scholarly journals Biosimilar formulations of gonadotropins in a central Italian region: use patterns and time trends

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
A Rosa ◽  
V Belleudi ◽  
A Addis ◽  
A Ciardulli ◽  
A Pacchiarotti ◽  
...  

Abstract Background Gonadotropins (Gonas) are hormones that play a central role in the follicular growth of women but also useful in male infertility. Gonas used for infertility treatment in women are available as urinary extracts or recombinants. In 2015, the first biosimilar of follitropin alfa was authorised. Objectives We aimed to evaluate use patterns, temporal and spatial variations of Gonas biosimilar formulations in an central Italian region. Methods From administrative healthcare databases of Lazio region, we extracted prescriptions that have occurred over the years 2015-2019. Gona's use was grouped as treatment with urinary (u) and recombinant (r). Special focus was made on biosimilar r-Gona. Use patterns were investigated with respect to characteristics of the patients treated, time trends, differences among local health units and type of prescribing physician. Results For the study period, we retrieved 136,333 Gona dispensations for 22,325 patients. The 10,927 r-Gona biosimilar dispensations (8.01% of all claims, of which 99.43% Bemfola®, and 0.57% Ovaleap®), were mostly referred to women, aged 18-45 years, (87.11% of all patients). Median age was 37 years for women, 38 for men. Since its authorisation, biosimilar r-Gona steadily gained market from 2015 (0,4% of claims) to 2017 (22,7%) followed by a decrease in 2019 (4,3%). Biosimilars claims are more frequent in treating men (10,8%) than women (6,1%). Most biosimilar prescriptions were issued by general practitioners (86.4%), followed by specialists (10.2%) and others. Biosimilar use patterns varied between different local health units (IQR 3.2%-8,5%). Conclusions In clinical pratice, r-Gona biosimilar dispensation, 8,8% of Gonas. are mostly prescribed from general practitioners and are proportionately more targeted at men than women. Further investigation is needed. Key messages More and more men and women are using artificial insemination techniques; it is important to monitor fertility drug use patterns. In times of savings for the economic system,the use of the biosimilar drugs is of increasing interest.

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
A Rosa ◽  
V Belleudi ◽  
A Addis ◽  
A Ciardulli ◽  
A Pacchiarotti ◽  
...  

Abstract Background Gonadotropins (Gona) are commonly used for infertility treatment in women. They are available as urinary purified extracts (u-Gona) and recombinants (r-Gona). Objectives:We investigated if socio-demographic characteristics of treated women, year of dispensation and type of prescriber may play a role in the choice of a treatment with respect to the other. Methods From administrative healthcare databases, we collected claims of Gona for women, aged 18-45, enrolled in the health care system in the year preceding the first prescription (years 2009-2018). Treatment cycles were defined as a 21-day mobile time window. We identified three groups: u-Gona, r-Gona and treatment with both formulations (m-Gona). To identify determinants, we linked women with the socio-economic position (SEP), a composite deprivation index, based on the 2011 Italian Census data,categorized in 4 levels (high, medium-high, medium-low, low). We associated prescriptions with the type of prescriber, distinguishing between specialists and general practitioners. Results We retrieved 38,598 Gona treatment cycles prescribed to 23,412 women and distributed between formulations as follows: r-Gona 47.4%, u-Gona 26.3% and m-Gona 26.3%. The median age was 38 years for r-Gona and u-Gona, 39 for m-Gona. Comparing the type of prescriber, specialists were more likely to prescribe u-Gona instead of r-Gona (OR: 2.14; 95%CI: 2.02-2.27) than general practitioners. No relation was found between SEP and Gona formulations, except for patients with the highest level who were more likely to be prescribed with r-Gona instead of u-Gona (OR: 1.12; 95%CI: 1.03-1.21). Time trends showed that treatment choices changed over time. Conclusions In the Lazio region, the choice of gonadotropin formulations varied over time and was found to be related to the prescriber and partly to socio-economic position. An analysis of outcomes related to different treatments is under way. Key messages More and more women are using artificial insemination techniques; it is important to monitor fertility drug use patterns and determinants of the choice of a treatment. The use of fertility drugs is a multifactorial phenomenon and a matter of public health interest.


Author(s):  
Asma Al-Turkait ◽  
Lisa Szatkowski ◽  
Imti Choonara ◽  
Shalini Ojha

Rational prescribing is challenging in neonatology. Drug utilization studies help identify and define the problem. We performed a review of the literature on drug use in neonatal units and describe global variations. We searched databases (EMBASE, CINAHL and Medline) from inception to July 2020, screened studies and extracted relevant data (two reviewers). The search revealed 573 studies of which 84 were included. India (n = 14) and the USA (n = 13) reported the most. Data collection was prospective (n = 56) and retrospective (n = 26), mostly (n = 52) from one center only. Sixty studies described general drug use in 34 to 450,386 infants (median (IQR) 190 (91–767)) over a median (IQR) of 6 (3–18) months. Of the participants, 20–87% were preterm. The mean number of drugs per infant (range 11.1 to 1.7, pooled mean (SD) 4 (2.4)) was high with some reporting very high burden (≥30 drugs per infant in 8 studies). This was not associated with the proportion of preterm infants included. Antibiotics were the most frequently used drug. Drug use patterns were generally uniform with some variation in antibiotic use and more use of phenobarbitone in Asia. This study provides a global perspective on drug utilization in neonates and highlights the need for better quality information to assess rational prescribing.


1976 ◽  
Vol 5 (2) ◽  
pp. 17-23
Author(s):  
Samuel E. Krug ◽  
Thomas J. Henry

1979 ◽  
Vol 9 (1) ◽  
pp. 67-78 ◽  
Author(s):  
Carol J. Turner ◽  
Robert J. Willis

As part of an extensive questionnaire on student drug use patterns at a small private college, this study was completed to determine the relationship between self-reported religiosity of college students and 1) the nature and incidence of current drug usage, 2) reasons for abstaining from drug use, 3) acceptable sources for referral in case of drug problems, and 4) persons with whom students would discuss their attitudes toward drugs. Statistically significant differences between religious and non-religious students at the 0.01 level were found in the current use of alcohol and marijuana, in reasons for abstaining from marijuana, amphetamines, barbiturates, and hallucinogens; in referral of drug problems to drug wise friends; and in discussing drug attitudes with parents and with college counselors.


2017 ◽  
Vol 61 (5) ◽  
pp. 612-618 ◽  
Author(s):  
Scott E. Hadland ◽  
Evan Wood ◽  
Ekaterina Nosova ◽  
Thomas Kerr ◽  
Kora DeBeck

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