Preventing Lethal Prostate Cancer with Diet, Supplements, and Rx: Heart Healthy Continues to Be Prostate Healthy and "First Do No Harm" Part II.

PURPOSE OF REVIEW: To discuss the overall and latest observations of the effect of diet, lifestyle, supplements, and some prescription heart healthy medications for prostate cancer prevention. RECENT FINDINGS: The concept of maximizing heart health to prevent aggressive prostate cancer continues to be solidified with the addition of more prospective observational and randomized controlled trial data. Heart healthy is prostate healthy, and heart unhealthy is prostate unhealthy. The primary goal of reducing the risk of all-cause and cardiovascular disease (CVD) morbidity and mortality also coincides with maximizing prostate cancer prevention. The obesity epidemic in children and adults along with recent diverse research has only strengthened the nexus between heart and prostate health. Greater dietary adherence toward a variety of healthy foods is associated with a graded improved probability of CVD and potentially aggressive cancer risk reduction. Preventing prostate cancer via dietary supplements should encourage a "first do no harm," or less is more approach until future evidence can reverse the concerning trend that more supplementation has resulted in either no impact or an increased risk of prostate cancer. Supplements to reduce side effects of some cancer treatments appear to have more encouraging data. A discussion of quality (QC) before utilizing any pill also requires attention. Medications or interventions that potentially improve heart health including statins, aspirin, and metformin (S.A.M.), specific beta-blocker medications, and even preventive vaccines are in general generic, low-cost, "natural," and should continue to garner research interest. A watershed moment in medical education has arrived where the past perception of a diverse number of trees seemingly separated by vast distances, in reality, now appear to exist within the same forest.

Current Status of Expiry of Homeopathic Medicines in Brazil, Germany, India and the United States: A Critical Review.

BACKGROUND: Assignment of expiry date to homeopathic medicines is a subject of important concern to its pharmacists and practitioners. This study compares the regulatory framework for the expiry of homeopathic medicines in four countries: Brazil, Germany, India and the United States. FINDINGS: Different or no expiry periods are variously followed. Whereas Germany, with some exceptions, employs a maximum expiry of 5 years for both potencies and finished products, Brazil adopts a 5-year expiry for finished products only, potencies used in manufacture being exempted from an assigned expiry date. In India, all homeopathic medicines except dilutions and back potencies have a maximum of 5 years' shelf-life, including those supplied to consumers. In the United States, homeopathic medicines are exempted from expiry dates. COMMENTS: There is neither a rational basis nor scientific evidence for assigning a short (3-5 years) expiry period for homeopathic medicines as followed in some of the countries, particularly in light of the fact that some studies have shown homeopathic medications to be effective even after 25 years. Homeopathic ultra-dilutions seem to contain non-material activity that is maintained over time and, since these exhibit different chemical properties compared to the original starting material, it is quite possible they possess properties of longer activity than conventional medicines. Regulators should acknowledge this feature and differentiate expiry of homeopathic medicinal products from that of conventional drugs.

Clinical and economic impacts of clinical pharmacists' interventions in Iran: a systematic review.

OBJECTIVES: There are many studies about Iranian clinical pharmacists' interventions and their impacts on medication safety and cost. The aim of this study is to collect data and critically evaluate the clinical and economic effects of Iranian clinical pharmacist interventions and activities. To our best of knowledge, this research is the first review of publications about Iranian clinical pharmacists' interventions and activities. EVIDENCE ACQUISITION: Six online databases, including PubMed, Scopus, Medline, Cochrane Central Register of Controlled Trials, Cochrane Database of Systemic Reviews, and Google Scholar were searched using the terms '"Iranian", "clinical pharmacist", 'adverse drug reactions", "medication errors", "drug interaction", "drug utilization evaluation", "cost", and "interventions" for English studies conducted in Iran and described clinical pharmacist-initiated interventions, published before December 2018. The search and extraction process followed PRISMA guidelines. Observational or retrospective studies, clinical trials, congress abstracts, and case reports or case series were excluded. The search strategy after full-text review identified 39 articles matching the eligibility criteria. RESULTS: Thirty-nine articles were recruited. They included establishing pharmaceutical care in out-patient clinics and drug information centers (n = 4); prevention, detection, and management of adverse drug reactions(n = 4), designing protocols and improving drug utilization pattern(n = 16), prevention, detection, and management of medication errors (n = 11), and all clinical pharmacist services(n = 4). Most clinical pharmacist interventions and activities were regarding designing protocols, improving drug utilization pattern, as well as detection, prevention, and management of medication errors. About three-fourth (74.35%) of included studies were from either ambulatory care or in-patient settings in Tehran. The median (interquartile range) duration of intervention as well as follow-up phases was 9 (5) months. CONCLUSION: Data of our review support the beneficial role of clinical pharmacists in the improvement of quality, safety, and efficiency of patients' pharmaceutical care in Iran. Graphical abstract Clinical pharmacists' interventions in Iran.

Seventeen-Year Nationwide Trends in Use of Long-acting Bronchodilators and Inhaled Corticosteroids among Adults - A Danish Drug Utilization Study.

Long-acting bronchodilators and inhaled corticosteroids (ICS) are the cornerstones in treatment of chronic obstructive and inflammatory pulmonary diseases. However, non-adherence to guidelines is widespread. Detailed information on real-life treatment patterns is needed to promote rational use. We aimed to investigate nationwide time trends in individual-level treatment patterns of long-acting bronchodilators and ICS. Using nationwide Danish health registries, we identified all Danish adults with a prescription for long-acting bronchodilators and/or ICS from 2000 to 2016. We investigated the total use of long-acting bronchodilators and ICS, the proportion of current users and the rate of new users over time. Finally, we assessed treatment persistence. We included 23,061,681 prescriptions for long-acting bronchodilators and ICS issued to 805,860 individuals from 2000 to 2016. Over this period, the total annual amount of prescribed long-acting bronchodilators and ICS increased by 39%. Similarly, the proportion of adult users increased from 2.6% to 4.5%, mainly driven by the introduction of combination therapy and long-acting muscarinic antagonist (LAMA). Although the rate of new users of fixed-dose combination drugs increased substantially over time, the overall rate of new users was stable. In general, the proportion of patients on therapy after 1 year was low (25-53%), especially among young individuals and users of ICS. We document a pronounced increase in the total use of long-acting bronchodilators and ICS over time, mainly driven by the introduction of combination drugs and LAMA. Special attention should be paid to the low level of persistence, especially among young individuals and users of ICS.

Cardiovascular disease and omega-3s: Prescription products and fish oil dietary supplements are not the same.

BACKGROUND AND PURPOSE: Despite achievement of optimal low-density lipoprotein cholesterol (LDL-C) control with statin therapy, patients with elevated triglycerides (TGs) and residual cardiovascular risk are commonly encountered in clinical practice. METHODS: We present information from completed and ongoing clinical trials examining Rx omega-3s for TG-lowering and omega-3 dietary supplements to highlight important differences affecting patient management for nurse practitioners. CONCLUSIONS: Rx omega-3s demonstrate robust reductions in TGs and may have a role in reducing residual cardiovascular risk. Products containing docosahexaenoic acid (DHA) may raise LDL-C and should not be substituted for Rx eicosapentaenoic acid (EPA)-only icosapent ethyl, which does not raise LDL-C. Omega-3 dietary supplements (e.g., fish oils containing EPA and DHA) may be used for general health promotion; however, they are not regulated as medications and concerns regarding quality, purity, safety, and variability of content exist. It is important to advise patients that omega-3 dietary supplements are not medications and should not be substituted for Rx omega-3s. Large-scale cardiovascular outcomes studies are underway for Rx omega-3s in statin-treated patients. IMPLICATIONS FOR PRACTICE: Nurse practitioners can take an active role in reducing residual cardiovascular risk and educating patients about important differences between Rx omega-3s and fish oil supplements.

Is Nutrient Content and Other Label Information for Prescription Prenatal Supplements Different from Nonprescription Products?

BACKGROUND: Prenatal supplements are often recommended to pregnant women to help meet their nutrient needs. Many products are available, making it difficult to choose a suitable supplement because little is known about their labeling and contents to evaluate their appropriateness. OBJECTIVE: To determine differences between prescription and nonprescription prenatal supplements available in the United States regarding declared nutrient and nonnutrient ingredients and the presence of dosing and safety-related information. DESIGN: Using two publicly available databases with information about prenatal supplement products, information from prescription and nonprescription product labels were extracted and evaluated. For the 82 prescription and 132 nonprescription products, declared label amounts of seven vitamins and minerals, docosahexaenoic acid (DHA), the presence of other nonnutrient components, and the presence of key safety and informational elements as identified in two Department of Health and Human Services Office of Inspector General (OIG)'s 2003 reports were compiled and compared. RESULTS: Compared with nonprescription products, prescription products contained significantly fewer vitamins (9±0.2 vs 11±0.3; P≤0.05) and minerals (4±0.1 vs 8±0.3; P≤0.05). Declared amounts of folic acid were higher in prescription products, whereas vitamin A, vitamin D, iodine, and calcium were higher in the nonprescription products. Amounts of iron, zinc, and DHA were similar. Virtually all products contained levels of one or more nutrients that exceeded the Recommended Dietary Allowances for pregnant and/or lactating women. Product type also influenced ingredients added. Fewer prescription products contained botanical ingredients (6% prescription vs 33% nonprescription) and probiotics (2% prescription vs 8% nonprescription). Only prescription products contained the stool softener docusate sodium. CONCLUSIONS: Our analysis of prenatal supplements indicates that prescription and nonprescription supplements differ in terms of declared composition and nutrient strength, but have labels that are similarly sparse regarding aspects of use such as dosing information.

Regulation of traditional herbal medicinal products in Japan.

Kampo medicines are the main traditional herbal medicines in Japan and are classified as pharmaceuticals. They are based on ancient Chinese medicine and have evolved to the Japanese original style over a long period of time. Ethical Kampo formulations are prescribed in general practice by physician under the National Health Insurance reimbursement system. Over-the-counter (OTC) Kampo formulations can be purchased and used for self-medication in primary health care settings. Kampo medicines have a substantial role in the Japanese healthcare system. In the early 1970s, "The Internal Assignments on the Review for Approval of OTC Kampo Products", known as "210 OTC Kampo Formulae", was published by the Ministry of Health and Welfare (currently the Ministry of Health, Labour and Welfare). In 2008, "210 OTC Kampo Formulae" was revised and presented as "The Approval Standards for OTC Kampo Products" and now 294 Kampo formulae are listed in the standards. These products have had wide spread usage in Japan. Crude drugs and Kampo extracts have been listed in The Japanese Pharmacopoeia. Both The Approval Standards and The Quality Standards play a key role in regulation of Kampo products. "Application Guideline for Western Traditional Herbal Medicines as OTC Drugs" was published in 2007. Other ethnopharmaceuticals mostly from Europe could be approved as OTC drugs in Japan.

National list of essential medicines of India: the way forward.

Essential medicines lists have been shown to improve the quality and cost-effectiveness of health care delivery when combined with proper procurement policies and good prescribing practices. The Ministry of Health, Government of India revised the National List of Essential Medicines of India (NLEMI 2011) in June 2011, eight years after the last revision. The NLEMI 2011 contains 348 medicines and was prepared over one and a half years by 87 experts. Though there are some positive aspects to the list such as the documentation of a detailed description of the revision process, inclusion of many experts from various fields in the review committee, well written description of the essential medicines concept and others, a critical review of the list reveals areas of major and minor concerns. Improper medicine selection like the inclusion of a nearly obsolete medicine such as ether, an anesthetic agent; non-inclusion of pediatric formulations; spelling errors; and errors in the strengths of formulations diminishes the significance of the NLEMI 2011. In its present form, the NLEMI 2011 did not align with the Indian Pharmacopoeia, and the National Health Programs as well as the National Formulary of India 2010. Formatting errors, non-inclusion of an index page, syntax and spelling errors may also undermine the usefulness of the NLEMI 2011 as a reference material. An urgent revision of the NLEMI 2011 is suggested so as to avert misinforming the wider international and local readers.

Nutritional and pharmacologic challenges in the bariatric surgery patient.

The purpose of this study was to describe vitamin and nutrient supplement practices and assess medication dosage formulations utilized in patients hospitalized with a history of bariatric surgery. Retrospective pilot study was conducted from January 1, 2006 through December 31, 2007 in patients with a past history of bariatric surgery. Demographic data, vitamin and nutrient supplements, and medication dosage formulations were evaluated upon admission. This was compared to published guidelines. Compliance with the following supplementation was categorized: daily multivitamin, calcium, iron, vitamin B-12, and folic acid. The frequency of non-immediate-release and enteric-coated medication dosage forms was also examined. Discrepancies were identified as lack of one of the supplements or if an inappropriate dosage formulation was ordered. Of 133 admissions, 117 (88%) had a history of a malabsorptive procedure and at least one discrepancy was found. Only 33.3% of admissions were ordered a multivitamin, 5.1% were ordered supplemental vitamin B-12, and 7.7% received a calcium supplement. Additional folic acid was ordered in 11.1% and iron ordered in 12.0%. Inappropriate medication formulations were ordered in 61.5% of patients; 34.7% included non-immediate-release formulations, 25.0% enteric-coated formulations, and 40.3% both non-immediate-release and enteric-coated. Upon discharge from the institution, 50% had inappropriate formulations continued. Patients with a history of bariatric surgery may not have their vitamin and nutrient needs met upon hospitalization. Prior bariatric surgery is not consistently taken into consideration when ordering medications. Healthcare providers need to be cognizant of vitamin regimens to recommend as well as medication dosage formulations to avoid.

Differences between dietary supplement and prescription drug omega-3 fatty acid formulations: a legislative and regulatory perspective.

The medical management of many diseases and conditions can include either restriction or provision of specific essential nutrients. When such nutrients are needed, there are often both prescription and nonprescription products available, as in the case of nicotinic acid or omega-3 fatty acids. Although they may seem to contain similar ingredients, there may be important differences between the prescription and dietary-supplement preparations. The manufacturing of prescription pharmaceutical products is regulated by the US Food and Drug Administration (FDA), which mandates standards for consistency and quality assurance. Dietary supplements are available to consumers under the provisions of the Dietary Supplement Health and Education Act of 1994, for which the FDA has the burden of proving a dietary supplement is harmful rather than requiring the manufacturer prove that the supplement is safe. Consumers and medical professionals should be aware of the important qualitative and quantitative differences between the FDA-approved prescription formulations and dietary supplements, particularly when an essential nutrient is part of the medical management of a disease or condition.