The burden of premature opioid-related mortality
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.
Individuals who died of opioid-related causes between January 1991 and December 2010.
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.
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.
Rates of opioid-related deaths are increasing rapidly in Ontario, Canada, and are concentrated among the young, leading to a substantial burden of disease.
Small Geographic Area Variations in Prescription Drug Use
BACKGROUND: Despite the frequency of pediatric prescribing little is known about practice differences across small geographic regions and payer type (Medicaid and commercial).
OBJECTIVE: The goal of this research was to quantify variation in prescription drug use among northern New England children.
METHODS: Northern New England, all-payer administrative data (2007–2010) permitted study of prescriptions for 949 821 children ages 0 to 17 years (1.75 million person-years [PYs]; 54% Medicaid, 46% commercial). Age- and gender adjusted overall and drug group–specific prescription use was quantified according to payer type (Medicaid or commercial) and within payer type across 69 hospital service areas (HSAs). We measured prescription fills per PY (rate) and annual, mean percentage of the population with any drug group–specific fills (prevalence).
RESULTS: Overall mean annual prescriptions per PY were 3.4 (commercial) and 5.5 (Medicaid). Generally, these payer type differences were smaller than HSA-level variation within payer type. HSA-level rates of attention-deficit/hyperactivity disorder drug use (5th–95th percentile) varied twofold in Medicaid and more than twofold in commercially insured children; HSA-level antidepressant use varied more than twofold within each payer type. Antacid use varied threefold across HSAs and was highest in infants where commercial use paradoxically exceeded Medicaid. Prevalence of drug use varied as much as rates across HSAs.
CONCLUSIONS: Prescription use was higher among Medicaid-insured than commercially insured children. Regional variation generally exceeded payer type differences, especially for drugs used in situations of diagnostic and therapeutic uncertainty. Efforts should advance best pediatric prescribing discussions and shared decision-making.
Examining the Number of Competitors and the Cost of Medicare Part D: Working Paper 2014-04
Source: Congressional Budget Office
Most beneficiaries of Medicare’s Part D prescription drug insurance choose among private drug plans to receive their coverage. This paper is the first to examine the relationship between the number of competing plan sponsors and the cost of Part D during the program’s first five years. Over the period from 2006 to 2010, regional Part D markets contained between 16 and 22 plan sponsors offering stand-alone plans. Consistent with economic theory, we find that increases in the number of plan sponsors within a market were associated with lower bids and lower overhead and profits of plans in that market. For example, among stand-alone plans that were not eligible to be assigned low-income beneficiaries, we find that each additional plan sponsor entering an 18-firm market was associated with a reduction in bids for a month of basic coverage to a beneficiary of average health of 0.4 percent—or $0.33 for a plan that bid $85—which corresponds to an elasticity of -0.071. (That result is an arithmetic average across six specifications in which estimates range from $0.20 to $0.50.) Because bids are used to directly determine government spending, we estimate that an additional plan sponsor nationwide was associated with a reduction in government spending of $7 million to $17 million each year.
Intellectual Property Underpinnings of Pharmaceutical Innovation: A Primer
Source: American Action Forum
Companies across the U.S. are meeting health challenges head on by investing in time, talent, and materials. U.S. federal law has long protected these endeavors through the intellectual property (IP) regime. Understanding the process of innovation in both health and medicine requires a basic knowledge of three areas: the legal underpinnings of patent law, the economics of patents, and how the two interact within a company. Today, we cannot forget just how important these laws have been in creating and sustaining the technological sectors, especially those where innovation is especially costly. A basic overview of intellectual property rights (IPR) in innovative industries, particularly in medical treatments, is a beginning point to explore where the regime has gotten things right.
Emergency department visits for drug-related suicide attempts rise over six year period
Source: Substance Abuse and Mental Health Services Administration
Two new reports highlight the rise in drug-related suicide attempt visits to hospital emergency departments especially among certain age groups. The reports by the Substance Abuse and Mental Health Services Administration (SAMHSA) show that overall there was a 51 percent increase for these types of visits among people 12 and older — from 151,477 visits in 2005 to 228,277 visits in 2011.
One report analyzed the increase in emergency department visits by age and found that the overall rise resulted from increases in visits by people aged 18 to 29 and people aged 45 to 64. Visits involving 18 to 29 year olds increased from 47,312 in 2005 to 75,068 — a 58 percent increase. Visits involving people aged 45 to 64 increased from 28,802 in 2005 to 58,776 visits in 2011 — a 104 percent increase. In 2011, these two age groups comprised approximately 60 percent of all drug-related emergency department visits involving suicide attempts.
The other SAMHSA report focused on the 45 to 64 age group, which had the largest increase in emergency department visits involving drug related suicide attempts, and characterized these visits. The report found that the majority (96 percent in 2011) of these visits involved the non-medical use of prescription drugs and over-the-counter-medications. In 2011, these drugs included anti-anxiety and insomnia medications (48 percent), pain relievers (29 percent) and antidepressants (22 percent).
Other substances involved in these drug-related suicide attempt emergency department visits during the same year included alcohol (39 percent) and illicit drugs (11 percent).
The report also found that these visits by patients aged 45 to 64 doubled for both men and women during this time period.
FDA approves new extended-release oxycodone with abuse-deterrent properties
Source: U.S. Food and Drug Administration
Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.
Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose. Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused. It is important to note that taking too much Targiniq ER for purposes of abuse or by accident, can cause an overdose that can result in death.
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.
Currently, there is concern that traditional statutes regulating “generic drugs” may be misapplied to new products that are not identical. This has led to a recent move to amend older state laws to address the medical and chemical characteristics of these “biologics,” as well as any future generic-style “follow-on biologics” or “biosimilars.”
In the past one and a half years at least 23 states have considered legislation establishing state standards for substitution of a “biosimilar” prescription product to replace an original biologic product.