In 2006 I found research from Health & Productivity Management – Vol. 2, No. 2, 2005, that estimated the cost of chronic pain management to be well over $120 Billion per year. As I was researching for this month’s posts, I came across a report by the Institute of Medicine (IOM) that stated the cost of chronic pain management in America today is over $635 Billion per year in direct medical costs and lost productivity.

This information validated my own experience of seeing this pattern of increase over the past five or six years. I also believe a significant percentage of this cost is due to under-treatment or in many cases late-treatment of a chronic pain condition. Another factor for these high costs is the failure to identify and/or treat coexisting psychological or other medical disorders. I believe this to be the number one cause of poor chronic pain management outcomes.

Here are some excerpts from the June 29, 2011 IOM report validating my premise that chronic pain is a serious national public health problem which should become a national priority. You can read the entire report brief at the IOM website.

Chronic pain affects an estimated 116 million American adults—more than the total affected by heart disease, cancer, and diabetes combined. Pain also costs the nation up to $635 billion each year in medical treatment and lost productivity. The 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services (HHS) to enlist the IOM in examining pain as a public health problem.

In this report, the IOM offers a blueprint for action in transforming prevention, care, education, and research, with the goal of providing relief for people with pain in America. To reach the vast multitude of people with various types of pain, the nation must adopt a population-level prevention and management strategy. The IOM recommends that HHS develop a comprehensive plan with specific goals, actions, and timeframes. Better data are needed to help shape efforts, especially on the groups of people currently under-diagnosed and undertreated, and the IOM encourages federal and state agencies and private organizations to accelerate the collection of data on pain incidence, prevalence, and treatments.

Because pain varies from patient to patient, healthcare providers should increasingly aim at tailoring pain care to each person’s experience, and self-management of pain should be promoted. In addition, because there are major gaps in knowledge about pain across health care and society alike, the IOM recommends that federal agencies and other stakeholders redesign education programs to bridge these gaps.

Pain as a Public Health Challenge

To reach the vast multitude of people with various types of pain, the nation must adopt a population-level prevention and management strategy. HHS should develop a comprehensive plan with specific goals, actions, and timeframes. The plan should:

• heighten awareness about pain and its health consequences;
• emphasize the prevention of pain;
• improve pain assessment and management in the delivery of health care and financing programs of the federal government;
• use public health communication strategies to inform patients on how to manage their own pain; and
• address disparities in the experience of pain among subgroups of Americans.

Blueprint for Action

The committee offers a blueprint for action in transforming prevention, care, education, and research, with the goal of providing relief for people with pain in America. The blueprint prioritizes the committee’s recommendations. While some recommendations should be implemented by the end of 2012—including developing a comprehensive strategy, developing strategies to reduce barriers in care, supporting collaboration between pain specialists and primary care clinicians, and designating a lead institute at the NIH that is responsible for moving pain research forward—all other recommended actions must build on these short-term achievements and should be taken soon afterward. These other actions must be ongoing efforts that should be firmly developed and put in place by the end of 2015.

The strategy should be comprehensive in scope, inclusive in its development, expeditious in its implementation, and practical in its application. Most importantly, the strategy must be far-reaching. As evidenced in this report, pain is a major driver for visits to physicians and other healthcare providers, a major reason for taking medications, a major cause of disability, and a key factor in quality of life and productivity. Given the burden of pain in human lives, dollars, and social consequences, relieving pain should be a national priority.

Over the past several years the chronic pain management field has seen a number of new medications and some old medications delivered in new ways. This has become known as the Novel Drug Delivery System (NDDS) that includes, but is not limited to, the following drug delivery solutions which I will highlight in this article:

• Transdermal Drug Delivery Systems
• Implant Drug Delivery Systems
• Oral Drug Delivery Systems

Transdermal drug delivery system is a formulation that is applied to the body surface and is designed to deliver the active drug across the skin, into the systemic circulation.

Posted below is the Abstract and some of the new systems reviewed in the International Pharmaceutica Sciencia—an international peer review journal—Jan-March 2011, Vol. 1, Issue 1 titled Innovations in Transdermal drug delivery system. You can read the entire post, at ipharmsciencia.

The transdermal route of drug delivery has attracted researchers due to many biomedicaladvantages associated with it. However, excellent impervious nature of skin is the greatestchallenge that has to be overcome for successfully delivering drug molecules to the systemiccirculation by this route. Various formulation approaches used to systemically deliver drug molecules include use of prodrugs/lipophilic analogs, permeation enhancers, sub saturatedsystems and entrapment into vesicular systems. Innovations in the area of drug delivery aretaking place at a much faster pace as compared to the last two decades. Improved patient compliance and effectiveness are inextricable aspects of a new drug delivery system.

Transdermal delivery offers several biomedical advantages over conventional routes includingavoidance of presystemic and systemic first pass metabolism and controlled release over extended period besides providing a convenient non-invasive and easily terminable means forsystemic as well as topical drug delivery. Some factors that limited the success of transdermaltechnology included skin irritation, limitation of dose that could be incorporated in the patch,lag time for drug absorption/ onset of action, variation in drug absorption rate with respect tosite of application and failure of adhesiveness. Thus the aim of this review work is to focus onthe recent innovations in Transdermal Drug Delivery Systems which can be a platform for the research and development of pharmaceutical drug dosage form for Transdermal Drug Delivery.

Drug in an Adhesive Type Patch: The drug reservoir is formed by dispersing the drug in an adhesive polymer and then spreading the medicated polymer adhesive by solvent casting or by melting the adhesive (in case of hot-melt adhesives) onto an impervious backing layer. The drug reservoir layer is then covered by a non-medicated rate controlling adhesive polymer of constant thickness to produce an adhesive diffusion controlling drug delivery system.

Matrix Dispersion System: The drug is dispersed homogeneously in a hydrophilic or lipophilic polymer matrix. This drug containing polymer disk then is fixed onto an occlusive base plate in a compartment fabricated from a drug-impermeable backing layer. Instead of applying the adhesive on the face of the drug reservoir, it is spread along the circumference to form a strip of adhesive rim.

Reservoir Transdermal Patch: In this system, the drug reservoir is embedded between an impervious backing layer and a rate controlling membrane. The drug releases only through the rate controlling membrane, which can be microporous or non-porous. In the drug reservoir compartment, the drug can be in the form of a solution, suspension, or gel or dispersed in solid polymer matrix. On the outer surface of the polymeric membrane a thin layer of drug-compatible, hypoallergenic adhesive polymer can be applied. The rate of drug release from this type of transdermal drug delivery system can be tailored by varying the polymer composition, permeability coefficient and thickness of the rate controlling membrane.

Microreservoir System: This drug delivery system is a combination of reservoir and matrix-dispersion systems. The drug reservoir is formed by first suspending the drug in an aqueous solution of water-soluble polymer and then dispersing the solution homogeneously in a lipophilic polymer to form thousands of unleachable, microscopic spheres of drug reservoirs. The thermodynamically unstable dispersion is stabilized quickly by immediately cross-linking the polymer in situ. A transdermal system therapeutic system thus formed as a medicated disc positioned at the centre and surrounded by an adhesive rim.

Laser Assisted Delivery (LAD): Two possible mechanisms: Ablative and Laser induced stress waves (photomechanical waves).

• In Ablation: The high energy of laser is imparted into the skin to form pores that permit the transit of drug through Stratum Corneum.
• In Laser induced stress waves: There is transient permeabilisation effect of macromolecules through SC due to changes in lacunar system
• Route of delivery: Transappendageal, transcellular and intercellular
• The laser is applied to target that is in contact with a drug solution or to the drug solution itself.
• The energy of the laser is strongly absorbed by the target or surface of water and this produces an ultrasonic pressure wave that propagates through the solution to the drug/skin interface.
• This wave drives the drug through ?natural physiological skin pore.

Another system often used is the intrathecal (or implant) drug delivery system that has significantly evolved since its inception in the late-1970s. Its use has spread to non-malignant patients as well. Apart from morphine, muscle relaxants, such as baclofen, have also been used to treat patients with spinal spasticity. The drug delivery method has evolved from direct injections to long-term infusions through a catheter implanted in the cerebrospinal space, with the aid of either an external or internal reservoir.

Due to the direct introduction of the drug into the central nervous system, intrathecal drug delivery has several advantages. The dosage is usually a fraction of the oral dose. The systemic side effects of the drug are reduced because the drug is delivered directly to the site of action. Clinical studies have documented the efficacy of this system in patients with back pain, spasticity, and cancer pain. However, the introduction of the catheter into a location at close proximity to the spinal cord requires expertise. Patient selection is also important in terms of their response and tolerance to the drug.

Among the implantable intrathecal devices, there are two main types: those that are programmable and those that are constant flow. The programmable devices are battery operated and have the ability to vary the drug delivery through an external telemetry system. The constant flow system does not require a battery to operate, but it cannot be programmed. The programmable systems are usually pricier than the constant flow systems due to their sophistication.

Oral Drug Delivery Systems

Below are some recent updates on the oral release delivery system from the International Journal of Pharmaceutical Sciences Review and Research I found at globalresearchonline where you can read the entire post.

Oral drug delivery has been known for decades as the most widely utilized route of administered among all the routes that have been employed for the systemic delivery of drug via various pharmaceutical products of different dosage forms. The reasons that the oral route achieved such popularity may be in part attributed to its ease of administration. Oral sustained drug delivery system is complicated by limited gastric residence times (GRTs).

Rapid GI transit can prevent complete drug release in the absorption zone and reduce the efficacy of the administered dose since the majority of drugs are absorbed in stomach or the upper part of small intestine. To overcome these limitations, various approaches have been proposed to increase gastric residence of drug delivery systems in the upper part of the gastrointestinal tract includes floating drug dosage systems (FDDS) swelling or expanding systems, mucoadhesive systems, modified-shape systems, high-density system, and other delayed gastric emptying devices. Among these systems, FDDS have been most commonly used.

Gastroretentive drug delivery system (GRDDS) comprised mainly of floating, bioadhesive, swelling, high density and magnetic systems have emerged as a current approaches of enhancing the bioavailability and controlled delivery of drugs that exhibit an absorption window. By prolonging the gastric emptying time of the dosage form, these systems not only provide controlled release of the drug for a prolonged period but also present the drug in an absorbable form at regions of optimal absorption. All these drug delivery systems are interesting and present their own advantages and drawbacks. Designing GRDDS requires a thorough understanding of the physicochemical properties of the drug, the physiological events of the GIT and formulation strategies. A careful consideration of the interplay of these parameters can help in designing a successful GRDDS.

I was first introduced to meditation while I was training in Karate over 30 years ago and have been using it ever since. After a serious injury I incorporated meditation as an important part of my own chronic pain management recovery plan. I also explored its use when I started working with patients living with chronic pain, many of whom found it helpful as well.

Participants at my pain management trainings often ask: yes it might work, but is it research based? I am please to say that yes it is! I’ve reviewed many studies over the past several years affirming this. As a matter of fact, I received an email from a colleague recently who told me about a new research study out of Wake Forest University titled Demystifying Meditation – Brain Imaging Illustrates How Meditation Reduces Pain. I've posted excerpts below of this research that was published in the April 6, 2011 edition of the Journal of Neuroscience. You can read the entire study at the Wake Forest University Website.

“This is the first study to show that only a little over an hour of meditation training can dramatically reduce both the experience of pain and pain-related brain activation,” said Fadel Zeidan, Ph.D., lead author of the study and post-doctoral research fellow at Wake Forest Baptist Medical Center.

“We found a big effect – about a 40 percent reduction in pain intensity and a 57 percent reduction in pain unpleasantness. Meditation produced a greater reduction in pain than even morphine or other pain-relieving drugs, which typically reduce pain ratings by about 25 percent.”

For the study, 15 healthy volunteers who had never meditated attended four, 20-minute classes to learn a meditation technique known as focused attention. Focused attention is a form of mindfulness meditation where people are taught to attend to the breath and let go of distracting thoughts and emotions.

Both before and after meditation training, study participants’ brain activity was examined using a special type of imaging -- arterial spin labeling magnetic resonance imaging (ASL MRI) -- that captures longer duration brain processes, such as meditation, better than a standard MRI scan of brain function. During these scans, a pain-inducing heat device was placed on the participants’ right legs. This device heated a small area of their skin to 120° Fahrenheit, a temperature that most people find painful, over a 5-minute period. The scans taken after meditation training showed that every participant’s pain ratings were reduced, with decreases ranging from 11 to 93 percent, Zeidan said.

At the same time, meditation significantly reduced brain activity in the primary somatosensory cortex, an area that is crucially involved in creating the feeling of where and how intense a painful stimulus is. The scans taken before meditation training showed activity in this area was very high. However, when participants were meditating during the scans, activity in this important pain-processing region could not be detected.

The research also showed that meditation increased brain activity in areas including the anterior cingulate cortex, anterior insula and the orbito-frontal cortex. “These areas all shape how the brain builds an experience of pain from nerve signals that are coming in from the body,” said Robert C. Coghill, Ph.D., senior author of the study and associate professor of neurobiology and anatomy at Wake Forest Baptist.

News & Research Archive — Here is a history of past Research for 2011.