The past few years have seen a number of legislative and regulatory changes at the federal level; both with the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). This article will address key changes impacting pharmacy practice in the areas of compounding, drug supply chain security, biosimilars, and the regulation of controlled substances in order to prevent diversion and abuse.

The passage of the Drug Quality and Security Act of 2013 (DQSA) updates the Federal Food, Drug, and Cosmetic Act (FDCA) in the areas of human drug compounding and drug supply chain security.1 Previously, compounding was mostly regulated by individual states under section 503A of the FDCA. In the years to come, the FDA will continue to clarify regulations surrounding compounding and drug supply chain security.

The FDA has developed policy regarding biological medications, particularly around nearly identical biological products (biosimilars) and their therapeutic substitution. A new online publication called the “Purple Book” lists biological products, and specifies those that are biosimilar and/or interchangeable....

2.0 Hours Pharmacy Law CE - 0.20 CEU. Target Audience: pharmacists, nurses, nurse practitioners, advanced practice nurses and pharmacy technicians.

Interest in medication errors was heightened by publication of the Institute of Medicine (IOM) report “To Err is Human,” which revealed the burden of medical errors and the impact on patients in the US. Following publication of the report in 2000, health care organizations bolstered efforts to reduce medical errors and the illness and death that result. Despite these efforts, a recent analysis based on studies conducted since the IOM’s report highlighted medical errors (including medication errors) as the third leading cause of death in the US. Extrapolating to the total number of US hospital admissions in 2013, the authors estimated that more than 250,000 deaths per year are caused by medical errors – and that includes only inpatient deaths.

Medication errors have been identified as the most common type of medical error. The FDA estimates that medication errors occur in about 1.3 million people annually and result in at least one death every day in the US. In the hospital setting, adverse drug events (ADEs) occur in nearly 5% of patients; preventable ADEs are one of the most common types of inpatient errors. In the outpatient setting, ADEs account for more than 3.5 million physician office visits, 1 million emergency department (ED) visits, and 125,000 hospital admissions annually. It is estimated that nearly half of these ADEs are preventable. Given the impact of medication errors and ADEs on healthcare utilization and costs in the US, error prevention practices remain key for both prescribers and pharmacists. Because pharmaceutical care involves the identification, resolution, and prevention of drug therapy problems and medication errors, pharmacy personnel, as well as prescribers and patients, have a key role in error prevention.

2.0 Hours Medication Errors CE - 0.20 CEU. Target Audience: pharmacists, nurses, nurse practitioners, advanced practice nurses and pharmacy technicians.

After a record-setting 45 approvals in 2015, the FDA approved only 22 new molecular entities in 2016.1 The FDA’s Office of New Drugs gave 3 explanations for the drop off: 1) 5 drugs with 2016 due dates were approved ahead of schedule in 2015; 2) biopharmaceutical companies filed fewer applications in 2016; and 3) there were more rejections. Of the 22 novel drugs, almost one third received breakthrough therapy designation, about two thirds were given priority review, and more than one third were for rare diseases. Two of the novel agents, elbasvir/grazoprevir and sofosbuvir/velpatasvir, were discussed in The Rx Consultant November 2016 issue on hepatitis C.

This issue reviews 8 novel drugs: crisaborole – the first topical phosphodiesterase 4 inhibitor for atopic dermatitis; ixekizumab – the second interleukin-17A inhibitor for psoriasis; lifitegrast – a first-in-class ophthalmic agent for dry eye disease; pimavanserin – the first drug to be approved for Parkinson’s disease psychosis; and 4 cancer drugs – atezolizumab for bladder and lung cancer, olaratumab for soft tissue sarcoma, rucaparib for ovarian cancer, and venetoclax for chronic lymphocytic leukemia Prasterone, a new option for a common postmenopausal disorder, is also reviewed. The 4 cancer drugs received accelerated approval; this means that their continued approval may depend on confirmation of benefit in further studies. Usual doses and selected drug interactions are summarized in Table 1. Nine more new drugs or new dosage forms that may be encountered in every day practice are described in Table 2. Both tables include pronunciation guides and brand names...

2.0 Hours Pharmacotherapy CE - 0.20 CEU. Target Audience: pharmacists, nurses, nurse practitioners, advanced practice nurses and pharmacy technicians.

The number of people affected by diabetes worldwide is growing rapidly. A 2014 national report estimates that 21 million people in the United States have diabetes and another 8.1 million people remain undiagnosed. All together, that is 9.3% of the US population. Around the world, 387 million people have diabetes, - which accounts for 8.3% of the global population. This burden is expected to increase by 205 million people by 2035. Despite advances in technology and drug therapy, many patients do not achieve adequate glycemic control. National guidelines generally recommend hemoglobin A1c (A1C) values less than 6.5-7%. However, the A1C goal should be individualized based on the patient's specific circumstances. The National Committee for Quality Assurance (NCQA) reported that in 2013, only 52-59% of adults with type 1 or type 2 diabetes who had commercial insurance had A1C levels less than 8%. For Medicaid patients, the percentage was even lower at 45.5%.

Heart Failure (HF) is a common disease affecting approximately 5 million adult Americans.The likelihood of developing HF increases with age and is greater in men. The 5-year mortality rate is remarkably high at 50%, and nearly 300,000 deaths annually are directly attributable to HF. HF creates a significant economic burden on the healthcare system; in 2012, direct medical costs were approximately $21 billion. Despite advances in therapy over the past few decades, the prevalence of HF is expected to rise to over 8 million by 2030.

Role of the Community Practitioner: Approximately 1 out of every 4 patients hospitalized for HF is readmitted within 30 days. Readmission accounts for a significant portion of HF costs and is linked with decreased survival. Pharmacists and nurses can play an important role during transitions of care (eg, from hospital to home) by providing medication reconciliation and patient education, which can help reduce hospital readmissions. Pharmacists in community practice should reinforce discharge instructions through medication counseling and lifestyle modification support.