History and Epidemiology of ACTIQ
The origin of ACTIQ can be traced to the 1960s when chemist Paul Janssen created fentanyl. Initially, fentanyl was used as an anesthetic because it could produce analgesia without making patients unconscious. Further developments saw the drug gain advance into different forms such as the fentanyl citrate (ACTIQ/oral transmucosal fentanyl citrate (OTFC). While ACTIQ was still being researched, a company named Anesta Corp was accused of publicizing the drug while at the development stage. The drug caused a stir in the cancer care world where it was lauded as the answer to breakthrough cancer pain (BTCP). True to the expectations, ACTIQ possessed an immaculate ability to arrest cancer pain within minutes of it being administered. ACTIQ, also commonly abbreviated as OTFC, is a narcotic (opioid) drug that is prescribed as pain medication for cancer patients who experience BTCP.
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BTCP has remained a major challenge to cancer patients for a long time. It is particularly worrying because it defies the ordinary cancer pain medication that patients are often prescribed. Patients who are tolerant of normal cancer pain medication are considered eligible for ACTIQ prescriptions. Despite taking at least 60 mg of morphine or 30 mg of oxycodone daily, such patients do not experience pain relief. Therefore, ACTIQ provides quick relief to breakthrough cancer pain by helping patients to manage this condition. Ordinary painkillers cause a “hurt respite gap”, which is the difference in time between when throbbing reprieve medication is taken and when the patient experiences pain relief. From the onset of its discovery, ACTIQ posed a major risk of being abused. Strictly, the drug is prescribed for cancer patients with breakthrough pain. However, due to its potent capabilities, ACTIQ can be appealing to people who experience different forms of acute pain. The drug is known to be fatal, particularly, to children. It can also pose serious health threats to adults. Notwithstanding, researchers are locked in efforts to determine the usability of ACTIQ to treat chronic non-cancer pain (Webster, Chun, Reinking, Stegman, & Taylor, 2013).
The Pharmacology: How ACTIQ Works in the System
As noted earlier, ACTIQ is a fast-acting prescription drug that arrests pain within minutes of administration. It is normally prescribed after the normal morphine dosage fails to curb cancer BTP. The fast-acting characteristic of ACTIQ is a result of being absorbed in the mucosal lining of the mouth. Once absorbed, ACTIQ attains maximum plasma concentrations within 22 minutes (Changg, Roeland, Atayee, Revta, & Ma, 2015). It navigates the blood-brain barrier faster compared to other opioids, including morphine and oxycodone.
Inside the body, ACTIQ combines with the m-opioid receptors, thus producing analgesia and sedation. Analgesia occurs because the binding of ACTIQ with the said receptors blocks pain pathways, causing pain response to be altered. Sedation, respiratory depression, and a feeling of relaxation also occur alongside analgesia. Simply defined, analgesia is the inability to experience pain. According to Wynn (2011), ACTIQ’s precise mechanism has not been identified. However, the drug’s action is associated with the opioid receptors contained along the spinal cord. Other drugs that have a similar mechanism such as ACTIQ include morphine, codeine, and oxycodone.
How ACTIQ is Grown, Manufactured, Transported, and Marketed
ACTIQ is a synthetic drug that is available as lozenges/lollipops, which are designed to be sucked in the mouth. It is made from reacting fentanyl and citric acid in the relative amount 1:1. ACTIQ is attached to a plastic stick to facilitate holding by the patient while sucking. Ingredients present in the lozenges include dextrose, sucrose, and glycol. ACTIQ is currently manufactured by various licensed companies, including Teva Pharmaceuticals, the company that acquired Cephalon in 2011. Because of the high risk of overdose, misuse, abuse, and addiction, ACTIQ is a strictly regulated drug. The Risk Evaluation and Mitigation Strategy (REMS) is a control program by the Food and Drug Administration (FDA) that monitors how the drug is issued to outpatients, pharmacies, and distributors. REMS requires ACTIQ to be prescribed strictly for opioid-cancer cases, particularly those with BTCP.
The number of pain prescriptions for ACTIQ increased from about half a million in 1994 to nearly 6 million in 2003. This increment is an indication that the drug has grown in popularity, owing to its success in arresting BTCP. However, the marketing of ACTIQ has landed Cephalon in trouble in the past after the company was found guilty of aggressive marketing strategies for unauthorized uses. The company was ordered to pay $425 million in a suit filed on behalf of the US government. While off-label prescriptions of ACTIQ are permissible for the part of physicians, pharmaceutical companies are barred from marketing drugs for off-label uses because such a practice poses a major risk since the drug can be accessed by the wrong people. For instance, the amount of ACTIQ circulating illegally has continued to increase, owing to activities such as theft and selling in the black market. ACTIQ as an abused drug is used for its sedative properties.
The Dosage, Expected Effects, Side Effects, and Potential for Overdose
ACTIQ is a highly potent drug that is about 100 times more powerful compared to morphine. For this reason, it is to be taken in small doses. To begin with, the drug is only available for use by cancer patients who develop BTCP (Chang et al., 2015). In other words, a patient must experience pain that cannot be managed by ordinary opioid-based medication. The ACTIQ dosage is administered by way of mouth whereby the patient sucks on the lozenge/lollipop. It is designed this way to facilitate quick absorption through the buccal cavity, hence initiating fast action. The method ensures that a minimal relief gap exists. Also, the lollipop design makes it difficult for the patient to accidentally swallow the unit. While swallowing may not pose a risk to an adult patient, it inhibits the drug’s action inside the body because absorption in the intestine occurs much slowly compared to assimilation in the mouth. As such, about 25 percent of the ACTIQ unit should be absorbed through the mouth cavity, a process that takes about 15 minutes. Afterward, the patient may swallow the remaining part, which will then be gradually absorbed in the intestinal region.
A single dose of ACTIQ contains about 200 micrograms of the drug in one lozenge/unit. As explained above, the patient is required to suck the unit to allow the drug to be taken gradually into the body. Usually, no standard dosage can render analgesia across all the patients’ cases. Instead, what constitutes enough dosage depends on an individual’s severity of pain, response to the drug, as well as the risk of developing side effects. Nevertheless, it is strictly required that patients should not take more than two units per BTCP episode. This plan serves as a precaution against possible misuse and hence fatal overdosing. Patients are advised to stop administration once pain ceases since this outcome indicates that they have reached an adequate dosage. Importantly, four hours should elapse before the patient can commence treatment for a subsequent episode. Sometimes, patients may skip a dosage. However, this case is uncommon in pain medication (Kuip, Zandvliet, Mathijssen, & Van der Rijt, 2012). In the event this happens, the patient is advised to ignore the skipped dosage to avoid possible overdoing. Also, since ACTIQ is a pain medication substance, no serious side effects of skipping a dosage have been witnessed.
The obvious effect is the arresting of pain within a short period of administration. By arresting the pain receptors in the spinal cord, ACTIQ causes the transmission of pain to be inhibited. As a result, the patient experiences pain relief (analgesia), beginning within the first 5 minutes of oral intake. The effect of ACTIQ in the body lasts for about 2 hours during which the breakthrough episode is expected to have subsided. A relaxed feeling will also accompany the analgesia lasting almost the same period. According to Wynn (2011), some patients may experience mild-to-intense mental impairment (confusion). Blurry vision has been reported at night. It is for this reason that users are advised to avoid driving or operating heavy machinery before figuring out how ACTIQ affects their level of alertness.
ACTIQ demonstrates a wide range of side effects depending on the patient’s tolerance and the amount of dosage. The most common side effects, which mostly affect about 10% of users, include respiratory depression, diarrhea, constipation, nausea, dry mouth, and confusion. Other less common side effects are sweating, headache, anorexia, and nervousness. Slowed breathing can also occur in extremely rare circumstances, except if occasioned by an overdose. In the event of an overdose, the breathing problem could become fatal. Some grave side effects also occur when ACTIQ is combined with other substances. On top of the list is alcohol, which has been shown to cause serious reactions when taken with pain medication.
Particularly, opioid medications if taken with alcohol may cause death (McWilliams & Fallon, 2013). Grapefruits and (grape) juices also cause harmful reactions if taken within a short period of having ACTIQ. To avoid reactions, patients are always advised to avoid eating or drinking anything alongside ACTIQ. Another serious side effect of ACTIQ is tooth decay. ACTIQ contains at least eight calories (2 grams) of sugar per lozenge, a factor that has been associated with widespread tooth crumbling in users. Following an outcry by affected patients and a subsequent story that showed Cephalon’s plans to release a sugar-free lozenge (Actiq, 2012). However, this version of the drug is yet to appear. Instead, the company and physicians strongly advise users to maintain high levels of dental hygiene to avoid tooth decay.
Potential for Overdose
Concerns over the possible overdose of ACTIQ are ever-present. These concerns result from the high incidence of overdose cases, many of which have resulted in fatalities. Fatalities often occur when the patient fails to seek medical assistance after overdosing. According to Chang et al. (2015), the number of overdose cases of fentanyl-based products in the US rose from 9,000in 2004 to over 20, 000 in 2008, despite a mitigation strategy (REMS) being in place aimed at preventing overdose and non-medical use of ACTIQ. Overdose can be identified by establishing any one of the following side effects:
- Sluggish/trouble in breathing
- Amassing of liquids in the lungs
- Incapability to talk/stroll
- Dawdling heartbeat
The above list is not conclusive since effects are likely to vary depending on the patient’s tolerance level. Besides, being on other medication or having other medical conditions can result in unpredicted side effects (Chang et al., 2015). Pain medications are among the most commonly abused prescription drugs in the United States. ACTIQ specifically belongs in the aforementioned opioid class that registers high numbers of overdose cases. One of the lead causes of an overdose of ACTIQ is improper prescriptions. As Webster et al. (2013) explain, ACTIQ has a much higher potency compared to other opioid drugs. As such, a patient transitioning from another opioid/fentanyl drugs should be given a much smaller prescription (200mcg) at the begging of such transition. However, physicians may sometimes issue a prescription similar to that of less potent medication that the patient was using previously. Similarly, the patient may plan to take a dose of ACTIQ that is similar to that of a previous but less potent drug, thus overdosing.
Specific Treatments that Might be Used in Rehabilitation
Abuse and misuse of fentanyl have become common over the years, having begun from within the medical profession in the 1970s. The first cases of abuse involved in medical professionals. Soon, the drug was being sold as an abuse substance across the world. Due to its widespread abuse, ACTIQ addiction has become a major challenge in the fight against narcotics. ACTIQ appears harmless probably because it is often referred to as ‘lollipop.’ However, its side effects are dire. On many occasions, one may suffer addiction. ACTIQ addiction can be extremely difficult to cure because it is a powerful narcotic. As such, quitting the drug abruptly and without guidance by a specialist can lead to nasty withdrawal symptoms and complications.
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Rehabilitation is the recommended approach to dealing with ACTIQ addiction. Rehabilitation services are classified into outpatient and inpatient. Outpatient rehabilitation involves attending a treatment program while living at home. One advantage of outpatient care is that patients can live at home and go on about their day-to-day life. They may receive moral support from family members. However, certain drawbacks are associated with outpatient rehabilitative care. First, ACTIQ is a potentially dangerous drug, which requires close monitoring by a physician. Besides, outpatient care presents the patient with many opportunities to access the drug, a situation that can lead to a relapse.
An inpatient/residential rehabilitation program is the most suitable approach to treating patients with ACTIQ addiction. It involves a comprehensive and intensive approach that offers consistent support for addicts. Specific treatments under the inpatient program may include detox, therapy/peer groups, and coping skills to address the risk of relapse (Webster et al., 2013). Certain prescriptions are also available to arrest withdrawal symptoms occasioned by the discontinuation of use. Inpatient rehabilitative care is usually more costly compared to outpatient, but the benefits of the former make it a worthy investment. Besides, inpatient rehabilitation is categorized into three types of programs, depending on the services offered. These services include typical, classified/magnificent and, supervisory treatment programs.
The length of inpatient treatment depends on the following factors:
- The rigorousness of the compulsion
- The patient’s record of treatment (e.g., cases of reversion)
- Individual desires of the patient
- Monetary resources: Rehabilitative care is a finance-intensive treatment
- Presence/absence of support at home or in the community
ACTIQ is one of the different drugs found under a category of opioids known as fentanyl. It is sold as lozenge units, each ranging between 200 and 1600 mcg. ACTIQ’s strength and ability to arrest BTCP pain has caused the drug to become popular in cancer treatment. However, only opioid-tolerant cancer patients should be prescribed to ACTIQ. While the standard dosage is 200 mcg, patients achieve analgesia differently because of many varying factors such as drug tolerance. For this reason, physicians should avail just the right amount to bring about analgesia in the patient. The administration of the drug is by way of mouth to attain rapid absorption. Conversely, swallowing the lozenge (before sucking first) may diminish the absorbability, hence making it less effective. ACTIQ is a commonly abused drug where people use it as an ordinary narcotic. This situation has resulted in deaths related to abuse and overdose. REMS is a control program established by the FDA to ensure that ACTIQ is not obtained for the wrong use. Nevertheless, the drug is still being abused at a worrying rate. Other than abuse, patients also commonly misuse prescribed ACTIQ by taking the wrong dosages. Physicians are advised to keep track of their patients, particularly those in the outpatient programs to ensure they stick to the prescribed dosages. Finally, switching between ACTIQ and other types of fentanyl requires a new prescription to avoid an overdose. If carefully utilized, ACTIQ can assist BTCP patients to live normal lives while taking the normal round-the-clock opioid prescription.
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