to contact me on telephone number: 916‐707‐3697 or email: naffe.nguyen@gmail.com.

52 Appendix 2: Informant consent form, page 2 I _ have read and understand the content of this consent form and I hereby approve to be cited from this interview in future publications of this master thesis.

Interviewee’s signature _ _ Date _ _ Interviewer’s signature _ _ Date _ _

53 Appendix 3: Example of prescription in the U.S. Figure 1. An example of an electronic prescription with a checked “DAW” box. Reference: http://www.psychnotesemr.com/prescriptionwriter.html, (2010‐12‐01)

54 Appendix 4: Data from the interviews Table A. The interviewees’ characteristics Respondent number Position Years of experience Education 1 Pharm tech 3,5 15 months of trait school 2 Pharmacist 5 Dr of Pharmacy, 5 years 3 Pharmacist 3 Dr of Pharmacy, 8 years 4 Pharmacist 3 Dr of Pharmacy, 8 years 5 Pharm tech 4 Trait school, 9 months 6 Pharm tech 4,5 Trait school 8 months 7 Pharmacist 8 Dr of Pharmacy, 7 years 8 Pharmacist 5 Dr of Pharmacy, 16 years 9 Pharm tech 3 No education, only state test 10 Pharmacist 3 Dr of Pharmacy 6 years 11 Pharmacist 8 Dr of Pharmacy 8 years 12 Pharmacist 26 BS in Pharmacy 5 years 13 Pharmacist 28 BS in Pharmacy 6 years