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At least 253 records · Page 14Linked to original sources
PubMed1984

Determination of the chemical constituents and spectral properties of commercial and NF reference standard potassium guaiacolsulfonate: implications of the findings on compendial analytical methodology.

HPLC analysis confirmed a difference in the chemical composition of commercial versus NF reference standard potassium guaiacolsulfonate. After separation by fractional crystallization, the two constituents comprising the former sample were identified by 1H-NMR as potassium guaiacol-4- and -5-sulfonate, respectively. The former isomer predominated. The reference standard material was identified as the 4-sulfonate salt by HPLC, NMR, IR, and UV. This difference raises questions concerning the validity of the compendial identification tests and assay procedure for the drug, which are based on methods requiring direct comparison between it and the reference standard. In fact, the IR test has now been shown to be unreliable as a rigorous criterion for identification, in light of significant differences found in the fingerprint regions of the spectra of the two isomers. However, because the two isomers exhibit identical UV absorption characteristics in solutions of pH less than or equal to 7 (but not in alkaline solution), the compendial UV identification test and assay procedure appear to be valid under the conditions specified. The pKa values of the isolated isomers were estimated by a spectrophotometric method to be 8.74 and 9.16 for the phenolic group of potassium guaiacol-4- and -5-sulfonate, respectively.

Acetylation↗
PubMed1994

A new isosorbide dinitrate extended-release formulation: pharmacokinetic and clinical parameters in patients with stable angina pectoris.

In a double-blind, cross-over study the acute clinical efficacy and pharmacokinetic profile of a newly developed isosorbide dinitrate extended-release (ISDN-ER) formulation (10 mg immediate release and 60 mg slow release) were examined in eight angina patients. Exercise tests were done 1 h before and 1, 6 and 10 h after acute ISDN or placebo; similar testing was repeated after 14 days of open-labelled treatment. At 1, 6 and 10 h after administration, ISDN-ER significantly reduced the mean ST depression at highest comparable workload (HCWL) by 0.8, 0.6, and 0.6 mm, respectively. Total exercise duration increased significantly by 46, 42 and 72 s. The rate-pressure product at HCWL was not reduced significantly at any time, while digital plethysmography demonstrated a significant effect on arterial pulse curves throughout the 10 h. After 14 days of once-daily treatment, similar or somewhat attenuated clinical effects were observed. Pharmacokinetic measurements showed a first peak of ISDN at 1-2 h and a second peak at 4-5 h. The 5-isosorbide mononitrate (5-ISMN) metabolite peaked at 5-8 h and remained high at 10 h. After 14 days of treatment, the mean plasma concentrations of ISDN and 5-ISMN before drug were 0 and 69 ng.ml-1, respectively. Thus, satisfactory acute clinical efficacy and low nitrate levels during the night were observed. However, long-term clinical efficacy needs to be established in larger, placebo-controlled trials.

Aged↗
PubMed1992

FARMAGUIDA: a databank for the analysis of the Italian drug market and drug utilization in general practice.

FARMAGUIDA, a databank of drugs marketed in Italy (2,596 pharmaceutical substances corresponding to 10,448 products), permits analysis of the nature and value of the drugs prescribed. It contains coded pharmaceutical and administrative information, an original classification, as well as indicators of the therapeutic status of each drug. The FARMAGUIDA classification was built hierarchically according to a three-level pattern: the first level (42 categories) corresponds to major pharmacological groups; the second level (157 groups) gathers drugs having similar clinical indications and/or pharmacological actions; and the third level (246 subgroups) classifies drugs according to chemical structure and/or the mechanism of action. Drugs not falling into well-established pharmacotherapeutic criteria (e.g. neurotropics or liver protectants) are classified into separate subgroups. Two larger groupings were also formulated: THER (11 headings), a utilization-oriented arrangement in which each heading also contained the corresponding placebo-like drugs, and PHARM (14 headings), a rational pharmacological arrangement, in which all placebo-like drugs were relegated into a separate set. The following quality indicators were created: DOC, which defines five degrees of documentation of clinical efficacy according to major textbooks of pharmacology and therapeutics; CLASS, which groups DOC values for a more simple evaluation of prescription data; PREP, which distinguishes monocomponent preparations from fixed-dose combinations, and also provides coded information about the rationale for the combination; HOSP, which hallmarks drugs that should be reserved for in-patients, e.g. anti-pseudomonal antibiotics. The composition of the list of reimbursable drugs, the Italian National Formulary (NF; 5782 products in 1990) was analyzed according to the FARMAGUIDA classification and indicators.(ABSTRACT TRUNCATED AT 250 WORDS)

Data Collection↗
PubMed1992

Drug utilization in general practice: prescribing habits of National Formulary drugs by GPs of Emilia Romagna (Italy) in 1988 and 1989.

Two years of prescriptions for all the drugs included in the Italian National Formulary by 3,866 general practitioners, in a region of Northern Italy of almost 4 million inhabitants, were analysed to determine the pattern of drug use. The data (official code and proprietary name of the drug, number of packages prescribed, price of the drug, dispensing pharmacy, and date of dispensing) were collected monthly by retail pharmacies and were recorded and organized in database files. Quantitative and qualitative profiles of prescription patterns were studied for all the major therapeutic areas. Overall drug prescriptions averaged 600 DDD/1,000 inhabitants/day. Comparison of 1988 and 1989 data showed only a slight increase in total drug prescriptions, but greater changes were detected in certain drug groups, especially those recently marketed. Overprescription of well-documented drugs, such as H2-antagonists, ACE-inhibitors, calcium antagonists and the HMG-CoA-reductase inhibitors, in comparison to other countries was shown. There was frequent prescribing of drugs devoid of documentation of their clinical efficacy, which were mainly given for clinical conditions lacking a specific treatment, or as placebos for minor disorders. The data demonstrate the need for educational intervention to improve the quality of drug prescribing habits in primary health care in Italy.

Drug Prescriptions↗
PubMed1996

Feasibility of an antibiotic order form. First experience in the department of internal medicine of a university hospital.

Inadequate control of antimicrobial drug use may lead to excessive expenditure for antimicrobial drugs and improper prescribing it may also result in the emergence of multiresistant bacteria. An antibiotic order form may improve the quality of prescriptions by increasing the awareness of the physician of the antimicrobial spectrum needed (i.e. which microorganism is expected in a given patient), the desired duration of treatment, the potential need to adjust dosage, and the potential allergy of the patient to the drug. Furthermore, such an antibiotic order form facilitates prospective evaluation of both the quantity and the quality of prescribing practice. However, the introduction of yet another form to fill in may be met with opposition from prescribers. We have developed an easy-to-use antibiotic order form that incorporated the conventional medication order that was already in use in our hospital. Compliance (percentage of antimicrobial drug prescriptions for which an order form was used) was on average 58% in the first two weeks after introduction, and remained thereafter between 60% and 90%, varying between the different wards. Data retrieved from the antibiotic order forms could be used for surveillance We conclude that this antibiotic order form was feasible in a large department of internal medicine of a university hospital. Future usefulness will depend on compliance and on personnel support for data processing and intervention.

Anti-Bacterial Agents↗
PubMed1995

Practical strategies for the appropriate use of antimicrobials.

The use and misuse of antimicrobial agents is well documented in the literature. A variety of mechanisms has been used to enhance the appropriate use of these agents. A widely used initial strategy is the formation of multidisciplinary groups, such as Pharmacy and Therapeutics Committees or antimicrobial subcommittees, which are responsible for all antimicrobial policies for the health-care facility. Other techniques include the use of antimicrobial order sheets, automatic stop orders, therapeutic substitution, antibiotic restriction systems, and the use of selective antimicrobial susceptibility reporting systems. Many of these strategies have been reported to be effective in the management of antimicrobial usage; however, they also result in increased administrative and monitoring costs. Antimicrobial control systems must be individualized to the health-care facility.

Anti-Bacterial Agents↗
PubMed1999

Decisions about access to health care and accountability for reasonableness.

Insurers make decisions that directly limit access to care (e.g., when deciding about coverage for new technologies or formulary design) and that indirectly limit access (e.g., by adopting incentives to induce physicians to provide fewer or different services). These decisions raise questions about legitimacy and fairness. By holding health plans accountable for the reasonableness of their decisions, it is possible to address these questions. Accountability for reasonableness involves providing publicly accessible rationales for decisions and limiting rationales to those that all "fair-minded" persons can agree are relevant to meeting patient needs fairly under resource constraints. This form of accountability is illustrated by examining its implications for the three examples of direct and indirect limit setting noted here.

Decision Making, Organizational↗
PubMedDate not supplied

Lowering the cost of lowering the cholesterol: a formulary policy for lovastatin.

OBJECTIVES: To describe a medical center policy designed to contain the cost of using the lipid-lowering drug lovastatin in a primary care setting, to examine the effect of the policy on cost containment, and to examine physician acceptance of the policy. SETTING: A Veterans Affairs medical center. INTERVENTIONS: The policy made lovastatin available to physicians when failure of therapy with diet and two first-line drugs was documented on an order form. The form also contained educational information including prices and recommended niacin as the drug treatment of first choice for most patients. DESIGN: To evaluate the effect of the policy, lipid-lowering drug use at the medical center was compared with that at a similar center that did not restrict lovastatin use, and with lipid-lowering drug use in the United States as a whole. A written questionnaire was used to survey physician reaction to the policy. RESULTS: The use of lovastatin as a percentage of total lipid-lowering drug use at the center with the lovastatin policy was one-fourth that at the other center or nationwide, and the use of niacin was four times greater (p less than 0.0001). The estimated savings in drug costs to the center with the lovastatin policy due to these differences was more than $30,000 per year. In the survey of physicians affected by the policy (n = 78, response rate = 100%), less than one-fourth viewed it unfavorably, and 90% favored this policy over restricting the drug to a subspecialty clinic. CONCLUSION: The authors' experience indicates that a formulary policy that permits limited use of an expensive drug in a primary care setting can contain costs in a way that is acceptable to physicians. A policy of this type could be useful to the increasing number of health care provider organizations that cover the cost of outpatient medications.

Ambulatory Care↗
PubMed2005

General practitioners choose within a narrow range of drugs when initiating new treatments: a cohort study of cardiovascular drug formularies.

OBJECTIVE: The aims of this study were (1) to develop and evaluate a new method for investigating personal drug formularies in general practice and (2) to test the hypothesis that there is a difference between personal drug formularies for incident and ongoing drug use. METHODS: In 2002, we studied prescribing patterns of beta-blockers, calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II antagonists and statins in the County of Funen, Denmark (180 general practices, 472,000 inhabitants). For each practice, we distinguished between an incident drug formulary consisting of prescriptions for new users and an ongoing drug formulary including prescriptions for patients already in treatment. Prescription data were retrieved from the Odense University Pharmacoepidemiologic Database (OPED). Four different formulary measures were evaluated and used for comparing incident and ongoing drug use. RESULTS: General practitioners' (GPs') incident drug formularies comprised significantly fewer drugs than their ongoing drug formularies for all drug groups except angiotensin-II antagonists. The difference in the total number of drugs used was between 1.8 and 3.3. We found differences between 0.5 and 1.6 analogues in the DU 90% (number of analogues accounting for 90% of the prescribed volume measured in defined daily doses) segment and the formulary selectivity index between 0.05 and 0.12. The preference for the most prescribed analogue was 9-18% higher among incident patients. The formulary selectivity index was highly correlated with the other formulary measures and quantified both range and skewed distribution of drug choice. CONCLUSION: Analysing GPs' prescriptions to incident patients is a simple and inexpensive method for studying their own current personal drug formularies. GPs choose within a narrow range of analogues for incident patients.

Adrenergic beta-Antagonists↗
PubMed2006

Narrow and wide prescribers among general practitioners: a cohort study of drug formularies used for new treatments.

OBJECTIVE: The aims of this study were to analyse (1) if it is possible to classify general practitioners (GPs) or groups of practitioners (practice units) as overall narrow or wide prescribers and (2) to what extent the size of practice drug formularies is associated with general prescribing behaviour, practice activity and demography. METHODS: Data were retrieved from the Odense University Pharmacoepidemiologic Database (OPED) and the prescribing patterns of 177 practice units were analysed in a 4-year period including 2000 and 2003. We characterised the drug repertoire for new treatments using a Formulary Diversity Scale based on two formulary measures, the DU 90% and the Formulary Selectivity Index. Multiple regressions were used to analyse the association between formulary size and practice characteristics. RESULTS: The final Formulary Diversity Scale comprised 15 therapeutic drug groups and 151 different analogues. The average score based on the DU 90% segment was 46 drugs (range: 28-65) corresponding to 30% of drugs available. Using the Formulary Selectivity Index the average diversity score was 0.70. Practices with a high number of patients and a high percentage of elderly patients were more likely to use a wide range of drugs. CONCLUSION: The Formulary Diversity Scale revealed wide variation between practice units, indicating the existence of both overall narrow and wide prescribers among GPs. The number of patients attending the practice and the percentage of elderly patients were directly associated with the use of more analogues.

Cohort Studies↗
PubMed2001

Personal formularies. An index of prescribing quality?

OBJECTIVES: (1) To determine the extent to which Australian general practitioners (GPs) restrict the numbers of agents they prescribe within a drug class ('personal formularies'); (2) To assess concordance of these drug choices with standards based on established guidelines or recognised good prescribing practices; (3) To assess the potential of these measures as indicators of the quality of prescribing. METHODS: Australian Health Insurance Commission (HIC) prescription data (1994 1997) for around 15,400 GPs providing 1500 or more Medicare services per year were analysed. Measures of an individual GP's use of a personal formulary (determined by number of agents) and concordance with prescribing criteria based on specified drugs for five classes of commonly prescribed drugs were derived. RESULTS: Non-steroidal anti-inflammatory drugs (NSAIDs): GP concordance was higher with a non-specified personal formulary (any five NSAIDs) than with a list of specified drugs (five NSAIDs of 'low' or 'medium' risk of gastrointestinal toxicity), and concordance with both increased over time. In 1997, around 70% of GPs used five or fewer NSAIDs for 90% of their prescribing; 47% of GPs had 90% of prescribing from five selected agents. Angiotensin converting enzyme inhibitors/angiotensin-II receptor antagonists: The introduction of new agents appeared to increase the size of the GPs' personal formularies, and concordance with defined standards decreased over time. Antibacterial agents: Concordance with a specified drug standard (nine drugs listed in the Australian Antibiotic Guidelines) increased substantially over time but was largely due to increased prescribing of two heavily promoted drugs. Beta-blocking agents: Over time, GPs restricted most prescribing to two agents, atenolol and metoprolol. Calcium channel blockers: GPs did not appear to restrict prescribing of these drugs; most GPs prescribed all five agents available. CONCLUSIONS: Australian GPs use 'personal formularies'. Formulary size varies with the drug class, can change over time as new agents become available, and its contents can be influenced by promotional activities. Prescribing standards based on numbers of drugs used may not always reflect rational prescribing choices. Criteria based on specified drugs provide more rigorous prescribing standards, but may give a misleading picture of prescribing quality in the absence of information on patients and the indications for treatment. Personal formulary measures are potentially useful prescribing indicators but need to be carefully defined and interpreted. GPs should be encouraged to identify their personal formularies and review the drugs included in them.

Australia↗