Case Study on Pharmacological, Ethical and Legal Implications

Introduction

I am Jennifer Rowling working as a nurse at a community health center. James is 37 years old and has visited his general practitioner at the community health center and it happened that I was in the same room with the doctor. James complained of abdominal pain and had not opened his bowel for one week. The doctor and I conducted the assessment, diagnosis and prescription for medication to James health condition. Supplementary prescribing was therefore used. This is where an independent prescriber who is the doctor and a supplementary prescriber being the nurse agree on a clinical management plan for a patient upon their agreement (Nuttall, D., and Rutt-Howard, 2016). However, nurses have the duty to ensure they have the right knowledge for proper medication and medication charts accurately filled for safe and best drug strategy. They need to make sure they administer medications safely according to the five rights of administration; right patient, right drug, right dosage, right route and the right time. More so, the nurse has the responsibility to find out any known drug allergies, any previous adverse drug reactions and observe on effects of drugs administered to patients.

The primary reason for attending the consultation was to help the general practitioner in assessment of patients and aid in conducting any procedure that the doctor would want to be conduct. Nurses play a major role in arranging equipment for use by the doctor and can help in taking down patient’s history. Studies even indicate that nurses provide detailed information during consultations than general practitioners and they also have even longer consultation times (Meleis, 2007). James was complaining of stomach pains and therefore I was left to gather much information to help identify the root cause of the pain. James complained to have felt sharp pains at about 6 on a scale of 1-10 for a week long and was unable to open his bowels. He showed the specific area of the stomach he felt the pain saying they were gradual until they became unbearable.

More so, he felt nausea, had a lot of gas and drinking hot water made him feel better for a short while. He had purchased over the counter buscopan 10mg tablets that he ingested one tablet three times in a day for only a day. James has a medical history of asthma and he is also obese and is on xopenex drugs for asthma 1.25mg three times a day. Xopenex is orally inhaled by nebulization with a standard jet nebulizer. A nebulizer converts this medication to fine mist to be inhaled via a face mask. Asthma is prevalent in the family owing to his condition and some traces of cardiac issues. James lives with his wife a son and a daughter. He as well has parents and two siblings, a brother and a sister. The family has weight management issues too and this is because of their poor nutrition. Feeding on junk is their order of the day. James however is not allergic to any drugs.

Physical Assessment

Physical assessment evaluates the anatomy and gives findings through the use of observation, palpation, percussion and auscultation. Data collected is considerately integrated with the history of the patient and pathophysiology (Health assessment, 2009). The assessment of the vitals showed; a blood pressure of 128/82, Pulse of 78, blood oxygen levels of 99, blood sugar levels of 141mg/dl, Height of 170m, weight of 84kg and BMI of 29. James’ asthma is aggravated by cats and can develop rashes. He rarely exercises but when he remembers to he does it once a week. The abdomen was physically examined and pain was detected in his abdomen with no bowel movements for a week. From the assessment, it was evident that James had a high BMI and blood sugar levels aside the pain in the abdomen and lack of bowel movements. Normal BMI ranges between 18.5-24.9 and 25 and above is rated as overweight thus obese. This necessitated referral to specialists in the same field to check on James and give further advice.

Diagnosis

The doctor made a rectal exam checkup for hidden blood or any other problems. He also examined James penis and scrotum to ensure there were no indications of abnormalities. A blood test was recommended to identify any infections. The blood test involved a look at the liver and pancreas to rule out any infections. Urine test was also involved to find out any infections with the urine tract. The organs, penis and scrotum showed no abnormalities, the blood test showed the pancreas, liver and other organs were free from infections and urine showed no infections with normal acidity levels. From the tests, the doctor ruled out all other possible conditions and constipation predominant irritable bowel syndrome was identified. Rome criteria was used to come to the syndrome. The criterion was used due to the recurrent abdominal pain and the alteration in defecation that had lasted a week.

Treatment

Linaclotide 290mcg was prescribed from supplementary prescription to help increase fluid secretion in the small intestine and aid in passing stool. They are capsules to be swallowed whole and not crushed or chewed once a day 30-60 minutes before meals the first meal. Adults with swallowing complications are advised to open the tablets and administer it orally in applesauce with water or rather with water through gastronomy tube. In any case the dose is missed the next dose is to be taken at the regular time and not the two doses at once. Psyllium fiber supplements were recommended too. 1 teaspoon is to be taken once a day in the morning mixed in 8 ounces of liquid with another 8-ounce glass of water. As a result of the latter, the stomach may feel bloated for the first few days but this is eased a week after when the body gets used to the increased fiber intake.

Pharmacodynamics and Pharmacokinetics of Linaclotide and Psyllium

Pharmacodynamics involves the study of how administered drug medication affects the body while pharmacokinetics establishes how an organism affects the drug. The two impact on the dosing, benefit and any adverse effects on the body. Linaclotide and its metabolite produce its pharmacological effects normally in the gastrointestinal tract. It has less general absorption after an oral administration. It is does not need any biochemical activation. The drug is highly resilient to degradation by the stomach acid, and trypsin, pepsin, chymotrypsin and aminopeptidase. It yields a single 13-amino acid degradation product when exposed to carboxypeptidase. They are strong agonists of guanylate cyclase-c (GC-C) and act in the lumen in the gastrointestinal tract with no peptide activated by oxidation. Linaclotide concentration needed to produce 50% maximum activity is eight-fold to ten-fold more powerful than guanylin. The drug however is active in the colon an hour later after administration (Zhou, H and Theil, F. 2016). Psyllium pharmacodynamics on the other hand adsorbs water in the gut as it acts as an ingestible fiber. It results to an improved stool bulk and moisture and hence contributing to peristaltic activity and bowel evacuation. With regard to pharmacokinetics, it acts locally and is not absorbed, spread locally in the gut and is released in feces (Kee, L. and Hayes, E. 1993).

In addition, psyllium has its own side effects; nausea, vomiting, diarrhea when used excessively. When it is taken in dry forms, gastric, small intestinal and rectal obstructions have been noted and cramps in the abdomen have also been noted in severe constipation cases. Linaclotide nevertheless has also its side effects; diarrhea, stomach discomforts, heartburn, bloating, vomiting, headache and stuffy nose or sneezing in some cases. Pharmacodynamically, drugs such as atropine, phenobarbital among others can promote constipation and may alter treatment of constipation by linaclotide (Zhou, H and Theil, F. 2016). However, there significance in potential interactions is not known. Psyllium has no proven severe, serious or moderate interactions with other drugs but has mild interactions with sodium picosulfate (Kee, L. and Hayes, E. 1993). Non pharmacological therapies can be involved in the treatment of IBS. Gastroenterologists have access to a range of treatments, for example diets, hypnotherapy, psychotherapy, relaxation therapy and bio-feedbacks. Consequently, patients can experiment with use of fiber to reduce on the constipation, avoiding foods that can activate the pain, exercising daily and eating at regular times can ease effects of IBS (Nuttall, D., and Rutt-Howard, J. 2016).

Advise and Follow UpJames was then advised to make a visit to the community health center if he realizes of no change after completing the medication. He should be able to note the side effects and if they advance, he should see the doctor. James was also advised to exercise regularly and visit a nutritionist for more advice on proper nutrition to avoid contracting diabetes as eminent from his sugar levels and obesity conditions. He was to visit the hospital after one week for monitoring his health. As the nurse, a follow up via calls would as well be implemented to ensure James attains a clean bill of health.

Critical Analysis

Section A: Consultation Process

A consultation process in a health care center is significant in enabling a specialist to identify patient’s problem and aids in planning, managing and identifying ways to result to a solution for the patient (Meleis, A. 2007). The consultation process involved the doctor in the room, the patient and I as the nurse. At first, we both introduced ourselves to make the patient feel at ease. Since James was a regular patient at the health center, history of his past medication was noted. Questions concerning the pain James was feeling were asked as records were taken to ensure future referrals were made easier. James was then given an opportunity to ask any questions of concern and provide any expectations he had.

The consultation ended with the doctor sending James to the laboratory for further tests. The consultation model used was Pendleton consultation model (Meleis, A. 2007). The model was useful to help the general practitioner to communicate effectively with the patient. Pendleton model as well involves defining the main agenda of the patient in consideration of other associated problems, selecting an appropriate action for the stomach pains which results to an accomplished collective understanding. The model carefully utilizes time and resources appropriately with an established relationship with the patient. It provokes ideas from patients, concerns and expectations. More so, it includes allowing questions from patients like, “what are your worries, concerns, expectations?”, among others.

On the other hand are socioeconomic factors that influence the prescription decision. They are employment status, age, weight, education and gender. They have been noted to influence the overall health status of patients. James is male and linaclotide was appropriate for the gender. The drug is affordable nonetheless James is employed and can easily purchase the drugs. Evidently, he is educated and can certainly read and follow instructions as directed by the general practitioner. James as well is of age and the dosage was applicable to his age. This obviously made sure an accurate decision was made.

Some drugs are also appropriate to a certain group of people for example, age and weight and these should be considerably looked into to ensure proper medication has been administered to the right people. These socioeconomic prescribing factors are also appropriate in covering a wider range of therapeutic areas. They ensure all considerations about the drug have been noted. Moreover, they enable prescribing quality has been measured objectively and is achieved. Section B: Pharmacology

Pharmacology for the Prescribed Drugs

According to Tomlin, M. (2010 p. 1) pharmacology is the branch in medicine that is concerned with the uses, effects and the modes of action of drugs. Prescription of drugs bases on various pharmacological factors; environmental factors, patient factors and individual factors. Environmental factors are high work load, time pressure, low staffing levels, doing a lot of tasks at the same time and distractions are some of them. These factors clearly negatively influence drug prescriptions with cases such as omissions and prescribing with uncertainties resulting to risky prescriptions thus adverse effects. Also take in consideration over the counter drugs the patient had taken from his history check on any prior adverse drug allergies and reactions. Physiological considerations are also essential for example, the age or other organ infections. Cost-effective efficient drugs would be appropriate and decisions should highly base on harm the drug might cause and most importantly should rely on published evidence for drug prescription. The right formulation, dose, frequency, duration and route of administration must not be left out. The patient as the other factor based on the complexities of patient’s medication schedule, problems in communication, pressure by the patient on the drugs to be prescribed to and treatment by various medical practitioners. According to this case, various aspects influenced the prescription. James had his own say of the type of drug he was to take and was continuously against psyllium. He thought the drug would make him have uncontrolled diarrhea inhibiting him from working. However, with proper advice and education he was able to agree and purchase the drugs for his medication.

Additionally, Linaclotide treats irritable bowel syndrome with constipation and chronic idiopathic constipation (Mager, D and Kimko, H. 2016). Pharmacologically, as measured by Bristol Stool Form Scale, it changes the look and evenness of stool. Linaclotide has active metabolites that bind to GC-C and has limited effects to the luminal surface of intestinal epithelium. Its activation leads to the intra and extracellular increase of cyclic guanosine monophosphate concentrations. High levels of guanosine monophosphate activate the emission of chloride and bicarbonate in the intestines through cystic fibrosis transmembrane conductance regulator. Eventually patients with IBS constipation are helped since it increases the release of intestinal fluids through the GI transit (Mager, D and Kimko, H. 2016). Psyllium instead is an anticoagulant, cardiac glycosides salicylate that adsorbs drugs and therefore requires separate administration with an interval of others at an approximate of 2 hours. With these in mind, linaclotide and psyllium were the best and most applicable drugs for the irritable bowel syndrome with constipation.

Section C: Legal, Ethical and Professional

Ethical Frameworks that Underpins the Prescription Episode

Health care practitioners have the legal right to prescribe drugs and they must follow ethical guidelines that ensure patients are protected from harm (American Nurses Association, 2001). Health practitioners therefore have to be educated on new medications to ensure proper medication is administered. They must also put in mind legal implications incase ethical obligations have not been followed to the later. Ethical practice is part of the most significant features that attributes to good nursing. More so, health care practitioners must exhibit moral practices by knowing and acting morally. Ideally there are ethical principles to guide health care practitioners in their practice. These are; the principle of autonomy, principle of beneficence, principle of non-maleficence and principle of justice (Ladd, E. and Hoyt, A. 2016).

Principle of autonomy enables individuals to make their own decisions. It allows them to have autonomy of thought, intention, action and all other decisions in regards to health care practices. Decisions made are free from coercion. Patients are therefore called to understand risks and the outcomes of a health care practice and the probability of success. For instance, patients are allowed to make informed decisions on the type of medication they are to receive unless in a condition they are unable to (Arcangelo V., Peterson A., Wilbur, V and Reinhold, J. 2017). James in this case was in good mental status and was able to agree on the kind of medication he was to receive to aid in his pain and lack of bowel movement.

According to the principle of justice, all patients are entitled to benefits of treatment that need to be equally distributed regardless of individual patient’s status and conditions. It requires that health care practices and procedures maintain the tradition of existing laws and are all just to all patients. Four main concerns in assessing justice are considered; fair distribution of scarce resources, rights and obligations, completing needs and possible conflicts with established legislation. In the field of reproductive technologies, there are ethical dilemmas since treatment involved is not equally available to all patients (Ladd, E. and Hoyt, A. 2016). Justice was maintained in James case, he was allowed to access the doctor just like any other patients and receive quality treatment. The right medication was administered without bias.

Beneficence simply calls for health care practitioners to do no harm to patients. Skills and knowledge should be the basic ground of providing quality health care. Health care practitioners are indebted to carefully render services that promote patient’s health. Subsequent trainings are needed to make health practitioners conversant with guidelines and putting in mind individual patient’s conditions before decision making obviously results to quality health care. Health care providers should therefore strive to be the best and provide the best (American Nurses Association, 2001). The case of James utilized all the aspects of beneficence. The nurse and the doctor ensured they James is well taken care of considering the sharp pains he was feeling and little time was taken to administer his treatment.

The principle of non-maleficence requires heath care practitioners to do what is good. They should ensure this by pursuing the greater good for the patients. There are extreme conditions that make it hard for health care givers to practice this principle. Cases of infertility issues in patients fall in this bracket. It is hard to break certain news to patients without negatively impacting them. Assistive reproductive technologies have indicated limited success rates thus making it hard to apply this principle in informing patients of the failed outcomes (Ladd, E. and Hoyt, A. 2016). James was carefully handled and results were professionally given to him. His case of obesity and threats of diabetes were well taken care of.

Legal Implications of Drug Prescriptions Episode

Health care providers are called to dispense medicine that they are sure of. No questionable, suspicious and origin factors should be involved. Health practitioners and pharmacists who intentionally ignore prescriptions with pointers of questionable legitimacy may be implicated for actively participating in dispensing wrong drugs knowingly (Moulton, L., 2007). Everything in drug prescription should be keenly looked into to avoid dire consequences. Prescription Drug Monitoring Programs (PDMPs) can be used as a valuable tool to help find out potential drug abuse. PDMPs are state run databases and are accessible to health practitioners administering drugs to help in reviewing patient’s history on controlled substance prescriptions (Dave D., Deza, M. and Horn B., 2018). They are also essential in drug epidemic early warning system, drug diversion and as a fraud investigative tool. Nevertheless, there are legal requirements for dispensing drugs. The age, weight and date of birth of patients should be indicated too as legal requirements in prescription for the purposes of transparency. They are vital requirements for prescription only medicines.

Legal implications that may be imposed to health care practitioners are disciplinary action by the board of nursing or pharmacy, litigation and professional license review which may result to reprimand or completely losing license in adverse situations (Sabatino, Pruchnicki, Sevin, Barker and Green, 2017). Supplementary drug prescription was used on James and this was keen to avoid making any obstructions that would lead to legal implications.

Professionalism in Drug PrescriptionAccording to Light, D. (2010, p. 140) taking the right prescribed drugs is essential in monitoring and controlling chronic health conditions, treating diseases and the overall long term health and patients well-being. Through supplementary prescription a nurse is able to learn and make informed choices concerning prescriptions. It aids a lot in helping nurses identify gaps of knowledge in prescription and consequently are able to have the courage of prescribing more often (Nuttall, D. and Rutt-Howard J.,2016). . Doctors and pharmacist can help suggest how best to take medications. The supplementary drug prescription episode on James gave some great insights on overall drug prescription. There were lessons learnt on prescription from the same.

Globalization of the world economy has led to worldwide distribution of drugs and a good number of people are exposed to large volumes of medicines. Free trade, communication and the use of internet have resulted to the widespread information on drugs and means to access medicinal products. Safety concerns have therefore increased to curb illegal sales of drugs on internets and improve on self- medication and allow the public to get only standard products. Public expectation has also been intensified through the increased public awareness and global exposures. This has led to pharmacovigilance centers to continue addressing safety concerns to ensure a healthy society (Doan T., Lievano F., Bhattacharya M., Scarazzini L. and Renz C., 2018).

However, there is an urgent need for growth and proper communication between the national drug regulatory centers with other countries as well. A considerable number of clinical trials have raised an alarm for this safety concerns. Potential conflicts of interest, unethical processes in enlisting patients, inadequate competence in clinical trial monitoring, poor ways of reporting adverse events and unethical clinical practices have been left with widespread concerns. Drug regulators have therefore been left with the duty to make sure patients’ rights and commitments are maintained for quality health. As a result, proper implementation of such ensures protection of the current health status and sustainability of the future (Doan T., Lievano F., Bhattacharya M., Scarazzini L. and Renz C., 2018).

Moreover, there are noted subsequent complications in clinical trials that pose greater challenges to health care. Clinical trials are conducted at various locations in different countries and international proceedings may not have a regulator for the same. This gives local regulators a challenge of ensuring efficient and appropriate clinical trials have been made. Future suitable prescriptions call for regular reporting systems for all safety concerns arising in clinical trials with a better organization between the ethics committee and all the investigators (Zhou H. and Theil F., 2016). Evidently, there is therefore the need to integrate pharmacovigilance in all clinical practices and the public policy. A complex and crucial relationship among partners in drug safety monitoring and this is vital to curb current and any future challenges in drug prescriptions.

Conclusion

Clearly from James case, there is the need for mass education on proper nutrition for quality healthy lifestyle. This is to avoid obesity and constipation that might have elevated from poor nutrition and even worse health conditions like diabetes. Regular check-ups and exercising should be made part of everyone’s lifestyle. The government can materialize this through provision of health check-up camps and also effect national health insurance funds to allow all even the less fortunate to access medication with ease. Furthermore, health practitioners must study pharmacology and pharmacokinetics of drugs to understand the advance effects of drugs before administering to patients. A thorough history of patients should be made to identify allergies to prevent adverse health effects of drugs. Appropriate prescription therefore should be made to ensure a healthy people.

References

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