The Healthy People 2020 report, published by the US Department of Health and Human Services, includes targets for reducing vaccine-preventable disease rates and increasing vaccination rates in all age groups. According to the report, for each birth cohort (group of individuals born in the same year), immunization with the routine childhood vaccination schedule prevents 14 million cases of disease and reduces direct healthcare costs by $9.9 billion. Vaccines are one of the most cost-effective clinical preventive services; however, thousands of people in the US do not receive them and suffer – even die – from vaccine preventable diseases. From 2010 through 2014, flu-related deaths in the US ranged from 12,000 to 56,000 per year. Pneumococcal pneumonia leads to about 19,000 deaths every year, and as many as 1.4 million people currently suffer from Hepatitis B, with liver cancer as a potential complication. There have been a number of recent measles and pertussis outbreaks in communities with pockets of unvaccinated and under-vaccinated children.

In order to meet the Healthy People 2020 targets, all healthcare providers should stay up-to-date on vaccine recommendations and play an active role in immunizations. The Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP) update their recommendations for routine immunizations annually, while vaccine-specific recommendations are typically updated every 3-5 years (except influenza, which is updated yearly). Additionally, the CDC publishes the General Recommendations on Immunization and the Epidemiology and Prevention of Vaccine-Preventable Diseases (known as “The Pink Book”), which are considered core references for vaccine providers...

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.

This CE activity meets the Florida Board of Pharmacy requirement for a Board-approved 2-hour continuing education course on the Validation of Prescriptions for Controlled Substances. It also meets other state board requirements for a continuing education course on patient safety.

The appropriate and safe management of pain, and concerns about opioid overuse, abuse and overdose, have been making headlines for the past 20 years. Historically, opioids have been used for chronic non-cancer pain despite a lack of high-quality evidence for efficacy. Pain management societies and organizations (eg, THE Joint Commission on Accreditation of Healthcare Organizations [JCAHO]) embraced pain as a “vital sign” in the mid-1990s and encouraged more aggressive use of opioids for chronic pain. The amount of prescription opioids sold in the US increased nearly 4-fold from 1999 to 2014, despite no increase in reported pain.

According to IMS Health, a firm that tracks national prescription statistics, the number of opioid prescriptions dispensed peaked in 2012. For the first time in 20 years, the IMS data indicated a 12% overall decline in US opioid dispensing since the peak. Tightening of federal regulations for opioid prescriptions (eg, moving hydrocodone to schedule II status) likely contributed to the decline. Experts note, however, that the level of prescribing is still very high – with a growing overdose epidemic including fatal overdoses, which reached 28,000 in 2014.

Regulators and the public are looking to clinicians to "do the right thing" regarding pain management, but the "right thing" has been a moving target. What actions are in the patient’s or public’s best interest, and in the best interest of the clinician and their professional practice? There are opposing pressures from 1) patients and pain management experts who advocate providing opioids for individuals with pain, and 2) families, caregivers, and regulatory officials, who want to prevent prescription drug diversion, abuse and overdose. Finding the right balance to provide safe and effective pain management is a “moral imperative,” professional responsibility, and duty of healthcare professionals.

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.