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Regulating opioid prescribing through prescription monitoring programs: balancing drug diversion and treatment of pain.

Social policies have evolved to address the associated concerns related to the public health crises of drug abuse and undertreated pain. Prescription monitoring programs (PMPs) have been used for many years in this effort but are undergoing re-evaluation and restructuring in light of changes in technology as well as changes in our understanding of the collateral impact of such programs. We reviewed the state of PMPs in the United States and highlighted recent changes in these programs that have occurred nationally. The current changes occurring in California, with the most physicians of any U.S. state as well as the oldest triplicate-based serialized prescription program, are reviewed, with focus on the transition to tamper-resistant prescriptions that use security paper forms. Future trends for PMPs are described, including the potential for widespread use of electronic prescribing, which is gaining favor with the Drug Enforcement Agency.

Analgesics, Opioid↗

Pharmacoepidemiology and the "impact factor".

The field of "Pharmacoepidemiology/Drug Utilization" research has been analysed by studying published research articles under the medical subject headings (MeSH terms) "Pharmacoepidemiology", "Drug Utilization" and "Drug Utilization Review". There were 1822 articles published, and stored in Medline, during the 32-month period between 1 January 2001 and 31 August 2003; these papers might represent a field of research, due to the similarity of MeSH terms used for coding and the set of journals in which the articles were published. A total of 457 articles, representing 25% of all articles in the field, were published in 14 different journals, and 50% of all articles (948) were collected in only 64 different journals. The two main journals publishing research in "Pharmacoepidemiology/Drug Utilization" are Pharmacoepidemiol Drug Saf and the Eur J Clin Pharmacol. These two publications are the official journals of the three main societies in the field and are at least partially focused on this subject, with 45.7% of all articles in Pharmacoepidemiol Drug Saf and 11.1% of all articles in Eur J Clin Pharmacol included under the studied MeSH terms; other journals only occasionally publish papers in this line of research. These two journals are the leaders in pharmacoepidemiology and drug utilization research, having impact factors (IFs) in 2002/2003 above (1.955/1.972 for EJCP) and a bit below (1.092/1.257 for PDS) the middle of the ranking of publications, according to the IF, in the "Pharmacology and Pharmacy" list of the Science Citation Index (SCI).

Bibliometrics↗

The clinical pharmacist in a family practice residency program.

A project of interdisciplinary family medicine education was conducted in which a clinical pharmacist served as a drug therapy consultant-educator in a family practice residency program. The clinical pharmacist provided drug information, advised about drug therapy, taught in formal conferences, prepared and disseminated a drug information bulletin, made rounds with the physicians, provided drug blood level consultation, and conducted a drug utilization review project. The family physicians' attitudes about clinical pharmacy were assessed by interviews before and after the project and by a questionnaire administered after the project. The physicians and the pharmacist in this model were observed to have a greater understanding of the interdisciplinary team practice concept; and an active role for the clinical pharmacist as a teacher and consultant was reinforced.

Attitude of Health Personnel↗

The antibacterial paradox: essential drugs, effectiveness, and cost.

The concept proposed by WHO of an essential drugs list that should comprise drugs corresponding to the health needs of the majority of the people has been embraced by countries, which have adapted it to their needs. In this study, the essential antibacterial drug lists of 16 countries chosen from the six WHO regions are reviewed. Most of these countries include 73% of WHO-recommended essential antibacterials on their lists. However, most are lacking reserve antibacterials, and even some main list antibacterials, which are essential when empirical therapy fails in cases of bacterial resistance. Many factors that may be responsible for the lack of selection of these drugs, not least cost considerations, are discussed.

Adult↗

Observations and effects of educational consults on allopurinol prescribing.

Allopurinol has been used in the management of hyperuricemic states for several years. Despite its efficacy for these indications, recent concerns have been raised regarding the unnecessary morbidity and mortality occasionally associated with its inappropriate use. In an effort to assess the utilization of allopurinol, a concurrent drug utilization review was undertaken. Fifty patients who were prescribed allopurinol were entered into the study and underwent health record review and patient interview, to determine appropriateness of therapy and the need for educational intervention. A number of inconsistencies with regard to established guidelines were identified. As well, 11 of 50 patients (22%) required intervention because of either lack of indication or excessive dose. Fifty-five percent of the educational interventions, performed by the pharmacist, were accepted as written. The current utilization of allopurinol at our facility differs substantially from guidelines developed for optimal utilization of allopurinol. Further, a pharmacy based intervention program can improve prescribing practices of allopurinol.

Aged↗

Evaluation of appropriateness and interpretation of serum theophylline assays.

A drug utilization review of serum theophylline assays was undertaken to: (1) evaluate the prescribers' usage and interpretation of serum theophylline levels (STLs), and (2) calculate the cost of inappropriate assays. Criteria for appropriate use and interpretation were defined by an audit committee and approved by the chief medical resident. STLs were evaluated on medicine patients for a one-month period. Results of 102 levels ordered showed that 47 percent were inappropriate. The reasons cited most often for inappropriateness were: (1) previously-known STLs with no reason to expect a change in subsequent levels (26 percent); and (2) STLs drawn prior to steady state (12 percent). None of the levels evaluated had a request entered for the sampling time to be recorded. STLs were interpreted with the same degree of accuracy regardless of whether they were ordered appropriately. Results from this study suggest significant cost savings can be realized if physicians' ordering habits are corrected.

California↗

Cost containment through therapeutic substitution of aminoglycosides.

A therapeutic substitution policy (TSP) for tobramycin and gentamicin sulfate was implemented at the University of Texas Medical Branch (UTMB). The policy was designed by various physician-chaired hospital committees and clinical departments that collaborated with the pharmacy service. The goal was to encourage the medical house staff to use the most economical yet safe and effective aminoglycoside, without limiting the medical team's prerogative to select among alternatives within this antibiotic group. Cost data from the first 6 months of aminoglycoside use under the new policy projected an annual savings of $139,071 in drug expenditures and $242,472 in patient charges. Following the implementation of the TSP, a concurrent drug utilization review (DUR) was performed in 50 consecutive inpatients prescribed amikacin, tobramycin, or gentamicin sulfate. The objectives were to identify those aspects of prescribing and monitoring of aminoglycosides by house staff that could be improved by specific policy and/or education, and to evaluate those specific cases in which attending physician's approval allowed house staff to prescribe an aminoglycoside other than designated in the TSP. The audit revealed that house staff were compliant with 72% of the DUR criteria; however, at least one instance (mean of 5.04 +/- 2.21) of noncompliance occurred during the treatment of each patient. The most frequently encountered deficiencies were failure to monitor for ototoxicity, incorrect orders for at least one set of serum aminoglycoside concentrations, and improper dosage adjustments for those patients with renal insufficiency. In three cases, the attending physician approved house staff use of tobramycin instead of gentamicin sulfate for reasons of organism resistance, pre-existing renal impairment, and long-term treatment of osteomyelitis.

Aminoglycosides↗

Formulary and funding implications of the gap between the national Essential Drugs List and current prescribing in a large health maintenance organisation.

BACKGROUND: The Department of Health has prepared an Essential Drugs List (EDL) for public sector implementation in 1996 and future extension to the private sector. Stakeholders have been consulted to ensure that the EDL achieves its objectives of safety, efficacy and quality at the lowest possible cost, while providing coverage for 90-95% of the common and important conditions in the country. This study was undertaken to gain insight into the current use of EDL products by 200 general practitioners (GPs) servicing a large health maintenance organisation (HMO). METHODS: Approximately 120,000 prescriptions were reviewed and the use of specified EDL medicines, other forms of EDL medicines and non-EDL medicines was analysed for several pharmacological groups. These included antibiotics and medicines for the cardiovascular, musculoskeletal, central nervous, respiratory and gastro-intestinal systems. To gauge potential savings to the private sector through the purchase of EDL products at state tender prices, current prices of a random sample of EDL products were compared. RESULTS: In the areas reviewed, only 22.4% of current GP prescriptions included EDL items; a further 19.6% included 'other forms of EDL' items. Simply obtaining those EDL products that are currently prescribed at state tender prices would reduce costs by almost 20%, while extending the use of EDL products might save in excess of 70% on private sector GP prescriptions. CONCLUSIONS: Assuming that all prescriptions were clinically indicated, the 'gap' between the EDL and medicines prescribed indicates that debate will be.

Drug Prescriptions↗

Explicit criteria for determining potentially inappropriate medication use by the elderly. An update.

This study updates and expands explicit criteria defining potentially inappropriate medication use by the elderly. Additional goals were to address whether adverse outcomes were likely to be clinically severe and to incorporate clinical information on diagnoses when available. These criteria are meant to serve epidemiological studies, drug utilization review systems, health care providers, and educational efforts. Consensus from a panel of 6 nationally recognized experts on the appropriate use of medication in the elderly was sought. The expert panel agreed on the validity of 28 criteria describing the potentially inappropriate use of medication by general populations of the elderly as well as 35 criteria defining potentially inappropriate medication use in older persons known to have any of 15 common medical conditions. Updated, expanded, and more generally applicable criteria are now available to help identify inappropriate use of medications in elderly populations. These criteria define medications that should generally be avoided in the ambulatory elderly, doses or frequencies of administrations that should generally not be exceeded, and medications that should be avoided in older persons known to have any of several common conditions.

Aged↗

Essential drugs supply and usage as a reflection of outpatient morbidity in Kirinyaga District, Kenya.

This study was carried out in all the twenty eight Government rural health facilities (RHF's) in Kirinyaga District of Kenya. It aimed at determining whether the quantities and types of drugs supplied to the RHF's matched the morbidity patterns, and also whether the disease patterns continued to be used as a basis for requesting stocks of essential drugs. It also investigated the constraints associated with the programme with an ultimate aim of improving service delivery. The information was obtained through records review of the Bin card books, Out-patients Department (OPD) register, morbidity monthly returns, staff and patient interviews. A highly significant (p < 0.01) variation in morbidity (workload) by season of the year and between the ecological divisions of the district was observed. Significant differences were also observed between the quantities of drugs supplied and the actual monthly requirements in all the RHF's, implying that the disease patterns were not necessarily being used for requesting stocks of essential drugs. A distribution of essential drugs based on two broad ecological divisions of the district was recommended. One of the major constraints found to be associated with the Essential Drugs Programme was the delay in procurement/distribution of essential drugs to the RHF's. This was mainly due to the tendering procedures of Kit 2 by the Ministry of Health (MOH) and also occasional lack of transport at the district level.

Drug Utilization Review↗

The influence of PHARMAC's National Hospital Pharmaceutical Strategy on Quality Use of Medicines activities in New Zealand hospitals.

AIM: To determine the influence of PHARMAC's National Hospital Pharmaceutical Strategy (NHPS) on Quality Use of Medicine (QUM) activities in New Zealand hospitals. METHOD: In July 2002 and July 2004, a questionnaire-based cross-sectional survey on QUM activities was administered to chief pharmacists at all 30 New Zealand public hospitals employing a pharmacist (29 in July 2004), to examine pre and post-NHPS activity. RESULTS: Both surveys achieved a 97% response rate. A range of QUM activities were undertaken in hospitals. Overall, Drug Utilisation Reviews (DURs) significantly decreased (67 vs 42) (p<0.05), although antimicrobial guidelines and intranet formularies significantly increased (p<0.05). PHARMAC's QUM initiatives, still evolving, did not appear to positively influence QUM activity in 2002-4. In 2004, PHARMAC put their original plans to coordinate QUM activity on hold and chose to participate in the processes of the Safe and Quality use of Medicines Group (SQM). Formed in 2003 by the District Health Boards of New Zealand, SQM focused attention on anticoagulants and high-risk medicines. CONCLUSION: QUM activities, similar in both periods, were not positively influenced by PHARMAC's Strategy.

Cross-Sectional Studies↗

Audit of antibiotic usage in medium-sized general hospital over an 11-year period. The impact of antibiotic policies.

The objective of the present study was to evaluate trends in antibiotic expenditure over an 11-year period (1982-1992) in a 370-bed district general hospital in Northern Ireland and to examine the impact of two separate antibiotic policies on antibiotic usage. A further objective was to examine the attitudes of prescribers to the second policy. Drug utilization review was used to collect information on antibiotic expenditure and usage before and after introduction of separate antibiotic policies in 1985 (not intensively monitored) and 1989 (intensively monitored). A main questionnaire was used to determine the attitudes of prescribers. The first policy (1985) showed no benefits with regard to the number of antibiotic entities stocked (45 before, 45 after), number of dosage units issued (9.3% increase) or expenditure (33.3% increase). The 1989 policy led to significant reductions in the number of antibiotic entities stocked (28.9%), number of antibiotics issued (11.9%) and expenditure (6.1%). Expenditure began to spiral upwards when active monitoring of the second policy was suspended. The majority of prescribers (87.2%) who responded to the questionnaire (56.5% response rate) felt that the 1989 policy made a positive contribution to antibiotic usage in the hospital.

Anti-Bacterial Agents↗

Electronic prescribing in ambulatory practice: promises, pitfalls, and potential solutions.

OBJECTIVE: To examine advantages of and obstacles to electronic prescribing in the ambulatory care environment. DATA SOURCES: MEDLINE and International Pharmaceutical Abstract searches were conducted for the period from January 1980 to September 2000. Key words were electronic prescribing, computerized physician order entry, prior authorization, drug utilization review, and consumer satisfaction. In September 2000, a public search engine (www.google.com) was used to find additional technical information. In addition, pertinent articles were cross-referenced to identify other resources. DATA EXTRACTION: Articles, symposia proceedings, and organizational position statements published in the United States on electronic prescribing and automation in healthcare are cited. DATA SYNTHESIS: Electronic prescribing can eliminate the time gap between point of care and point of service, reduce medication errors, improve quality of care, and increase patient satisfaction. Considerable funding requirements, segmentation of healthcare markets, lack of technology standardization, providers' resistance to change, and regulatory indecisiveness create boundaries to the widespread use of automated prescribing. The potential solutions include establishing a standardizing warehouse or a router and gaining stakeholder support in implementation of the technology. CONCLUSIONS: Electronic prescribing can provide immense benefits to healthcare providers, patients, and managed care. Resolution of several obstacles that limit feasibility of this technology will determine its future.

Ambulatory Care Information Systems↗

The impact of a general practice group intervention on prescribing costs and patterns.

BACKGROUND: The formation of primary care groups (PCGs) and trusts (PCTs) has shifted the emphasis from individual practice initiatives to group-based efforts to control rising prescribing costs. However, there is a paucity of literature describing such group initiatives. We report the results of a multilevel group initiative, involving input from a pharmaceutical adviser, practice comparison feedback, and peer review meetings. AIM: To determine the impact of a prescribing initiative on the prescribing patterns of a group of general practices. DESIGN OF STUDY: A comparative study with non-matched controls. SETTING: Nine semi-rural/rural practices forming a commissioning group pilot, later a PCG, in Southern Derbyshire with nine practices as controls. METHOD: Practice data were collated for overall prescribing and for therapeutic categories, between the years 1997/1998 and 1998/1999 and analysed statistically. Prescribing expenditure trends were also collated. RESULTS: Although both groups came well within their prescribing budgets, in the study group this was for the first time in five years. Their rate of increase in expenditure slowed significantly following the initiative compared with that of the comparison group, which continued to rise (median practice net ingredient cost/patient unit (nic/PU) increase: Pound Sterling0.69 and Pound Sterling3.80 respectively; P = 0.03). The study group's nic/PU dropped below, and stayed below, that of the comparison group one month after the start of the initiative. For most therapeutic categories the study group had lower increases in costs and higher increases in percentage of generic items than the comparison group. Quality markers were unaffected. CONCLUSION: We suggest that practices with diverse prescribing patterns can work together effectively within a PCT locality to control prescribing costs.

Budgets↗

European healthcare policies for controlling drug expenditure.

In the last 20 years, expenditures on pharmaceuticals - as well as total health expenditures - have grown faster than the gross national product in all European countries. The aim of this paper was to review policies that European governments apply to reduce or at least slow down public expenditure on pharmaceutical products. Such policies can target the industry, the wholesalers and retailers, prescribers, and patients. The objectives of pharmaceutical policies are multidimensional and must take into account issues relating to public health, public expenditure and industrial incentives. Both price levels and consumption patterns determine the level of total drug expenditure in a particular country, and both factors vary greatly across countries. Licensing and pricing policies intend to influence the supply side. Three types of pricing policies can be recognised: product price control, reference pricing and profit control. Profit control is mainly used in the UK. Reference pricing systems were first used in Germany and The Netherlands and are being considered in other countries. Product price control is still the most common method for establishing the price of drugs. For the aim of fiscal consolidation, price-freeze and price-cut measures have been frequently used in the 1980s and 1990s. They have affected all types of schemes. For drug wholesalers and retailers, most governments have defined profit margins. The differences in price levels as well as the introduction of a Single European Pharmaceutical Market has led to the phenomenon of parallel imports among member countries of the European Union. This may be facilitated by larger and more powerful wholesalers and the vertical integration between wholesalers and retailers. To control costs, the use of generic drugs is encouraged in most countries, but only few countries allow pharmacists to substitute generic drugs for proprietary brands. Various interventions are used to reduce the patients' demand for drugs by either denying or limiting reimbursement of products and providing an incentive for patients to reduce their consumption of drugs. These interventions include defining a list either of drugs reimbursed (positive list) or one of drugs not reimbursed (negative list), and patient co-payments, which require patients to pay a proportion of the cost of a prescribed product or a fixed charge. Policies intended to affect physicians' prescribing behaviour include guidelines, information (about price and less expensive alternatives) and feedback, and the use of budgetary restrictions.

Cost Control↗

Impact of 3-tier formularies on drug treatment of attention-deficit/hyperactivity disorder in children.

BACKGROUND: Expenditures for medications used to treat attention-deficit/hyperactivity disorder (ADHD) in children have increased rapidly. Many employers and health plans have adopted 3-tier formularies in an attempt to control costs for these and other drugs. OBJECTIVE: To assess the effect of copayment increases associated with 3-tier formulary adoption on use and spending patterns for ADHD medications for children. DESIGN AND SETTING: Observational study using quasi-experimental design to compare effects on ADHD medication use and spending for children enrolled as dependents in an employer-sponsored plan that made major changes to its pharmacy benefit design and a comparison group of children covered by the same insurer. The plan simultaneously moved from a 1-tier (same copayment required for all drugs) to a 3-tier formulary and implemented an across-the-board copayment increase. The plan later moved 3 drugs from tier 3 to tier 2. PARTICIPANTS: An intervention group of 20 326 and a comparison group of 15 776 children aged 18 years and younger. MAIN OUTCOME MEASURES: Monthly probability of using an ADHD medication; plan, enrollee, and total ADHD medication spending; and medication continuation. RESULTS: A 3-tier formulary implementation resulted in a 17% decrease in the monthly probability of using medication (P<.001), a 20% decrease in expected total medication expenditures, and a substantial shifting of costs from the plan to families (P<.001). Intervention group children using medications in the pre-period were more likely to change to a medication in a different tier after 3-tier adoption, relative to the comparison group (P = .08). The subsequent tier changes resulted in increased plan spending (P<.001) and decreased patient spending (P = .003) for users but no differences in continuation. CONCLUSIONS: The copayment increases associated with 3-tier formulary implementation by 1 employer resulted in lower total ADHD medication spending, sizeable increases in out-of-pocket expenditures for families of children with ADHD, and a significant decrease in the probability of using these medications.

Adolescent↗

[Effects of restrictions on use of vancomycin in a German university hospital].

BACKGROUND: Recently, increasing antibiotic resistance has been observed among gram-positive bacteria. However, only few isolates were found to be resistant against glycopeptides. Therefore, internationally accepted guidelines recommend a restricted use of vancomycin and other glycopeptide antibiotics in order to prevent the development of resistance against these clinically important antibiotics. In many countries, the hospital pharmacies play a key role in control and reinforcement of antibiotic formulary restrictions. In Germany, however, the hospital pharmacies usually do not take over such control functions, and most wards keep a stock of regularly used drugs including antibiotics, which makes reinforcement of restrictions difficult. METHODS: In an attempt to achieve a restriction of vancomycin use, the pharmacy of our university hospital was advised to deliver vancomycin to the wards only on request with a special order form signed by an attending, individually for every patient who should receive vancomycin. The efficacy of this restriction measure was evaluated in 3-month periods before and after the restriction became effective. RESULTS: Hospitalwide, this led to a 20.1% reduction of i.v. vancomycin and an 85.7% reduction of oral vancomycin use per 1000 patient days. If the hematology/oncology units were not considered, the reduction of i.v. vancomycin use was 41.8%, and the total use after the restriction 24.2 g per 1000 patient days. Microbiology results which justified the use of vancomycin decreased by 8.3% (10.9% hematology/oncology units not considered) between the 2 observation periods. Assuming a 7-day mean course of i.v. vancomycin therapy, the empirical use of i.v. vancomycin decreased from 39.9% to 8% after the restriction had been instituted. CONCLUSION: Allowing only experienced physicians (attendings) to decide on the use of vancomycin therapy, proved in our experience to be an effective measure to reduce unnecessary vancomycin use.

Drug Utilization↗

Drug-use practices in teaching hospitals of Khartoum State, Sudan.

PURPOSE: The present study was carried out to investigate current prescribing and dispensing practices in the largest two teaching hospitals in Sudan and compare them with those of published studies in developing countries. METHODS: A descriptive, quantitative and cross-sectional study was conducted among hospital outpatients. The sample was selected using systematic random sampling. In each hospital, prescribing indicators were investigated through collection of data on 100 patient encounters, determination of consultation time and dispensing time for 100 patients, and by interview of 100 patients for the evaluation of dispensing practices. RESULTS: The present findings showed that 96% (95% CI: 92.0-98.1%) of patient encounters did not include one or more necessary elements. Strength of drug and the quantity to be dispensed were omitted in 57.5% (95% CI: 50.3-64.4%) and 91% (95% CI: 85.9-94.4%) of patient encounters, respectively. Other variables measured per patient encounter were mean (SD) number of drugs prescribed, 1.9 (0.9); percentage prescribed by generic name, 43.6 % (95% CI: 38.6-48.8%); percentage of patient encounters involving an antibiotic, 65.0% (95% CI: 57.9-71.5%); percentage of patient encounters with an injection prescribed, 10.5% (95% CI: 6.5-15.8%). The mean (SD) consultation and dispensing times were 4.5 (2.8) min and 46.3 (21.8) s, respectively. The percentages of dispensed drugs that were adequately labeled was 37.6% (95% CI: 33.1-41.8%), whilst adequate patient knowledge was demonstrated for 37.2% (95% CI: 32.3-42.0%) of drugs. CONCLUSIONS: Cost-effective, multifaceted interventions are needed to improve current prescribing and dispensing practices at the teaching hospitals in Khartoum State, Sudan.

Cross-Sectional Studies↗