Research Article
Availability and Accuracy of Information Regarding Nonprescription Emergency Contraception
Journal of Pharmacy Practice 1-7 ª The Author(s) 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0897190014568378 jpp.sagepub.com
Katherine Kelly Orr, PharmD1, Virginia A. Lemay, PharmD1, Amanda P. Wojtusik, PharmD2, Margaret Opydo-Rossoni, PharmD3, and Lisa B. Cohen, PharmD1
Abstract Background: Although access to emergency contraception (EC) has increased with nonprescription status and approval of Plan B One-Step without age restrictions, barriers may still remain in patient education. This study assesses product availability and accuracy of information for EC among community pharmacies in Rhode Island, comparing changes from 2009 to 2012. Methods: Two female investigators posing as patients seeking EC followed a standardized script over telephone conversations. Investigators assessed EC availability, product use information, and cost at all community (retail) pharmacies in Rhode Island. Data were reported as group results with no identifiers. Chi-square and Fisher exact tests were used to analyze results. Results: During spring of 2009 and 2012, 165 and 171 pharmacies were telephoned, respectively. Approximately 90% of pharmacies stocked EC both years. In all, 62% versus 28% (P < .001) indicated EC should be taken as soon as possible; 82.5% versus 87.7% (P ¼ .220) provided correct administration information; 67% versus 84% (P < .001) warned about adverse effects; and 67% versus 53% (P ¼ .123) provided the correct minimum age for purchase. Conclusions: Access to nonprescription EC in Rhode Island is very good. Sites not stocking EC should reassess plans for patients to obtain medication. There is need for reeducation on EC labeling to improve counseling provided over the telephone. Keywords ambulatory care, women’s health
Background Nonprescription, or over-the-counter (OTC), sale of levonorgestrel-only (Plan B) emergency contraception (EC) was approved by the US Food and Drug Administration (FDA) in August 2006.1 Initially sales were limited to those 18 years of age and above but were lowered to 17 years in April 2009.2 Although the FDA recommended approval to make Plan B One-Step available OTC for all women of reproductive age in December 2011, the Secretary of the US Department of Health and Human Services overruled their recommendation.3 In late 2012, The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics released statements in support of nonprescription hormonal contraceptive access and increased nonprescription availability of EC for adolescents, respectively, in an effort to improve contraceptive access and potentially reduce unintended pregnancies.4,5 Most recently, in June 2013, the FDA approved Plan B One-Step as a nonprescription product without any age restrictions for all women of child-bearing potential. Marketed exclusively by Teva Pharmaceuticals for 3 years, Plan B One-Step is available in the OTC aisles, although all other versions of levonorgesterol-containing EC, including all generic alternatives, are
available for purchase for those 17 years of age and older and prescription only for less than 17 years with valid governmentissued identification.6 Nonprescription EC is proven to be safely used by adult women, as well as adolescents, and increases their ability to access medication within 24 hours of unprotected intercourse when it is most effective.7,8 Nonprescription availability places the responsibility for counseling with the community pharmacist, though for some, challenging their personal, moral, and religious beliefs. Many pharmacies have adapted the American Pharmacists Association position statement regarding the right for a pharmacist to refuse EC dispensing; however, establishing a plan within the pharmacy by still allowing the patient timely access
1 The University of Rhode Island, Department of Pharmacy Practice, Kingston, RI, USA 2 Providence Medical Group, Clinical Pharmacy, Portland, OR, USA 3 CVS Pharmacy, Johnston, RI, USA
Corresponding Author: Katherine Kelly Orr, The University of Rhode Island, 7 Greenhouse Road, Kingston, RI 02818, USA. Email: [email protected]
Downloaded from jpp.sagepub.com at UNIV NEBRASKA LIBRARIES on December 8, 2015
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Journal of Pharmacy Practice
to the medication.9 In 2012 after 7 years of litigation, an Illinois appellate court ruled that pharmacists in that state cannot be forced to dispense EC in violation of their religious views. This ruling was considered a victory for those pharmacists who believed their Rights of Conscience were being violated.10 In 2008, the Rhode Island Department of Health’s Women’s Health Advisory Committee expressed concerns about reports of limited access and inappropriate counseling that was occurring in pharmacies. This prompted the development of educational sheets by Rhode Island Emergency Contraception Task Force (available in English, Spanish, and Portuguese) directed toward providers, pharmacists, and patients. Included on the educational sheet was EC description/products, appropriate use, mechanism of action, and instructions of usage. The Rhode Island Board of Pharmacy and Women’s Health Advisory Committee edited the pharmacist materials. The educational sheets were then mailed to every Rhode Island pharmacy in the winter of 2010 in between the 2 standardized telephone assessments. In between these, a 2012 change to regulatory language was approved including pharmacists may choose not to dispense a drug, although the pharmacy owner ‘‘shall establish protocols to ensure the patient has timely access.’’11 Due to concerns from the Rhode Island Department of Health regarding EC, we wanted to evaluate the information and access to EC at community pharmacies.
Objectives The objectives of this study are (1) to evaluate product availability and accuracy of information regarding nonprescription EC among community pharmacies in Rhode Island and (2) compare significant changes in access and education provided by pharmacies in 2009 to 2012.
Methods Two female investigators posing as patients seeking EC, following a standardized script consisting of 5 questions, telephoned all community pharmacies in Rhode Island from February through April both in 2009 and in 2012. Any individual answering the telephone in the pharmacy and proceeding to answer questions was included in the analysis. Due to the fact the pharmacist does not always answer the phone when a patient calls the pharmacy, investigators wanted to capture what a patient may experience by beginning to ask questions, unknown whether it was a pharmacist, intern, or technician they were speaking with. The investigators clarified with whom they were speaking at the end of the conversation. Often a technician may start to answer questions but consult with the pharmacist for certain details while relaying the information back to the patient. If a technician or student pharmacist answered the telephone and referred the telephone call to a pharmacist midconversation, the investigator reasked the pharmacist each of the scripted questions. The investigators also timed their conversations. The information provided was collected in an anonymous manner with no linking data of the specific pharmacy or
subject and was approved by the University of Rhode Island Institutional Review Board. The standardized questions assessed availability and product use information related to available EC products on the market, see Appendix A. Those answering questions were not told the information they were providing would be included in a study, as this would likely change the manner in which they answered questions. The questionnaires used objective ‘‘yes’’ and ‘‘no’’ questions to evaluate the different sites. A few open-ended questions to record cost and alternate pharmacies were included. Other comments were documented by the investigator if they were not able to fully determine at the time if the question was adequately answered. The survey tool from 2009 included 11 ‘‘yes’’ and ‘‘no’’ questions for documentation. The 2012 survey included an additional 2 questions with ‘‘yes’’ and ‘‘no’’ responses due to labeling changes prior to that survey date. The nature of the questions changed as a result of the new release of Plan B One-Step and generic availability, therefore the investigators wanted to include those options in 2012, although they were not available in 2009. If a pharmacy stated it usually stocked EC, but was out of inventory, the investigators recontacted the pharmacy in 2 weeks to further determine availability. If the store employee referred to another pharmacy where EC could be obtained, it was considered ‘‘nearby’’ if within a 10-minute drive according to Google Maps1. Results were analyzed after all data had been completed and collected. Data are reported as group results and no company or subjects are identified. The type of community pharmacy was defined as chain, independent, grocery, or superstore (pharmacy located within a department store).
Statistical Analysis Investigators utilized chi-square analysis or Fisher’s exact test to compare differences in survey question responses between 2009 and 2012. All statistical analyses were conducted using SPSS (IBM SPSS Statistics 19; IBM Corporation Somers, New York). Statistical significance was defined as P < .05. Data are presented as percentages.
Results One hundred sixty-six pharmacies were called between February and April 2009. This included 118 chain, 18 independent, 17 grocery store, and 13 superstore. From February to April 2012, 171 stores were telephoned, including 124 chain, 19 independent, 15 grocery, and 13 superstore. These numbers include every community pharmacy in the state at that time and none were excluded. The 2012 sample included all stores in the 2009 sample plus 5 additional stores that were opened between 2009 and 2011. The majority of discussion took place with the pharmacist (72.0% in 2009 and 75.9% in 2012), or the pharmacist provided answers through their technician who was actually on the phone with the investigator. Although the majority of those answering did answer all survey questions,
Downloaded from jpp.sagepub.com at UNIV NEBRASKA LIBRARIES on December 8, 2015
Orr et al
3
Table 1. EC Availability and Information. Chain pharmacy, N ¼ 242 2009
2012
Supermarket pharmacy, N ¼ 32
Independent pharmacy, N ¼ 37 2009
2012
2009
2012
Superstorea, N ¼ 26 2009
2012
Number of pharmacies surveyed 118 (71.0) 124 (72.5) 18 (10.8) 19 (11.1) 17 (10.2) 15 (8.8) 13 (7.8) 13 (7.6) number (%) Do you stock EC? % 93.2 96.8 88.9 78.9 70.6 66.7 92.3 84.6 Available to pick up today? % 92.4 98.4 88.9 89.5 70.6 66.7 92.3 84.6 Directed to take ASAP after 59.3 32.3 66.7 21.1 58.8 6.7 69.2 38.5 unprotected sex, % Directed to take within 3 days after 58.5 46.0 55.6 52.6 41.2 33.3 46.2 38.5 unprotected sex, % Directed to take up to 5 days after 2.5 0.8 0 0 0 0 15.4 0 unprotected sex, % Directed to take within 3 or 5 days 57.6 46.8 55.6 52.6 41.2 33.3 46.2 38.5 after unprotected sex, % Correct directions? % 86.4 92.7 66.7 78.9 64.7 66.7 92.3 76.9 Provided information on adverse 70.3 90.3 61.1 73.3 47.1 60.0 61.5 69.2 effects Speaking with pharmacist, % 69.5 74.0 83.3 44.4 100 93.3 92.3 63.3
Total, N ¼ 337
Total 2009 vs 2012 2009 2012 P values 166
171
90.4 89.8 60.8
93.6 89.5 29.2
.857 .857
Availability and Accuracy of Information Regarding Nonprescription Emergency Contraception
Journal of Pharmacy Practice 1-7 ª The Author(s) 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0897190014568378 jpp.sagepub.com
Katherine Kelly Orr, PharmD1, Virginia A. Lemay, PharmD1, Amanda P. Wojtusik, PharmD2, Margaret Opydo-Rossoni, PharmD3, and Lisa B. Cohen, PharmD1
Abstract Background: Although access to emergency contraception (EC) has increased with nonprescription status and approval of Plan B One-Step without age restrictions, barriers may still remain in patient education. This study assesses product availability and accuracy of information for EC among community pharmacies in Rhode Island, comparing changes from 2009 to 2012. Methods: Two female investigators posing as patients seeking EC followed a standardized script over telephone conversations. Investigators assessed EC availability, product use information, and cost at all community (retail) pharmacies in Rhode Island. Data were reported as group results with no identifiers. Chi-square and Fisher exact tests were used to analyze results. Results: During spring of 2009 and 2012, 165 and 171 pharmacies were telephoned, respectively. Approximately 90% of pharmacies stocked EC both years. In all, 62% versus 28% (P < .001) indicated EC should be taken as soon as possible; 82.5% versus 87.7% (P ¼ .220) provided correct administration information; 67% versus 84% (P < .001) warned about adverse effects; and 67% versus 53% (P ¼ .123) provided the correct minimum age for purchase. Conclusions: Access to nonprescription EC in Rhode Island is very good. Sites not stocking EC should reassess plans for patients to obtain medication. There is need for reeducation on EC labeling to improve counseling provided over the telephone. Keywords ambulatory care, women’s health
Background Nonprescription, or over-the-counter (OTC), sale of levonorgestrel-only (Plan B) emergency contraception (EC) was approved by the US Food and Drug Administration (FDA) in August 2006.1 Initially sales were limited to those 18 years of age and above but were lowered to 17 years in April 2009.2 Although the FDA recommended approval to make Plan B One-Step available OTC for all women of reproductive age in December 2011, the Secretary of the US Department of Health and Human Services overruled their recommendation.3 In late 2012, The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics released statements in support of nonprescription hormonal contraceptive access and increased nonprescription availability of EC for adolescents, respectively, in an effort to improve contraceptive access and potentially reduce unintended pregnancies.4,5 Most recently, in June 2013, the FDA approved Plan B One-Step as a nonprescription product without any age restrictions for all women of child-bearing potential. Marketed exclusively by Teva Pharmaceuticals for 3 years, Plan B One-Step is available in the OTC aisles, although all other versions of levonorgesterol-containing EC, including all generic alternatives, are
available for purchase for those 17 years of age and older and prescription only for less than 17 years with valid governmentissued identification.6 Nonprescription EC is proven to be safely used by adult women, as well as adolescents, and increases their ability to access medication within 24 hours of unprotected intercourse when it is most effective.7,8 Nonprescription availability places the responsibility for counseling with the community pharmacist, though for some, challenging their personal, moral, and religious beliefs. Many pharmacies have adapted the American Pharmacists Association position statement regarding the right for a pharmacist to refuse EC dispensing; however, establishing a plan within the pharmacy by still allowing the patient timely access
1 The University of Rhode Island, Department of Pharmacy Practice, Kingston, RI, USA 2 Providence Medical Group, Clinical Pharmacy, Portland, OR, USA 3 CVS Pharmacy, Johnston, RI, USA
Corresponding Author: Katherine Kelly Orr, The University of Rhode Island, 7 Greenhouse Road, Kingston, RI 02818, USA. Email: [email protected]
Downloaded from jpp.sagepub.com at UNIV NEBRASKA LIBRARIES on December 8, 2015
2
Journal of Pharmacy Practice
to the medication.9 In 2012 after 7 years of litigation, an Illinois appellate court ruled that pharmacists in that state cannot be forced to dispense EC in violation of their religious views. This ruling was considered a victory for those pharmacists who believed their Rights of Conscience were being violated.10 In 2008, the Rhode Island Department of Health’s Women’s Health Advisory Committee expressed concerns about reports of limited access and inappropriate counseling that was occurring in pharmacies. This prompted the development of educational sheets by Rhode Island Emergency Contraception Task Force (available in English, Spanish, and Portuguese) directed toward providers, pharmacists, and patients. Included on the educational sheet was EC description/products, appropriate use, mechanism of action, and instructions of usage. The Rhode Island Board of Pharmacy and Women’s Health Advisory Committee edited the pharmacist materials. The educational sheets were then mailed to every Rhode Island pharmacy in the winter of 2010 in between the 2 standardized telephone assessments. In between these, a 2012 change to regulatory language was approved including pharmacists may choose not to dispense a drug, although the pharmacy owner ‘‘shall establish protocols to ensure the patient has timely access.’’11 Due to concerns from the Rhode Island Department of Health regarding EC, we wanted to evaluate the information and access to EC at community pharmacies.
Objectives The objectives of this study are (1) to evaluate product availability and accuracy of information regarding nonprescription EC among community pharmacies in Rhode Island and (2) compare significant changes in access and education provided by pharmacies in 2009 to 2012.
Methods Two female investigators posing as patients seeking EC, following a standardized script consisting of 5 questions, telephoned all community pharmacies in Rhode Island from February through April both in 2009 and in 2012. Any individual answering the telephone in the pharmacy and proceeding to answer questions was included in the analysis. Due to the fact the pharmacist does not always answer the phone when a patient calls the pharmacy, investigators wanted to capture what a patient may experience by beginning to ask questions, unknown whether it was a pharmacist, intern, or technician they were speaking with. The investigators clarified with whom they were speaking at the end of the conversation. Often a technician may start to answer questions but consult with the pharmacist for certain details while relaying the information back to the patient. If a technician or student pharmacist answered the telephone and referred the telephone call to a pharmacist midconversation, the investigator reasked the pharmacist each of the scripted questions. The investigators also timed their conversations. The information provided was collected in an anonymous manner with no linking data of the specific pharmacy or
subject and was approved by the University of Rhode Island Institutional Review Board. The standardized questions assessed availability and product use information related to available EC products on the market, see Appendix A. Those answering questions were not told the information they were providing would be included in a study, as this would likely change the manner in which they answered questions. The questionnaires used objective ‘‘yes’’ and ‘‘no’’ questions to evaluate the different sites. A few open-ended questions to record cost and alternate pharmacies were included. Other comments were documented by the investigator if they were not able to fully determine at the time if the question was adequately answered. The survey tool from 2009 included 11 ‘‘yes’’ and ‘‘no’’ questions for documentation. The 2012 survey included an additional 2 questions with ‘‘yes’’ and ‘‘no’’ responses due to labeling changes prior to that survey date. The nature of the questions changed as a result of the new release of Plan B One-Step and generic availability, therefore the investigators wanted to include those options in 2012, although they were not available in 2009. If a pharmacy stated it usually stocked EC, but was out of inventory, the investigators recontacted the pharmacy in 2 weeks to further determine availability. If the store employee referred to another pharmacy where EC could be obtained, it was considered ‘‘nearby’’ if within a 10-minute drive according to Google Maps1. Results were analyzed after all data had been completed and collected. Data are reported as group results and no company or subjects are identified. The type of community pharmacy was defined as chain, independent, grocery, or superstore (pharmacy located within a department store).
Statistical Analysis Investigators utilized chi-square analysis or Fisher’s exact test to compare differences in survey question responses between 2009 and 2012. All statistical analyses were conducted using SPSS (IBM SPSS Statistics 19; IBM Corporation Somers, New York). Statistical significance was defined as P < .05. Data are presented as percentages.
Results One hundred sixty-six pharmacies were called between February and April 2009. This included 118 chain, 18 independent, 17 grocery store, and 13 superstore. From February to April 2012, 171 stores were telephoned, including 124 chain, 19 independent, 15 grocery, and 13 superstore. These numbers include every community pharmacy in the state at that time and none were excluded. The 2012 sample included all stores in the 2009 sample plus 5 additional stores that were opened between 2009 and 2011. The majority of discussion took place with the pharmacist (72.0% in 2009 and 75.9% in 2012), or the pharmacist provided answers through their technician who was actually on the phone with the investigator. Although the majority of those answering did answer all survey questions,
Downloaded from jpp.sagepub.com at UNIV NEBRASKA LIBRARIES on December 8, 2015
Orr et al
3
Table 1. EC Availability and Information. Chain pharmacy, N ¼ 242 2009
2012
Supermarket pharmacy, N ¼ 32
Independent pharmacy, N ¼ 37 2009
2012
2009
2012
Superstorea, N ¼ 26 2009
2012
Number of pharmacies surveyed 118 (71.0) 124 (72.5) 18 (10.8) 19 (11.1) 17 (10.2) 15 (8.8) 13 (7.8) 13 (7.6) number (%) Do you stock EC? % 93.2 96.8 88.9 78.9 70.6 66.7 92.3 84.6 Available to pick up today? % 92.4 98.4 88.9 89.5 70.6 66.7 92.3 84.6 Directed to take ASAP after 59.3 32.3 66.7 21.1 58.8 6.7 69.2 38.5 unprotected sex, % Directed to take within 3 days after 58.5 46.0 55.6 52.6 41.2 33.3 46.2 38.5 unprotected sex, % Directed to take up to 5 days after 2.5 0.8 0 0 0 0 15.4 0 unprotected sex, % Directed to take within 3 or 5 days 57.6 46.8 55.6 52.6 41.2 33.3 46.2 38.5 after unprotected sex, % Correct directions? % 86.4 92.7 66.7 78.9 64.7 66.7 92.3 76.9 Provided information on adverse 70.3 90.3 61.1 73.3 47.1 60.0 61.5 69.2 effects Speaking with pharmacist, % 69.5 74.0 83.3 44.4 100 93.3 92.3 63.3
Total, N ¼ 337
Total 2009 vs 2012 2009 2012 P values 166
171
90.4 89.8 60.8
93.6 89.5 29.2
.857 .857
