Archive for the ‘prescription drugs’ Category

Empirically Characterizing Domain Abuse and the Revenue Impact of Blacklisting

September 29, 2014 Comments off

Empirically Characterizing Domain Abuse and the Revenue Impact of Blacklisting (PDF)
Source: George Mason University Department of Computer Science

Using ground truth sales data for over 40K unlicensed prescription pharmaceuticals sites, we present an economic analysis of two aspects of domain abuse in the online counterfeit drug market. First, we characterize the nature of domains abused by affiliate spammers to monetize what is evidently an overwhelming demand for these drugs. We found that the most successful affiliates are agile in adapting to adversarial circumstances, and channel the full spectrum of domain abuse to advertise to customers. Second, we use contemporaneous blacklisting data to provide an economic analysis of the revenue impact of domain blacklisting, a technique whereby lists of “known bad” registered domains are distributed and used to filter email spam. We found that blacklisting rapidly and effectively limited per-domain sales. Nevertheless, blacklisted domains continued to monetize, likely as a result of high demand, non-universal use of blacklisting, and delay in deployment. Finally, our results suggest that increasing the number of domains discovered and using blacklists to block access to spam domains could undermine profitability more than further improving the speed with which domains are added to blacklists.

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International scientists’ priorities for research on pharmaceutical and personal care products in the environment

September 24, 2014 Comments off

International scientists’ priorities for research on pharmaceutical and personal care products in the environment (PDF)
Source: Integrated Environmental Assessment and Management

Pharmaceuticals and personal care products (PPCPs) are widely discharged into the environment via diverse pathways. The effects of PPCPs in the environment have potentially important human and ecosystem health implications, so credible, salient, and legitimate scientific evidence is needed to inform regulatory and policy responses that address potential risks. A recent “big questions” exercise with participants largely from North America identified 22 important research questions around the risks of PPCP in the environment that would help address the most pressing knowledge gaps over the next decade. To expand that analysis, we developed a survey that was completed by 535 environmental scientists from 57 countries, of whom 49% identified environmental or analytical chemistry as their primary disciplinary background. They ranked the 22 original research questions and submitted 171 additional candidate research questions they felt were also of high priority. Of the original questions, the 3 perceived to be of highest importance related to: 1) the effects of long-term exposure to low concentrations of PPCP mixtures on nontarget organisms, 2) effluent treatment methods that can reduce the effects of PPCPs in the environment while not increasing the toxicity of whole effluents, and 3) the assessment of the environmental risks of metabolites and environmental transformation products of PPCPs. A question regarding the role of cultural perspectives in PPCP risk assessment was ranked as the lowest priority. There were significant differences in research orientation between scientists who completed English and Chinese language versions of the survey. We found that the Chinese respondents were strongly orientated to issues of managing risk profiles, effluent treatment, residue bioavailability, and regional assessment. Among English language respondents, further differences in research orientation were associated with respondents’ level of consistency when ranking the survey’s 15 comparisons. There was increasing emphasis on the role of various other stressors relative to PPCPs and on risk prioritization as internal decision making consistency increased. Respondents’ consistency in their ranking choices was significantly and positively correlated with SETAC membership, authors’ number of publications, and longer survey completion times. Our research highlighted international scientists’ research priorities and should help inform decisions about the type of hazard and risk-based research needed to best inform decisions regarding PPCPs in the environment. Disciplinary training of a scientist or engineer appears to strongly influence preferences for research priorities to understand PPCPs in the environment. Selection of participants and the depth and breadth of research prioritization efforts thus have potential effects on the outcomes of research prioritization exercises. Further elucidation of how patterns of research priority vary between academic and government scientists and between scientists and other government and stakeholders would be useful in the future and provide information that helps focus scientific effort on socially relevant challenges relating to PPCPs in the environment. It also suggests the potential for future collaborative research between industry, government, and academia on environmental contaminants beyond PPCPs. Integr Environ Assess Manag 2014;10:576–587. © 2014 SETAC

See: Priorities for research on pharmaceutical and personal care products in the environment (EurekAlert!)

A Sense of Déjà Vu: The Debate Surrounding State Biosimilar Substitution Laws

September 23, 2014 Comments off

A Sense of Déjà Vu: The Debate Surrounding State Biosimilar Substitution Laws
Source: AARP Public Policy Institute

The Affordable Care Act created an approval pathway for less expensive generic versions of biologic drugs, known as biosimilars, or follow-on biologics. This Insight on the Issues discusses controversial new state legislation that could greatly limit the savings from biosimilars and notes similarities to the debate ignited by the passage of federal legislation that encouraged the development of traditional generic drugs.

Mild hypertension in people at low risk

September 22, 2014 Comments off

Mild hypertension in people at low risk
Source: British Medical Journal

Summary box

  • Clinical context—Up to 40% of adults worldwide have hypertension, complications of which may account for up to 9.4 million deaths annually from cardiovascular disease
  • Diagnostic change—Recommendations for drug treatment have decreased from diastolic pressure of >115 mm Hg to ≥140/90 mm Hg. A new category, prehypertension (120/80-139/89 mm Hg), has also been introduced
  • Rationale for change—Patients with even mildly raised blood pressure may have increased cardiovascular risk
  • Leap of faith—Lowering threshold blood pressures will lead to increased diagnosis and treatment, which will decrease mortality
  • Impact on prevalence—22% of adults worldwide have mild hypertension (systolic pressure 140-159 mm Hg) and 13.5% have a systolic pressure ≥160 mm Hg
  • Evidence of overdiagnosis—Use of a uniform threshold (140 mm Hg) to mark hypertension risk ignores evidence that risk varies by individual and includes many people who will not benefit from drug treatment
  • Harms from overdiagnosis—Studies suggest over half of people with mild hypertension are treated with drugs even though this approach has not been proved to decrease mortality or morbidity. Overemphasis on drug treatment risks adverse effects, such as increased risk of falls, and misses opportunities to modify individual lifestyle choices and tackle lifestyle factors at a public health level
  • Limitations of evidence — Lack of randomised trials that use hard outcomes and compare drugs with lifestyle interventions and placebo in patients with mild hypertension
  • Conclusion—Lowering definitions of hypertension has led to identification and drug treatment of larger populations of patients despite lack of evidence that drugs reduce morbidity or mortality

HHS OIG — Medicare Part B Prescription Drug Dispensing and Supplying Fee Payment Rates Are Considerably Higher Than the Rates Paid by Other Government Programs

September 19, 2014 Comments off

Medicare Part B Prescription Drug Dispensing and Supplying Fee Payment Rates Are Considerably Higher Than the Rates Paid by Other Government Programs
Source: U.S. Department of Health and Human Services, Office of Inspector General

Medicare Part B would have saved millions of dollars in 2011 if dispensing fees for inhalation drugs administered through durable medical equipment and supplying fees for immunosuppressive drugs associated with an organ transplant, oral anticancer chemotherapeutic drugs, and oral antiemetic drugs used as part of an anticancer chemotherapeutic regimen had been aligned with the rates that Part D and State Medicaid programs paid. Part B paid $132.9 million in dispensing and supplying fees. We estimated that if Part B rates had been the same as the average Part D rates, Part B would have paid dispensing and supplying fees of $22 million, a savings of $110.9 million. We also estimated that if Part B rates had been the same as the average State Medicaid program rates, Part B would have paid dispensing and supplying fees of $26.6 million, a savings of $106.3 million.

We recommended that CMS amend current regulations to decrease the Part B payment rates for dispensing and supplying fees to rates similar to those of other payers, such as Part D and Medicaid. CMS did not concur with our recommendation and requested that OIG conduct a study to identify the specific activities involved with dispensing inhalation drugs and supplying oral drugs under Part B and collect information about the actual costs that are directly associated with dispensing these Part B drugs. We maintain that pharmacies are overpaid for dispensing drugs under Part B when compared with what they are paid for dispensing the same drugs under Part D and Medicaid.

New — National Strategy for Combating Antibiotic-Resistant Bacteria

September 19, 2014 Comments off

National Strategy for Combating Antibiotic-Resistant Bacteria (PDF)
Source: White House

The discovery of antibiotics in the early 20th century fundamentally transformed human and veterinary medicine. Antibiotics now save millions of lives each year in the United States and around the world. The rise of antibiotic-resistant bacterial strains, however, represents a serious threat to public health and the economy. The Centers for Disease Control and Prevention (CDC) estimates that annually, at least two million illnesses and 23,000 deaths are caused by antibiotic-resistant bacteria in the United States alone.1 If the effectiveness of antibiotics (drugs that kill or inhibit the growth of bacteria) is lost, we will no longer be able to reliably and rapidly treat bacterial infections, including bacterial pneumonias, foodborne illnesses, and healthcareassociated infections. As more strains of bacteria become resistant to an ever-larger number of antibiotics, our drug choices have become increasingly limited and more expensive and, in some cases, nonexistent. In a world with few effective antibiotics, modern medical advances such as surgery, transplants, and chemotherapy may no longer be viable due to the threat of infection.

The National Strategy for Combating Antibiotic Resistant Bacteria identifies priorities and coordinates investments: to prevent, detect, and control outbreaks of resistant pathogens recognized by CDC as urgent or serious threats, including carbapenem-resistant Enterobacteriaceae (CRE), methicillin-resistant Staphylococcus aureus (MRSA), ceftriaxoneresistant Neisseria gonorrhoeae, and Clostridium difficile, which is naturally resistant to many drugs used to treat other infections and proliferates following administration of antibiotics (Table 1); to ensure continued availability of effective therapies for the treatment of bacterial infections; and to detect and control newly resistant bacteria that emerge in humans or animals. This National Strategy is the basis of a 2014 Executive Order on Combating Antibiotic Resistance, as well as a forthcoming National Action Plan that directs Federal agencies to accelerate our response to this growing threat to the nation’s health and security. The National Action Plan will be informed by a report approved by the President’s Council of Advisors on Science and Technology (PCAST) on July 11, 2014.

Emergency Hospitalizations for Unsupervised Prescription Medication Ingestions by Young Children

September 16, 2014 Comments off

Emergency Hospitalizations for Unsupervised Prescription Medication Ingestions by Young Children
Source: Pediatrics

BACKGROUND: Emergency department visits and subsequent hospitalizations of young children after unsupervised ingestions of prescription medications are increasing despite widespread use of child-resistant packaging and caregiver education efforts. Data on the medications implicated in ingestions are limited but could help identify prevention priorities and intervention strategies.

METHODS: We used nationally representative adverse drug event data from the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project and national retail pharmacy prescription data from IMS Health to estimate the frequency and rates of emergency hospitalizations for unsupervised prescription medication ingestions by young children (2007–2011).

RESULTS: On the basis of 1513 surveillance cases, 9490 estimated emergency hospitalizations (95% confidence interval: 6420–12 560) occurred annually in the United States for unsupervised prescription medication ingestions among children aged <6 years from 2007 through 2011; 75.4% involved 1- or 2-year old children. Opioids (17.6%) and benzodiazepines (10.1%) were the most commonly implicated medication classes. The most commonly implicated active ingredients were buprenorphine (7.7%) and clonidine (7.4%). The top 12 active ingredients, alone or in combination with others, were implicated in nearly half (45.0%) of hospitalizations. Accounting for the number of unique patients who received dispensed prescriptions, the hospitalization rate for unsupervised ingestion of buprenorphine products was significantly higher than rates for all other commonly implicated medications and 97-fold higher than the rate for oxycodone products (200.1 vs 2.1 hospitalizations per 100 000 unique patients).

CONCLUSIONS: Focusing unsupervised ingestion prevention efforts on medications with the highest hospitalization rates may efficiently achieve large public health impact.


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