Corresponding responsibility vs Duty to Warn

Lawsuits Claiming That Pharmacies Must Warn Customers About Dangers Associated With Prescription Drugs

Complete Text   duty_to_warn

INTRODUCTION
Patients injured by prescription drugs sometimes claim that their pharmacists had a duty to warn
them about potential side effects and other dangers associated with prescription drugs. This
memorandum provides citations to court decisions from across the country that address the issue
of whether and when pharmacists have a duty to warn.
Most courts have ruled that pharmacists do not have a general duty to warn patients about their
prescribed drugs. Instead, the general rule is that drug manufacturers have a duty to provide
general warnings to physicians, and then physicians have a duty to warn their patients about the
drugs they prescribe. Most courts impose this duty to warn on physicians, rather than
pharmacists, because physicians decide which drugs to prescribe. Physicians know which
warnings are appropriate for a particular patient because they have access to the patient’s
complete medical history. This “learned intermediary doctrine” is the traditional rationale for
rejecting claims that pharmacists have a duty to warn.
A few state courts have rejected the learned intermediary doctrine, and have instead decided that
pharmacists do have a general duty to warn patients. Although most courts that have considered
the issue reject the notion that state counseling laws create a duty to warn, a minority of courts
have pointed to counseling laws as evidence that pharmacists have a duty to warn.
Other courts have held that pharmacists have a duty to warn only in certain circumstances. For
example, some courts have ruled that pharmacists have a duty to warn about known
contraindications, or clear errors on the face of a prescription (e.g., excessive dosages). Other
courts reject the notion of a general duty to warn, but hold that a pharmacy can voluntarily
assume a duty to warn. For example, a pharmacy that advertises its drug utilization review and
computer warning systems may have assumed a duty to warn about dangerous side effects.

It would seem that the edicts by the DEA and the rulings of our court system.. in regards of a Pharmacist’s responsible are in conflict.. Courts in different states have come to different conclusions as to a Pharmacist’s Duty to Warn… some of which are in direct conflict to the DEA’s interpretation of a Pharmacist’s Corresponding Responsibility.

CVS employee calls for better security as police investigate four weekend robbery attempts

guntohead

CVS employee calls for better security as police investigate four weekend robbery attempts

http://fox59.com/2015/03/23/cvs-employee-calls-for-better-security-as-police-investigate-four-weekend-robbery-attempts/

INDIANAPOLIS, Ind. (March 23, 2015)– An Indianapolis CVS pharmacy employee is calling on the company to make big changes in their stores in order to discourage robbery attempts. The woman, who does not want to be identified, says she has been through five robberies and two robbery attempts at her job. She has personally been handed a robbery demand note while working at the pharmacy counter.

“It always starts as a list of drugs,” she said, recalling a recent robbery note.  “Toward the end of the note, it says ‘this is a robbery, I have a gun, I’ll kill everybody in here.’”

The employee says she and her coworkers are constantly on edge, never knowing when the next robbery attempt may happen.

“Every person who walks through the door in a hoodie, you want to say ‘is this that guy,’” she said.  “Oh no, here it goes.  You get that sick feeling.  And when you have to turn your back to get a medication off the shelf, you have to look over your shoulder.”

Her concerns follow another rash of CVS pharmacy robbery attempts over the weekend.  On Saturday, robbery attempts were reported at CVS locations in the 2300 block of East 46th Street, the 6500 block of North Keystone Avenue and the 6200 block of Allisonville Road.  All three northeast side incidents happened between 12:40 and 1:50pm.  In each case, employees told police a male between the ages of 18 and 20 approached the pharmacy counter and presented a note, demanding several prescription pain killers.  Only one of the robbery attempts was successful.  One attempt was thwarted when a security guard approached the suspect and he ran out the door.  In another attempt, the suspect left the store empty handed when the pharmacist simply refused to accept the note.

A fourth CVS robbery attempt was reported Sunday afternoon around 3 p.m. in the 7200 block of North Michigan Road.  A male suspect in his 20s approached the pharmacy counter and presented a note that listed several prescription painkillers.  The rest of the note said “This is a robbery!  I am armed!  Do not push button or I’ll shoot you!  Give everything!  No trackers!”

The suspect in that incident also left empty handed when the pharmacist got on the phone to call police.

While three of the four robbery attempts were thwarted, the CVS employee we spoke to says the company needs to take steps to discourage people from even attempting the robberies.

“I mean there`s things they can do as a company to secure the safety of their employees and at least take part of the anxiety level off of us,” she said.

Michael DeAngelis, a CVS corporate spokesperson, sent a statement in response to the recent robberies:

“The safety and well-being of our customers and employees is our highest priority and we work closely with law enforcement in their investigations of robbery incidents.  We have security policies and procedures in place at all of our stores and we regularly review them to ensure effectiveness, including hi-def security cameras (pop over to this web-site for options)and security guard presence at select locations. We do not comment on specific security measures because we do not want to undermine them. We are committed to ensuring that CVS/pharmacy remains a safe environment for our customers to shop and fill their prescriptions.”

The CVS employee says the company needs to remodel their older stores to make working conditions safer for employees.  She says pharmacy counters should be protected behind bulletproof safety glass, security guards should be posted at all locations from open until close, and popular narcotics should be stored in special safes behind the safety glass.

Steve Dubois, of Central Indiana Crime Stoppers doesn’t know if bulletproof glass is the answer.  He believes it could get in the way of the personal interaction between a pharmacist and a customer.  But he also thinks CVS and other pharmacies need to constantly be analyzing their security measures and store layouts.

“So that industry has to create something,” Dubois said.  “They have to get something in between, where they can still have that interaction but they keep their pharmacists and their people safe.”

Dubois also points out that people who are addicted to prescription painkillers, and those who make their money from illegally selling them, will stop at nothing to get them.

“You could probably have an armed policeman in some of these places, and there’s still going to be a robbery,” Dubois said.  “And there’s going to be that confrontation between the policeman and the armed robber.”

Metro police are still investigating the weekend robbery attempts.  It’s not clear if all the incidents were the work of the same suspect, but detectives always investigate possible connections between cases.

Pharmacy school creates website to track overdose deaths

Pharmacy school creates website to track overdose deaths

http://drugtopics.modernmedicine.com/drug-topics/news/pharmacy-school-creates-website-track-overdose-deaths#comment-5971

The University of Pittsburgh School of Pharmacy School has developed a website that will track drug overdoses in some Pennsylvania counties.

West Virginia panel targets doctors, pharmacies linked to overdoses

The website, OverdoseFreePa.Pitt.edu, currently receives overdose data from medical examiners’ offices in 13 Pennsylvania counties. It provides statistic information such as gender, age, location, race, and type of drug involved in the death.

“There was a need for this information,” said Sherry Aasen, project manager for the website, told Triblive.com. “Ideally, we’d like to have this created for the entire state. It’s a growing process.”

The co-chairman of the Westmoreland County’s Drug Overdose Prevention Task Force, Dirk Matson, said the website would help healthcare officials and addiction specialists identity and react to trends.

“One real example is that last year in Allegheny County, the number of deaths went up in the younger age categories,” Dirkson told Triblive.com. “Allegheny County could be a predictor for us, as we’re a year behind some of their trends. It gives us a blueprint to work ahead.”

The website also provides information about overdose prevention and links to drug treatment programs. “Overdose is a national epidemic, resulting in thousands of deaths per year in the United States. The problem of overdose is perceived to exist in urban settings, however, the overdose epidemic has spread throughout suburban and rural communities at alarming rates,” a statement on the website reads. “The problem is especially severe in Pennsylvania, due to increasing misuse of prescription pain medications. In some counties, drug overdose deaths outnumber all other types of accidental deaths combined, including motor vehicle deaths.”

The statement continues: “The overall goal of this project is to increase community awareness and knowledge of overdose and overdose prevention strategies as well as to support initiatives aimed at decreasing drug overdoses and deaths within the participating counties.”

If you notice the data points gathered.. apparently makes no reference if the “dead person” had been diagnosed with any disease issues, was ever diagnosed or currently or ever been treated for mental health issues or some other subjective disease.

There seems to be no data point as to the person’s health/mental status before the “overdose” happened… were they suicidal … were they a chronic pain pt that was unable to get their medication and/or the prescriber had been reducing their dose and they were no longer able to tolerate their typical pain level.

This sort of like trying to determine what made people die from a plane crash.. and not try to figure out what caused the plane to crash.  Chances are everyone on a commercial plane crash died of blunt force trauma or smoke inhalation. Why did the plane fall out of the sky ?… What trigger the person to take what ended up being a overdose ?

Arachnoiditis – when the cure/treatment is worse than the disease ?

tom bresnahan

My Life with Arachnoiditis

http://www.painnewsnetwork.org/stories/2015/3/23/my-life-with-arachnoiditis

By Tom Bresnahan

Let me tell you briefly about my past before I describe the hell I live with every day.

Before moving to Florida in 2000, I owned and operated a 6 store Domino’s Pizza franchise in Tacoma, Washington. I served as an elected fire commissioner, belonged to two search and rescue groups, and was trained and certified as a swift water rescue technician. As you can see, I’m no couch potato.

tom bresnahan

After selling my business and moving to Florida I decided to pursue a career in healthcare, something I had wanted to do for many years. I went back to school and received a degree in Radiological Technology.

While attending school I fell off of a roof, damaged my back, and required surgery. In 2003, I had a triple fusion of my lumbar region performed by a local orthopedic surgeon. Everything went well and I went on to work as cardiac catheter technician, a fast paced, adrenaline junkie’s dream job! I took a lot of calls and enjoyed the challenge of working with a team trying to save the life of someone having a heart attack. 

In 2009, I started to have sciatica pain in my right leg. It was interfering with my work, so I went back to the doctor who had performed my surgery. He suggested a series of epidural steroid injections. He said they were extremely safe and could eliminate my pain.

When I arrived for my first injection, I reminded the nurse to tell the doctor of the “outpouching” I had on my spinal cord. This is known as a pseudomeningoceale. It was caused when the doctor doing my first back surgery performed a laminectomy and didn’t take the right steps to keep the pouch from forming. When I discovered this on an MRI and asked him about it, I was told that it was completely normal and that I shouldn’t be concerned. 

The image on the right shows the pouch as a white mass on my spine.

The first steroid injection had no effect, so a few months later I went in for a second. Again I reminded the nurse about the outpouching. This message was never shared with the doctor, although he should have looked at my chart prior to the procedure.  The injection was given and within hours my pain became elevated. I called the doctor and was told this is normal and not to be concerned.

Over the next several days my pain increased, and it was difficult to concentrate and perform my job. I was seen again by the doctor and he scheduled a discogram, a test is to see if a disk is ruptured or torn. It is a very painful test. The results came back stating I had a torn disk above the level of my first surgery. The doctor said I would need another fusion. 

I went in for surgery on September 8, 2009. By then the pain was quite bad and I was looking for anything to give me some relief. After I was partially sedated the doctor came in and told my wife that this surgery would most likely not help with my pain. I was nearly out and she didn’t know what to do, so in I went for what would be a totally unnecessary procedure. 

As the pain medication from surgery wore off, the pain was so bad it made me scream out loud. This went on for months! My wife took me to the ER and back to the doctor’s office, where I was told, “We don’t know what’s wrong.” 

I couldn’t work and after being out for 90 days I was terminated. I was devastated that I was losing a job I loved and spending every moment in horrific pain.  I finally went to see a neurosurgeon who ordered a myelogram, an image of my spine that was performed at the hospital where I had worked.

The neurosuregon, who I had worked with on several occasions, did the test. Afterward he came into the recovery room and said, “Tom, you’re screwed!” 

I laughed thinking he was joking. 

“You have a condition known as Adhesive Arachnoiditis,” the doctor told me. “You’re going to be in pain the rest of your life!” 

I was shocked and couldn’t believe this was happening. He told me the nerves within my spine were all clumped together. He said over time scar tissue would form and probably make the pain worse and cause things like bladder and bowel dysfunction. And there was no cure.

The test was done and I learned my fate on Dec 31, 2009. Happy New Year!   

Over the next few months I went through many medications, trying to get the pain under control. The drugs did very little to help. I also ordered copies of the dictations from all of the procedures I had done by my surgeon. On the dictation done for my last injection the surgeon stated, “I did get withdrawal so I repositioned the needle and did 4 injections.” 

The “withdrawal” was spinal fluid. He had punctured my spinal cord, yet continued to inject the steroid Depo-Medrol into my spine. When I confronted him at what was to be my last appointment, he told me, “You would have a hard time proving it!” 

Since that time I’ve been through the 5 stages of grief, with anger being the hardest to overcome.  I was determined to find a fix, but eventually realized there was none. 

I came close to ending my life on two occasions. My wife of 3 years told me, “I didn’t sign up for this!” We divorced shortly after that. 

I have spent the last 2 years trying to effect a change and educating people on the dangers of epidural steroid injections. I have tried to help others with Arachnoiditis find medications, support and the faith to continue on each day.

I have a phrase that I tell those who feel the desire to end their pain and their life, “As long as we are breathing there is hope!” 

The pain has gotten worse over the last 2 years. I have had episodes of not being able to move my legs when I wake up in the morning. This alone will scare a person terribly! My legs go numb if I sit for more than 15 minutes.  The pain now extends into my arms and hands. 

Because this condition affects the nervous system I have developed an internal thermostat problem. I will feel cold and actually shiver in a room that is 76 degrees. At other times I will break into a sweat that’s so bad I’m drenched within a few minutes, to the point that I have to change shirts. I can’t tell you how many times I’ve lain in bed screaming because the pain is so bad. 

I have never in my life been one to take it easy, yet I’ve had people actually tell me, “It couldn’t be that bad!” 

This is demoralizing, frustrating and depressing. Steroid injections are a band aid at best and the destroyer of life at worst. Please help us put a stop to these injections that are causing so many to suffer so much!

I want to thank you for taking the time to read my story. I pray every night that if we can stop anyone else from ending up with this hellish pain then I will feel that I have made a difference. 

Tom Bresnahan lives in Florida. He is a patient advocate and activist with the Arachnoiditis Society for Awareness and Prevention.

Pain News Network invites other readers to share their stories with us. 

Send them to:  editor@PainNewsNetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Last Week Tonight with John Oliver: Civil Forfeiture (HBO)

Last Week Tonight with John Oliver: Civil Forfeiture (HBO)

When facts are so far from the “circle of sanity” .. the comedians take it to task ?

 

Pain knows no age ? Complex Regional Pain Syndrome

Amelia Watt: Complex Regional Pain Syndrome

http://danablog.org/2015/03/20/seeing-pain/

 

Another good example of how well drug prohibition works ?

HIV cases on the rise in Scott Co.

http://www.whas11.com/story/news/health/2015/03/10/hiv-scott-county-opana/24712561/

The Scott County Health Department said they increase is due to IV drug users sharing needles.

Scott County’s health department says all 42 people who’ve tested positive, admitted to injecting Opana into their system and sharing needles in the process. Opana is an opioid, often prescribed to cancer patients for extreme pain.

“Until now, everybody thought they could just do that at will and there was no consequence to it. Now we see so many people with HIV that never knew they had it,” Scott County Sheriff Dan McClain said

Sheriff McClain says the pain killer, often prescribed to cancer patients, us now the drug of choice, above heroin. He says 90 percent of his inmates are in jail due to drug-related crimes.

“Methamphetamine, heroin, marijuana, all those things are a lot easier for us to fight because they’re illegal drugs to start with. A prescription pill is only illegal if you don’t have a prescription,” McClain said.

So how are so many people getting the drug?

“The doctors of our county are doing a good job banding together and saying, we’re not going to prescribe these as much anymore. Our hospital has a whole policy with pain pills and not giving them out in the ER. So, that’s the question, where they’re getting them coming from,” Combs said.

With the I-65 corridor running through the county, Combs says the pills could come from anywhere.

“The only thing we can do right now is education. We need to educate. Don’t share needles,” Combs said.

For the first time, the Scott County Health Department is now hosting free HIV and STD screenings on Mondays and Thursday between 9 a.m. and 3 p.m. in Scottsburg. The tests are confidential and takes just minutes. Staff are also working to provide a screening office in Austin, where a majority of people infected with HIV live.

Combs says while HIV is on the rise, the number of people testing positive for Hepatitis C is “astronomical.” In many cases today, it’s possible those with HIV also have Hep. C and should learn how the diseases spread and how to prevent from giving them to others.

You may need a higher dose of opiates to manage your pain because …

Cytochrome P450 Testing In High-dose Opioid Patients

http://www.practicalpainmanagement.com/treatments/pharmacological/opioids/cytochrome-p450-testing-high-dose-opioid-patients

Severe, chronic pain patients who seek opioid dosages above normal standards should now be tested for genetic cytochrome P450 deficiencies.

While it is common knowledge that the cytochrome P450 (CYP450) enzyme system is critical for the metabolism of some opioids, genotype testing of pain patients for CYP450 polymorphism has not been generally recommended.1,2 This situation, however, may change as pain specialists begin to recognize that patients who require high doses of opioids may have a genetic defect that may affect their ability to metabolize these agents.

In the past, genotyping for CYP450 polymorphisms was not cost effective or convenient. However, testing technology, commercial availability, third-party reimbursement, and most of all, clinical understanding, have recently coalesced to make CYP450 genetic testing an essential component of high-dose opioid therapy. It is my recommendation, therefore, that patients who require more than 150 mg per day of morphine equivalents be tested for three specific CYP defects—2D6, 2C9, and 2C19.

To study the validity of genotype testing, I prospectively studied 66 patients on high-dose opioids in my pain clinic. The study found that the vast majority of these patients had CYP450 defects.

What Is CYP450?
Although the name cytochrome P450 is somewhat unfortunate—perhaps a better name would have been “drug metabolizing enzyme system”—the enzyme derives its name from the heme pigment (deep red color), which absorbs light at a characteristic wavelength of 450 nanometers. CYP450 enzymes are primarily found in the liver, but can exist in the intestine, lungs, brain, and kidney. The CYP450 system consists of 481 separate genes that code for 74 unique families. A family name is denoted by an Arabic number, the subfamily by a Roman uppercase letter, and the individual enzymes by another Arabic number following the letter indicating the subfamily (ie, CYP-2D6).3-5

Table: Metabolism of opiods

Why Is CYP450 Important?
There are a number of opioids that are affected by CYP450 (Table 1).6-20 Those that are metabolized via CYP enzymes include codeine, hydrocodone, oxycodone, tramadol (Ultram), fentanyl, and methadone. Some of these opioids are metabolized to metabolites for analgesic effectiveness and for elimination from the body to prevent a toxic build-up of opioids. Those opioids that are unaffected or mildly affected by CYP450 include morphine, hydromorphone, oxymorphone (Opana), and tapentadol (Nucynta).6-19 Three opioids—hydromorphone, oxymorphone, and tapentadol—primarily use the alternate system, glucuronidation, for metabolism, so they may be used as therapeutic alternatives for clinical trials in patients who have defective CYP450 metabolism.1,20

Patients vary in their CYP enzyme expression and function, which leads to distinct phenotypes. Genetic CYP testing has a terminology that may be unfamiliar to some medical practitioners.4 Laboratory results will list patient results as extensive metabolizer (EM; normal enzyme), rapid or ultrarapid metabolizer (UM; overactive enzyme), intermediate metabolizer (IM; underactive), or poor metabolizer (PM; inactive or minimally active). The latter two, IM and PM, mean the enzyme has decreased function (Table 2).21

Table: Opioid dosage and CYP enzyme deficiencies

It is also important to point out that most opioids will act without biotransformation at the opioid receptor, and provide pain relief without being metabolized by the CYP or glucuronidation system. However, some opioids are robustly metabolized in first-pass effect. This explains the increasing utilization of sublingual, buccal, patch, subcutaneous and intravenous injection, and intrathecal routes for opioid administration, since these non-oral routes allow either greater opioid effect or reach the central nervous system (CNS) prior to entering the liver.

Who Should Be Screened?
No published guidelines yet exist for generalized testing of the CYP system outside of certain populations (specific cancers, patients requiring anticoagulation, and human immunodeficiency virus patients). A major reason to perform CYP450 genetic testing is to identify pain patients who legitimately require a high-dose, or unusual, opioid regimen.2,22 This includes patients who continually complain of inadequate pain relief despite standard opioid dosages, identify drugs that are more effective, or describe medicines that do not work well. Patients with a daily morphine equivalent dosage requirement of more than 150 mg per day should be tested to help validate that a high opioid dosage is needed. Caution must be exercised, however. All too often, these patients may be erroneously labeled as drug seekers or addicts. Before these labels are applied to a patient in pain, CYP450 testing should be considered.

Another reason to consider testing is the risk of drug–drug interactions (DDIs). A significant number of drugs may inhibit or enhance (induce) the activity of certain agents, thereby increasing or reducing clinical effects of drugs. Most DDIs involving opioid medications involve CYP450 inhibitors, which cause an increased level of opioids in the system—thus, placing a patient at risk of sedation, respiratory depression, and possible toxic effect.1,10,13

CYP450 testing also may guide the practitioner in the selection of opioids that are compatible with a patient’s genetic status. For example, a patient with a CYP-2D6 defect may not respond well to codeine, which is considered a prodrug with the active metabolite morphine. Therefore, the efficacy and safety of codeine as an analgesic are governed by CYP-2D6 polymorphisms. Codeine has little therapeutic effect in patients who are CYP-2D6 PMs, whereas the risk of morphine toxicity following codeine administration is higher in UMs.23

Since the CYP450 system is primarily liver-based, routes that avoid oral administration and first-pass liver metabolism may be an option in certain populations. This is particularly true in patients who demonstrate multiple CYP defects. Non-oral routes include sublingual, buccal, suppository, injection, topical (patches), and intrathecal.

Table 3: CYP450 enzymes to be tested

Three CYPs to Test
Of all the enzymes in the CYP family, researchers have identified three that account for a significant amount of opioid metabolism and may currently be tested—2D6, 2C9, and 2C19 (Table 3).1,3,12 These three enzymes have been intensively studied and there are now data detailing their interactions with numerous drugs.1,4 Laboratory testing technology is reliable for these three enzymes, and third-party carriers, including Medicare, are now paying for these tests. Biologic samples for analysis can be taken from saliva, blood, or a buccal swab.

Consequences of unrelieved chronic pain ?

Understanding the physiological effects of unrelieved pain

http://www.nursingtimes.net/nursing-practice/clinical-zones/pain-management/understanding-the-physiological-effects-of-unrelieved-pain/205262.article

A noxious stimulus or pain is a stressor that can threaten homeostasis (a steady physiological state). The adaptive response to such a stress involves physiological changes that, in the initial stages, are useful and are also potentially life-saving.

Peripheral adaptation involves moving energy substrates from storage sites to the bloodstream to overcome the stressor. It also includes an analgesic response, a reflex escape response and a variety of other physiological changes mediated by the sympathetic nervous system (Johnson et al, 1992). However, if the stress response is allowed to continue, a variety of harmful effects may ensue that involve multiple systems of the body and are potentially life-threatening.

Transmission of pain

The initial physiological changes that take place within the body after a painful episode are concerned with the transmission of pain. The four basic principles that are involved are:

– Transduction: this process involves changing a noxious stimulus in the sensory nerve endings into a nerve impulse. Nociceptors (primary afferent neurones) are nerve endings with the capacity to distinguish between noxious and innocuous stimuli. When they are exposed to noxious stimuli, a number of substances, including prostaglandins, bradykinin, serotonin, substance P and histamine, are released that facilitate the movement of the pain impulse from the periphery to the spinal cord;

– Transmission: the movement of impulses from the site of transduction to the brain. Transmission occurs in three stages: from the nociceptor fibres to the spinal cord, from the spinal cord to the brain stem and thalamus, and finally from the thalamus to the cortex. For the pain stimulus to be changed to an impulse and move from the periphery to the spinal cord, an action potential must be created; that is, the movement of sodium and potassium ions from the extracellular fluid to the intracellular fluid, and vice versa. Transmission occurs in C fibres and A delta fibres and neurotransmitters are needed at each synapse to continue the pain impulse across the synaptic cleft;

– Perception: the process involved in recognising, defining and responding to pain. It is a result of neural activity and is where pain becomes a conscious experience. Perception takes place predominantly in the cortex, but the limbic system and reticular systems are also involved;

– Modulation: this involves the activation of descending pathways that exert inhibitory effects on pain transmission. Descending fibres release substances such as endogenous opioids, serotonin, noradrenaline, gamma-aminobutyric acid, and neurotensin that have the capacity to inhibit the transmission of noxious stimuli and produce analgesia (McCaffery and Pasero, 1999).

Analgesic response

The stress response includes the production of naturally occurring endogenous opioids, which are also known as encephalins and endorphins. They are found throughout the central nervous system and bind to opioid receptor sites. These substances prevent the release of neurotransmitters such as substance P and, therefore, inhibit the transmission of pain impulses, bringing about an analgesic effect. Unfortunately endogenous opioids degrade too quickly to be considered as useful analgesics (McCaffery and Pasero, 1999).

Reflex escape response

Activation of the sympathetic nervous system during an episode of acute pain is known as the ‘fight or flight’ response. The physiological responses that take place via the sympathetic nervous system and the neuro-endocrine system are numerous and intrinsically linked.

Sympathetic nervous system

The sympathetic nervous system consists of a double chain of ganglia in front of the vertebral column in the cervical, thoracic and lumbar regions, giving rise to nerves supplying the internal organs. This system is involved in the immediate bodily response to emergencies, such as severe, acute pain.

Although the initial effects of the sympathetic nervous system allow survival of an individual, prolonged activation can be detrimental (Marieb, 2000).

The sympathetic nervous system is particularly concerned with the regulation of vascular tone, blood flow and blood pressure because sympathetic nerves have a stimulating effect on the heart to improve circulation. It also has a stimulating effect on the respiratory system by causing dilation of the bronchioles to increase oxygen intake (Ganong, 1995).

The sympathetic nervous system has an inhibiting effect on digestion by reducing or preventing the secretion of digestive enzymes throughout the alimentary canal and inhibiting peristaltic action in the gut wall. It achieves all of these physiological responses via the endocrine system and an increase in hormone production (Ganong, 1995).

Neuroendocrine system

The endocrine system comprises the pancreas; thalamus; hypothalamus; kidneys; pituitary, thyroid, parathyroid, pineal and adrenal glands; and the ovaries and testes. Its principal function is to maintain internal homeostasis despite changes in the environment.

The endocrine and nervous systems work in conjunction with each other to achieve this metabolic regulation (Vander et al, 1994). Multiple hormones cooperate to bring about appropriate biochemical and physiological responses to noxious stimuli such as pain.

These stimuli activate a coordinated neuroendocrine stress response by increasing levels of certain hormones, including adrenocorticotrophic hormone (ACTH), catcholamines, antidiuretic hormone (ADH), angiotensin and glucagon. The hormones are secreted directly from the endocrine organs into the bloodstream (Fig 1).

Corticotrophin-releasing hormone

Corticotrophin-releasing hormone (CRH) is released, as a result of stimulation by noradrenaline, and transported to the anterior pituitary gland where it activates the sympathetic nervous system and stimulates ACTH biosynthesis. CRH increases blood pressure and heart rate and also produces behavioural responses to stress. Cardiovascular responses are also controlled by CRH signals (Marieb, 2000).

ACTH

The release of CRH from the hypothalamus into the systemic circulatory system stimulates the secretion of ACTH in the anterior pituitary gland. Increased levels of ACTH activate the sympathetic nervous system. However, the main function of CRH is to regulate the endocrine activity of the cortex portion of the adrenal gland so as to stimulate cortisol production and increase the levels of circulating glucocorticoids (Johnson et al, 1992).

Cortisol

Cortisol is the principal glucocorticoid that promotes normal cell metabolism. It is produced and released by the adrenal cortex in response to rising blood levels of ACTH. An increased plasma concentration of adrenal corticosteroids is the major regulator of an adaptive response to stress that, in the short term, is beneficial.

However, in the long term it is disruptive and harmful. It has a widespread effect on most organs and is particularly involved in the coordination of the actions of catecholamines.

Cortisol also has the function of maintaining blood glucose levels and energy metabolism during periods of stress. It suppresses the inflammatory response by inhibiting prostaglandin activity and has an adverse effect on the immune system. Glucocorticoids are also thought to prevent other stress-induced changes from becoming excessive (Marieb, 2000).

Adrenaline and noradrenaline

These are both catecholamines released from the adrenal medulla when it is stimulated by the sympathetic nervous system during the stress response. The adrenal medulla is not essential for life but contributes to the stress situation by secreting catecholamines, which act directly on blood vessels, causing vasoconstriction. Blood pressure then rises to allow better perfusion of vital organs, and cardiac output also increases. In addition, adrenaline and noradrenaline dilate the small passageways of the lungs to increase oxygenation (Vander et al, 1994).

Adrenaline has an effect on metabolism and has a role in the inhibition of insulin release. It also causes an increased glycogenolysis in the liver (Thomas, 1998). Finally, heightened emotional awareness occurs with increased adrenaline levels.

Glucagon

Glucagon is a polypeptide produced by the pancreatic islets in the upper gastrointestinal tract. The stress response causes glucagon levels to increase, so elevating the metabolic rate and lowering insulin levels. The result is hyperglycaemia and impaired glucose tolerance, together with carbohydrate, protein and fat destruction (Park et al, 2002). An increase in glucagon and catecholamines stimulates glycogenolysis and the release of glucose from the liver into the circulation for immediate use by critical organs, such as the brain.

Vasopressin or ADH

This hormone is released from the posterior pituitary gland. Its function is to excrete water via the kidneys. During the stress response it causes sodium and water to be retained by the renal tubules and stored in the extracellular fluid (Thomas, 1998). It also has a role in controlling blood pressure.

Renin and angiotensin II

Renin is an acid protease enzyme secreted by the kidneys into the bloodstream. Its major function is the stimulation and release of aldosterone from the adrenal gland, promoting sodium re-absorption by the kidney. Renin secretion is increased by sympathetic activity and is mediated by increased circulating catecholamines (Fig 2). Renin is also involved in the conversion of enzymes to form angiotensin II, which causes generalised arteriole constriction resulting in hypertension.

Growth hormone

Growth hormone is secreted by the anterior pituitary gland and has a direct action on cellular activity and the metabolism of protein, carbohydrate and fat. Increased protein breakdown leads to a negative nitrogen balance, resulting in reduced wound healing (Marieb, 2000).

Interleukin 1

Following tissue damage, interleukin 1 (IL-1) is released from the hypothalamus and its effects are widespread, including activation of the inflammatory effects of the immune system. IL-1 interacts with the hypothalamic pituitary adrenal axis at two levels. First, it acts in the hypothalamus to induce the production of corticotrophin-releasing factor, which mediates ACTH release. Second, IL-1 acts directly with the adrenal cortex. Both of these events lead to the release of anti-inflammatory glucocorticoids such as cortisol (Vander et al, 1994).

Effects of physiological changes

The physiological changes described above have an impact on the cardiovascular, gastrointestinal, respiratory, genitourinary, musculoskeletal and immune systems. Increased heart and breathing rates facilitate the increasing demands of oxygen and other nutrients to vital organs (O’Hara, 1996). The physiological changes that take place can also induce vomiting and potentially can pre-empt chronic pain conditions. Psychological and cognitive adverse effects are also relatively common.

Cardiovascular system

The cardiovascular system responds to the stress of unrelieved pain by increasing sympathetic nervous system activity which, in turn, increases heart rate, blood pressure and peripheral vascular resistance. As the workload and stress of the heart increase, owing to hypertension and tachycardia, the oxygen consumption of the myocardium also increases. When oxygen consumption is greater than oxygen supply, myocardial ischaemia and, potentially, myocardial infarction, occur. The myocardial oxygen supply may be further compromised by the presence of any pre-existing cardiac or respiratory disease or by hypoxaemia due to impaired respiratory function (Macintyre and Ready, 2001).

Hypercoagulation occurs when there is a reduction in fibrinolysis together with an increased cardiac rate, workload and blood pressure. This activity increases the risk of deep vein thrombosis (DVT) and pulmonary embolism (Wood, 2003).

Gastrointestinal system

Increased sympathetic nervous system activity can lead to temporarily impaired gastrointestinal function. This can include delays in gastric emptying and reduced bowel motility with the potential for the development of paralytic ileus (Macintyre and Ready, 2001).

Respiratory system

Unrelieved pain can result in a patient limiting the movement of the thoracic and abdominal muscles in a bid to reduce pain. This may cause some degree of respiratory dysfunction with secretions and sputum being retained because of a reluctance to cough. Atelectasis and pneumonia may follow (Macintyre and Ready, 2001). This pulmonary dysfunction, caused by painful excursion of the diaphragmatic muscles of the chest wall, is also associated with a reduction in vital lung capacity, increased inspiratory and expiratory pressures and reduced alveolar ventilation. The resulting hypoxia can cause cardiac complications, disorientation and confusion and delayed wound healing (Wood, 2003).

Genitourinary system

Unrelieved pain can increase the release of hormones and enzymes, such as catecholamines, aldosterone, ADH, cortisol, angiotensin II and prostaglandins, which help to regulate urinary output, fluid and electrolyte balance as well as blood volume and pressure (McCaffery and Pasero, 1999). This causes retention of sodium and water, resulting in urinary retention. Increased excretion of potassium causes hypokalaemia (Park et al, 2002). A decrease in extracellular fluid occurs as fluid moves to intracellular compartments, causing fluid overload, increased cardiac workload and hypertension (McCaffery and Pasero, 1999).

Musculoskeletal system

Involuntary responses to noxious stimuli can cause reflex muscle spasm at the site of tissue damage (McCaffery and Pasero, 1999). Impaired muscle function and muscle fatigue can also lead to immobility, causing venous stasis, increased blood coagulability and, therefore, an increased risk of developing DVT (Park et al, 2002).

Pain can limit thoracic and abdominal muscle movement in an attempt to reduce muscle pain, a phenomenon known as ‘splinting’. The lack of respiratory muscle excursion can potentially lead to reduced respiratory function (McCaffery and Pasero, 1999).

Immune system

Depression of the immune system can be caused by unrelieved pain. This may predispose the patient to wound infection, chest infection, pneumonia and, ultimately, sepsis (Wood, 2003).

Psychological and cognitive effects

Anxiety and pain are positively correlated (Johnson et al, 1992). Individuals who express unusually high levels of anxiety also tend to have a higher than expected incidence of early noxious stress. The acute stress-induced hormonal changes that have been described in this article closely resemble the symptom complex of anxiety and depression and, finally, hypercortisolism, which is a consistent feature of anxiety physiology (Johnson et al, 1992). Therefore, the stressor effects of unrelieved pain have the potential to increase anxiety levels further and interfere with activities of daily living, such as diet, exercise, work or leisure activities and to interrupt normal sleep patterns causing varying degrees of insomnia (Macintyre and Ready, 2001).

Unrelieved pain can also result in an individual experiencing distressing cognitive impairment, such as disorientation, mental confusion and a reduced ability to concentrate (Wood, 2003).

Nausea and vomiting

When pain receptors in the central nervous system are stimulated, the true vomit centre in the brain is activated, causing vomiting to occur. Disturbance of the gastrointestinal tract can activate the release of the neurotransmitter 5-hydroxytryptamine (5-HT3), which can also initiate vomiting. Initially, 5HT3 travels via the circulatory system to the chemoreceptor trigger zone in the brainstem and on to the true vomit centre, again initiating vomiting (Jolley, 2001).

Chronic pain

Poorly controlled acute pain can lead to debilitating chronic pain syndromes. Appropriate aggressive acute pain management is essential to prevent this from occurring (McCaffery and Pasero, 1999).

Conclusion

Unrelieved pain has serious side-effects, therefore the containment of such a stressor is vital. The chronic activation of the catabolic process of the stress response can ultimately cause multiple system dysfunction (Johnson et al, 1992).

Good acute pain management, including an expert knowledge of analgesic drugs and an understanding of the physiological effects of pain, is an essential element of holistic nursing care.

When corporations have to chose between pt safety and profit …guess ???

skullandbones

After Target wage hike, labor groups turn to drugstore chains

http://www.globalpost.com/dispatch/news/thomson-reuters/150320/after-target-wage-hike-labor-groups-turn-drugstore-chains

Major drug chains are already cutting staffing in the Rx dept… even with Rx volume is increasing… med errors are increasing dramatically… 90% + of the Rxs are billed to PBM’s  (Express Scripts..etc..etc..) who controls what reimbursements are.  Guess what is going to happen when they are forced to pay higher wages to technicians ? Most likely, they will cut man hours in the pharmacy even further and med errors will increase that much more.. 

CHICAGO (Reuters) – Some labor groups looking to broaden their push for minimum wage hikes after success at big U.S. retailers including Target Corp, are preparing to take on drugstore chains.

A source this week said Target will raise its minimum wage to $9 per hour in April, matching moves by rivals Wal-Mart Stores Inc and TJX Cos .

The retailers, which were targeted by labor advocates and their allies, are also facing tougher competition for employees as unemployment drops to its lowest level in more than six years.

Labor activists said the wage hikes by big retailers will give them greater leverage with drugstore operators, who make up one of the fastest-growing and most profitable areas in retail.

The United Food and Commercial Workers International (UFCW), a union which played a key role in pressuring Wal-Mart, said it will accelerate its efforts to organize Walgreens Boots Alliance Inc workers to demand better pay.

Walgreens is the top U.S. drug retailer, followed by CVS Health Corp and Rite Aid Corp .

“Given the current momentum, we expect a faster chance of success in hiking minimum wage within the retail space which includes drug chains, than say the fast food sector,” said Marc Goumbri, a spokesman for the UFCW.

Another labor group, The New York-New Jersey Joint Board of Workers United, an affiliate of the Service Employees International Union (SEIU), is planning to start wage negotiations this summer with the management of Duane Reade, a local subsidiary of Walgreens.

“What jumps out at me is that drugstores are not only reporting strong profits but expanding at a rapid pace and making multi-billion dollar acquisitions,” said the group’s President Julie Kelly.

“That puts them in a position to lead here and raise the wages they pay,” said Kelly. The recent moves by large retailers raises the chances of success, she added.

Kelly said her union has not decided on wage demands, although it broadly supports the $15 an hour “living wage” backed by labor groups nationwide.

Twelve percent of Walgreens employees earn less than $9 an hour, with a typical cashier earning about $8.60 per hour, compared to $8.70 per hour at CVS Health Corp, according to compensation analytics firm Payscale.com, which usually collects pay data from a sample of a company’s employees.

Walgreens spokesman Michael Polzin said the company meets or exceeds all wage ordinances and its pay scale varies as it seeks to remain competitive in local markets. He declined to comment on the prospect of wage hikes or the number of employees who earn less than $9.

Payscale data showed 10 percent of CVS employees’ hourly earnings and 16 percent of Rite Aid Corp workers’ are below $9.

CVS declined comment while Rite Aid did not respond to requests seeking comment.

A BETTER SHOT AT SUCCESS

Drugstores are a good target in part because of relatively high employee retention rates, which make organizing easier than in other sectors, including fast food, analysts say. Annual worker turnover at fast food chains is as high as 50-100 percent in some areas, they said. Some analysts last year put the turnover at drugstore chains as low as 11 percent.

With drugstores moving into 24 hour operations and employees demanding better benefits, the opportunity to organize the workforce has improved, said Burt Flickinger, managing director of retail consultancy Strategic Resource Group and a lecturer at Cornell University.

Flickinger said even regional drugstore operators like Fred’s Pharmacy, part of discount retailer Fred’s Inc , New York- and Vermont-based chain Kinney Drugs could see their workers organize and press for higher wages. Another target could be Florida-based Navarro Discount Pharmacies Inc, which was acquired by CVS last year, he said.

The companies did not respond to requests seeking comment.

“It will take 6-8 months for the results to start coming in,” he said. “But drugstores most certainly appear to be the ones next in line for a wage hike.”

(Reporting by Nandita Bose in Chicago, editing by Peter Henderson and Christian Plumb)