McNutt, Louise-Anne PHD*; Davis, Christopher F. MPH*; Bednarczyk, Robert A. MS*; Fischer, Andrea MPH*; Zeolla, Mario PharmD†; Coles, Bruce F. DO*‡
The centers for disease control and Prevention recommends expedited partner therapy as part of Chlamydia and gonorrhea control. Expedited partner therapy is the “clinical practice of treating the sex partners of patients diagnosed with Chlamydia or gonorrhea by providing prescriptions or medications to the patient to take to his/her partner without the health care provider first examining the partner.”1,2A core component of expedited partner therapy is patient delivered partner therapy (PDPT), for example, providing a prescription to a patient who would deliver the prescription to their partner(s).2 Recently the American Medical Association supported the use of PDPT and also noted the potential role for pharmacists in its implementation.3,4 It is possible that for partners receiving prescriptions through PDPT, the only contact with the medical community may be at pharmacies. In these instances pharmacists may fill a void in sexually transmitted disease (STD) counseling and assessment of allergies and other contraindications to prescribed medication.
PDPT is now legally permissible in several states with legislation pending in New York State (NYS) and elsewhere.5,6 The purpose of this study was to learn pharmacists’ perspectives on PDPT, including the extent of their support for the legislation, their ability to provide confidential STD counseling, and what is needed for them to provide appropriate patient service. Additionally, we assessed the interest in instituting a behind-the-counter, nonprescription status for antibiotics used to treat Chlamydia for partners with supporting documentation, such as an exposure notice from medically diagnosed individuals distributed to their sexual partners. This option would remove the need for physicians to write prescriptions for individuals they have never examined.
MATERIALS AND METHODS
This study was conducted from April 2007 to June 2007. NYS counties were selected to represent varying populations (i.e., urban, suburban, rural) in adjoining regions. In addition, other areas across NYS where STDs are prevalent were visited. Community pharmacies (e.g., chain, independent, grocery, merchandise) in 8 counties of NYS Capital Region (Albany, Columbia, Greene, Rensselaer, Saratoga, Schenectady, Schoharie, and Washington) and in urban counties across the state (Erie, Jefferson, Nassau, Niagara, NY, Oneida, Onondaga, Orange, Queens, and Suffolk) were recruited and visited during the study.
The sample list for the 8 counties of the Capital Region was created using NYS Office of Professions’ online registry that lists state licensed pharmacies, updated August 2006.7 This was supplemented by telephone directories and major pharmacy chain websites. All eligible community pharmacies in the 8 counties of the Capital Region were visited and recruited for the pharmacist survey. Pharmacies within hospitals or clinics, those functioning as distribution centers, and those not open to the public were excluded. For logistical purposes, pharmacies were geographically grouped (4–7 per group). Each grouping was randomly assigned to a sampling day (Monday through Sunday) and time (morning, afternoon, evening).
Pharmacies in urban areas outside the Capital Region were selected by first defining a small geographic area and subsequently selecting a random sample within that area. In addition, sampling times were chosen based upon logistical constraints including researcher availability and geographic distance from the research center.
Pharmacist Survey Implementation
During each visit, an on duty pharmacist was randomly selected to participate in the study. After an explanation of the study and informed consent, the survey was provided to the pharmacist with an envelope to seal upon completion. Within the Capital Region, pharmacies where the randomly selected pharmacist refused participation were revisited 1 time if the reason for refusal was not due to corporate policy. One corporation’s headquarters learned of the study and faxed their pharmacies a “reminder of corporate policy” and some pharmacies chose to honor this request. No additional attempts were made to resample pharmacists at these locations.
The survey included demographic and pharmacy specific questions (e.g., prescription volume, staffing, counseling areas, and average time spent with customers). Eleven questions regarding PDPT, measured on a 5-point Likert scale (i.e., strongly agree, agree, no opinion, disagree, strongly disagree), were asked. To inform pharmacists about PDPT, information was provided twice: in the informed consent and in the survey immediately before specific questions about PDPT (“We would like to know your opinions about patient-delivered partner therapy (PDPT), a method of treating partners of individuals diagnosed with Chlamydia where the index patient is given medication or a prescription for medication for their partner without the partner undergoing an examination by a health care provider.”)
Pharmacists were asked if they felt PDPT was acceptable for Chlamydia, gonorrhea, and syphilis, if they possessed adequate time and knowledge to provide STD counseling, and whether they would discuss condom use with those diagnosed with STDs. The question about PDPT acceptability for syphilis was asked as a control measure, because without specific information about stage (requiring assessment of clinical and laboratory criteria) it is not possible to determine the appropriate treatment. Opinions were also sought on whether antibiotics for STDs should be prescription only, if prescriptions written through PDPT should be identifiable as such, and if the submission of claims to the partner’s insurance company would be delayed until the preferred method of payment was determined.
Researchers observed all customer-staff interactions from over a 6-foot distance to respect privacy. The following distances were measured for this study: customer at the counter to the nearest customer; staff member speaking to the customer to the nearest staff member; and the farthest a pharmacy conversation could be heard.
Distances were measured using one of the following techniques: the product of either premeasured floor tile/carpet squares, or heel to toe foot measures. When these techniques were not possible, distances were visually estimated. Our operational definition of a “private encounter” was based upon a “6-foot rule” derived from prior acoustics studies that found with appropriate sound-dampening materials used to construct the interaction space, conversations could be considered private from a distance of 6 feet.8,9
Researchers observed 3 encounters or stayed 15 minutes in each pharmacy, whichever was shorter. Pharmacies where this did not occur at the initial visit were revisited at a later date for observation.
The collected survey data were double entered into Epi Info v.3.3.2, verified, and imported into SAS (v.9.1.3, SAS institute, Cary, NC) for analysis. PDPT-related responses were cross-tabulated against demographic information to identify existing associations. Data were stratified into 4 groups based upon sampling method and urban-rural county continuum.10 For cross-tabulations statistical associations were determined using Fisher’s exact test.
Institutional Review Board Approval
The study was approved by the authors’ university institutional review board. Participating pharmacists were offered $2 bills as a token for their time.
Thirty-one of the 318 pharmacies visited to recruit participants were ineligible or did not exist. Of 287 eligible pharmacies, 193 pharmacists (67.3%) responded to the survey, 51 refused due to corporate policy, and 45 refused for other reasons (e.g., too busy, not interested). Excluding the pharmacy chain that actively discouraged participation, 76.7% of pharmacists responded to the survey (178/232).
Over half of participating pharmacists were under 40 years of age; 86.1% were white; 51.6% were men, and 48.7% were staff level (Table 1). In large urban areas outside the Capital Region, 51.4% of respondents were nonwhite, primarily South Asians.
In general, pharmacists supported PDPT for Chlamydia and gonorrhea (62.6% and 58.3%, respectively) whereas 51.4% supported its use for syphilis (Table 2). The level of support for PDPT varied with the organizational position of the pharmacist, but was unrelated to the geographic setting of the pharmacy (urban vs. rural). Support for the concept of PDPT for Chlamydia and syphilis was highest for pharmacist owners/partners, followed by supervisory pharmacists and staff pharmacists (for Chlamydia: 73.7%, 68.4%, 57.0%, respectively, P = 0.046; for syphilis: 68.4%, 56.6%, 46.5%, respectively, P = 0.031). For gonorrhea, support among supervising pharmacists was slightly higher than for pharmacy owners/partners, followed by staff pharmacists (67.1%, 63.2%, 52.3%, respectively, P = 0.122).
The majority (88%) of pharmacists wanted a specific notation placed on prescriptions issued for PDPT. About half (56.5%) indicated they would wait to bill a patient’s insurance company until receiving the patient’s approval if they were aware that this was a PDPT-related prescription.
Most pharmacists (74.1%) believed they had sufficient knowledge to provide STD counseling, would provide such counseling (79.4%) and discuss condom use (78.8%) with everyone presenting with prescriptions for STD treatment. However, only 49.2% reported having sufficient time for such counseling (Table 3). No significant associations were seen when responses were stratified by the urban-rural continuum. Pharmacists who perceived their pharmacy design as poor for counseling purposes were less likely to report having time for counseling compared with those with more counseling-friendly environments (26.7% vs. 66.6%, respectively, P = 0.009).
A majority did not support having behind-the-counter availability of antibiotics for Chlamydia (78.1%) or gonorrheal infections (79.2%) for partners without prescriptions.
Twenty-four pharmacists (12.4%) provided comments at the end of the survey. Some felt PDPT would be a good health care option [“PDPT would benefit the health care system, (i.e., time, money) and the overall health of individuals,” “PDPT is great for advancing and improving sexual health.”] Others offered mixed perspectives [“great idea, but the partner should be examined by the physician for preexisting medical conditions, drug allergies to antibiotics, and drug interactions to other medications,” “…I think there is a lot of potential (for) abuse with PDPT.”] Participants pointed out the importance of providing education on the diseases including symptoms, treatments, and prevention methods (“Education about STDs needs to be incorporated into any plan for PDPT, especially for younger patients”) and concerns about their capacity to provide these services. [“This situation assumes pharmacists have the time to provide this counseling. Pharmacists are running ‘at the limit’ the whole 10–12 hour shift,” “this puts too much responsibility on pharmacists and (there is) too much liability and room for error in our profession.”] Finally, some expressed clear opposition to the practice [“I don’t believe any prescriptions (should) be given to anyone without them first seeing and getting it from an MD”, and “I don’t think any partner should be trusted to give their partner an Rx for an antibiotic for an STD.”]
Of the 287 pharmacies visited, sufficient observational data were collected at 282 pharmacies. No customer-staff interactions were observed in 43 pharmacies. In the remaining 239 pharmacies, 597 customer-staff interactions were observed (Table 4). No other customer was present in 43.7% of the interactions. When including the 6-foot rule about the closest customer, 72.0% (430/597) of the observed interactions met the criteria for confidentiality. With regard to staff-staff distance, 70.3% (419/596) of encounters had no staff member within 6 feet of the staff person speaking with the customer. Combining customer and staff measures, 53.0% of all encounters met the criteria for confidential interactions. However, in 81.3% of pharmacies, researchers noted that a conversation in the pharmacy area could be overheard at a distance beyond 6 feet and 166 (60.7%) pharmacies had conversations at the counter that could be heard from a distance of at least 15 feet away. Customer volume did not vary significantly by time of day.
In our survey, pharmacists expressed favorable attitudes toward PDPT for gonorrhea and Chlamydia by a margin of 20% to 30%. They were also willing to provide education and counseling to individuals with STD prescriptions regarding aspects of the infections and condom use. This perspective is compatible with the general movement among the pharmacy profession to increase their scope of practice to include disease counseling and management.11 A growing number of pharmacists are becoming certified in diabetes education, providing monitoring, education, and counseling for type II diabetes patients.12 Pharmacy-based chronic disease management programs are having positive effects on patient outcomes and satisfaction.13,14 Nationally and internationally there is movement toward expanded roles for pharmacists to provide not only education and counseling but also direct prescribing.15
Education, reimbursement, and confidentiality are important factors to be considered when a pharmacists’ scope of practice is changed. In our survey, most pharmacists believed they had sufficient knowledge to provide counseling about the STDs and associated medications. However, STD education is minimal in pharmacy schools16 and perception of knowledge may be overestimated as has been seen among related health professionals.17 Currently, the Centers for Disease Control and prevention recommends PDPT for Chlamydia and gonorrhea, but not syphilis. Syphilis without specification of stage was included in the survey as a control measure of knowledge. It is reasonable to expect knowledgeable pharmacists to be against PDPT for syphilis given that proper treatment depends on establishing the stage of infection (based upon on a combination of clinical and laboratory criteria) and treatment requires either intramuscular injection or multiday dosing of oral antibiotics.18 Indeed, while the proportion was less compared with Chlamydia and gonorrhea, still about half supported the use of PDPT for syphilis, clearly indicating a need for additional education. Courses on STDs could be provided to practicing pharmacists through continuing education programs making this training feasible. Additionally, if PDPT is legalized in New York, it is likely that pharmacy colleges will include STD modules in their standard curriculum (personal communication, Albany College of Pharmacy, 2007).
Reimbursement may be a significant issue with an expansion of services, such as counseling. For pharmacists to provide confidential counseling, it will require time to move to a private area of the pharmacy (e.g., consultation room) and speak with customers. At a minimum, assessment for potential contraindications for medications must occur. However, counseling about temporarily abstaining from sex, STD prevention, and the value of follow-up tests to document disease-free status is important. With training and reimbursement for counseling, it is reasonable to expect pharmacists to provide comparable counseling on these issues compared with physicians.19 Without reimbursement, meaningful counseling is unlikely given the structure of community pharmacist practice. Time was the primary barrier to implementation identified in this study, a finding consistent with the literature and general observations of pharmacist-customer interactions.20–23
Confidentiality is fundamentally important and must be considered in multiple dimensions. First, for sensitive topics like STDs, where not only antibiotic use, but disease and risk-behavior are discussed, a truly private environment is required. When no other customers are present, confidentiality is obviously not an issue and conversation can be conducted at the pharmacy counter. However, this is certainly not the norm. Furthermore, our observations revealed that over half of interactions occurring at the pharmacy counter could be heard at a distance exceeding 15 feet. Concerning other pharmacy personnel, although technicians and clerks may have knowledge of indications for the prescription (i.e., the STD diagnosis), customers may still feel more comfortable where other staff cannot overhear. Therefore, in many instances to provide confidential counseling, it will require moving to a private area.
Another aspect of confidentiality relates to the prescription itself. Our findings indicated pharmacists wanted PDPT prescriptions clearly marked as such. This was deemed important for 2 specific reasons. First, it serves to alert pharmacists to a client who may require more intensive counseling. Secondly, it would assist in preventing inadvertent confidentiality violations due to automatic submission to insurance companies. As only about half of respondents stated they would put a hold on insurance submission, education around this point is clearly needed. Because a prescription is issued in an individual’s name likely without their knowledge, and the medication-dose combination typically may be unique to a STD diagnosis, this creates a potential for breach of confidentiality. Alternatives to named prescriptions are possible but pose their own limitations. At present, unnamed prescriptions are not legally allowed in NYS. In addition, using an unnamed prescription or placing the prescription for the partner in the index patient’s name limits the partners’ ability to use his/her insurance if desired.
Given the support for PDPT and the fact that direct prescription authority for US pharmacists has been discussed for about 2 decades and exists in some areas of Europe,24 we were surprised that most participants were against providing behind-the-counter antibiotics without prescription for individuals identifying themselves as exposed to Chlamydia. Such direct provision of antibiotics without a physician prescription could serve to expedite treatment. However, it more clearly places the responsibility for the medical care and risk assessment upon the pharmacist as opposed to a physician who has no medical relationship with the individual. As opposition to this option was widespread among our study population, this issue requires further investigation to understand the specific underlying reasons why pharmacists do not support it.
The following limitations are noteworthy. First, although the survey had some geographic limitations, the results were similar across the various regions. Second, the response proportion though moderate (67%) compares favorably with the 40% seen in most major pharmacist surveys. Third, the organizational level of the respondents was mixed (owners, supervisors, staff pharmacists) and the observed attitudes differed somewhat at the different levels. However, we chose to randomly sample a pharmacist on duty at the time of visit. The rationale for this choice was to have a sample representing pharmacists’ at-risk for receiving prescriptions and customer interactions. Lastly, IRB constraints did not permit the linking of the observational findings to the survey responses without obtaining pharmacists’ permission. We preferred to forgo linkage of the data as pharmacist awareness of the observational segment of the study would likely bias the results.
This study found that pharmacists are generally open to and supportive of the practice of PDPT for STDs. However, education and possible adaptation of the physical environment is needed to prepare pharmacists for the new responsibilities related to STD counseling and assessment for contraindications for exposed individuals who may or may not have contact with a physician. Requiring prescriptions for PDPT to be clearly marked may be essential to provide appropriate services and prevent undesired disclosures to insurance providers through automated systems, although such labeling may also have drawbacks as far as confidentiality is concerned. Issues related to confidentiality and privacy must be comprehensively addressed along with expressed concerns regarding potential abuse, safety, and the program’s impact on staff time in order for pharmacists to play a viable role in PDPT.
2. Centers for Disease Prevention and Control. Expedited partner therapy in the management of sexually transmitted diseases. US Department of Health and Human Services, Atlanta, GA: 2006. Available at: http://www.cdc.gov/std/treatment/EPTFinalReport2006.pdf
. Accessed February 15, 2007.
3. American Medical Association: Report 7 of the Council on Science and Public Health. C:βTDÅMA (CSAPH) Report 7 of the Council on Science and Public Health (A-06) Full Text.htm. Accessed January 5, 2008.
5. Untitled act-“Authorizes a health care practitioner diagnosing a sexually transmitted chlamydia trachomatis infection to provide antibiotic drugs to such patient’s partner,” A8730, NYS legislative session (2007).
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