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Family Physician attitudes about prescribing using a drug formulary

Family Physician attitudes about prescribing using a drug formulary Background: Drug formularies have been created by third party payers to control prescription drug usage and manage costs. Physicians try to provide the best care for their patients. This research examines family physicians' attitudes regarding prescription reimbursement criteria, prescribing and advocacy for patients experiencing reimbursement barriers. Methods: Focus groups were used to collect qualitative data on family physicians' prescribing decisions related to drug reimbursement guidelines. Forty-eight family physicians from four Ontario cities participated. Ethics approval for this study was received from the Hamilton Health Sciences/Faculty of Health Sciences Research Ethics Board at McMaster University. Four clinical scenarios were used to situate and initiate focus group discussions about prescribing decisions. Open-ended questions were used to probe physicians' experiences and attitudes and responses were audio recorded. NVivo software was used to assist in data analysis. Results: Most physicians reported that drug reimbursement guidelines complicated their prescribing process and can require lengthy interpretation and advocacy for patients who require medication that is subject to reimbursement restrictions. Conclusion: Physicians do not generally see their role as being cost-containment monitors and observed that cumbersome reimbursement guidelines influence medication choice beyond the clinical needs of the patient, and produce unequal access to medication. They observed that frustration, discouragement, fatigue, and lack of appreciation can often contribute to family physicians' failure to advocate more for patients. Physicians argue cumbersome reimbursement regulations contribute to lower quality care and misuse of physicians' time increasing overall health care costs by adding unnecessary visits to family physicians, specialists, and emergency rooms. Page 1 of 8 (page number not for citation purposes) BMC Family Practice 2009, 10:69 http://www.biomedcentral.com/1471-2296/10/69 This article describes the three levels of drug coverage and Background In Canada and elsewhere, in recognition of the fact that the associated administrative burden on physicians as resources for health care (including drugs) are con- they existed in 2002, prior to the reforms. Under the first strained, formularies have been established to maximize ODBP level of coverage, physicians could prescribe gen- the health of the population from available resources. eral benefit (GB) drugs without consulting reimburse- With the rise of formularies, physicians grapple with ment criteria. When drugs are available from multiple issues such as: determining best therapeutic choices based manufacturers, however, the ODBP required pharmacists on current evidence and clinical experience, and formu- to dispense products with the lowest listed prices. The sec- lary rules controlling third party payers' costs [1-6]. ond level of coverage permitted physicians to prescribe Limited Use (LU) drugs. LU prescriptions required precise Most research in this area has relied on quantitative eligibility codes that justified LU drugs for treatment of approaches such as observational studies of prescription predefined conditions under restricted circumstances. LU drug claims data[7,8] to provide information on what prescriptions required physicians to handwrite and sign physicians prescribe, but are unable to provide insight prescriptions using special ministry-supplied prescription into physicians' attitudes about the prescribing process. pads. The prescriptions were valid for one year from the Qualitative methods are well suited to identify and signing date. explore the complex decision-making processes physi- cians experience when prescribing. A third level of ODBP coverage applied to drugs not listed as benefits. Drugs may not be listed on the ODBP if the The Ontario Drug Benefit Program (ODBP) DQTC finds the evidence has not shown them to be effec- The Government of Ontario manages a publicly-funded tive or safe for the patient population that is covered by prescription drug insurance plan for eligible beneficiaries. the Ontario public plan. These drugs may be made avail- The Ministry of Health and Long-term Care (MOHLTC) able under special circumstances i.e., "to treat conditions provides coverage through the ODBP formulary for or diseases that would otherwise cause severe debilitating patients who are over 65 years or who receive social assist- effects"[9] to patients who are unable to benefit from any ance. This formulary also applies to the ODBP's Trillium of the drugs listed by the ODBP (GB or LU), or who do not drug program to which individuals apply for coverage for meet the strict LU drug eligibility criteria[11]. For coverage prescription expenses in excess of a threshold amount rel- to be granted for unlisted drugs, physicians had to care- ative to their income. fully document a clinical description and therapeutic plan and other information for reimbursement under the Indi- The MOHLTC established the formulary in 1974 in con- vidual Clinical Review Mechanism (Section 8) of the sultation with the ministry's external expert drug advisory ODBP. Medical experts contracted by the MOHTLC committee, the Drug Quality and Therapeutics Commit- reviewed the request and advised physicians if coverage tee (DQTC), that provides independent and specialized was approved. Under the regulations in place in 2002, advice to the Minister of Health and the Drug Programs coverage had to be renewed annually. A full description of Branch on drug-related issues. The DQTC (now known as this mechanism is available in Part VIII of the formu- the Committee to Evaluate Drugs) monitors and evaluates lary[9]. the list of drugs available based on drug use patterns, experience, and current scientific knowledge monthly. For The objective of this qualitative study was to examine fam- drug products to be eligible for consideration for listing in ily physicians' attitudes toward restrictions on prescrip- the formulary, a drug manufacturer must provide a com- tion reimbursement through the ODBP and how this plete submission in accordance with provincial drug leg- influences their prescribing practices. Physicians articu- islation. A complete submission undergoes a thorough lated that formulary requirements exacerbate existing ten- review using current therapeutic guidelines and evidence- sions in clinical practice. This study, however, does not based data[9]. provide a definitive evaluation of the consequences of reimbursement criteria nor does it compare and contrast In June of 2006, Royal Assent was granted The Transparent systems. Rather, it more fully explores the attitudes of Drug System for Patients Act, 2006 that revised a number of physicians in relation to the public drug insurance pro- elements of the publicly funded insurance program fol- gram in Ontario as it was structured in 2002, and expands lowing a comprehensive program review. The MOHTLC's on physicians' sentiments to suggest that additional objectives for the ODBP reforms were: improving patient research is needed to determine how formulary manage- access to drugs, ensuring better value for money, promot- ment practices may impact patient outcomes[12]. ing the appropriate use of drugs, rewarding innovations, and strengthening transparency and accountability[10]. Page 2 of 8 (page number not for citation purposes) BMC Family Practice 2009, 10:69 http://www.biomedcentral.com/1471-2296/10/69 Ethics approval was received for this study from McMaster Methods Participants University's Hamilton Health Sciences/Faculty of Health Using purposive sampling, family physicians from four Sciences Research Ethics Board (REB). cities in Southern Ontario were recruited to participate in one of six focus group sessions in this exploratory qualita- Focus Groups tive study. In cooperation with the researchers, recruit- Focus group questions were developed and pre-tested by ment was conducted by Pollara, a national public and the investigators with five physicians who were represent- private research firm. For the purposes of this study, Pol- ative of the study population. Six focus groups were con- lara contacted physicians who met practice-type eligibility ducted over a two week period in December 2002 with an criteria with the intent to find a sample of Ontario family average of eight physicians per focus group. Sessions aver- physicians. Physicians were drawn from larger and aged two hours in length and were led by a trained focus smaller cities (population range: 2.4 million to 74 thou- group facilitator. sand), and were in full-time family practice in either pri- vate practice, academic or non-academic hospital settings. At the start of each focus group, the facilitator explained Physicians recruited had active practice experience that the purpose of the session and asked physicians to sign a ranged from  10 years to  10 years, and experience in statement of informed consent. Once those were signed, caring for patients > 65 years of age. physicians were presented with two of four possible clini- cal practice scenarios describing conditions commonly A total of 51 physicians agreed to participate and 48 managed by family physicians (see Table 1). The patients attended the sessions. Eighty percent of the physicians in the scenarios were either ODBP beneficiaries or self-pay were in private practice with 10% of the remainder prac- or private insurance beneficiaries. Medications that might ticing in academic and non-academic hospital settings, be prescribed included those available as a GB or through respectively. Most of the physicians were male 69% (n = LU or section 8 processes. The two scenarios were 33), which approximates Ontario's family physician gen- intended to situate the participants in a patient encounter der ratio, 100% were in clinical practice more than 80% of leading to a prescribing decision; thus, they were asked to their time, and 85% had been in practice for more than 10 quietly read each scenario and write a mock prescription. years. Their practice populations included 10 - 75% of The moderator then used semi-structured and open- patients over the age of 65 (mean = 36%). Having experi- ended questions to facilitate interaction and guide partic- ence prescribing for seniors is important given persons 65 ipants through a discussion of their decision-making years of age and over are the largest group of beneficiaries process when prescribing and attitudes about their pre- under the ODBP. A $200.00 (Canadian) incentive was scribing decisions. provided. In this focus group research, sample size was estimated by aiming for 6-8 persons per group with a base In the osteoarthritis scenario the clinical history suggested of 3-4 groups or more until theoretical saturation and that gastrointestinal protection should be considered in information richness was reached[13]. the event a non-steroidal anti-inflammatory drug was chosen. Coxibs, an LU product, were a possible choice but there were safety and efficacy data in the public domain that was stimulating debate about their place in therapy. Table 1: Clinical practice scenarios employed to situate focus group sessions Condition Presentation Asthma A 35 year old asthmatic woman has recently moved into subsidized housing where there are cats. One year ago she had a normal spirometry but has recently experienced coughing, and dyspnea with wheezing and disturbed sleep. She inhales budesonide daily and has increased her use of terbutaline with the recent increase in symptoms. She is reluctant to increase her us e of corticosteroids. Hypertension A 55 year old male has type 2 diabetes that is currently managed with diet and exercise. Physical exam, ECG, BMI, and renal function are normal. Lipid levels are not at recommended targets per the CCS guidelines and repeated BP readings indicate mild to moderate hypertension. Osteoarthritis A 41 year old female began to have right hip pain four years ago that progressed to both hips and knees. Three months of acetaminophen was ineffective for pain relief; naproxen caused dyspepsia and a positive occult blood stool sample. Her smoking cessation efforts (pack-a-day) resulted in weight gain that exacerbated her joint pain. Pain is now daily and may force a job change if not controlled. Osteoporosis A 75 year old male has become progressively more stooped and experienced episodes of back pain over the past 6 months. Densiometry revealed a BMI > 2 SD below the mean for young men and a serum testosterone level on the low end of normal. He has now suffered a fractured wrist in an accidental fall. Page 3 of 8 (page number not for citation purposes) BMC Family Practice 2009, 10:69 http://www.biomedcentral.com/1471-2296/10/69 Proton pump inhibitors, in combination with traditional restricted, they are not always "hassle-free", and require non-steroidal anti-inflammatory drugs, were also recom- formulary consultation for dosage compliance and special mended by existing guidelines and these were also agents forms if a "non-substitution" order is required. that required an LU prescription for ODBP beneficiaries. The osteoarthritis scenario was included in each focus Some physicians reported that, despite it not being their group session because our earlier research[14] confirmed first choice, they might still prescribe a GB drug for a vari- that general practitioners made different osteoarthritis ety of reasons: a) the GB drug is covered, thus the patient management choices (3 different prescribing behavior could get medication immediately, b) the patient's symp- types) depending on the patient's insurance status. How- toms were not acute at the time of presentation, c) a trial ever, the medications actually chosen by the participants of the GB drug might be effective in improving the in response to each scenario were not the focus of the patient's condition, d) the GB drug, while not the most research and were relevant only in so far as they stimu- effective drug in the physician's opinion, was safe and lated discussion among the participants on prescribing effective and did no harm, e) the desire to balance quality choice and attitudes towards prescribing. of care with fiscal restraint, f) if the patient experienced side-effects or the GB drug proved ineffective then the Analysis patient's chart would contain the necessary proof that a Focus group recordings were transcribed and verified GB drug was tried and the patient could then meet the LU against the original recordings. A set of preliminary cod- coverage criteria, and g) the GB drug was a stopgap to be ing categories based on the key questions and content of used while awaiting the lengthy Section 8 approval proc- the data collected were created and then refined and ess. sorted into sub-themes with the assistance of NVivo soft- ware. Two researchers independently coded the tran- Prescribing Limited Use (LU) Drugs scripts and discussed their emergent themes to reach Physicians see their primary responsibility - providing the consensus. Content validity was supported through the best possible care for patients - as "covenantal"[18]. They emergence of substantively similar perspectives held by find it worrisome when patients do not precisely fit the LU physicians across the focus groups. Using these themes we eligibility criteria, especially when clinical experience, describe the common steps of the decision-making proc- interpretation of the evidence, and patient history make a ess and factors influencing prescribing behavior. It should convincing case for an LU drug. One physician explained be noted that focus group responses constitute self-reports that, "it's almost clinical malpractice to give him [the patient] and may not predict actual physician behavior in patient the drug that's free, knowing there is no efficacy, OK?" Physi- consultations. cians see themselves as duty-bound to fulfill their primary responsibility to patients, but realize that health care costs are rising and that potential legal and financial penalties Results Influence of reimbursement guidelines on prescribing loom if they are in contravention of ODBP regulations. Physicians reported that during the clinical consult they diagnose and assess concomitant conditions such as Individual Clinical Review (Section 8) mechanisms and social and environmental factors, prior treatment history, prescribing risks for adverse events including comorbidity and, if drug "Section 8" refers to the "Individual Clinical Review Mechanisms" section of the ODBP Formulary. It is used therapy is chosen, possible drug interactions. Most physi- cians in this study, unlike their counterparts elsewhere, when ODBP-eligible patients either may benefit from LU explained that they review with patients their ability to drugs but do not fit the criteria or when they require drugs pay for medications [15-17]. When most physicians dis- not listed as GB or LU. Physicians must send a written covered that a patient was over the age of 65 years, request for Section 8 review to the Drug Programs Branch received professional services under the home care pro- of the MOHLTC. Ministry staff coordinates a review that gram, or received social assistance, prescribing decisions includes recommendations from the DQTC and expert based on the reimbursement guidelines of the ODBP medical advisors. Written requests must provide a diagno- came into play. sis and rationale for the drug, its trade name, strength and dosage, evidence of effectiveness if the patient has already Prescribing General Benefit (GB) Drugs taken the product, details of alternatives tried including Physicians noted that GB drugs are generally well toler- dosages, length of therapy and patient response. Concom- ated and effective. However, some participants perceived itant drug therapy and other relevant information, such as that current evidence and clinical experience may run con- sensitivity reports or laboratory results, are also trary to ODBP guidelines in which multiple-source GB required[19]. drugs are classified as interchangeable. Participants noted that while GB drugs are commonly viewed as un- Page 4 of 8 (page number not for citation purposes) BMC Family Practice 2009, 10:69 http://www.biomedcentral.com/1471-2296/10/69 A decision to access Section 8 represents a commitment to facilitating clinical decisions. Words such as "red tape", writing multiple letters annually to maintain coverage as "hoops", "barriers", and "bureaucracy" were commonly extensions are not automatic. In cases where the coverage used to describe their experience with the ODBP. In addi- is approved but the dosage changes, a new request must tion, it was common to hear physicians note that they be completed. Some physicians reported that it could take were not confident in the formulary's ability to reflect cur- up to four attempts to get a drug covered. It is relatively rent evidence or clinical experience. common to be turned down on the first try. Physician "burn-out" Advocating for ODBP-eligible patients In general, physicians perceived that the ODBP processes We identified three themes associated with physician seem to have been created to wear down family physi- advocacy: issues related to time, physician frustration and cians. They identified the cumbersome 500-page formu- burnout, and physician-patient rapport. The dominant lary binder, rigid dosages, changing LU codes, complex theme relates to issues of time. regulations and long waits for approval (three weeks to three months) as daily hurdles on the ODBP obstacle Issues related to time course. While most physicians reported that they contin- Physicians believe that already they do not have enough ued to advocate for patients amid frustrations, for some, time with patients and coping with ODBP regulations the daily burden of coping with ODBP barriers resulted in aggravates this problem. One physician noted, "I don't them becoming disheartened and taking the path of least book my patients that tight together. I give them their 15 min- resistance. These physicians could be termed "discouraged utes. But my goodness, you know, I consider that my 15 min- advocates"; they surrender and prescribe the GB drug. utes [are] for diagnosis and a treatment plan, not to handle Physicians reported that they may want to comply with bureaucracy and it gets really frustrating." Other time issues the stepped care approach, (i.e., trying a GB drug and then include: a) time to review patient charts for reimburse- following all steps needed to access restricted drugs in the ment eligibility, b) time to interpret the ODBP guidelines event of treatment failure), but they have many patients and write compliant prescriptions, c) non-billable time requiring advocacy and thus are spending more time for telephone calls with pharmacists, dealing with reim- "jumping through hoops" than providing quality care. bursement problems or writing Section 8 letters, and d) "The frustrating thing, which I think all of us could probably time spent waiting for Section 8 approval. There is the per- attest to, is that we're the ones always holding the bag, because ception that the prescribing process is deliberately made in the end, patients get all kinds of red tape but the family phy- complex and time-consuming to ensure guideline compli- sician has to wade through all of it." Some physicians ance and that this interferes with timely delivery of quality reported that the ministry's inconsistent application of healthcare. Section 8 guidelines eroded their confidence in the system and their ability to successfully advocate for patients. Physicians noted that they must use non-billable time Physician/Patient Rapport (usually at the end of the day) to write and fax paperwork. "Now they [ODBP]don't have a 1-800 number if you want to Despite these obstacles, physicians say they advocate fax so you have to call and wait in line at your own expense for because they care about their patients and feel that they the patient or you have to send it by registered mail as if you are morally and legally bound to provide them with the have nothing better to do then spend time, at least half an hour, best care. One physician summed up the common thread to compose a letter, do it right for the government and then at heard from most physicians: "We could say, 'no, sorry, there our own expense, getting it there and wait for rejection and you is nothing that I can do,' but we care." Physicians admit that know, there are a lot of barriers." Some physicians also per- the rapport that grows between patients and physicians ceived an expectation that they complete LU prescriptions can influence their decision to go the extra distance, but it and Section 8 letters for specialists that their patients also is not a requirement. Having patients who appreciate their visit. advocacy encourages physicians to continue to do so. Committing to a patient's case is time consuming over the Frustration with the ODBP Program long and short haul, and requires tenacity and a convic- Physicians generally perceived ODBP guidelines as disin- tion of the restricted-access drug's efficacy. centive hoops, and saw themselves being used as free watchdog gate-keepers to monitor drug costs. They Factors that influence family physicians' decisions not to thought that strict adherence to ODBP guidelines might advocate fall into two categories relating to patients' cut drug costs, but could create ancillary costs through attributes and the working conditions and policies associ- poor use of physicians' time and burdening other sectors ated with practicing medicine. Physicians noted that they of the system (i.e., emergency room visits). Most physi- tend to advocate more actively for patients who do not cians perceive the formulary as complicating rather than have the income to pay for non-covered drugs. They are Page 5 of 8 (page number not for citation purposes) BMC Family Practice 2009, 10:69 http://www.biomedcentral.com/1471-2296/10/69 disinclined to advocate for patients who have a strong a having the necessary time, stamina, conviction, and sense of entitlement even when they can pay or those who encouragement. These findings are similar to those of pay for expensive alternative/complementary therapies of other published literature[20,21]. Findings reveal that the dubious benefit but resist paying for a more effective but ODBP regulations of 2002 were seen by these physicians non-covered medication. as complex and onerous and had a substantial impact on the physician-patient relationship and on patient out- Some physicians reported that they typically avoid con- comes. The findings and conclusions of this preliminary sulting the ODBP formulary when writing prescriptions study also find resonance in the Ontario Medical Associa- except in extreme circumstances. The most common rea- tion's response to the Drug Strategy Review (DSR) that son given is that the formulary was not usually in the preceded the recent reforms to the ODBP: "When consid- examination room and/or referring to it is onerous and ering the LU and Section 8 processes the DSR Steering consumes precious consultation time with their patients. Committee should not underestimate the depth and Some physicians explained that they write prescriptions intensity of physician enmity to these programs"[22]. for drugs and let the pharmacist research, screen and sort When reimbursement hurdles remain difficult and out the ramifications regarding ODBP coverage. The gen- numerous, there will be some physicians who will eral trend in responses from these physicians is that they become worn down. The result is that reimbursement see their responsibility as primarily caring for their guidelines can influence medication choice and can pro- patients rather than implementing cost-containment duce unequal access to medication. strategies on behalf of the provincial government. In situ- ations where a patient's need was acute, these discouraged Conclusion advocates would advocate for the patient to receive cover- This study provides an understanding of family physi- age, but they appear to struggle with taking a proactive cians' attitudes about prescribing under the ODBP formu- stance. lary as it was designed in 2002. At that time, these family physicians were concerned about the impact of the ODBP formulary on patient outcomes, the loss of their diagnosis Discussion Formulary-based public drug plans extend health cover- and treatment time due to drug coverage paperwork, age for most financially disadvantaged populations and, whether some generic drugs were as effective as name- in some Canadian provinces, for their citizens as a whole. brand counterparts, and the lengthy wait times for drug The formulary review process that is part of every public coverage that they felt could put some patients at risk. drug plan in Canada assesses each new drug for safety, These concerns were addressed in 2006 when the provin- efficacy, and cost-effectiveness. This provides physicians cial government passed legislation to overhaul the ODBP with some assurances of the composite value of those to increase overall transparency and accountability, estab- drugs that do get listed on the formulary. While physi- lish faster drug funding decisions, assess the administra- cians in this study generally agreed that cost-effectiveness tive barriers of the Section 8 mechanism, and replace it is a worthy goal, they did not generally see their role as with a new faster process with the intention of dramati- cost monitors. With respect to their experience with the cally reducing paperwork for physicians and pharma- ODBP as it was structured in 2002, they felt it would be cists[23]. more effective if it more accurately reflected standard clin- ical practice and current clinical guidelines and was less Allan and Innes report that Canadian physicians in British complicated to administer. Physicians also argued that, Columbia have limited knowledge of the actual price of while the ODBP should ideally contribute to the improve- drugs[24]. However, physicians do know that if a drug is ment of the quality of care and keep costs down, it can not included in a formulary it is likely to be more costly also contribute to lower quality of care and to the misuse than formulary alternatives[24]. It may be that the oner- of physicians' time thereby increasing costs to the pub- ous nature of the old ODBP guidelines actually precipi- licly-funded health care system in Ontario by adding tated physicians asking about coverage and ability to pay unnecessary visits to family physicians, specialists, and because they were attempting to determine if they would emergency rooms. require additional time to complete paperwork. Alterna- tively, physicians could be responding to a social desira- Data from this relatively small qualitative study suggests bility factor. that advocacy is situationally bound. While we learned that physicians' decisions to advocate are influenced by While the focus of this qualitative study was not family their understanding of the patient's condition, the level physicians' knowledge of drug costs but on their attitudes and immediacy of risk created by the patient's condition, about prescribing using a formulary, we learned that these and the perceived benefit of a restricted drug, we discov- family physicians' knowledge of relative costs of drugs is ered that their decision to advocate is also influenced by based on their experience that formularies list less costly Page 6 of 8 (page number not for citation purposes) BMC Family Practice 2009, 10:69 http://www.biomedcentral.com/1471-2296/10/69 generic or brand-name drugs and not newer more expen- Competing interests sive ones. Family physicians reported that they learned the Dr. Susan Grant and Mr. Kevin Skilton were, at the time of costs of drugs through daily clinical practice, especially the study, members of the Corporate Affairs Group of when their patients returned to report the high price of a Merck FrosstCanada and were engaged in Canadianpub- drug they prescribed or when pharmacists called saying licpolicy respecting access to innovative medicines. They their patients weren't covered or couldn't afford a drug. participated in the development ofthe research question, Reports of formulary inclusion decisions indicate that the but not in the analysis of the results. Dr. Grant developed coverage decision can be sensitive to the price of a medi- the scenarios, assisted in transcription of the medical ter- cation [25,26]. In their analysis of 58 drugs approved for minology, and in refining the presentation of the analysis sale in Canada in 1996-1997, Anis et al[25] found a sig- of physician prescribing behaviour. All publications nificant association (p < .001) between the price ratio reporting research in which Merck Frosst participatesare (price of the new drug relative to price of the cheapest reviewed prior to publication in accordance with corpo- available comparator on the formulary) and whether cov- rate disclosure policy. erage was granted. This research was sponsored by Merck Frosst, and per- Study Limitations and directions for future research formed by McMaster University researchers and staff. The The findings from this preliminary study cannot be gener- full study team confirms that this paper reflects our own alized to physicians practicing in other provinces or coun- interpretation of the data and that Merck Frosst has not tries, or Ontario physicians practicing under the new biased the research in any way. ODBP regulations. Our findings differ substantially from US data regarding the practice of family physicians asking Authors' contributions patients about their ability to pay. It may be that adminis- All authors participated in the study design and coordina- trative hurdles actually precipitate physicians asking and tion and helped to draft the manuscript. All authors read is an attempt to gauge the impact of embarking on patient and approved the final manuscript. advocacy in relation to the themes described in this study. The relative influence of a social desirability factor could Acknowledgements The authors would like to acknowledge the financial support of Merck not be determined from our results. Moreover, it is possi- Frosst. Parminder Raina holds a Canadian Institute of Health Research ble that some physicians in this study lacked full and accu- Investigator award, an Ontario Premier's Research Excellence Award and a rate information in some aspects of the ODBP, and this Labarge Chair in Research and Knowledge Application for Optimal Aging. could have influenced their discussion. Nonetheless, their comments are still valid, as they are making prescribing References decisions for their patients with this limited understand- 1. Huskamp HA, Keating NL: The new medicare drug benefit: for- ing. Future research, possibly with a larger sample using a mularies and their potential effects on access to medica- tions. 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Ontario Ministry of Health and Long-Term Care Drug System Secre- tariat: Right Drug, Right Person, Right Price: Improving and Governing the Provincial Drug System. 2006 [http:// www.health.gov.on.ca/english/public/legislation/drugs/ drugsact_stakeholder.pdf]. Ontario Ministry of Health and Long- Term Care Drug 1-6-2009. 24. Allan GM, Innes GD: Do family physicians know the costs of medical care? Survey in British Columbia. Can Fam Physician 2004, 50:263-270. 25. Anis AH, Guh D, Wang X: A dog's breakfast: prescription drug coverage varies widely across Canada. Med Care 2001, 39:315-326. 26. Laupacis A: Incorporating economic evaluations into decision- making: the Ontario experience. Med Care 2005, 43:15-19. 27. Allan GM, Lexchin J, Wiebe N: Physician awareness of drug cost: a systematic review. PLoS Med 2007, 4:e283. Pre-publication history The pre-publication history for this paper can be accessed Publish with Bio Med Central and every here: scientist can read your work free of charge "BioMed Central will be the most significant development for http://www.biomedcentral.com/1471-2296/10/69/pre disseminating the results of biomedical researc h in our lifetime." pub Sir Paul Nurse, Cancer Research UK Your research papers will be: available free of charge to the entire biomedical community peer reviewed and published immediately upon acceptance cited in PubMed and archived on PubMed Central yours — you keep the copyright BioMedcentral Submit your manuscript here: http://www.biomedcentral.com/info/publishing_adv.asp Page 8 of 8 (page number not for citation purposes) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png BMC Family Practice Springer Journals

Family Physician attitudes about prescribing using a drug formulary

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Publisher
Springer Journals
Copyright
Copyright © 2009 by Suggs et al; licensee BioMed Central Ltd.
Subject
Medicine & Public Health; General Practice / Family Medicine; Primary Care Medicine
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1471-2296
DOI
10.1186/1471-2296-10-69
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19835601
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Abstract

Background: Drug formularies have been created by third party payers to control prescription drug usage and manage costs. Physicians try to provide the best care for their patients. This research examines family physicians' attitudes regarding prescription reimbursement criteria, prescribing and advocacy for patients experiencing reimbursement barriers. Methods: Focus groups were used to collect qualitative data on family physicians' prescribing decisions related to drug reimbursement guidelines. Forty-eight family physicians from four Ontario cities participated. Ethics approval for this study was received from the Hamilton Health Sciences/Faculty of Health Sciences Research Ethics Board at McMaster University. Four clinical scenarios were used to situate and initiate focus group discussions about prescribing decisions. Open-ended questions were used to probe physicians' experiences and attitudes and responses were audio recorded. NVivo software was used to assist in data analysis. Results: Most physicians reported that drug reimbursement guidelines complicated their prescribing process and can require lengthy interpretation and advocacy for patients who require medication that is subject to reimbursement restrictions. Conclusion: Physicians do not generally see their role as being cost-containment monitors and observed that cumbersome reimbursement guidelines influence medication choice beyond the clinical needs of the patient, and produce unequal access to medication. They observed that frustration, discouragement, fatigue, and lack of appreciation can often contribute to family physicians' failure to advocate more for patients. Physicians argue cumbersome reimbursement regulations contribute to lower quality care and misuse of physicians' time increasing overall health care costs by adding unnecessary visits to family physicians, specialists, and emergency rooms. Page 1 of 8 (page number not for citation purposes) BMC Family Practice 2009, 10:69 http://www.biomedcentral.com/1471-2296/10/69 This article describes the three levels of drug coverage and Background In Canada and elsewhere, in recognition of the fact that the associated administrative burden on physicians as resources for health care (including drugs) are con- they existed in 2002, prior to the reforms. Under the first strained, formularies have been established to maximize ODBP level of coverage, physicians could prescribe gen- the health of the population from available resources. eral benefit (GB) drugs without consulting reimburse- With the rise of formularies, physicians grapple with ment criteria. When drugs are available from multiple issues such as: determining best therapeutic choices based manufacturers, however, the ODBP required pharmacists on current evidence and clinical experience, and formu- to dispense products with the lowest listed prices. The sec- lary rules controlling third party payers' costs [1-6]. ond level of coverage permitted physicians to prescribe Limited Use (LU) drugs. LU prescriptions required precise Most research in this area has relied on quantitative eligibility codes that justified LU drugs for treatment of approaches such as observational studies of prescription predefined conditions under restricted circumstances. LU drug claims data[7,8] to provide information on what prescriptions required physicians to handwrite and sign physicians prescribe, but are unable to provide insight prescriptions using special ministry-supplied prescription into physicians' attitudes about the prescribing process. pads. The prescriptions were valid for one year from the Qualitative methods are well suited to identify and signing date. explore the complex decision-making processes physi- cians experience when prescribing. A third level of ODBP coverage applied to drugs not listed as benefits. Drugs may not be listed on the ODBP if the The Ontario Drug Benefit Program (ODBP) DQTC finds the evidence has not shown them to be effec- The Government of Ontario manages a publicly-funded tive or safe for the patient population that is covered by prescription drug insurance plan for eligible beneficiaries. the Ontario public plan. These drugs may be made avail- The Ministry of Health and Long-term Care (MOHLTC) able under special circumstances i.e., "to treat conditions provides coverage through the ODBP formulary for or diseases that would otherwise cause severe debilitating patients who are over 65 years or who receive social assist- effects"[9] to patients who are unable to benefit from any ance. This formulary also applies to the ODBP's Trillium of the drugs listed by the ODBP (GB or LU), or who do not drug program to which individuals apply for coverage for meet the strict LU drug eligibility criteria[11]. For coverage prescription expenses in excess of a threshold amount rel- to be granted for unlisted drugs, physicians had to care- ative to their income. fully document a clinical description and therapeutic plan and other information for reimbursement under the Indi- The MOHLTC established the formulary in 1974 in con- vidual Clinical Review Mechanism (Section 8) of the sultation with the ministry's external expert drug advisory ODBP. Medical experts contracted by the MOHTLC committee, the Drug Quality and Therapeutics Commit- reviewed the request and advised physicians if coverage tee (DQTC), that provides independent and specialized was approved. Under the regulations in place in 2002, advice to the Minister of Health and the Drug Programs coverage had to be renewed annually. A full description of Branch on drug-related issues. The DQTC (now known as this mechanism is available in Part VIII of the formu- the Committee to Evaluate Drugs) monitors and evaluates lary[9]. the list of drugs available based on drug use patterns, experience, and current scientific knowledge monthly. For The objective of this qualitative study was to examine fam- drug products to be eligible for consideration for listing in ily physicians' attitudes toward restrictions on prescrip- the formulary, a drug manufacturer must provide a com- tion reimbursement through the ODBP and how this plete submission in accordance with provincial drug leg- influences their prescribing practices. Physicians articu- islation. A complete submission undergoes a thorough lated that formulary requirements exacerbate existing ten- review using current therapeutic guidelines and evidence- sions in clinical practice. This study, however, does not based data[9]. provide a definitive evaluation of the consequences of reimbursement criteria nor does it compare and contrast In June of 2006, Royal Assent was granted The Transparent systems. Rather, it more fully explores the attitudes of Drug System for Patients Act, 2006 that revised a number of physicians in relation to the public drug insurance pro- elements of the publicly funded insurance program fol- gram in Ontario as it was structured in 2002, and expands lowing a comprehensive program review. The MOHTLC's on physicians' sentiments to suggest that additional objectives for the ODBP reforms were: improving patient research is needed to determine how formulary manage- access to drugs, ensuring better value for money, promot- ment practices may impact patient outcomes[12]. ing the appropriate use of drugs, rewarding innovations, and strengthening transparency and accountability[10]. Page 2 of 8 (page number not for citation purposes) BMC Family Practice 2009, 10:69 http://www.biomedcentral.com/1471-2296/10/69 Ethics approval was received for this study from McMaster Methods Participants University's Hamilton Health Sciences/Faculty of Health Using purposive sampling, family physicians from four Sciences Research Ethics Board (REB). cities in Southern Ontario were recruited to participate in one of six focus group sessions in this exploratory qualita- Focus Groups tive study. In cooperation with the researchers, recruit- Focus group questions were developed and pre-tested by ment was conducted by Pollara, a national public and the investigators with five physicians who were represent- private research firm. For the purposes of this study, Pol- ative of the study population. Six focus groups were con- lara contacted physicians who met practice-type eligibility ducted over a two week period in December 2002 with an criteria with the intent to find a sample of Ontario family average of eight physicians per focus group. Sessions aver- physicians. Physicians were drawn from larger and aged two hours in length and were led by a trained focus smaller cities (population range: 2.4 million to 74 thou- group facilitator. sand), and were in full-time family practice in either pri- vate practice, academic or non-academic hospital settings. At the start of each focus group, the facilitator explained Physicians recruited had active practice experience that the purpose of the session and asked physicians to sign a ranged from  10 years to  10 years, and experience in statement of informed consent. Once those were signed, caring for patients > 65 years of age. physicians were presented with two of four possible clini- cal practice scenarios describing conditions commonly A total of 51 physicians agreed to participate and 48 managed by family physicians (see Table 1). The patients attended the sessions. Eighty percent of the physicians in the scenarios were either ODBP beneficiaries or self-pay were in private practice with 10% of the remainder prac- or private insurance beneficiaries. Medications that might ticing in academic and non-academic hospital settings, be prescribed included those available as a GB or through respectively. Most of the physicians were male 69% (n = LU or section 8 processes. The two scenarios were 33), which approximates Ontario's family physician gen- intended to situate the participants in a patient encounter der ratio, 100% were in clinical practice more than 80% of leading to a prescribing decision; thus, they were asked to their time, and 85% had been in practice for more than 10 quietly read each scenario and write a mock prescription. years. Their practice populations included 10 - 75% of The moderator then used semi-structured and open- patients over the age of 65 (mean = 36%). Having experi- ended questions to facilitate interaction and guide partic- ence prescribing for seniors is important given persons 65 ipants through a discussion of their decision-making years of age and over are the largest group of beneficiaries process when prescribing and attitudes about their pre- under the ODBP. A $200.00 (Canadian) incentive was scribing decisions. provided. In this focus group research, sample size was estimated by aiming for 6-8 persons per group with a base In the osteoarthritis scenario the clinical history suggested of 3-4 groups or more until theoretical saturation and that gastrointestinal protection should be considered in information richness was reached[13]. the event a non-steroidal anti-inflammatory drug was chosen. Coxibs, an LU product, were a possible choice but there were safety and efficacy data in the public domain that was stimulating debate about their place in therapy. Table 1: Clinical practice scenarios employed to situate focus group sessions Condition Presentation Asthma A 35 year old asthmatic woman has recently moved into subsidized housing where there are cats. One year ago she had a normal spirometry but has recently experienced coughing, and dyspnea with wheezing and disturbed sleep. She inhales budesonide daily and has increased her use of terbutaline with the recent increase in symptoms. She is reluctant to increase her us e of corticosteroids. Hypertension A 55 year old male has type 2 diabetes that is currently managed with diet and exercise. Physical exam, ECG, BMI, and renal function are normal. Lipid levels are not at recommended targets per the CCS guidelines and repeated BP readings indicate mild to moderate hypertension. Osteoarthritis A 41 year old female began to have right hip pain four years ago that progressed to both hips and knees. Three months of acetaminophen was ineffective for pain relief; naproxen caused dyspepsia and a positive occult blood stool sample. Her smoking cessation efforts (pack-a-day) resulted in weight gain that exacerbated her joint pain. Pain is now daily and may force a job change if not controlled. Osteoporosis A 75 year old male has become progressively more stooped and experienced episodes of back pain over the past 6 months. Densiometry revealed a BMI > 2 SD below the mean for young men and a serum testosterone level on the low end of normal. He has now suffered a fractured wrist in an accidental fall. Page 3 of 8 (page number not for citation purposes) BMC Family Practice 2009, 10:69 http://www.biomedcentral.com/1471-2296/10/69 Proton pump inhibitors, in combination with traditional restricted, they are not always "hassle-free", and require non-steroidal anti-inflammatory drugs, were also recom- formulary consultation for dosage compliance and special mended by existing guidelines and these were also agents forms if a "non-substitution" order is required. that required an LU prescription for ODBP beneficiaries. The osteoarthritis scenario was included in each focus Some physicians reported that, despite it not being their group session because our earlier research[14] confirmed first choice, they might still prescribe a GB drug for a vari- that general practitioners made different osteoarthritis ety of reasons: a) the GB drug is covered, thus the patient management choices (3 different prescribing behavior could get medication immediately, b) the patient's symp- types) depending on the patient's insurance status. How- toms were not acute at the time of presentation, c) a trial ever, the medications actually chosen by the participants of the GB drug might be effective in improving the in response to each scenario were not the focus of the patient's condition, d) the GB drug, while not the most research and were relevant only in so far as they stimu- effective drug in the physician's opinion, was safe and lated discussion among the participants on prescribing effective and did no harm, e) the desire to balance quality choice and attitudes towards prescribing. of care with fiscal restraint, f) if the patient experienced side-effects or the GB drug proved ineffective then the Analysis patient's chart would contain the necessary proof that a Focus group recordings were transcribed and verified GB drug was tried and the patient could then meet the LU against the original recordings. A set of preliminary cod- coverage criteria, and g) the GB drug was a stopgap to be ing categories based on the key questions and content of used while awaiting the lengthy Section 8 approval proc- the data collected were created and then refined and ess. sorted into sub-themes with the assistance of NVivo soft- ware. Two researchers independently coded the tran- Prescribing Limited Use (LU) Drugs scripts and discussed their emergent themes to reach Physicians see their primary responsibility - providing the consensus. Content validity was supported through the best possible care for patients - as "covenantal"[18]. They emergence of substantively similar perspectives held by find it worrisome when patients do not precisely fit the LU physicians across the focus groups. Using these themes we eligibility criteria, especially when clinical experience, describe the common steps of the decision-making proc- interpretation of the evidence, and patient history make a ess and factors influencing prescribing behavior. It should convincing case for an LU drug. One physician explained be noted that focus group responses constitute self-reports that, "it's almost clinical malpractice to give him [the patient] and may not predict actual physician behavior in patient the drug that's free, knowing there is no efficacy, OK?" Physi- consultations. cians see themselves as duty-bound to fulfill their primary responsibility to patients, but realize that health care costs are rising and that potential legal and financial penalties Results Influence of reimbursement guidelines on prescribing loom if they are in contravention of ODBP regulations. Physicians reported that during the clinical consult they diagnose and assess concomitant conditions such as Individual Clinical Review (Section 8) mechanisms and social and environmental factors, prior treatment history, prescribing risks for adverse events including comorbidity and, if drug "Section 8" refers to the "Individual Clinical Review Mechanisms" section of the ODBP Formulary. It is used therapy is chosen, possible drug interactions. Most physi- cians in this study, unlike their counterparts elsewhere, when ODBP-eligible patients either may benefit from LU explained that they review with patients their ability to drugs but do not fit the criteria or when they require drugs pay for medications [15-17]. When most physicians dis- not listed as GB or LU. Physicians must send a written covered that a patient was over the age of 65 years, request for Section 8 review to the Drug Programs Branch received professional services under the home care pro- of the MOHLTC. Ministry staff coordinates a review that gram, or received social assistance, prescribing decisions includes recommendations from the DQTC and expert based on the reimbursement guidelines of the ODBP medical advisors. Written requests must provide a diagno- came into play. sis and rationale for the drug, its trade name, strength and dosage, evidence of effectiveness if the patient has already Prescribing General Benefit (GB) Drugs taken the product, details of alternatives tried including Physicians noted that GB drugs are generally well toler- dosages, length of therapy and patient response. Concom- ated and effective. However, some participants perceived itant drug therapy and other relevant information, such as that current evidence and clinical experience may run con- sensitivity reports or laboratory results, are also trary to ODBP guidelines in which multiple-source GB required[19]. drugs are classified as interchangeable. Participants noted that while GB drugs are commonly viewed as un- Page 4 of 8 (page number not for citation purposes) BMC Family Practice 2009, 10:69 http://www.biomedcentral.com/1471-2296/10/69 A decision to access Section 8 represents a commitment to facilitating clinical decisions. Words such as "red tape", writing multiple letters annually to maintain coverage as "hoops", "barriers", and "bureaucracy" were commonly extensions are not automatic. In cases where the coverage used to describe their experience with the ODBP. In addi- is approved but the dosage changes, a new request must tion, it was common to hear physicians note that they be completed. Some physicians reported that it could take were not confident in the formulary's ability to reflect cur- up to four attempts to get a drug covered. It is relatively rent evidence or clinical experience. common to be turned down on the first try. Physician "burn-out" Advocating for ODBP-eligible patients In general, physicians perceived that the ODBP processes We identified three themes associated with physician seem to have been created to wear down family physi- advocacy: issues related to time, physician frustration and cians. They identified the cumbersome 500-page formu- burnout, and physician-patient rapport. The dominant lary binder, rigid dosages, changing LU codes, complex theme relates to issues of time. regulations and long waits for approval (three weeks to three months) as daily hurdles on the ODBP obstacle Issues related to time course. While most physicians reported that they contin- Physicians believe that already they do not have enough ued to advocate for patients amid frustrations, for some, time with patients and coping with ODBP regulations the daily burden of coping with ODBP barriers resulted in aggravates this problem. One physician noted, "I don't them becoming disheartened and taking the path of least book my patients that tight together. I give them their 15 min- resistance. These physicians could be termed "discouraged utes. But my goodness, you know, I consider that my 15 min- advocates"; they surrender and prescribe the GB drug. utes [are] for diagnosis and a treatment plan, not to handle Physicians reported that they may want to comply with bureaucracy and it gets really frustrating." Other time issues the stepped care approach, (i.e., trying a GB drug and then include: a) time to review patient charts for reimburse- following all steps needed to access restricted drugs in the ment eligibility, b) time to interpret the ODBP guidelines event of treatment failure), but they have many patients and write compliant prescriptions, c) non-billable time requiring advocacy and thus are spending more time for telephone calls with pharmacists, dealing with reim- "jumping through hoops" than providing quality care. bursement problems or writing Section 8 letters, and d) "The frustrating thing, which I think all of us could probably time spent waiting for Section 8 approval. There is the per- attest to, is that we're the ones always holding the bag, because ception that the prescribing process is deliberately made in the end, patients get all kinds of red tape but the family phy- complex and time-consuming to ensure guideline compli- sician has to wade through all of it." Some physicians ance and that this interferes with timely delivery of quality reported that the ministry's inconsistent application of healthcare. Section 8 guidelines eroded their confidence in the system and their ability to successfully advocate for patients. Physicians noted that they must use non-billable time Physician/Patient Rapport (usually at the end of the day) to write and fax paperwork. "Now they [ODBP]don't have a 1-800 number if you want to Despite these obstacles, physicians say they advocate fax so you have to call and wait in line at your own expense for because they care about their patients and feel that they the patient or you have to send it by registered mail as if you are morally and legally bound to provide them with the have nothing better to do then spend time, at least half an hour, best care. One physician summed up the common thread to compose a letter, do it right for the government and then at heard from most physicians: "We could say, 'no, sorry, there our own expense, getting it there and wait for rejection and you is nothing that I can do,' but we care." Physicians admit that know, there are a lot of barriers." Some physicians also per- the rapport that grows between patients and physicians ceived an expectation that they complete LU prescriptions can influence their decision to go the extra distance, but it and Section 8 letters for specialists that their patients also is not a requirement. Having patients who appreciate their visit. advocacy encourages physicians to continue to do so. Committing to a patient's case is time consuming over the Frustration with the ODBP Program long and short haul, and requires tenacity and a convic- Physicians generally perceived ODBP guidelines as disin- tion of the restricted-access drug's efficacy. centive hoops, and saw themselves being used as free watchdog gate-keepers to monitor drug costs. They Factors that influence family physicians' decisions not to thought that strict adherence to ODBP guidelines might advocate fall into two categories relating to patients' cut drug costs, but could create ancillary costs through attributes and the working conditions and policies associ- poor use of physicians' time and burdening other sectors ated with practicing medicine. Physicians noted that they of the system (i.e., emergency room visits). Most physi- tend to advocate more actively for patients who do not cians perceive the formulary as complicating rather than have the income to pay for non-covered drugs. They are Page 5 of 8 (page number not for citation purposes) BMC Family Practice 2009, 10:69 http://www.biomedcentral.com/1471-2296/10/69 disinclined to advocate for patients who have a strong a having the necessary time, stamina, conviction, and sense of entitlement even when they can pay or those who encouragement. These findings are similar to those of pay for expensive alternative/complementary therapies of other published literature[20,21]. Findings reveal that the dubious benefit but resist paying for a more effective but ODBP regulations of 2002 were seen by these physicians non-covered medication. as complex and onerous and had a substantial impact on the physician-patient relationship and on patient out- Some physicians reported that they typically avoid con- comes. The findings and conclusions of this preliminary sulting the ODBP formulary when writing prescriptions study also find resonance in the Ontario Medical Associa- except in extreme circumstances. The most common rea- tion's response to the Drug Strategy Review (DSR) that son given is that the formulary was not usually in the preceded the recent reforms to the ODBP: "When consid- examination room and/or referring to it is onerous and ering the LU and Section 8 processes the DSR Steering consumes precious consultation time with their patients. Committee should not underestimate the depth and Some physicians explained that they write prescriptions intensity of physician enmity to these programs"[22]. for drugs and let the pharmacist research, screen and sort When reimbursement hurdles remain difficult and out the ramifications regarding ODBP coverage. The gen- numerous, there will be some physicians who will eral trend in responses from these physicians is that they become worn down. The result is that reimbursement see their responsibility as primarily caring for their guidelines can influence medication choice and can pro- patients rather than implementing cost-containment duce unequal access to medication. strategies on behalf of the provincial government. In situ- ations where a patient's need was acute, these discouraged Conclusion advocates would advocate for the patient to receive cover- This study provides an understanding of family physi- age, but they appear to struggle with taking a proactive cians' attitudes about prescribing under the ODBP formu- stance. lary as it was designed in 2002. At that time, these family physicians were concerned about the impact of the ODBP formulary on patient outcomes, the loss of their diagnosis Discussion Formulary-based public drug plans extend health cover- and treatment time due to drug coverage paperwork, age for most financially disadvantaged populations and, whether some generic drugs were as effective as name- in some Canadian provinces, for their citizens as a whole. brand counterparts, and the lengthy wait times for drug The formulary review process that is part of every public coverage that they felt could put some patients at risk. drug plan in Canada assesses each new drug for safety, These concerns were addressed in 2006 when the provin- efficacy, and cost-effectiveness. This provides physicians cial government passed legislation to overhaul the ODBP with some assurances of the composite value of those to increase overall transparency and accountability, estab- drugs that do get listed on the formulary. While physi- lish faster drug funding decisions, assess the administra- cians in this study generally agreed that cost-effectiveness tive barriers of the Section 8 mechanism, and replace it is a worthy goal, they did not generally see their role as with a new faster process with the intention of dramati- cost monitors. With respect to their experience with the cally reducing paperwork for physicians and pharma- ODBP as it was structured in 2002, they felt it would be cists[23]. more effective if it more accurately reflected standard clin- ical practice and current clinical guidelines and was less Allan and Innes report that Canadian physicians in British complicated to administer. Physicians also argued that, Columbia have limited knowledge of the actual price of while the ODBP should ideally contribute to the improve- drugs[24]. However, physicians do know that if a drug is ment of the quality of care and keep costs down, it can not included in a formulary it is likely to be more costly also contribute to lower quality of care and to the misuse than formulary alternatives[24]. It may be that the oner- of physicians' time thereby increasing costs to the pub- ous nature of the old ODBP guidelines actually precipi- licly-funded health care system in Ontario by adding tated physicians asking about coverage and ability to pay unnecessary visits to family physicians, specialists, and because they were attempting to determine if they would emergency rooms. require additional time to complete paperwork. Alterna- tively, physicians could be responding to a social desira- Data from this relatively small qualitative study suggests bility factor. that advocacy is situationally bound. While we learned that physicians' decisions to advocate are influenced by While the focus of this qualitative study was not family their understanding of the patient's condition, the level physicians' knowledge of drug costs but on their attitudes and immediacy of risk created by the patient's condition, about prescribing using a formulary, we learned that these and the perceived benefit of a restricted drug, we discov- family physicians' knowledge of relative costs of drugs is ered that their decision to advocate is also influenced by based on their experience that formularies list less costly Page 6 of 8 (page number not for citation purposes) BMC Family Practice 2009, 10:69 http://www.biomedcentral.com/1471-2296/10/69 generic or brand-name drugs and not newer more expen- Competing interests sive ones. Family physicians reported that they learned the Dr. Susan Grant and Mr. Kevin Skilton were, at the time of costs of drugs through daily clinical practice, especially the study, members of the Corporate Affairs Group of when their patients returned to report the high price of a Merck FrosstCanada and were engaged in Canadianpub- drug they prescribed or when pharmacists called saying licpolicy respecting access to innovative medicines. They their patients weren't covered or couldn't afford a drug. participated in the development ofthe research question, Reports of formulary inclusion decisions indicate that the but not in the analysis of the results. Dr. Grant developed coverage decision can be sensitive to the price of a medi- the scenarios, assisted in transcription of the medical ter- cation [25,26]. In their analysis of 58 drugs approved for minology, and in refining the presentation of the analysis sale in Canada in 1996-1997, Anis et al[25] found a sig- of physician prescribing behaviour. All publications nificant association (p < .001) between the price ratio reporting research in which Merck Frosst participatesare (price of the new drug relative to price of the cheapest reviewed prior to publication in accordance with corpo- available comparator on the formulary) and whether cov- rate disclosure policy. erage was granted. This research was sponsored by Merck Frosst, and per- Study Limitations and directions for future research formed by McMaster University researchers and staff. The The findings from this preliminary study cannot be gener- full study team confirms that this paper reflects our own alized to physicians practicing in other provinces or coun- interpretation of the data and that Merck Frosst has not tries, or Ontario physicians practicing under the new biased the research in any way. ODBP regulations. Our findings differ substantially from US data regarding the practice of family physicians asking Authors' contributions patients about their ability to pay. It may be that adminis- All authors participated in the study design and coordina- trative hurdles actually precipitate physicians asking and tion and helped to draft the manuscript. All authors read is an attempt to gauge the impact of embarking on patient and approved the final manuscript. advocacy in relation to the themes described in this study. The relative influence of a social desirability factor could Acknowledgements The authors would like to acknowledge the financial support of Merck not be determined from our results. Moreover, it is possi- Frosst. Parminder Raina holds a Canadian Institute of Health Research ble that some physicians in this study lacked full and accu- Investigator award, an Ontario Premier's Research Excellence Award and a rate information in some aspects of the ODBP, and this Labarge Chair in Research and Knowledge Application for Optimal Aging. could have influenced their discussion. Nonetheless, their comments are still valid, as they are making prescribing References decisions for their patients with this limited understand- 1. Huskamp HA, Keating NL: The new medicare drug benefit: for- ing. Future research, possibly with a larger sample using a mularies and their potential effects on access to medica- tions. 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