Lisa Boothby

... Lisa Anne Boothby, PharmD,BCPS* Paul L. Doering, MS, FAPhA†, and Randy C. Hatton, PharmD, BCPS, FCCP‡ ... to be no compelling rea-son to have this product available in the hospital, the Pharmacy and Therapeu-tics (P&T) Committee reviewed the pol-icy to determine if ...

ABSTRACT Objective: To determine local pharmacists' willingness to recommend/allow the use of OTC ibuprofen when prescription-strength ibuprofen had been prescribed for symptomatic relief of rheumatoid arthritis, to examine the evidence-based medicine supporting the use of ibuprofen for rheumatoid arthritis treatment, and to determine the impact this evidence has for nonprescription ibuprofen drug labeling.

ABSTRACT Objective: To determine local pharmacists' willingness to recommend/allow the use of OTC ibuprofen when prescription-strength ibuprofen had been prescribed for symptomatic relief of rheumatoid arthritis, to examine the evidence-based medicine supporting the use of ibuprofen for rheumatoid arthritis treatment, and to determine the impact this evidence has for nonprescription ibuprofen drug labeling.

To review the drug therapy for the treatment of itching associated with intrahepatic cholestasis of pregnancy (ICP). A comprehensive literature search was conducted in MEDLINE (1966-July 2002) using the following MeSH terms: pregnancy, itching, intrahepatic cholestasis, cholestyramine, ursodeoxycholic acid, and phenobarbital. Current Contents (1966-July 2002), International Pharmaceutical Abstracts (1970-June 2002), and Cochrane Database were also searched using those terms. Web of Science search was used to search references found in articles. Eight clinical trials and several observational studies were identified evaluating the safety and efficacy of ursodeoxycholic acid (UDCA) in the treatment of ICP. Although these studies were small and inconsistent, improvement in maternal and fetal morbidity was demonstrated. Observational studies suggest that cholestyramine may be associated with improved maternal morbidity without a documented improvement in fetal outcome. Two observational studies evaluated the efficacy of phenobarbital for ICP treatment. Phenobarbital use was not associated with improved maternal or fetal morbidity/mortality. Data from large, well-designed, randomized, controlled trials of treatment of ICP are lacking. Data that are available support the use of UDCA as a first-line agent and cholestyramine as a second-line agent for treatment of ICP. There is little evidence to recommend phenobarbital in the treatment of itching associated with that condition.

To review the drug therapy for the treatment of itching associated with intrahepatic cholestasis of pregnancy (ICP). A comprehensive literature search was conducted in MEDLINE (1966-July 2002) using the following MeSH terms: pregnancy, itching, intrahepatic cholestasis, cholestyramine, ursodeoxycholic acid, and phenobarbital. Current Contents (1966-July 2002), International Pharmaceutical Abstracts (1970-June 2002), and Cochrane Database were also searched using those terms. Web of Science search was used to search references found in articles. Eight clinical trials and several observational studies were identified evaluating the safety and efficacy of ursodeoxycholic acid (UDCA) in the treatment of ICP. Although these studies were small and inconsistent, improvement in maternal and fetal morbidity was demonstrated. Observational studies suggest that cholestyramine may be associated with improved maternal morbidity without a documented improvement in fetal outcome. Two observational studies evaluated the efficacy of phenobarbital for ICP treatment. Phenobarbital use was not associated with improved maternal or fetal morbidity/mortality. Data from large, well-designed, randomized, controlled trials of treatment of ICP are lacking. Data that are available support the use of UDCA as a first-line agent and cholestyramine as a second-line agent for treatment of ICP. There is little evidence to recommend phenobarbital in the treatment of itching associated with that condition.

Although preventability criteria have been assessed for all adverse drug reactions (ADRs) investigated at our institution over the past 12 years, a systematic evaluation of the data had not been performed. This project analysed preventability data previously collected to identify the potential areas for process improvements. A 3-year retrospective analysis was performed. All ADRs were categorised by drug, drug class, severity, probability of causality and preventability. Factors involved in preventability were assessed and tallied. Descriptive statistics was used to analyse the data. Most ADRs occurred prior to admission. In the outpatient setting, anticoagulants and anticonvulsants were associated with more preventable ADRs (pADRs) than other drug classes, followed by cardiotonic agents and non-steroidal anti-inflammatory drugs (NSAIDs). For ADRs that occurred in hospitalised patients, antibiotics and opiates were associated with approximately half of all pADRs. The preventability categories most frequently associated with ADRs prior to admission were presence of a toxic drug level and drug–drug interactions, while inappropriate dose, route or frequency was the most common preventability category for inpatient ADRs. The majority of pADRs were moderate in severity in both the in- and outpatient settings. Drugs and drug classes involved in pADRs differ in the in- and outpatient settings. Preventability categories also differ by setting. Most pADRs occur prior to admission in our healthcare system. This presents a challenge in terms of implementing the process changes to reduce the pADRs, as patients in the community are outside our control.

To evaluate the literature on supplemental vitamin C and vitamin E therapy in the prevention and treatment of Alzheimer's disease (AD). Literature retrieval was accessed through MEDLINE (1966-March 2005) using the key words antioxidants, vitamin C, vitamin E, Alzheimer's disease, and dementia. International Pharmaceutical Abstracts (1970-March 2005), Current Contents (1996-March 2005), Cochrane Database of Systematic Reviews (1994-March 2005), and Ebsco's Academic Search Elite (1975-March 2005) were searched with the same key words. Articles related to the objective that were identified through PubMed were included. Oral supplementation of vitamin C (ascorbic acid) and vitamin E (D-alfa-tocopherol acetate) alone and in combination have been shown to decrease oxidative DNA damage in animal studies in vivo, in vitro, and in situ. Recent results of a prospective observational study (n = 4740) suggest that the combined use of vitamin E 400 IU daily and vitamin C 500 mg daily for at least 3 years was associated with the reduction of AD prevalence (OR 0.22; 95% CI 0.05 to 0.60) and incidence (HR 0.36; 95% CI 0.09 to 0.99). Contradicting this is a previous prospective observational study (n = 980) evaluating the relationship between 4 years of vitamin C and E intake and the incidence of AD, which detected no difference in the incidence of AD during the 4-year follow-up. Recent meta-analysis results suggest that doses of vitamin E > or =400 IU daily for more than one year are associated with increased all-cause mortality. Mega-trial results suggest that vitamin E doses > or =400 IU daily for 6.9 years in patients with preexisting vascular disease or diabetes mellitus increase the incidence of heart failure, with no other outcome benefits noted. In the absence of prospective, randomized, controlled clinical trials documenting benefits that outweigh recently documented morbidity and mortality risks, vitamin E supplements should not be recommended for primary or secondary prevention of AD. Although the risks of taking high doses of vitamin C are lower than those with vitamin E, the lack of consistent efficacy data for vitamin C in preventing or treating AD should discourage its routine use for this purpose.

The clinical issues surrounding the use of buprenorphine for the treatment of opioid dependence are reviewed. Opioids continue to be some of the most frequently reported prescription medications in substance abuse- related cases. A semisynthetic derivative of thebaine, buprenorphine hydrochloride is a partial mu-opioid receptor agonist and kappa-receptor antagonist with a long duration of action. The pharmacokinetic and pharmacodynamic profiles of buprenorphine are not well characterized. The ethical and legal issues associated with the maintenance treatment of opioid dependence are complex. Clinical trials have compared the efficacy of methadone, buprenorphine, and buprenorphine-naloxone for the detoxification and maintenance treatment of opioid dependence. Based on the available literature, it appears that buprenorphine, buprenorphine-naloxone, and methadone are similarly efficacious for the treatment of opioid-dependent patients. Buprenorphine-naloxone has less potential for abuse and diversion. The adverse-effect profiles for buprenorphine, buprenorphine-naloxone, and methadone are similar. Once-weekly office visits for patient evaluation and dispensing of buprenorphine seem feasible and convenient for both practitioners and patients. The three phases of opioid maintenance treatment are induction, stabilization, and maintenance. It is good practice for the admitting physician to consult with the patient's addiction treatment provider, when possible, to obtain the patient's treatment history. Buprenorphine is an attractive option for the pharmacologic treatment of opioid dependence. Compliance and adherence to buprenorphine therapy for opioid-dependent patients remain clinical issues. Future research efforts should focus on improving compliance and adherence to buprenorphine therapy.

Evidence-based medicine that is designed to guide benefit/risk drug therapy decisions does not exist for pregnant women. The types of studies that do exist are usually conducted in animals, which may not reflect human benefits and risks. The types of studies that do exist in humans are typically limited and, at best, may show an "association" between a particular drug therapy and an undesirable effect. This review outlines the difficulties that are associated with the assessment of the benefits/risks of drug therapy during pregnancy, the history of the Food and Drug Administration regulations for labeling prescription drugs, and the strengths and weaknesses of the current Food and Drug Administration pregnancy labeling system. Proposed changes to the current system are reviewed.

Attention-deficit/hyperactivity disorder is a highly diagnosed psychiatric disorder in children. This widespread and complex condition requires extensive evaluation involving clinicians, parents and teachers. Proper management involves individual assessment and treatment. Psychostimulants remain the primary medication of choice as they have been shown to be efficacious for this condition. Newer, long-acting medications are providing expanded options for children and their caregivers. Failure to assess and treat can lead to serious long-term effects later in life.

Both inpatient and outpatient treatment centers that focus solely on psychosocial therapies for the treatment of alcohol dependence have high relapse rates. Thus, extensive research has focused on the development of pharmacologic moieties to attenuate the craving for alcohol after acute alcohol detoxification. Three drug therapies are currently approved by the US Food and Drug Administration (FDA) for this purpose: disulfiram, naltrexone, and acamprosate. The latter was approved by the FDA in 2004. This article describes the pharmacologic properties and clinical usefulness of acamprosate for the treatment of alcohol dependence. Relevant information was identified through searches of MEDLINE (1966 to March 2005), International Pharmaceutical Abstracts (1970-2005), Current Contents (1996-2005), and Cumulative Index to Nursing and Allied Health Literature (1982-Week 2, 2004) using the key words acamprosate, alcohol dependence, and alcoholism (MeSH). Acamprosate limited to randomized, controlled clinical trials yielded 33 hits in MEDLINE. Twenty-two articles were reviewed for efficacy end points, and 10 were reviewed for pharmacology and pharmacokinetics data. Acamprosate plus pharmacokinetics and pharmacodynamics yielded 19 hits, some of which were duplicates from the previously described search. Acamprosate plus meta-analysis (MeSH) yielded 5 hits, naltrexone plus meta-analysis (MeSH) yielded 9 hits, and disulfiram plus meta-analysis yielded 3 hits. The most recent review articles and their reference lists were assessed to ensure completeness of literature searches. Based on these searches, acamprosate is known to be an analogue of taurine and gamma-aminobutyric acid (GABA), 2 central nervous system neuromodulators. Acamprosate is thought to share some of the cellular actions of taurine affecting GABA and glutaminergic receptors in the nucleus accumbens, a brain region that may be responsible for the reinforcing effects received after alcohol consumption. Acamprosate is thought to also suppress excitation-induced calcium entry that results from chronic alcohol exposure, thereby altering the conformation of the N-methyl-d-aspartate receptors. The percentage of patients taking acamprosate who were completely abstinent throughout the different durations of the studies varied from approximately 18% to 61%, compared with 4% to 45% with placebo. Diarrhea was the most common adverse effect accompanying acamprosate therapy, and this was generally described as dose related and transient. Acamprosate is associated with modest treatment effects. Its efficacy is similar to naltrexone, and the combination of acamprosate and naltrexone appears to be more efficacious than acamprosate alone, when combined with psychosocial interventions.

In the practice of 'bioidentical hormone therapy', it is our belief that pharmacists are compounding bioidentical hormone therapy with the best intentions. These pharmacists are, however, ill informed regarding the lack of scientific underpinning associated with the efficacy and safety of the practice of bioidentical hormone therapy. It is the purpose of this review to systematically examine the scientific rigor of the arguments posed by the proponents of bioidentical hormone therapy, and to differentiate the practice of bioidentical hormone therapy from the legitimate practice of pharmacy compounding. Most medical organizations have in essence refuted the bioidentical hormone therapy claims as unsubstantiated. The profession of pharmacy needs to address this issue in an authoritarian, scientific way, outside of the compounding issue. Bioidentical or natural hormones are expected to have similar efficacy and safety profiles as the commercially available hormonal therapies that have been studied in clinical trials, regardless of whether the active principle hormones are compounded by individual pharmacies or manufactured by large companies. Estriol is a weak estrogen that is not Food and Drug Administration approved for use as a prescription drug in the United States; thus, clinical trials are necessary to demonstrate the efficacy and safety profile for estriol. Further, supplementary clinical trials are necessary to determine whether there are efficacy or safety differences between natural progesterone and synthetic progestin, as studies to date are inconclusive.