Drug Protocol Development for Atorvastatin in Hypercholesterolemia
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This article discusses the drug protocol for administering atorvastatin for the treatment of hypercholesterolemia. It covers the clinical indications, inclusion and exclusion criteria, pharmacodynamics, pharmacokinetics, drug interactions, adverse effects, and response to adverse events. Additionally, it provides a critical discussion on the nursing process, including assessment, implementation, evaluation, and patient education.
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Running head: DRUG PROTOCOL DEVELOPMENT 1
Drug protocol development
Name
Student Number
NURS12154 Pharmacology for Nursing Practice
Unit Coordinator/s Name
Drug protocol development
Name
Student Number
NURS12154 Pharmacology for Nursing Practice
Unit Coordinator/s Name
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DRUG PROTOCOL DEVELOPMENT 2
Drug therapy protocol for administering atorvastatin for the treatment of hypercholesterolemia
Clinical Indication for
Use
Hypercholesterolemia, reducing risk of atherosclerotic vascular
disease. (Mclever et al., 2017)
Inclusion Criteria
Prevention of cardiovascular disease
Hyperlipidemia (Ferreira et al.,2017)
Adults
As an adjunct to diet in Fredrickson II and IIb
and adults with Fredrickson (Bhatt et al.,
2016)
Exclusion Criteria
Current medication with Cyclosporine,
Tipranavir plus Ritonavir and Telaprevir
Patients with HIV and Hepatitis C risk
myopathy thus precaution required.
Pregnancy (Barrios., et al 2015)
Pharmacodynamics (Mechanism of Action)
Atorvastatin is a selective competitive inhibitor of HMG-CoA reductase. An enzyme that
converts 3-hydroxy-3methylglutaryl-coenzyme A to mevalonate, which is a precursor to
body sterols including cholesterol. Atorvastatin thus lowers blood plasma cholesterol by
inhibition of the enzyme HMG -CoA reductase and cholesterol synthesis in the liver. Also
increases the hepatic LDL receptors enhancing LDL catabolism and uptake.
Pharmacokinetics (ADME)
Absorption:
Atorvastatin is rapidly absorbed after oral administration. Within 1-2 hours maximum
plasma concentration is reached. Food availability decreases rate and extent of drug
absorption by 25% and 9 % respectively. Evening administration shows lower plasma
concentration as compared to evening. LDL -C is however reduced regardless of time of
administration.
Distribution:
Atorvastatin has a mean volume of distribution of 381 litres.
Approximately 98 % of atorvastatin is bound to plasm proteins with poor penetration of 0.25
into red blood cells. Atorvastatin is secreted in human milk.
Metabolism.
Atorvastatin is metabolized in the liver to ortho and parahydroxylated derivatives and other
beta oxidation products.
Excretion.
Atorvastatin and its metabolites are primarily eliminated in bile. (Patel et al ., 2015 )
Drug Interactions
Clarithromycin -Atorvastatin AUC increased, thus in patients using clarithromycin, dosage
should not exceed 20 mg.
Protease inhibitors -HIV protease inhibitors and hepatitis protease C inhibitor increase
atorvastatin AUC thus the lowest dose should be use in such patients.
Drug therapy protocol for administering atorvastatin for the treatment of hypercholesterolemia
Clinical Indication for
Use
Hypercholesterolemia, reducing risk of atherosclerotic vascular
disease. (Mclever et al., 2017)
Inclusion Criteria
Prevention of cardiovascular disease
Hyperlipidemia (Ferreira et al.,2017)
Adults
As an adjunct to diet in Fredrickson II and IIb
and adults with Fredrickson (Bhatt et al.,
2016)
Exclusion Criteria
Current medication with Cyclosporine,
Tipranavir plus Ritonavir and Telaprevir
Patients with HIV and Hepatitis C risk
myopathy thus precaution required.
Pregnancy (Barrios., et al 2015)
Pharmacodynamics (Mechanism of Action)
Atorvastatin is a selective competitive inhibitor of HMG-CoA reductase. An enzyme that
converts 3-hydroxy-3methylglutaryl-coenzyme A to mevalonate, which is a precursor to
body sterols including cholesterol. Atorvastatin thus lowers blood plasma cholesterol by
inhibition of the enzyme HMG -CoA reductase and cholesterol synthesis in the liver. Also
increases the hepatic LDL receptors enhancing LDL catabolism and uptake.
Pharmacokinetics (ADME)
Absorption:
Atorvastatin is rapidly absorbed after oral administration. Within 1-2 hours maximum
plasma concentration is reached. Food availability decreases rate and extent of drug
absorption by 25% and 9 % respectively. Evening administration shows lower plasma
concentration as compared to evening. LDL -C is however reduced regardless of time of
administration.
Distribution:
Atorvastatin has a mean volume of distribution of 381 litres.
Approximately 98 % of atorvastatin is bound to plasm proteins with poor penetration of 0.25
into red blood cells. Atorvastatin is secreted in human milk.
Metabolism.
Atorvastatin is metabolized in the liver to ortho and parahydroxylated derivatives and other
beta oxidation products.
Excretion.
Atorvastatin and its metabolites are primarily eliminated in bile. (Patel et al ., 2015 )
Drug Interactions
Clarithromycin -Atorvastatin AUC increased, thus in patients using clarithromycin, dosage
should not exceed 20 mg.
Protease inhibitors -HIV protease inhibitors and hepatitis protease C inhibitor increase
atorvastatin AUC thus the lowest dose should be use in such patients.
DRUG PROTOCOL DEVELOPMENT 3
Itraconazole – AUC of atorvastatin increased with administration of 40 mg atorvastatin and
200mg Itraconazole
Cyclosporine -increases bioavailability of atorvastatin. Administration of both
concomitantly should be avoided. (Patel et al ., 2015 )
Dose, Route, Duration of Therapy
Adult:
Oral administration 10 -80 mg daily
(Bays et al.,2015 )
Adverse Effects
Common: Nasopharyngitis, Arthralgia, Diarrhea, Pain in extremities Urinary tract infection,
Dyspepsia, Nausea, Musculoskeletal pain, Muscle spasms, Myalgia, Insomnia,
Pharyngolaryngeal pain
Rare: Pyrexia, Hepatitis, Epistaxis, Blurred vision (Adams et al.,2015)
Response to Adverse Event (this is directed at the practitioner to respond to an adverse
event occurring)
Stop the medication immediately.
Assess the extent of severity.
Conduct lab hepatic tests.
Itraconazole – AUC of atorvastatin increased with administration of 40 mg atorvastatin and
200mg Itraconazole
Cyclosporine -increases bioavailability of atorvastatin. Administration of both
concomitantly should be avoided. (Patel et al ., 2015 )
Dose, Route, Duration of Therapy
Adult:
Oral administration 10 -80 mg daily
(Bays et al.,2015 )
Adverse Effects
Common: Nasopharyngitis, Arthralgia, Diarrhea, Pain in extremities Urinary tract infection,
Dyspepsia, Nausea, Musculoskeletal pain, Muscle spasms, Myalgia, Insomnia,
Pharyngolaryngeal pain
Rare: Pyrexia, Hepatitis, Epistaxis, Blurred vision (Adams et al.,2015)
Response to Adverse Event (this is directed at the practitioner to respond to an adverse
event occurring)
Stop the medication immediately.
Assess the extent of severity.
Conduct lab hepatic tests.
DRUG PROTOCOL DEVELOPMENT 4
Critical discussion
In clinical decision-making process, nurses gather relevant information available and
utilize the information gathered to appropriately evaluate prevailing patient conditions and thus
make sound judgement. Clinical decision making is a pivotal skill required by all nurses (Morton
et al.,2017), more often newly registered nurses or novices encounter challenges as they try to
execute this responsibility. Clinical decision-making process plays a major role in the quality of
nursing care provided by the nurses to the patients. The decision-making process entails
application of sound decisions at each stage in the processes, which are diagnosis, planning,
implementation of existing patient needs and prevailing health demands that require to be
attended to (Goode et al.,2015). For this essay requirements the assessment implementation
processes will be elaborately discussed.
Assessment entails obtaining and gathering relevant informant regarding a patient’s
psychological, health, physiological status, usually by a registered nurse. (Jin -Kyoung et
al.,2015). Nursing assessment is the first step to be undertaken in the nursing process. The
assessment in order, involves inspection, palpation, percussion then followed by auscultation of
the patient. Health history of the patient is also obtained from records and verbal questions.
Assessment data is then recorded. The assessment must be comprehensive and systematic.
In the presented case study, where Mavis is the patient, adequate assessment is
conducted whereby adequate history is obtained even including her social and psychological
status whereby, it is clear that she is the one who takes care of her husband who is got a below
the knee amputation. This would cause her psychological stress. also tells the nurse that she
doesn’t have enough time to ensure she eats healthy, she further says she is not able to read her
watch anymore this implies progression of her condition as her sight is affected. She also forgets
Critical discussion
In clinical decision-making process, nurses gather relevant information available and
utilize the information gathered to appropriately evaluate prevailing patient conditions and thus
make sound judgement. Clinical decision making is a pivotal skill required by all nurses (Morton
et al.,2017), more often newly registered nurses or novices encounter challenges as they try to
execute this responsibility. Clinical decision-making process plays a major role in the quality of
nursing care provided by the nurses to the patients. The decision-making process entails
application of sound decisions at each stage in the processes, which are diagnosis, planning,
implementation of existing patient needs and prevailing health demands that require to be
attended to (Goode et al.,2015). For this essay requirements the assessment implementation
processes will be elaborately discussed.
Assessment entails obtaining and gathering relevant informant regarding a patient’s
psychological, health, physiological status, usually by a registered nurse. (Jin -Kyoung et
al.,2015). Nursing assessment is the first step to be undertaken in the nursing process. The
assessment in order, involves inspection, palpation, percussion then followed by auscultation of
the patient. Health history of the patient is also obtained from records and verbal questions.
Assessment data is then recorded. The assessment must be comprehensive and systematic.
In the presented case study, where Mavis is the patient, adequate assessment is
conducted whereby adequate history is obtained even including her social and psychological
status whereby, it is clear that she is the one who takes care of her husband who is got a below
the knee amputation. This would cause her psychological stress. also tells the nurse that she
doesn’t have enough time to ensure she eats healthy, she further says she is not able to read her
watch anymore this implies progression of her condition as her sight is affected. She also forgets
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DRUG PROTOCOL DEVELOPMENT 5
to take her medication thus the nurse is aware that Mavis condition if not mediated could go out
of hand. Further assessment indicates that Mavis has put on weight and she is currently 85 kg
with a BMI of 37. Mavis has come to hospital presenting a wound on her left foot that is not
healing.
Thus, admission for wound management s advised by the doctor. At this juncture,
the registered nurse in charge must conduct an admission assessment. Vital parameters of blood
pressure, temperature, heart rate or pulse are obtained. Further tests due to her condition are also
obtained, the blood sugar level, cholesterol level, triglycerides level is taken. The tests indicate
elevated blood sugar level and serum cholesterol levels. During patient assessment, questions on
prevailing allergies are key and from the assessment it comes to the nurse’s attention that Mavis
is allergic to Penicillin. The nurse ought to ensure that the information obtained from assessment
is complete, accurate and properly documented. It is from the information obtained during the
assessment that the nurse can plan for appropriate patient care.
The implementation phase of the nursing process follows the planning stage that happens
just after the diagnosis stage. (Freisen -Storms et al., 2015). In implementation, the nurses take
on the responsibility of putting into action the clinical intervention plan set out to manage the
prevailing condition of the patient. The plan set out to be implemented is usual specific,
measurable, achievable, realistic and timely. In implementation the nurse monitors the patient for
any deteriorating or improvement signs, executing proper nursing care for the patient,
performing health education for the patient, making contact to the patient for a follow up regime.
Usually this phase can extend to varied time periods from hours to even several months.
The final phase of the nursing process is the evaluation phase. Evaluation is a
planned, ongoing, purposeful activity whereby the health professionals check on the progress of
to take her medication thus the nurse is aware that Mavis condition if not mediated could go out
of hand. Further assessment indicates that Mavis has put on weight and she is currently 85 kg
with a BMI of 37. Mavis has come to hospital presenting a wound on her left foot that is not
healing.
Thus, admission for wound management s advised by the doctor. At this juncture,
the registered nurse in charge must conduct an admission assessment. Vital parameters of blood
pressure, temperature, heart rate or pulse are obtained. Further tests due to her condition are also
obtained, the blood sugar level, cholesterol level, triglycerides level is taken. The tests indicate
elevated blood sugar level and serum cholesterol levels. During patient assessment, questions on
prevailing allergies are key and from the assessment it comes to the nurse’s attention that Mavis
is allergic to Penicillin. The nurse ought to ensure that the information obtained from assessment
is complete, accurate and properly documented. It is from the information obtained during the
assessment that the nurse can plan for appropriate patient care.
The implementation phase of the nursing process follows the planning stage that happens
just after the diagnosis stage. (Freisen -Storms et al., 2015). In implementation, the nurses take
on the responsibility of putting into action the clinical intervention plan set out to manage the
prevailing condition of the patient. The plan set out to be implemented is usual specific,
measurable, achievable, realistic and timely. In implementation the nurse monitors the patient for
any deteriorating or improvement signs, executing proper nursing care for the patient,
performing health education for the patient, making contact to the patient for a follow up regime.
Usually this phase can extend to varied time periods from hours to even several months.
The final phase of the nursing process is the evaluation phase. Evaluation is a
planned, ongoing, purposeful activity whereby the health professionals check on the progress of
DRUG PROTOCOL DEVELOPMENT 6
the patient towards the achievement of the desired goal. Evaluation is always continuous as
health always varies. The measures implemented from the planning are thoroughly and
adequately assessed and the effectivity discussed. Questions as to whether the patient is making
progress are key and whether the desired goals have been achieved is also considered. If the
patient shows no or minimal progress then, reassessment of the plans is done and decisions of
modification or elimination are made by the medical personnel evaluations enable doctors and
nurses to follow the right course of action for the wellbeing of the patients. For Mavis, evaluation
on whether the prescribed drugs are improving her condition is key to determining whether the
dosage can be adjusted or the drugs changed. The effectiveness and appropriateness of the
medications can be determined. It is through evaluation, that the nurse in charge shows required
responsibility and accountability for the actions and decisions they made and undertook. It is a
demonstration of the willingness to help the patient recover and feel better through adoption of
more effective actions, disregarding the ineffective actions and procedures.
Nursing comes with a myriad of challenges and responsibilities to be executed for
the care of the patient, one of which is patient education and sensitization. (Shin et al.,2015 ).
Without effective patient education, is minimal effective healthcare with improved outcomes in
the long -run. Incorporation of patient education by nurses in their daily routine, increases the
possibility of positive and optimal patient outcomes.
In the execution of patent education, the patient ought to be assessed so that he or she
receives relevant education on what is related to his or her case .For ,instance ,Mavis is diabetic
and has hypocholesteremia .Relevant education on the importance of checking her diet, limiting
the sugar she consumes ,consuming more vegetables and water for appropriate renal function and
not forgetting incorporating exercise and deviation from sedentary lifestyle would be handy .The
the patient towards the achievement of the desired goal. Evaluation is always continuous as
health always varies. The measures implemented from the planning are thoroughly and
adequately assessed and the effectivity discussed. Questions as to whether the patient is making
progress are key and whether the desired goals have been achieved is also considered. If the
patient shows no or minimal progress then, reassessment of the plans is done and decisions of
modification or elimination are made by the medical personnel evaluations enable doctors and
nurses to follow the right course of action for the wellbeing of the patients. For Mavis, evaluation
on whether the prescribed drugs are improving her condition is key to determining whether the
dosage can be adjusted or the drugs changed. The effectiveness and appropriateness of the
medications can be determined. It is through evaluation, that the nurse in charge shows required
responsibility and accountability for the actions and decisions they made and undertook. It is a
demonstration of the willingness to help the patient recover and feel better through adoption of
more effective actions, disregarding the ineffective actions and procedures.
Nursing comes with a myriad of challenges and responsibilities to be executed for
the care of the patient, one of which is patient education and sensitization. (Shin et al.,2015 ).
Without effective patient education, is minimal effective healthcare with improved outcomes in
the long -run. Incorporation of patient education by nurses in their daily routine, increases the
possibility of positive and optimal patient outcomes.
In the execution of patent education, the patient ought to be assessed so that he or she
receives relevant education on what is related to his or her case .For ,instance ,Mavis is diabetic
and has hypocholesteremia .Relevant education on the importance of checking her diet, limiting
the sugar she consumes ,consuming more vegetables and water for appropriate renal function and
not forgetting incorporating exercise and deviation from sedentary lifestyle would be handy .The
DRUG PROTOCOL DEVELOPMENT 7
nurse should also remind Mavis on the importance of taking her medication regularly and on
time to avoid further complications resulting from high blood sugar levels .
Nurses, ought to provide culturally competent care in the execution of their nursing
care and patient education responsibilities. (Jeffreys and Marianne ,2015). Nurses in practice,
encounter varied cultural elements that have a direct or indirect influence on the reactions of
patients and families in an event of illness. Culturally competent nursing, enables the patient
needs to be fulfilled. There should be an element of cultural awareness, cultural knowledge,
cultural skill, cultural encounter and a cultural desire. For instance, Mavis is an indigenous ,45-
year-old woman from Darwin. In this case the nurse should be competent enough to avoid using
medically complicated jargon while issuing medication to Mavis. The nurse ought to use the
simplest terms possible, be slow but sure to ensure that Mavis fully understands, her medication
regime to ensure both medication safety, reduces medication errors and achieve a desirable
patient outcome.
Adherence to the nursing process in practice incurs overwhelming benefit to both the
patient and the registered nurse in charge. This is because, the whole process provides a
stipulated systematic method of nursing care provision, nursing efficiency is enhanced, quality
care is increased as the actions taken are of deliberation and duplication of care and service is
curtailed. The fact that the nursing process is goal -oriented, makes the possibility of the patient
outcome be favorable thus proper management of patient conditions and enhanced recovery
periods.
nurse should also remind Mavis on the importance of taking her medication regularly and on
time to avoid further complications resulting from high blood sugar levels .
Nurses, ought to provide culturally competent care in the execution of their nursing
care and patient education responsibilities. (Jeffreys and Marianne ,2015). Nurses in practice,
encounter varied cultural elements that have a direct or indirect influence on the reactions of
patients and families in an event of illness. Culturally competent nursing, enables the patient
needs to be fulfilled. There should be an element of cultural awareness, cultural knowledge,
cultural skill, cultural encounter and a cultural desire. For instance, Mavis is an indigenous ,45-
year-old woman from Darwin. In this case the nurse should be competent enough to avoid using
medically complicated jargon while issuing medication to Mavis. The nurse ought to use the
simplest terms possible, be slow but sure to ensure that Mavis fully understands, her medication
regime to ensure both medication safety, reduces medication errors and achieve a desirable
patient outcome.
Adherence to the nursing process in practice incurs overwhelming benefit to both the
patient and the registered nurse in charge. This is because, the whole process provides a
stipulated systematic method of nursing care provision, nursing efficiency is enhanced, quality
care is increased as the actions taken are of deliberation and duplication of care and service is
curtailed. The fact that the nursing process is goal -oriented, makes the possibility of the patient
outcome be favorable thus proper management of patient conditions and enhanced recovery
periods.
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DRUG PROTOCOL DEVELOPMENT 8
References
Adams, S. P., Tsang, M., & Wright, J. M. (2015). Lipid-lowering efficacy of atorvastatin.
Barrios, V., & Escobar, C. (2015). Edoxaban in the prevention and treatment of thromboembolic
complications from a clinical point of view. Expert review of cardiovascular therapy,
13(7), 811-824.
Bays, H., Gaudet, D., Weiss, R., Ruiz, J. L., Watts, G. F., Gouni-Berthold, I., ... & Donahue, S.
(2015). Alirocumab as add-on to atorvastatin versus other lipid treatment strategies:
ODYSSEY OPTIONS I randomized trial. The Journal of Clinical Endocrinology &
Metabolism, 100(8), 3140-3148.
Bhatt, D. D., & Ghose, T. (2016). Clinical Approach to Lipid Disorders. Handbook of
Lipidology, 45.
Ferreira, A. M., & da Silva, P. M. (2017). Defining the place of ezetimibe/atorvastatin in the
management of hyperlipidemia. American Journal of Cardiovascular Drugs, 17(3), 169-
181.
Friesen‐Storms, J. H., Moser, A., Loo, S., Beurskens, A. J., & Bours, G. J. (2015). Systematic
implementation of evidence‐based practice in a clinical nursing setting: A participatory
action research project. Journal of clinical nursing, 24(1-2), 57-68.
goode Jr, J. S., & O’Donnell, J. M. (2015). Simulation in nursing education and practice. Manual
of Simulation in Healthcare, 115.
Hirota, T., & Ieiri, I. (2015). Drug–drug interactions that interfere with statin metabolism. Expert
opinion on drug metabolism & toxicology, 11(9), 1435-1447.
References
Adams, S. P., Tsang, M., & Wright, J. M. (2015). Lipid-lowering efficacy of atorvastatin.
Barrios, V., & Escobar, C. (2015). Edoxaban in the prevention and treatment of thromboembolic
complications from a clinical point of view. Expert review of cardiovascular therapy,
13(7), 811-824.
Bays, H., Gaudet, D., Weiss, R., Ruiz, J. L., Watts, G. F., Gouni-Berthold, I., ... & Donahue, S.
(2015). Alirocumab as add-on to atorvastatin versus other lipid treatment strategies:
ODYSSEY OPTIONS I randomized trial. The Journal of Clinical Endocrinology &
Metabolism, 100(8), 3140-3148.
Bhatt, D. D., & Ghose, T. (2016). Clinical Approach to Lipid Disorders. Handbook of
Lipidology, 45.
Ferreira, A. M., & da Silva, P. M. (2017). Defining the place of ezetimibe/atorvastatin in the
management of hyperlipidemia. American Journal of Cardiovascular Drugs, 17(3), 169-
181.
Friesen‐Storms, J. H., Moser, A., Loo, S., Beurskens, A. J., & Bours, G. J. (2015). Systematic
implementation of evidence‐based practice in a clinical nursing setting: A participatory
action research project. Journal of clinical nursing, 24(1-2), 57-68.
goode Jr, J. S., & O’Donnell, J. M. (2015). Simulation in nursing education and practice. Manual
of Simulation in Healthcare, 115.
Hirota, T., & Ieiri, I. (2015). Drug–drug interactions that interfere with statin metabolism. Expert
opinion on drug metabolism & toxicology, 11(9), 1435-1447.
DRUG PROTOCOL DEVELOPMENT 9
Jeffreys, M. R. (2015). Teaching cultural competence in nursing and health care: Inquiry, action,
and innovation. Springer Publishing Company.
Jin-Kyoung, P., & Suk-Won, H. (2015). The relationship between communication and nursing
performance in simulation-based team learning. Indian Journal of Science and
Technology, 8(26).
McIver, L. A., & Siddique, M. S. (2017). Atorvastatin.
Morton, P. G., Fontaine, D., Hudak, C. M., & Gallo, B. M. (2017). Critical care nursing: a
holistic approach (p. 1056). Lippincott Williams & Wilkins.
Patel, G., Dutta, S., King, T. A., Korb, S., Wade, J. R., Foulds, P., & Sumeray, M. (2015).
Evaluation of Effects of the Weak CYP3A4 Inhibitors Atorvastatin and Ethinyl
Estradiol/Norgestimate on Lomitapide Pharmacokinetics in Healthy Subjects. Journal of
Clinical Lipidology, 9(3), 447-448.
Shin, S., Park, J. H., & Kim, J. H. (2015). Effectiveness of patient simulation in nursing
education: meta-analysis. Nurse Education Today, 35(1), 176-182.
Jeffreys, M. R. (2015). Teaching cultural competence in nursing and health care: Inquiry, action,
and innovation. Springer Publishing Company.
Jin-Kyoung, P., & Suk-Won, H. (2015). The relationship between communication and nursing
performance in simulation-based team learning. Indian Journal of Science and
Technology, 8(26).
McIver, L. A., & Siddique, M. S. (2017). Atorvastatin.
Morton, P. G., Fontaine, D., Hudak, C. M., & Gallo, B. M. (2017). Critical care nursing: a
holistic approach (p. 1056). Lippincott Williams & Wilkins.
Patel, G., Dutta, S., King, T. A., Korb, S., Wade, J. R., Foulds, P., & Sumeray, M. (2015).
Evaluation of Effects of the Weak CYP3A4 Inhibitors Atorvastatin and Ethinyl
Estradiol/Norgestimate on Lomitapide Pharmacokinetics in Healthy Subjects. Journal of
Clinical Lipidology, 9(3), 447-448.
Shin, S., Park, J. H., & Kim, J. H. (2015). Effectiveness of patient simulation in nursing
education: meta-analysis. Nurse Education Today, 35(1), 176-182.
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