Managing costs and care for chronic idiopathic constipation.

For decades, chronic idiopathic constipation (CIC) has been one of the most common chronic functional gastrointestinal disorders encountered by clinicians. Common comorbidities include depression, diabetes, functional dyspepsia, hypothyroidism, overweight, obesity, and neurological disorders. CIC imposes a large economic burden on the American healthcare system with estimated costs of $1912 to $7522 in 2007 US dollars per patient per year. Individuals affected by CIC indicate significant rates of absenteeism and presenteeism at work. Those with constipation have poorer general health, mental health, and social functioning compared with healthy controls. The average patient with CIC tries approximately 4 over-the-counter (OTC) and 2 prescription medications before finding an effective treatment. Guideline-directed treatment generally recommends moving from lifestyle modifications to OTC products and prescription laxatives. Most patients report that the relief they receive is unacceptable. Reliable evidence indicates that newer prescription drugs offer greater relief of symptoms than those of traditional approaches. Appropriate formulary management of CIC offers opportunities to impact patient care in 3 major areas: clinical, economic, and humanistic outcomes. Plans will need to be flexible, especially because patient dissatisfaction with treatment is prevalent in CIC.

Prior Authorization Policies and Preferred Drug Lists in Medicaid Plans: Stakeholder Perspectives on the Implications for Youth with ADHD.

This qualitative study describes how Medicaid policies create challenges for the delivery and receipt of mental health treatment for low-income youth in Georgia. We conducted focus groups with caregivers of Medicaid-enrolled children with ADHD and semi-structured interviews with providers and administrators at four safety net clinics that provided mental health care to these youth. Stakeholders reported that prior authorization policies for psychosocial services, restrictiveness of preferred drug lists, and changes in preferred drug lists in Medicaid plans created barriers to treatment continuity and quality for youth with ADHD and led to more administrative burden for safety-net clinics serving these youth.

Drug-Drug Interactions (DDIs) in Psychiatric Practice, Part 2: Strategies to Minimize Adverse Outcomes From Unintended DDIs.

This column is the second in a series exploring drug-drug interactions (DDIs) with a special emphasis on psychiatric medications. The first column in this series discussed why patients being treated with psychiatric medications are at increased risk for taking multiple medications and thus experiencing DDIs and how to recognize such DDIs, and strategies for avoiding them. This second column in the series discusses strategies for minimizing adverse outcomes from such unintended DDIs. Given the huge and rapidly increasing number of available prescription and over-the-counter medications as well as nutritional supplements, the author recommends that all prescribers develop a personal formulary of ∼30 drugs that they use in everyday practice and with which they are intimately familiar. It is recommended that their knowledge of these drugs include both their generic and brand names (to avoid confusion leading to prescription of the wrong drugs), routinely used doses, pharmacokinetics including half-lives, pharmacodynamics including mechanism(s) of action and binding profile for specific receptors, adverse effect profiles, potential DDIs, and the evolving research literature on these agents. The author stresses the value of establishing a therapeutic alliance involving the patient and the people around him or her (eg, prescribers, family members, pharmacists, nurse practitioners, home health professionals, friends when appropriate) to promote the patient's understanding of and adherence to treatment. It is also important to establish a therapeutic goal with a specific time expectation (eg, reduction in depressive symptoms within 4 wk), after which the prescriber should discuss adherence with the patient and significant others, consider a dose adjustment, or discontinue the drug after an adequate therapeutic trial or the development of an adverse effect that outweighs any benefit the drug may be having. The author outlines major principles for avoiding adverse DDIs and includes a table of online resources that provide information concerning different types of DDIs. The column ends with a discussion of limitations of currently available drug alert software programs and information on how and where to report adverse drug reactions.

Association between FDA black box warnings and Medicare formulary coverage changes.

OBJECTIVES: To assess whether Medicare formularies restrict access to drugs receiving new FDA black box warnings for which safer drug alternatives are available. STUDY DESIGN: A retrospective analysis using Medicare Prescription Drug Plan Formulary files to determine formulary changes for drugs receiving FDA black box warnings between 2007 and 2013. METHODS: We identified all FDA-approved medications available in tablet or capsule formulation that received a black box warning between 2007 and 2013 related to death and/or cardiovascular risk. We then determined formulary coverage of these drugs pre-black box warning, 1 year after, and 2 years after. For each formulary, we identified formulary restrictiveness, defined as: unrestrictive coverage (no prior authorization or step therapy), restrictive coverage (prior authorization or step therapy required), or no coverage. RESULTS: Nine drugs with at least 1 FDA-approved safer drug alternative received 10 new black box warnings for death and/or cardiovascular risk between 2007 and 2013. In response to FDA black box warnings, overall formulary restrictiveness increased for 40% (n = 4) of drugs at 1 year, and for 50% (n = 5) at 2 years. However, for the majority of drugs (n = 7), most formularies remained unrestrictive 2 years after a new black box warning. CONCLUSIONS: Medicare formularies became more restrictive for half of the drugs that recently received new FDA black box warnings for death and/or cardiovascular risk and for which safer drug alternatives are available. However, a substantial proportion of formularies remained unrestrictive, suggesting inconsistent responses to new safety information to curtail the use of these medications.

Biosimilar uptake by British local formularies: a cross sectional study.

Background Biological medicines are starting to lose their patent protection, so similar, inexact copies (biosimilars) are being developed and licensed. The high acquisition costs of biologics for healthcare providers could be reduced by switching to biosimilars, thus alleviating budgetary pressures and increasing patient access. Therefore, the acceptance of biosimilars by prescribers in Great Britain (GB; England, Scotland, Wales) needs to be described and understood. Objective To determine uptake of the first wave of biosimilars (somatropin, epoetin, filgrastim) by local formularies (lists of preferred medicines for prescribing in local healthcare settings). Settings This study targeted local formularies in GB. Method In November 2014, local formularies (medicines formularies of Acute Trusts and Health Boards in GB) were screened for their approach to listing of biologics and their biosimilars as well as recommendations on usage of these pharmaceuticals. Main Outcomes Measures Listing frequencies of biosimilars. Results One hundred and forty-six British local formularies were screened. Amongst the 80% of formularies in which brand names were specified, biosimilar filgrastim was the most frequently listed when compared to the other targeted biosimilars. Biosimilars were listed in preference to reference biologic medicine in 49% of local formularies for filgrastim, 11% for somatropin and in only 6% for epoetin. Conclusion Although the market for biosimilars can act in parallel to the generic market, their uptake measured using local British formularies was less than what is expected given that the British market for medicines has a strong focus on generics. Finally, geographical variability within GB requires further investigation.

Implementation of a formulary management process.

PURPOSE: The application of lean methodology in an initiative to redesign the formulary maintenance process at an academic medical center is described. SUMMARY: Maintaining a hospital formulary requires clear communication and coordination among multiple members of the pharmacy department. Using principles of lean methodology, pharmacy department personnel within a multihospital health system launched a multifaceted initiative to optimize formulary management systemwide. The ongoing initiative began with creation of a formulary maintenance redesign committee consisting of pharmacy department personnel with expertise in informatics, automation, purchasing, drug information, and clinical pharmacy services. The committee met regularly and used lean methodology to design a standardized process for management of formulary additions and deletions and changes to medications' formulary status. Through value stream analysis, opportunities for process and performance improvement were identified; staff suggestions on process streamlining were gathered during a series of departmental kaizen events. A standardized template for development and dissemination of monographs associated with formulary additions and status changes was created. In addition, a shared Web-based checklist was developed to facilitate information sharing and timely initiation and completion of tasks involved in formulary status changes, and a permanent formulary maintenance committee was established to monitor and refine the formulary management process. CONCLUSION: A clearly defined, standardized process within the pharmacy department was developed for tracking necessary steps in enacting formulary changes to encourage safe and efficient workflow.

Computational health economics for identification of unprofitable health care enrollees.

Health insurers may attempt to design their health plans to attract profitable enrollees while deterring unprofitable ones. Such insurers would not be delivering socially efficient levels of care by providing health plans that maximize societal benefit, but rather intentionally distorting plan benefits to avoid high-cost enrollees, potentially to the detriment of health and efficiency. In this work, we focus on a specific component of health plan design at risk for health insurer distortion in the Health Insurance Marketplaces: the prescription drug formulary. We introduce an ensembled machine learning function to determine whether drug utilization variables are predictive of a new measure of enrollee unprofitability we derive, and thus vulnerable to distortions by insurers. Our implementation also contains a unique application-specific variable selection tool. This study demonstrates that super learning is effective in extracting the relevant signal for this prediction problem, and that a small number of drug variables can be used to identify unprofitable enrollees. The results are both encouraging and concerning. While risk adjustment appears to have been reasonably successful at weakening the relationship between therapeutic-class-specific drug utilization and unprofitability, some classes remain predictive of insurer losses. The vulnerable enrollees whose prescription drug regimens include drugs in these classes may need special protection from regulators in health insurance market design.

Validating pharmaceutical product claims: questions a formulary committee should ask.

Claims, justifying the acceptance and placement of new products on health system formularies, are all too often presented in terms that are either unverifiable or only verifiable in a timeframe that is of no practical benefit to formulary committees. One solution is for formulary committees to request that (i) all predictive claims made should be capable of empirical testing and (ii) manufacturers in making submissions should be asked to submit a protocol that details how their claims are to be assessed. Evaluation of claims can provide not only a significant input to ongoing disease area and therapeutic reviews, but can also provide a needed link to comparative effectiveness research and value-based healthcare. This paper presents a set of protocol standards (PROST) together will questions that should be addressed in a protocol review.

Antenatal corticosteroids for management of preterm birth: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: Preterm birth complications are the leading cause of deaths for children under five years. Antenatal corticosteroids (ACS) are effective at reducing mortality and serious morbidity amongst infants born at <34 weeks gestation. WHO guidelines strongly recommend use of ACS for women at risk of imminent preterm birth where gestational age, imminent preterm birth, and risk of maternal infection can be assessed, and appropriate maternal/newborn care provided. However, coverage remains low in high-burden countries for reasons not previously systematically investigated. METHODS: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the Every Newborn Action Plan process. Country workshops involved technical experts to complete the survey tool, which is designed to synthesise and grade health system "bottlenecks", factors that hinder the scale up, of maternal-newborn intervention packages. We used quantitative and qualitative methods to analyse the bottleneck data, combined with literature review, to present priority bottlenecks and actions relevant to different health system building blocks for ACS. RESULTS: Eleven out of twelve countries provided data in response to the ACS questionnaire. Health system building blocks most frequently reported as having significant or very major bottlenecks were health information systems (11 countries), essential medical products and technologies (9 out of 11 countries) and health service delivery (9 out of 11 countries). Bottlenecks included absence of coverage data, poor gestational age metrics, lack of national essential medicines listing, discrepancies between prescribing authority and provider cadres managing care, delays due to referral, and lack of supervision, mentoring and quality improvement systems. CONCLUSIONS: Analysis centred on health system building blocks in which 9 or more countries (>75%) reported very major or significant bottlenecks. Health information systems should include improved gestational age assessment and track ACS coverage, use and outcomes. Better health service delivery requires clarified policy assigning roles by level of care and cadre of provider, dependent on capability to assess gestational age and risk of preterm birth, and the implementation of guidelines with adequate supervision, mentoring and quality improvement systems, including audit and feedback. National essential medicines lists should include dexamethasone for antenatal use, and dexamethasone should be integrated into supply logistics.

Formulary status of drugs in Ontario after Health Canada has issued a serious safety warning: a cohort study.

BACKGROUND: Drugs are approved for formulary listing based on limited knowledge of their safety. Serious safety issues are often identified after a drug is marketed. OBJECTIVE: To determine whether the listing status of drugs on the Ontario Drug Benefit (ODB) Formulary changes following the identification of safety concerns by Health Canada and whether the results of reviews by people responsible for the ODB Formulary are made public. METHODS: All new active substances (NAS) approved by Health Canada from January 1, 2002 to March 31, 2012 that subsequently had a warning issued about a serious safety concern were identified. Editions of the ODB Formulary were searched to find which of these drugs were listed on the Formulary before the safety warning was issued. RESULTS: A total of 263 NAS were approved of which 42 subsequently acquired one or more serious safety warnings and 15 of these were listed on the ODB Formulary before the safety warning was issued. The listing status of 14 of the 15 drugs was unchanged after the release of the safety warning. No information is available about whether the listing status of these 14 drugs was reassessed. CONCLUSIONS: The ODB Formulary should develop a set of criteria to determine whether the listing status of drugs should be reviewed after Health Canada issues a serious safety warning. The results of any reconsiderations should made public so that prescribers and patients alike know that the ODB Formulary officials still regard the drugs as having a positive benefit to harm ratio.

The rise and fall of the thiazolidinediones: impact of clinical evidence publication and formulary change on the prescription incidence of thiazolidinediones.

BACKGROUND: Numerous factors affect drug utilization including clinical trials, promotional activity, drug safety signals and funding practices. We sought to investigate the impact of cardiovascular safety concerns and public drug formulary restrictions on the use of the thiazolidinediones (TZDs): rosiglitazone and pioglitazone. METHODS: We conducted a population-based cross-sectional time series analysis among more than 1.6 million older residents of Ontario, Canada using administrative healthcare claims databases from January 2000 to September 2010 to examine the impact of two events on the rate of initiation of TZDs among those aged 66 years and older: 1) the publication of a prominent meta-analysis suggesting cardiovascular harm for rosiglitazone, and 2) the introduction of prescribing restrictions for TZDs on the public formulary. RESULTS: Incident rosiglitazone prescribing decreased significantly from 5.32 to 0.44 prescriptions per 1,000 patients in the quarter following the publication of a meta-analysis, suggesting safety concerns for rosiglitazone (p<0.01). Similarly, incident pioglitazone prescribing continued to decline from 1.89 just prior to the publication of the meta-analysis to 0.53 prescriptions per 1,000 patients just prior to the policy implementation (p<0.01). Following the implementation of formulary restrictions for TZDs in Q2 of 2009, the rate of incident prescriptions for rosiglitazone fell further, from 0.20 prescriptions per 1,000 patients in the preceding quarter to 0.03 prescriptions per 1,000 patients in the subsequent quarter (Q3 of 2009; p<0.01). The rate of prescriptions dispensed for pioglitazone also decreased from 0.53 in Q1of 2009 to 0.11 prescriptions per 1,000 patients in Q3 of 2009 (p <0.01). CONCLUSION: Both the publication of clinical evidence and drug policy changes can significantly influence the utilization of the TZDs.

National Essential Medicines List and policy practice: a case study of China's health care reform.

BACKGROUND: In 2009, China implemented the national essential medicines system by enacting the National Essential Medicines List 2009. According to the policy of this system, primary health care institutions can only stock and use essential medicines on the prescribed List. Meanwhile, each province can choose to make its own list of supplemented medicines. The goal of the study is to provide suggestions for emerging problems and identify future policy-making trends. METHODS: In this study, we statistically analyzed the National Essential Medicines List 2009 and lists of supplemented medicines of all 29 provinces. We also examined the rationality of such medicines based on the DELPHI method and literature review, after which we studied the provincial supplements in relation to the national essential medicines system. RESULTS: We demonstrated that the National Essential Medicines List 2009 provides a comprehensive coverage of diseases as well as reasonable varieties of drugs for their treatment. The average number of supplemented medicines in 29 provinces is 207, with each medicine included in 2.9 provincial lists on average. Only 2.6% supplemented medicines are included by more than half of the provinces (>15), indicating great regional variance. Among the 32 most frequently supplemented medicines, only 18 meet the selection principles, including two with strict usage restrictions. CONCLUSION: The structure and selection of the National Essential Medicines List 2009 are relatively reasonable. The main problems, however, include the excessive and non-scientific selection of medicines on the supplemented medicines list. The function of the provincial lists of supplemented medicines has not been achieved, which has influenced the effectiveness of the national essential medicines system in China.