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CONTROLLED SUBSTANCE SPECIALTY PHARMACY

CSAPP-- Controlled Substance Advanced Practice Pharmacy

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.

 

http://www.keyt.com/news/tipline-investigation-the-secret-rx-war/-/17671600/21009816/-/oy9vkez/-/index.html

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.

 

GOAL:

 

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.


 

 

PARADIGM SHIFT:

 

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.

 

RESPECT

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.

 

IMPLEMENTATION:

 

DEA

  1. Establish and fund a DEA section under the Office of Diversion Control dedicated to the special oversight of pharmacies that dispense greater than 30% controlled substances by dosage unit.
  2. Train DEA CSAPP investigation units comprised of agents with Narcotics enforcement experience teamed with medical professionals trained and experienced in Pain Medicine. These are two vast and vastly different fields so these investigations require a two-person, two-specialty approach.
  3. Establishment of a DEA-supervised Controlled Substance Advanced Practice Pharmacies (CSAPP) registry certification for those pharmacies that dispense greater than 30% controlled substances by dosage unit. The CSP will be assigned a unique identifier in the DEA Registration number for quick and easy recognition. Require that CSAPPs implement Policies and Procedures to detect and prevent diversion including internal audits and increased patient/prescriber monitoring. {We recommend our award-winning PainTrac™ system.} Recognize that statistical algorithms are not effective at preventing diversion.

Wholesalers

  1. Provide (limited) legal immunity for wholesalers that sell controlled substances to CSAPP pharmacies with current registration and who report sales properly to the DEA. For example, if a wholesaler makes a suspicious pharmacy activity report to the DEA, the wholesaler is exempt from sanctions for any sales made to the suspect pharmacy until DEA contacts them with a result of their investigation.
  2. Wholesaler’s pharmacy sales representatives, while not being responsible for any investigation, will add a 3-5 item checklist to their on-site visit notes indicating they have looked at the top few ‘red flags’ for illicit dispensing. Sample checklist items might include: licensed area not clean, obvious pharmacist/technician ratio problems, many out-of-state cars in parking lot or drive-through line, and obvious loitering in parking area.


 

Pharmacies

  1. Require Government-issued photo ID and signature for all CS dispensing, including mail-order/delivery. In-house photo, signature, and thumbprint are adequate in place of ID. If necessary, call prescriber for a physical description for those patients who cannot produce a photo ID. If we can do it for dextromethorphan we can do it for controlled substances.
  2. Give pharmacy ability to scan/slide State-issued ID and get photograph (only) to limit fake ID use.
  3. Prescription Drug Monitoring Program Access Reports should be available in all states and across state lines.
  4. CSP-certified dispensers must demonstrate basic knowledge of Pain Medicine by obtaining a credential from the American Academy of Pain Management, or The American Society of Pain Educators or other pain management specialty board. The APHA BCPS board is in the process of developing criteria for a BCPS in Pain Management.
  5. Require a pharmacist to see and handle the actual hard copy of any C-II prescription.
  6. Stop ‘timed’ filling protocols for all controlled substances

Manufacturers

  1. In the new, safer environment, raise levels of production by controlled substance manufacturers to prevent shortages that threaten patient safety. It is dangerous and sometimes fatal for patients regularly treated with CS to have to suspend or change their treatment regimen due to shortages.
  2. Implement micro-coding of controlled substances both to document counterfeiting and source.

Local LE

  1. Allow local Law Enforcement access to registry listings and ask that they report suspicious behavior to the DEA. This gives patients HIPPA protection, and doesn’t overburden local Law Enforcement.
  2. Allow local LE to issue BOL to local pharmacies with appropriate information. It does little good for LE if the pharmacies are unaware of what to watch for.


 

  1. Allow CSAPPs to receive an abbreviated report of a suspicious patient identified by local LE. CSAPP must then show due diligence (confirmation of diagnosis and pain control regimen by prescriber) before continuing to fill. This process is less about making arrests and more about keeping CS out of illegitimate hands.
  2. Continue with Drug-Take-Back locations.
  3. Allow CSAPP pharmacies to keep prescriptions they have declined to fill when they have multiple, strong indications that they may be fraudulent, even without MD approval. This provides evidence which is often not available for prosecution now. Unusual dose is not necessarily an indication of fraud.
  4. Require CSAPP pharmacies to keep copies of all CS prescriptions they have declined to fill (even those that don’t meet the ‘strong indication of fraud’ criteria) which are returned to the patient. This still provides evidence that can be used for prosecution that is often unavailable now.
  5. Require all pharmacies to report to CURES daily.

Prescribers

  1. Prohibit physicians, or clinics where physicians work, from dispensing controlled substances. The ‘second set of eyes’ at a second location is a barrier to diversion and helps prevent prescription errors. Make an exception for Hospital Emergency Departments who may dispense up to a three-day supply of CS.
  2. Prohibit non-hospital physicians who prescribe more than 8 prescriptions of C-II CS per day from greater than 2% ownership of a CSP pharmacy.
  3. ...deleted...
  4. Prohibit e-prescribing of C-II medications. A stolen prescription pad gives 25 opportunities for fraud and is usually easily spotted if a pharmacist handles the actual hard copy; a stolen password gives unlimited opportunities.
  5. CS prescribers must return pharmacy’s patient verification forms to pharmacy within two business days
  6. Prescriber must return pharmacy calls within one business day. Office staff should schedule this into the prescribers day.  Third-party payers must reimburse for this critical communication.
  7. Prohibit 90-day supplies of controlled substances to be dispensed. This does not disallow the issue of sequential 30-day supplies as allowed by the DEA rules. Sequential prescriptions must have:
    1. Numerical designation, i.e. 1 of 3, 2 of 3…
    2. Release date
    3. Signed and dated in the prescriber’s handwriting
    4. All other usual prescription regulations as required by the State of Issue
    5. Exceptions may be granted in the event of documented, extended travel. Security measures during travel must be documented. Patients with pain still have the right to freedom of travel. Patients with pain commonly travel great distances for testing, diagnosis or treatment from specialists. It is recognized that patients with pain may, in fact, require that travel be done in shortened segments and so trips will take longer than usual.
    6. Physicians who require repeated, unsuccessful, invasive procedures before they will prescribe CS for patients with pain may be sanctioned.

Third Party Payers

  1. Required third-party payers to increase reimbursement rates and dispensing fees to pay for the increased security. They will make up these increased costs with fewer ER visits due to under-treated pain as well as both unintentional and intentional overdoses.
  2. Require that third-party payers allow therapy changes in CS (controlled substances) prescriptions before the next prescription is due. Disallowing changes, while cost-effective, costs lives!  This allows prescribers to begin treatment with a low-dose that can be increased before the next office visit if required.
  3. Stop delays that suspend the treatment of regular CS patients.  Frequent or prolonged delays in the treatment of legitimate patients are statistically linked to loss of life.
  4. Prohibit 90-day supplies of controlled substances to be dispensed. This does not disallow the issue of sequential 30-day supplies as allowed by the DEA rules.
  5. Prohibit auto-refill of controlled substances.
  6. Stop mail-order of controlled substances. Mis-delivery is common, theft of packages is common, and more mail order of CS puts more postal carriers in mortal danger. For short-term pain, mail-order takes too long to be effective.
  7. Require that CS delivered to a patient’s home meet the same pharmacy standards as in-store pick-up, i.e. photo ID and adult signature. CS must never be left ‘on the porch’ or ‘with a neighbor.’
  8. Prohibit e-prescribing of C-II medications. A stolen prescription pad gives 25 opportunities for fraud; a stolen password gives unlimited opportunities.

 

 

CSAPP RUBRIC:

 

  1. CSAPPs must vet their own patients and prescribers
  2. DEA must vet manufacturers, wholesalers, software vendors, prescribers, dispensers, and transport companies
  3. Third party payers must not allow 90-day dispensing of CS
  4. Mail or common carrier delivery of controlled substances presents a danger to the patient (mis-delivery) as well as the postal carrier (theft). Controlled substances should be filled at community pharmacies and delivered directly into the hands of the patient or caregiver.

 

 

CSAPPs

          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

          In/Out Audits

          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:

Patients--

          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.

         

Prescribers:

          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

         

Pharmacists:

          AAPM basic training

          Background checks

          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

 

Pharmacy Staff:

          Double-check licenses

          Background check

          Office staff must be background checked

          Licensed staff should establish and address of record that is not their residence

 

EXCERPTED REFERENCE ARTICLES

 

  1. “However, Mehling said he would like to see a law passed requiring customers to show identification before purchasing prescription pills to reduce the use of stolen prescriptions. Nonetheless, Mehling said new laws and stricter enforcement won’t stop drug abuse.

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 egoodenow@chroniclet.com.

  1. Living with Pain: Physician Abandonment and Suicide in Florida

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.

  1. Fishbain DA, Goldberg M, Rosomoff RS, Rosomoff H.

SourceDepartment of Psychiatry, University of Miami School of Medicine, Florida.

Abstract

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.

  1. Prescription Drug Abuse: America's War On Drugs Moves To The Pharmacy

(excerpted)

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.

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