NCM 106 Pharmacology in Nursing Module 1 PDF

COLEGIO DE SAN ANTONIO DE PADUA Supervised by the Lasallian School Supervision Office Ramon M. Durano Foundation Compound Guinsay, Danao City Tel. No. (032)344-4709...

COLEGIO DE SAN ANTONIO DE PADUA Supervised by the Lasallian School Supervision Office Ramon M. Durano Foundation Compound Guinsay, Danao City Tel. No. (032)344-4709 NCM 106 PHARMACOLOGY IN NURSING MODULE 1 (PRELIM) DRUG DEVELOPMENT & ETHICAL CONSIDERATIONS ____________________________________ OBJECTIVES: 1. Identify the three core ethical principles. 2. Relate the core ethical principles that govern informed consent and risk benefit ratio. 3. Discuss the 2015 American Nurses Association Code of Ethics and its nine provisions. 4. Describe the objectives of each phase of human clinical experimentation. 5. Differentiate between chemical, generic, and brand names of drugs. 6. Define “over – the – counter” as it relates to drugs. CORE ETHICAL PRINCIPLES Three Core Ethical Principles are relevant to research involving human subjects: respect for persons, beneficence, and justice. Derived from the Belmont Report, the World Medical Association Declaration of Helsinki set out ethical principles for medical research that involves human subjects. These ethical principles are integral to the issues of informed consent and risk – benefit ratio in such research. RESPECT FOR PERSONS Patients should be treated as independent persons capable of making decisions on their own best interests. Patients with diminished decision – making capacity are entitled to protection. When making healthcare decisions, patients should be made aware of alternatives available to them as well as the consequences that stem from those alternatives. INFORMED CONSENT Informed consent has dimensions beyond protection of the individual patient’s choice:  It is a mutual sharing of information, a process of communication.  It expresses respect for the person.  It gains the patient’s active involvement in their care.  It respects the patient’s right to self – determination. It is the role of the healthcare provider, not the nurse, to explain the study to the patient and what is expected of the patient and to respond to questions from the patient. Nurses are patient’s advocates. In collaboration with the with the health care provider and the pharmacist, the nurse must be knowledgeable about all aspects of a drug study – including all inclusions and exclusion criteria for participants, study protocol, and study – related documentation – to promote participant safety and quality study results. BENEFICENCE  Beneficence is the duty to protect research subjects from harm. It involves ensuring the risk and possible benefits from participating in a research study are clearly defined and ensuring the benefits are greater than the risk. RISK - BENEFIT RATIO  All possible consequences of a clinical study must be analyzed and balanced against inherit risks and the anticipated benefits. JUSTICE  Justice requires that the selection of research subjects be fair. OBJECTIVES AND PHASES OF PHARMACEUTICAL RESEARCH The FDA requires clinical research to follow the Good Clinical Practice (GCP) Consolidated Guideline, an international ethical and scientific quality standard for designing, conducting, monitoring, auditing, recording, analyzing, and reporting clinical research. It is the foundation of clinical trials that involve human subjects. PRECLINICAL TRIALS Through these trials, drug developers are able to determine genotoxicity, the ability of a compound to damage genetic information in a cell, in addition to drug absorption, distribution, metabolism and excretion. HUMAN CLINICAL EXPERIMENTATION Historically, drug research was done only with Caucasian males, causing uncertainty as to the validity of research results for people of other ethnicities and for women and for children. Clinical experimentation in drug research and development encompasses four phases, each with objectives. FOUR PHASES PHASE I  Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. PHASE II  The drug or treatment is given to a larger group of people to see whether it is effective and to further evaluate its safety. PHASE III  The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it with commonly used treatments, and collect information that will allow the drug or treatment to be used safely. PHASE IV  Studies are done after the drug or treatment has been marketed to gather information on the drug’s effects in various populations and to assess any side effects associated with long term use. AMERICAN NURSES ASSOCIATION CODE OF ETHICS The American Nurses Association (ANA) Code of Ethics “was developed as a guide for carrying out nursing responsibilities in a manner consistent with quality in nursing care and the ethical obligations for the profession.” THE NURSE’S ROLE IN CLINICAL RESEARCH Nurses are the forefront of clinical research. Regardless of the setting (inpatient or outpatient), nurses are likely to encounter patients eligible to participate, considering participation, or actively participating in clinical research. As such, nurses are responsible for both the safety of the patient and the integrity of the research protocol. DRUG STANDARDS AND DRUG LEGISLATION DRUG STANDARDS The set of drug standards used in the United States is the United States Pharmacopeia (USP). The United States Pharmacopeia and the National Formulary (USP – NF), the authoritative source of drug standards (dosage, forms, drug substances, excipients, biologics, compounded preparations, and dietary supplements), is published annually. Drugs included in the USP – NF have met high standards for therapeutic use, patient safety, quality, purity, strength, packaging safety, and dosage form. Drugs that have meet these standards have the initials “USP” following their official name, denoting global recognition of high quality.  Sample Informed Consent Form for Randomized Clinical Trial of a Drug Title of study: Comparison of a new drug [A] with an existing drug [B] used in treatment of disease X Principal Investigator: Dr. ABC Institute: Department of Pediatrics, Aga Khan University Introduction: I am Dr. [SAK] from Department of Pediatrics, the Aga Khan University and doing a research on treatment of disease [X, for example malaria]. There is a new drug [A] which is being recommended for its treatment. I want to see if the new drug [A] is as good as or better than the commonly used drug [B] for the treatment of disease [malaria]. Since you are a patient of (or suffering from) disease [malaria], I would like to invite you to join this research study. Background Information: Disease X (Malaria) is a common disease in Pakistan, Asia and Africa, caused by a germ (parasite) spread by mosquito. It causes high grade fever. Some patients may have complications and even die. The commonly used drugs are losing their effectiveness and germs are getting resistant to it. A new drug known as [A] is supposed to be effective in treatment of disease (malaria) but there is not enough evidence that it is as good as other drugs used for treatment of disease (malaria). Purpose of this research study The purpose of study is to find out if the new drug is as good as or better than other drugs used for treatment of malaria in our population and; also to see if germs are not resistant to it. Procedures In this study, all patients aged 15 to 50 years of age, presenting at the clinic with fever for less than one week duration and having no other diagnosis will be registered and screened for malaria. For diagnosis of disease (malaria), one ml of blood will be taken from the patients and checked for presence of germs (malarial parasite). Those patients having positive test for the disease (malaria), will be included in the study. They will be divided randomly in to two groups by a computer draw. One group will get the new drug (A) and the other group will get the commonly used drug (B). Neither the doctor nor the patient will know which drug he/she is getting for treatment of his/her disease. A record will be kept for the duration of fever and other symptoms including any other side effect. Other necessary treatment will also be provided if needed. Possible risks or benefits No significant side effects have been reported for this new drug (A). however, some patients may feel nausea or may have vomiting. Drawing of blood may cause some discomfort or blue discoloration at the side of bleeding. Lowering of white blood cells and platelet is a common feature of the disease. There is no direct financial or other benefit for the participant of the study. However, all the investigations, will be done free of cost to the patients and; the drugs (A) or (B) will be provided free. Treatment of any side effect will also be provided free of cost. Sponsor of the study will bear the cost of drugs, investigations and treatment of side effects related to the study drugs. Right of refusal to participate and withdrawal You are free to choose participants in the study. You may refuse to participate without any loss of benefit which you are otherwise entitled to. Your child will receive the same standard care and treatment which is considered best for him irrespective of your decision to participate in the study. You may also withdraw any time from the study without any adverse effect on management of your child or any loss of benefit which you are entitled to. You may also refuse to answer some or all the questions if you don’t feel comfortable with those questions. Confidentiality The information provided by you will remain confidential. Nobody except principal investigator will have an access to it. Your name and identity will also not be disclosed at any time. However, the data may be seen by Ethical review committee and may be published in journal and elsewhere without giving your name or disclosing your identity. Available sources of information If you have any further questions you may contact Principal Investigator (Dr. SAK), department of pediatrics at Aga Khan University on following phone number 486xxxx. 1. AUTHORIZATION I have read and understand this consent form, and I volunteer to participate in this research study. I understand that I will receive a copy of this form. I voluntarily choose to participate, but I understand that my consent does not take away any legal rights in the case of negligence or other legal fault of anyone who is involved in this study. I further understand that nothing in this consent form is intended to replace any applicable Federal, state, or local laws. Participant’s Name (Printed or Typed): Date: Participant’s Signature or thumb impression: Date: Principal Investigator’s Signature: Date: Signature of Person Obtaining Consent: Date: CLINICAL JUDGMENT [NURSING PROCESS] Clinical Research Concept: Safety  Protection of the patient from potential or actual harm; it is a basic human need. Recognize Cues [Assessment]  Identify patients who are eligible to participate in or who are participating in clinical research.  Assess response to the study agent and identify adverse events (an unfavorable or unintended sign, symptom, or disease that was not present at the time of study enrollment and is associated with the treatment or procedure). Analyze Cues and Prioritize Hypothesis [Patient Problems]  Need for health teaching  Potential for decreased adherence Generate Solutions [Planning]  Have a process in place to identify persons who are eligible to participate in clinical research or to identify participants actively participating in clinical research studies.  Have a process in place to facilitate education and informed consent of eligible study participants.  Plan educational programming for staff who provide direct care to study participants.  Plan participant care to ensure integrity and compliance with study protocol. Take Action [Nursing Interventions]  Support the process of informed consent in a culturally competent manner.  Provide an interpreter when necessary.  Provide enough time for the person to read the consent and ask questions.  Serve as a witness to informed consent.  After reviewing the study protocol, administer study agent(s).  Accurately document all participant care, assessment findings, and study agent administration.  Accurately and safely collect biospecimens.  Act as advocate, educator, and collaborator in the research process.  Ensure safe care.  Ensure integrity of study data.  Communicate clearly. Evaluate Outcomes [Evaluation]  Determine whether the potential participant understands what it means to participate in the study by asking open – ended questions.  Monitor response to the study agent or other interventions.  Determine whether participants understand how to take their study agents, what to do if they miss a dose, how to store the study agent, and when to call their health care provider. Informed Consent Checklist: Basic Elements  A statement that the study involves research.  An explanation of the purposes of the research.  The expected duration of the subject’s participation.  A description of the procedures to be followed.  Identification of any experimental procedures.  A description of any reasonably foreseeable risks or discomforts to the subject.  A description of any benefits to the subject or to others that may reasonably be expected from the research.  A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.  A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.  For research that involves more than minimal risk, an explanation as to whether any compensation will be paid and whether any medical treatments are available if injury occurs, and if so, what the treatments consist of or where further information may be obtained.  An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights and whom to contact in the event of a research – related injury to the subject.  A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. INITIATIVES TO COMBAT DRUG COUNTERFEITING  Distribution of counterfeit drugs is a worldwide problem; it is estimated that more than 10% of all drugs available are counterfeit. Counterfeit drugs may contain the incorrect ingredients, insufficient amounts of active ingredients, or no active ingredients. Additionally, they may contain impurities and contaminants or may be distributed in fake packaging. DRUG NAMES CHEMICAL NAME – describe the drug’s chemical structure. GENERIC NAME – non-propriety name for the drug; this name is not owned by any drug company and is universally accepted. BRAND (TRADE) NAME – Known as the propriety name, is chosen by the drug company and is usually a registered trademark. OVER – THE – COUNTER DRUGS  Over – the – counter drugs (OTC) drugs have been found to be safe and appropriate for use without the direct supervision of a health care provider. Examples:  Pseudoephedrine  Emergency contraception OTC drugs must have labels that provide the following information in this specific order:  The product’s active ingredients, including the amount in each dosage unit.  The purpose of the product.  The uses (indications) for the product.  Specific warnings, including when the product should not be used under any circumstances, substances or activities to avoid, side effects that could occur, and when it is appropriate to consult with a doctor or pharmacist.  Dosage instructions that include when, how, and how often to take the product.  The product’s inactive ingredients and important information to help consumers avoid ingredients that may cause an allergic reaction. The acronym SAFER is a mnemonic for the instructions that the FDA recommends before taking any medicine: Speak up Ask questions Find the facts Evaluate your choices Read labels NURSING CONSIDERATIONS REALTED TO OVER – THE – COUNTER DRUGS Nurses should advice patients of the following when over – the – counter (OTC) drugs are considered:  Always read the instructions on the label.  Do not take OTC medicines in higher dosages or for a longer time than the label states.  If you do not get well, stop treating yourself and talk with a health care professional.  Side effects from OTCs are relatively uncommon.  Your response to the medicine may be different than another person’s response.  OTC medicines often interact with other medicines and with food or alcohol, or they might have an effect on other health problems you may have.  If you do not understand the label, check with the pharmacist.  Do not take medicine if the package does not have a label on it.  Throw away medicines that have expired.  Do not use medicine that belongs to a friend.  Buy products that treat only the symptoms you have.  If cost is an issue, generic OTC products may be cheaper than brand name items.  Avoid buying these products online, outside of well – known Internet insurance company sites. Parents should know the following special information about using OTCs for children:  Parents should never guess about the amount of medicine.  Always follow the age limits listed.  Throw away old, discolored, or expired medicine or medicine that has lost its label instructions.  Do not give medicine containing alcohol to children.