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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
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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.

State laws and legislation related to biologic medications and substitution of biosimilars

September 11, 2014 Comments off

State laws and legislation related to biologic medications and substitution of biosimilars
Source: National Conference of State Legislatures

For several decades, every state has regulated the use of brand-name and generic prescription drugs through statutes and agency or board rules. These state actions include when and how generics may be substituted for brand-name prescriptions, by pharmacists or others. Generic drugs typically have active ingredients that are identical to those of their brand-name counterpart. These traditional drugs include familiar pills used regularly by tens of millions of Americans as well as some specialty drugs.

Biologic medicines are much more complex than traditional chemically synthesized drugs. Biologics are manufactured from living organisms by programming cell lines to produce the desired therapeutic substances and consist of large molecules. Common biologics in use today include human growth hormone, injectable treatments for arthritis and psoriasis, the Hepatitis B vaccine and stem cell therapy.

Regulating biologics raises new issues for both state and federal policymakers. Because of their complexity, biologic drugs are much more difficult to replicate than the chemically produced generics for other drugs. The cell lines used and modifications in the manufacturing process affect biologic medicines. As a result, truly identical “generic” versions are currently virtually impossible to produce. However, once patents expire for the existing brand-name biologic drugs, “biosimilar” medicines can be produced, which is an occurrence that raises regulatory issues in the states.

Emergency department visits linked to zolpidem overmedication nearly doubled

September 3, 2014 Comments off

Emergency department visits linked to zolpidem overmedication nearly doubled
Source: Substance Abuse and Mental Health Services Administration

The estimated number of emergency department visits involving zolpidem overmedication (taking more than the prescribed amount) nearly doubled from 21,824 visits in 2005-2006 to 42,274 visits in 2009-2010, according to a new study by the Substance Abuse and Mental Health Services Administration (SAMHSA).

The report also indicates that 68 percent of all zolpidem overmedication visits in 2010 involved females, the number of zolpidem overmedication emergency department visits for males increased 150 percent from 2005-2006 to 2009-2010 compared to an increase of 69 percent for females over the same time period.

In 2010 there were a total of 4,916,328 drug-related visits to emergency departments throughout the nation.

Other prescription drugs were involved in 57 percent of the emergency department visits involving zolpidem overmedication. These medications included benzodiazepines (26 percent) and narcotic pain relievers (25 percent). Alcohol was also combined with zolpidem in 14 percent of these hospital emergency department visits.

CA — The burden of premature opioid-related mortality

August 19, 2014 Comments off

The burden of premature opioid-related mortality
Source: Addiction

Background and Aims
The burden of premature mortality due to opioid-related death has not been fully characterized. We calculated temporal trends in the proportion of deaths attributable to opioids and estimated years of potential life lost (YLL) due to opioid-related mortality in Ontario, Canada.

Design
Cross-sectional study.

Setting
Ontario, Canada.

Participants
Individuals who died of opioid-related causes between January 1991 and December 2010.

Measurements
We used the Registered Persons Database and data abstracted from the Office of the Chief Coroner to measure annual rates of opioid-related mortality. The proportion of all deaths related to opioids was determined by age group in each of 1992, 2001 and 2010. The YLL due to opioid-related mortality were estimated, applying the life expectancy estimates for the Ontario population.

Findings
We reviewed 5935 opioid-related deaths in Ontario between 1991 and 2010. The overall rate of opioid-related mortality increased by 242% between 1991 (12.2 per 1 000 000 Ontarians) and 2010 (41.6 per 1 000 000 Ontarians; P < 0.0001). Similarly, the annual YLL due to premature opioid-related death increased threefold, from 7006 years (1.3 years per 1000 population) in 1992 to 21 927 years (3.3 years per 1000 population) in 2010. The proportion of deaths attributable to opioids increased significantly over time within each age group (P < 0.05). By 2010, nearly one of every eight deaths (12.1%) among individuals aged 25–34 years was opioid-related.

Conclusions
Rates of opioid-related deaths are increasing rapidly in Ontario, Canada, and are concentrated among the young, leading to a substantial burden of disease.

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