The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures.

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80-90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 - €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.

Adverse drug reaction reporting and development of pharmacovigilance systems in Bosnia and Herzegovina, Croatia, Serbia, and Montenegro: a retrospective pharmacoepidemiological study.

AIM: To compare individual case safety reports (ICSR) rates and characteristics between Croatia, Serbia, Montenegro, and Bosnia and Herzegovina (B&H). METHODS: This retrospective pharmacoepidemiological study used the data from ICSR received by the Agency for Medicines and Medical Devices in B&H in 2011-2016. The number, characteristics, and sources of reports, suspected drugs, and patient characteristics were analyzed. The results were compared with the publicly available data from Croatia, Serbia, and Montenegro. RESULTS: The number of reported adverse drug reactions per one million of inhabitants was lowest in B&H and highest in Croatia. There were significant differences in reporter characteristics, sources of reports, and the percentage of missing data in ICSR, while the Anatomical Therapeutic Chemical product classes, patient's sex, and adverse drug reaction System Organ Classes were similar. CONCLUSION: Despite the historical and geographical vicinity of B&H and its neighboring countries, there were significant differences in indicators of pharmacovigilance development.

Initiatives to Reduce Nonprescription Sales and Dispensing of Antibiotics: Findings and Implications.

OBJECTIVE: Irrational use of antimicrobials is a major driver of antimicrobial resistance, exacerbated by dispensing antibiotics without a prescription. Our previous study suggested this was a problem in the Republic of Srpska despite legislation. Since then, a number of activities have been initiated. Consequently, the study aimed to ascertain whether these multiple initiatives had reduced this. METHODS: Patients visiting all community pharmacies in the Republic from October 2014 to July 2015 presenting with symptoms typical of an acute, viral, and mostly uncomplicated upper respiratory tract infection, with results compared to the previous study. If an antibiotic was suggested, the maximum allowance was €3/pack. FINDINGS: Self-medication with antibiotics significantly decreased from 58% to 18.5% of pharmacies. In both studies, most patients were offered over-the-counter medication. The most common reason for not dispensing an antibiotic was "antibiotics can be dispensed with a prescription only." The penicillins were the most dispensed antibiotic. Fewer patients than the previous study were given instructions about antibiotic use and no discussion on their side effects. CONCLUSION: While encouraging that self-medication decreased significantly, 18.5% were disappointing given recent initiatives. Fewer instructions about antibiotics if an antibiotic was dispensed were also disappointing. This suggests the need for even stronger enforcement of the laws as well as further training of pharmacy personnel to ensure the future appropriate use of medicines.

Self-medication with antibiotics in the Republic of Srpska community pharmacies: pharmacy staff behavior.

PURPOSE: Self-medication with antibiotics adds to the global risk of increased spread of bacterial resistance. Attitudes and behavior of health professionals also may reinforce self-medication with antibiotics. The aim of this study was to determine whether self-medication with antibiotics is possible in our community pharmacies and to what extent, and to evaluate the behavior and service of pharmacy health professionals regarding non-prescription antibiotic dispensation. METHODS: An observational, cross-section study was conducted, and pseudo-patient methodology was used to establish the kind of professional service provided in case of patient's explicit demand to buy an antibiotic for treatment of self-diagnosed upper respiratory tract infection. RESULTS: Of the total 318 community pharmacies, 131 (41%) were visited and included in the study. Non-prescription antibiotics were dispensed in 76 (58%) pharmacies. Counseling and symptomatic therapy was offered in 88 (67%) pharmacies. In 25% of pharmacies, no symptomatic therapy was offered; instead, only an antibiotic was sold. Amoxicillin was sold in 85% of cases and, mostly, the one of 1.30 Euro per pack. Both oral and written use instructions were given in 78% cases, whereas none was given in 3% of cases. CONCLUSIONS: Self-medication with antibiotics occurs in our community pharmacies, despite being illegal. Pharmacy staff behavior can be a factor that puts patients at risk for self-medication with antibiotics. Community pharmacies are failing their tasks in enhancing rational use of antibiotics. Such a practice may be a consequence of weak enforcement and control over the legislation and professional standards.