Compared to the preventable deaths from medical errors .. opiate OD deaths are a non-issue ?

RxtotheheadOvercoming Obstacles to Medication Error Reporting

http://www.pharmacytimes.com/contributor/alan-polnariev-pharmd-ms-cgp/2016/07/overcoming-obstacles-to-medication-error-reporting

In 1999, the landmark paper “To Err is Human” estimated 100,000 deaths are caused by medication errors each year.1 More recently, a 2013 article cited the related death toll between 210,000 and 440,000.2
 
According to a 2012 study, preventable medical errors cost the US economy as much as $1 trillion annually in “lost human potential and contributions.”3 The study’s researchers used quality-adjusted life years to develop what they called a “more complete accounting of the economic impact when someone dies from a preventable error.”3
 
Still, their figures may represent only the tip of the iceberg. For every reported medication error that causes injury to a patient, there may be as many as 100 errors that go unreported or undetected. 
 
Results from other research indicate the frequency of medication error reporting could be improved if the process of reporting errors were made easier and staff was adequately educated about reporting and received timely feedback about the results from the reports submitted. To reach this conclusion, the investigators conducted in-depth interviews and focus groups with physicians, pharmacists, and nurses from 4 community hospitals and compiled a list of the most commonly cited barriers to medication error reporting:5

  1. Extra time required in reporting
  2. Cumbersome report forms
  3. Hesitancy about “telling” on someone
  4. Perceived severity of the error

The researchers recommended 3 interventions that could overcome barriers to medication error reporting.
 
The first was reducing reporter burden to simplify the process of reporting errors as a means to increase reporter compliance. The general consensus of the study participants was incident reporting systems were “not user friendly, and as a result, took too long to complete.”
 
The second recommendation was improving the channels of communication between senior management and front-line staff, as “many participants voiced frustration that they did not receive feedback about error reports that had been submitted.” Participants commonly expressed the desire to receive recognizable feedback from administration.
 
The third recommendation was increasing awareness and education to help front-line staff better understand the process of reporting (how to report, why to report, and how reports were being used). Education is an important feature because skeptics may not be completely persuaded that reporting errors improves patient safety. 
 
All 3 of those interventions may help staff members feel more confident about reporting medication errors and contributing to efforts to advance patient safety.
 
“Reporting should be made as easy as possible (forms should be accessible and straightforward), people should receive timely feedback about reports submitted, and people should receive up-to-date education about all aspects of the medication error reporting process at their hospitals,” the researchers concluded.5 
 
The simple yet effective approaches they offered are an excellent foundation to not only improve medication error reporting, but also markedly improve the frequency of reported medication errors. Still, broader approaches are warranted. Identifying the hurdles health care professionals face on a regular basis is an important first step to improve error reporting, but there’s plenty more work to be done.
 
Nobody has all of the answers to the problem, but arriving at the solution involves brainstorming sessions and the combined efforts of interdisciplinary health care teams. Most approaches to address this problem will likely fall into 1 of 3 categories: organizational culture, system improvements, and staff education.
 
Organizational culture focuses on the behaviors, stigmas, and attitudes toward patient safety processes in a health care setting. How senior management responds to reported errors from front-line staff is one example. Another is a structured process to prioritize and thoroughly investigate medication errors and patient safety concerns.
 
System improvements involve communication channels for sharing information (eg, error reporting systems) and their accessibility and ease of use in allowing reporters to enter the details of a medication error efficiently and effectively. Providing a highly visible and open means of communicating information between senior management and front-line staff is an essential component of the error reporting cycle.
 
Finally, staff education would encompass topics like which incidents should be reported; differentiating terms like medication error, adverse drug event, and near miss; and how to properly report an incident.
 
Medication errors are as a dire a concern today as they were in 1999. The call to action is loud and clear, with hundreds of thousands of lives lost and hundreds of billions of dollars spent annually. The health care industry can’t afford to stay idle any longer. 
 
In order to prevent medication errors, we must modify how we view them and learn from our past mistakes. Understanding how to overcome obstacles to error reporting is a great way to start.  – See more at: http://www.pharmacytimes.com/contributor/alan-polnariev-pharmd-ms-cgp/2016/07/overcoming-obstacles-to-medication-error-reporting#sthash.8NaWuRWe.dpuf

Someone doesn’t know how to count or using different criteria as to what is a “drug death”

Two reports offer different numbers for drug deaths in Pennsylvania

http://www.readingeagle.com/news/article/two-reports-offer-different-numbers-for-drug-deaths-in-pennsylvania&template=mobileart

Glaring differences between two high-profile reports on how many people died from drug overdoses in Pennsylvania in 2014 have called into question the reliability of numbers given to the public on the toll of the heroin and opioid drug crisis.

The reports were produced by the Pennsylvania State Coroners Association and the federal Drug Enforcement Administration. The coroners association report lists 2014 drug death totals for Lehigh, Chester and Lebanon counties as 85, 82 and 15, while the federal report lists the totals as 66, 36 and 11, respectively.

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The reports show large discrepancies involving many other counties, as well. Both got media coverage across the state.”I think it’s important to get the numbers right,” said Frances Cortez Funk, director of health promotion and alcohol and other drug services at Kutztown University. “The numbers are important because every number represents a life.”

Berks County Coroner Denny Hess said drug death numbers generated by coroners have changed as they pass through the state Department of Drug and Alcohol Programs, which has served as a resource for the DEA.

He said he had no indication the changes were intentional, but they made the information inaccurate.”Ours are real numbers,” he said. “Nobody is looking at the state and saying, ‘Why are they changing those numbers?’ “Hess’ office sends reports on drug deaths to DDAP and the state coroners association. The association’s legislative liaison, Susan Shanaman, said she has found inaccuracies in a DDAP spreadsheet on statewide drug deaths.”I have found discrepancies in the numbers, where I know the data has been sent to both DDAP and myself. I don’t have an explanation for why DDAP’s numbers are fewer,” Shanaman said.DDAP spokesman Jason Snyder said any assertion the department gave out information significantly different from what it had collected was “unequivocally false.”He said human error may have produced a few mistakes in a spreadsheet, but it would not explain the “sweeping discrepancies” between the two reports.”What comes in to DDAP goes out, just as it came in,” Snyder said.He stressed the importance of accurate data.”There is no question about that. We do need to come up with a way where we are sure what we are looking at is accurate,” Snyder said. “This is something on a lot of people’s radar screens.”But he said questions about the accuracy of two reports should be put to the organizations that produced them.On Wednesday afternoon, the author of the DEA report, Laura Hendrick, said in a telephone interview that DEA’s source material for its 2014 report included a spreadsheet from DDAP. She said it was understood that the spreadsheet was “not complete” because it did not include information from some counties.DEA will issue revisions to some of its 2014 numbers when it issues the 2015 report, Hendrick said. All of the revisions will be increases in county totals.State Rep. Gen Yaw, a Lycoming County Republican who has gone around the state for hearings about the heroin crisis, said he heard of differences between the reports and then learned that the DEA had changed its 2014 numbers.He said he believed the 2014 coroners association report was the more accurate of the two.But Shanaman, who compiled the association report, acknowledged it had at least one inaccuracy.The single largest county discrepancy involved Bucks, for which the coroners’ association reported 205 deaths and the DEA 113 deaths. In that case, Shanaman said her Bucks drug death tally included many fatalities where drugs were present but did not actually cause the death.”Bucks is the only one I did that on,” she said.Coroners are not required by law to report drug deaths. Some coroners – especially those in counties with very few deaths – worry that sharing data on them might lead to identities becoming known, against families’ wishes.Hendrick, who is the highest ranking intelligence officer in DEA’s Philadelphia Field Division, said the original sources for all the data in both reports are county coroners.In some cases, the DEA has issued subpoenas to obtain information from coroners, she said. The lack of mandatory reporting has hampered efforts to get good data.”We have struggled for years to get this information,” she said.At the same time, she said, the type of training and experience of each coroner may affect how they classify deaths. And they have latitude in deciding which deaths to report.”There is a lot of leeway,” she said.Yaw has floated a concept for strengthening the drug death reporting system with other lawmakers.He said, “We need accurate reporting.”Chuck Kiessling, Lycoming County coroner and president of the association, said it was vital to have accurate information. The number of deaths, he said, gives the public a “gauge” to measure the drug crisis.Shanaman said she believed coroners should remain the primary conduits for information.She described them as “the guys and gals who are there and who are seeing the bodies and seeing the deaths up close and personal.”

What part of our corrupt Washington DC system are we have trouble understanding ?

What part of our corrupt Washington DC system are we have trouble understanding ?

When does “extremely careless ” crosses the line into intentional deceitful behavior ?
clintonwhatdoseitmatter

DEA takes Utah to federal court for access to prescription drug database

 


DEA takes Utah to federal court for access to prescription drug database

http://fox13now.com/2016/07/06/dea-takes-utah-to-federal-court-for-access-to-prescription-drug-database/

The question that has to be asked is why isn’t the OFFICE OF CIVIL RIGHTS… which is part of the Dept of Education.. not defending HIPAA when the DEA is out to violate PHI (Personal Health Information) of Utah’s Prescription Monitoring Program ? Could it be.. as some has suggested that the whole Washington DC system is CORRUPT ?govworker

SALT LAKE CITY — The Drug Enforcement Administration is asking a federal judge to enforce subpoenas served on Utah’s Department of Commerce seeking access to the state’s prescription drug database.

In court papers obtained by FOX 13, it appears the state of Utah is resisting the DEA’s attempts.

The DEA revealed in a declaration it is investigating a “licensed medical professional” in the Salt Lake City area. The court filings do not reveal who is under investigation, but the federal agency claims that person has been prescribing a lot of pills to people who turn around and sell them. The DEA claims those people are members of a “criminal organization” with overseas ties.

As part of its investigation into that physician, the DEA served administrative subpoenas on Utah’s Department of Commerce and the Utah Division of Professional Licensing for access to the controlled substance database. The state of Utah has apparently refused to grant federal agents access.

Utah Department of Commerce Executive Director Francine Giani declined to comment to FOX 13 on the subpoenas, referring the matter to the Utah Attorney General’s Office. It also declined to comment, but is expected to reply in court filings by next month.

Access to the controlled substance database recently required a warrant after state lawmakers changed the rules. It followed an incident where Unified Fire Authority firefighters found their records accessed by police looking into missing medications.

Greg Skordas, a criminal defense attorney who represented an accused firefighter in that case, said the problem with the DEA request is it involves more than the specific doctor — it would drag in patients, too.

“Administrative subpoenas are issued based on a very low standard. They’re really just investigative,” he said. “Whereas a warrant requires a higher level of what we call probable cause. You have to go to a judge and say, ‘I have probable cause to believe the information is where I’m looking,’ where an investigative subpoena you go to a judge and say, ‘I’m curious.'”

Skordas said the DEA has tried this same tactic in other states, and said the battle between subpoena and warrant may go beyond federal court in Salt Lake City to appellate level courts to weigh in.

“It’s all going to come to a head probably with the United States Supreme Court or with the circuit courts,” he said.

There were about one million heroin users in the U.S. as of 2014

17 Heroin Overdoses, 1 Death: Could Happen Anywhere Says DEA Agent

detroit.cbslocal.com/2016/07/06/17-heroin-overdoes-1-death-could-happen-anywhere-says-dea-agent/

THREE TIMES  the Heroin user in abt 10 yrs and FIVE TIMES the Heroin related deaths in abt 15 yrs.  Wonder why that is.. the DEA is not doing their job of preventing drugs from crossing the boarder ? Heroin is now the least expensive opiates ? All too many chronic pain pts have been denied their needed pain medication by prescriber and has turned to “the street” in an effort to help address their unrelenting pain. Remember the chemical name of Heroin is ACETYLMORPHINE… which metabolizes into MORPHINE in the body… it is about 2-3 times mg/mg stronger than Morphine. Still FRACTION OF  PEOPLE die every year from opiate overdoses than die from the use/abuse of the drug drugs ALCOHOL & NICOTINE !

The city of Akron, Ohio, is reeling with a rash of heroin overdoses within a 24-hour span.

Special Agent Rich Issacson with the DEA’s Detroit field division isn’t surprised.

“It’s a huge problem in Akron, Ohio but it’s also a huge problem across the United States,” said Issacson. “There is not a community in southeast Michigan that hasn’t been hit hard by the opiate abuse problems, that’s including pain killers, like hydrcodone and oxycodone products as well as heroin.”

Issacson says word of the deaths probably won’t scare a lot of people into rehab.

“On occasion when there’s talk of heroin overdose deaths – or a series of heroin overdose deaths; sometimes as counter-intuitive as it sounds – that actually sounds attractive to a heroin addict because they know that if that heroin caused the death of another user, that must have been pretty strong heroin,” Issacson said.

Police in Ohio say the calls began around 1 p.m. and continued through the afternoon and evening and three of the victims include a mother and her two daughters.

The Summit County Medical Examiner’s Office says a 44-year-old man died of a suspected overdose and an autopsy is set for Wednesday.

Edwards says 55 people have died from heroin overdoses in the city this year.

Heroin use has reached the highest level in 20 years in the United States, according to a recent global drug report that calls the trend “alarming.”

The UN Office on Drugs and Crime released its World Drug Report last month, which said heroin is the deadliest drug worldwide, and said its increasing use in the U.S. is of particular concern.

There were about one million heroin users in the U.S. as of 2014, almost three times the number in 2003. Deaths related to heroin use have increased five-fold since 2000.

There are an estimated one million heroin users in the U.S. as of 2014 … three times the number of a decade before.

Attorneys/judicial system continue to practice medicine without a license ?

https://www.washingtonpost.com/national/health-science/pfizer-agrees-to-truth-in-opioid-marketing/2016/07/05/784223cc-42c6-11e6-88d0-6adee48be8bc_story.html

This is just a slippery slope for everyone.. the judicial system has gotten Pfizer to admit that they are against off-label use… which it is estimated that 1:5 outpatient Rxs are written for off-label.  Yet one of Pfizer’s products  (methylprednisolone)  is routinely use in off-label Epidural Spinal Injections. What happens if insurance companies start refusing to pay for any Rxs that are prescribed off-label ?

The reason that there is no studies on the long term use of opiates is that opiates were commercially available before the FDA and all their need for clinical trials and they were “grandfathered” as a FDA approved medication. Since no manufacturer would be granted a patent – and high price – on a opiate… no one was going to invest the money to prove the long term use/benefit. anecdotal evidence based on pt feedback, does not meet the FDA’s criteria for double blind studies.  Thus there is no “studies” that prove that opiates are beneficial for the long term treatment of pain.

http://www.webmd.com/a-to-z-guides/features/off-label-drug-use-what-you-need-to-know

More than one in five outpatient prescriptions written in the U.S. are for off-label therapies.

https://www.pennlawreview.com/debates/index.php?id=50

Off-label promotion�pharmaceutical manufacturers� marketing of FDA-approved drugs for unapproved uses�is considered a First Amendment right by some, a threat to the safety and effectiveness of pharmaceutical drugs by others.

Pfizer, the world’s second- ­largest drug company, has agreed to a written code of conduct for the marketing of opioids that some officials hope will set a standard for manufacturers of narcotics and help curb the use of the addictive painkillers.

Though Pfizer does not sell many opioids compared with other industry leaders, its action sets it apart from companies that have been accused of fueling an epidemic of opioid misuse through aggressive marketing of their products.

Pfizer has agreed to disclose in its promotional material that narcotic painkillers carry serious risk of addiction — even when used properly — and promised not to promote opioids for unapproved, “off-label” uses such as long-term back pain. The company also will acknowledge there is no good research on opioids’ effectiveness beyond 12 weeks.

The terms of the agreement were reached with the city of Chicago, which two years ago sued five other opioid manufacturers over alleged misleading marketing of opioids. An announcement of the agreement is expected Wednesday. Pfizer has also been aiding the city’s investigation and lawsuit.

Stephen R. Patton, Chicago’s corporation counsel, called Pfizer “a company that has agreed to embrace what we think are the common-sense proscriptions that we are seeking as part of our lawsuit. We hope that this trailblazing agreement . . . will set the bar for others in this industry.”

 Pfizer released a statement saying that it is “pleased to work with the city of Chicago to help address the serious problem of prescription opioid abuse. We support efforts that encourage the safe use and appropriate prescribing of opioids.” The company said it already follows many of these rules voluntarily.

But Adriane Fugh-Berman, an associate professor of pharmacology and physiology at Georgetown University School of Medicine, and director of Pharmed Out, which advocates rational prescribing practices, said she saw limited value in the agreement.

“Maybe it’s a first step, but I think counting on pharmaceutical companies to get us out of this opioid mess is not likely to be successful,” she said.

Aggressive, sometimes fraudulent marketing of OxyContin by Purdue Pharma, one of the targets of Chicago’s lawsuit, is widely blamed for the rapid growth of painkiller use across the United States. Around the turn of the century, the company mounted an aggressive campaign, initially claiming that the long-acting formulation reduced the risk of abuse and addiction.

The company swarmed primary care physicians, who had little expertise in pain management, in their offices and at ­company-sponsored conferences, at a time when the medical profession was concerned that it was not treating pain aggressively enough. Subsequent research has shown that the effort helped achieve stunning growth in the use of the painkiller, which was developed for severe pain after surgery and end-of-life care.

In 2007, Purdue pleaded guilty to criminal charges of misleading physicians, regulators and the public about the drug’s addictive qualities.

 Nearly 165,000 people have died from overdoses of prescription narcotics since the turn of the century, in what the Centers for Disease Control and Prevention has called an epidemic of opiate use. The government estimates that 2.1 million people are addicted to prescription painkillers.

In its lawsuit, Chicago contends that in 2009, about 1,100 emergency room visits were the result of opioid misuse or overdose. The city also said it paid out $12.3 million in insurance claims for painkiller prescriptions between 2008 and 2015.

This year, the federal government has redoubled its efforts to address the crisis. The CDC released new guidelines that call on doctors to sharply curtail the use of narcotic painkillers. The Food and Drug Administration required that its strongest warning on immediate-release opioids include information about misuse, abuse, addiction, overdose, death and risk of neonatal withdrawal syndrome. The House and Senate each have approved bills that address the drug crisis.

Other cities and states, including Santa Clara and Orange counties in California and the state of West Virginia, have also sued pharmaceutical manufacturers and distributors for stoking the opiate epidemic.

New York City-based Pfizer actively promotes only one opioid painkiller, Embeda, which it acquired when it bought King Pharmaceuticals in 2011. A spokeswoman said she had no separate total for its sales, but a first- ­quarter report for 2016 shows that it is part of an “other” category of drugs that brought in $171 million worldwide.

Purdue’s blockbuster OxyContin, by contrast, produced $3.1 billion in revenue in 2010. So many opioids are sold, however, that the drug has never made up a large share of the opioid analgesic market. Last year it accounted for just 2 percent of the market, according to the company.

Pharmaceutical and biotechnology companies adhere to voluntary standards last updated in 2009 by their trade association, the Pharmaceutical Research and Manufacturers of America.

State Legal Restrictions and Prescription- Opioid Use among Disabled Adults

State Legal Restrictions and Prescription- Opioid Use among Disabled Adults

CONCLUSIONS
Adoption of controlled-substance laws was not associated with reductions in potentially hazardous use of opioids or overdose among disabled Medicare beneficiaries, a population particularly at risk. (Funded by the National Institute on Aging and others.)

The New England Journal of Medicine

nejmsa1514387

Chronic fatigue syndrome is in your gut, not your head

Chronic fatigue syndrome is in your gut, not your head

https://www.sciencedaily.com/releases/2016/06/160627160939.htm

Physicians have been mystified by chronic fatigue syndrome, a condition where normal exertion leads to debilitating fatigue that isn’t alleviated by rest. There are no known triggers, and diagnosis requires lengthy tests administered by an expert.

Now, for the first time, Cornell University researchers report they have identified biological markers of the disease in gut bacteria and inflammatory microbial agents in the blood.

In a study published June 23 in the journal Microbiome, the team describes how they correctly diagnosed myalgic encephalomyeletis/chronic fatigue syndrome (ME/CFS) in 83 percent of patients through stool samples and blood work, offering a noninvasive diagnosis and a step toward understanding the cause of the disease.

“Our work demonstrates that the gut bacterial microbiome in chronic fatigue syndrome patients isn’t normal, perhaps leading to gastrointestinal and inflammatory symptoms in victims of the disease,” said Maureen Hanson, the Liberty Hyde Bailey Professor in the Department of Molecular Biology and Genetics at Cornell and the paper’s senior author. “Furthermore, our detection of a biological abnormality provides further evidence against the ridiculous concept that the disease is psychological in origin.”

“In the future, we could see this technique as a complement to other noninvasive diagnoses, but if we have a better idea of what is going on with these gut microbes and patients, maybe clinicians could consider changing diets, using prebiotics such as dietary fibers or probiotics to help treat the disease,” said Ludovic Giloteaux, a postdoctoral researcher and first author of the study.

In the study, Ithaca campus researchers collaborated with Dr. Susan Levine, an ME/CFS specialist in New York City, who recruited 48 people diagnosed with ME/CFS and 39 healthy controls to provide stool and blood samples.

The researchers sequenced regions of microbial DNA from the stool samples to identify different types of bacteria. Overall, the diversity of types of bacteria was greatly reduced and there were fewer bacterial species known to be anti-inflammatory in ME/CFS patients compared with healthy people, an observation also seen in people with Crohn’s disease and ulcerative colitis.

At the same time, the researchers discovered specific markers of inflammation in the blood, likely due to a leaky gut from intestinal problems that allow bacteria to enter the blood, Giloteaux said.

Bacteria in the blood will trigger an immune response, which could worsen symptoms.

The researchers have no evidence to distinguish whether the altered gut microbiome is a cause or a whether it is a consequence of disease, Giloteaux added.

In the future, the research team will look for evidence of viruses and fungi in the gut, to see whether one of these or an association of these along with bacteria may be causing or contributing to the illness.

Lyrica may be linked to Birth Defects

Drug Used for Pain, Anxiety May Be Linked to Birth Defects

http://www.painmedicinenews.com/Clinical-Pain-Medicine/Article/07-16/Drug-Used-for-Pain-Anxiety-May-Be-Linked-to-Birth-Defects/36827/ses=ogst

The drug pregabalin (Lyrica, Pfizer), commonly used to treat pain, epilepsy, anxiety and other brain health disorders, may be associated with an increased risk for major birth defects (Neurology 2016 May 18. [Epub ahead of print]).

Pregabalin is approved by the FDA to treat epilepsy, fibromyalgia and neuropathic pain, such as pain from diabetic neuropathy and pain after shingles or spinal cord injury. It also is used off-label for generalized anxiety disorder and other mental health issues.

Pregnancies of the women who took pregabalin during the first trimester were three times more likely to result in major birth defects than those of the women who did not take antiseizure drugs. Seven of the 116 pregnancies in women taking antiseizure drugs (6%) had major birth defects, compared with 12 of 580 pregnancies (2%) in women who did not take the drug. Birth defects due to chromosomal abnormalities were not included in these results.

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The major birth defects included heart defects and structural problems with the central nervous system (CNS) or other organs. The women taking pregabalin were six times more likely to have a pregnancy with a major defect in the CNS than the women who were not taking the drug, with four CNS defects out of 125 pregnancies (3.2%) compared with three CNS defects out of 570 pregnancies (0.5%).

“Pregabalin should be prescribed for women of childbearing age only after making sure that the benefits of the drug outweigh the risks and after counseling them about using effective birth control. In cases where women have taken pregabalin during pregnancy, extra fetal monitoring may be warranted,” said study author Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Lausanne University Hospital, in Switzerland.

Of the women taking pregabalin, 115 were taking it to treat neuropathic pain; 39 for psychiatric disorders, including depression, anxiety, bipolar disorder and psychosis; five for epilepsy; and one was taking it for restless legs syndrome.

A total of 77% of the women started taking pregabalin before they became pregnant. The women in the study stopped taking the drug at an average of six weeks into their pregnancies. Of the women taking pregabalin, 22 (13%) also were taking another antiseizure drug.

“We can’t draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects, and because the study was small and the results need to be confirmed with larger studies, but these results do signal that there may be an increased risk for major birth defects after taking pregabalin during the first trimester of pregnancy,” Dr. Winterfeld said.

State of denial ?

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Click on image to enlarge…

These is two letters that I received today as email attachments about forged Rxs floating around Kentucky. Notice that both letters remind Pharmacists to get ID’s on all controlled Rxs.  Just read all the illegal things that these people did.. from stealing Rx pads, putting phone numbers on the Rx blanks that are not the doc’s number… and on .. and on… but make sure that you get a ID.. what do you think the chances are that their Driver’s license or other ID’s ARE VALID ?  Are they in a state of denial… or just totally CLUELESS ?