Developing a System Dynamic Model for Product Life Cycle Management of Generic Pharmaceutical Products: Its Relation with Open Innovation

The purpose of this study is to identify elements that influence the sale of generic pharmaceutical products during their life cycle in order to achieve more comprehensive planning and to prevent a decline stage of the product life cycle (PLC). We used a system dynamic model to identify the behaviors of demand, supply, and competition as three major subsystems of PLC in generic pharmaceutical products. We first investigated the PLC patterns of 527 medicines to identify their “reference mode”, determined the causal loop of the pharmaceuticals phase of PLC based on both an in-depth literature review and experts’ opinions, and finally simulated a quantitative dynamic model based on real-world data between 2012 and 2019 from Iran. Based on the results, “total demand and accurate forecasting”, “marketing efforts”, and “R and D activities of a firm” are the most critical factors involved in the formation of a generic drug PLC. An increase of 20–50% of manufacturers’ marketing and R and D activities can raise sales by more than 50% in the decline stage of the PLC. The product life cycle can give generic manufacturers more insights into the processes leading to declining sales of their products. PLC may help to prevent a product from entering the decline stage even if the total demand for a generic drug is dropping in the market.

INTENSIVE PHARMACOVIGILANCE STUDY, CARRIED OUT IN MEXICAN POPULATION WITH A HISTORY OF ACUTE MYOCARDIAL INFARCTION OR ANGINA TREATED WITH CLOPIDOGREL, GENERIC DRUG, FOR SECONDARY PROPHYLAXIS

The results obtained from an intensive pharmacovigilance, phase IV, single-center study, with an oral treatment for secondary prophylaxis of acute myocardial infarction or angina with clopidogrel, generic drug, in Mexican population, at a daily dose of 75 mg, alone or associated with acetylsalicylic acid, are described. A total of 60 patients were admitted; 10 patients were discontinued from the study due to different causes. The patients had, at least, 2 comorbidities in addition to heart disease. Among the most important history were obesity 40% and overweight 41.6%; the age range (tenths) with the greatest number of participants was 51 to 60 years with 25 patients, which represents 41.6%. A total of 247 adverse events were reported (57 patients had adverse events) of which 39 (15.7%) events were heart events, 32 (12.9%) vascular events; 14 (5.7%) events were serious, 9 (3.6%) of the serious events were heart events, 2 (0.8%) vascular events and 3 (1.2%) lithiasis; Of the 24 (9.7%) events, than were classified with a possible causal relation with clopidogrel, 1 (0.4%) was classified as serious. All the other events were non-serious. It was, therefore, concluded that generic clopidogrel is safe, and risk possibility should continue to be monitored for the type of disease that patients suffer and that may have a fatal outcome

Lixarit — clinical and pharmaceutical aspects of efficacy and safety of flecainide acetate generic drug

The article considers the use of flecainide, an antiarrhythmic agent. The results of comparing the bioequivalence of Lixarit, flecainide acetate generic drug (flecainide acetate, 100 mg tablets, Laboratorios Normon SA, Spain), and Apocard®, flecainide acetate reference drug (Health Care Ltd, UK, 100 mg tablets), are presented.

Reasons for patients’ generic drug switching at the pharmacy counter: a pilot study

Background: Drug switching describes switching between drug products with the same active substance. Drug switching occurs commonly in the Netherlands and mostly between generic drug products, however, the specific reasons for switching are incompletely understood. Methods: To document reasons for drug switches between products with the same active substance in the Netherlands. Results: In total, 207 drug switches were recorded. Most drug switches were caused by nationwide drug shortages (32%, n = 66) and the Dutch price-based tender system (23%, n = 47). Other reasons for switching included deals between pharmacists and wholesalers (12%, n = 25), distribution issues at wholesalers (11%, n = 22), and a financially favourable margin for pharmacists (11%, n = 21). Conclusion: This study indicates that drug shortages and the Dutch price-based tender system are likely to be major causes of drug switches in the Netherlands. However, other reasons, such as drug product distribution issues and local economic incentives, were also identified.