Many legitimate pain patients are finding that they can no longer purchase the medicine they need from their regular pharmacy. Big Box pharmacies have placed strict limits on pain medicine purchases and many smaller pharmacies cannnot provide the medication at all.
Google "The Secret Rx War" or cut and paste the link below into your browser to see a 5-minute news story about a patient whose pharmacy can no longer purchase the pain medicine he needs.
PROPOSED DEA DESIGNATION & SPECIALTY REGISTRY FOR:
‘CONTROLLED SUBSTANCE ADVANCED PRACTICE PHARMACY’
STATEMENT OF NEED:
Legitimate patients with pain are being denied care because of the fear of regulatory sanctions upon pharmacies, prescribers, and wholesalers who may be mistakenly accused of providing medication to addicts. We recognize that addiction is part of the human condition and that addicts will do whatever they can to acquire their next dose. Unscrupulous people will take advantage of this. Therefore, the public is endangered both by addicts and unscrupulous enablers. This group of addicts and illicit users of controlled substances only represents 5% of prescriptions for Controlled Substances (CS). It is, however, unconscionable to deny care to suffering patients with pain, for whom 95% of CS prescriptions are written, because of the dangers presented by just a few abusers. The atmosphere of fear is so great now that even Hospice patients are being denied access to care.
To protect the public interest and ease the pain of the suffering by establishing a registered and certified Controlled Substance Pharmacy (CSAPP) classification that will securely provide access to controlled substances (CS) to legitimate patients while having policies, procedures, and protocols in place to greatly preventing diversion of those controlled substances into illegitimate channels.
In the past, Law Enforcement has been trained to see the high-CS-use pharmacy as a problem, but with programs like the TIRFREMS programs already put in place by the FDA and more to follow, the trend is that some pharmacies will be high dispensers of CS while others will dispense very little. Already, many pharmacies have decided not to join the TIRFREMS programs and shifted their patients being treated with rapid release fentanyl products to pharmacies who are TIRFREMS certified. With increased oversight, the New Paradigm is that CSAPP pharmacies are the safest place for the dispensing of controlled substances.
Prescribers, dispensers, wholesalers, and Law Enforcement must recognize that almost all of the members of these groups are well-informed, well-trained professionals whose intent is to serve the public interest by providing optimal patient care and preventing diversion. The fact that there are some bad apples in any group means that we must be vigilant; it does not mean that all professionals are guilty until proven innocent.
Internationally, and across all ages, 1 in 4 people are in chronic pain. Not all need medication, and of those who do, not all require controlled substances. But, most patients with chronic pain are legitimate and have the right to be treated with the same respect, dignity, and care as any other patient in the health care system.
Despite our best efforts, medical professionals are sometimes deceived. CSAPPs and Prescribers who are deceived after taking reasonable care and who can show documented diligence should not be subject to punishment or loss of certification. They will be required to attempt to amend their diligence processes to prevent, if possible, future deceptions. Some Pain Medicine researchers believe that up to 10%* of patients in any pain management practice are deceiving their prescribers/dispensers. Pain Practitioners and their national specialty societies accept that as a rational risk in order to treat the 90% of legitimate patients. Most of the time, the deceivers do not fool their prescribers for long, but new ones arrive to take their place.
*The statistics are different from the first paragraph because patients with real pain still may divert or be unknowing victims of diversion.
Third Party Payers
Must develop a Policy and Procedure manual that detects & prevents diversion from any source which they can observe, that is prescribers, patients, and employees
Strong Impaired employee policy
Limited access to licensed area (NO delivery personnel, salespeople, janitorial staff, bookkeeping staff, friends, relatives, or store managers w/o constant supervision/approval by licensed personnel)
C-II medications stored behind two locked barriers
Alarm with monitoring (door/window, motion, glass-break, fire)
Battery/cell phone alarm back-up
Continuous record (or motion-activated) camera system
Develop patient intake forms to establish identity, history, and contact information
Keep copies of denied Rx with intake forms
Report multiple denied Rx to DEA
The CSAPP policies must include:
Pharmacist must have in-person contact with the patient or verified caregiver at least upon first visit and quarterly
Government-issued photo ID or reasonable substitute for first-time dispensing. ID is to be kept on file. Those without ID such as children, the elderly, trauma victims, or those who simply can’t obtain it must be identified by staff or have their photo/identifying marks kept on file at pharmacy
Patients must be educated to avoid telling others about their CS use, supply, or fill dates as well as the proper security, disposal and use of their CS medication.
Pharmacist in Charge must make un-announced MD office visit (to local, individual prescribers) upon initial identification with documented evaluation. Return visits should be made when prescriber’s habits have changed. Large, out-of-area tertiary pain centers, cancer treatment centers, hospitals, and other out-of-area prescribers should have their licensure verified.
CS prescribers must return pharmacy’s patient verification forms to pharmacy within two business days
Prescriber must return pharmacy calls within one business day
Prescriber must speak to pharmacist in person when necessary to clarify a prescription within one day
AAPM basic training
Establish extended legal knowledge with respect to CS dispensing. CSP pharmacists must be well-versed in both State and Federal CS laws and regulations
Initial each required section of Rx as it is checked
Be aware of, but not rely on, statistical algorithms to establish patient legitimacy
Establish an address of record that is not their residence
Be aware that:
PAPERWORK DOES NOT EQUAL VIGILANCE!!!!!!
Statistical algorithms do not substitute for in-person experienced evaluation
Not all high-risk patients are misusing and not all low risk patients are using their meds properly
Office staff must be background checked
Licensed staff should establish and address of record that is not their residence
EXCERPTED REFERENCE ARTICLES
Supply will remain as long as there is demand and he said there needs be more focus on education and treatment.
“We can’t arrest our way out of this,” Mehling said. “People are going to make choices. There are consequences when you make bad choices.””
Contact Evan Goodenow at 329-7129 or firstname.lastname@example.org.
by MARK MAGINN, COLUMNIST on JUNE 7, 2012
Last December, Joe Malone came home from work and found his wife, Michelle, dead from an intentional overdose of prescription medicine. She was only 49.
“I lost the person I loved most in the whole world. She’s never coming back. I’ll never be the same person,” Joe says of his wife’s suicide.
Like thousands of other pain patients, Michelle was a casualty of a war on drugs gone mad. The battlefield was Florida – a state that’s enacted tough laws and regulations to combat the abuse of opioid medicine. The crackdown has led to the needed closure of many pill mills, but it has so intimidated doctors and pharmacists – who fear losing their licenses — that many are denying opioid analgesics to legitimate pain patients.
Some patients, like Michelle, simply can’t live with the pain anymore.
3 Completed suicide in chronic pain.
SourceDepartment of Psychiatry, University of Miami School of Medicine, Florida.
Although convergent lines of evidence indicate that one can expect a high rate of suicide completion for chronic pain patients, this problem has not previously been investigated. Follow-up data from our pain center revealed three chronic pain patients (two men and one woman) who completed suicide. These three cases are presented. The sequential nature of the data enabled us to calculate suicide rates for our chronic pain population and subsamples of this population: 16.5 women per year; 29.3 men per year; 57.1 white men and 34.9 white women in the age range of 35-64 years per year; and 78.6 white worker compensation men in the age range of 35-64 years per year. Calculation of the 95% confidence interval and comparison of these suicide rates to the general population of the United States using the Z statistic indicated that all chronic pain patient suicide rates were significantly greater than that of the general population. White men, white women, and white worker compensation men with chronic pain in the age range of 35-64 years are twice, three, and three times as likely, respectively, as their counterparts in the general population to die by suicide. Although no firm conclusions can be drawn because of the small suicide sample, these case reports indicate a need for further studies of chronic pain patient suicide rates at other pain centers.
By Toni Clarke
* As prescription drug abuse has risen, the DEA has come under increasing
pressure from Congress to show it is containing the problem. A report last year from the nonpartisan Government Accountability Office said the DEA had not shown its strategy was working and called
for clearer performance measures.
*Over the past six months, however, the Fort Lauderdale, Florida, resident has found it increasingly difficult to get her medications. Her regular pharmacy is often out of stock, and others refuse to dispense painkillers to new patients.
*"They look at you like you're an addict, a lowlife," she said.
*But critics say applying the same strategy to the legitimate supply chain as to Colombian drug lords is ineffective and is also causing supply shortages that hurt pain patients.
*"Going after a pharmaceutical manufacturer is not like going after the Medellin cartel," said Adam Fein, president of Pembroke Consulting, which advises pharmaceutical manufacturers. "I don't believe it is appropriate for the DEA to shrink the supply of prescription drugs, because it has unanticipated effects that have nothing to do with the problem."
*Pharmacists confirm that they are indeed fearful. Some are reluctant to take new painkiller customers. Others will only accept patients within a certain geographic area or refuse to accept cash.
*"Every hour of the day I have concerns I'll be audited, that my ability to take care of my patients and my family can be taken away, and I'm as legitimate as you can get," said Hale, who has a private orthopedic practice a few miles from Fort Lauderdale and is an assistant professor at Nova Southeastern University. "You're constantly watching over your shoulder, and it takes a toll."
*Other wholesalers, pharmacists and physicians say they are also keen to help, but would welcome more communication from the DEA.
*With all sides in the prescription drug fight blaming each other, nothing will be achieved without more communication and cooperation, Stutman says.