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Öğe Analysis of pregnancy and lactation-related expressions in the summary of product characteristics and patient information leaflets of the drugs used for the treatment of nausea and vomiting(Galenos Yayıncılık, 2021) Aydın, Volkan; Bahar, Ayfer; Bayram, Dilara; Vızdıklar, Caner; Akıcı, AhmetObjective: Concerns and limited data on drug use in pregnancy and lactation raise the importance of relevant information in summary of product characteristics (SmPC) and patient information leaflets (PIL). This study aimed to examine the consistency of the information related to pregnancy/ lactation periods in SmPCs/PILs of drugs used for the treatment of nausea/vomiting. Methods: Details of the statements regarding pregnancy and lactation periods included in the current SmPCs/PILs of a total of 118 preparations, 21 of which were original, belonging to 12 drugs with nausea/vomiting indication, were examined. SmPCs/PILs of the generic drugs was compared with that of the original drugs to identify any "minor" or "major" difference. Results: Any of SmPCs or PILs did not contain pregnancy indication or related posology information. Pregnancy was contraindicated in all tropisetron preparations; pregnancy in 38.5% and lactation in 46.2% of metoclopramide preparations; and lactation in 66.7% of dimenhydrinate preparations. It is stated that drug is passed in milk and placenta in 60.2% and 35.6% of SmPCs respectively. The presence of the expression regarding the placental passage showed inconsistency only among metoclopramide preparations. The presence of "pregnancy" and "lactation" in the "cautions before use" section of the PILs showed intra-drug variations for dimenhydrinate, metoclopramide, ondansetron, and domperidone. Except aprepitant, at least one major difference was detected between the SmPCs/PILs of original and generic preparations. Major differences were most commonly (15.0%) seen in the lactation section of the PILs. Conclusion: It was determined that presence of specific expressions that may be critical for clinical practice, like the management of nausea/vomiting in pregnancy, might differ in the informative documents of medicinal products. It is noteworthy that there is at least one major difference in the documents of six of the seven drugs and that the warnings/precautions in the SmPCs/PILs of the originals of the drugs vary considerably from those of the generics. These findings indicate the need for new approaches in terms of both standardization and usefulness in clinical practice when developing informative content in SmPCs/PILs.Öğe Comparison of paracetamol and diclofenac prescribing preferences for adults in primary care(Cambridge University Press, 2021) Bayram, Dilara; Aydın, Volkan; Şanlı, Abdullah; Abanoz, Mustafa Naci; Sıbıç, Büşra; Pala, Sedat; Ataç, Ömer; Akıcı, AhmetIntroduction: The most frequently prescribed analgesic drugs in primary care centers in Turkey are diclofenac and paracetamol, respectively. In this study, we aimed to compare paracetamol-included prescriptions (PIP) and diclofenac-included prescriptions (DIP) generated for adult patients in primary care. Methods: In this cross-sectional study, PIPs (n = 280 488) and DIPs (n = 337 935) created for adults by systematic sampling among primary care physicians working in Istanbul in 2016 (n = 1431) were examined. The demographic characteristics, diagnoses, and additional drugs in PIPs and DIPs were compared. Results: Women constituted the majority in both groups (69.8% and 67.9%, respectively; P < 0.05), and mean age at PIP (52.6 +/- 18.8 years) was lower compared to DIP (56.3 +/- 16.1 years), (P < 0.05). In single-diagnosis prescriptions, 11 of the 15 most common diagnoses in PIP were respiratory tract infections (47.9%); three pain-related diagnoses formed 4.6% of all these prescriptions. In DIP, the number of pain-related diagnoses, mostly of musculoskeletal origin, was eight (28.5%); four diagnoses (7.8%) were upper respiratory tract infections. While hypertension was the third most common diagnosis in PIP (6.1%), it was ranked first in DIP (8.0%). The percentage of prescriptions with additional analgesic (14.0% versus 18.3%, P < 0.001), proton-pump inhibitor (13.8% versus 18.4%; P < 0.001), and antihypertensive (22.0% versus 24.8%, P < 0.001) was lower in PIP compared to DIP. However, the percentage of prescriptions with antibiotics (31.3% versus 14.7%, P < 0.001) was higher in PIP. Conclusion: Paracetamol appears to be preferred mostly in upper respiratory tract infections compared to the preference of diclofenac rather in painful/inflammatory musculoskeletal conditions. The presence of hypertension among the most commonly encountered diagnoses for these analgesic drugs points to challenges in establishing the diagnosing-treatment match and indicates potential irrational prescribing practice, especially for interactions.Öğe Dünyada ve Türkiye’de jenerik ilaç kullanımı ile ilgili gelişmeler(2021) Bayram, Dilara; Aydın, Volkan; Vızdıklar, Caner; Akıcı, AhmetJenerik ilaç, referans alınan orijinal ilaç ile aynı etkin maddeyi aynı dozda aynı ya da benzer farmasötik şekilde içeren ve orijinal ilacın patent koruma süresi bittikten sonra üretilebilen ilaçtır. 1984 yılında yürürlüğe giren “Hatch-Waxman Hareketi” olarak bilinen “İlaç Fiyat Rekabeti ve Patent Yenileme Kanunu” ile jenerik ilaçların kullanımının yaygınlaşmasında, preklinik ve klinik faz çalışması koşulunun jenerik ilaçların ruhsat başvuru sürecinden çıkarılarak “kısaltılmış yeni ilaç başvurusu” hâline getirilmesi etkili olmuştur. Sınırlı sayıda sağlıklı gönüllü ile yapılan biyoyararlanım/biyoeşdeğerlik çalışmaları ile jenerik ilacın referans ile terapötik eşdeğer olduğunun gösterilmesi yeterli olarak kabul edilir. Bu nedenle daha düşük maliyet ile piyasaya çıkan jenerikler referans ilaçlara göre genellikle daha ucuzdur. Bu sayede jenerikler, sağlık hizmeti kalitesinden ödün vermeden ilaç harcamalarının azaltılmasına kritik katkı sağlar. Nitekim özellikle gelişmiş ülkelerde, jenerik ilaçların kullanımının yaygınlaştırılması ile ilaçların sağlık bütçesinde meydana getirdiği baskının azaltılması amaçlanmış ve bu doğrultuda özel politikalar uygulanmaya başlanmıştır. Jenerik kullanımının yaygınlaştırılmasında, uygulanan idari politikalarının yanısıra tüketicilerin, eczacıların ve hekimlerin jenerik ilaçlar ile ilgili algıları ve davranışları, tanıya ve ilaca ilişkin özellikler vb. faktörler de etkili olabilmektedir. Bu derlemede, jenerik ilaçlara yönelik temel bilgilere yer verilmesi ve farklı yerlerde kullanımı gittikçe yaygınlaşmakta olan bu ilaçlara ilişkin dünyadaki ve Türkiye’deki gelişmelerin sunulması amaçlanmıştır.Öğe Investigation of diclofenac and paracetamol prescribing for adults in primary care(Wiley, 2021) Şanlı, Abdullah; Bayram, Dilara; Abanoz, Mustafa Naci; Pala, Sedat; Sıbıç, Büşra; Aydın, Volkan; Ataç, Ömer; Akıcı, Ahmet[Abstract Not Available]Öğe Knowledge, opinions and attitudes of primary care physicians about generic drugs: A cross-sectional study(Oxford University Press, 2021) Öncü, Şeyma; Bayram, Dilara; Aydın, Volkan; İsli, Fatma; Aksoy, Mesil; Akıcı, Ahmet; Uçku, Reyhan; Gelal, AyşeBackground: Generic drug (GD) use is affected by many factors, including physicians' approach.Objective: This study aimed to investigate the knowledge, opinions and attitudes of primary care physicians (PCPs) about GDs and potentially associated factors.Methods: An adequately representative sample (n = 354) of PCPs was determined via stratified and simple random sample selection method in this descriptive, cross-sectional study. The research data were collected through a face-to-face 40-item survey, where the knowledge, opinions and attitudes about GDs were questioned. The prescribing percentage of GDs overall was also examined.Results: The survey was completed by 305 PCPs (mean age: 49.2 ± 7.9 years; 57.4% male). The rate of correct responses about GDs was 67.6% for basic knowledge and 46.6% for the development process. The percentages of PCPs who declared that GDs were 'less efficacious', 'of lower quality' and 'less safe' than original drugs were 65.2%, 53.4% and 35.4%, respectively. More than half (60.3%) of the PCPs declared not to pay attention to whether the drug is generic while prescribing. It was observed that, as the knowledge level of the physicians increased, negative opinions and prescribing attitudes regarding the effectiveness, quality and safety of the GDs decreased. The rate of GD prescribing (51.6%) in Izmir was lower than the rest of the country (54.6%; P < 0.001).Conclusion: This study shows that the knowledge of PCPs about GDs is generally inadequate, which reflects negatively on their opinions and attitudes regarding the use of GDs. Educational activities can help establish awareness that GDs can be used without doubt of their effectiveness, quality and safety.Öğe Pharmacoeconomic implications of preference toward reference- versus generic-brand antidepressants in primary care(2024) Gültekin, Onur; Aydın, Volkan; Bayram, Dilara; Ataç, Ömer; Akıcı, AhmetBackground: The prevalence of depression is gradually increasing worldwide with an increasing utilization of antidepressants. Nevertheless, despite their lower costs, generic-brand antidepressants were reported to be less prescribed. We aimed to examine the costs of reference- versus generic-brand antidepressant prescriptions in primary care practice. Methods: This cross-sectional study included electronic prescriptions for adult patients that contained antidepressants (World Health Organization's Anatomical Therapeutic Chemical (ATC)A code: N06A), which were generated by a systematically selected sample of primary care doctors (n = 1431) in Istanbul in 2016. We examined the drug groups preferred, the reference- versus generic-brand status, and pharmacotherapy costs. Findings: The majority of the prescriptions were prescribed for women (71.8%), and the average age of the patients was 53.6 ± 16.2 years. In prescriptions with a depression-related indication (n = 40 497), the mean number and cost of drugs were 1.5 ± 1.0 and 22.7 ± 26.4 United States Dollar per prescription, respectively. In these prescriptions, the mean number and cost of antidepressants per encounter were 1.1 ± 0.2 and 17.0 ± 13.2, respectively. Reference-brand antidepressants were preferred in 58.2% of depression-related prescriptions, where the mean cost per prescription was 18.3 ± 12.4. The mean cost per prescription of the generics, which constituted 41.8% of the antidepressants in prescriptions, was 15.1 ± 11.4. We found that if the generic version with the lowest cost was prescribed instead of the reference-brand, the mean cost per prescription would be 12.9 ± 11.2. Conclusions: Our study highlighted the substantial pharmacoeconomic impact of generic-brand antidepressant prescribing, whose preference over reference-brands could reduce the cost of antidepressant medication treatment by 17.5% in primary care, which could be approximately doubled if the cheapest generic antidepressant had been prescribed.Öğe Supratherapeutic utilization of paracetamol versus ibuprofen among <12-year-old children in primary care in Istanbul(2024) Bayram, Dilara; Vızdıklar, Caner; Aydın, Volkan; Akıcı, Narin; Ataç, Ömer; Akıcı, AhmetBackground: Paracetamol and ibuprofen are the most preferred analgesics for pain and fever management in children. Prescribing of these drugs in supratherapeutic doses may predispose to their toxicity. We aimed to compare prescribing patterns and potential overdosing of paracetamol and ibuprofen in primary care for <12-year-old children. Methods: We analysed paracetamol- and ibuprofen-containing prescriptions (PCPs, n = 173,575 and ICPs, n = 145,655) of 1- to 11-year-old children, issued by 3:1 systematically sampled primary care physicians (n = 1,431) in Istanbul during 2016. We compared drug use parameters and prescriptions surpassing daily and single-use dose limits for paracetamol and ibuprofen. Results: We identified that 29.9% of PCPs and 20.8% of ICPs were generated for those aged 1-2 years. Concomitant analgesic use was higher in ICPs than in PCPs (15.1% vs. 12.8%). We found that 4.4% of PCPs and 3.1% of ICPs exceeded maximum daily dose limit of paracetamol and ibuprofen, respectively (P < 0.001). This was more common in girls (5.1% and 3.3%, respectively) and at 1 year of age in both groups (9.2% and 8.5%, respectively). Single-use supratherapeutic dosing was encountered in 16.5% of PCPs and 13.2% of ICPs (P < 0.001, pessimistic model) and in 8.6% of PCPs and 10.6% of ICPs (P < 0.001, optimistic model). Conclusions: Paracetamol and ibuprofen were generally used in primary care for similar clinical conditions with subtle differences. However, more pronounced in younger children and girls, potential overdosing seems to be more practiced for paracetamol than ibuprofen both in terms of maximal daily and single-use setting.
