scholarly journals Drug Manufacturer

2020 ◽  
Author(s):  
Keyword(s):  
Drug Manufacturer

High-Dose Clopidogrel Loading in Percutaneous Coronary Intervention

2005 ◽  
Vol 39 (5) ◽  
pp. 918-922 ◽  
Author(s):  
Kristen L Longstreth ◽  
James R Wertz
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Coronary Intervention ◽  
Drug Manufacturer ◽  
Platelet Inhibition ◽  
High Dose ◽  
Loading Dose ◽  
Percutaneous Coronary ◽  
Safety Studies ◽  
Risk Patients ◽  
Time Required

OBJECTIVE: To review the use of a 600-mg clopidogrel loading dose in patients undergoing percutaneous coronary intervention (PCI). DATA SOURCES: Human clinical trials and platelet studies available through PubMed (1966–March 2005), bibliographies of pertinent articles, and citations supplied by the drug manufacturer were accessed. DATA SYNTHESIS: The administration of a 600-mg loading dose of clopidogrel can decrease the time required for maximum platelet inhibition to 2 hours compared with ⩾6 hours achieved with 300 mg. This higher loading dose has been investigated in multiple platelet studies and one observational report. Several randomized controlled trials have used a 600-mg loading dose; however, these studies were not designed to evaluate the efficacy and safety of this loading regimen. To date, only one randomized trial has compared the 600-mg loading dose with a 300-mg loading dose. CONCLUSIONS: When compared with a conventional loading regimen of 300 mg in lower-risk patients, pretreatment with clopidogrel 600 mg was shown to be more effective in reducing periprocedural events and demonstrated similar safety. Studies are needed to clarify the use of a 600-mg loading dose in higher-risk patients, with concomitant glycoprotein IIb/IIIa receptor antagonism, or when administration is delayed until immediately before or after PCI.

scholarly journals Pharmaceutical assistance foundations in the financing of cancer care.

2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 8-8
Author(s):  
Aaron Philip Mitchell
Keyword(s):  
North Carolina ◽  
Cancer Care ◽  
Kinase Inhibitors ◽  
Care Delivery ◽  
Private Insurance ◽  
Standard Of Care ◽  
Drug Manufacturer ◽  
Cancer Drugs ◽  
Assistance Programs ◽  
Patients With Cancer

8 Background: The rising cost of cancer drugs may make treatment unaffordable for some patients. Patients often rely on drug manufacturer-administered Pharmaceutical Assistance Programs (PAPs) to obtain drugs at reduced or no cost. The overall impact of PAPs on cancer care delivery is unknown. Methods: We identified all patients obtaining cancer drugs across an academically affiliated, integrated health system in the state of North Carolina during 2014. The proportion of patients receiving PAP assistance, and the retail value of the assistance, were quantified for each oncology drug. Cancer drugs were analyzed with respect to route of administration. Results: 215 unique patients submitted a total of 478 successful PAP requests for cancer drugs. The majority of the retail value of drugs obtained was for oral cancer drugs, particularly targeted therapies including tyrosine kinase inhibitors. Among all cancer patients who received medical treatment, 5.5% required PAP assistance, whereas 10.6% receiving an oral agent required PAP assistance (Table). The proportion receiving PAP assistance varied substantially by drug, ranging from <1% of patients (e.g., carboplatin, methotrexate) to 50% of patients (e.g., ponatinib, temsirolimus). Patients obtained a total of $1,556,575 of imatinib and $1,449,633 of dasatinib, which were the two drugs with the highest aggregate retail value. 40% of PAP-utilizing patients were uninsured, 26% had Medicaid coverage, 20% had Medicare coverage, and 14% were commercially insured. Conclusions: A substantial proportion of patients with cancer receive private charitable assistance through PAPs in order to obtain standard-of-care treatments. In particular, a disproportionate share of patients treated with orally-available cancer drugs require PAP assistance. This includes patients with federal and private insurance, suggesting an inability of patients to meet cost-sharing requirements. [Table: see text]

"THERAPEUTIC ORPHANS" AND THE PACKAGE INSERT

PEDIATRICS ◽  
1970 ◽  
Vol 46 (5) ◽  
pp. 811-813
Author(s):  
Keyword(s):  
Chemical Structure ◽  
Adverse Reactions ◽  
Package Insert ◽  
Drug Manufacturer ◽  
Full Disclosure ◽  
Package Inserts ◽  
Federal Food ◽  
The Status ◽  
Definition Of ◽  
Official Information

In the practice of pediatrics, drugs which are not approved by the Food and Drug Administration (FDA)* as safe and effective in children are prescribed daily. This is due in part to the fact that many drugs released since 1962 carry an "orphaning clause" in the package insert such as, "not to be used in children, since clinical studies have been insufficient to establish recommendations for its use." What is the status of the package insert? Is it a legal directive to the physician, or is it intended as a guide for the physician in prescribing a drug? The package insert, by legal definition of the Federal Food, Drug and Cosmetic Law, is the official information piece for a drug. The information it contains is derived from data supplied by investigators and submitted by the pharmaceutical firm to the FDA. The insert is written and printed by the drug manufacturer, but its contents must be approved by the FDA. The Food, Drug and Cosmetic Law, as amended in 1962, requires full disclosure of all known facts pertaining to the use of the drug. Therefore, a great deal of information is included in the insert, including the chemical structure of the drug, a summary of its pharmacological and toxicological action, its clinical indications and contraindications, precautions, reported adverse reactions, dosage recommendations, and available dosage forms. Many drugs have package inserts approved by the FDA before the Drug Amendments of 1962 when manufacturers were required to show the safety but not the effectiveness of their products.

Language localization in scientific drug information

2016 ◽  
Vol 3 (1) ◽  
pp. 74-94 ◽  
Author(s):  
Maria-Cornelia Wermuth
Keyword(s):  
Cultural Adaptation ◽  
Drug Information ◽  
Medical Knowledge ◽  
Drug Manufacturer ◽  
Medical Discourse ◽  
European Medicines Agency ◽  
Source Text ◽  
Linguistic Features ◽  
Written Materials

Although localization is, in the first place, related to the cultural adaptation and translation of software and websites, it is important for written materials as well. In this paper we investigate how specialized medical discourse used in the Summary of Product Characteristics (SmPC) is localized in patient leaflets (PL). Both documents are issued by the European Medicines Agency (EMA) and provide detailed information on the product compiled and distributed by the drug manufacturer, after EMA review and approval. We describe by means of a case study the formal and linguistic features of SmPCs and PLs and we investigate how the specialized source text is localized in its patient-friendly version. The aim of this investigation is to increase awareness and understanding of localization strategies adopted on the intralingual level in the communication of scientific-medical knowledge to a non-expert audience.

Pharmaceutical assistance programs for cancer patients in the era of orally administered chemotherapeutics

2017 ◽  
Vol 24 (6) ◽  
pp. 424-432 ◽  
Author(s):  
Aaron Mitchell ◽  
Benyam Muluneh ◽  
Rachana Patel ◽  
Ethan Basch
Keyword(s):  
North Carolina ◽  
Cancer Patients ◽  
Care Delivery ◽  
Private Insurance ◽  
Standard Of Care ◽  
Drug Manufacturer ◽  
Cancer Drugs ◽  
Oral Agent ◽  
Assistance Programs ◽  
Oral Agents

Introduction The rising cost of cancer drugs may make treatment unaffordable for some patients. Patients often rely on drug manufacturer-administered Pharmaceutical Assistance Programs (PAPs) to obtain drugs and reduced or no cost. The overall usage of PAPs within cancer care delivery is unknown. Methods We included all cancer patients across an academically affiliated, integrated health system in North Carolina during 2014 ( N = 8591). We identified the subset of patients receiving PAP assistance to afford one or more cancer drugs, in order to calculate the proportion of patients receiving PAP assistance, and the retail value of the assistance. Results Among 8591 cancer patients, 215 unique patients submitted a total of 478 successful PAP requests for cancer drugs. 40% of PAP-utilizing patients were uninsured, 23% had Medicaid coverage, 20% had Medicare coverage, 2% were dual Medicare/Medicaid eligible, and 14% were commercially insured. Among all cancer patients who received medical treatment, 6.0% required PAP assistance, whereas 10.6% receiving an oral agent required PAP assistance. The proportion receiving PAP assistance varied substantially by drug, ranging from <1% of patients (e.g. carboplatin, methotrexate) to 50% of patients (e.g. ponatinib, temsirolimus). The majority of the retail value obtained was for oral agents, including $1,556,575 of imatinib and $1,449,633 of dasatinib, which were the two drugs with the highest aggregate retail value. Conclusions A substantial proportion of cancer patients receive private charitable assistance to obtain standard-of-care treatments. This includes patients with federal and private insurance, suggesting an inability of patients to meet cost-sharing requirements.

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