Journal of Pharmacy Practice

Osteoporosis is a leading cause of debility and declining quality of life in postmenopausal women worldwide. Treatment of osteoporosis has been ubiquitous throughout the developed world since the mid-1990s, most notably with the introduction of bisphosphonates in 1995. Nonetheless, the incidence of hip fractures increased by 25% between 1990 and 2000, despite advances in osteoporosis therapy. Studies indicate that bone density increases over the first 3 years of bisphosphonate therapy and then plateaus or perhaps even declines, placing these patients at greater risk of fracture. Since hip fractures are associated with increased morbidity, mortality, and increased cost of health care, improvements in treating osteoporosis are critical. Denosumab is a novel monoclonal antibody targeted against the receptor activator of nuclear factor-κB ligand (RANKL) that inhibits osteoclast activity. Initial data suggest that denosumab increases bone mineral density for greater than 3 years. Of greater importance, denosumab has been shown to decrease vertebral fractures by 68%, nonvertebral fractures by 19%, and hip fractures by 42% for at least 36 months. Data also indicate that the safety profile of denosumab is equivalent to other drugs used in osteoporosis management, but potential risks of immunosuppression and cancer have been hypothesized.

Triple negative breast cancer (TNBC), an aggressive variant of breast cancer, is characterized by lack of expression of the estrogen (ER) and progesterone receptors (PRs) and the human epidermal growth factor receptor (HER-2) that are commonly observed in other breast cancer subtypes. The TNBC subtype primarily occurs in younger women of African American or Hispanic descent and tumors tend to be high grade and initially responsive to chemotherapy. However, TNBC is characteristically aggressive with high recurrence, metastatic, and mortality rates. Treatment options are limited since the hormonal receptor and HER-2 antagonists typically used for other breast cancers are ineffective. As such, the mainstay of treatment of TNBC is traditional systemic cytotoxic chemotherapy. Potential future therapies for TNBC include targeted molecular strategies including poly (adenosine diphosphate ribose) polymerase (PARP) and epidermal growth factor receptor (EGFR) inhibitors and antiangiogenic agents. Further research aimed at identifying unique genetic characteristics of TNBC may allow development of other targeted molecular chemotherapy treatment options.

The perceptions of menopausal hormone therapy (MHT) have evolved considerably. Observational studies suggested that MHT could relieve vasomotor symptoms and prevent coronary heart disease (CHD). However, randomized controlled trials later showed no reduction in CHD and an increased risk of stroke. Subsequent analyses of these trials have shown that in women younger and closer to menopause, the risks associated with MHT may not be as great as originally thought. Several organizations, including the North American Menopause Society, the International Menopause Society, and the Endocrine Society, have published guidelines and statements that help health care providers translate the research findings into clinical practice. A common theme from these organizations is the need for health care providers to tailor information to their patients so they may make informed treatment decisions (especially considering the media attention MHT has received). It is particularly important to individualize therapy, considering patients’ risk factors for atherosclerotic disease, venous thromboembolic disease, osteoporosis, and breast cancer. Ongoing research in women younger than those in prior trials is evaluating lower doses of MHT and directly comparing transdermal and oral formulations. Such research should help define the population of women most likely to benefit from MHT without undue risk of adverse outcomes.

Maximizing bone mass in youth is touted as the best strategy to offset the natural losses of aging and the menopausal transition. Not achieving maximum peak bone mineral density (BMD) is an independent risk factor for osteoporosis and thus a public health concern. Adolescence is a critical time of bone mineralization mediated by endogenous estradiol. Research has shown that the highest velocity of bone mass accrual occurs 1 year before menarche and after the first 3 years. Low-peak attainment of BMD in young women is associated with contributing factors such as diets low in calcium, eating disorders, lack of exercise, smoking, and low estrogen states. Oral contraceptives (OCs) suppress endogenous estradiol production by suppressing the hypothalamic–pituitary–ovarian axis. Thus, OCs, by replacing endogenous estradiol with ethinyl estradiol (EE), establish and maintain new hormone levels. The early initiation and the use of very low dose of EE raises the possibility that bone mass accrual at a critical time of bone mineralization in young women or adolescents may be jeopardized. This review examines the studies of BMD in adolescents and young women that use combination hormonal contraception. Some studies had inherent limitations, such as small trial, poor control of confounders, failure to exclude women with prior use of hormonal contraceptives, or prior pregnancy from control groups. The vast majority of reviewed studies showed OCs containing 20 to 30 µg of EE interfere with acquisition of peak BMD. Limited numbers of studies examine the effects of OCs containing 35 µg on adolescents and young adults. Additionally, studies are needed evaluating the progestin component of OCs as their differing androgenic properties may affect bone mineralization as well.

When drug therapy is necessary and cannot be avoided during a pregnancy, the decision of what drug therapy is best may be difficult for the health care provider because the vast majority of drugs are classified as Pregnancy Category C. This classification indicates that information regarding the risk to the fetus is unknown. For ethical reasons, pregnant women are not included in drug studies, so most decisions regarding the safety of a particular drug are based on animal studies, available cases reports, or are theoretical and are based on pharmacokinetic properties. Fortunately, with the development of Pregnancy Registries, more information has been collected, analyzed, and is available regarding the safety of drugs during pregnancy. These registries have expanded in recent years allowing better determination of fetal safety for triptans and antiepileptic drugs (AEDs). The information assists health care providers in selecting optimal therapy for women seeking pregnancy or those already pregnant. This review presents the most recent information for the treatment and prophylaxis of migraines and seizures during pregnancy.

One of the most difficult challenges health care providers encounter is drug selection for pregnant patients. Drug selection can be complex as efficacy and maternal side effects must be weighed against potential risk to the embryo or fetus. Verification of an individual drug’s fetal safety is limited as most evidence is deduced from epidemiologic, prospective cohort, or case–control studies. Medication selection for the pregnant inpatient is a particularly complex task as the illnesses and conditions that require hospitalization mandate different medications, and the risk versus benefit ratio can vary significantly compared to the outpatient setting. Some degree of acute pain is not uncommon among inpatients. Acetaminophen is generally considered the drug of choice in pregnancy for mild to moderate acute pain, while most opioids are thought to be safe for short-term use to manage moderate to severe pain. Providing sedation is particularly challenging as the few options available for the general population are further limited by either known increased risk of congenital malformations or very limited human pregnancy data. Propofol is the only agent recommended for continuous sedation, which has a Food and Drug Administration classification as a pregnancy category B medication. Treatment of infections in hospitalized patients requires balancing the microbiology profile against the fetal risk. Older antimicrobials proven generally safe include beta-lactams, and those with proven fetal risks include tetracyclines. However, little to no information regarding gestational use is available on the newer antimicrobials that are frequently employed to treat resistant infections more commonly found in the inpatient setting. Management of maternal blood pressure is based on the severity of blood pressure elevations and not the hypertensive classification. Agents generally considered safe to use in hypertensive pregnant patients include methyldopa, labetolol, and hydralazine, while angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, hydrochlorothiazide, and atenolol should be avoided.

Objective: The present study was taken up to assess the prevalence of the metabolic syndrome in schizophrenic patients receiving second-generation antipsychotic agents and to determine the most sensitive and specific clinical parameters used for screening of metabolic syndrome in these patients. Materials and Methods: The present study was taken up in a tertiary care hospital. Eighty patients diagnosed with schizophrenia and receiving a single second-generation antipsychotic for 3 months or more were enrolled in the study after obtaining written informed consent. Patients were screened for metabolic syndrome using American Heart Association and National, Heart, Lung and Blood Institute (AHA NHLBI)-modified National Cholesterol Education Program, Adult Treatment Panel III (NCEP ATP III) criteria. Results: Prevalence of metabolic syndrome was found to be 35%. The clinical parameter with highest sensitivity for screening of metabolic syndrome is low-serum high-density lipoprotein cholesterol with a sensitivity of 89.28%. Elevated fasting blood glucose and increased waist circumference were found to have highest and equal specificity of 90.38%. Conclusion: There is a high prevalence of the metabolic syndrome in patients with schizophrenic patients receiving second-generation antipsychotic agents. Increasing awareness of this fact among psychiatrists will help to prevent, detect, and treat this condition that is associated with considerable morbidity and mortality.

This study aimed to determine the availability and usage of printed and electronic references and Patient Medication Record in community pharmacy. It was conducted for over 3 months from 15 January to 30 April 2007. Ninety-three pharmacies participated. Structured questionnaires were mailed to community pharmacies. Six weeks later a reminder was sent to all non responders, who were given another six weeks to return the completed questionnaire. Outcomes were analyzed using descriptive statistics and chi-square test of independence. Almost all the pharmacies (96.8%) have at least Monthly Index of Medical Specialties (MIMS) while 78.5% have at least MIMS ANNUAL in their stores. Only about a third (31.2%) of the pharmacies were equipped with online facilities of which the majority referred to medical websites (88.9%) with only a minority (11.1%) referring to electronic journals. More than half (59.1%) of the pharmacists kept Patient Medication Record profiles with 49.1% storing it in paper, 41.8% electronically and 9.1% in both printed and electronic versions. In general, prevalence and usage of electronic references in community pharmacies were rather low. Efforts should be increased to encourage wider usage of electronic references and Patient Medication Records in community pharmacies to facilitate pharmaceutical care.

Purpose: The objective of this project was to determine the amount and type of clinical skills and diabetes education provided by recent pharmacy school graduates. Methods: Six hundred and one graduates were e-mailed a link to an online survey. Subjects were asked to report how frequently they either educate patients on diabetes self-care activities or perform diabetes-related patient care skills and to rate their ability to do so as poor, fair, good, or excellent. Results: Data from 155 (25.8%) respondents were analyzed. The most commonly reported clinical activity was changing medication, followed by interpreting blood glucose patterns, medication management therapy, and interpreting laboratory results. Subjects reported educating patients more on the signs and symptoms of hypoglycemia, blood glucose monitoring, and diet information relative to other topics. The majority of subjects rated their skills as good or excellent. Conclusion: Pharmacists reported the most commonly performed diabetes-related clinical skill was changing medication and they most often educate patients about hypoglycemia and blood glucose monitoring. Subjects, who rated themselves poor/fair in these skills, preferred active learning strategies to enhance their ability.

Gemcitabine, alone or in combination with a platinum-based agent, is indicated for the first-line treatment of patients with locally advanced or metastatic non–small-cell lung cancer. It is generally a well-tolerated drug. Despite its lack of significant toxicity, the most commonly reported side effects include myelosuppression, gastrointestinal disturbances (eg, nausea and vomiting), influenza-like symptoms, skin rash with pruritus, and elevation of liver transaminase enzymes. Peripheral edema has rarely been described as an adverse effect. Herein, we report a patient with advanced non–small-cell lung cancer who experienced severe peripheral edema after gemcitabine administration. Immediate gemcitabine discontinuation and the administration of diuretics resulted in definite regression of peripheral edema.

Purpose: Gastrointestinal (GI) adverse effects have been reported with oral bisphosphonate formulations and are the primary adverse effects influencing their tolerability. New intermittent formulations, including intravenous (IV) ibandronate, may increase compliance and decrease the rate of GI adverse effects. We describe a 67-year-old woman with a 2-day history of hematemesis and melena 1 week after administration of IV ibandronate. Summary: The patient was initially stable but began to develop a small bowel obstruction for which a nasogastric (NG) tube was placed. During placement of the NG tube, the patient vomited and aspirated. Due to continued nausea and vomiting with the NG tube and shortness of breath, the patient was intubated and an orogastric tube was placed. Despite the use of a ventilator, the patient’s blood pressure and oxygen saturation began to fall. Even with the use of mechanical ventilation and 3 pressors, her condition deteriorated, she was made DNR/DNI (do not resuscitate or intubate) and subsequently expired. The Naranjo adverse drug reaction score was 2, indicating a possible association between GI bleed and IV ibandronate. The exact mechanism of this is not known. Conclusion: Clinicians should be aware of this possible adverse effect and monitor high-risk patients for bleeding when administering IV bisphosphonates.