Judith A. Soon

Effects of making emergency contraception available without a physician's prescription: a population-based study

Background: Timely access to emergency contraception has the potential to reduce the number of unwanted pregnancies and subsequent abortions. A public health policy initiative in British Columbia beginning in December 2000 allowed pharmacists to provide emergency contraceptives (ECs) without a prescription. We sought to determine changes in EC use after the policy was introduced and to analyze EC use with data generated by the policy. Methods: All Ovral, Preven and Plan B EC prescriptions from Jan. 1, 1996, to Dec. 31, 2003, were identified through the BC PharmaNet and Medical Services Plan administrative databases and the data analyzed to determine changes between 1996 and 2002. Changes over time were determined in the frequency of EC provision, choice of EC agent, frequency of EC use by age group, repeat use and geographic distribution of EC prescription for the pre- and post-policy periods. Anonymized patient-specific data from treatment consent forms were used to describe the reason for EC use, interval between unprotected intercourse and EC prescription, proportion prescribed for immediate or future use, referrals for regular birth control and STD screening and concomitant antiemetic use. Consent data also provided the time in the menstrual cycle that the EC was requested. Results: The number of EC prescriptions increased from a pre-policy mean of 8805 (99% confidence interval 7823–9787) in the years 1996 to 2000 to a post-policy total in 2002 of 17 794. Physicians prescribed the levonorgestrel regimen (Plan B) less frequently than did pharmacists. The frequency of EC use was highest among women aged 20–24 years across all study years, and all age groups demonstrated a post-policy increase in use. On average, 2.1% of the women received an EC 3 or more times a year over the period of the study. More women in urban regions received ECs than women in more rural areas of the province. Analysis of pharmacist treatment consent forms used in 2001 and 2002 showed that 56.2% of women receiving an EC reported using a method of birth control that had failed, 55.7% of pharmacist-provided ECs were obtained within 24 hours after unprotected intercourse, 1.1% of ECs were obtained for future use, antiemetics were provided to 57.7% of women receiving the Yuzpe regimen (Ovral, Preven) and to 20.5% of women receiving levonorgestrel, and women tended to seek ECs when unprotected intercourse occurred at the time of highest risk of pregnancy in their menstrual cycle. Women in greatest financial need obtained ECs more frequently from physicians than from pharmacists. Interpretation: The policy change that granted pharmacists authority to provide ECs to women without a physicians prescription did not simply expand EC availability but was associated with an overall increase in EC use in the province.

Barriers to Rural Induced Abortion Services in Canada: Findings of the British Columbia Abortion Providers Survey (BCAPS)

Background Rural induced abortion service has declined in Canada. Factors influencing abortion provision by rural physicians are unknown. This study assessed distribution, practice, and experiences among rural compared to urban abortion providers in the Canadian province of British Columbia (BC). Methods We used mixed methods to assess physicians on the BC registry of abortion providers. In 2011 we distributed a previously-published questionnaire and conducted semi-structured interviews. Results Surveys were returned by 39/46 (85%) of BC abortion providers. Half were family physicians, within both rural and urban cohorts. One-quarter (17/67) of rural hospitals offer abortion service. Medical abortions comprised 14.7% of total reported abortions. The three largest urban areas reported 90% of all abortions, although only 57% of reproductive age women reside in the associated health authority regions. Each rural physician provided on average 76 (SD 52) abortions annually, including 35 (SD 30) medical abortions. Rural physicians provided surgical abortions in operating rooms, often using general anaesthesia, while urban physicians provided the same services primarily in ambulatory settings using local anaesthesia. Rural providers reported health system barriers, particularly relating to operating room logistics. Urban providers reported occasional anonymous harassment and violence. Conclusions Medical abortions represented 15% of all BC abortions, a larger proportion than previously reported (under 4%) for Canada. Rural physicians describe addressable barriers to service provision that may explain the declining accessibility of rural abortion services. Moving rural surgical abortions out of operating rooms and into local ambulatory care settings has the potential to improve care and costs, while reducing logistical challenges facing rural physicians.

Mechanisms of Action of Hormonal Emergency Contraceptives

Hormonal emergency contraceptives have been used to prevent unwanted pregnancy for more than 3 decades. The mechanisms of action of the regimen containing a combination of estrogen and progestin, known as the Yuzpe regimen, and those of the levonorgestrel regimen continue to be controversial, especially over the possibility that these regimens might act by interfering with implantation of the fertilized ovum. We performed a search of the PubMed (1949‐July 2009) and EMBASE (1980‐July 2009) databases to identify literature on the mechanisms of action of these contraceptive regimens, and data were extracted from pertinent English‐language studies. We classified studies according to the approach taken by the investigators to study the actions of emergency contraceptives on pregnancy: an indirect method that uses statistical models to determine whether emergency contraceptives would be as effective as reported if they act only by disrupting ovulation; direct observation of the effects of emergency contraceptives on surrogate outcomes, including ovulation, sperm activity, hormonal levels, and endometrial receptivity to implantation; and analysis of directly observed pregnancy outcomes against statistical data. Acceptability of emergency contraceptives by women and clinicians may depend on personal opinions about when life or pregnancy begins. The evidence strongly supports disruption of ovulation as a mechanism of action. The data suggest that emergency contraceptives are unlikely to act by interfering with implantation, although the possibility has not been completely excluded. The data also suggest that emergency contraceptives are ineffective after ovulation. Women and clinicians who consider implantation or later events to be the beginning of pregnancy should be aware that emergency contraceptives are likely nonabortive by this definition of pregnancy.

Outcomes of Bupropion Therapy for Smoking Cessation during Routine Clinical Use

Background: Knowledge pertaining to the effectiveness of smoking cessation treatments and patient characteristics that may affect success may enable smokers and clinicians to select individualized treatment for each patient and ultimately increase the success rate of smoking cessation in general. Objective: To evaluate the effectiveness of bupropion as a smoking cessation agent when used in routine clinical practice. Methods: This was a prospective, observational study with a one year follow-up period. Adult smokers presenting to community pharmacies in British Columbia, Canada, with an index prescription for bupropion for smoking cessation (N = 205) were eligible. The primary outcome was the biochemically validated 12 month point abstinence (PA) rate from smoking. Secondary outcomes included the frequency of adverse events, patterns of bupropion use in routine clinical practice, and possible predictors of bupropion effectiveness. Results: The validated 12 month PA rate was 21.0%. Of subjects who reported taking at least one dose of bupropion, 70.4% (126/179) experienced at least one adverse event and 29.6% (53/179) reported stopping the drug due to adverse effects. Greater length of time on bupropion (OR 0.98) and a lower cigarette pack-year history (OR 1.05) were associated with an increase in the odds of smoking cessation. Conclusions: Subjects receiving bupropion in a real-life setting exhibited a similar abstinence rate at 12 months as has been observed in the active drug groups of placebo-controlled clinical trials. However, the patterns of use and discontinuation rate due to adverse events differed substantially from those observed in early efficacy studies.

The Perspective of Rural Physicians Providing Abortion in Canada: Qualitative Findings of the BC Abortion Providers Survey (BCAPS)

Background An increasing proportion of Canadian induced abortions are performed in large urban areas. For unknown reasons the number of rural abortion providers in Canadian provinces, such as British Columbia (BC), has declined substantially. This study explored the experiences of BC rural and urban physicians providing abortion services. Methods The mixed methods BC Abortion Providers Survey employed self-administered questionnaires, distributed to all known current and some past BC abortion providers in 2011. The optional semi-structured interviews are the focus of this analysis. Interview questions probed the experiences, facilitators and challenges faced by abortion providers, and their future intentions. Interviews were transcribed and analyzed using cross-case and thematic analysis. Results Twenty interviews were completed and transcribed, representing 13/27 (48.1%) rural abortion providers, and 7/19 (36.8%) of urban providers in BC. Emerging themes differed between urban and rural providers. Most urban providers worked within clinics and reported a supportive environment. Rural physicians, all providing surgical abortions within hospitals, reported challenging barriers to provision including operating room scheduling, anesthetist and nursing logistical issues, high demand for services, professional isolation, and scarcity of replacement abortion providers. Many rural providers identified a need to “fly under the radar” in their small community. Discussion This first study of experiences among rural and urban abortion providers in Canada identifies addressable challenges faced by rural physicians. Rural providers expressed a need for increased support from hospital administration and policy. Further challenges identified include a desire for continuing professional education opportunities, and for available replacement providers.

The Developing Role of Pharmacists in Patient Access to Emergency Contraception

Unintended pregnancy and subsequent abortion remain major public health issues in many countries, despite evidence that post-coital emergency contraceptives have a good safety profile, are easy to use, and are effective in preventing unwanted pregnancies. Although emergency contraceptives have been prescribed in developed countries for more than 25 years, abortion rates have continued to rise steadily in many jurisdictions. Barriers to the use of emergency contraceptives reduce ready access of women to this birth control option. Because the effectiveness of emergency contraceptives is time dependent, establishing prescribing and dispensing mechanisms that are convenient to women is crucial to their ability to use the therapy in a timely manner.Emergency contraceptives in developed countries are traditionally prescribed by physicians in organized healthcare settings. In these countries, pharmacists are ideally situated to improve patient access to emergency contraceptives, since community pharmacies are widely available in both urban and rural settings and are open extended hours. Innovative initiatives using a variety of regulatory mechanisms now allow pharmacists a greater role in prescribing and distributing emergency contraceptives. In Washington State, USA, pharmacists entering into a collaborative drug therapy agreement with a physician or nurse practitioner can initiate emergency contraceptives based on a prescribing protocol. Several local programs in the United Kingdom have utilized accredited community pharmacists to supply emergency contraceptives using a patient group directive. In British Columbia, Canada, specially-certified pharmacists with independent prescriptive authority utilize an informed consent during the interactive consultation with the potential emergency contraceptive user. In yet other jurisdictions, emergency contraceptives have been transferred to over-the-counter (OTC) status.Relevant public health research questions can now be posed. Future studies will be able to compare the effectiveness of various regulatory mechanisms to expand access, to identify and address potential drawbacks of pharmacist-initiated1 emergency contraceptives, and to explore whether pharmacist-initiated prescriptions represent expanded access or simply a transfer of the prescribing of these agents from physicians to pharmacists. Countries with OTC emergency contraceptives will be able to explore the relationship between varying levels of pharmacist interaction with emergency contraceptive users and health outcomes, and to investigate whether the change in prescriptive status has resulted in unintentional barriers to access for populations such as teenagers and those with restricted discretionary income. These findings will provide valuable new information on the impact of initiatives designed to expand access to emergency contraceptives.

Risk of Pregnancy Among Women Seeking Emergency Contraceptives From Pharmacists in British Columbia

OBJECTIVE Recent revision of the method used to estimate risk of pregnancy among women requesting medication for emergency contraception (EC) suggests that the effectiveness of EC may be lower than is generally believed. We undertook a population-based study to estimate the risk of pregnancy among women requesting EC from pharmacists in British Columbia under conditions of routine care. METHODS We obtained data on time since unprotected intercourse and medication provided for women in British Columbia requesting EC from January 1, 2001 to December 31, 2002. RESULTS More women obtained levonorgestrel (60.7%) than the Yuzpe regimen (39.3%) for EC, and of those reporting contraceptive failure, 90% requested EC because of condom failure. Overall, the estimated risk of pregnancy among the 11 795 women who obtained EC was 4.12 % (95% confidence interval 3.77-4.49). CONCLUSION Under routine conditions, the population-based predicted risk of pregnancy is lower than has previously been estimated. This suggests that the relative reduction in pregnancies achieved with EC is lower than is currently assumed by clinicians and patients.

Measuring and reporting of the treatment effect of hormonal emergency contraceptives

To derive summary estimates of observed pregnancy rates in women who used the Yuzpe or levonorgestrel emergency contraceptive regimen and identify the various ways in which data related to regimen effectiveness were reported, to discuss the limitations of the effectiveness estimates as they are currently reported, and to propose alternative reporting methods that are less susceptible to misinterpretation.

Provision of Emergency Contraceptives by Pharmacists British Columbia Experience a Template for other Provinces

CPJ/RPC • JULY/AUGUST 2004, VOL. 137, NO. 6 On December 1, 2000, specially trained pharmacists in British Columbia became the first in Canada to be formally granted independent prescriptive authority for emergency contraceptives (ECs). The provincial government implemented this precedent-setting health policy initiative to reduce barriers to access for this time-sensitive birth control option. Since legislation to enhance the scope of pharmacy practice was enacted three years ago, the provision of ECs to women at risk of an unwanted pregnancy has increased substantially. In the process, pharmacists have gained increasing recognition of their role as collaborative health care professionals. This article describes the change in BC health policy that granted pharmacists independent prescriptive authority, explains how pharmacist prescribing relates to Canadian federal and provincial drug schedules, and describes the impact of the expanded role of pharmacists on EC utilization. It also explores issues that remain to be considered should one or more of the EC agents be transferred to non-prescription status.

Design of a randomized trial of a multidisciplinary intervention for knee osteoarthritis: Pharmacist Initiated Intervention Trial in Osteoarthritis (PhIT-OA)

3 3 Arthritis is the leading cause of disability in North America, with osteoarthritis (OA) the most prevalent disease within this classification. In Canada, the economic impact of musculoskeletal disease is second only to cardiovascular disease. It is estimated that, in the next 10 to 20 years, the prevalence of OA will increase by 50%, resulting in a large personal and societal burden. Knee OA, in particular, is common and disabling. Evidence-based management of knee OA involves the use of both nonpharmacological and pharmacological approaches. Recent studies, however, have shown gaps in identifying knee OA and in delivering the appropriate interventions. In the Pharmacist Identification of New, Diagnostically confirmed OA (PhIND-OA) study, we demonstrated that pharmacists could identify people with previously undiagnosed knee OA. A recent randomized controlled trial by Hay and colleagues indicated that enhanced pharmacist medication review was as effective as exercise in the short-term management of knee pain, and both were more effective than usual care. A strategy, therefore, that uses pharmacists to identify those individuals in the community with knee OA in order to perform a medication review and to provide a referral to other health care practitioners (i.e., primary care physicians and physiotherapists) may prove effective in addressing the care gap for knee OA. We hypothesize that R E S E A R C H I N P R O G R E S S