Influence of reimbursement guidelines on prescribing
Physicians reported that during the clinical consult they diagnose and assess concomitant conditions such as social and environmental factors, prior treatment history, risks for adverse events including comorbidity and, if drug therapy is chosen, possible drug interactions. Most physicians in this study, unlike their counterparts elsewhere, explained that they review with patients their ability to pay for medications [15–17]. When most physicians discovered that a patient was over the age of 65 years, received professional services under the home care program, or received social assistance, prescribing decisions based on the reimbursement guidelines of the ODBP came into play.
Prescribing General Benefit (GB) Drugs
Physicians noted that GB drugs are generally well tolerated and effective. However, some participants perceived that current evidence and clinical experience may run contrary to ODBP guidelines in which multiple-source GB drugs are classified as interchangeable. Participants noted that while GB drugs are commonly viewed as un-restricted, they are not always "hassle-free", and require formulary consultation for dosage compliance and special forms if a "non-substitution" order is required.
Some physicians reported that, despite it not being their first choice, they might still prescribe a GB drug for a variety of reasons: a) the GB drug is covered, thus the patient could get medication immediately, b) the patient's symptoms were not acute at the time of presentation, c) a trial of the GB drug might be effective in improving the patient's condition, d) the GB drug, while not the most effective drug in the physician's opinion, was safe and effective and did no harm, e) the desire to balance quality of care with fiscal restraint, f) if the patient experienced side-effects or the GB drug proved ineffective then the patient's chart would contain the necessary proof that a GB drug was tried and the patient could then meet the LU coverage criteria, and g) the GB drug was a stopgap to be used while awaiting the lengthy Section 8 approval process.
Prescribing Limited Use (LU) Drugs
Physicians see their primary responsibility - providing the best possible care for patients - as "covenantal". They find it worrisome when patients do not precisely fit the LU eligibility criteria, especially when clinical experience, interpretation of the evidence, and patient history make a convincing case for an LU drug. One physician explained that, "it's almost clinical malpractice to give him [the patient] the drug that's free, knowing there is no efficacy, OK?" Physicians 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 loom if they are in contravention of ODBP regulations.
Individual Clinical Review (Section 8) mechanisms and prescribing
"Section 8" refers to the "Individual Clinical Review Mechanisms" section of the ODBP Formulary. It is used when ODBP-eligible patients either may benefit from LU drugs but do not fit the criteria or when they require drugs not listed as GB or LU. Physicians must send a written request for Section 8 review to the Drug Programs Branch of the MOHLTC. Ministry staff coordinates a review that includes recommendations from the DQTC and expert medical advisors. Written requests must provide a diagnosis and rationale for the drug, its trade name, strength and dosage, evidence of effectiveness if the patient has already taken the product, details of alternatives tried including dosages, length of therapy and patient response. Concomitant drug therapy and other relevant information, such as sensitivity reports or laboratory results, are also required.
A decision to access Section 8 represents a commitment to writing multiple letters annually to maintain coverage as extensions are not automatic. In cases where the coverage is approved but the dosage changes, a new request must be completed. Some physicians reported that it could take up to four attempts to get a drug covered. It is relatively common to be turned down on the first try.
Advocating for ODBP-eligible patients
We identified three themes associated with physician advocacy: issues related to time, physician frustration and burnout, and physician-patient rapport. The dominant theme relates to issues of time.
Issues related to time
Physicians believe that already they do not have enough time with patients and coping with ODBP regulations aggravates this problem. One physician noted, "I don't book my patients that tight together. I give them their 15 minutes. But my goodness, you know, I consider that my 15 minutes [are] for diagnosis and a treatment plan, not to handle bureaucracy and it gets really frustrating." Other time issues include: a) time to review patient charts for reimbursement eligibility, b) time to interpret the ODBP guidelines and write compliant prescriptions, c) non-billable time for telephone calls with pharmacists, dealing with reimbursement problems or writing Section 8 letters, and d) time spent waiting for Section 8 approval. There is the perception that the prescribing process is deliberately made complex and time-consuming to ensure guideline compliance and that this interferes with timely delivery of quality healthcare.
Physicians noted that they must use non-billable time (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 fax so you have to call and wait in line at your own expense for the patient or you have to send it by registered mail as if you have nothing better to do then spend time, at least half an hour, to compose a letter, do it right for the government and then at our own expense, getting it there and wait for rejection and you know, there are a lot of barriers." Some physicians also perceived an expectation that they complete LU prescriptions and Section 8 letters for specialists that their patients also visit.
Frustration with the ODBP Program
Physicians generally perceived ODBP guidelines as disincentive hoops, and saw themselves being used as free watchdog gate-keepers to monitor drug costs. They thought that strict adherence to ODBP guidelines might cut drug costs, but could create ancillary costs through poor use of physicians' time and burdening other sectors of the system (i.e., emergency room visits). Most physicians perceive the formulary as complicating rather than facilitating clinical decisions. Words such as "red tape", "hoops", "barriers", and "bureaucracy" were commonly used to describe their experience with the ODBP. In addition, it was common to hear physicians note that they were not confident in the formulary's ability to reflect current evidence or clinical experience.
In general, physicians perceived that the ODBP processes seem to have been created to wear down family physicians. They identified the cumbersome 500-page formulary binder, rigid dosages, changing LU codes, complex regulations and long waits for approval (three weeks to three months) as daily hurdles on the ODBP obstacle course. While most physicians reported that they continued to advocate for patients amid frustrations, for some, the daily burden of coping with ODBP barriers resulted in them becoming disheartened and taking the path of least resistance. These physicians could be termed "discouraged advocates"; they surrender and prescribe the GB drug. Physicians reported that they may want to comply with the stepped care approach, (i.e., trying a GB drug and then following all steps needed to access restricted drugs in the event of treatment failure), but they have many patients requiring advocacy and thus are spending more time "jumping through hoops" than providing quality care. "The frustrating thing, which I think all of us could probably attest to, is that we're the ones always holding the bag, because in the end, patients get all kinds of red tape but the family physician has to wade through all of it." Some physicians reported that the ministry's inconsistent application of Section 8 guidelines eroded their confidence in the system and their ability to successfully advocate for patients.
Despite these obstacles, physicians say they advocate because they care about their patients and feel that they are morally and legally bound to provide them with the best care. One physician summed up the common thread heard from most physicians: "We could say, 'no, sorry, there is nothing that I can do,' but we care." Physicians admit that the rapport that grows between patients and physicians can influence their decision to go the extra distance, but it is not a requirement. Having patients who appreciate their advocacy encourages physicians to continue to do so. Committing to a patient's case is time consuming over the long and short haul, and requires tenacity and a conviction of the restricted-access drug's efficacy.
Factors that influence family physicians' decisions not to advocate fall into two categories relating to patients' attributes and the working conditions and policies associated with practicing medicine. Physicians noted that they tend to advocate more actively for patients who do not have the income to pay for non-covered drugs. They are disinclined to advocate for patients who have a strong a sense of entitlement even when they can pay or those who pay for expensive alternative/complementary therapies of dubious benefit but resist paying for a more effective but non-covered medication.
Some physicians reported that they typically avoid consulting the ODBP formulary when writing prescriptions except in extreme circumstances. The most common reason given is that the formulary was not usually in the examination room and/or referring to it is onerous and consumes precious consultation time with their patients. Some physicians explained that they write prescriptions for drugs and let the pharmacist research, screen and sort out the ramifications regarding ODBP coverage. The general trend in responses from these physicians is that they see their responsibility as primarily caring for their patients rather than implementing cost-containment strategies on behalf of the provincial government. In situations where a patient's need was acute, these discouraged advocates would advocate for the patient to receive coverage, but they appear to struggle with taking a proactive stance.