Fourth and final issue of GaBI Journal’s 10th volume

This issue of the GaBI Journal contains only a limited number of articles, but these include two scientifi c very data-rich articles and an interesting and important expose on the use and misuse of products to treat COVID-19 patients. All three articles have potentially major implications for the global struggle to deal with the current COVID-19 pandemic; either with respect to the proper use of biosimilar products to safely reduce COVID-19 related and non-related pharmaceutical expenditures, as well as to the effects of the pandemic on the criminal use and abuse of human and veterinary pharmaceuticals and other products, e.g. disinfectants.

National trends in prescription drug expenditures and projections for 2021

Purpose To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2021 in the United States, with a focus on the nonfederal hospital and clinic sectors. Methods Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2021 were reviewed—including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, generics, coronavirus disease 2019 (COVID-19) pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2021 were based on a combination of quantitative analyses and expert opinion. Results In 2020, overall pharmaceutical expenditures in the United States grew 4.9% compared to 2019, for a total of $535.3 billion. Utilization (a 2.9% increase) and new drugs (a 1.8% increase) drove this increase, with price changes having minimal influence (a 0.3% increase). Adalimumab was the top drug in 2020, followed by apixaban and insulin glargine. Drug expenditures were $35.3 billion (a 4.6% decrease) and $98.4 billion (an 8.1% increase) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals the decrease in expenditures was driven by reduced utilization. Several new drugs that will influence spending are expected to be approved in 2021. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic. Conclusion For 2021, we expect overall prescription drug spending to rise by 4% to 6%, whereas in clinics and hospitals we anticipate increases of 7% to 9% and 3% to 5%, respectively, compared to 2020. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

Trend Analysis of Anti-Allergic Medicines During the 11-Year Period in Iran (2006-2017)

Up to 40% of the global and 7.4-41.3% of the Middle East population are affected by Allergic Rhinitis (AR). Patients with AR versus control group experience approximately twofold pharmaceutical expenditures and 1.8-fold number of visits. Since drug utilization can show various times of developing a disease in a country, it is used as an alternative for prevalence. In this study, we try to examine and explain the consumption of anti-allergic medicines during the past 11 years to have a perspective view of these kinds of medicines. In this descriptive and cross-sectional study that investigates anti-allergic medicines over a 11-year period (2006-2017), we used the Iranian pharmaceutical statistical datasheet published by the Iranian Ministry of Health. According to treatment guidelines of AR and WHO ATC code, we categorized anti-allergic medicines into five groups (antihistamines, Beta 2 agonists, Corticosteroids, Fixed-dose, and others), Then DIDs for these groups were calculated and analyzed. Based on our findings in this study, cetirizine, Loratadine, and Inhaled Salbutamol got the highest DID among all five groups, with 99.2, 65.4, and 57.6 retrospectively. Generally based on the third level of ATC code (second-generation anti-histamines, respiratory system drugs for obstructive airway disease, respiratory system nasal preparation, and corticosteroid for systemic use) are faced with ascending market sales. Generally, with the upward trend of anti-allergic medicines, we can conclude that the incidence of AR in Iran during the past 11 years has increased, and policymakers should follow this trend concerning a better supply chain.

Access to medicines in Turkey: Evaluation of the process of medicines brought from abroad

ObjectiveTurkey's health reforms started in 2003 with providing changes in regulatory, financing, and healthcare services. Access to health care and pharmaceuticals increased rapidly, and this resulted with an increase in public pharmaceutical expenditures. Our study aims to quantify and to evaluate the impact of a specific process within the Turkish system called “Medicines Brought From Abroad" (MBFA).MethodsWe reviewed the general reimbursement legislations of Social Security Institution (SSI), the guideline on MBFA, the SSI reimbursement list, the list of MBFA published by the Ministry of Health to describe the current supply mechanism of medicines and, in particular, the role of MBFA.ResultsTotal costs of the of MBFA medicines over the period 2011–17 went up to more than $520 million, which takes 7.5 percent of total public pharmaceutical expenditure for 2017. Our results showed that MBFA provides access to many orphan drugs and in total, forty-two orphan drugs listed in MBFA accounted for 83 percent of all MBFA budget in the year 2017. Nine of the top ten MBFA medicines were orphan drugs and total costs were $408 million. The highest budget impact was for eculizumab for “paroxysmal nocturnal hemoglobinuria” (PNH), covering 31 percent of total MBFA costs and 2.3 percent of overall drug costs in 2017.ConclusionsTurkey faced significant challenges for creating an access pathway for innovative medicines while continuing the sustainability of the public pharmaceutical budget like many other countries. Therefore, it may be argued that Turkey needs to create an independent health technology assessment organization to provide sustainable access to medicines in the future.

Prescription and dispensing guidelines in Lebanon: initiative of the Order of Pharmacists of Lebanon

Background In Lebanon, difficulties in accessing medications are due to two main barriers, mainly: high cost and the lack of medication safety, related to poor-quality (irrational) prescription and use. The objective of this work is to suggest guidelines to implement a unified medical prescription in Lebanon. These guidelines are expected to promote medication safety and decrease pharmaceutical expenditures in the Lebanese context. Methods The Order of Pharmacists of Lebanon (OPL) developed a comprehensive set of guidelines for physicians and pharmacists, including a detailed workflow process to improve the use of the unified medical prescription. The guidelines were presented to the Lebanese Ministry of Public Health (MOPH). Results The project covered prescription guidelines to physicians (handwritten and electronic-prescriptions), and medication dispensing and generic substitution guidelines to pharmacists. Prescription guidelines included all required information about both the prescribing physician and the patient with the maximum of details, comprehensibility, and caution regarding specific populations/co-morbidities/co-prescriptions. Dispensing guidelines included details for safe and appropriate treatment dispensing, pearls for medications’ counseling and generic substitution, as well as specific consideration for at-risk populations or those with concomitant medications and co-morbidities. Finally, a suggested workflow clarified the process for improving the unified medical prescription. Conclusions The implementation of the guidelines should now be formally evaluated, to assess if they achieve the aims to reduce prescribing and dispensing errors, to improve the quality of medicines' prescription and use, the patient care, and the interaction between all stakeholders

National trends in prescription drug expenditures and projections for 2020

Purpose To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2020 in the United States, with a focus on the nonfederal hospital and clinic sectors. Methods Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2020 were reviewed, including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for specialty drugs, biosimilars, and diabetes medications. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2020 were based on a combination of quantitative analyses and expert opinion. Results In 2019, overall US pharmaceutical expenditures grew 5.4% compared to 2018, for a total of $507.9 billion. This increase was driven to similar degrees by prices, utilization, and new drugs. Adalimumab was the top drug in US expenditures in 2019, followed by apixaban and insulin glargine. Drug expenditures were $36.9 billion (a 1.5% increase from 2018) and $90.3 billion (an 11.8% increase from 2018) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals growth was driven by new products and price increases. Several new drugs that will likely influence spending are expected to be approved in 2020. Specialty and cancer drugs will continue to drive expenditures. Conclusion For 2020 we expect overall prescription drug spending to rise by 4.0% to 6.0%, whereas in clinics and hospitals we anticipate increases of 9.0% to 11.0% and 2.0% to 4.0%, respectively, compared to 2019. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.