Introduction
Controlled substances are illicit or prescription pharmaceuticals that are governed by the Controlled Substances Act in the United States (CSA). In response to the potential for certain medications to be abused and become addictive, the CSA was enacted as part of the Comprehensive Drug Abuse Prevention and Control Act of 1970. This statute categorizes all federally regulated compounds into “schedules” based on their potential for damage. The schedule for a drug is decided by its medicinal value, the potential for misuse, safety, or how quickly people become hooked to it. This classification has been given a lot of thought.
The purpose of drug control is to protect individuals from the hazards that these medications can create. It is based on research into the potential of the substance for damage to both individuals and society from a range of sources. While not all prescription drugs are under control, some can be controlled. If a doctor prescribes one of these drugs, the patient must follow the instructions in the letter. In addition to having limited refills, patients may be forced to sign a pain medication agreement or a contract between them and the doctor to ensure that they are taking the medications strictly as recommended.
Morphine is a prescription-controlled medication commonly used to alleviate severe pain in cancer patients. Morphine induces euphoria, which is often compared to a dreamy condition. Most people abuse it as a narcotic substance because of its euphoric benefits. People with chronic pain are more likely to misuse their medications, which increases their risk of developing a substance use problem. The medicine can be taken as a syrup, injection, syrup, or smoked in some situations. This article will identify, research, and resolve issues related to a specific restricted substance situation involving morphine.
The problem of Using a Single License
The cost of developing new pharmaceuticals is rising, necessitating infrastructure and efficient resources. As a result, several global pharmaceutical corporations are turning to license relationships as a viable option. These license options allow businesses to avoid the time-consuming process of innovation and development. In the first scenario, the morphine company in question used a single license for several sub-stations. When sub-stations license out products, in this case, morphine, they effectively create competition for themselves. As a result, they may attempt to limit the scope of the license as much as possible to avoid providing their competitors an unfair competitive advantage.
However, these stations may find themselves in conflicts or need to settle legal bills if things go wrong. Another problem caused by sharing a license is that revenue is not guaranteed when pharmaceutical companies employ a single license. Because the licensee is unable to produce any sales, the corporations may agree to a specific royalty rate yet never get any money. As a result, many products go unregistered, even when they are offered at a reduced price because there is no consumer demand for them. As a result, the corporation, as well as the substations, suffer damaged morphine returns, resulting in a decrease in overall revenues.
Finally, employing a single license could jeopardize the reputation of the sub-stations and the main company. This is a concern because when one aspect of the connection, such as licensing, is mismanaged, the parties’ brand reputation for the IP involved suffers. Additionally, giving different licenses can harm the global brand of the company. As a result, multiple firms that are not involved in the scenario suffer because of the global reputation damage. As a result, the only option to fix this issue is to use good quality management techniques. That is why many licenses that are utilized by several companies include a set of best practices to follow, ensuring brand consistency across all licenses.
Morphine Has a Short Shelf-Life, Which Is A Problem
Due to a statewide morphine shortage, the corporation identified a pharmacy just north of Texas that would provide them with morphine until the issue was resolved. The morphine produced by this pharmacy, on the other hand, contained no preservatives because the shelf life was so short. Sodium metabisulfite and glycerin are the principal preservatives in morphine. Because morphine is prone to oxidation, sodium metabisulfite is used in morphine medications to prevent it. Because the product had a maximum shelf life of ninety days, the price was exceedingly high. This short period was damaging because it provided consumers with a limited window of opportunity to consume the goods.
The product quickly expired due to its limited shelf life; therefore, the corporation only had to purchase a small quantity of morphine. A stability test in the United States was used to establish the storage environment and BUD of morphine HCL oral solution (Howard et al., 2020). Morphine oral solutions were employed as study samples in this investigation. The solutions were created using raw morphine HCL received from the US Food and Drug Administration. To make a one percent morphine HCL solution, the solutions were dissolved in sterile water for irrigation. For irrigation, the HCL morphine solution was diluted to 0.1 percent with sterile water. 500mL high-density polyethylene bottles along with polypropylene lids were used to hold the final solution.
The compounding average humidity and temperature of the room were 64.6 and 21.6 percent, respectively. Preservatives were added to the extemporaneous aqueous solution, according to some researchers, to prevent contamination by microorganisms. If this preservative addition is contracted, the BUD can be placed at fourteen days when the solutions are stored under refrigeration. This study discovered that morphine HCL oral solutions produced with sterile water and no preservatives could be refrigerated for up to twenty-eight days without losing their microbiological stability (Howard et al., 2020). Whether the bottles are open or closed, microbial development is improbable in the solution while refrigerated. When maintained at ambient temperature, however, all of the solutions in both groups only remained microbially stable for the first week.
The total combined yeast count bypassed the maximum, which was (>10 CFU/ml) during the second week in the group of bottles that were opened daily and four weeks in the sealed group. When the solutions were stored at room temperature, these findings demonstrated that daily bottle opening influenced microbiological stability. Furthermore, the results show that morphine oral solution is chemically and microbially stable for at least seven days at room temperature (Howard et al., 2020). This finding supports the recommendation that morphine oral solution is kept at room temperature in a locked medication cart or area. This method of morphine storage also eliminates the difficulty of fitting bulkier bottles into the restricted refrigerator space seen in most nursing stations.
The morphine solution, on the other hand, can be kept in a medication cart at a nursing station with 24-hour air conditioning for one week. When establishing the storage environment and BUD for an extemporaneous oral aqueous solution, microbial stability is crucial. Extrapolation of this finding may be limited due to differences in compounding settings, containers, and formulas. Overall, this investigation determined the optimum storage conditions, which was significant assistance in preventing the morphine delivered by the pharmacy located in the north of Dallas from quickly expiring. Furthermore, if this pharmacy used the preservation methods recommended in this study, morphine would have a longer shelf life. As a result, businesses that purchase morphine from this pharmacy will profit from decreased prices.
Storage of Expired Morphine
Another company, an Emergency Medical Provider (EMS), purchased the morphine company in the second scenario.. This scenario occurs after a company has established itself as a successful owner-operator. This company decides to buy a competitor in the same industry. As a result, either a means of expansion or an impediment to even greater financial success is provided. However, before making a choice, the buying business weighs the benefits and drawbacks of acquiring a company that sells similar products or services to its own. One consequence of this arrangement is that the purchasing firm may become obsolete. This means that unless the two organizations have separate geographic domains and target consumers, they may wind up competing. Previous employees are also affected by this issue, and in most situations, they will lose their jobs. However, if the new company hires these employees, there will be an issue because the buyer will not offer the same position with the same pay and benefits as the former employer.
In this case, both companies were ordering and distributing under the same license. As previously stated, this is a risk because it could affect the reputations of both organizations. Furthermore, expired controlled substances were not thrown away. However, not discarding expired morphine was a benefit because destroying the substance is more effective than disposing of it. Expired products have the potential to hurt a brand, pose a health risk to consumers, and generate unneeded waste. These morphine companies were able to take control and rest confident that their expired or outdated medicines were no longer on the market through product destruction and de-packaging.
Morphine destruction functioned in the same way that firms delete outdated computer hard drives or shred paperwork to protect confidential data. After the morphine was broken down, the essential ingredients were repurposed. Only items that are unable to be repurposed end up in landfills. The goal is to reduce landfill usage and approach products with an eye on the environment and zero waste to landfill. Furthermore, not throwing expired morphine away was a good idea because it would mean discarding it in the trash or dumping it in rivers. Discarding them in waterways will lead to residue in landfills and ecosystems, endangering animal and plant life (Schatman & Wegrzyn, 2020). As a result, pharmaceuticals collected at drug take-back locations are either dissolved in a specific solution or incinerated in EPE-approved incinerators. Furthermore, the Food and Drug Administration (FDA) allows several exceptions to the no-flushing rule.
Other drugs, like morphine, are deemed harmful therefore flushing them is preferable to risking their overuse. Another study in the United States established how long morphine could last until it expires (Goedel et al., 2022). In this study, three hundred devices were filled with a 40mg/ml morphine solution and stored for thirty days without any morphine preservatives. No light was allowed to pass through this solution, which was held at ambient temperature. The solution stayed sterile for thirty days, according to the culture article. Furthermore, no turbidity was observed in morphine samples collected twice a week, although osmolality and PH remained consistent. The drug concentration was assessed using a stability-indicating HPLC approach, which demonstrated that breakdown products from morphine may be separated. Due to the evaporation of the solvent, the concentration of morphine increased after twenty-one days. Additionally, there were no signs of breakdown products such as pethidicacid or pseudomorphic. Finally, the microbiological and physicochemical stability of morphine hydrochloride held in these devices was tested at room temperature for twenty-one days.
Oral morphine administration is no longer possible for a large number of terminally ill patients, so it is administered via portable pumps. This enables the patient to receive treatment in the comfort of his or her own home. Storage of pre-filled reservoirs and administration over a long period are commonplace in this situation, necessitating data on morphine solution stability, which is presented in this study (Goedel et al., 2022). Because most of these patients have many symptoms, admixtures with other drugs are frequently used, necessitating knowledge of morphine compatibility. The findings of this study reveal that morphine degrades in aqueous solutions, resulting primarily in pseudomorphine production. In general, data on the shelf life of morphine found that it had a total shelf-life of three months or ninety days in the absence of light and preservatives.
Although the corporation did well by not just discarding the expired morphine, it failed by stocking the outdated morphine to properly dispose of it at a later date. The easiest approach to get rid of this addictive sort of medication was to take it to a licensed drug disposal facility rather than stockpiling it. These institutions address the issue of firms hoarding expired medications. The Drug Enforcement Administration (DEA) has designated these venues or businesses to collect outdated pharmaceuticals. The DEA website can help businesses and individuals locate the closest facility.
In conclusion, a wide range of powerful opioids and their formulations are available to treat pain around the world. Morphine is the most often prescribed opioid in the world, and it is used to treat moderate to severe pain. Morphine has been designated as one of the essential medications by the World Health Organization (WHO). Aside from analgesia use, studies have shown that it is beneficial in the relief and treatment of a variety of debilitating and distressing illnesses, such as dyspnea and cough. The significance of morphine in diarrhea and opioid substitution treatment (OST) is, however, still unknown.
Opioid replacement treatment is an evidence-based strategy for opiate abusers that involves the use of medically prescribed, orally given opiates such as methadone and buprenorphine to substitute illegal drug usage. Finally, old morphine can be disposed of at a drug disposal facility. If a firm is not situated in the vicinity of these institutions, it should verify the FDA’s flush listing to determine if its drug is on the list (Beletsky, 2020). Medicines on the flush list are sought after because of their potential for misuse and abuse or because if taken wrongly, they can result in death. Morphine is one of the most common medications on the flush list since it contains opioids. Before taking the medicines to a take-back center, make sure to remove all personal information from the drugs, such as the address and name labels. Overall, it is essential to remember that animals and people may be put in danger if they come upon poorly dumped medication.
References
Beletsky, L. (2020). Controlled Substances Act at 50: A Blueprint for Reform. SSRN Electronic Journal, 1-4. Web.
Goedel, W. C., Macmadu, A., Shihipar, A., Moyo, P., Cerdá, M., & Marshall, B. D. (2022). Association of medical cannabis licensure with prescription opioid receipt: A population-based, individual-level retrospective cohort study. International Journal of Drug Policy, 100, 103502. Web.
Howard, M., Russo, P., Haymond, A. N., Ortiz, V. C., Andes, S. R., Espina, V., Luchini, A., Liotta, L., & Guirguis, R. (2020). LC-MS/MS validation for drug of abuse testing utilizing a split sample oral fluid collection system. Web.
Schatman, M., & Wegrzyn, E. (2020). The United States drug enforcement administration and prescription opioid production quotas: An end game of eradication. Journal of Pain Research, 13, 2629-2631. Web.