Module 3 Therapeutic Care Planning 2012

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    Module 03: Therapeutic Care Planning

    Current Content Expert:Kevin W. Chamberlin, PharmD

    Assistant Clinical ProfessorUniversity of Connecticut School of Pharmacy&UConn Center on Aging

    Legacy Content ExpertsH.E. Davidson, PharmD, MPHPartner, and Assistant Professor of Internal MedicineInsight Therapeutics, and Eastern Virginia Medical School, Norfolk, VA

    Barry Rumble, RPh

    Director of Consulting ServicesRiverside Regional Convalescent Center

    Course Objectives:

    At the conclusion of this application based activity, the participant will beable to:

    Assess the basic elements of therapeutic care planning.

    Specify the steps and principles in designing a therapeutic regimen,explaining the purpose and contents of the medication regimen and theanticipated outcomes of the data assessment process.

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    03.01.01 Steps in Therapeutic Care Planning

    Define Needs:

    Determining health care problems

    Defining health care needs

    Identifying patient needs

    Identify Goals:

    Therapeutic goals

    Pharmacological goals

    Goals of other practitioners

    Design the Therapeutic Regimen

    Monitor the Patient

    Document Patient Progress

    Therapeutic care planning involves defining a patients health care needs basedon actual and potential health care problems. By accurately identifying theseproblems, relevant health care needs arise. It is from these needs thatpharmacological and other therapeutic goals are established, and a therapeutic

    regimen is designed, implemented, and monitored.

    Therapeutic care planning focuses on the whole patient in order to:

    A. Identify as many opportunities for pharmacological intervention aspossible

    B. Ensure patient compliance with the therapeutic regimenC. Treat possible psychological barriers to success of the therapeutic care

    planD. All of the above

    CORRECT ANSWER: B. Therapeutic care planning takes into accountphysical, psychological, and any other barriers thay may prevent the patient frommaintaining compliance with the recommended therapeutic regimen.

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    03.01.02 Identifying Actual and Potential Health Problems

    Patient demographics

    Medical, social and family history

    Medications and related products Patient complaints, signs, and symptoms

    In order to identify a pharmacotherapeutic need, you must look to the underlyingproblem and collect data to gain the most complete picture possible. These datamust provide clues to actual or potential health care problems. Data on patientcharacteristics, medication history, other substances being used, presentingcomplaints, and signs and symptoms should be gathered during this part of thecare planning process.

    03.01.03 Identifying Problems: Patient Demographics, Social and MedicalHistory

    Demographic Data

    o age

    o gender

    o ethnicity

    o race

    o religious preferences

    Family History

    Social History

    Medical History

    o past health problems

    o past surgeries, treatments, etc.

    o current health status physical, nutritional, cognitive

    Data on patient demographics, such as age, gender, ethnicity, race,and religious preferences should be collected. The patients family,social and medical histories are also relevant. Current health statusconsiders the patients nutritional, functional, and cognitive status, aswell as other patient-specific issues.

    03.01.04 Identifying Problems: Medications and Related Products

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    Present and past

    o how and when drugs are/were taken

    o allergies and drug reactions

    o toxicity profile of drug

    Appropriate dose

    Identify drug interactions and duplication

    o drug-drug interactions

    o drug-food interactions

    o duplicative medications

    Drug administration technique (e.g., PO, IV, PEG)

    Other products consumed (e.g., smoking, alcohol, caffeine)

    Patients beliefs in therapy Compliance

    o Medication administration record (MAR)

    o Refill records

    Information on concurrent medications is critical in order to identify actual orpotential health care problems. Both past and present medication historiesshould be considered in regards to how and when the drugs were taken, allergiesnoted, and the toxicity profile of the drug.

    Drug-drug interactions, drug-food interactions, and duplicative medicines shouldbe identified and screened. The technique for administering the drug should benoted and compliance assessed through reviews of the medicationadministration record and refill records. Information on other products consumedsuch as caffeine, alcohol, smoking and homeopathic remedies should also begathered at this time.

    03.01.05 Identifying Problems: Patients Complaints, Signs, and Symptoms

    Present medical problems

    o description

    o severity

    o duration

    Impairments

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    Disabilities

    Perception of disease process

    The patients complaints, signs, and symptoms should be described andassessed for severity and duration. Impairments and disabilities should be notedalong with the patients perception of the disease. Remember that subjectiveand objective both may influence the identified need and potential solution.

    03.01.06 Identifying Problems: Data Collection Sources

    Individuals:

    patient

    physician

    physician extenders (nurse practitioners / physician assistants)

    other caregivers (e.g., nurses aids, nurses, other ancillary staff)

    family

    Records:

    medical records

    patients pharmacy profile

    lab reports

    Medical Professionals:

    physicians

    nurses

    others

    In order to confirm the medical problem, the pharmacist should collect patientdata from a variety of sources including the patient, physician, other caregivers orfamily members. Medical records, pharmacy profiles, and laboratory reports canhelp uncover quantifiable data. Observations of medical professionals such as

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    physicians, nurses and other long-term care facility staff can reinforce qualitativedata findings.

    03.01.07 Considerations in Defining Health Care Needs

    Ability to resolve actual problems

    Ability to avoid potential future problems

    After collecting the various data and identifying the problem or problems, thehealth care needs should become evident. Two considerations must be kept inmind when identifying needs: the ability to resolve current problems and theability to avoid potential future problems.

    03.01.08 Defining Needs: Care Planning Process and Patient Factors

    Focus must be on whole person

    Individual needs must be taken into account

    Patients must have:

    o an understanding of their illness

    o an understanding of their drug therapy

    o realistic expectations

    o their concerns addressed

    The care process is driven by patient needs and preferences; therefore, the careplan must take the whole person approach, rather than focus solely on thepharmacotherapy that addresses an illness. The patients individual needs mustbe considered at the onset of care planning, because cooperation andcompliance are essential to the success of the plan. Compliance depends onpatients having a basic understanding of their illness and how their actions canaffect the condition. Patients also need to have an understanding of their drugtherapy, so that they can help monitor their progress, and report any unexpectedeffects that may arise. Working with the patient to set realistic therapeuticexpectations is important, as is addressing any concerns they may have aboutthe condition and treatment. Side effects, allergies, and costs are commonconcerns of the elderly undergoing treatment.

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    03.01.09 Special Consideration for Long Term Care Patients

    For the elderly in long-term care facilities, many of these issues will not apply.

    Due to the high prevalence of cognitive and functional impairment in thispopulation, many of these issues will be addressed through caregiverdiscussions or directed by regulatory guidelines. Frequently, the resident will beunable to express clinical outcome of drug therapy.

    03.01.10 Characteristics of Therapeutic Goals

    measurable

    observable

    specific

    attainable over a definite time period

    addresses the gap between where patient is and where patient should be

    The ultimate goal of care is to improve a patients quality of life through reachingdefined or predefined medication-related outcomes that address a need.Therapeutic goals must be measurable and observable. The more specific thegoal, the greater ability to measure the goal.

    All goals should have definitive and realistic time frames in which to attain them.

    Understanding where patients are in terms of their health status and where youwould like them to be is the first step in determining goals for a given condition.

    03.01.11 Establishing Therapeutic Goals: Roles of the Patient and Family

    The patient can help establish quality of life goals

    Patient involvement must be monitored

    The patients family may play a key role in setting goals and achieving

    therapeutic outcomes

    To be effective, care must be provided directly to the patient, and requirehis or her participation. Patients who are involved in establishing quality oflife goals for their therapy are more likely to reach them. However, thisinvolvement must be monitored to ensure that the patient does notinterfere with the reaching the desired therapeutic outcomes. For

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    example, the patients administration of medication must be periodicallychecked to make sure that he or she is taking the correct dosages.Elderly patients who are cognitively or functionally impaired may not beable to become directly involved in their own care. Family intervention is amajor consideration in setting goals and meeting therapeutic outcomes for

    these patients.

    03.01.12 Establishing Therapeutic Goals: Roles of the Pharmacist andOther Caregivers

    The pharmacist and other medical professionals must provide educationas to how to best achieve therapeutic goals

    The roles of the patient, family, pharmacist, and other caregivers must beconsidered when planning and providing patient care

    While patients have a responsibility to help achieve desired outcomes, thepharmacist and other medical professionals are responsible for educatingcaregivers and patients about behaviors that will help patients reach theirtherapeutic goals. The roles and responsibilities of the patient, family,pharmacist and other caregivers must all be considered when defining goals andproviding care.

    03.01.13 Establishing Therapeutic Goals: Medication-RelatedConsiderations

    Whether or not to use medications, based on

    o advance directives

    o potential to achieve desired outcomes

    o potential risks

    o patient or family preferences

    Which medication to use

    How to deliver medication selected

    o dosage amounts and frequency

    o routes of administration

    o duration of therapy

    Medication safety issues

    Monitoring protocols

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    Education and counseling needs

    The decision to avoid pharmacotherapy is a valid care option for some patientsbased on advance directives, the ability to achieve desired therapeutic outcomes,

    potential risks, and patient or family preferences. If pharmacotherapy is used,the pharmacist must consider other medication-related factors that affecttherapeutic goals. These factors include the nature of the medication selected,the dosage, routes of administration, the drugs safety profile, monitoring andcounseling considerations, and quality of life issues.

    03.01.14 Determining and Prioritizing Pharmaceutical Goals

    Determine Goals by Integrating:

    problem characteristics

    health care needs

    patient/family needs and preferences

    therapeutic goals

    Prioritize Goals by Considering:

    what problems will be addressed

    what problems will be the responsibility of the pharmacist what goals will be addressed first

    Achieve Goals by Making Sure Each Goal:

    is measurable

    is attainable

    is associated with a specific time frame

    In order to determine pharmaceutical goals, the pharmacist must integrate theproblem characteristics, the health care needs and preferences of the patient andfamily, and the therapeutic goals established by health professionals andcaregivers involved in the case. These pharmaceutical goals are then prioritizedby clearly identifying what problems will be addressed, what problems will be theresponsibility of the pharmacist, and what goals will be addressed first. As withall therapeutic goals, each pharmaceutical goal should be measurable andassociated with a specific time frame for achievement.

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    03.01.15 Pharmaceutical Goals and Therapeutic Outcomes

    Focus on meeting the patients health care needs, not just resolving drugtherapy problems

    Consider therapeutic goals of other health care providers and their impacton pharmacotherapy

    Remember that therapeutic goals change as the patients health statusand needs change

    When identifying pharmaceutical goals, one should keep in mind that such goalsare definite or predefined, and related to therapeutic outcomes. Pharmacistsmust focus on meeting the patients health care needs, not simply resolving drugtherapy problems.

    The therapeutic goals of other health professionals on the team must beconsidered, as well as the impact of these goals on pharmacotherapy.Remember that therapeutic goals and the medication regimen will requireupdates as the patients status changes.

    03.01.16 Resources

    For additional information, see:

    Adamcik, B. A. & Rhodes, R. S. (1993). The pharmacist's role in rational drugtherapy of the aged. Drugs Aging; 3(6): 481-486.

    Anderson, R. J. & Miller, S. W. (1992). Geriatric drug therapy. In: Herfindel, E.T., Gourley, D. R. & Hart L. L., (Eds.). Clinical Pharmacy and Therapeutics, 5thed. Baltimore: Williams & Wilkins, 1489-1507.

    Cipolle, R.J., Strand, L.M. & Morley P.C. (1998). Pharmaceutical Care Practice.New York: McGraw Hill. updated 2nd edition available ( 2004).

    Faden, R. & German, P. S. (1994). Quality of life. considerations in geriatrics.Clin Geriatr Med; 10(3): 541-51.

    Feinberg, J. L. (1991). Taking responsibility for therapeutic outcomes:barriers toconsultant pharmacists. Consult Pharm; 6(12): 958-965.

    McKenzie, L. C., Kimberlin, C. L., Berardo, D. H., Pendergast, J. F. (1991).Pharmacists care of elderly patients. University of Florida, College of Pharmacy.

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    Torg, E. (1992). Life since OBRA: roles and responsibilities of consultantpharmacists and physicians in long-term care. Consult Pharm; 7(12): 1282-1290.

    Wong, B. J., et al. (1994). Role of the pharmacist on a geriatric assessment

    team. Consult Pharm; 9(10): 1149-1158.

    Websites:

    American Society of Health-System Pharmacistshttp://www.ashp.org

    American Society of Consultant Pharmacistshttp://www.ascp.com

    American Pharmacists Association

    http://www.aphanet.org/

    Agency for Healthcare Research and Qualityhttp://www.ahrq.gov/

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    Module 3, Section 2: Designing a Therapeutic Regimen

    Current Content Expert:

    Kevin W. Chamberlin, PharmDAssistant Clinical ProfessorUniversity of Connecticut School of Pharmacy&UConn Center on AgingFarmington, CT

    Legacy Content Experts

    H.E. Davidson, PharmD, MPHPartner, and Assistant Professor of Internal MedicineInsight Therapeutics, and Eastern Virginia Medical School, Norfolk, VA

    Barry Rumble, RPhDirector of Consulting ServicesRiverside Regional Convalescent CenterNewport News, VA

    03.02.01 Steps in Designing a Therapeutic Regimen

    Define Needs

    Identify Goals

    Design the Therapeutic Regimen:

    Select the proper regimen

    o

    drug selectiono simplify regimen

    o dosing

    o written directions and product information

    Explain the treatment regimen

    Consider factors that affect compliance

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    Devise strategies for avoiding adverse drug reactions

    Monitor the Patient

    Document Patient Progress

    After determining the medical problem, health care needs and therapeutic andpharmacologic goals, a therapeutic regimen may be designed. Designing atherapeutic regimen involves selecting the appropriate interventions, explainingthe regimen to the patient and family and considering factors that influencenoncompliance. Strategies for avoiding adverse drug reactions are alsoconsidered at this time.

    03.02.02 Principles for Designing a Therapeutic Regimen

    Individualize therapy based on the patients:

    o overall health

    o concomitant disease

    o concurrent medications

    o drug therapy problems

    Consider the role of medications:

    o Is the problem caused by medication?

    o Should the problem be treated by medication?

    Consider medical risks and potential toxicity

    Identify and evaluate therapeutic alternatives

    The therapeutic regimen must be individualized to the needs of the patient. Thepharmacist must consider individual patient characteristics such as overallhealth, concomitant disease, and concurrent drug therapy problems.

    Each health care problem needs to be considered with regard to whether the

    problem is caused by a medication or needs to be treated with one. Medicalrisks and potential medication toxicity must also be considered. Therapeuticalternatives should be identified and evaluated for potential inclusion in thepharmaceutical care plan.

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    03.02.03 Factors in Selecting the Proper Medication

    Efficacy and effectiveness

    Safety

    Contraindications

    Real and potential drug-related problems

    o drug-drug interactions

    o drug-food interactions

    Patient characteristics

    Route of administration

    Regulations regarding use

    o Formulary of approved medications

    o Approved uses of the selected medication

    o Legislative guidelines (e.g., OBRA, other CMS regulations)

    In selecting a proper medication and regimen, the pharmacist must consider thedrugs efficacy, safety, contraindications, real and potential drug interactions, andany patient characteristics that might affect treatment.

    In most instances, the selection of an appropriate medication must take into

    consideration the formulary of approved medications within the health caresystem, approved uses of the selected medication for specific patient conditions,and regulations such as the Omnibus Budget Reconciliation Act and guidelinesfrom CMS regarding medication use in nursing facilities.

    03.02.04 Determining Proper Administration of the Medication

    Frequency of Administration:

    half-life and duration of action

    immediate versus sustained release

    Type of Administration:

    oral

    nasogastric/gastrostomy

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    topical

    injectable

    Dosing:

    pharmacokinetic issues (e.g., renal and hepatic function)

    concomitant medications

    patient factors (e.g., age, weight)

    Once an appropriate medication is selected, the pharmacist must determine theproper administration of the drug. The frequency of administration is generallyrelated to the pharmacokinetic properties of the medication. Drug half-life andduration of action allow for many medications to be administered once daily,which will save nursing time and allow for increased patient compliance in most

    cases.

    While sustained release preparations allow for decreased administrationfrequency and are usually preferred, elderly patients receiving nutrition throughnasogastric or gastrostomy tubes cannot receive these medications. Liquidmedications that do not need to be crushed beforehand are usually preferred forthese patients when they are available.

    Patient-specific pharmacokinetic issues need to be considered, such as impairedrenal function. Dosage adjustments for renally administered drugs must often beconsidered for elderly patients. Concomitant medications that interact with the

    selected medication may need to be eliminated. They may be continued with adosage reduction in some cases, and require follow-up monitoring for toxicity andeffectiveness.

    03.02.05 Packaging the Medication for Use

    Containers:

    consider special needs of older adults avoid packaging that is difficult to open

    Labels:

    use matte, not glossy use large boldfaced type

    Instructions and Product Information:

    must be clear and concise state generic or brand name

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    display special storage considerations

    include purpose of medication, dosage schedule, side effects

    For the geriatric patient, who is functionally and cognitively able to participate in

    his or her own treatment regimen, several issues need to be considered toensure compliance. One of these issues is the selection of appropriatecontainers.

    Childproof lids and blister packs tend to be difficult to open for elderly patientswith limited manual dexterity. Another issue is how critical information about themedication is communicated. Directions for use and product information must beclear and concise.

    Medication containers should be labeled with large boldface type for easierreading. Matted labels are preferred over glossy labels. Special storage

    considerations, such as refrigeration, must be prominently displayed.

    The generic or brand name of the drug, its purpose, thedosing and potential sideeffects should be included on the label if possible. In institutional environmentssuch as long term care facilities, these issues are more important to thoseindividuals who are administering the medication. Selected elements may beimportant to communicate in the rare instance when patient self-administration isallowed.

    03.02.06 Explaining the Therapeutic Regimen

    Speak slowly, directly and distinctly

    Limit comments to essential points

    Invite questions after each point

    Use examples and demonstrations

    Help the patient understand illness, drug regimen, and goals

    Use education, memory and compliance aids

    o heart-shaped sticker for cardiovascular medications

    o weekly pill reminder

    o electronic pill boxes

    o vial cap

    o drug diary or calendar

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    In the institutionalized setting, the interdisciplinary health care team, includingfamily members, must have an awareness of the therapeutic regimen to ensureits proper implementation.

    If the patient is directly involved in treatment, he or she must be educatedaccordingly. When explaining the regimen to a patient, speak slowly, directly anddistinctly. Limit comments to essential points, and invite questions after eachone. Use examples to illustrate when one would take the medication, anddemonstrate if appropriate.

    Help the patient become knowledgeable about his or her illness, drug regimen,

    and therapeutic goals, and encourage the use of memory and compliance aidssuch as a drug diary or calendar.

    03.02.07 Sources of Noncompliance

    Physical limitations

    o poor visual acuity

    o impaired hearing

    o decreased manual dexterity

    o memory loss

    o dry mouth

    Cognitive limitations

    Therapeutic effects

    o incomplete therapeutic regimens

    o adverse drug reactions Financial constraints

    Psychosocial factorso interfering health beliefs

    o influence of family and friends

    o influence of caregivers

    Noncompliance with the therapeutic regimen may be influenced by a variety of

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    factors that include physical limitations, adverse reactions, and health beliefs.These factors are listed on your screen. Awareness of these factors can assistthe pharmacist in identifying and reducing potential barriers to successfulachievement of therapeutic goals.

    03.02.08 Avoiding Adverse Drug Reactions and Interactions

    Discuss potential side effects

    Discourage self-medication of symptoms

    Encourage reporting of new symptoms

    Report new prescriptions to providers

    The pharmacist must consider strategies for avoiding adverse drug reactions andinteractions. These strategies include discussing the potential side effects ofmedications with patients and discouraging the self-medication of symptoms.Encourage the patient to contact you or his or her doctor if new symptomsdevelop while following the drug regimen.

    In the institutional environment, physicians, nurses, ancillary service providers,and family and friends need to be aware of the dangers of adverse drugreactions and self-medication, and the importance of reporting changes incognitive and functional status. Some side effects are expected with certain

    medications and strategies for management should be discussed. It is importantthat all health care providers are aware of the entire medication regimen.

    03.02.09 Completing the Therapeutic Regimen and Care Plan

    Goals established

    Interventions agreed upon

    Responsibilities accepted

    Design of a care plan is complete when reasonable goals and expectations areset, interventions are agreed upon, and responsibilities of the practitioner,caregivers, family, and patient are accepted. Once the plan is implemented, thepatient must be monitored and evaluated to ensure that therapeutic goals arebeing met.

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    03.02.10 Resources

    For additional information, see:

    Adamcik, B.A. & Rhodes, R. S. (1993). The pharmacist's role in rational drugtherapy of the aged. Drugs Aging; 3(6): 481-486.

    Anderson, R. J. & Miller, S. W. (1992). Geriatric drug therapy. In: Herfindel ET,Gourley D. R. & Hart L. L., (Eds.). Clinical Pharmacy and Therapeutics, 5th ed.Baltimore: Williams & Wilkins, 1489-1507.

    Anon. (1992). Guidelines for consultant pharmacists practicing in nursingfacilities. Consult Pharm; 7: 1094, 1099.

    Anon. (1993). Guidelines for consultant pharmacists practicing in residential carefacilities. Consult Pharm; 8: 150-153.

    Delafuente, J. C. (1991). Perspectives on geriatric pharmacotherapy.Pharmacotherapy; 11(3): 222-4.

    Delafuente, J.C. & Stewart, R.B., (Eds.) (2001). Therapeutics in the elderly, 3rded. Cincinnati: Harvey Whitney Books Company.

    Feinberg, J. L. (1991). Taking responsibility for therapeutic outcomes:barriers toconsultant pharmacists. Consult Pharm; 6(12): 958-965.

    McKenzie, L. C., Kimberlin, C. L., Berardo, D. H., Pendergast, J. F. (1991).Pharmacists care of elderly patients. University of Florida, College of Pharmacy.

    Wong, B. J., et al. (1994). Role of the pharmacist on a geriatric assessmentteam. Consult Pharm; 9(10): 1149-1158.

    Websites:

    American Society of Health-System Pharmacists

    http://www.ashp.org

    American Society of Consultant Pharmacists

    http://www.ascp.com

    American Pharmacists Association

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    http://www.aphanet.org/

    Agency for Healthcare Research and Qualityhttp://www.ahrq.gov/

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    Module 3, Section 3: Devising a Therapeutic Monitoring Plan

    03.03.01 Steps in Devising a Therapeutic Monitoring Plan

    Define Needs

    Identify Goals

    Design the Therapeutic Regimen

    Monitor the Patient:

    Review therapeutic regimen

    oevaluate plan for safety

    o evaluate patient compliance

    o evaluate plan for effectiveness

    o determine if therapeutic goals are met

    Use feedback to revise planDocument Patient Progress

    The design of the pharmaceutical regimen and patient care plan represents thebeginning, not the end, of the therapeutic planning process. Once treatment has

    been initiated, both the patient and the therapeutic regimen must be continuallymonitored for safety and effectiveness. The impact of therapy on the patientsquality of life must also be evaluated on a regular basis.

    At some point a determination must be made as to whether the therapeutic goalshave been met. Data gathered during this monitoring period are used to developrecommendations for modifying the plan.

    03.03.02 Reviewing the Therapeutic Regimen: Medication Safety

    Side effects

    Adverse reactions

    Pharmacodynamic and pharmacokinetic interactions

    Drug-drug interactions

    Drug-food interactions

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    Medications incorporated into every patient care plan must be monitored andreviewed on a regular systematic basis. Federal regulations in long term carefacilities require monthly drug regimen reviews. Other institutions may havetheir own review policies. During these reviews, the safety of the medication

    is evaluated.

    Side effects and adverse reactions experienced by the patient are noted,along with any potential pharmacodynamic and pharmacokinetic interactions.Direct observations for adverse drug events and laboratory data should bepart of the monitoring process.

    Which of the following must always be considered when evaluating medicationsafety?

    A. Drug-drug interactionsB. Patient's ability to self-administer the drugC. Risk of environmental contaminationD. BioavailabilityE. All of the above

    CORRECT ANSWER: A. While all the listed factors are important, drug-druginteractions must be continuously monitored for and anticipated when evaluatingmedication safety.

    03.03.03 Reviewing the Therapeutic Regimen: Patient Adherence

    Sources of Nonadherence:

    physical limitations

    cognitive limitations

    incomplete therapeutic regimens

    adverse drug reactions

    financial constraints

    interfering health beliefs

    influence of family and friends

    influence of caregivers

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    Evaluation Strategies:

    review of medication administration record

    comparison of refill record and directions for use

    monitoring patient for adverse effects

    Another area that must be evaluated during the monitoring process is patientadherence. Nonadherence with the pharmacotherapeutic regimen may beinfluenced by a variety of factors that include physical and cognitive limitations,financial constraints, and psychosocial factors. Assessment of the medicationadministration record may reveal adherence issues that need to be addressed.

    For example, an inconsistency between the refill frequency and directions for usesuggest an adherence problem. Continuous monitoring for drug toxicities,tolerance, and adverse effects may uncover additional sources ofnonadherence.-

    For more information on medication adherence:http://www.adultmeducation.com/

    03.03.04 Reviewing the Therapeutic Regimen: Medication Efficacy

    Effect of prescribed medications on patients health Effect of unnecessary medications on therapy

    The monitoring process should evaluate the efficacy of therapy. Is the agentpotentially causing, or contributing to, any significant change in the patientsstatus? Is the patient taking any unnecessary medications that should bediscontinued? The risk-benefit of each medication must be evaluated on anongoing basis, and appropriate actions taken in order to optimize the continuingquality of the therapy.

    03.03.05 Evaluating Therapeutic Outcomes

    STATUS GoalsAchieved

    Progress Continue Discontinue New AgentRecommended

    Comment

    Resolved(acute

    concern)

    Yes Yes No Yes For acuteconcerns, drutherapy may b

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    discontinued

    Stable Yes Yes Yes No For chronicmaintenancetherapy, drug

    therapy may b

    continuedImproved No Yes Yes No substantia

    drug therapychanges mad

    Partialimproveme

    nt

    Not yet Some Yes Minoradjustments in

    care plan may indicated to me

    goals

    Unimproved Not yet Little ornone

    Depends Depends Depends Depends ontiming of

    evaluationWorsened No No No Yes Yes Decline in

    patients healthmay require

    discontinuatioafter side effecdrug interactiononcomplianc

    issues assesse

    Failure No No No Yes Yes

    Expired No No No Yes No Patient dies wh

    receiving drugtherapy

    Integral to themonitoring process is the evaluation of therapeutic outcomes. Thechart on your screen illustrates the types of patient status indicators that areimportant in this evaluation. Data collected during this process one is rolled intoa recommendation, and reviewed with the multidisciplinary health care teambefore instituting changes.

    03.03.06 Evaluating Therapeutic Outcomes

    Vital Signs:

    temperature

    heart rate

    blood pressure

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    respiratory rate

    Status of Affected Systems:

    cardiovascular

    pulmonary

    fluid and electrolyte status

    renal functions

    hepatic functions

    endocrine functions

    gastrointestinal

    GU/ reproductive

    musculoskeletal

    neurological psychiatric/psychological

    skin

    EENT

    nutritional status

    Appropriate assessment tools and procedures must be used to evaluate thehealth status of the patient and the degree to which therapeutic goals have beenachieved. The patients vital signs should be assessed frequently, depending on

    the severity of the disorder and pharmacotherapeutic treatment. A check ofsystems affected by the disorder and its treatment should also be conducted.

    These assessment data must be analyzed, translated into recommendations,and reviewed with the interdisciplinary health care team before instituting anychanges.

    03.03.07 Using Feedback to Revise the Therapeutic Regimen

    Document findings

    Roll findings back into recommendation

    Adjust if necessary

    The results of the evaluation process should bedocumented on the patientsmedication record or individualized monitoring form, either in written or electronic

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    format. This recorded feedback then becomes the foundation forrecommendations as to how to modify the therapeutic plan. For example, fromdocumented evidence of adverse effects experienced by the patient, you mayconclude that it is necessary to lower the dosage, alter the administration of thedrug, or replace the drug with an alternative that is safer and equally effective.

    All recommendations should be discussed with the interdisciplinary team.

    03.03.08 Factors in Determining Monitoring Frequency

    Therapeutic Factors:

    pharmacotherapeutic goal

    characteristics of the illness

    characteristics of medication

    Specific Needs of:

    the patient

    the family

    other caregivers

    Logistical Considerations:

    Cost and reimbursement

    Practical constraints of monitoring

    The final step in the monitoring process is to determine the appropriatemonitoring frequency. The time frame between successive follow-ups should betied to the therapeutic goal, the nature of the illness, and the characteristics ofthe medication prescribed. The factors shown here should be consideredwhenever monitoring frequency is in question.

    03.03.09 Resources

    For additional information, see:

    Adamcik, B. A. & Rhodes, R. S. (1993). The pharmacist's role in rational drugtherapy of the aged. Drugs Aging; 3(6): 481-486.

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    Anderson, R. J. & Miller, S. W. (1992). Geriatric drug therapy. In: Herfindel, E.T., Gourley, D. R. & Hart L. L., (Eds.). Clinical Pharmacy and Therapeutics, 5thed. Baltimore: Williams & Wilkins, 1489-1507.

    Anon. (1992). Guidelines for consultant pharmacists practicing in nursing

    facilities. Consult Pharm; 7: 1094, 1099.

    Anon. (1993). Guidelines for consultant pharmacists practicing in residential carefacilities. Consult Pharm; 8: 150-153.

    Bulpitt, C. J. & Fletcher, A. E. (1990). Drug treatment and quality of life in theelderly. Clin Geriatr Med; 6(2): 309-318.

    Cipolle, R .J., Stroud, L. M., & Marley, P. C. (2004). Pharmaceutical carepractice; New York: McGraw Hill.

    Clark TR, Gruber J, Sey M. The early history and evolution of DRR. ConsultPharm; 2003;3:215-35.

    Clark TR, Gruber J, Sey M. Revisiting drug regimen review, part II: art orscience. Consult Pharm; 2003;6:506-13.

    Clark TR, Gruber J, Sey M. Revisting drug regimen review, part III: a systematicapproach to DRR. Consult Pharm; 2003;8:656-66.

    Delafuente, J. C. (1991). Perspectives on geriatric pharmacotherapy.Pharmacotherapy; 11(3): 222-4.

    Delafuente, J.C. & Stewart, R.B., (Eds.) (2001). Therapeutics in the elderly, 3rded. Cincinnati: Harvey Whitney Books Company.

    Faden, R. & German, P. S. (1994). Quality of life. Considerations in geriatrics.Clin Geriatr Med; 10(3): 541-51.

    Feinberg, J. L. (1991). Taking responsibility for therapeutic outcomes:barriers toconsultant pharmacists. Consult Pharm; 6(12): 958-965.

    McKenzie, L. C., Kimberlin, C. L., Berardo, D. H., Pendergast, J. F. (1991).

    Pharmacists care of elderly patients. University of Florida, College of Pharmacy.

    Torg, E. (1992). Life since OBRA: roles and responsibilities of consultantpharmacists and physicians in long-term care. Consult Pharm; 7(12): 1282-1290.

    Wong, B. J., et al. (1994). Role of the pharmacist on a geriatric assessmentteam. Consult Pharm; 9(10): 1149-1158.

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    Websites:

    American Society of Health-System Pharmacistshttp://www.ashp.org

    American Society of Consultant Pharmacistshttp://www.ascp.com

    American Pharmacists Associationhttp://www.aphanet.org/

    Agency for Healthcare Research and Qualityhttp://www.ahrq.gov/

    Cytochrome P450 Drug Interaction Tablehttp://www.drug-interactions.com

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    Module 3, Section 4: Documenting thePharmaceutical Health Plan

    03.04.01 Purpose of Documentation

    To record the steps in the therapeutic planning process:

    o assessment of needs

    o establishment of therapeutic goals

    o design of the therapeutic regimen

    o monitoring and following up schedule

    o achievement of therapeutic outcomes

    To promote acceptance of the therapeutic plan

    To provide a basis for solving health care problems

    To provide a vehicle for communication among patient, family, andcaregivers

    Documenting the pharmaceutical care relationship is essential in todays healthcare environment. All steps of the therapeutic planning process must bedocumented, from the assessment of patient/family needs and identification oftherapeutic goals, to the design of the therapeutic regimen and monitoring plan.

    Effective documentation using a problem-oriented approach will facilitate planacceptance, patient-caregiver communication, and achievement of therapeuticoutcomes. The time you spend on documenting the pharmaceutical carerelationship will aid you and ultimately your patient to resolve his or her healthproblems.

    Documentation of the therapeutic plan:

    A. Is based on a standard problem-solving formatB. Is determined by the healthcare settingC. Requires the consent of the patient

    D. Must be done by hand

    CORRECT ANSWER: B. The environment of the healthcare setting where thedocumentation is occurring will dictate the format in which it is done.

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    03.04.02 The SOAP Format

    Identify problem --> Subjective data

    Quantify data --> Objective data

    Assess the data --> Assessment

    Solve the problem --> Plan

    The SOAP format provides a problem-oriented method for documenting thepharmaceutical care relationship. SOAP represents a four-step process thatconsists of identifying the problem with subjective data, quantifying the dataobjectivelywith tests if possible, assessing these subjective and objective dataand recommending a plan to solve the problem. Each component of the SOAPformat is described in the next series of frames.

    03.04.03 Documenting Subjective Data

    Characteristics of Data:

    focuses on patients perspective

    descriptive in nature

    can incorporate perspective of family members or other caregiversperspective

    Data Gathering Methods:

    listening to patient complaints or symptoms

    listening to family and primary care givers observations

    asking questions

    observing the patient

    Examples of Subjective Data Collected:

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    chief complaint (e.g., pain, fatigue, shortness of breath)

    mental status (e.g., depressed, anxious,happy)

    medical status (e.g., worse, no change, better)

    When you identify the problem using subjective data, you are really asking howthe patient feels and observing what you can regarding his or her healthcondition. Identifying the problem subjectively can help you quantify it objectivelyin the next step.

    Subjective data documentation should be descriptive in nature, and may not beverifiable through tests. This type of data is gathered by listening to the patientscomplaints or symptoms, and questioning the patient on areas such as theduration of symptoms and effectiveness of therapy. While documenting thisinformation, you will also want to note the patients mental status.

    Listening to the observations of family members or primary caregivers willprovide additional critical information regarding the patients physical and mentalstatus.

    03.04.04 Quantifying the Data Objectively

    Characteristics of Data:

    countable

    measurable

    Data Gathering Methods:

    physical examination

    laboratory tests and procedures

    imaging procedures

    assessment instruments

    Examples of Objective Data Collected:

    routine patient data (e.g., vital signs, I/O, weight)

    signs and symptoms (e.g., frequency of behaviors, number of lesions)

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    Once the subjective and objective data have been collected, you must assessthe data in order to determine the need for therapy or the patients response tocurrent therapy. Your assessment should provide clues to the cause of theproblem. For example, is the patients condition drug-induced? From your

    assessment you should also be able to determine the aggressiveness of thetherapy needed, and whether it should be implemented in place of or in additionto the patients current therapeutic regimen.

    03.04.06 Solve the Problem and Document the Plan

    Recommend:

    continuing therapy

    discontinuing therapy

    beginning new therapy

    Document:

    reasons for recommendations

    therapeutic goals

    therapeutic regimen, including:

    o selected medication(s)

    o medication form and route of administration

    o starting and maintenance dosage

    o dosing schedule and duration of therapy

    drugs to avoid

    therapeutic and toxicity monitoring parameters

    patient/family/other caregiver education

    follow up plans

    Solving the problem involves documenting the therapeutic plan, includingrecommendations to continue, discontinue or begin therapy, and the reasonsbehind the recommendations. If new drug therapy is recommended, documentthe medication of choice, dose and dosage form, route, schedule and duration.Be sure to note the medications to avoid due to allergies or compliance issues.

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    Treatment goals, therapeutic and toxicity monitoring parameters, patienteducation, and future plans, as in follow-ups, should also be noted.

    03.04.07 Documentation Format

    Dictated by setting and administrative policies

    May be paper-based or electronic

    The documentation format is dictated by the practice setting. Some settings forexample, have specific policies prohibiting pharmacists to write on the patientschart. If available, the consulting pharmacist should consider using an electronicdocumentation system for recording therapeutic interventions and outcomes.This format will allow the pharmacist to track patient progress, evaluate the level

    of success with patient care recommendations, and generate reports foradministrative and reimbursement purposes.

    03.04.08 The Medication Record

    Purpose - Outlines relationship between:

    patients indication for drug therapy

    the drug product

    dosage regimen

    patients response to therapy

    Contents:

    all drug products being taken or anticipated

    for each medication:

    o the type of medication (e.g., prescription/nonprescription., samples,

    herbal remedies, vitamins)o indication for use (e.g., cure illness, prevent illness, provide

    comfort, assist in diagnosis, correct abnormal test values)

    The medication record outlines the relationship between the patients indication

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    for drug therapy, the drug product, dosage regimen, and patients response totherapy. It is here that you must list all the drug products that a patient is takingor expected to take. Note in each case the type of medication and whether it isprescription, nonprescription, an herbal remedy, or a vitamin. In each case, youshould also document the indication for taking the drug, whether it be for curing

    an illness, preventing one, or providing comfort from signs and symptoms.

    03.04.09 Documenting Outcomes

    STATUS GoalsAchieved

    Progress Continue Discontinue New AgentRecommended

    Comment

    Resolved(acute

    concern)

    Yes Yes No Yes For acuteconcerns, drutherapy may bdiscontinued

    Stable Yes Yes Yes No For chronicmaintenancetherapy, drug

    therapy may bcontinued.

    Improved No Yes Yes No substantiadrug therapy

    changes mad

    Partialimproveme

    nt

    Not yet Some Yes Minoradjustments in

    care plan may

    indicated to megoals

    Unimproved Not yet Little ornone

    Depends Depends Depends Depends ontiming of

    evaluation

    Worsened No No No Yes Yes Decline inpatients health

    may requirediscontinuatioafter side effecdrug interactio

    noncompliancissues assesse

    Failure No No No Yes Yes

    Expired No No No Yes No Patient dies whreceiving drug

    therapy

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    When documenting therapeutic outcomes, determine the appropriate status asshown here. Roll feedback into plan, adjusting if necessary and documentingchanges.

    03.04.10 Resources

    For additional information, see:

    Adamcik, B. A. & Rhodes, R. S. (1993). The pharmacist's role in rational drugtherapy of the aged. Drugs Aging; 3(6): 481-486.

    Anderson, R. J. & Miller, S. W. (1992). Geriatric drug therapy. In: Herfindel, E. T.,Gourley, D. R. & Hart L. L., (Eds.). Clinical Pharmacy and Therapeutics, 5th ed.Baltimore: Williams & Wilkins, 1489-1507.

    Anon. (1992). Guidelines for consultant pharmacists practicing in nursingfacilities. Consult Pharm; 7: 1094, 1099.

    Cipolle, R .J., Stroud, L. M., & Marley, P. C. (1998). Pharmaceutical carepractice. New York: McGraw Hill.

    Delafuente, J. C. (1991). Perspectives on geriatric pharmacotherapy.Pharmacotherapy; 11(3): 222-4.

    Faden, R. & German, P. S. (1994). Quality of life. considerations in geriatrics.Clin Geriatr Med; 10(3): 541-51.

    Feinberg, J. L. (1991). Taking responsibility for therapeutic outcomes:barriers toconsultant pharmacists. Consult Pharm; 6(12): 958-965.

    McKenzie, L. C., Kimberlin, C. L., Berardo, D. H., Pendergast, J. F. (1991).Pharmacists care of elderly patients. University of Florida, College of Pharmacy.

    Torg, E. (1992). Life since OBRA: roles and responsibilities of consultantpharmacists and physicians in long-term care. Consult Pharm; 7(12): 1282-1290.

    Wong, B. J., et al. (1994). Role of the pharmacist on a geriatric assessmentteam. Consult Pharm; 9(10): 1149-1158.

    Websites:

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    American Society of Health-System Pharmacistshttp://www.ashp.org

    American Society of Consultant Pharmacistshttp://www.ascp.com

    American Pharmacists Associationhttp://www.aphanet.org/

    Agency for Healthcare Research and Qualityhttp://www.ahrq.gov/