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The article discusses the implementation of legislation by Nevada and the growing number of states that protects hospitals and other participants in the 340B Drug Pricing Program against discriminatory practices initiated by pharmacy benefit managers (PBMs). Topics include key provisions in the law, support of the Nevada Society of Health-System Pharmacists (NVSHP) to the bill, and comments from Adam Porath, legislative director for NVSHP.

The article discusses the prevalence of cost-related medication underuse (CRMU) or cost-related nonadherence (CRN) in the U.S., as well as the recommended strategies to bolster medication adherence at care transitions. Topics include CRMU prevalence in other countries like Canada, Norway and Sweden, healthcare-associated costs like out-of-pocket cost (OOPC), and the factors resulting in increased drug prices in the U.S. like research and development costs.

The article presents a speech by outgoing American Society of Health System Pharmacists (ASHP) president Paul W. Bush delivered at the ASHP Summer Meetings held in Denver, Colorado on June 5, 2018. Topics of the speech included the ASHP's promotion of resilience, pharmacy leadership and technician training during his term, and his call for all to build on the progress made during the year by continuing support for the pharmacy workforce and frontline staff.

Objectives: To explore the trends of antibiotic consumption in public healthcare institutions through analysing the provincial centralized bidding procurement (CBP) data in Shandong, China.Methods: The Shandong CBP system has been established since 2011, covering public healthcare institutions of 500 secondary and tertiary hospitals, 600 urban primary healthcare centres (PHCs) and 1600 rural PHCs. We collected all the antibiotic procurement records from the CBP system between 2012 and 2016. Antibiotic consumption data were calculated using Anatomical Therapeutic Chemical (ATC)/DDD methodology and normalized using DDD per 1000 inhabitants per day (DID).Results: Overall antibiotic consumption increased from 12.859 DID in 2012 to 15.802 DID in 2014, then decreased to 13.802 DID in 2016. The top three antibiotics consumed in 2016 were penicillins (4.251 DID), quinolones (2.957 DID) and macrolides (2.057 DID). PHCs consumed 80% of the total antibiotics, of which rural PHCs accounted for 88%. Antibiotic consumption peaked in 2014 for rural PHCs and in 2015 for hospitals, and declined thereafter. In urban PHCs, the consumption steadily increased from 2012 to 2016.Conclusions: Zero mark-up drug policies and national policies to improve rational use of antibiotic were associated with the reduction of antibiotic consumption in public healthcare institutions in Shandong Province. Regulations for antibiotic use in PHCs should be strengthened. [ABSTRACT FROM AUTHOR]

The article discusses a report from the National Academies of Sciences, Engineering, and Medicine which calls for the U.S. government's action on high drug prices. The report provides recommendations to increase transparency within the drug supply chain, to reform federal reimbursement policies for medications, and to expand the government's ability to negotiate drug prices. The American Society of Health-System Pharmacists (ASHP) commended the organization for addressing the issue.

The article offers information on the guidance issued by the U.S. Food and Drug Administration (FDA) on January 12, 2017 on repackaging drug products. Topics discussed include guidelines on the beyond-use-date (BUD) for tablets taken from a manufacturer's large container and repackaged into smaller containers, explanation given by the FDA on BUDs for pharmacy-repackaged drug products, and the biggest challenge to pharmacists, according to Eric Kastango of consulting company Clinical IQ LLC.

Purpose. Drug expenditure trends in 2009 and 2010, projected drug expenditures for 2011, and factors likely to influence drug expenditures are discussed. Summary. Various factors are likely to influence drug expenditures in 2011, including drugs in development, the diffusion of new drugs, generic drugs, health care reform, and biosimilars. Two distinct patterns of drug expenditures continue to exist. The dominant trend over the past several years is substantial moderation in expenditure growth for widely used drugs, primarily due to the ongoing introduction of generic medications for high-cost, frequently used medications and the influence of the economic downturn. The second pattern is substantial increases in expenditures for specialized medications, particularly in the outpatient setting. The influence of health care reform, the economy, and the emergence of biosimilars will be important trends to follow over the next several years, but they are unlikely to have substantial impact on drug expenditures in 2011. From 2008 to 2009, total U.S. drug expenditures increased by 5.2%, with total spending rising from $284.8 billion to $299.5 billion. Growth in drug expenditures in clinics grew by 5.1% from 2008 to 2009. Hospital drug expenditures increased at the moderate rate of 2.8% from 2008 to 2009; through the first nine months of 2010, hospital drug expenditures increased by only 0.8% compared with the same period in 2009. Conclusion. For 2011, we project a 3-5% increase in drug expenditures in outpatient settings, a 4-6% increase in expenditures for clinic-administered drugs, and a 1-3% increase in hospital drug expenditures. [ABSTRACT FROM AUTHOR]

Purpose. Drug expenditure trends in 2008 and 2009, projected drug expenditures for 2010, and factors likely to influence drug expenditures are discussed. Summary. Various factors are likely to influence drug expenditures in 2010, including drugs in development, the diffusion of new drugs, generic drugs, health care reform, drug safety concerns, and comparative effectiveness research. The increasing availability of important generic drugs continues to moderate growth in drug expenditures. Health care reform initiatives, including the potential for biosimilars legislation, will influence drug expenditures in all settings. From 2007 to 2008, total U.S. drug expenditures increased by 1.8%, with total spending rising from $279.6 billion to $284.7 billion. Growth in drug expenditures in clinics declined to the lowest level in a decade, a 1.0% increase from 2007 to 2008. Hospital drug expenditures increased at a moderate rate of only 2.1% from 2007 to 2008; through the first nine months of 2009, hospital drug expenditures increased by 3.0% compared with the same period in 2008. Conclusion. In 2010, we project a 3-5% increase in drug expenditures in outpatient settings, a 6-8% increase in expenditures for clinic-administered drugs, and a 2-4% increase in hospital drug expenditures. [ABSTRACT FROM AUTHOR]

Purpose. The regulation of homeopathic drug products is discussed. Summary. Homeopathy is a system of medicine based on the observation that high doses of pharmacologically active substances cause symptoms when administered to healthy individuals. These same substances, when prepared in very dilute form, may relieve similar symptoms in conditions resulting from different etiologies. Unlike dietary supplements, homeopathic drugs are subject to the Food, Drug, and Cosmetic Act and regulations issued by FDA. Instead of the new-drug-approval process, premarket approval for homeopathic drugs is by way of monograph approval by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). Monographs are published in the Homeopathic Pharmacopoeia of the United States (HPUS). The criteria for inclusion in the HPUS require that a homeopathic drug product be determined by HPCUS to be safe and effective and to be prepared according to the specifications of the HPUS general pharmacy section. The long history and established nature of homeopathic drug regulation may provide a model for the regulation of dietary supplements. Conclusion. Homeopathic drugs in the United States are subject to well-defined regulatory processes that more closely resemble those that apply to allopathic medications than to dietary supplements. [ABSTRACT FROM AUTHOR]

The article reports on the draft legislation which was released by U.S. Congress in April 2013, which would create federal standards for monitoring pharmaceuticals that are distributed in the market. A federal track-and-trace electronic system for drug distribution will be implemented, according to Janet Woodcock, chief of drugs division of the U.S. Food and Drug Administration (FDA). The version from the House of Representatives included an improvement of the security of this distribution.

The article reports that the U.S. Congress held its fifth meeting on drug shortages without arriving at any conclusion. The Prescription Drug User Fee Act (PDUFA) is up for renewal in 2012, which helps the FDA to collect fees from companies producing certain pharmaceuticals. The main issue being debated is whether to address drug shortages in the upcoming PDUFA reauthorization or do it alone. Some of the improvements that have taken place according to the FDA are described.

The article reports that accelerated approval by the U.S. Food and Drug Administration which allows drugs for life-threatening diseases , including cancer, to be given marketing approval. The approval is given on the condition that companies conduct post-marketing confirmatory studies. Those studies have proven difficult to complete and are raising some ethical concerns as companies move them overseas in attempts to meet accrual targets.

The article reports on the summaries of safety labeling changes on drugs and therapeutic biologicals approved by the U.S. Food and Drug Administration (FDA) under its MedWatch program in October-December 2018. Also cited are the use of boxed warnings to highlight serious adverse reactions and restrictions of use, as well as the drugs like Lemtrada (alemtuzumab), Serevent (salmeterol xinafoate), and Unithroid (levothyroxine sodium).

The article reports on the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patient and Communities Act signed by U.S. President Donald Trump on October 24, 2018. It aims to defeat the opioid epidemic. It was introduced in the U.S. House of Representatives on June 13, 2018 by Energy and Commerce Committee Chairman Greg Walden. The American Society of Health-System Pharmacists (ASHP) released an issue brief summarizing provisions that ASHP supported.

The article discusses the FDA Safety and Innovation Act, which experts believe will ensure continued production of critical drugs. The law addresses potential drug shortages by requiring drug makers to notify FDA about a manufacturing interruption that could lead to a "meaningful disruption" in drug supply. The law does not address the role of economic factors in drug shortages. The implications of the law for repackaged drugs and new user fees are noted.

The article discusses the FDA's interim rule which states that a company that interrupts the production of a critical drug product will also have to issue a six month advance notice to the FDA, in a move to address the shortage of prescription drugs. This rule will be effective from January 18, 2012. The article also includes comments from Amy Klobuchar of Minnesota, who introduced Senate bill 296, and mentions that Congress awaits the results of the Drug Shortage Working Group's assignment.

Reports that drugstores in Oklahoma have the permission to dispense prescription medication that had been dispensed earlier by other drugstores under the Unused Prescription Drug Program. Type of medications that pharmacies are allowed to dispense; Reason for the creation of the program; Role of pharmacists in the distribution of the medications.

Reports on the new drug and biological products approval from the Food and Drug Administration in the U.S. on 2003. Regulatory clearance for pyridostigmine bromide oral tablets, used for the protection of soldiers against the effects of the nerve gas soman; Marketing approval for the Prussian blue capsules, or Radiogardase, used for the treatment of radiation contamination caused by the exposure to cium-137 or thallium; Approval for the vardenafil hydrochloride product of Bayer, which focused attention on men with erectile dysfunction.

The article introduces a debate over the proposed upscheduling of hydrocodone combination products (HCPs) by the U.S. Food and Drug Administration (FDA) based on its potential for abuse and lethality.