Fulfilling an Unmet Need: Roles for Clinical Pharmacists in Preconception Care.

Preconception care refers to a set of interventions that identify and address biomedical, behavioral, and social risks to a woman's health that may negatively impact a future pregnancy. A great need for preconception care currently exists in the United States, and women's attitudes about discussions with health care providers about healthy and safe pregnancies are positive. Clinical pharmacists are well positioned to work with other health care and public health professionals to ensure that all women of childbearing potential have access to preconception care. As part of the collaborative health care team, clinical pharmacists can directly provide services or support and referrals to other members of the health care team or to community resources through clinical-community linkages. Specifically, clinical pharmacists can provide education, counseling, and/or services to women to address family planning, medication and disease state management, immunizations, screenings, health promotion, and substance use. Clinical pharmacists can also impact preconception care through drug information services, advocacy, and research. Preconception care services can be incorporated into daily pharmacy practice, and there are potential means for reimbursement. Multiple roles exist for clinical pharmacists to fulfill unmet needs in preconception care.

Effectiveness of a computerized drug-monitoring program to detect and prevent adverse drug events and medication non-adherence in outpatient ambulatory care: study protocol of a randomized controlled trial.

BACKGROUND: Medications are an effective intervention for managing and preventing health problems but their benefit can be undermined by non-adherence or adverse drug events (ADEs). Since these issues may be interconnected, efforts to improve non-adherence should also include reduction of ADEs. We have developed the ISTOP-ADE system (Information Systems-enabled Outreach for Preventing Adverse Drug Events), which enables timely monitoring and managing of ADEs. The objectives of this study are to determine whether the ISTOP-ADE system, compared to routine care, will reduce: a) the probability of discontinuing the use of prognosis-altering medications; b) the probability of a patient experiencing a severe ADE; c) the proportion of patients experiencing ADEs, preventable ADEs and ameliorable ADEs; and d) health services utilization. METHODS/DESIGN: We will randomly assign 2,200 adult ambulatory patients in the province of Québec who have been prescribed an incident medication for the management or prevention of a chronic health condition, to routine care or the ISTOP-ADE system. The ISTOP-ADE system consists of an interactive voice response system (IVRS) paired with pharmacist support. The IVRS will call patients at 3 and 17 days post-prescription to determine if they are experiencing any problems and connect them with a pharmacist when required or desired by the patient. We will evaluate medication persistence at 180 days and health-care utilization using provincial administrative data. Two blinded physicians will ascertain ADE status through a case review. DISCUSSION: We expect the ISTOP-ADE intervention to be feasible and to improve the quality of patient care through improved medication adherence, reduced ADE duration and reduced number of ADEs resulting in an emergency department or inpatient encounter. This in turn could lower health-care utilization, saving costs and lowering the burden on emergency departments and family practices. The success of ISTOP-ADE would present opportunities to implement this intervention through health systems, health insurance agents and commercial pharmacies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02059044. Date registered: 10 January 2014.

Intended and unintended consequences of the gabapentin off-label marketing lawsuit among patients with bipolar disorder.

OBJECTIVE: The number of lawsuits accusing pharmaceutical companies of off-label marketing has risen in recent years. The impact of such lawsuits on drug prescribing and spending has not been examined. We evaluated a nationwide sample to determine whether the $430 million gabapentin off-label marketing lawsuit and accompanying media coverage affected gabapentin market share, substitution of other scientifically substantiated and unsubstantiated anticonvulsants, and anticonvulsant spending of Medicare/Medicaid patients diagnosed with bipolar disorder. METHOD: Using a national 5% sample of Medicare recipients linked to Medicaid claims, we used an interrupted times series design to evaluate the impact of the lawsuit on monthly market share, utilization, and spending from January 1, 2001, to December 31, 2005. RESULTS: The start of the lawsuit was associated with a 28% relative reduction in gabapentin market share (from ∼ 21% to ∼ 15%) and a reduction in the rate of prescribing from 108 prescriptions per 1,000 patients per month before the start of the lawsuit to 90 by the end of follow-up (P < .001). We also observed increases in market share for 3 other anticonvulsants. Total anticonvulsant use and spending per 1,000 patients increased by 13% and 74%, respectively, after the intervention. The increase in anticonvulsant spending was equivalent to $7,554 per 1,000 patients per year higher than expected compared with the baseline trend (P = .01). CONCLUSIONS: We conclude that the lawsuit resulted in a reduction in gabapentin market share, increased market share for other anticonvulsants, and substantially increased total anticonvulsant spending to approximately half of the settlement amount, not counting substitutions of newer drugs for other illnesses affected by the lawsuit. These findings support the need for further study of the effects of current lawsuits regarding off-label drug marketing.

Funding for teratology information services: up, down, and all around.

Funding for Teratology Information Services has been an ongoing struggle over the 25 years of its existence. Traditional and novel funding mechanisms have been explored with varying success. The importance of providing teratology risk assessment and counseling to all women of reproductive age is now an established health care objective. Sufficient and stable funding for these services is essential.

Multifaceted determinants of online non-prescription drug information seeking and the impact on consumers' use of purchase channels.

The growing importance of the Internet as an information and purchasing channel is drawing widespread attention from marketing decision makers. Nevertheless, the relevance of the Internet to the so-called self-medication market in Germany has been paid barely enough attention. Our study aims to contribute insights concerning the penetration of the Internet in this market, as well as to give an overview of the critical determinants of Internet use for non-prescription drug information seeking, such as the accessibility of professional information, trust in health professionals' opinion and the ability to search online, as well as the perceived usefulness and credibility of online non-prescription drug information. Furthermore, we demonstrate that the preferred use of the Internet as a non-prescription drug information source positively influences the choice of unconventional purchase channels for non-prescription drugs and negatively affects the use of stationary pharmacies.

A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis.

BACKGROUND: Medication errors are common in primary care and are associated with considerable risk of patient harm. We tested whether a pharmacist-led, information technology-based intervention was more effective than simple feedback in reducing the number of patients at risk of measures related to hazardous prescribing and inadequate blood-test monitoring of medicines 6 months after the intervention. METHODS: In this pragmatic, cluster randomised trial general practices in the UK were stratified by research site and list size, and randomly assigned by a web-based randomisation service in block sizes of two or four to one of two groups. The practices were allocated to either computer-generated simple feedback for at-risk patients (control) or a pharmacist-led information technology intervention (PINCER), composed of feedback, educational outreach, and dedicated support. The allocation was masked to researchers and statisticians involved in processing and analysing the data. The allocation was not masked to general practices, pharmacists, patients, or researchers who visited practices to extract data. [corrected]. Primary outcomes were the proportions of patients at 6 months after the intervention who had had any of three clinically important errors: non-selective non-steroidal anti-inflammatory drugs (NSAIDs) prescribed to those with a history of peptic ulcer without co-prescription of a proton-pump inhibitor; ß blockers prescribed to those with a history of asthma; long-term prescription of angiotensin converting enzyme (ACE) inhibitor or loop diuretics to those 75 years or older without assessment of urea and electrolytes in the preceding 15 months. The cost per error avoided was estimated by incremental cost-effectiveness analysis. This study is registered with Controlled-Trials.com, number ISRCTN21785299. FINDINGS: 72 general practices with a combined list size of 480,942 patients were randomised. At 6 months' follow-up, patients in the PINCER group were significantly less likely to have been prescribed a non-selective NSAID if they had a history of peptic ulcer without gastroprotection (OR 0·58, 95% CI 0·38-0·89); a ß blocker if they had asthma (0·73, 0·58-0·91); or an ACE inhibitor or loop diuretic without appropriate monitoring (0·51, 0·34-0·78). PINCER has a 95% probability of being cost effective if the decision-maker's ceiling willingness to pay reaches £75 per error avoided at 6 months. INTERPRETATION: The PINCER intervention is an effective method for reducing a range of medication errors in general practices with computerised clinical records. FUNDING: Patient Safety Research Portfolio, Department of Health, England.

Attention-deficit hyperactivity disorder, drug companies and the internet.

This study investigated the influence of drug-company funding on websites about attention-deficit hyperactivity disorder (ADHD). Websites in the top 60 for either Google or Yahoo!Xtra with information about causation and treatment were analysed. Likert scales, based on those used in previous similar studies, were developed to rate aetiological explanations and recommended treatment approaches, on a dimension from psycho-social to biological. Overall, the quality of information on websites was poor with a strong bias towards bio-genetic aetiological explanations of ADHD. Twenty-one of the 57 websites (37%) were funded by drug companies. The drug-company funded (DCF) websites were significantly more likely than non-DCF websites to recommend medication rather than psycho-social treatments. The selective lack of consideration of psycho-social treatments by DCF websites is discussed in relation to the relevant research literature, including the evidence in favour of a multimodal approach. The findings, which are consistent with previous similar studies in relation to websites about adult mental health problems, confirm that the pharmaceutical industry is seeking to influence public opinion via the internet.

Drug safety in pregnancy: utopia or achievable prospect? Risk information, risk research and advocacy in Teratology Information Services.

Even though from preclinical testing to drug risk labeling, the situation with drugs in pregnancy has improved substantially since the thalidomide scandal, there is still an increasing need to provide healthcare professionals and patients with updated individualized risk information for clinical decision making. For the majority of drugs, clinical experience is still insufficient with respect to their safety in pregnancy. There is often uncertainty in how to interpret the available scientific data. Based on 20 years of experience with Teratology Information Services (TIS) cooperating in the European Network of Teratology Information Services (ENTIS) methods of risk interpretation, follow-up of exposed pregnancies through the consultation process and their evaluation is discussed. Vitamin K antagonists, isotretinoin and angiotensin (AT) II-receptor-antagonists are presented as examples of misinterpretation of drug risks and subjects of research based on observational clinical data recorded in TIS. As many TIS are poorly funded, advocacy is necessary by establishing contacts with decision makers in health politics and administration, informing them of the high return in terms of health outcomes and cost savings provided by TIS as reference institutions in clinical teratology.

[Clinical evaluation of drug information provided by the pharmacists in the intensive care unit].

Pharmacists working in the intensive care unit (ICU) in Saiseikai Yokohamashi Tobu Hospital are mainly responsible for managing the stock of drugs, providing drug information to other medical staff, educating them for rational drug therapy, and providing pharmaceutical care to the patients. In order to evaluate the contribution to the rational drug therapy, we investigated the acceptance rate of the drug information that the pharmacists in the ICU provided to the physicians from February to May in 2009. The number of cases in which drug information was provided by the pharmacists to the physicians during the period was 288. It was suggested that more than half of the information could optimize the drug dosage regimens and correct the inadequate prescriptions. Furthermore, 98.9% of the information provided by pharmacists was accepted by physicians. We questioned 5 intensivists to evaluate the information with a 5 point scale (maximum score was 4, minimum score was 0) and then the average of score was 3.3. In addition, their evaluation of the information about optimizing the drug dosage regimens marked the highest point (over 3.5). Meanwhile, providing drug information which led the physicians to correct the inadequate prescriptions contributed to reduce the cost of the drug therapy by 900000 yen during the period. As a result, it was suggested that the intensivists highly appreciated the information offered by the pharmacists and the information contributed to enhance high-quality drug therapy. Additionally, the economic impact was identified through the cost reduction in drug therapy.

Protocol for the PINCER trial: a cluster randomised trial comparing the effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices.

BACKGROUND: Medication errors are an important cause of morbidity and mortality in primary care. The aims of this study are to determine the effectiveness, cost effectiveness and acceptability of a pharmacist-led information-technology-based complex intervention compared with simple feedback in reducing proportions of patients at risk from potentially hazardous prescribing and medicines management in general (family) practice. METHODS: RESEARCH SUBJECT GROUP: "At-risk" patients registered with computerised general practices in two geographical regions in England. DESIGN: Parallel group pragmatic cluster randomised trial. INTERVENTIONS: Practices will be randomised to either: (i) Computer-generated feedback; or (ii) Pharmacist-led intervention comprising of computer-generated feedback, educational outreach and dedicated support. PRIMARY OUTCOME MEASURES: The proportion of patients in each practice at six and 12 months post intervention: - with a computer-recorded history of peptic ulcer being prescribed non-selective non-steroidal anti-inflammatory drugs; - with a computer-recorded diagnosis of asthma being prescribed beta-blockers; - aged 75 years and older receiving long-term prescriptions for angiotensin converting enzyme inhibitors or loop diuretics without a recorded assessment of renal function and electrolytes in the preceding 15 months. SECONDARY OUTCOME MEASURES; These relate to a number of other examples of potentially hazardous prescribing and medicines management. ECONOMIC ANALYSIS: An economic evaluation will be done of the cost per error avoided, from the perspective of the UK National Health Service (NHS), comparing the pharmacist-led intervention with simple feedback. QUALITATIVE ANALYSIS: A qualitative study will be conducted to explore the views and experiences of health care professionals and NHS managers concerning the interventions, and investigate possible reasons why the interventions prove effective, or conversely prove ineffective. SAMPLE SIZE: 34 practices in each of the two treatment arms would provide at least 80% power (two-tailed alpha of 0.05) to demonstrate a 50% reduction in error rates for each of the three primary outcome measures in the pharmacist-led intervention arm compared with a 11% reduction in the simple feedback arm. DISCUSSION: At the time of submission of this article, 72 general practices have been recruited (36 in each arm of the trial) and the interventions have been delivered. Analysis has not yet been undertaken.

An assessment of direct-to-consumer advertising of prescription drugs.

Advertising is widely seen by economists and regulators as beneficial to markets and consumers. The prescription drug market offers exceptional opportunities for direct-to-consumer advertising (DTCA) to provide new-product information, improve compliance, alleviate widespread underdiagnosis and undertreatment, and motivate new-product development.5 DTCA can also induce excess or even dangerous prescribing, however, partly because patients are poorly informed and usually pay far less than the full cost of drugs. Empirical research can help resolve these issues.