Abstract

Objectives: to assess national trends in the use of emergency contraception (EC) and rates of induced abortion in Italy from 2017 to 2023, considering the impact of the COVID-19 pandemic and the 2020 AIFA decision that expanded over-the-counter access to ulipristal acetate (UPA) for minors. 

Design: quasi-experimental ecological study using Interrupted Time Series (ITS) analysis of national data on EC use and induced abortion rates. Three interventions were evaluated: onset of the COVID-19 pandemic, end of the first lockdown, and the AIFA policy for minors. Hormonal contraceptive use and total fertility rates were included as control series.

Setting and participants: monthly aggregated data from 2017 to 2023 on EC use, hormonal contraception, induced abortions, and fertility rates among the Italian resident women aged 15-49 years.

Main outcome measures: use of EC and UPA, induced abortion rates, regular hormonal contraceptive use, and total fertility rates. ITS parameters were expressed as incidence rate ratios (IRRs) with 95% confidence intervals.

Results: between 2017 and 2023, EC use increased from approximately 3 to 5 packages dispensed per 1,000 women, with UPA use increasing approximately twofold. The COVID-19 pandemic was associated with a temporary but significant decline in EC use and induced abortions, followed by a rapid post-lockdown rebound (IRR trend UPA: 2.22; 95%CI 1.57-3.15; IRR trend induced abortion: 1.20; 95%CI 1.01-1.42). Induced abortion rates declined modestly but steadily (IVG: from 0.59 in January 2017 to 0.44 in December 2023), while fertility rates (from 3.06 in January 2017 to 3.07 in December 2022) and hormonal contraceptive (from 155.82 in January 2017 to 176.82 in December 2023) use remained stable. No ecological evidence of substitution effect following increased EC access was observed.

Conclusions: extending over-the-counter access to UPA for minors was associated with increased use without reducing hormonal contraceptive use. Changes observed during the COVID-19 pandemic were temporary and followed by a rapid recovery, without altering long-term trends. The modest decline in induced abortion rates is consistent with a pre-existing trend rather than a direct effect of expanded EC availability, suggesting a complementary role of EC within broader reproductive health strategies.

 Keywords: , , , , ,

Riassunto

Obiettivi: valutare l’andamento nazionale dell’uso della contraccezione di emergenza (EC) e dei tassi di interruzione volontaria di gravidanza (IVG) in Italia dal 2017 al 2023, tenendo conto dell’influenza della pandemia di COVID-19 e della decisione dell’AIFA che nel 2020 ha esteso l’accesso senza ricetta all’ulipristal acetato (UPA) per le minorenni. 

Disegno: studio ecologico quasi-sperimentale basato su serie temporali interrotte (ITS) dei dati nazionali su EC e IVG. Sono stati valutati tre interventi: inizio della pandemia, fine del primo lockdown e politica AIFA per le minorenni. L’uso della contraccezione ormonale e il tasso di fecondità totale sono stati inclusi come serie di controllo.

Setting e partecipanti: dati aggregati mensili dal 2017 al 2023 su EC, contraccezione ormonale, IVG e tassi di fecondità relativi alla popolazione residente femminile italiana di età 15-49 anni.

Principali misure di outcome: uso di EC e singolarmente di UPA, tasso di IVG, uso di contraccettivi ormonali e tasso di fecondità totale. I parametri ITS sono stati espressi come rapporto tra tassi di incidenza (IRR) con intervalli di confidenza al 95%.

Risultati: l’uso della EC è aumentato tra il 2017 e il 2023 da 3 a 5 confezioni vendute per 1.000 donne, trainato da un raddoppio dell’UPA. La pandemia è risultata associata a un calo temporaneo ma significativo di EC e IVG, seguito da un rapido recupero post lockdown (IRR trend UPA: 2,22; IC95% 1,57-3,15; IRR trend IVG: 1,20; IC95% 1,01-1,42). I tassi di IVG sono diminuiti lentamente e stabilmente nel periodo di studio (IVG: da 0,59 a gennaio 2017 a 0,44 a dicembre 2023), mentre i tassi di fecondità (da 3,06 a gennaio 2017 a 3,07 a dicembre 2022) e l’uso di contraccettivi ormonali (da 155,82 a gennaio 2017 a 176,82 a dicembre 2023) sono rimasti stabili. Non emergono evidenze di sostituzione a seguito dell’aumento della EC.

Conclusioni: l’accesso delle minorenni senza ricetta a UPA ha aumentato il suo utilizzo senza ridurre l’uso dei contraccettivi ormonali. Le variazioni osservate durante la pandemia sono risultate temporanee e non hanno modificato i trend di lungo periodo. La lieve diminuzione dei tassi di IVG riflette una tendenza preesistente e non un effetto diretto della maggiore disponibilità di EC, suggerendo un ruolo complementare della EC nelle strategie a sostegno della salute riproduttiva.

 Parole chiave: , , , , ,

Introduction

Since the 1994 United Nations International Conference on Population and Development in Cairo,1 access to contraception has been widely recognized as a key determinant of women’s health, empowerment, and educational attainment.2,3

Despite overall progress across Europe, Italy still faces significant gaps in both contraceptive access and reproductive health policy implementation. According to the 2025 Contraception Atlas, Italy ranks 25th among European countries4 and still lacks a national law mandating comprehensive sexuality and affective education in schools. At the same time, induced abortion – which is legal in Italy since 1978 – has steadily declined, reaching one of the lowest rates worldwide, with 5.2 induced abortions per 1,000 women aged 15-49 in 2022.5

Emergency contraception (EC) prevents unintended pregnancies following unprotected sexual intercourse, including sexual violence.6 EC is safe and effective regardless of age, body weight, or breastfeeding status.7 The World Health Organization (WHO) recommends unrestricted access to EC, without prior clinical examination or pregnancy testing, and includes EC in its model list of essential medicines.8 Available evidence indicates that increased availability of EC is not associated with higher level of risky sexual behaviour or increased rates of unintended pregnancy.9 EC methods include levonorgestrel (LNG), ulipristal acetate (UPA) and the copper intrauterine device.7

In 2009, the European Medicines Agency (EMA) approved UPA;10 in 2014, EMA authorized its over-the-counter availability,11 a decision subsequently adopted by most EU countries. In Italy, however, access to EC has historically been more restricted. LNG was introduced in 2000 as a prescription-only drug,12 with physicians allowed to exercise conscientious objection,13 while UPA was authorized in 201114. Persistent social stigma and misconceptions equating EC with induced abortion have been identified as contributing factors to barriers in access.15

A policy shift occurred in 2015, when the Italian Medicines Agency (AIFA) removed the prescription requirement for UPA for women aged 18 years and older,16 followed in 2020 by the extension of non-prescription access to minors, allowing direct dispensing through community pharmacy17.

This study aims to describe the association between changes in UPA use following the AIFA policy that extended non-prescription access to minors and trends in induced abortion rates in Italy, in the context of COVID-19-related events. Secondary analyses examine trends in hormonal contraceptive use, total fertility rates, and overall EC use to contextualize the primary findings and support the plausibility of the interrupted time series (ITS) assumptions. 

Methods

Study design

This was a quasi-experimental ecological study conducted within the Italian national project “Interventions to improve the quality of data, service provision, and appropriateness of procedures and information dissemination regarding voluntary termination of pregnancy”, funded in 2022 by the Italian Ministry of Health.18 The study protocol was approved by the National Ethics and Scientific Committee of the Italian National Health Service (SSN).

An ITS design was used to examine trends over time in contraceptive use and induced abortion rates and to assess the impact of major contextual and policy-related events.19,20

Data sources and population

Data on hormonal contraceptive sales were obtained from the OsMED (Italian National Observatory on Medicines) database through the national Drug Traceability System,21 as mandated by the Decree of the Italian Ministry of Health (15.07.2004). This system collects aggregated wholesale data on medicinal products dispensed by public and private pharmacies, including marketing authorization code (AIC), number of packages, and date of purchase. The database collects data on both reimbursed and non-reimbursed medicinal products, regardless of their reimbursement status, including those dispensed with or without a medical prescription, in accordance with their regulatory classification. It covers all products moving along the distribution chain, up to the final dispensing points: community pharmacies, hospitals, outpatient clinics, and retail outlets. Individual-level data, such as users’ age or indication for use, are not available.

In Italy, contraceptives are not reimbursed by the SSN, except in 4 of the 21 regions/autonomous provinces where limited reimbursement policies apply under specific conditions (e.g., young age, unemployment, or economic vulnerability).22-25

Hormonal contraceptives were classified according to the Anatomical Therapeutic Chemical (ATC) classification system. EC included ulipristal acetate (UPA; ATC G03AD02) and levonorgestrel (LNG; ATC G03AD01). Hormonal contraceptives included progestins and combined oestrogen-progestin formulations (ATC codes G03AA, G03AB, G03AC). Defined Daily Doses (DDDs), as defined by the World Health Organization, were used as measurement units.26

Data on induced abortions were obtained from the national epidemiological Surveillance System for voluntary termination of pregnancy, coordinated by the Italian National Institute of Health (ISS), the Italian National Institute of Statistics (Istat), the Ministry of Health and the Italian Regions.27 Monthly live birth data were retrieved from Istat.28

Outcomes

Primary outcomes:

  • UPA use;
  • induced abortion rates.

Secondary outcomes:

  • hormonal contraceptive use: progestins only and combined oestrogen-progestin products, assessed under the assumption that most purchasers were sexually active women aged 15-49 years;
  • total fertility rates, examined as an indicator of broader reproductive patterns during the study period, under the assumption that the proportion of sexually active women remained stable across months within each year;
  • EC use, defined as the combined use of UPA and LNG, analysed the description of overall temporal trends, under the assumption that changes in EC use were largely driven by variations in UPA utilization and followed a similar pattern.

    Contraceptive use was approximated by the number of dispensed packages, assuming that each package corresponded to one user only. However, dispensing data reflect medication acquisition rather than confirmed use and may be influenced by changes in purchasing behaviour.

All-time series were expressed as rates per 1,000 sexually active women aged 15-49 years. Denominators were estimated using data from the 2019 Istat European Health Interview Survey (EHIS), which provided the proportion of sexually active women in this age group.29 This proportion was applied to Istat annual resident population estimates to approximate the monthly sexually active female population.30

All data covered the period from 01.01.2017 to 31.12.2023, except for total fertility rates, which were available from 01.01.2017 to 31.12.2022.

Statistical analysis

ITS analyses were conducted to assess the impact of three predefined interventions:

1. March 2020: onset of the COVID-19 pandemic and national lockdown;

2. May 2020: end of the first national lockdown;

3. October 2020: AIFA policy allowing non-prescription access to UPA for minors.

For each intervention, the ITS analysis compared the observed post-intervention trend with the expected trend under a counterfactual scenario in which the intervention had not occurred if the pre-existing trend continues uninterrupted. Any deviation, whether in terms of level or slope, between the actual and expected trends were interpreted as the impact of the intervention. The time series were segmented at each intervention point using indicator variables for each intervention and corresponding interaction terms with time. The ITS analysis was conducted using a single segmented regression model including all intervention points, with level and slope changes estimated within the same model; no separate models were fitted for individual segments.

The interventions were expected to have different temporal effects on UPA use. The COVID-19 lockdown and its end were hypothesized to produce immediate but temporary changes, whereas the AIFA policy was expected to have an immediate and a more sustained impact. Given that the AIFA policy enabled over-the-counter access to UPA in pharmacies, an immediate effect was considered plausible, and no lag period was specified in the model. For the other outcomes, no a-priori assumptions were made regarding the expected temporal pattern of effects; therefore, ITS models were specified to estimate both level and slope changes, allowing the data to capture these patterns empirically.

Secondary outcomes were included to contextualize the primary analyses and to assess the plausibility of the ITS assumptions, namely that no other major contemporaneous changes occurred that could plausibly explain variations in UPA use or induced abortion rates. Total fertility rates were evaluated descriptively and complemented by formal stationarity testing to account for temporal trends.

Model parameters were expressed as incidence rate ratios (IRRs) with 95% confidence intervals (95%CIs). Effects were considered statistically significant when the 95%CI did not include the null value of 1.

Negative binomial regression models were used to account for overdispersion in count data. Seasonal variation was evaluated using Fourier terms and nested models with and without seasonal components were compared using likelihood ratio tests. Residual autocorrelation was assessed through visual inspection of autocorrelation and partial autocorrelation function plots.

Stationarity of the total fertility rate time series was assessed using the KPSS test. All statistical tests were two-tailed. Analyses were conducted using R software, version 4.2.2.31

Results

Descriptive analysis of the time series

A total of 84 monthly observations, from 2017 to 2023, were included for each time series, except for fertility rates time series, where observations covered 72 months, because data were updated in 2022. Over the study period, UPA use increased from 1.37 per 1,000 women in January 2017 to 3.29 in December 2023, with a minimum value of 0.68 observed in the second month of lockdown period and a maximum of 5.37 in May 2023. Induced abortion rates ranged from 0.59 to 0.44 per month, showing relatively stable levels over time. Regular hormonal contraceptive use ranged monthly from 155.82 to 176.82, with a lower value of 137.06 in March 2017 and a peak of 196.77 observed in May 2023. Total fertility rates ranged from 3.06 to 3.07 per month over the available period. Visual inspection of both time series suggested marked disruptions during the lockdown period, followed by a rebound especially in contraceptive use (Figure 1).

art-mayer_fig1.png
 

Emergency contraception use

As for UPA use specifically, a modest but statistically significant monthly increase was observed prior to March 2020 (IRR 1.01; 95%CI 1.01-1.01) (Table 1). 

art-mayer_tab1.png
 

At the onset of the COVID-19 lockdown, no significant immediate change in UPA use was detected (IRR 1.14; 95%CI 0.67-1.97). However, a marked and statistically significant decline in the monthly trend occurred during the lockdown period (IRR 0.51; 95%CI 0.36-0.72), consistent with a reduction in UPA utilization (Figure 1A).

Following the end of the first lockdown in May 2020, UPA use increased sharply, with both a significant immediate level increase (IRR 2.02; 95%CI 1.42-2.85) and a strong positive trend change (IRR 2.22; 95%CI 1.57-3.15) reflecting a rapid rebound and sustained growth in use. After the October 2020, with the introduction of the AIFA policy extending non-prescription access to minors, no significant immediate level change was observed (IRR 0.95; 95%CI 0.77-1.17), while a small but statistically significant negative change in trend occurred (IRR 0.88; 95%CI 0.82-0.96), indicating a stabilization or slight attenuation of the increasing trajectory over time of UPA.

Overall, the observed pattern is consistent with the hypothesized immediate and temporary effects of the lockdown and its end, and partially consistent with expectations for the AIFA policy, which did not produce an immediate increase in use, but was associated with a modest change in trend over time.

Trends in overall EC use, including both UPA and LNG, were largely driven by changes in UPA utilization and followed a similar temporal pattern. Marked reductions occurred during the first COVID-19 lockdown, followed by a sharp increase after its end, and a subsequent stabilization after the October 2020 policy allowing non-prescription access to UPA for minors. Detailed results of the combined methods trends are reported in the Online Supplementary Material (Table S1, Figure S1).

Induced abortion rates

Induced abortion rates remained stable during the pre-pandemic period (IRR 0.99; 95%CI 0.99-0.99) (Table 2). 

art-mayer_tab2.png
 

Following the end of the first lockdown, a small but statistically significant immediate decrease in level was observed (IRR 0.82; 95%CI 0.69-0.97), accompanied by a modest increase in trend (IRR 1.20; 95%CI 1.01-1.42). The October 2020 policy extending non-prescription access to UPA for minors was not associated with significant changes in induced abortion rates, either in level (IRR 0.92; 95%CI 0.83-1.01) or in trend (IRR 0.94; 95%CI 0.90-0.98) (Figure 1B). 

Ecological comparison between UPA use and induced abortion rates

Comparison of the ITS models showed divergent post-intervention trajectories for UPA use and induced abortion rates. UPA use increased sharply following the end of the first lockdown and subsequently stabilized after the policy extending non-prescription access to minors. In contrast, induced abortion rates remained stable throughout the study period, showing no temporal correspondence with changes in UPA use (Figures 1A and 1B).

Hormonal contraceptive use

Hormonal contraceptive use showed no evidence of a sustained decline following the expansion of UPA access (Table 3). 

art-mayer_tab3.png
 

At the onset of the first lockdown, a significant immediate increase was observed (IRR 1.35; 95%CI 1.03-1.77), followed by a modest decline in trend (IRR 0.84; 95%CI 0.71-0.99). After the end of the lockdown, a significant positive change in trend was detected (IRR 1.23; 95%CI 1.04-1.47). Following the October 2020 policy allowing non-prescription access to UPA for minors, no statistically significant changes in level (IRR 0.92; 95%CI 0.83-1.02) or trend (IRR 0.97; 95%CI 0.94-1.01) were observed (Figure 1C).

Fertility trends

Total fertility rates declined gradually between 2017 and 2022 (Figure 2). The KPSS test did not reject the null hypothesis of level stationarity (KPSS statistic 0.065; p = 0.10), indicating that no major structural changes occurred in fertility trends during the study period. 

art-mayer_fig2.png
 

Discussion

This study provides a comprehensive assessment of trends in EC use and induced abortion rates in Italy from 2017 to 2023, contextualized by trends in hormonal contraceptive use and total fertility. The study period was marked by both an unprecedented public health emergency, the COVID-19 pandemic,32 and a major policy change allowing minors to access UPA without a prescription.

The results here presented suggest that pandemic-related lockdowns were associated with reductions in both EC use and induced abortions, likely due to decreased sexual activity outside stable relationships. The subsequent expansion of non-prescription access to UPA for minors was not accompanied by clear temporal changes in hormonal contraceptive use, fertility, or induced abortion rates; however, these findings should be interpreted cautiously, particularly for fertility, which is influenced by multiple demographic and socioeconomic factors. At the ecological level, trends in induced abortions remained largely stable throughout the study period and did not mirror the marked post-lockdown changes observed in UPA use. These findings suggest a lack of temporal association between the two indicators. The greater trend variability observed from 2020 onwards likely reflects the combined effects of the COVID-19 pandemic and subsequent recovery phases, which introduced abrupt changes in healthcare access, mobility, and individual behaviour. In contrast, the pre-pandemic period was characterized by a more stable and gradually increasing trend. In addition, the short time intervals between interventions may have contributed to overlapping effects, further increasing variability in the post-intervention segments. Overall, the findings of this work do not support a temporal association between increased access to UPA and changes in induced abortion rates. 

Including hormonal contraceptive use and total fertility rates in the analyses reinforced the plausibility of the ITS assumptions. Hormonal contraceptive use did not show a sustained decline following the UPA policy change, suggesting that increased access to EC did not substitute for ongoing contraceptive practices. Although the ATC codes used to identify contraceptives may also capture prescriptions for conditions such as polycystic ovary syndrome, acne, hirsutism, and amenorrhea, these mostly concern women of reproductive age who typically also have a need for contraception. Fertility trends also showed a gradual and stationary decline without structural breaks, supporting the interpretation that changes in UPA use were unlikely to be driven by concurrent shifts in other major reproductive health behaviours or demographic trends. These observations reinforce the internal validity of the ITS analysis.

The findings of the present paper are consistent with international evidence. In France, wider EC access did not reduce regular contraception use.33 A Cochrane review found that advanced provision of EC increased use and accelerated intake, without significantly reducing pregnancy rates or increasing sexual risk-taking.34 Similarly, the 2023 Clinical Recommendations by the Society of Family Planning reaffirmed that all EC methods –including UPA, LNG, and copper IUDs – are safe, and that non-prescription access does not promote unsafe sexual behaviour.6

Over-the-counter availability is associated with earlier and more frequent use of EC, without negatively affecting regular contraceptive behaviour.35 However, population-level reductions in unintended pregnancies remain inconsistent, possibly because EC is commonly used as a one-time solution without integration into ongoing contraceptive strategies.36 Although this study did not assess individual-level behaviours such as sexual risk-taking or contraceptive method switching, observed trends suggest that EC functions as a complementary component of contraceptive strategies. These findings highlight the importance of integrating EC into broader reproductive health programmes that ensure continuous access to regular contraception.

This study provides a long-term, population-level perspective by integrating data on EC use, induced abortions, hormonal contraception, and fertility. The use of interrupted time series analysis strengthens the internal validity of the findings and allows the assessment of temporal patterns in a real-world setting. However, several limitations should be considered when interpreting the results. First, the ecological design precludes causal inference at the individual level and does not allow evaluation of contraceptive switching, adherence, or whether EC users were the same women who avoided unintended pregnancies or induced abortions. In addition, the use of aggregated national data limits the ability to explore subgroup differences, including minors – the primary target of the policy – and may mask regional heterogeneity in contraceptive use, abortion services, and policy implementation.

Methodological constraints related to ITS design should also be acknowledged. The short time intervals between interventions, particularly between the end of the lockdown and the AIFA policy, may have affected the stability of slope estimates, and residual effects from the post-lockdown recovery period could have influenced the estimated impact of the policy. Moreover, although an immediate effect of the AIFA policy was considered plausible, no lag period was specified; therefore, the estimated effect should be interpreted as an average change following policy introduction, especially given that administrative data do not capture implementation dynamics or changes in awareness.

Finally, the use of pharmacy dispensing data reflects medication acquisition rather than confirmed consumption and may be influenced by changes in purchasing behaviour, such as stockpiling during the COVID-19 lockdown. Similarly, assumptions regarding one package per user and a stable proportion of sexually active women over time may not fully capture temporal changes in sexual behaviour. In addition, as fertility is influenced by multiple demographic and socioeconomic factors, the absence of marked changes over time should not be interpreted as evidence of no effect of the policy.

Overall, the findings presented in this work indicate that non-prescription access to EC was not associated with changes in fertility or induced abortion rates and did not appear to replace hormonal contraception. Nevertheless, EC remains insufficiently integrated into a comprehensive reproductive health framework. Access to contraception in Italy remains unequal: free provision is available only in 4 out of 21 regions and it is restricted to specific groups such as young adults, the unemployed, and economically disadvantaged individuals,22-25 while most women must pay out-of-pocket for both hormonal and EC, creating financial barriers and limiting equitable access. In 2023, total spending on oral contraceptives, including EC, reached € 373 million.37 Persistent gaps exist in sexual education, access to accurate information, family planning services, counselling, and free provision of contraceptives. Strengthening these areas is essential to ensure that EC contributes to a sustainable and equitable reproductive health system.

Conflicts of interest: none declared.

Acknowledgment: the authors would like to thank Silvia Andreozzi and Mauro Bucciarelli for their valuable contribution to the activities of the Italian surveillance system on the induced abortion.

Funding: this project was supported by the Italian Ministry of Health/CCM.

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