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Written patient information on prescription drugs. The evolution of government and voluntary programs in the United States.

This paper describes the evolution of written patient information on prescription drugs, FDA's patient package insert proposal and its revocation before its implementation in the early 1980s, the status of voluntary and government efforts since that time, and a review of current trends in this area. The burgeoning practice of direct-to-consumer advertising of prescription drugs in the lay press is viewed within the context of these efforts. This paper also reviews the current developments in certain FDA-regulated consumer products--over-the-counter drug labeling and nutrition labeling. The current state of patient information in the United States is reviewed in light of programs to improve prescription drug counseling, and current research in this area is discussed.

Consumer Advocacy↗

A prescription and administration error of cisplatin: a case report.

Automated prescribing has been reported to reduce medication errors from 80% to 50%. However, we report a medication error involving both physicians and pharmacists, as a result of the characteristics of the specific prescription software. Thus, a patient treated for an oesophagus carcinoma was administered 760 mg cisplatin instead of 190 mg intravenously. Consequences for the patient included pancytopenia and renal failure requiring hemodialysis. The medication error was identified as wrong prescription copying by a junior prescriber and the prescription was validated by mistake by the pharmacist in charge of dispensing.

Aged↗

Efficacy of prescription-eligible digital health applications for depression and generalized anxiety disorder in Germany: a systematic review and meta-analysis.

In Germany, prescription-eligible digital mental health applications (DiGA) were introduced in 2020 as promising interventions to address, among others, depression and anxiety disorders, two of the most prevalent mental health conditions worldwide. Despite growing interest in DiGAs, their overall efficacy remains uncertain. This study aimed to systematically evaluate and quantify the efficacy of prescription-eligible digital interventions for depression and generalized anxiety disorder by synthesizing evidence from randomized controlled trials (19 trials; total N = 4,078; pooled mean age = 38.7 years, SD = 12.1). Here we show that prescription-eligible digital applications for depression and generalized anxiety disorder reduce symptom severity compared with control conditions. For depression, effects were observed both immediately after the intervention (number of apps = 5; k = 17; SMD = - 0.49; 95% CI - 0.65 to - 0.32) and at follow-up (number of apps = 1; k = 4; SMD = - 0.35; 95% CI - 0.46 to - 0.29), while evidence for generalized anxiety disorder was limited due to a small number of available studies (number of studies = 2). These findings support the integration of evidence-based digital tools into mental health treatment strategies in Germany. However, the available evidence is currently dominated by a small number of applications, particularly Deprexis, and should therefore not be interpreted as equally representative of all DiGAs currently listed for depression in Germany. The findings also highlight methodological limitations of current research and underscore the need for real-world evaluations, which address not only efficacy but also the effectiveness, content, quality and implementation.

Generalized Anxiety Disorder↗

Ramp length/grade prescriptions for wheelchair dependent individuals.

The aim of this work was to provide well defined criteria for ramp construction for wheelchair dependent individuals (WDI). Force capability was measured in a large sample (140) of WDI, who presented different levels of motor impairment. Levels of impairment were established on the basis of the answers given in a questionnaire regarding the degree of self sufficiency at home as well as outside the home and active participation in sports events. Taking into account those WDI who exhibited at least a minimal level of self-sufficiency, the following prescriptions are indicated. For a 1 metre ramp length, allowable maximal incline 15%; up to 3 metre ramp length, maximal incline 10%. The reliability of such prescriptions was confirmed by having a test ramp traversed by 43 WDI. These values are suggested as confidence limits when faced with public building accommodations. Special prescriptions could be adopted for selected populations of WDI.

Architectural Accessibility↗

Safety profile of orlistat: results of a prescription-event monitoring study.

INTRODUCTION: Orlistat, the first of a new class of drugs for the treatment of obesity, was launched in the UK in December 1998. The prescribing information recommends that treatment with orlistat should be discontinued after 12 weeks if the patient has not achieved a specified loss of weight. OBJECTIVE: To monitor the safety of orlistat prescribed in the primary care setting in England using prescription-event monitoring (PEM). METHODS: A postmarketing surveillance study using the observational cohort technique of PEM. Patients were identified from dispensed prescriptions issued by primary care physicians for orlistat between December 1998 and November 1999. The outcome data were event reports obtained by sending questionnaires (green forms) to the prescribing doctor at least 6 months after the first prescription for an individual patient. Incidence densities, expressed as number of first reports of an event/1000 patient-months of exposure, were calculated. Significant differences between incidence densities (IDs) for events reported in the 1st month (ID(1)) and months 2 and 3 (ID(2-3)) of exposure were regarded as potential signals. Reasons for stopping orlistat were analysed. Follow-up information was requested for selected events and used to assess the causal association with orlistat. RESULTS: Green forms containing clinically useful information on 16 021 patients (median age 45 years (interquartile range 35-54); 80.1% females) were received. The events reported most frequently during the 1st month of treatment were 'not effective' (639; 4.0% of cohort), diarrhoea (371; 2.3%) and weight loss (230; 1.4%). Twelve clinical adverse events were identified for which ID(1) was significantly greater than ID(2-3). These included non-specific events (e.g. intolerance, malaise/lassitude, unspecified side effects), weight loss and vaginitis/vulvitis. The remaining events were gastrointestinal in nature and included diarrhoea, pain abdomen, flatulence, nausea/vomiting, rectal discharge, faecal incontinence and 'gastrointestinal unspecified' events. A similar pattern of predominately gastrointestinal events was seen for reasons for stopping and suspected adverse drug reactions. Review of selected events for causality revealed 45 events which were assessed as possibly or probably related to orlistat. CONCLUSIONS: This study shows that orlistat is fairly well tolerated. The safety profile of orlistat was similar to the prescribing information and experience reported in the literature.

Adult↗

A therapeutic trial of growth hormone in hypopituitary adults and its influence upon continued prescription by general practitioners.

OBJECTIVES: Adult GH deficiency (GHD) is associated with profound alterations in body composition, lipid profiles and quality of life which frequently improve after GH therapy. However, the beneficial effects of treatment are not derived by all and consequently some scepticism persists with regard to the use of GH therapy in adults. We assessed whether a 3-month therapeutic assessment with GH therapy could be used to determine which GHD adults should be treated over the longer term. We also assessed the continued prescription of GH by general practitioners (GPs) following the initial therapeutic assessment. DESIGN: A three month open therapeutic trial of GH in GHD adults. Patients were treated with GH at an initial dose of 0.01 iU/kg/d, increased after 1 month to 0.015 iU/kg/d for males and 0.02 iU/kg/d for females. After completion of the three months the continued prescription of GH by the GPs was assessed. PATIENTS: All adult GHD patients were considered for GH therapy. Thirty-nine GHD adults wanted GH therapy (group 1) and their baseline characteristics such as age, duration of GHD, and IGF-1 concentration were compared with 24 subjects who declined to receive GH (group 2). MEASUREMENTS: Measurements of body composition using bioelectrical impedance analysis, lipids and quality of life measured using a dedicated questionnaire were made before and after GH therapy. The response of the general practitioners to continued GH therapy after the initial therapeutic assessment was also noted. RESULTS: Compared with subjects who declined GH therapy (group 2), subjects of group 1 were younger (46.4 +/- 14.4 vs. 54.2 +/- 15.7 years, P < 0.05) and had lower peak GH responses to provocative testing (1.4 +/- 2.1 vs. 2.9 +/- 2.7 mU/l, P < 0.001), though there were no differences between IGF-1 concentration (11.7 +/- 6.2 vs. 14. 2 +/- 7.9 nmol/l). Following three months of GH therapy, there were significant improvements in all measured parameters including increased free fat mass (50.2 vs. 52.4 kg, P < 0.005) and total body water (37 vs. 38.7 l, P < 0.005), reduced fat mass (31.6 vs. 29.8 kg, P < 0.005), reduced AGHDA score (7 vs. 4, P < 0.001) and reduced cholesterol (6.3 vs. 5.8 mmol/l, P < 0.001), LDL (4 vs. 3.33 mmol/l, P < 0.001) and cholesterol/HDL ratio (5.57 vs. 4.67, P < 0.001). IGF-1 concentrations were significantly increased following treatment (12 vs. 32.4 nmol/l). Six subjects decided to discontinue GH therapy, 2 before the end of the study due to potential drug-related side-effects and 4 subjects derived no benefit from treatment. Despite the demonstrable benefits of treatment for the remaining 33 GHD adults, 6 GPs refused to continue to prescribe GH therapy for reasons of lack of familiarity with the drug or advice from their health authority. CONCLUSION: Patients who wanted GH therapy were usually younger and more severely GHD than counterparts who elect not to be treated. However, a therapeutic trial of GH therapy is required to distinguish those subjects who derive benefit from treatment. We have shown that three months of low dose GH therapy is a sufficient period to elicit significant beneficial responses in quality of life, body composition parameters and lipids for the majority of patients and appears to be a sufficient period for patients to decide whether they want longer term therapy. The initial therapeutic trial also provides the objective evidence for the general practitioners to decide upon the continued prescription of therapy. Despite the positive evidence provided by this study, a small minority of general practitioners still refuse to prescribe GH therapy.

Adult↗

Cardiotoxicity and prescription of thioridazine in New Zealand.

OBJECTIVE: To review the production of cardiac arrhythmia by thioridazine, and consider the role of government regulation in light of antipsychotic prescribing trends in New Zealand. METHODS: We conducted a focused literature review on psychotropic-induced cardiotoxicity, including mechanisms and incidence. In addition, we considered trends in antipsychotic prescription in New Zealand and decisions made by regulatory bodies in Australia, North America and the United Kingdom regarding restrictions on the prescription of thioridazine. RESULTS: In general, the cardiotoxicity of antipsychotics, including thioridazine, relates to the ability of these drugs to antagonize voltage-sensitive potassium channels, and thereby prolong the QT interval. This action can lead to malignant arrhythmias in a very small proportion (< < 1%) of patients; the risk may be increased by other drugs or factors which prolong QT or inhibit the metabolism of thioridazine. A review of prescription doses and volumes in New Zealand indicates that thioridazine is prescribed mainly in low doses by non-specialists, and its use has been waning significantly over the past 2 years. These trends predate recent publicity regarding cardiotoxicity. CONCLUSION: Recommendations regarding thioridazine use are presented. Although new patients should not receive this drug, existing patients benefiting from modest doses should not be denied access unless clear-cut risk factors for cardiotoxicity are evident.

Antipsychotic Agents↗

An evaluation of short-term oxygen therapy: the prescription of oxygen to patients with chronic lung disease hypoxic at discharge from hospital.

The provision of domiciliary oxygen to patients hypoxic at hospital discharge has been termed short-term oxygen therapy (STOT). This practice appears widespread, although there is a paucity of literature and no evidence-based guidelines. We undertook this audit to examine the prescription of STOT and determine the proportion fulfilling for long-term oxygen therapy (LTOT) 2 months post-discharge. STOT was defined prospectively: resting PaO2 < or = 7.3 kPa (55 mmHg) or PaO2 between 7.3 and 8.0 kPa (60 mmHg) with any of the following: clinical evidence of cor pulmonale (pedal oedema or jugular venous distension), ECG evidence of pulmonale, echocardiogram evidence of pulmonary hypertension, haematocrit > 0.55 (adapted directly from LTOT criteria). Patients were evaluated for LTOT 2 months post-discharge when clinically stable on optimal medical management. All referrals to the Auckland Regional Oxygen Service between July 1998 and 1999 were systematically reviewed. The majority 289/405 (71%) of new referrals were for the prescription of STOT/LTOT in patients with chronic lung disease: 160/289 (55%) derived from hospitalized patients with the majority 130 (81%) fulfilling criteria for STOT, median age 73, range 24-96 years. Mean hospital stay was 10.2 days. Two months after discharge 22/127 (17%) of STOT patients had died, comparable with 4/22 (18%) not fulfilling criteria for STOT. A total of 123 patients were assessed for LTOT at 2 months; 76 (62%) fulfilled criteria for LTOT. The prescription of oxygen at hospital discharge represented a considerable proportion of our referral load. There was a high mortality in the 2-month follow-up period. A significant proportion of STOT patients did not subsequently fulfill criteria for LTOT. Further prospective studies are required in order to develop evidence-based guidelines.

Adolescent↗

Determination of the components in a Chinese prescription, yu-ping-feng san, by RAPD analysis.

In this study, the RAPD (random amplified polymorphic DNA) technique was employed for the first time to determine the components in a Chinese herbal prescription. Forty decamer oligonucleotide primers were screened in the RAPD analysis to identify three Chinese medicines, the dried root of Astragalus membranaceus (Fisch.) Bge., the dried root of Ledebouriella seseloides Wolff, and the dried rhizome of Atractylodes macrocephala Koidz, in a Chinese prescription. Only primer OPP-10 simultaneously generated three distinct markers were each specific to one component. The marker with 200 bp is specific to Astragalus membranaceus; the 440 bp marker is specific to Atractylodes macrocephala; and the remaining marker with 500 bp was present in Ledebouriella seseloides. The presence of the three herbal medicines in the mixed sample, the Chinese prescription, was determined when the primer OPP-10 RAPD reaction was performed. The technique was proved to contribute to the identification of components in the Chinese medicinal preparations.

Astragalus propinquus↗

Barriers and facilitators to the prescription of automated external defibrillators for home use in patients with heart disease: a survey of cardiologists.

OBJECTIVE: Because the majority of cardiac arrests occur at home, the use of automated external defibrillators (AEDs) in the home could potentially improve survival of out-of-hospital cardiac arrest. Currently, physicians must prescribe AEDs for home use by patients. The purpose of this study was to investigate the barriers and facilitators to prescription of home use of AEDs. DESIGN: Telephone interviews were conducted with 85 cardiologists and paper and pencil surveys (via fax) with 59 additional cardiologists in Washington State. OUTCOME MEASURES: Cardiologists were asked about their current practices and their perceived barriers and facilitators to prescription of AEDs for home use. RESULTS: Eighty-five percent of the sample believed that AEDs could be effective in preventing death, although only 7% of the cardiologists had ever prescribed an AED. Reasons for nonprescription included the use of implantable cardioverter defibrillators, perceived lack of a clear patient niche, and lack of knowledge about the device. The majority of respondents reported that they would be more likely to prescribe AEDs if they were the standard of care (71%), were covered by insurance (67%), and came with comprehensive training (58%). CONCLUSION: The results showed that cardiologists believe that home use of AEDs can be effective but that many issues regarding the prescription of AEDs remain.

Adult↗

High dose-rate intracavitary brachytherapy for carcinoma in situ of the vagina occurring after hysterectomy: a rational prescription of radiation dose.

OBJECTIVE: Our purpose was to profile patients who were treated with high dose-rate intracavitary brachytherapy for carcinoma in situ of the vagina that occurred after hysterectomy, with special reference to a rational prescription of radiation dose. STUDY DESIGN: We reviewed 13 patients who were treated for posthysterectomy carcinoma in situ of the vagina by the brachytherapy as the sole treatment. The brachytherapy was delivered by a remote-controlled afterloading intracavitary radiation system. RESULTS: The mean age of the patients was 62 years. The total dose of absorbed radiation was 36 and 30 Gy that was prescribed at 1.0-cm depth to the vaginal surface in 3 cases and at 40 and 30 Gy that was prescribed at 0.5-cm depth in 10 cases. All patients had vaginal mucosal radiation changes of mild to moderate grade. Three cases that were irradiated to a total dose of 30 Gy at 1.0-cm depth had rectal bleeding and/or macroscopic hematuria. Complaints regarding sexual functioning were not found in this retrospective analysis. All patients remain free of disease after a median follow-up period of 127 months. CONCLUSION: High dose-rate brachytherapy with a dose prescription at 0.5-cm depth can yield a promising rate of tumor control, with lower associated morbidity than that with a dose prescription at 1.0-cm depth in the treatment of posthysterectomy carcinoma in situ of the vagina.

Aged↗

General practitioners' patterns of antimicrobial drugs prescription in the therapy of acute pharyngitis.

OBJECTIVE: To analyse the patterns of antibiotic prescription in the treatment of acute pharyngitis among a group of general practitioners (GPs). DESIGN: From the records of their patients, 11 specialists in general practice have collected post hoc data on their patients and on acute pharyngitis in the period from October 1, 1994 to September 30, 1995. SETTING: 11 teaching practices in four health centres in Zagreb, Croatia. SUBJECTS: GPs grouped according to whether they had pre-school children in their care. MAIN OUTCOME MEASURES: The choice and cost of the prescribed antimicrobial drug, and the impact of the characteristics of the population in care to the prescription rate and structure. RESULTS: An antimicrobial drug was prescribed in 784 (72.1%) cases of pharyngitis. Two groups of GPs have shown significant differences in the prescription rate (p < 0.001), and in the choice of antimicrobial drugs (p < 0.001). CONCLUSION: GPs with a larger number of patients in their care suffering from chronic diseases tend to prescribe antimicrobial drugs more often in the treatment of acute pharyngitis.

Acute Disease↗

Patients receiving a prescription for diamorphine (heroin) in the United Kingdom.

The United Kingdom is unusual internationally in that it is one of few countries able to prescribe diamorphine for the treatment of opiate dependence. Prescribing diamorphine has been part of the UK response to drug problems since the 1920s. Despite this, little is known about who receives diamorphine and how treatment is delivered. This study aims to describe the characteristics and treatment regimes of opiate-dependent drug users receiving a prescription for diamorphine in the United Kingdom in 2000, and report on their status in 2002. A retrospective case-note review was conducted in England and Wales. Two hundred and ten (72%; 210/292) patients' sets of case-notes were reviewed at 27 of the 42 (64%) drug clinics where diamorphine was prescribed by the doctor. Patients had been receiving a prescription for diamorphine for a median length of six years. The majority were unemployed white males, with a median age of 44 years. Illicit drug use and criminal activity, while low, had not been eliminated totally. The majority were prescribed ampoules and few had significant health problems. In some cases patients had been transferred to injectable diamorphine from injectable methadone to reduce injection related problems. There were wide variations in dose. The majority of patients had no serious drug, health or social problems. Diamorphine prescribing was a long-term commitment. The experience from the United Kingdom has been one of long-term prescribing with the aim of retaining patients in treatment and reducing the harms caused by illicit drug use. Prospective studies are needed to determine the long-term consequences of receiving a diamorphine prescription.

Ambulatory Care Facilities↗

Prevalence and Factors Associated with Receiving a Prescription for a Direct Oral Anticoagulant Among Patients with Atrial Fibrillation on Hospice Admission.

Atrial fibrillation (AF) is prevalent in hospice care, but anticoagulation decisions in this population are not well understood. In this cross-sectional study, we described the prevalence and characteristics associated with direct oral anticoagulant (DOAC) prescription on hospice admission. We used electronic health data from adult decedents with AF in a large, for-profit hospice chain in the United States between January 1, 2017 and December 31, 2019. We used multivariable logistic regression with results reported as adjusted odds ratios (AORs) and 95% confidence intervals (CIs). Among 13,233 decedents, mean (standard deviation [SD]) age was 84.2 (9.9) years, 53.6% were female, 65.1% were White, and 56.1% were referred to hospice from a hospital. Mean (SD) CHA2DS2-VASc score were 3.8 (1.4) for males and 4.8 (1.3) for females, and mean (SD) HAS-BLED score was 2.2 (1.0). Overall, 8% of patients received a DOAC prescription on hospice admission. Characteristics associated with receiving a DOAC prescription included PPS scores of &#x2265; 20% (compared to scores < 20%), and receiving hospice care at home, nursing home, assisted living facility, or residential care home (compared to inpatient hospice). Further studies about the risks and benefits of DOAC use are needed to optimize decision-making in this population.

DOAC↗

Dependence of normal brain integral dose and normal tissue complication probability on the prescription isodose values for gamma-knife radiosurgery.

A recent multi-institutional clinical study suggested possible benefits of lowering the prescription isodose lines for stereotactic radiosurgery procedures. In this study, we investigate the dependence of the normal brain integral dose and the normal tissue complication probability (NTCP) on the prescription isodose values for gamma-knife radiosurgery. An analytical dose model was developed for gamma-knife treatment planning. The dose model was commissioned by fitting the measured dose profiles for each helmet size. The dose model was validated by comparing its results with the Leksell gamma plan (LGP, version 5.30) calculations. The normal brain integral dose and the NTCP were computed and analysed for an ensemble of treatment cases. The functional dependence of the normal brain integral dose and the NCTP versus the prescribing isodose values was studied for these cases. We found that the normal brain integral dose and the NTCP increase significantly when lowering the prescription isodose lines from 50% to 35% of the maximum tumour dose. Alternatively, the normal brain integral dose and the NTCP decrease significantly when raising the prescribing isodose lines from 50% to 65% of the maximum tumour dose. The results may be used as a guideline for designing future dose escalation studies for gamma-knife applications.

Algorithms↗

Determinants of satisfaction with prescription drug plans.

Satisfaction among health plan members with their prescription drug coverage was studied. Interviews of patrons of 10 randomly selected community pharmacies in the Pittsburgh area were conducted by entry-level Pharm.D. students during spring 1999. Survey participants were asked to indicate their level of satisfaction with each of nine items dealing with various components of pharmacy benefit plans and to provide health-related and sociodemographic information. Differences in responses were assessed with univariate and multivariate statistics. A total of 504 people were interviewed. The results of general linear model and multivariate procedures indicated that the sociodemographic characteristics of respondents did little to explain variations in satisfaction. Differences were governed primarily by having a choice of plans in which to enroll and of perceptions of plan limitations. Most respondents were overwhelmingly satisfied with the quality of their prescription drug plans. Government-sponsored plans were rated at least as well as private plans. Members of health care plans in a metropolitan region were satisfied with their prescription drug coverage. Satisfaction was primarily determined by perceptions about coverage limitations and having a choice of plans.

Analysis of Variance↗

Applying the theory of planned behaviour to pharmacists' beliefs and intentions about the treatment of vaginal candidiasis with non-prescription medicines.

BACKGROUND: It is important to understand health professionals' attitudes and beliefs about practice and the barriers to achieving best practice. The theory of planned behaviour (TPB) has been widely used to understand behaviour. In this study, TPB was used to explore the psychological variables that influence community pharmacists and the supply of non-prescription medicines. OBJECTIVES: The objectives of the study were to: (i) apply the TPB to community pharmacy behaviour; (ii) identify barriers to/facilitators of evidence-based practice; (iii) describe psychological variables and responses to written scenarios of patients presenting in community pharmacies for non-prescription antifungals for the treatment of vulvovaginal candidiasis; and (iv) to examine the relationships between beliefs and behavioural intention. METHODS: A questionnaire survey was constructed using the TPB and disseminated to pharmacies in Grampian, Scotland. The purpose of the study was to explore community pharmacists' attitudes, beliefs and intentions about the supply of non-prescription antifungals for the treatment of vulvovaginal candidiasis. RESULTS: Of the 121 questionnaires disseminated, 76 (63%) were returned. Behavioural intention to sell antifungals to women with vulvovaginal candidiasis symptoms was strong. Attitude towards recommending these medicines was positive. However, only half of the sample responded appropriately to all four patient scenarios (n=42, 54%). Most pharmacists felt that they were able to recommend antifungals if they wished, but did not feel under social pressure to recommend them. Local doctors did not appear to be influential with respect to selling antifungals. If a customer was elderly, pregnant or if the pharmacist was uncertain of the diagnosis of candidiasis, an antifungal was less likely to be recommended. CONCLUSION: TPB provides a valid and useful summary of the key psychological variables influencing practice. There is more to pharmacy practice than the knowledge and attitudes of the pharmacist.

Antifungal Agents↗

A national study examining the effect of making emergency hormonal contraception available without prescription.

BACKGROUND: In January 2001, emergency hormonal contraception was made available for women over the age of 16 years directly from a pharmacist without prescription. It is of interest whether this change in the UK has led to any improvements or deterioration in the service provided for the women who need it. METHODS: Self- completed, anonymous questionnaires were distributed to women requesting emergency hormonal contraception through a single group of pharmacies located throughout England, Wales and Scotland. RESULTS: A total 419 women returned completed questionnaires. A greater proportion of women were able to take emergency contraception within 24 h when they obtained their tablets directly from a pharmacy without a prescription (64% versus 46%, P = 0.029). Women who obtained their drugs directly from the pharmacist were just as well informed, just as likely to arrange regular follow-up and generally preferred this system, although they disliked having to pay. CONCLUSION: Making emergency hormonal contraception available without prescription has improved services to women who need them, but these improvements are quantitatively minimal, preventing only five additional pregnancies per 10,000 users.

Contraceptives, Postcoital, Hormonal↗