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Has introduced 3 generic versions of existing drugs to the US market, including the first and only available intermediate dosages of transdermal fentanyl. Expanding its existing offering of its fentanyl transdermal system 12 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, and 100 mcg/hr, Mylan received final approval from the FDA for its Supplemental Abbreviated New Drug Application for 37.5 mcg/hr, 62.5 mcg/hr, and 87.5 mcg/hr dosages. “Mylan’s Fentanyl Transdermal System is the number 1 dispensed fentanyl transdermal system in the US, and now, for the first time, patients have access to additional dosing options through Mylan's launch of 3 new strengths,' Mylan CEO Heather Bresch commented. Transdermal fentanyl is indicated for the management of persistent, moderate-to-severe chronic pain. The company also launched buprenorphine hydrochloride sublingual tablets, 2 mg and 8 mg, the generic version of Reckitt Benckiser's Subutex, as well as disulfiram tablets, 250 mg and 500 mg, the generic version of Odyssey Pharmaceutical's Antabuse, after receiving FDA approval of its ANDAs for both drugs. Buprenorphine hydrochloride is indicated for the treatment of opioid dependence, while disulfiram tablet is meant to help patients manage chronic alcoholism and maintain a state of sobriety. Pharmacy Times® is the #1 full-service pharmacy media resource in the industry.
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Fentanyl pain relief patches, sold under the brand name, have caused some serious concerns within the medical community. The FDA issued a Public Health Advisory in July 2005 in response to numerous reports of death in patients using this powerful narcotic for pain relief. The FDA is currently investigating these Fentanyl death cases to determine whether the fatal risks are associated with the quality of the product or with its inappropriate use. Fentanyl Transdermal Patches The fentanyl transdermal patch is a topical adhesive strip that slowly administers the pain medication fentanyl through the skin.
About 81 times stronger than morphine, or chronic pain that doesn't respond to other pain relievers. Given the potency of this drug, it's crucial that patients use the fentanyl patch only as directed. Do NOT use more than fentanyl than prescribed. Similarly, do NOT use the fentanyl pain patch without a prescription. Both of these events can lead to, which can result in:.
serious addiction. life-threatening side effects. death. Fentanyl Patch Placement Fentanyl patches come in five sizes of varying strengths, including (in order of increasing strength):. 12.5 micrograms/hour (-g/h).
25 g/h. 50 g/h. 75 g/h.
100 g/h Stronger patches are larger, as larger areas of skin need to be covered to ensure that more of the drug is being absorbed. Doctors will specify the ideal fentanyl patch placement based on an individual patient's needs, medical history and known drug tolerance. In general, the site of fentanyl patch placement will need to be rotated to achieve optimal pain relief.
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISK OF INCREASED FENTANYL ABSORPTION WITH APPLICATION OF EXTERNAL HEAT; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Fentanyl transdermal system exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing fentanyl transdermal system, and monitor all patients regularly for the development of these behaviors and conditions see. Life-threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of fentanyl transdermal system. Monitor for respiratory depression, especially during initiation of fentanyl transdermal system or following a dose increase. Because of the risk of respiratory depression, fentanyl transdermal system is contraindicated for use as an as-needed analgesic, in non-opioid tolerant patients, in acute pain, and in postoperative pain see and. Accidental Exposure Accidental exposure to even one dose of fentanyl transdermal system, especially in children, can result in a fatal overdose of fentanyl. Deaths due to an overdose of fentanyl have occurred when children and adults were accidentally exposed to fentanyl transdermal system.
Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure see. Neonatal Opioid Withdrawal Syndrome Prolonged use of fentanyl transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available see.
Cytochrome P450 3A4 Interaction The concomitant use of fentanyl transdermal system with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving fentanyl transdermal system and any CYP3A4 inhibitor or inducer see and. Risk of Increased Fentanyl Absorption with Application of External Heat Exposure of the fentanyl transdermal system application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl.
Warn patients to avoid exposing the application site and surrounding area to direct external heat sources see. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death see,. Reserve concomitant prescribing of fentanyl transdermal system and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit treatment to the minimum effective dosages and durations. Follow patients for signs and symptoms of respiratory depression and sedation. WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISK OF INCREASED FENTANYL ABSORPTION WITH APPLICATION OF EXTERNAL HEAT; and RISKS FROM CONCOMITANT USE OF BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning.
Fentanyl transdermal system exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing, and monitor regularly for these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur.
Monitor closely, especially upon initiation or following a dose increase. Accidental exposure to fentanyl transdermal system, especially in children, can result in fatal overdose of fentanyl. Prolonged use of fentanyl transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Concomitant use with CYP 3A4 inhibitors (or discontinuation of CYP 3A4 inducers) can result in a fatal overdose of fentanyl. Exposure of the fentanyl transdermal system application site and surrounding area to direct external heat sources has resulted in fatal overdose of fentanyl.
Warn patients to avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources. Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. Fentanyl transdermal system contains fentanyl, an opioid agonist, and is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ( ) Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. ( ) Limitations of use:.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( ). Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.
To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain. ( ).
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( ). Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.
( ). Initial dose selection: consult conversion instructions. ( ). Each transdermal system is intended to be worn for 72 hours. ( ). Adhere to instructions concerning administration and disposal of fentanyl transdermal system. (, ).
Mild to Moderate Hepatic and Renal Impairment: Initiate treatment with one half the usual starting dose, titrate slowly, and monitor for signs of respiratory and central nervous system depression. (, ). Do not abruptly discontinue fentanyl transdermal system in a physically-dependent patient.
Risk of Increased Fentanyl Absorption with Elevated Body Temperature: Monitor patients with fever closely for sedation and respiratory depression and reduce the dose if necessary. Warn patients to avoid strenuous exertion that may lead to increased body temperature. ( ). Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. ( ). Serotonin Syndrome with Concomitant Use of Serotonergic Drugs: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue fentanyl transdermal system immediately if serotonin syndrome is suspected.
( ). Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( ). Severe Hypotension: Monitor during dose initiation and titration. Lost cardscan software serial number.
Avoid the use of fentanyl transdermal system in patients with circulatory shock. ( ). Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of fentanyl transdermal system in patients with impaired consciousness or coma.
Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations see , reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic. 2.1 Important Dosage and Administration Instructions Fentanyl transdermal system should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Due to the risk of respiratory depression, fentanyl transdermal system is only indicated for use in patients who are already opioid-tolerant. Discontinue or taper all other extended-release opioids when beginning fentanyl transdermal system therapy. As fentanyl transdermal system is only for use in opioid-tolerant patients, do not begin any patient on fentanyl transdermal system as the first opioid see.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals see. Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse see. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with fentanyl transdermal system when serum concentrations from the initial patch will peak see. 2.2 Initial Dosage Do not initiate treatment with fentanyl transdermal system in opioid nontolerant patients see. The recommended starting dose when converting from other opioids to fentanyl transdermal system is intended to minimize the potential for overdosing patients with the first dose. Discontinue all other around-the-clock opioid drugs when fentanyl transdermal system therapy is initiated. While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.
As such, it is preferable to underestimate a patient’s 24-hour fentanyl requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour fentanyl requirements which could result in adverse reactions. In a fentanyl transdermal system clinical trial, patients were converted from their prior opioid to fentanyl transdermal system using Table 1 as a guide for the initial fentanyl transdermal system dose. Consider the following when using the information in Table 1:. This is not a table of equianalgesic doses. The conversion doses in this table are only for the conversion from one of the listed oral or parenteral opioid analgesics to fentanyl transdermal system.
The table cannot be used to convert from fentanyl transdermal system to another opioid. Doing so will result in an overestimation of the dose of the new opioid and may result in fatal overdose. To convert patients from oral or parenteral opioids to fentanyl transdermal system, use Table 1. Do not use Table 1 to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative and will overestimate the dose of the new agent. Table 1: Dose Conversion to Fentanyl Transdermal System Alternatively, for adult and pediatric patients taking opioids or doses not listed in Table 1, use the conversion methodology outlined above with Table 2. Table 1 should not be used to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative. Use of Table 1 for conversion to other analgesic therapies can overestimate the dose of the new agent.
Overdosage of the new analgesic agent is possible see. Table 2: Recommended Initial Fentanyl Transdermal System Dose Based Upon Daily Oral Morphine Dose NOTE: In clinical trials, these ranges of daily oral morphine doses were used as a basis for conversion to fentanyl transdermal system. Table 2 should not be used to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative. Use of Table 2 for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible see.
Oral 24 hour Morphine (mg/day) Fentanyl Transdermal System Dose (mcg/hour) 60 to 134 25 135 to 224 50 225 to 314 75 315 to 404 100 405 to 494 125 495 to 584 150 585 to 674 175 675 to 764 200 765 to 854 225 855 to 944 250 945 to 1034 275 1035 to 1124 300 For delivery rates in excess of 100 mcg/hour, multiple systems may be used. For patients that may be more sensitive to the effects of opioids, additional intermediate strengths may be considered during conversion from prior opioids or titrating the dose of the fentanyl transdermal system. For example, rather than converting or titrating to a 50 mcg/hr system, a 37.5 mcg/hr system is available. Similarly a 62.5 mcg/hr system is available for use as an intermediate strength between the 50 mcg/hr and the 75 mcg/hr system, and an 87.5 mcg/hr system is available as an intermediate strength between the 75 mcg/hr system and the 100 mcg/hr system. The additional intermediate strengths, 37.5 mcg/hr, 62.5 mcg/hr and 87.5 mcg/hr, were not used in the clinical studies.
2.3 Titration and Maintenance of Therapy Individually titrate fentanyl transdermal system to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving fentanyl transdermal system to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse see. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for opioid analgesics. Patients who experience breakthrough pain may require a dosage adjustment of fentanyl transdermal system, or may need rescue medication with an appropriate dose of an immediate-release analgesic.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the fentanyl transdermal system dosage. The dosing interval for fentanyl transdermal system is 72 hours. Do not increase the fentanyl transdermal system dose for the first time until at least 3 days after the initial application. Titrate the dose based on the daily dose of supplemental opioid analgesics required by the patient on the second or third day of the initial application. It may take up to 6 days for fentanyl levels to reach equilibrium on a new dose see. Therefore, evaluate patients for further titration after no less than two 3‑day applications before any further increase in dosage is made. Base dosage increments on the daily dosage of supplementary opioids, using the ratio of 45 mg/24 hours of oral morphine to a 12 mcg/hour increase in fentanyl transdermal system dose.
If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions. A small proportion of adult patients may not achieve adequate analgesia using a 72-hour dosing interval and may require systems to be applied at 48 hours rather than at 72 hours, only if adequate pain control cannot be achieved using a 72-hour regimen. An increase in the fentanyl transdermal system dose should be evaluated before changing dosing intervals in order to maintain patients on a 72-hour regimen. Dosing intervals less than every 72 hours were not studied in children and adolescents and are not recommended. Application and Handling Instructions. Patients should apply fentanyl transdermal system to intact, non-irritated, and non-irradiated skin on a flat surface such as the chest, back, flank, or upper arm.
In young children and persons with cognitive impairment, adhesion should be monitored and the upper back is the preferred location to minimize the potential of inappropriate patch removal. Hair at the application site may be clipped (not shaved) prior to system application. If the site of fentanyl transdermal system application must be cleansed prior to application of the patch, do so with clear water. Do not use soaps, oils, lotions, alcohol, or any other agents that might irritate the skin or alter its characteristics. Allow the skin to dry completely prior to patch application. Patients should apply fentanyl transdermal system immediately upon removal from the sealed package. The patch must not be altered (e.g., cut) in any way prior to application.
Fentanyl transdermal system should not be used if the pouch seal is broken or if the patch is cut or damaged. The transdermal system is pressed firmly in place with the palm of the hand for 30 seconds, making sure the contact is complete, especially around the edges. Each fentanyl transdermal system may be worn continuously for 72 hours. The next patch is applied to a different skin site after removal of the previous transdermal system. If problems with adhesion of the fentanyl transdermal system occur, the edges of the patch may be taped with first aid tape.
If problems with adhesion persist, the patch may be overlayed with a transparent adhesive film dressing. If the patch falls off before 72 hours, dispose of it by folding in half and flushing down the toilet. A new patch may be applied to a different skin site. Patients (or caregivers who apply fentanyl transdermal system) should wash their hands immediately with soap and water after applying fentanyl transdermal system.
Contact with unwashed or unclothed application sites can result in secondary exposure to fentanyl transdermal system and should be avoided. Examples of accidental exposure include transfer of a fentanyl transdermal system from an adult’s body to a child while hugging, sharing the same bed as the patient, accidental sitting on a patch and possible accidental exposure of a caregiver’s skin to the medication in the patch while applying or removing the patch. Instruct patients, family members, and caregivers to keep patches in a secure location out of the reach of children and of others for whom fentanyl transdermal system was not prescribed. 2.7 Disposal Instructions Failure to properly dispose of fentanyl transdermal system has resulted in accidental exposures and deaths, including deaths of children see. Instruct patients to dispose of used patches immediately upon removal by folding the adhesive side of the patch to itself, then flushing down the toilet. Instruct patients to remove unused patches from their pouches, remove the protective liners, fold the patches so that the adhesive side of the patch adheres to itself, and to immediately flush the patches down the toilet. Instruct patients to dispose of any patches remaining from a prescription as soon as they are no longer needed.
2.8 Discontinuation of Fentanyl Transdermal System Significant amounts of fentanyl continue to be absorbed from the skin for 24 hours or more after the patch is removed see. To convert patients to another opioid, remove fentanyl transdermal system and titrate the dose of the new analgesic based upon the patient’s report of pain until adequate analgesia has been attained. Upon system removal, 17 hours or more are required for a 50% decrease in serum fentanyl concentrations. Withdrawal symptoms are possible in some patients after conversion or dose adjustment see. Do not use Tables 1 and 2 to convert from fentanyl transdermal system to other therapies to avoid overestimating the dose of the new agent resulting in overdose of the new analgesic and possibly death. When discontinuing fentanyl transdermal system and not converting to another opioid, use a gradual downward titration, such as a 50% dosage reduction every 6 days, while monitoring carefully for signs and symptoms of withdrawal.
If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue fentanyl transdermal system see,. It is not known at what dose level fentanyl transdermal system may be discontinued without producing the signs and symptoms of opioid withdrawal. Fentanyl Transdermal System is available as 12 mcg/hour., 25 mcg/hour, 37.5 mcg/hour, 50 mcg/hour, 62.5 mcg/hour, 75 mcg/hour, 87.5 mcg/hour or 100 mcg/hour of fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with blue ink, on a removable release liner.
The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. Fentanyl Transdermal System 12 mcg/hour.
(system size 3.13 cm 2). Fentanyl Transdermal System 25 mcg/hour (system size 6.25 cm 2). Fentanyl Transdermal System 37.5 mcg/hour (system size 9.38 cm 2). Fentanyl Transdermal System 50 mcg/hour (system size 12.5 cm 2). Fentanyl Transdermal System 62.5 mcg/hour (system size 15.63 cm 2).
Fentanyl Transdermal System 75 mcg/hour (system size 18.75 cm 2). Fentanyl Transdermal System 87.5 mcg/hour (system size 21.88 cm 2). Fentanyl Transdermal System 100 mcg/hour (system size 25 cm 2).This lowest dosage is designated as 12 mcg/hour (however, the actual dosage is 12.5 mcg/hour) to distinguish it from a 125 mcg/hour dosage that could be prescribed by multiple patches. Fentanyl transdermal system is contraindicated in:. patients who are not opioid-tolerant. the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of time. the management of post-operative pain, including use after out-patient or day surgeries, (e.g., tonsillectomies).
the management of mild pain. patients with significant respiratory depression see.
in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment see. in patients with known or suspected gastrointestinal obstruction, including paralytic ileus see. in patients with hypersensitivity to fentanyl (e.g., anaphylaxis) or any components of the transdermal system see. 5.1 Addiction, Abuse, and Misuse Fentanyl transdermal system contains fentanyl, an opioid agonist and a Schedule II controlled substance. As an opioid, fentanyl transdermal system exposes users to the risks of addiction, abuse, and misuse.
Because modified-release products such as fentanyl transdermal system deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of fentanyl present see. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed fentanyl transdermal system. Addiction can occur at recommended doses and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing fentanyl transdermal system, and monitor all patients receiving fentanyl transdermal system for the development of these behaviors and conditions.
Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as fentanyl transdermal system, but use in such patients necessitates intensive counseling about the risks and proper use of fentanyl transdermal system along with intensive monitoring for signs of addiction, abuse, and misuse.
Abuse or misuse of fentanyl transdermal system by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose, and death see. Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing fentanyl transdermal system. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug see. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. 5.2 Life-Threatening Respiratory Depression 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.
Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status see. Carbon dioxide (CO 2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. Fentanyl transdermal system is indicated only in opioid tolerant patients because of the risk for respiratory depression and death. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of fentanyl transdermal system, the risk is greatest during the initiation of therapy or following a dosage increase.
Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy with and following dosage increases of fentanyl transdermal system. To reduce the risk of respiratory depression, proper dosing and titration of fentanyl transdermal system are essential see. Overestimating the fentanyl transdermal system dosage when converting patients from another opioid product can result in fatal overdose with the first dose. Accidental exposure to fentanyl transdermal system, especially in children, can result in respiratory depression and death due to an overdose of fentanyl. 5.3 Accidental Exposure A considerable amount of active fentanyl remains in fentanyl transdermal system even after use as directed. Death and other serious medical problems have occurred when children and adults were accidentally exposed to fentanyl transdermal system.
Accidental or deliberate application or ingestion by a child or adolescent will cause respiratory depression, and has resulted in deaths. Placing fentanyl transdermal system in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking or overdose that could result in death.
Improper disposal of fentanyl transdermal system in the trash has resulted in accidental exposures and deaths. Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental exposure to fentanyl transdermal system see.
Key:PJMPHNIQZUBGLI-UHFFFAOYSA-N Y Fentanyl, also known as fentanil, is an which is used as a and together with other medications for. It has a rapid onset and effects generally last less than an hour or two. Fentanyl is available in a number of forms including by, as a, and to be absorbed through the. Common side effects include, sleepiness, and confusion. Serious side effects may include a (respiratory depression),. Fentanyl works in part by receptors.
It is about 75 times stronger than for a given amount. Some may be as much as 10,000 times stronger than morphine. Fentanyl was first made by in 1960 and approved for medical use in the United States in 1968. It was developed by testing chemicals similar in structure to (meperidine) for opioid activity. In 2015, 1,600 kilograms (3,500 lb) were used globally. As of 2017, fentanyl was the most widely used in medicine.
Fentanyl patches are on the, the most effective and safe medicines needed in a. The wholesale cost in the as of 2015 is between 0.08 and 0.81 USD per 100 micrograms vial. Ems sql manager for mysql torrent. In the United States this amount costs about 0.40 USD as of 2017. Fentanyl is also made illegally and used as a often mixed with. In 2016 more than 20,000 deaths occurred in the United States due to overdoses of fentanyl and its analogues. Contents. Medical uses Intravenous and intrathecal Intravenous fentanyl is often used for and.
During anaesthesia it is often used along with a hypnotic agent like. It is also administered in combination with a, such as, to produce for procedures such as, and oral surgery, or in emergency rooms.
It is often used in the of including. Fentanyl is sometimes given as part of or epidurally for and. Because of fentanyl's high lipid solubility, its effects are more localized than morphine, and some clinicians prefer to use morphine to get a wider spread of analgesia.
A fentanyl transdermal patch with a release rate of 12 micrograms / hour, on a persons arm. Fentanyl (Durogesic/Duragesic) are used in chronic pain management. The patches work by slowly releasing fentanyl through the skin into the bloodstream over 48 to 72 hours, allowing for long-lasting pain management.
Dosage is based on the size of the patch, since, in general, the transdermal absorption rate is constant at a constant skin temperature. Rate of absorption is dependent on a number of factors. Body temperature, skin type, amount of body fat, and placement of the patch can have major effects. The different delivery systems used by different makers will also affect individual rates of absorption. Under normal circumstances, the patch will reach its full effect within 12 to 24 hours; thus, fentanyl patches are often prescribed with a fast-acting opioid (such as morphine or ) to handle breakthrough pain. It is unclear if fentanyl gives long term pain relief to people with. In, transdermal fentanyl has a definite, but limited, role for:.
people already stabilized on other opioids who have persistent swallowing problems and cannot tolerate other parenteral routes such as subcutaneous administration. people with moderate to severe. troublesome side effects of oral morphine, or oxycodone. Care must be taken to guard against the application of external heat sources (such as direct sunlight, heating pads, etc.) which in certain circumstances can trigger the release of too much medication and cause life-threatening complications. Duragesic was first approved by the College ter Beoordeling van Geneesmiddelen, the Medicines Evaluation Board in the Netherlands, on July 17, 1995, as 25, 50, 75 and 100 µg/h formulations after a set of successful clinical trials, and on October 27, 2004, the 12 µg/h (actually 12.5 µg/h) formulation was approved as well. On January 28, 2005, the U.S.
Approved first-time generic formulations of 25, 50, 75, and 100 µg/h fentanyl transdermal systems (made by Mylan Technologies, Inc.; brand name Duragesic, made by Alza Corp.) through an FTC consent agreement derailing the possibility of a monopoly in the treatment of breakthrough chronic pain by Alza Corp. In some cases, physicians instruct patients to apply more than one patch at a time, giving a much wider range of possible dosages. For example, a patient may be prescribed a 37.5 µg dosage by applying one 12.5 µg patch and one 25 µg patch simultaneously, or contingent on the large size of the (largest) 100 μg/h patch, multiple patches are commonly prescribed for doses exceeding 100μg/h, such as two 75 μg/h patches worn to afford a 150 μg/h dosage regimen. Although the commonly referred to dosage rates are 12/25/50/75/100 µg/h, the '12 µg' patch actually releases 12.5 µg/h. It is designed to release half the dose of the 25 µg/h dose patch. As of July 2009, construction of the Duragesic patch had been changed from the gel pouch and membrane design to 'a drug-in-adhesive matrix designed formulation', as described in the prescribing information.
This construction makes illicit use of the fentanyl more difficult. Storage and disposal The fentanyl patch is one of a small number of medications that may be especially harmful, and in some cases fatal, with just one dose, if used by someone other than the person for whom the medication was prescribed. Unused fentanyl patches should be kept in a secure location that is out of children’s sight and reach, such as a locked cabinet.
When patches cannot be disposed of through a medication take-back program, flushing is recommended for fentanyl patches because it is the fastest and surest way to remove them from the home so they cannot harm children, pets and others who were not intended to use them. Recalls In February 2004, a leading fentanyl supplier, Janssen Pharmaceutica Products, L.P., recalled one lot, and then later, additional lots of fentanyl (brand name: Duragesic) patches because of seal breaches which might have allowed the medication to leak from the patch.
A series of Class II recalls was initiated in March 2004, and in February 2008 ALZA Corporation recalled their 25 µg/h Duragesic patches due to a concern that small cuts in the gel reservoir could result in accidental exposure of patients or health care providers to the fentanyl gel. In February 2011, the manufacturer suspended production of all Duragesic patches due to quality control issues involving unspecified 'microscopic crystallization' detected during the manufacturing process of the 100 µg/h strength. Intranasal The bioavailability of intranasal fentanyl is about 70–90%, but with some imprecision due to clotted nostrils, pharyngeal swallow and incorrect administration. For both emergency and palliative use, intranasal fentanyl is available in doses of 50, 100, and 200 µg.
In emergency medicine, safe administration of intranasal fentanyl with a low rate of side effects and a promising pain reducing effect was demonstrated in a prospective observational study in about 900 out-of-hospital patients. In children, intranasal fentanyl is useful for the treatment of moderate and severe pain and is well tolerated. Sublingual Abstral dissolves quickly and is absorbed through the mucosa to provide rapid. Fentanyl is a highly lipophilic compound, which is well absorbed sublingually and generally well tolerated. Such forms are particularly useful for breakthrough cancer pain episodes, which are often rapid in onset, short in duration and severe in intensity. Lozenges.
Package and example of fentanyl lollipop (brand: Actiq), 400 micrograms. Fentanyl lozenges ( Actiq) are a solid formulation of fentanyl citrate on a in the form of a lollipop that dissolves slowly in the mouth for transmucosal absorption. These lozenges are intended for opioid-tolerant individuals and are effective in treating breakthrough cancer pain. It has also been used for breakthrough pain for patients with nonmalignant (not cancer related) pain, but this application is controversial.
The unit is a berry-flavoured lozenge on a stick swabbed on the mucosal surfaces inside the mouth—inside of the cheeks, under and on the tongue and gums—to release the fentanyl quickly into the system. It is most effective when the lozenge is consumed within 15 minutes. About 25% of the medication is absorbed through the oral mucosa, resulting in a fast onset of action, and the rest is swallowed and absorbed in the small intestine, acting more slowly. The lozenge is less effective and acts more slowly if swallowed as a whole, as despite good absorbance from the small intestine there is extensive first-pass metabolism, leading to an oral bioavailability of about 33% as opposed to 50% when used correctly, (25% via the mouth mucosa and 25% via the gut). Actiq is produced by the pharmaceutical company on a plastic stick; this provides the means by which the medication can maintain its placement while it dissolves slowly in the mouth for absorption across the, in a manner similar to sublingual film strips. An Actiq lozenge contains two grams of sugar (eight calories).
Actiq has been linked to dental decay, with some users who had no prior dental issues suffering tooth loss, and in the U.S many users have started their own Facebook pages to educate users about the severe dental issues caused by the so-called fentanyl lollipops. CBS News reported the issue 28 September 2009. The status of a sugar-free version, called Actiq-SF, is unclear. Since the release of —an effervescent buccal fentanyl tablet for —Cephalon has indefinitely postponed plans to release a sugar-free version of Actiq.
Beginning late September 2006, a generic 'oral transmucosal fentanyl citrate' has been available, made. The and Swedish armed forces combat medics utilize lollipops with fentanyl.
Navy corpsmen working with the United States Marine Corps in Afghanistan use Fentanyl lollipops on combat casualties from IED blasts and other mechanisms of injury. The lollipop is taped to the casualty's finger and inserted in between the teeth and cheek (buccal area) of the patient. When enough of the medication has been absorbed the finger will generally fall from the patient's mouth, thereby indicating that the medication has become effectively administered. Other Some preparations such as nasal sprays and inhalers may result in a rapid response, but the fast onset of high blood levels may compromise safety.
In addition, the expense of some of these appliances may greatly reduce their cost-effectiveness. In children it is unclear if intranasal fentanyl is as good as or the same as morphine. A fentanyl patient-controlled transdermal system (PCTS) is under development, which aims to allow patients to control administration of fentanyl through the skin during the treatment of pain. Adverse effects Fentanyl's most common side effects (more than 10% of patients) include diarrhea, nausea, constipation, dry mouth, confusion, (weakness), sweating, and less frequently (3 to 10% of patients) abdominal pain, headache, fatigue, anorexia and weight loss, dizziness, nervousness, hallucinations, anxiety, depression, flu-like symptoms, (indigestion), and urinary retention.
Fentanyl use has also been associated with. Despite being a more potent analgesic, fentanyl tends to induce less nausea, as well as less -mediated itching, than morphine. Fentanyl may produce more prolonged than other opioid analgesics.
In 2006 the (FDA) began investigating several respiratory deaths, but doctors in the United Kingdom were not warned of the risks with fentanyl until September 2008. The FDA reported in April 2012 that twelve young children had died and twelve more made seriously ill from separate accidental exposures to fentanyl skin patches. The precise reason for sudden respiratory depression is unclear, but there are several hypotheses:. Saturation of the body fat compartment in patients with rapid and profound body fat loss (patients with cancer, cardiac or infection-induced can lose 80% of their body fat).
Early carbon dioxide retention causing cutaneous vasodilation (releasing more fentanyl), together with acidosis, which reduces protein binding of fentanyl, releasing yet more fentanyl. Reduced sedation, losing a useful early warning sign of opioid toxicity and resulting in levels closer to respiratory-depressant levels. Fentanyl has a of 270. Overdose. See also: In July 2014, the (MHRA) of the UK issued a warning about the potential for life-threatening harm from accidental exposure to transdermal fentanyl patches, particularly in children, and advised that they should be folded, with the adhesive side in, before being discarded. The patches should be kept away from children, who are most at risk from fentanyl overdose.
Death from fentanyl overdose was declared a public health crisis in Canada in September 2015, and it continues to be a significant public health issue. In 2016, deaths from fatal fentanyl overdoses in British Columbia, Canada, averaged two persons per day. In 2017 the death rate rose over 100% with 368 overdose related deaths in British Columbia between January and April 2017. Medical examiners concluded that musician died on April 21, 2016, from an accidental fentanyl overdose. Fentanyl was among many substances identified in counterfeit pills recovered from his home, especially some that were mislabeled as Watson 385, a combination of.
American rapper also died of an accidental fentanyl overdose on November 15, 2017. On January 19, 2018, the medical examiner-coroner for the county of Los Angeles announced that died from an accidental drug overdose as a result of mixing medications that included fentanyl, acetyl fentanyl and despropionyl fentanyl (among others). He was reportedly treating 'many serious ailments' that included a broken hip. In the US, Fentanyl caused 20,100 deaths in 2016, a rise of 540% over the past 3 years. Pharmacology. Main article: Fentanyl provides some of the effects typical of other opioids through its agonism of the. Its strong potency in relation to that of morphine is largely due to its high, per the.
Because of this, it can more easily penetrate the. Detection in biological fluids Fentanyl may be measured in blood or urine to monitor for abuse, confirm a diagnosis of poisoning, or assist in a medicolegal death investigation. Commercially available immunoassays are often used as initial screening tests, but chromatographic techniques are generally used for confirmation and quantitation.
Blood or plasma fentanyl concentrations are expected to be in a range of 0.3–3.0 μg/l in persons using the medication therapeutically, 1–10 μg/l in intoxicated patients and 3-300 μg/l in victims of acute overdosage. History Fentanyl was first synthesized by under the label of his relatively newly formed in 1959. The widespread use of fentanyl triggered the production of fentanyl citrate (the salt formed by combining fentanyl and citric acid in a 1:1 ), which entered medical use as a general anaesthetic under the trade name Sublimaze in the 1960s. In the mid-1990s, Janssen Pharmaceutica developed and introduced into clinical trials the Duragesic patch, which is a formation of an inert alcohol gel infused with select fentanyl doses, which are worn to provide constant administration of the opioid over a period of 48 to 72 hours. After a set of successful clinical trials, Duragesic fentanyl patches were introduced into medical practice. Following the patch, a flavoured of fentanyl citrate mixed with inert fillers was introduced in 1998 under the brand name of Actiq, becoming the first quick-acting formation of fentanyl for use with chronic breakthrough pain. In 2009, the US approved Onsolis (fentanyl buccal soluble film), a fentanyl drug in a new dosage form for cancer pain management in opioid-tolerant subjects.
It uses a medication delivery technology called BEMA (BioErodible MucoAdhesive), a small dissolvable polymer film containing various fentanyl doses applied to the inner lining of the. Fentanyl has a US of 9801 and a 2013 annual aggregate manufacturing quota of 2,108.75 kg, unchanged from the prior year. Society and culture Brand names Brand names include Sublimaze, Actiq, Durogesic, Duragesic, Fentora, Matrifen, Haldid, Onsolis, Instanyl, Abstral, Lazanda and others. Subsys is a sublingual spray of fentanyl manufactured. Cost The wholesale cost in the as of 2015 is between 0.08 and 0.81 USD per 100 micrograms vial. In the United States this amount costs about 0.40 USD as of 2017.
In the United States the patches cost 11.22 USD for a 12 µg/hr version and 8.74 USD for a 100 µg/hr version. Legal status In the UK, fentanyl is classified as a controlled Class A drug under the. In the Netherlands, fentanyl is a List I substance of the Opium Law. In the U.S., fentanyl is a Schedule II controlled substance per the.
Distributors of Abstral are required to implement an FDA-approved (REMS) program. In order to curb misuse, many health insurers have begun to require for Actiq prescriptions.
Legal action On June 19, 2007, a $5.5 million jury verdict was awarded in a US case against Johnson & Johnson subsidiaries, Alza Corporation and Janssen Pharmaceutica Products, the manufacturers of the Duragesic fentanyl transdermal pain patch. This case, the first Federal trial involving the Duragesic fentanyl patch, was tried in the Federal District Court for the Southern District of Florida, West Palm Beach Division.
Fentanyl Patch Strength Compared
Public health advisories The US (FDA) has issued public health advisories related to fentanyl patch dangers. Among these, in July 2005, the FDA issued a Public Health Advisory, which advised that 'deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product.' In December 2007, as part of this continuing investigation, the FDA issued a second Public Health Advisory stating, 'The FDA has continued to receive reports of deaths and life-threatening side effects in patients who use the fentanyl patch.
The reports indicate that doctors have inappropriately prescribed the fentanyl patch. In addition, the reports indicate that patients are continuing to incorrectly use the fentanyl patch.' Recreational use. Fentanyl powder seized by a sheriff.
Of pharmaceutical fentanyl and its analogues first appeared in the mid-1970s in the medical community and continues in the present. United States authorities classify fentanyl as a and an. To date, more than 12 different analogues of fentanyl have been produced and identified in the U.S. Drug traffic. The biological effects of the fentanyl analogues are similar to those of heroin, with the exception that many users report a noticeably less euphoric high associated with the drug and stronger sedative and analgesic effects.
Fentanyl analogues may be hundreds of times more potent than street heroin, and tend to produce significantly more, making it much more dangerous than heroin to users. Fentanyl is used orally, smoked, snorted, or injected. Fentanyl is sometimes sold as heroin or, often leading to overdoses. Many fentanyl overdoses are initially classified as heroin overdoses.
Has the highest rate of overdose deaths in the EU, due to its high rate of recreational use. Fentanyl is sometimes sold on the black market in the form of transdermal fentanyl patches such as, diverted from legitimate medical supplies.
The gel from inside the patches may be ingested or injected. Another form of fentanyl that has appeared on the streets is the Actiq lollipop formulation. The pharmacy retail price ranges from $15 to $50 per unit based on the strength of the lozenge, with the black market cost ranging from $5 to $25, depending on the dose.
The attorneys general of Connecticut and Pennsylvania have launched investigations into its diversion from the legitimate pharmaceutical market, including Cephalon's 'sales and promotional practices for, Actiq and '. Non-medical use of fentanyl by individuals without opiate tolerance can be very dangerous and has resulted in numerous deaths. Even those with opiate tolerances are at high risk for overdoses. Once the fentanyl is in the user's system, it is extremely difficult to stop its course because of the nature of absorption. Illicitly synthesized fentanyl powder has also appeared on the United States market. Because of the extremely high strength of pure fentanyl powder, it is very difficult to dilute appropriately, and often the resulting mixture may be far too strong and, therefore, very dangerous. Some heroin dealers mix fentanyl powder with heroin to increase potency or compensate for low-quality heroin.
In 2006, illegally manufactured, non-pharmaceutical fentanyl often mixed with or heroin caused an outbreak of overdose deaths in the United States and Canada, heavily concentrated in the cities of Dayton, Ohio; Chicago; Detroit; and Philadelphia. Several large quantities of illicitly produced fentanyl have been seized by U.S. Law enforcement agencies. In June 2006, 945 grams (2.08 lbs) of 83%-pure fentanyl powder was seized by agents in California from a vehicle that had entered from Mexico. Mexico is the source of much of the illicit fentanyl for sale in the U.S.
However, in April 2006, there was one domestic fentanyl lab discovered by law enforcement in. The lab was a source of counterfeit 80 mg tablets containing fentanyl instead of oxycodone, as well as bulk fentanyl and other drugs.
In November 2016, the DEA uncovered an operation making counterfeit oxycodone and from a home in Cottonwood Heights, Utah. They found about 70,000 pills in the appearance of oxycodone and more than 25,000 in the appearance of Xanax. The DEA reported that millions of pills could have been distributed from this location over the course of time. The accused owned a pill press and ordered fentanyl in powder form from China. The 'China White' form of fentanyl refers to any of a number of clandestinely produced analogues, especially (AMF). This Department of Justice document lists 'China White' as a synonym for a number of fentanyl analogues, including 3-methylfentanyl and α-methylfentanyl, which today are classified as in the United States.
Part of the motivation for AMF is that, despite the extra difficulty from a synthetic standpoint, the resultant drug is relatively more resistant to metabolic degradation. This results in a drug with an increased duration. In June 2013, the United States (CDC) issued a health advisory to emergency departments alerting to 14 overdose deaths among intravenous drug users in Rhode Island associated with, a synthetic opioid analog of fentanyl that has never been licensed for medical use. In a separate study conducted by the CDC, 82% of fentanyl overdose deaths involved illegally manufactured fentanyl, while only 4% were suspected to originate from a prescription. Beginning in 2015, Canada has seen a widespread number of fentanyl overdoses. Authorities suspect that the drug is being imported from Asia to the western coast by organized crime groups in powder form and being pressed into pseudo-OxyContin tablets.
Traces of the drug have also been found in other recreational drugs including cocaine, and heroin. The drug has been implicated in multiple deaths from the homeless to young professionals, including multiple teens and young parents. Because of the rising deaths across the country, especially in where the deaths for 2016 is 668 and deaths for 2017 (Jan-Oct) is 999, is putting a rush on a review of the prescription-only status of in an effort to combat overdoses of the drug. Incapacitating agent. Main article: Russian security forces used a 'fentanyl gas' to incapacitate people rapidly in the in 2002. The siege was ended, but about 130 of the 850 hostages died from the gas.
The Russian Health Minister later stated that the gas was based on fentanyl, but the exact chemical agent has not been identified. Veterinary use Fentanyl in injectable formulation is commonly used for analgesia and as a component of balanced sedation and general anaesthesia in small animal patients. Its potency and short duration of action make it particularly useful in critically ill patients. In addition, it tends to cause less vomiting and regurgitation than other pure-opioid agonists (morphine, hydromorphone) when given as a continuous post-operative infusion.
As with other pure opioids, fentanyl can be associated with in both dogs and cats. Fentanyl has also been used for many years in dogs and cats for post-operative analgesia. This is usually done with off-label fentanyl patches manufactured for humans with chronic pain. In 2012 a highly concentrated (50 mg/ml) transdermal solution, trade name Recuvyra, has become commercially available for dogs only.
It is FDA approved to provide four days of analgesia after a single application prior to surgery. It is not approved for multiple doses or other species. The drug is also approved in Europe. References. Agonists (abridged; see for a full list):. PAMs:.
Fentanyl Patch Strength Conversion
Antagonists:. Unknown/unsorted:.
It is different for each person, and also dependent on how long you've been using it. Higher levels take longer for the body to remove over time. In general, you'll start feel ing the withdrawals within 6 hours after total depletion of the patch contents, and really feel it at 12 - 18 hours. This does not mean that it has left your system - it means that your body's Fentanyl level is below what it has become used to and is reacting. The longer you use Duragesic, the harder it is to end your overall dependence. As I write this, I'm in the final stages of ending my own 11 year dependence on Duragesic and Oxycodone, Demerol, and just about every other known chronic and acute pain medication. It has taken 6 months of continuous lowering of my opiate levels, and 2 hard withdrawal periods.
For those who haven't used it for very long, it is usually out of the body within 72 hours, assuming good kidney function. However, few people like myself are ever prescribed Duragesic for a short period, and if they are, it's due to a doctor's incompetence. Duragesic is intended for long-term, opiate tolerant, chronic pain patients only, and not as a short term pain medication. Fentanyl is 30 times stronger than morphine, and I can tell you it is not easy to end your dependence at all. For those who disrespect and attempt to misuse Duragesic, it's not a problem, since most people usually kill themselves in the process, not realizing just how strong it is, and how fast it can kill you if you are not tolerant to opiates - and by opiates, I don't mean minor street drugs like Cocaine or Heroin.
For true long term opiate patients, stuff like that is nothing, and it's why addicts fail to realize the dangers of Fentanyl misuse until it's too late. There aren't many studies or data available on long-term Fentanyl (or opiate for that matter) patients for a variety of reasons, but in general it's because that until the las t few years, opiate therapy wasn't really widely accepted, and it still hasn't been by all doctors. The other reason is that opiate patients typically tend to be terminally ill, so they're not around long enough to study the effects on. A smaller percentage of patients are long term chronic pain patients and Duragesic users like myself, but the number is growing who are being prescribed it.
Pain management hasn't really been at the forefront of medicine until the past few years. However, again it comes down to a quality of life decision - if you're in constant extreme pain 24/7/365, it doesn't make a difference what the long term effects are - I guarantee you that the short term effects of that pain will kill your spirit long before the effects of long term opiate use will. For any long-term user of Duragesic like myself, it is fundamentally a quality of life decision to start or continue with opiate therapy. Of course there are long term physical considerations, and the normal side effects of opiates in general (mood swings, urination problems, constipation, etc.), but those can be dealt with as long as you learn how to deal with them.
The reality is that if you're in enough constant extreme pain to require Duragesic use, then long term effects aren't really an issue, as the extreme pain will kill your spirit long before the effects of using opiates long term will. You can, but most pharmacies, especially chain drug stores, typically don't stock them regularly. If you want to get them there regularly, you'll need to establish a good rela tionship with their pharmacists, and allow time for ordering / delivery after you get your 'scripts.
The other problem with CVS and others like Wal-Mart, Rite Aid, etc., is that they change pharmacists more often than I change my socks and underwear. When dealing with Schedule II opiates, you need to have a pharmacist that knows you and your medication history, not some bumpkin right off the boat whose only knowledge of you is what he sees on a computer monitor. For that reason, I always use a local pharmacy that has only one or two pharmacists. My pharmacy, which I've used for over 20 years, would order my Duragesic and other meds after I called them and let them know what my 'script dosage/quantities were going to be (usually the same each month). Of course I had to give them the 'script, but it cut down the time before I got my meds. It usually only takes a day or two.
My point is that by using a pharmacy that has regular pharmacists, you can build up that trust and rapport needed as a Schedule II opiate patient.