IS SUBLINGUAL SUFENTANIL DANGEROUS?

Physician anesthesiologist at Stanford at Associated Anesthesiologists Medical Group
Richard Novak, MD is a Stanford physician board-certified in anesthesiology and internal medicine.Dr. Novak is an Adjunct Clinical Professor in the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University, the Medical Director at Waverley Surgery Center in Palo Alto, California, and a member of the Associated Anesthesiologists Medical Group in Palo Alto, California.
email rjnov@yahoo.com
phone 650-465-5997

Is sublingual sufentanil dangerous? The United States Food and Drug Administration (FDA) voted to approve the narcotic sufentanil for sublingual use in November of 2018. Sublingual sufentanil is 5-10 times more potent than fentanyl, and dissolves under the tongue in seconds.

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In an era of opioid overdose crisis, we now have a new, even more potent pill form of opiate.

Opioid deaths 1999-2017Sublingual sufentanil is approved for use only in medical settings, for the treatment of moderate to severe acute pain. But it is also possible that sublingual sufentanil will become the most dangerous street opiate ever known. This column reviews the arrival of sublingual sufentanil, from the viewpoint of a practicing anesthesiology attending.

Raeford Brown, Jr., MD, chair of the Anesthetic and Analgesic Drug Products Advisory Committee, and professor of anesthesiology and pediatrics at the University of Kentucky, disagreed with the FDA approval for sublingual sufentanil, citing the drug’s risk for “diversion, abuse, and death.” He cited the possible harms of such a “dangerous” drug — estimated to be 500-600 times more potent than morphine — coming to market in a tablet form. He warned of the risks of diversion of sufentanil by anesthesiologists and other medical personnel. He was quoted, “Sufentanil is a very potent opioid that is in a preparation that will be easily divertible. In the IV formulation, it has been a drug of abuse for health care providers.”

I agree with Dr. Brown. Sublingual sufentanil raises dangerous concerns. Sublingual sufentanil has the potential become the hydrogen bomb of all opiates—the mother of all lethal street drugs.

I have extensive experience administering intravenous sufentanil to patients. Intravenous sufentanil was FDA-approved in 1984. Its original primary use was as an anesthetic for cardiac surgery. I practiced cardiac anesthesia from 1985 until 2000. In the 1980s, cardiac anesthesia was achieved by high dose narcotic techniques, specifically with high dose fentanyl (100 micrograms/kg) techniques. For a 70-kilogram patient, this required injecting 7000 micrograms of fentanyl, or 140 ml of fentanyl (nearly two and an half sixty-milliliter syringes full of fentanyl) at the time of anesthetic induction. When intravenous sufentanil was approved at the same 50 mcg/ml concentration as fentanyl, but with a potency of 10 X of fentanyl, the narcotic induction only required 14 ml of sufentanil total. I can still remember my wide-eyed professors saying, “With sufentanil, the entire cardiac anesthetic is here in one syringe.” The use of sufentanil for cardiac anesthesia faded as anesthesiologists began using lower doses of narcotic as part of early-extubation techniques in the late 1990s.

We also used intravenous sufentanil to supplement anesthesia for non-cardiac surgeries. The most common method was to dilute the sufentanil 10:1 with saline, to a concentration of 5 mcg/ml. At this concentration, sufentanil was indistinguishable from fentanyl at 50 mcg/ml. After several years it became apparent that there was no advantage of using sufentanil IV over fentanyl IV in non-cardiac anesthesia, and the administration of IV sufentanil dwindled. The intravenous sufentanil form of the drug was also approved for epidural anesthesia. Over time, the use of sufentanil for epidural anesthesia also decreased, also supplanted by fentanyl.

Just when it looked like sufentanil was a drug nobody really neededà enter AcelRx Pharmaceuticals, a San Francisco Bay Area company which manufactured and tested a sublingual sufentanil product designed to melt under a patient’s tongue. Pamela Palmer, the founder and Chief Medical Officer of AcelRx, received her MD and PhD at Stanford, and is an acquaintance of mine. Dr. Palmer is an anesthesiologist who is brilliant and well informed regarding the pharmacology of sufentanil and the use of sufentanil in anesthetic practice.

Because sufentanil is highly lipid (fat) soluble, it is quickly absorbed into the bloodstream through the mucosal lining of the mouth. AcelRx will market the drug under the name Dsuvia, in a sublingual sufentanil tablet system (SSTS) which consists of a single-dose applicator prefilled with a single 3-mm-diameter 30-mcg tablet, administered by a healthcare professional no more frequently than hourly.

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A radio frequency identification (RFID) cartridge, requiring the patient’s thumbprint, helps reduce unauthorized dosing. The device is tethered to the patient’s bed to reduce risk of product loss. Each tablet is pre-loaded into a single-dose applicator within a pouch so it is suitable for field/trauma use. Both the fixed drug and dose and lockout time interval eliminate the end-user programming error risk associated with Patient Controlled Analgesia (PCA) intravenous narcotic pumps.

Studies documented the efficacy and safety of the SSTS in the treatment of postoperative pain in patients following open abdominal surgery compared with placebo.

SSTS was rated a success by significantly more patients when compared to intravenous PCA morphine. There was a faster onset of analgesia and both higher patient and nurse satisfaction scores with the SSTS as measured by validated questionnaires.

Dsuvia will be marketed as “postoperative, sublingual, patient controlled analgesia.” Once administered under the tongue, the sufentanil tablets typically dissolve within 5  minutes. The FDA approved the drug to be used in hospital settings only, for the treatment of moderate-to-severe acute pain, where a narcotic is needed and rapid onset is desired, but the route of administration does not require intravenous access. Typical settings would be the surgical wards after major orthopedic or general surgery procedures. The chief competition for Dsuvia will likely be Patient Controlled Analgesia (PCA) intravenous narcotic pumps, a commonly used analgesic method in which patients push a bedside button and self-administer intravenous narcotic (e.g. morphine, fentanyl, or Dilaudid) on demand through their IV line.

The most significant risk involving sublingual sufentanil is its potency, specifically its extreme potency as a respiratory depressant. The product description by AcelRx states that sufentanil has a “high therapeutic index” of 26,716. The Therapeutic Index is the ratio that compares the blood concentration at which a drug becomes toxic and the concentration at which the drug is effective. The larger the therapeutic index (TI), the safer the drug is. The TI affirms that sufentanil toxicity starts at a concentration of 26716 times its therapeutic concentration, but this ignores the risk of respiratory depression at much, much lower doses. A patient treated with an overdose of sufentanil will stop breathing at a dose only slightly greater, i.e. in the ballpark of only 2 – 4 times greater, than its therapeutic concentration. Like all opiates, sufentanil has side effects of respiratory depression, sedation, nausea and constipation. Respiratory depression is the reason why opiate overdose patients die. Opiate overdoses do not cause death because of an inherent “toxicity” of the drug concentration in the blood, but rather because of respiratory depression. People simply stop breathing.

Regarding sufentanil, the National Institute of Health website states: WARNINGS: Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Sufentanil Citrate injection should be administered only by persons specifically trained in the use of anesthetic drugs and the management of the respiratory effects of potent opioids, including respiration and cardiac resuscitation of patients in the age group being treated. Such training must include the establishment and maintenance of a patent airway and assisted ventilation. Adequate facilities should be available for postoperative monitoring and ventilation of patients administered anesthetic doses of Sufentanil Citrate Injection. It is essential that these facilities be fully equipped to handle all degrees of respiratory depression. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status.

There is also hope that sublingual sufentanil will have battlefield applications. A statement from FDA Commissioner Scott Gottlieg, MD on November 2, 2018 read: “(Sublingual sufentanil) has some unique features in that the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible. This includes potential uses on the battlefield. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine. This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield. The involvement and needs of the DoD in treating soldiers on the battlefield were discussed by the advisory committee . . . The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds.”

In conclusion, will sublingual sufentanil be dangerous or not?

My assessment of sublingual sufentanil, based on the information above, is as follows:

  1. Sublingual sufentanil (SS) can be useful in hospitalized post-operative patients following major, painful surgeries such as orthopedic total joint replacements or intra-abdominal surgeries. SS could replace PCA intravenous morphine or fentanyl.
  2. The market share, or prevalence of SS use will largely depend on its cost versus intravenous PCA units. AcelRx will market the drug beginning in early 2019, at a wholesale price of $50 to $60 per dose.
  3. SS will not be frequently used in Post Anesthesia Care Units, Intensive Care Units, or the Emergency Department, because patients in these settings all have intravenous lines in place, and can receive traditional IV narcotics as needed. There is no need or demand for a sublingual narcotic product in these settings.
  4. If SS tablets are diverted or stolen and are taken outside of medical settings, they can cause death. Overdoses as low as two to four times a therapeutic dose could cause respiratory depression and death. If hospital personnel divert the drug for recreational use, these personnel will be at high risk for mortality.
  5. If SS ever reaches the streets as a recreational drug or heroin substitute, users will achieve opiate overdose and death at a very high rate. If anyone naively believes the drug will not reach the streets, consider that manufactured forms of all the other pill forms of opiates, i.e. Percocet, Vicodin, and Oxycodone, eventually reached the streets. What will prevent this new drug from doing the same?
  6. Efforts to educate street users regarding the dangers of this new drug will likely fail. There can be no safe use of SS outside a medical setting. People will likely overdose and die.
  7. Regarding battlefield use: In military settings where IVs are not common, the capacity to administer potent sublingual narcotic may become standard. But misuse and abuse in the military and on the battlefield are also possible. Tales of rampant drug abuse by soldiers in the Vietnam War are part of the lore of that conflict. Access to sublingual sufentanil in the military would need to be strictly confined and monitored.
  8. An added note: An intentional overdose with SS is probably an outstanding drug for physician-aided suicide.

I have no crystal ball, but the bottom line is this:

If sublingual sufentanil use is confined to acute care hospital settings, it will be useful and not dangerous. But if sublingual sufentanil reaches the streets as a drug of abuse, it will be lethal.

Time will tell which of these fates is the truth.

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ANESTHETIC RISKS IN CHILDREN

Physician anesthesiologist at Stanford at Associated Anesthesiologists Medical Group
Richard Novak, MD is a Stanford physician board-certified in anesthesiology and internal medicine.Dr. Novak is an Adjunct Clinical Professor in the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University, the Medical Director at Waverley Surgery Center in Palo Alto, California, and a member of the Associated Anesthesiologists Medical Group in Palo Alto, California.
email rjnov@yahoo.com
phone 650-465-5997

What are the anesthetic risks for children? What should you do if your 2-year-old son or daughter requires surgery and anesthesia? Should you consent to proceed? Should you wait until he or she is 3 years old?

The answer to all these questions is: “It depends.”

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Let’s look at recommendations as they exist in 2018.

On December 14, 2016, the United States Food and Drug Administration (FDA) issued a Drug Safety Communication Drug Safety Communication Warning that general anesthesia and sedation drugs used in children less than 3 years of age who were undergoing anesthesia for more than 3 hours, or repeated use of anesthetics, “may affect the development of children’s brains.”

The text of this December 2016 FDA statement reads:

The U.S. Food and Drug Administration (FDA) is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains. . . . Consistent with animal studies, recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. However, further research is needed to fully characterize how early life anesthetic exposure affects children’s brain development. . . . Health care professionals should balance the benefits of appropriate anesthesia in young children and pregnant women against the potential risks, especially for procedures that may last longer than 3 hours or if multiple procedures are required in children under 3 years. Discuss with parents, caregivers, and pregnant women the benefits, risks, and appropriate timing of surgery or procedures requiring anesthetic and sedation drugs.”

This FDA warning resulted in a labeling change for these 11 common general anesthetics drugs and sedative agents:

  • Propofol
  • Sevoflurane
  • Midazolam
  • Isoflurane
  • Desflurane
  • Halothane
  • Pentobarbital
  • Etomidate
  • Ketamine
  • Lorazepam
  • Methohexital

Of these, sevoflurane and propofol are mainstay drugs used in pediatric anesthetics. Anesthesia for infants and children is most frequently initiated with an inhalation induction of sevoflurane vapor, because most infants and children do not have an IV line prior to induction. The primary intravenous hypnotic drug for children is propofol.

Because of this FDA statement, the propofol package insert warning label now reads:

Pediatric Use; ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY). Some published studies in children suggest that similar deficits may occur after repeated or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects. These studies have substantial limitations, and it is not clear if the observed effects are due to the anesthetic/sedation drug administration or other factors such as the surgery or underlying illness. Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other. Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks.”

For sevoflurane, the package insert warning label now reads:

Repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in neonates, infants, and children younger than 3 years, including in utero exposure during the third trimester, may have negative effects on brain development. Consider the benefits of appropriate anesthesia in young children against the potential risks, especially for procedures that may last more than 3 hours or if multiple procedures are required during the first 3 years of life. It may be appropriate to delay certain procedures if doing so will not jeopardize the health of the child. No specific anesthetic or sedation drug has been shown to be safer than another. Human studies suggest that a single short exposure to a general anesthetic in young pediatric patients is unlikely to have negative effects on behavior and learning; however, further research is needed to fully characterize how anesthetic exposure affects brain development.

There are no real alternatives to these 11 general anesthetic drugs regarding pediatric anesthesia. Dexmedetomidine and narcotics are not on the FDA list, but dexmedetomidine and narcotics are not sufficient to provide general anesthesia by themselves.

What does this mean to physicians and parents regarding anesthetics on children under the age of 3 years?

The most common indications for infants and toddlers to be placed under general anesthesia are for short procedures such as ear tubes for chronic ear infections, hernia repair, or removal of the adenoids. At times infants or toddlers require general anesthesia or sedation so they will stay still during a procedure, such as when they need an MRI or a CT scan.

There are an estimated 1.5 -2 million children under 3 years of age who undergo anesthesia annually in the United States. Prior to the FDA statement, Texas Children’s Hospital performed more than 43,000 cases each year. Approximately 13,000 of these cases involved patients under 3 years of age, and more than 11,000 of these anesthetics lasted more than 3 hours. Nearly all of the prolonged anesthetics were for serious congenital conditions for which treatment could not be delayed until the patient reached 3 years of age. Because of the FDA warning, the hospital adopted the warning’s recommendation that a discussion occur among parents, surgeons and other physicians, and anesthesiologists regarding the duration of anesthesia, any plan for multiple general anesthetics for multiple procedures, and the possibility that the procedure could be delayed until after 3 years of age.1

Dr. Constance Houck, chair of the American Academy of Pediatrics’ Surgical Advisory Panel and an Associate Professor of Anesthesia at Harvard Medical School said, “two recently published studies examining short-term anesthesia exposure for hernia repair did not show neurobehavioral differences between those who had received a general anesthetic and those who had not. . . . Most surgeries are less than one hour, but some infants and children with significant congenital defects require more prolonged surgery. . . Examples would include such defects as cleft lip and palate and malformations of the urinary or gastrointestinal tract.” Postponing major reconstructive surgery until children are older is generally not an option. “There is no evidence to suggest that short procedures should be postponed, but parents should always discuss with their child’s pediatrician and surgeon the risks and benefits of timing of procedures.2

The American Society of Anesthesiologists response to the FDA statement read: “the accumulated human data suggest that one brief anesthetic is not associated with cognitive or behavioral abnormalities in children. Most but not all studies in children do however suggest an association between repeated and or prolonged exposure and subsequent difficulties with learning or behavior.”3

In addition to the FDA drug recommendations, there are well documented surgical concerns with operating on children under age 3. For example, the recommendations for pediatric tonsillectomy are to delay until age 3, based on a high degree of evidence for increased respiratory complications at ages younger than 3.4

An overriding important consideration regarding pediatric anesthetics is: Who will be doing the anesthesia? It’s important to inquire regarding the experience and training of the physician anesthesiologist who is about to anesthetize your child. (See my related column Pediatric Anesthesia: Who is Anesthetizing Your Child?)

Some anesthesiologists do specialty fellowship education for one or two years in pediatric anesthesia, usually at an academic pediatric hospital, and are therefore well-trained to attend to your child. In community hospitals, experienced physician anesthesiologists who have attended to children since their residency training commonly do pediatric anesthetics. My practice fits this model: I am not a fellowship-trained pediatric anesthesiologist, but I have anesthetized thousands of children safely over 33+ years since my Stanford residency.

Let’s return to the question of whether your 2-year-old should have anesthesia and surgery.

My family had a personal experience with this question. My oldest son fell and cracked his upper right incisor when he was 1½ years old. He had three general anesthetics in the following nine months for dental surgeries: the first surgery to place a cap on the fractured tooth, the second surgery to extract the tooth because it died, and a third surgery to place a prosthetic incisor to replace the lost tooth. These three surgeries were performed in 1998 and 1999 when my son was between 1½ and 3 years of age. He suffered no apparent developmental delays secondary to anesthesia, but in the present day, following the FDA statement, both the physicians and the parents would be unlikely to proceed with three repeated anesthetics on such a young child.

The answer for you depends on whether your child’s surgery is elective and can wait until he or she is 3 years old, whether it is a one-time surgery, whether the surgery is brief, whether it is an emergency or whether it is to remedy a congenital deformity and can not be delayed. You’ll need to have an informed consent discussion with the surgeon, the physician anesthesiologist, and perhaps your pediatrician. If your child’s surgery is a one-time anesthetic for a common short procedure such as ear ventilation tubes or an inguinal hernia repair, it’s likely that proceeding with anesthesia and surgery will be the correct answer. If the surgery is urgent or if delaying surgery will cause an adverse outcome, then proceeding with anesthesia and surgery will be the correct answer. Trust your surgeon and physician anesthesiologist as consultants, and you’ll make the correct choice.

Be reassured. The Society for Pediatric Anesthesiology states that “complications are extremely rare. In the United States, the chance (risk) of a healthy child dying or sustaining a severe injury as a result of anesthesia is less than the risk of traveling in a car.”5

 

References:

  1. Andropoulos DB, Greene MF. Anesthesia and Developing Brains — Implications of the FDA Warning. N Engl J Med 2017; 376:905-907
  2. https://www.forbes.com/sites/ritarubin/2016/12/17/fda-has-ordered-new-label-warnings-but-its-not-clear-that-anesthesia-is-risky-in-pregnancy-kids/#45afde9138c9
  3. https://www.asahq.org/advocacy/fda-and-washington-alerts/washington-alerts/2016/12/asa-response-to-the-fda-med-watch
  4. Lescanne E, et al. Pediatric tonsillectomy: clinical practice guidelines. Eur Ann Otorhinolaryngol Head Neck Dis. 2012 Oct;129(5):264-71.
  5. http://www2.pedsanesthesia.org/patiented/risks.iphtml

 

The most popular posts for laypeople on The Anesthesia Consultant include:

How Long Will It Take To Wake Up From General Anesthesia?

Why Did Take Me So Long To Wake From General Anesthesia?

Will I Have a Breathing Tube During Anesthesia?

What Are the Common Anesthesia Medications?

How Safe is Anesthesia in the 21st Century?

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The most popular posts for anesthesia professionals on The Anesthesia Consultant  include:

10 Trends for the Future of Anesthesia

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Advice For Passing the Anesthesia Oral Board Exams

What Personal Characteristics are Necessary to Become a Successful Anesthesiologist?

 

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Published in September 2017:  The second edition of THE DOCTOR AND MR. DYLAN, Dr. Novak’s debut novel, a medical-legal mystery which blends the science and practice of anesthesiology with unforgettable characters, a page-turning plot, and the legacy of Nobel Prize winner Bob Dylan.

KIRKUS REVIEW

In this debut thriller, tragedies strike an anesthesiologist as he tries to start a new life with his son.

Dr. Nico Antone, an anesthesiologist at Stanford University, is married to Alexandra, a high-powered real estate agent obsessed with money. Their son, Johnny, an 11th-grader with immense potential, struggles to get the grades he’ll need to attend an Ivy League college. After a screaming match with Alexandra, Nico moves himself and Johnny from Palo Alto, California, to his frozen childhood home of Hibbing, Minnesota. The move should help Johnny improve his grades and thus seem more attractive to universities, but Nico loves the freedom from his wife, too. Hibbing also happens to be the hometown of music icon Bob Dylan. Joining the hospital staff, Nico runs afoul of a grouchy nurse anesthetist calling himself Bobby Dylan, who plays Dylan songs twice a week in a bar called Heaven’s Door. As Nico and Johnny settle in, their lives turn around; they even start dating the gorgeous mother/daughter pair of Lena and Echo Johnson. However, when Johnny accidentally impregnates Echo, the lives of the Hibbing transplants start to implode. In true page-turner fashion, first-time novelist Novak gets started by killing soulless Alexandra, which accelerates the downfall of his underdog protagonist now accused of murder. Dialogue is pitch-perfect, and the insults hurled between Nico and his wife are as hilarious as they are hurtful: “Are you my husband, Nico? Or my dependent?” The author’s medical expertise proves central to the plot, and there are a few grisly moments, as when “dark blood percolated” from a patient’s nostrils “like coffee grounds.” Bob Dylan details add quirkiness to what might otherwise be a chilly revenge tale; we’re told, for instance, that Dylan taught “every singer with a less-than-perfect voice…how to sneer and twist off syllables.” Courtroom scenes toward the end crackle with energy, though one scene involving a snowmobile ties up a certain plot thread too neatly. By the end, Nico has rolled with a great many punches.

Nuanced characterization and crafty details help this debut soar.

 

 

Click on the image below to reach the Amazon link to The Doctor and Mr. Dylan:

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LEARN MORE ABOUT RICK NOVAK’S FICTION WRITING AT RICK NOVAK.COM BY CLICKING ON THE PICTURE BELOW:

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