Attitudes of women and pharmacists on the opportunity to obtain a progestogen-only pill over the counter – Italian outcomes

Abstract

Purpose

Scrutinizing, among potential providers and users, the perceived claim and interest for over the counter (OTC) accessibility of a progestogen-only pill (POP).

Methods

Cross-sectional, descriptive study based on an online survey of 1000 women and 100 pharmacists in Italy, part of a larger sample including Germany and Spain.

Results

Hormonal contraceptive methods are used by 35%; 5% of women reported currently not using contraception, 40% using a barrier method, and 20% a method considered less effective than male condoms (including 16% withdrawal and 4% natural methods and fertility/contraceptive applications). Almost 80% of women felt knowledgeable about the different contraceptive method, but about 1/3 had experienced difficulty accessing their oral contraceptive (OC) in the past two years. Women reacted positively to the proposition of an OTC-POP and 85% agreed that they would discuss the decision to buy it with their doctor; 75% reported they would continue to see their doctor for other reproductive health issues, including screening. The most frequent barrier is cost (reported by 25–33% of women) followed by long waiting times for doctor appointments and lack of personal time to schedule an appointment.

Pharmacists (66%) would be likely/fairly likely to recommend the POP after appropriate training, agreeing that the benefits of an OTC-POP included improved access for women, saving them time and giving them more independence.

Conclusions

Potential users of contraception in Italy have a positive attitude toward OTC-POP, with doctors continuing to have a relevant role. Following training, pharmacists are also positive.

Keywords:

• Oral contraception
• progestogen-only pill
• OTC
• prescription
• pharmacists
• consumers
• users

Introduction

Despite widespread availability of modern methods of contraception in most European countries [1,2] unintended pregnancy (UIP) remains a public health concern [2,3]. In industrialized countries, the average woman, even one who wants children at some point in her life, spends about 30 years trying to avoid pregnancy [4]. Most women will use a variety of contraceptive methods throughout their reproductive years. Preferences for contraceptive methods vary from woman to woman and for the same woman over the course of her reproductive life. Women choose their contraceptive methods for a variety of different reasons, such as effectiveness, lack of side effects, affordability, or means of access to the method [5,6].

Use of hormonal contraception in Italy is the lowest among the European countries [7]. Accessibility is one of the most important factors influencing the use of contraceptive methods [8,9]. Worldwide, OTC access to oral contraceptives seems an appropriate approach to empower women to take control of their reproductive choices [10]. In the US, pharmacist-prescribed contraception may be an option to expand patient access to contraception [11]. In the United Kingdom, some progestogen-only pills (POP) were recently approved for sale in pharmacies without the need to visit a doctor [12]. Data collected in other European countries, including Italy, suggested the positive attitudes of women and pharmacists about an OTC-POP [13].

Here, we present a detailed analysis of the Italian data collected from both women and pharmacists to further evaluate the perceived interest for and/or concerns about the opportunity to obtain a contraceptive pill OTC (especially a POP) in our country.

Methods

Detailed methodology of the survey was described in Arisi et al. [13]. Briefly, based on qualitative research, an online quantitative survey was undertaken with one thousand women aged 16–50, by Ipsos (3 Thomas More Square London E1W 1YW – UK). To be eligible for the study, women had to have reported having heterosexual sexual intercourse in the preceding 3 months and not be wanting to conceive in the near future or ever. Recruitment was through an online panel (Toluna, https://uk.toluna.com). For the survey, quotas were set by age and region in order to identify a representative sample for Italy, and data were weighted to bring the sample in line with the known population profile. Fieldwork took place between November 11 and December 7, 2021, in Italian, and lasted 20 min. One hundred community pharmacists were also recruited. To be eligible for the study pharmacists needed to have been qualified for 3–30 years, to be discussing OCs with clients on at least two days in a typical week, and dispensing OCs at least once in a typical week. The online surveys lasted 15 min, were in Italian and took place between November 16 and December 2, 2021.

The survey included a variety of types of question including, open numeric, single code, multi-code, and statement ratings, and all multi-code list questions included an ‘Other (please specify)’ option giving respondents the opportunity to write their own answers. Both potential users and pharmacists were given general information in the survey about POPs, no type or brand of POP was specified. The content of the survey is available in Appendix 1 for consumers and Appendix 2 for the pharmacists.

The quantitative study was approved by an independent Institutional Review Board (IRB Pearl Pathways https://www.pearlirb.com). When invited to participate and in the introduction to the questionnaire, respondents were given information about the study and data were anonymized; consent was implicit, and respondents were informed that they were free to decline to answer any question and to discontinue the survey at any time. Consumers and pharmacists were compensated in panel points.

The survey was tested before fielding. Pilot surveys were carried out in Italian before moving the survey to the live production server; the live link was further checked by the project management team to make sure the data is captured correctly. The Z test was used for proportion testing, and the T test was used for means testing, at a 95% confidence level.

Results

Detailed consumer and pharmacist demographics are shown in Table 1A and B, respectively. The mean age of women surveyed was 34.6 ± 9.2 years. More than half were between 36 and 50 years, and more than 2/3 reported living with a partner. Forty percent were employed full time, and over 60% had an annual gross household income of less than 40,000 euros. Only 17% were students. Use of public (43%) vs private healthcare (52%) was almost equally distributed.

Table 1A. Detailed demographic of Italian women.

Please write your age (years) in the box below, as of your last birthday			All respondents (n = 1,000)
16-20 (n = 106)	21-35 (n = 378)	36-50 (n = 516)
11%	38%	52%	Mean: 34.6 +/- 9.2
Do you currently live with a partner? Base: All respondents (n = 1,000)
Yes			67%
No			32%
Don’t know			1%
Which of the following, if any, is the highest educational or professional qualification you have obtained? Base: All respondents (n = 1,000)
No diploma			–
Diploma middle school			7%
High school / technical / professional education diploma			51%
Degree			16%
Master’s degree			13%
Specialization diploma / Master / Specialization			7%
Research doctorate / PhD			2%
Still studying			4%
Don’t know			–
Which of the following statements, if any, best describes your current situation? Base: All respondents (n = 1,000)
I do not want to become pregnant in the near future, but maybe later			66%
I will never want to become pregnant (again)			34%
Employment. Which of these applies to you? Base: All respondents (n = 1,000)
Full time (38+ hours per week)			40%
Part time (less than 38 h per week)			19%
Student			17%
Unemployed			9%
Homemaker			14%
Retired			–
I prefer not to say			1%
I do not know			–
What is your approximate annual gross household income? Base: All respondents (n = 1,000)
<€40,000			62%
€40,000 - €99,999			19%
€100,000 +			2%
Don’t know			5%
Prefer not to say			11%
Thinking about where you typically go to discuss contraception with a doctor, which of the following settings do you primarily use? Base: All respondents (n = 1,000)
Private healthcare			52%
Public healthcare system / national healthcare system			43%
Don’t know			4%
Prefer not to say			2%

Table 1B. Detailed demographic of Italian pharmacists.

For approximately how many years have you been qualified in your current specialty?
Base: All respondents (n = 100)	11 +/- 6.6
Gender Base: All respondents (n = 100)
Male	27%
Female	72%
In another way	–
I prefer not to say	1%
What is your role within the pharmacy? Base: All respondents (n = 100)
Head pharmacist	18%
Pharmacist	82%
Which of the following best describes the pharmacy in which you work?
Small pharmacy (up to 5 employees)	42%
Medium pharmacy (6-10 employees)	44%
Large pharmacy (more than 11 employees)	14%
Which of the following best describes the location of the setting in which you work? Base: All respondents (n = 100)
Rural	16%
Small-medium town	36%
Suburban	19%
Inner city	28%
None of the above	1%
I do not know	–
In a typical week, how many customers do you dispense daily oral contraceptives to? Base: All respondents (n = 100)	27 patients
In a typical week, which of the following best describes the number of days that you have discussions with customers about daily oral contraceptives? For example, answering queries, explaining how to take the daily OC. Base: All respondents (n = 100)
Every day	45%
2-5 days	55%

A minority of pharmacists were male (27%). Discussion/dispensing of OCs was frequent: in a typical week, pharmacists dispensed OCs to at least 27 patients on average and almost half of them spoke about OCs to customers every day. A minority of pharmacists worked in large pharmacies (14%), while 42% worked in small and 44% in medium pharmacies with 6–10 employees. A minority were head pharmacists (18%). The mean number of years qualified as pharmacist was 11 ± 6.6.

Current contraceptive practice

The current method use by age is shown in Table 2. The term OC includes both combined oral contraceptive (COC) and POP. Male condom is the method used by women across different ages and independent from whether living with a partner or not, followed by OCs. Women aged 36–50 (11%) had the highest use of long-acting reversible (LARC) methods. Asked about which different contraceptive methods, if any, they have ever used, 50% reported having used OCs, almost 70% had used condoms (highest use in 16–20 age group) and 17% reported having used emergency contraception (no difference among age groups). Among all women, the most frequent reasons for using their current method of contraception was ease of use (46%), convenience (42%) and ease of access (35%). However, 61% of barrier method users (n = 403) reported good protection against sexually transmitted diseases as their main reason (Table 2). Asked about their discussion with a doctor regarding contraception, 41% in the age range 16–20 years reported have never discussed it (Table 3). Among women who have discussed contraception with their doctor, 72% already knew what contraceptive method they wanted to use before going to see their doctor, an answer independent of their age (Table 3). In line with some other European countries, almost 80% of respondents felt knowledgeable about the different contraceptive methods available to them [13]. A total of 625 women reported they have switched their contraceptive method during the past five years, with 28% switching following medical advice and 37% for personal reason/modification in personal contraceptive needs, and 21% because of a negative experience on a previous method used (Table 3).

Table 2. Current contraceptive practice among Italian women.

Which contraceptive method, if any, is your current primary method to prevent pregnancy? Statistically valid differences are marked by*
Respondents	16-20 (n = 107)	21-35 (n = 391)		36-50 (n = 502)		All (n = 1,000)
Daily oral contraceptive	25%	28%		26%		27%
Condoms/ rubbers (male)	53%	46%		32% *		40%
Female condoms	0%	0%		1%		0%
Natural methods	3%	1%		4%		3%
Fertility/ contraceptive app	3%	1%		1%		1%
Withdrawal	9%	12%		20% *		16%
Implant	0%	1%		0%		0%
Hormone injection	0%	0%		0%		0%
Contraceptive patch	0%	1%		2%		2%
IUS/ IUD (coil with or without hormone)	0%	1%		4% *		3%
Vaginal ring	2%	2%		4%		3%
I am not currently using any contraception	6%	4%		6%		5%
Other	0%	0%		0%		0%
Which different contraceptive method(s), if any, have you ever used in order to prevent pregnancy? Statistically valid differences are marked by*
	16-20 (n = 107)		21-35 (n = 391)	36-50 (n = 502)	All (n = 1,000)
Condoms/rubbers (male)	78% *		73% *	63%	69%
Daily oral contraceptive pill	31%		43% *	58% *	50%
Withdrawal	29%		36%	41% *	38%
Emergency contraception (e.g. morning after pill)	16%		17%	16%	17%
Fertility/contraceptive app	14%		12%	8%	10%
Natural methods (e.g. basal temperature, rhythm/calendar, cervical mucus)	4%		9%	11%	10%
Vaginal ring	2%		5%	9% *	7%
Contraceptive patch	2%		5%	9% *	7%
IUS/IUD (coil with or without hormones)	–		4%	6% *	5%
Female condoms	7%		3%	2%	3%
Contraceptive jelly, cream, foam, sponge (without diaphragm)	1%		1%	2%	2%
Diaphragm with/without spermicide	–		1%	3%	2%
Permanent contraception method (e.g. tubal ligation, partner vasectomy etc.)	–		–	2%	1%
Implant	1%		1%	1%	1%
Hormone injection	–		1%	1%	1%
Don’t know	2%		1%	–	1%
Prefer not to say	1%		–	–	–
Thinking about your current method of contraception, what are the main reason(s), if any, that you use this method of contraception? Base: All respondents (n = 1,000) Statistically valid differences are marked by *
Respondents	OC Users (n = 208)	Long-acting methods (n = 76)	Barrier methods (n = 403)	Natural methods (n = 195)	Not using any methods (n = 54)	Total (n = 1,000)
Easy to use	46%	42%	57%	33%	13%	46%
Very effective against pregnancy	71% *	55% *	49%	10%	5%	45%
Safe	38%	55% *	26%	15%	2%	28%
Ease of access	29%	8%	60%	10%	0%	35%
Convenience	47%	55% *	43%	35% *	20% *	42%
Good protection against sexually transmitted diseases	3%	4%	61% *	3%	2%	26%
Help controls menstrual bleeding / periods	60% *	46%	1%	7%	9%	22%
Low cost	15%	13%	28%	21%	5%	21%
No need to discuss with a healthcare professional	2%	0%	27%	28% *	9%	18%
Help controls acne	14%	1%	0%	2%	2%	4%
Another reason	5%	9%	0%	7%	17%	5%
Don’t know	0%	0%	1%	6%	20% *	3%
Prefer not to say	0%	0%	1%	3%	13%	1%

Table 3. Discussion with doctors about contraceptive practice among Italian women.

When thinking about your discussions with your doctor (gynecologist, GP, family doctor or family planning doctor), to what extent do you agree or disagree with the following statements: Base: All respondents who have discussions Italy (n = 741)
	16-20 (n = 61)						21-35 (n = 287)						36-50 (n = 393)
Respondents	Strongly agree	Slightly agree	Neither	Slightly disagree	Strongly disagree	Don’t know	Strongly agree	Slightly agree	Neither	Slightly disagree	Strongly disagree	Don’t know	Strongly agree	Slightly agree	Neither	Slightly disagree	Strongly disagree	Don’t know
My doctor is able to answer all questions I have about my contraception	41%	35%	19%	2%	2%	1%	45%	40%	11%	2%	1%	1%	49%	37%	9%	3%	1%	1%
My doctor listens and understands my personal needs then recommends a contraceptive method that worked for me	41%	28%	22%	3%	6%	–	33%	43%	16%	6%	2%	–	36%	41%	17%	3%	2%	1%
I knew what contraceptive method I wanted to use before going to see my doctor	35%	39%	13%	8%	5%	–	27%	46%	18%	5%	3%	1%	26%	44%	20%	6%	4%	–
My doctor has explained all the available options of contraception to me	38%	18%	8%	25%	10%	2%	36%	37%	15%	7%	5%	–	37%	38%	14%	9%	3%	–
The need for contraception is reviewed in every appointment with my doctor	10%	30%	33%	20%	8%	–	14%	27%	25%	17%	16%	1%	15%	25%	24%	18%	19%	–
I have regular appointments with my doctor to discuss my contraception	16%	21%	18%	28%	16%	–	14%	19%	27%	22%	18%	–	14%	19%	24%	20%	23%	–
Have you ever discussed contraception with your doctor (gynecologist, GP, family doctor or family planning doctor)? Base: All respondents (n = 1,000) Statistically valid differences are marked by *
Respondents	16-20 (n = 107)	21-35 (n = 391)	36-50 (n = 502)	All (n = 1,000)
Yes	57% *	73%	78%	74%
No	41% *	25%	21%	24%
Don’t know	2%	2%	1%	1%
Prefer not to say	0%	0%	0%	0%
To what extent do you agree or disagree with the below statements, Base all correspondents n = 1,000
	16-20 (n = 107)						21-35 (n = 391)						36-50 (n = 502)
Respondents	Strongly agree	Slightly agree	Neither	Slightly disagree	Strongly disagree	Don’t know	Strongly agree	Slightly agree	Neither	Slightly disagree	Strongly disagree	Don’t know	Strongly agree	Slightly agree	Neither	Slightly disagree	Strongly disagree	Don’t know
I see my doctor if I experience any gynecology problems	48%	27%	11%	5%	8%	1%	48%	34%	10%	4%	4%	–	47%	33%	12%	4%	4%	–
I feel knowledgeable about the different contraception methods available to me	39%	41%	8%	10%	2%	1%	32%	45%	16%	5%	2%	–	32%	49%	14%	4%	1%	–
I see my doctor if I ever experience side effects from contraception	42%	33%	7%	6%	9%	3%	40%	35%	10%	7%	5%	3%	39%	36%	13%	5%	6%	2%
I attend routine appointments with my doctor to discuss other women’s health issues not related to contraception	20%	16%	20%	16%	24%	5%	23%	29%	19%	13%	14%	2%	27%	26%	21%	12%	13%	1%
My doctor reviews my contraception needs at each visit	8%	32%	23%	16%	20%	2%	14%	23%	23%	17%	20%	3%	14%	20%	26%	19%	20%	1%
I prefer to use other sources of information rather than ask my doctor questions about contraception	6%	20%	15%	32%	28%	–	9%	15%	19%	23%	34%	–	8%	14%	23%	23%	20%	35%
Thinking about your most recent switch of contraception method,why did you switch? Base: Respondents who have used more than one different contraceptive method to prevent pregnancy, n = 625
Respondents	16-20 (n = 60)	21-35 (n = 234)	36-50 (n = 331)	Total (n = 625)
My personal life changed, so I wanted to change my contraception	25%	39%	37%	37%
My doctor (gynecologist, family doctor, GP, family planning doctor) recommended that I switched	25%	29%	28%	28%
I had a bad experience on my previous method of contraception	19%	26%	17%	21%
My friends / family were using something else that I wanted to try	16%	10%	5%	7%
I saw something on the internet that motivated me to switch	8%	7%	2%	5%
I saw something in the media that motivated me to switch	5%	3%	3%	3%
My pharmacist recommended that I switched	2%	1%	1%	1%
Other	10%	4%	7%	6%
I don’t remember	10%	6%	11%	9%
Prefer not to say	5%	3%	1%	2%

Among current OCs users (n = 268), 30% reported having experienced difficulties, such as struggling to find time to attend appointments and not being able to get their prescription on time in the preceding two years (Table 4). Among those who had problems, while 51% used another method of contraception due to the interruption to in accessing their OCs, 31% avoided having sex, 18% used emergency contraception and 5% got pregnant. Only 1/3 of current OCs users reported having an in-person consultation with their doctor every time they need a repeat prescription, 12% reported getting their repeat OCs without a prescription at the pharmacy and another 32% received a mailed prescription or contacted the doctor by telephone (Table 4). Challenges currently faced by women regarding contraception included the cost of contraception and consultations with a doctor, lack of personal time to schedule an appointment and attend, and long wait time for doctor appointments (Table 4). Among the current non-OCs users (n = 732), fear of side effects and fear of hormones are the leading reasons for not using OCs. In younger aged women (16–20 years, n = 80), regularly seeing a doctor, obtaining a prescription and the need for gynecological examinations were reported as barriers to the use of OCs (Table 4).

Table 4. Accessing OC.

Below is a list of things that women may or may not experience when accessing their daily oral contraceptive pill. Which of the following, if any, have you experienced in the past 2 years? Base: Respondents currently using daily oral contraception, (n = 268) *SMALL BASE SIZE
Respondents	16-20 (n = 27*)	21-35 (n = 110)	36-50 (n = 131)	Total (n = 268)
I have struggled to find time to attend appointments for contraception	0%	12%	9%	10%
I have had gaps of not taking my contraceptive pill as I have been unable to get my prescription on time	22%	11%	4%	9%
I have struggled to get a prescription for my contraceptive pill	11%	2%	3%	3%
My appointment for my contraceptive pill has been delayed	0%	5%	3%	4%
I have struggled to get an appointment for my contraceptive pill	4%	1%	4%	3%
My appointment for my contraceptive pill has been canceled	0%	0%	2%	1%
None of the above	59%	67%	70%	68%
Don’t know	4%	1%	4%	3%
Prefer not to say	0%	0%	1%	0%
You previously mentioned that you have experienced an interruption to using your oral contraceptive pill because of an access issue. Have you ever experienced any of the below statements due to an interruption to being able to access your oral contraceptive pill? Base: Respondents who have experienced an interruption to using their oral contraceptive pill Italy (n = 78) *SMALL BASE SIZE
Respondents	16-20 (n = 10*)	21-35 (n = 35)	36-50 (n = 33)	Total (n = 78)
I used another method of contraception due to the interruption to accessing my oral contraceptive pill	80%	54%	40%	51%
I didn’t have sex due to the interruption to accessing my oral contraceptive pill	28%	29%	33%	31%
I used no contraception due to the interruption to accessing my oral contraception	10%	6%	12%	9%
I used emergency contraception due to the interruption to accessing my oral contraceptive pill	0%	17%	24%	18%
I got pregnant due to the interruption to accessing my oral contraceptive pill	0%	9%	3%	5%
None of the above	10%	6%	6%	6%
Don’t know	0%	0%	3%	1%
Thinking about how you usually get your repeat oral contraceptive pills, which of the following, if any, is the primary approach that you use? By ‘doctor’, we are referring to gynecologist, family doctor, GP or family planning doctor. Base: Respondents currently using daily oral contraception, (n = 268)
Respondents	16-20 (n = 27*)	21-35 (n = 110)	36-50 (n = 131)	Total (n = 268)
I have an in-person consultation with my doctor every time I need a repeat prescription for my oral contraceptive pill	48%	30%	31%	32%
I phone my doctor who sends the repeat prescription to me	7%	26%	22%	22%
I’m able to get my oral contraceptive pill without a prescription at the pharmacy	15%	12%	12%	12%
I receive the repeat prescription for my oral contraceptive pill in the post	4%	11%	11%	10%
I pick it up at the doctor’s office without seeing my doctor	12%	9%	9%	9%
I do not need a repeat prescription for my oral contraceptive pill	15%	7%	8%	9%
I use an online platform to get the repeat prescription for my oral contraceptive pill	–	4%	4%	4%
I have not been on the oral contraceptive pill long enough to need a repeat prescription	0%	0%	1%	0%
Which of the following, if any, do you believe are the challenges you currently face regarding contraception? By ‘doctor’, we are referring to gynecologist, family doctor, GP or family planning doctor. Base: All respondents (n = 1,000)
Respondents	16-20 (n = 107)	21-35 (n = 391)	36-50 (n = 502)	Total (n = 1,000)
Cost of contraception	34%	39%	27%	32%
Long waiting times for doctor appointments	18%	19%	15%	17%
Lack of personal time to schedule an appointment and attend	16%	19%	19%	19%
Lack of information on the different methods of contraception	24%	16%	9%	13%
Cost of contraception consultations with a doctor	37%	23%	23%	25%
Lack of sex education	30%	19%	8%	14%
The effort that is required to get hold of the contraception I need	18%	8%	8%	9%
Being able to get hold of the contraception I prefer	15%	6%	9%	9%
Cannot find a method that suits me	6%	6%	7%	6%
Too frequent doctor appointments	5%	6%	8%	7%
Other challenge	1%	0%	1%	1%
None of the above	13%	21%	29%	24%
Don’t know	1%	2%	2%	2%
What is your main reason(s), if any, for not using an oral contraceptive? Base: Respondents who are not currently using a daily oral contraceptive pill as their current method of contraception to prevent pregnancy, (n = 732)
Respondents	16-20 (n = 80)	21-35 (n = 281)	36-50 (n = 371)	Total (n = 732)
Side effects	48%	46%	42%	44%
I don’t want to take hormones	26%	36%	43%	38%
I am satisfied with my current method of contraception	26%	28%	31%	30%
I worry I would forget to take the pill daily	34%	23%	19%	22%
I have tried it in the past and did not like it	4%	20%	18%	17%
The need to regularly see a doctor for oral contraception	19%	10%	9%	10%
The cost of oral contraception	21%	11%	7%	10%
The need to obtain a prescription for oral contraception	16%	10%	10%	11%
My doctor told me not to take the oral contraceptive pill	9%	11%	12%	11%
Impact on future fertility	15%	10%	3%	7%
The need for a gynaecological examination for oral contraception	20%	7%	5%	7%
The time taken to access oral contraception	5%	2%	1%	2%
I do not have enough information	8%	5%	2%	4%
None of my friends are taking the oral contraceptive pill	7%	1%	0%	1%
Another reason	4%	4%	5%	4%
Don’t know	1%	2%	1%	1%
Prefer not to say	0%	0%	0%	0%

Reactions to the concept of over-the-counter progestogen-only pill

Women

Asked about their initial reaction to the proposal for a POP at the pharmacy without a prescription, 65% of all women were very positive or fairly positive, with 42% feeling that they would be very likely or fairly likely to switch their current contraceptive method should a POP become available OTC (Table 5). Almost 50% of all women stated they would be likely to buy a POP from a pharmacy as back up if they ran out of their usual contraceptive supplies. The reaction to the concept of OTC-POP was most positive among the young age group (16-20 years) and current OCs users (Table 5). Over 70% of the entire sample, across all ages and current contraceptive method users, agreed with the statement that the ability to get an OTC-POP ‘breaks down current barriers to accessing contraception for women’ (Supplementary data). More than 60% of all women surveyed would have confidence in discussing the POP with their pharmacist.

Table 5. Reactions of women to switch.

Please now imagine a scenario where you are using progestin-only oral contraceptive pill without prescription as your primary method of contraception. To what extent do you agree or disagree with the following statements:By ‘doctor’, we are referring to gynecologist, family doctor, GP or family planning doctor Base: All respondents n = 1,000
	16-20 (n = 107)						21-35 (n = 391)						36-50 (n = 502)
Respondents	Strongly agree	Slightly agree	Neither	Slightly disagree	Strongly disagree	Don’t know	Strongly agree	Slightly agree	Neither	Slightly disagree	Strongly disagree	Don’t know	Strongly agree	Slightly agree	Neither	Slightly disagree	Strongly disagree	Don’t know
I would go to see my doctor if I experienced side effects	62%	28%	6%	2%	2%	–	59%	33%	5%	2%	1%	–	59%	33%	6%	1%	1%	–
I would discuss this pill with my doctor before buying it	53%	33%	7%	4%	4%	–	49%	35%	9%	4%	2%	–	52%	32%	11%	3%	2%	–
I would go to see my doctor for other women’s health issues not related to contraception (e.g. cervical and breast cancer screening)	33%	34%	20%	6%	2%	–	38%	40%	12%	5%	3%	–	42%	37%	13%	4%	3%	–
I would discuss this pill with a doctor before buying it	36%	42%	11%	7%	3%	–	36%	40%	15%	6%	2%	–	39%	36%	16%	6%	3%	–
I would go to see a pharmacist if I experienced side effects	28%	26%	21%	18%	5%	–	17%	31%	22%	19%	9%	–	18%	33%	21%	16%	10%	–
What are your initial reactions, if any, to the idea of this progestin-only oral contraceptive pill being available to buy without prescription? Base: All respondents n = 1,000
	All respondents (n = 1,000)	16-20 (n = 107)	21-25 (n = 391)	36-50 (n = 502)
Very positive	30%	44%	27%	31%
Fairly positive	35%	29%	37%	34%
Neither positive nor negative	18%	10%	19%	19%
Fairly negative	11%	15%	11%	10%
Very negative	4%	1%	5%	4%
Don’t know	2%	1%	1%	3%
What do you believe the main benefits, if any, would be, of a progestin-only oral contraceptive pill available to buy at the pharmacy without a prescription? Base: All respondents, Italy (n = 1,000)
Respondents	OC Users (n = 268)	Long-acting methods (n = 76)	Barrier methods (n = 403)	Natural methods (n = 195)	Not using any methods (n = 54)	Total (n = 1,000)
No need to see a doctor (gynecologist, family doctor, GP or family planning doctor) to get a prescription	45%	47%	47%	52%	42%	47%
Easier access	36%	33%	35%	47%	35%	38%
Saves time	40%	39%	32%	35%	40%	36%
No need for arranging an appointment	38%	34%	40%	46%	46%	41%
Greater independence	43%	32%	45%	43%	53%	44%
Greater freedom	36%	21%	35%	32%	39%	34%
Greater flexibility	23%	16%	19%	22%	22%	21%
No need for a gynaecological exam	16%	20%	25%	27%	33%	23%
Easier to take	15%	9%	22%	24%	20%	19%
Cost	17%	10%	9%	12%	7%	12%
Other	0%	0%	1%	0%	–	*
No benefits	5%	4%	4%	4%	9%	4%
Don’t know	3%	3%	4%	3%	–	3%
What would be your main concerns, if any, of buying a progestin-only oral contraceptive pill without a prescription in a pharmacy? Base: All respondents, Italy (n = 1,000)
Respondents	OC Users (n = 268)	Long-acting methods (n = 76)	Barrier methods (n = 403)	Natural methods (n = 195)	Not using any methods (n = 54)	Total (n = 1,000)
I would prefer to discuss contraception with my doctor	51%	64%	52%	42%	49%	50%
I would be concerned that my doctor does not know I am using this method	29%	30%	32%	20%	29%	29%
I would be concerned that pharmacists have a lack of knowledge about contraception	26%	25%	28%	30%	34%	28%
I would be concerned about a lack of privacy in the pharmacy	9%	8%	12%	9%	9%	10%
Other	2%	3%	4%	5%	2%	3%
No concerns	19%	8%	13%	21%	15%	16%
Don’t know	3%	3%	4%	1%	7%	3%

When asked to imagine a scenario in which they were considering buying an OTC-POP, over 80% of women in all age groups agreed that they would discuss this pill with their doctor before buying it, and at least 90% in all age groups affirmed they would see their doctor if they were concerned about side effects (Table 5). Between 67% and 80% of women, depending on the age group, agreed with the statement that they would see their doctor for other women’s health issues not related to contraception (e.g. cervical and breast cancer screening) if they were using POP without prescription as their primary method of contraception (Table 5).

The most important benefits that women (independent of their age and current method use) reported in buying POP at the pharmacy without a prescription are no need to see a doctor (47%), greater independence (53%), saving time (40%), no need for an appointment (46%), and greater freedom (39%). Nonetheless, most women (50%) would like to discuss their contraceptive choice with their doctor or would worry that their doctor is not informed (29%) (Table 5).

Pharmacists

The opinion and view of Italian pharmacists are reported in Table 6. The vast majority of pharmacists (80%) feel that OTC availability of POP would overcome existing access barriers to OC, at least to some extent. Around three quarters of pharmacists felt that the availability to provide a POP without prescription would have a positive impact on their role. When asked what the key challenges of an OTC-POP would be, almost all pharmacists felt that they would need additional training before they could provide the POP without a prescription.

Table 6. The views of Italian pharmacists.

To what extent, if at all, would the availability of a progestin-only pill without prescription at a pharmacy overcome existing barriers in the access of daily oral contraceptives? Base: All respondents, n = 100
A great extent	14%
To some extent	66%
Hardly	16%
Not at all	2%
Don’t know	2%
To what extent, if at all, will being able to offer a progestin-only pill without prescription to your customers positively or negatively impact on your role as a pharmacist? Base: All respondents, n = 100
Very positive	18%
Fairly positive	55%
Neither positive nor negative	25%
Fairly negative	–
Very negative	1%
Don’t know	1%
Which of the following do you thik will be the key challenges, if any, of a progestin-only pill available without prescription in a pharmacy? Base: All respondents, n = 100
Challenges for pharmacists
Pharmacists need additional training	81%
Pharmacists need ongoing manufacturer support	27%
Other / None
Another challenge (specify)	1%
No challenges	5%
Don’t know	2%
How confident, if at all, do you currently feel about advising women on the different contraceptive methods that are available to them from your pharmacy? Base: All respondents, n = 100
Very confident	44%
Fairly confident	51%
Not very confident	5%
Not at all confident	–
Don’t know	–
Which one of the following statements best applies to how frequently you provide advice to women on daily oral contraceptives? This could include information on dosing and side effects, as well as information on the different types of daily oral contraceptives. Base: All respondents, n = 100
I always offer advice when I dispense daily oral contraceptives	27%
I sometimes offer advice when I dispense daily oral contraceptives	44%
I hardly ever offer advice when I dispense daily oral contraceptives	2%
I provide advice only if the customer hasn’t taken daily oral contraceptives before	5%
I provide advice only when the customer asks	22%
I never offer advice when I dispense daily oral contraceptives	–
None of the above	–
Don’t know	–
Which challenges, if any, have you ever experienced when discussing contraception with women? Base: All respondents, n = 100
There is no privacy in my pharmacy to have these conversations	20%
I am not able to help women when they have run out of their oral contraceptive pill and don’t have a prescription	17%
I am not always able to provide the brand written on the prescription for the oral contraceptive pill	12%
I do not feel that I am knowledgeable enough to answer all of women’s questions about contraception	20%
Other (specify)	2%
No challenges	40%
Don’t know	3%
To what extent do you agree or disagree with the following statement: ‘Due to COVID-19 I have been providing more advice to customers, and I expect this trend to continue’ Base: All respondents, n = 100
Strongly agree	26%
Slightly agree	28%
Neither agree nor disagree	29%
Slightly disagree	10%
Strongly disagree	4%
Don’t know	–
Not applicable	3%
Which of the following customer types, if any, would you recommend the non-prescription progestin-only pill to? Base: All respondents (n = 100)
Women aged 16 – 20	9%
Women aged 21-30	32%
Women aged 31-40	32%
Women aged 40 and over	23%
Women currently taking oral contraception	23%
Women currently using barrier methods (e.g. condoms, diaphragm, etc)	25%
Women currently using long acting reversible contraception (e.g. implant or IUD)	9%
Women currently using natural methods (e.g. fertility apps, withdrawal method)	49%
Women who can’t use estrogen	64%
Women who are overweight	30%
Women who have high blood pressure	29%
Women who are currently breastfeeding	34%
None of the above customer types	–
I would not recommend the non-prescription progestin-only pill to anyone	4%
Don’t know	4%
To what extent, if at all, would each of the following encourage you to recommend the progestin-only pill without a prescription?
Base: All respondents (n = 100)	A great extent	To some extent	Hardly	Not at all	Don’t know
Recommendation from health authority in my country	44%	39%	16%	1%	–
Guidelines from health organisations/ medical societies in my country	57%	29%	11%	3%	–
Customer request	16%	44%	25%	14%	1%
Peers / colleagues recommending the product to their customers	13%	32%	21%	33%	1%
Receiving training on progestin-only pill and different methods of contraception	56%	34%	9%	1%	–
Receiving training on how to assess customer suitability for the progestin-only pill	65%	22%	11%	2%	–
Receiving training on side effects of the progestin-only pill	60%	31%	7%	2%	–
Customer already taking daily oral contraceptive	26%	36%	30%	7%	1%
Knowing women will go to the doctor if they experience side effects	43%	39%	14%	3%	1%
Online tools for women to consult in case of emergencies	35%	38%	21%	6%	–
Online tools for women to consult when they have questions	33%	35%	22%	9%	1%
Which of the following customer types, if any, would you recommend the non-prescription progestin-only pill to? Base: All respondents (n = 100)
Women aged 16 – 20	9%
Women aged 21-30	32%
Women aged 31-40	32%
Women aged 40 and over	23%
Women currently taking oral contraception	23%
Women currently using barrier methods (e.g. condoms, diaphragm, etc)	25%
Women currently using long acting reversible contraception (e.g. implant or IUD)	9%
Women currently using natural methods (e.g. fertility apps, withdrawal method)	49%
Women who can’t use estrogen	64%
Women who are overweight	30%
Women who have high blood pressure	29%
Women who are currently breastfeeding	34%
None of the above customer types	–
I would not recommend the non-prescription progestin-only pill to anyone	4%
Don’t know	4%
Regarding emergency contraception: To what extent do you agree or disagree with the following statements regarding emergency contraception:
Base: All respondents (n = 100)	Strongly agree	Slightly agree	Neither agree nor disagree	Slightly disagree	Strongly disagree	Don’t know
When supplying emergency contraception, I ask whether the women is taking regular contraception	53%	29%	11%	3%	3%	1%
When supplying emergency contraception, I would like to also be able to provide oral contraception as an ongoing method	18%	33%	26%	13%	7%	3%
Now, thinking specifically about non-prescription products that you are already providing in your pharmacy, and by this we mean products such as irritable bowel syndrome, acute and chronic secretolytic treatment, cough tablets, nutritional supplements How often, if at all, do you…
Base: All respondents (n = 100)	Always	Frequently	Occasionally	Hardly	Never	Don’t know
Ask questions to determine appropriateness before supplying a product	59%	34%	6%	1%	–	–
Provide advice to consumer before supplying a product	54%	41%	5%	–	–	–
Refer customer to a doctor if their condition needs further investigation before supplying a product	54%	32%	13%	1%	–	–

As we have already published in Arisi et al. [13], the majority of Italian pharmacists surveyed (98%) think that gaining easy access to hormonal contraception is important for women but 27% of them felt that restrictions for pharmacists to dispense OCs without a prescription was a main barrier to the optimal access of daily oral contraceptive pill. About two thirds of pharmacists (66%) would be very likely or fairly likely to recommend the POP when training will be available for this new method of supply at pharmacies.

Overall, more than 95% of pharmacists responding to the survey felt confident advising women on the different contraceptive methods available to them from their pharmacy and indeed at least 71% already did so. Some pharmacists provide advice only when the costumer asks, rather than being proactive. Privacy in the pharmacy does not seem to be a major challenge.

When asked about non-prescription products already in the pharmacy, 93% of pharmacists reported they always or frequently ask questions to determine appropriateness before supplying and 86% refer customers to a doctor if their condition needs further investigation before supplying the product. The majority felt knowledgeable about POP dosing (84%), side effects (79%), and its suitability for women (75%). At least 90% would be encouraged to recommend the POP if they were to receive training on the following areas: the POP in the context of different methods of contraception, assessment of customer suitability or side effects.

Discussion

This is the first survey that investigates attitudes of women and pharmacists in Italy regarding OTC-POP.

Our results show that Italian sexually active women who do not want to become pregnant in the near future are positive about the concept of OTC-POP. Pharmacists are positive and think being able to provide POP without prescription would have a positive impact on their role.

Interestingly, there is no age difference (17% in every age group) in the use of EC, whereas the percentage of women 16-20 years who currently use condoms (78%) is significantly higher than those aged 36-50 (63%). In addition, the percentage of women 16-20 years old who currently use OC (31%) is significantly lower compared with those aged 21-35 (43%) and 36-50 (58%). Even though gynecological examination is not mandatory according to WHO [16], this is still a common practice in some countries including Italy.

While the use of the POP in Italy is not currently high, it has increased by 18.9% from 2015 to 2021 [14]. POPs are effective, have low prevalence of contraindications among reproductive aged women [15], and are suitable to most of them [16].

Women do not need help from a doctor to identify their need for contraception and can self-screen and self-manage during use [17]. Indeed, they already know which method they want to use when they visit their doctor. Moreover, women trust pharmacists who are able to provide OTC POP and related information if necessary. The COVID-19 pandemic and lockdown have clearly shown a reduction in use of estrogen-containing methods compared to POP in the UK [18]. On the other hand, pharmacists are increasingly providing patient-focused services in the area of sexual and reproductive health [19], a policy feasible also in Italy according to our data.

Concerns that women would not follow other health related screening if buying OTC is unfounded. Provision of contraception and other women’s health related issues are two different topics: pelvic and breast exams, cervical cancer screenings, or sexually transmitted infection screening are not required before initiating hormonal contraception and should not be used as reasons to deny access to these methods [16,20]. OCs are still the most widely used effective contraceptive in Europe [1] and the idea of obtaining them without the need for a doctor’s prescription has been constantly scrutinized over the last thirty years [21–23]. The recent approval in the UK of a POP for sale in pharmacies without the need to visit a doctor [12] has prompted renewed awareness, given the effectiveness of POPs and their suitability for availability without prescription [8].

Today, access to effective contraceptives (hormonal and long-acting methods) involves consulting a healthcare provider. Availability of a safe and effective non-prescription POP would help those women who for some reason or another cannot plan to go to the doctor in advance, or forget their prescription and repeat prescription. Furthermore, it would allow women to take an active role in optimizing their overall health and well-being. Based on our investigation, Italian women are waiting for this opportunity. Different route of access to effective contraceptive methods, while meeting people’s needs, would increase the likelihood that every individual can identify and use an effective method, and therefore would decrease the risk for UIP [10]. Retrospective analysis of the medical records of 1,782 Italian women with induced abortion performed between 2009 and 2011 investigated the use of contraception in this subset [24]. At the time of conception, 39% had used withdrawal, 19% natural methods, 15.2% condom, only 7% hormonal contraception and the remaining 19% reported not using any contraception. Even though the number of voluntary pregnancy termination has reduced over the years in our Country [25], further reducing the possibility of UIP leading to voluntary termination is the fundamental goal of increasing the use of safe contraception.

Our survey has explored views about OTC availability of OC in general, and having not distinguished between COC and POP, could be considered a limitation. Closed-ended questions unavoidably restrict the respondents in the expression of their views. Nevertheless, we sought the views of a large number of both consumers and pharmacists.

Conclusions

The possibility of a POP without prescription under the supervision of pharmacists is an acceptable option to increase the use of effective contraception. From the present survey, we can conclude that Italian women will be, in a certain percentage, favorable to get an effective contraceptive directly from the pharmacist. Pharmacist during the consultation should inform women about the importance of gynecological examination and adhesion to screening programs.

That being so, we believe the availability of a POP without prescription represents a great opportunity to empower Italian women, further giving them more possibilities to avoid UIP, the ultimate goal that should inspire OTC-POP availability in our country.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This study was funded by HRA Pharma, Chatillon, France. The study was designed by HRA and endorsed by the authors, which was then undertaken by IPSOS.