Patient case study

Introduction

Case studies are an invaluable record of the clinical practices of a profession. While case studies cannot provide specific guidance for the management of successive patients, they are a record of clinical interactions which help us to frame questions for more rigorously designed clinical studies. Case studies also provide valuable teaching material, demonstrating both classical and unusual presentations which may confront the practitioner. Quite obviously, since the overwhelming majority of clinical interactions occur in the field, not in teaching or research facilities, it falls to the field practitioner to record and pass on their experiences.

A case study is a story about something unique, special, or interesting—stories can be

about individuals, organizations, processes, programs, neighborhoods, institutions, and

even events.1 The case study gives the story behind the result by capturing what happened

to bring it about, and can be a good opportunity to highlight a project’s success, or to

bring attention to a particular challenge or difficulty in a project. Cases2 might be selected

because they are highly effective, not effective, representative, typical, or of special interest.

Elements of a patients Case Study

Case studies do not have set elements that need to be included; the elements of each will

vary depending on the case or story chosen, the data collected, and the purpose (for

example, to illustrate a best case versus a typical case). However, case studies typically

describe a program or intervention put in place to address a particular problem. Therefore,

we provide the following elements and example on which you might draw:

1. The Problem

i. Identify the problem

ii. Explain why the problem is important

iii. How was the problem identified?

iv. Was the process for identifying the problem effective?

2. Steps taken to address the problem

3. Results

4. Challenges and how they were met

5. Beyond Results

6. Lessons Learned

Guideline of patient case study

1. Title page:
1. Title: The title page will contain the full title of the article. Remember that many people may find our article by searching on the internet. They may have to decide, just by looking at the title, whether or not they want to access the full article. A title which is vague or non-specific may not attract their attention. Thus, our title should contain the phrase “case study,” “case report” or “case series” as is appropriate to the contents. The two most common formats of titles are nominal and compound. A nominal title is a single phrase, for example “A case study of hypertension which responded to spinal manipulation.” A compound title consists of two phrases in succession, for example “Response of hypertension to spinal manipulation: a case study.”

2. Other contents for the title page should be as in the general JCCA instructions to authors. Remember that for a case study, we would not expect to have more than one or two authors. In order to be listed as an author, a person must have an intellectual stake in the writing – at the very least they must be able to explain and even defend the article. Someone who has only provided technical assistance, as valuable as that may be, may be acknowledged at the end of the article, but would not be listed as an author. Contact information – either home or institutional – should be provided for each author along with the authors’ academic qualifications. If there is more than one author, one author must be identified as the corresponding author – the person whom people should contact if they have questions or comments about the study.
1. Key words: Provide key words under which the article will be listed. These are the words which would be used when searching for the article using a search engine such as Medline. When practical, we should choose key words from a standard list of keywords, such as MeSH (Medical subject headings). A copy of MeSH is available in most libraries.
2. Abstract: Abstracts generally follow one of two styles, narrative or structured.A narrative abstract consists of a short version of the whole paper. There are no headings within the narrative abstract. The author simply tries to summarize the paper into a story which flows logically.A structured abstract uses subheadings. Structured abstracts are becoming more popular for basic scientific and clinical studies, since they standardize the abstract and ensure that certain information is included. This is very useful for readers who search for articles on the internet. Often the abstract is displayed by a search engine, and on the basis of the abstract the reader will decide whether or not to download the full article (which may require payment of a fee). With a structured abstract, the reader is more likely to be given the information which they need to decide whether to go on to the full article, and so this style is encouraged. The JCCA recommends the use of structured abstracts for case studies.

Since they are summaries, both narrative and structured abstracts are easier to write once we have finished the rest of the article. We include a template for a structured abstract and encourage authors to make use of it. Our sub-headings will be:

1. Introduction: This consists of one or two sentences to describe the context of the case and summarize the entire article.
2. Case presentation: Several sentences describe the history and results of any examinations performed. The working diagnosis and management of the case are described.
3. Management and Outcome: Simply describe the course of the patient’s complaint. Where possible, make reference to any outcome measures which you used to objectively demonstrate how the patient’s condition evolved through the course of management.
4. Discussion: Synthesize the foregoing subsections and explain both correlations and apparent inconsistencies. If appropriate to the case, within one or two sentences describe the lessons to be learned.
3. Introduction: At the beginning of these guidelines we suggested that we need to have a clear idea of what is particularly interesting about the case we want to describe. The introduction is where we convey this to the reader. It is useful to begin by placing the study in a historical or social context. If similar cases have been reported previously, we describe them briefly.
4. Case presentation: This is the part of the paper in which we introduce the raw data. First, we describe the complaint that brought the patient to us. It is often useful to use the patient’s own words. Next, we introduce the important information that we obtained from our history-taking. We don’t need to include every detail – just the information that helped us to settle on our diagnosis. Also, we should try to present patient information in a narrative form – full sentences which efficiently summarize the results of our questioning. In our own practice, the history usually leads to a differential diagnosis – a short list of the most likely diseases or disorders underlying the patient’s symptoms. We may or may not choose to include this list at the end of this section of the case presentation.

The next step is to describe the results of our clinical examination. Again, we should write in an efficient narrative style, restricting ourselves to the relevant information. It is not necessary to include every detail in our clinical notes.

If we are using a named orthopedic or neurological test, it is best to both name and describe the test (since some people may know the test by a different name). Also, we should describe the actual results, since not all readers will have the same understanding of what constitutes a “positive” or “negative” result.

X-rays or other images are only helpful if they are clear enough to be easily reproduced and if they are accompanied by a legend. Be sure that any information that might identify a patient is removed before the image is submitted.

At this point, or at the beginning of the next section, we will want to present our working diagnosis or clinical impression of the patient.

6. Management and Outcome: In this section, we should clearly describe the plan for care, as well as the care which was actually provided, and the outcome.

It is useful for the reader to know how long the patient was under care and how many times they were treated. Additionally, we should be as specific as possible in describing the treatment that we used. It does not help the reader to simply say that the patient received “chiropractic care.” Exactly what treatment did we use? If we used spinal manipulation, it is best to name the technique, if a common name exists, and also to describe the manipulation. Remember that our case study may be read by people who are not familiar with spinal manipulation, and, even within chiropractic circles, nomenclature for technique is not well standardized.

We may want to include the patient’s own reports of improvement or worsening. However, whenever possible we should try to use a well-validated method of measuring their improvement. For case studies, it may be possible to use data from visual analogue scales (VAS) for pain, or a journal of medication usage.

7. Discussion: In this section we may want to identify any questions that the case raises. It is not our duty to provide a complete physiological explanation for everything that we observed. This is usually impossible. Nor should we feel obligated to list or generate all of the possible hypotheses that might explain the course of the patient’s condition. If there is a well established item of physiology or pathology which illuminates the case, we certainly include it, but remember that we are writing what is primarily a clinical chronicle, not a basic scientific paper. Finally, we summarize the lessons learned from this case.
8. Acknowledgments: If someone provided assistance with the preparation of the case study, we thank them briefly. It is neither necessary nor conventional to thank the patient (although we appreciate what they have taught us). It would generally be regarded as excessive and inappropriate to thank others, such as teachers or colleagues who did not directly participate in preparation of the paper.
9. References: References should be listed as described elsewhere in the instructions to authors. Only use references that you have read and understood, and actually used to support the case study. Do not use more than approximately 15 references without some clear justification. Try to avoid using textbooks as references, since it is assumed that most readers would already have this information. Also, do not refer to personal communication, since readers have no way of checking this information.
10. Legends: If we used any tables, figures or photographs, they should be accompanied by a succinct explanation. A good rule for graphs is that they should contain sufficient information to be generally decipherable without reference to a legend.
11. Tables, figures and photographs should be included at the end of the manuscript.
12. Permissions: If any tables, figures or photographs, or substantial quotations, have been borrowed from other publications, we must include a letter of permission from the publisher. Also, if we use any photographs which might identify a patient, we will need their written permission.

In practice, case studies should include:

• A description of the client’s presenting problem and the initial context/circumstances of their case. NB: The focus should be on that which is essential to foster the reader’s understanding; incidental details which do not contribute directly to the reader’s understanding should be omitted;

• A description of the ‘trigger’ incident, for example a traumatic event, if applicable;

• The client’s symptoms and the resulting consequences/sequelae, for example detrimental effect on the client’s relationships and constraints on their mobility as a consequence of, for instance, trauma;

• In short, case studies should focus on a description of the problem and the relevant circumstances, the consequences for the client and/or others, the treatment provided and the outcome.

Formats of patients case study

Section	Information to Include
Introduction (patient and problem)	Explain who the patient is (Age, gender, etc.) Explain what the problem is (What was he/she diagnosed with, or what happened?) Introduce your main argument (What should you as a nurse focus on or do?)
Pathophysiology	Explain the disease (What are the symptoms? What causes it?)
History	Explain what health problems the patient has (Has she/he been diagnosed with other diseases?) Detail any and all previous treatments (Has she/he had any prior surgeries or is he/she on medication?)
Nursing Physical Assessment	List all the patient’s health stats in sentences with specific numbers/levels (Blood pressure, bowel sounds, ambulation, etc.)
Related Treatments	Explain what treatments  the patient is receiving because of his/her disease
Nursing Care Plan
Nursing Diagnosis & Patient Goal	Explain what your nursing diagnosis is (What is the main problem for this patient? What need to be addressed?) Explain what your goal is for helping the patient recover (What do you want to change for the patient?)
Nursing Interventions	Explain how you will accomplish your nursing goals, and support this with citations (Reference the literature)
Evaluation	Explain how effective the nursing intervention was (What happened after your nursing intervention? Did the patient get better?)
Recommendations	Explain what the patient or nurse should do in the future to continue recovery/improvement

Example

Asthma Case Study

A 37 y/o black female with a history of asthma, presents to the ER with tachypnea, and acute shortness of breath with audible wheezing. Patient has taken her prescribed medications of Cromolyn Sodium and Ventolin at home with no relief of symptoms prior to coming to the ER. A physical exam revealed the following: HR 110, RR 40 with signs of accessory muscle use. Ausculation revealed decreased breath sounds with inspiratory and expiratory wheezing and pt was coughing up small amounts of white sputum. SaO2 was 93% on room air. An arterial blood gas (ABG) was ordered with the following results: pH 7.5, PaCO2 27, PaO2 75. An aerosol treatment was ordered and given with 0.5 cc albuterol with 3.0 cc normal saline in a small volume nebulizer for 10 minutes. Peak flows done before and after the treatment were 125/250 and ausculation revealed loud expiratory wheezing and better airflow. 20 minutes later a second treatment was given with the above meds. Peak flows before and after showed improvements of 230/360 and on ausculation there was clearing of breath sounds and much improved airflow. RR was 24 at this time and HR 108. Symptoms resolved and patient was given prescription for inhaled steroids to be used with current home meds. Instruction was given for use of inhaled steroids and the patient was sent home.

 

 

References

1. Malach M. Book review. Baim DS, Grossman W (Ed). Cardiac catheterization, angiography, and intervention, 5th ed. J Comm Health. 1996;21:466-467.
2. Davis C, Van Riper S, Longstreet J, Moscucci M. Vascular complications of coronary interventions. Heart Lung. 1997;26(2):118-127.
3. Arnold A. Hemostasis after radial artery cardiac catheterization. J Invasive Card. 1996;8(supp D):26D-29D.
4. Mick M. Transradial approach for coronary angiography. J Invasive Card. 1996;8(supp D): 9D-12D.
5. Glucophage. Physicians’ Desk Reference. 51st ed. Montvale, NJ: Medical Economics; 1997; 754-58.
6. Beckerman A, Grossman D, Marquez L. Cardiac catheterization: the patient’s perspective. Heart Lung. 1995;24:213-9.
7. White R, Frasure-Smith N. Uncertainty and psychological stress after coronary angioplasty and coronary bypass surgery. Heart Lung. 1995;24(3):19-27
8. Taylor AD. Emotions of the heart. Cardiac Lab Digest. 2000;8(5):12-20.
9. Schickel S, Cronin S, Mize A, Voelker C. Removal of femoral sheaths by registered nurses: issues and outcomes. Crit Care Nurs. 1994;14(2):32-36.

Tu SW, Musen MA. From guideline Modeling to guideline execution: Defining guideline-based decision-support Services. Proc AMIA Annu Symp 2000:863–867.

10. Tu SW, Musen MA. Modeling data and knowledge in the EON guideline architecture. Proc Medinfo 2001; 280–284.

Pharmaceutical Industry has grown in Bangladesh

Pharmaceutical Industry has grown in Bangladesh in the last two decades at a considerable rate. Its healthy growth supports development of auxiliary industries for producing glass bottles, plastic containers, aluminium collapsible tubes, aluminium PP caps, infusion sets, disposable syringes, and corrugated cartons. Some of these products are also being exported. Printing and packaging industries and even the advertising agencies consider pharmaceutical industry as their major clients and a key driving force for their growth.
The sector consistently creates job opportunities for highly qualified people. Many established entrepreneurs of today started with pharmaceutical companies in the country. Pharmaceutical companies are either directly or indirectly contributing largely towards raising the standard of healthcare through enabling local healthcare personnel to gain access to newer products and also to latest drug information.
Following the Drug (Control) Ordinance of 1982, some of the local pharmaceutical companies improved range and quality of their products considerably. The national companies account for more than 65% of the pharmaceutical business in Bangladesh. However, among the top 20 companies of Bangladesh 6 are multinationals. Almost all the life saving imported products and new innovative molecules are channelled into and marketed in Bangladesh through these companies. Multinational and large national companies generally follow current good manufacturing practices (cGMP) including rigorous quality control of their products. The Drug Act of 1940 and its rules formed the basis of the country's drug legislation. Unani, ayurvedic, homeopathic and biochemic medicines were exempted from control under the legislation. The pharmaceutical industry was dominated by the foreign companies at that time. Even in the allopathic market there were extemporaneous preparations dispensed from retail pharmacies.
The pharmaceutical industry, however, like all other sectors in Bangladesh, was much neglected during Pakistan regime. Most multinational companies had their production facilities in West Pakistan. With the emergence of Bangladesh in 1971, the country inherited a poor base of pharmaceutical industry. For several years after liberation, the government could not increase budgetary allocations for the health sector. Millions of people had little access to essential life saving medicines. With the promulgation of the Drug (Control) Ordinance of 1982 many medicinal products considered harmful, useless or unnecessary got removed from the market allowing availability of essential drugs to increase at all levels of the healthcare system. Increased competition helped maintain prices of selected essential drugs at the minimum and affordable level.
In 1981, there were 166 licensed pharmaceutical manufacturers in the country, but local production was dominated by eight multinational companies (MNCs) which manufactured about 75% of the products. There were 25 medium sized local companies which manufactured 15% of the products and the remaining 10% were produced by other 133 small local companies. All these companies were mainly engaged in formulation out of imported raw materials involving an expenditure of Tk 600 million in foreign exchange. In spite of having 166 local pharmaceutical production units, the country had to spend nearly Tk 300 million on importing finished medicinal products. A positive impact of the Drug (Control) Ordinance of 1982 was that the limited available foreign currency was exclusively utilised for import of pharmaceutical raw materials and finished drugs, which are not produced in the country. The value of locally produced medicines rose from Tk 1.1 billion in 1981 to Tk 16.9 billion in 1999. At present, 95% of the total demand of medicinal products is met by local production. Local companies (LCs) increased their share from 25% to 70% on total annual production between 1981 and 2000.
In 2000, there were 210 licensed allopathic drug-manufacturing units in the country, out of which only 173 were on active production; others were either closed down on their own or suspended by the licensing authority for drugs due to non compliance to GMP or drug laws. They manufactured about 5,600 brands of medicines in different dosage forms. There were, however, 1,495 wholesale drug license holders and about 37,700 retail drug license holders in Bangladesh. Anti-infective is the largest therapeutic class of locally produced medicinal products, distantly followed by antacids and anti-ulcerants.
Other significant therapeutic classes include non-steroidal anti-inflammatory drug (NSAID), vitamins, central nervous system (CNS) and respiratory products. A most remarkable progress the local industry has made in recent time is the phenomenal increase in the local production of basic chemicals. There are now 13 drug manufacturing units, which also manufacture certain basic materials. These include Paracetamol, Ampicillin Trihydrate, Amoxycillin Trihydrate, Diclofenac Sodium, Aluminium Hydroxide Dried Gel, Dextrose Monohydrate, Hard Gelatin capsule shell, Chloroquine Phosphate, Propranolol Hydrochloride, Benzoyl Metronidazole, Sodium Stibogluconate (Stibatin) and Pyrantel Pamoate. However, most of these are confined to the last stage of synthesis. There are three public sector drug manufacturing units. Two of them are the Dhaka and Bogra units of Essential Drug Company Ltd. (EDCL), which is functioning as a public limited company under the Ministry of Health and Family Welfare. EDCL produced medicines worth Tk 964 million in 2000. There are separate vaccines and large volume IV fluids production units under the Institute of Public Health (IPH). The productions of both EDCL and IPH are mostly used in government hospitals and institutions. In 2000, there were 261 unani, 161 ayurvedic, 76 homeopathic and biochemic licensed manufacturing units. They produced medicines worth Tk 1.2 billion in 2000.
One of the major positive impacts of Drug (Control) Ordinance is the rapid development of local manufacturing capability. Almost all types of possible dosage forms include tablets, capsules, oral and external liquids (solutions, suspensions, emulsions), ointments, creams, injections (small volume ampoules/dryfill vials/suspensions and large volume IV fluids), and aerosol inhalers are now produced in the country. In recent years, the country has achieved self-sufficiency in large volume parenterals, some quantities of which are also exported to other countries. The development of local manufacturing capability helped contain dependence on the import of pharmaceutical products (raw material and finished product) around pre-1982 level. Under the Drug (Control) Ordinance government fixes the maximum retail prices (MRP) of 117 essential drug chemical substances. Drugs other than these essential ones are priced through a system of indicative prices. This rule applies on the locally manufactured products only. For imported finished products, a fixed percentage of markup is applied on the C&F price to arrive at the MRP, regardless of whether they are within the list of essential 117 molecules or not. It is interesting to note that, even with withdrawal of price control from many products, prices have not shot up; healthy competition has been keeping the prices within affordable levels.
Physical distribution of pharmaceuticals in Bangladesh has evolved in a unique way. Unlike other countries Bangladesh pharmaceutical industry is more retail oriented and bulk of distribution is done by the companies themselves. Pharmaceutical companies distribute their products from their own warehouses located in different parts of the country, as no professional distribution house is available. Wholesalers play a limited role in this regard since companies supply goods to both retailers and wholesalers. Export of pharmaceutical products is still in an infant stage, although a number of private pharmaceutical companies have already entered the export market with their basic materials and finished products. They export their products to Vietnam, Singapore, Myanmar, Bhutan, Nepal, Sri Lanka, Pakistan, Yemen, Oman, Thailand, and some countries of Central Asia and Africa.
The primary responsibility for drug quality control lies with the manufacturers. However, the government's drug testing laboratories (DTL) and the Directorate of Drug Administration (DDA) have the monitoring and supervising role. There are two government drug testing laboratories. DTL at Dhaka is in the Institute of Public Health and the regional DTL at Chittagong is under DDA. Drug administration is responsible for registration of drugs for marketing in Bangladesh and for inspection of premises and licensing. With its present set up and inadequate strength, DDA often finds it difficult to carry out its very large volume of assigned work. The national drug policy and the regulatory control policies are yet to achieve best results for a healthy growth of the pharmaceutical industry. Because of the limited capacity of the government's drug testing laboratories, the quality of products manufactured locally cannot be uniformly ensured. Restrictions on patent rights discourage foreign investors to come up actively in the pharmaceutical market in Bangladesh. Introduction of new research molecules is difficult due to slow registration process and restrictions on patent protection. Although the fixed mark-up system of pricing helped keep the prices of pharmaceutical products low, this made it difficult to cover costs of marketing and distribution. The fixed mark-up system also discourages some companies to invest for cGMP and assurance of high quality production. Some important therapeutic classes of the pharmaceutical market (antacids and oral vitamins) are only open to the local companies even after 20 years of the drug ordinance. This policy is discriminatory and also contrary to the announced investment policy of the government.
The annual per capita drug consumption in Bangladesh is one of the lowest in the world. However, the industry has been a key contributor to the Bangladesh economy since independence. With the development of healthcare infrastructure and increase of health awareness and the purchasing capacity of people, this industry is expected to grow at a higher rate in future. Healthy growth is likely to encourage the pharmaceutical companies to introduce newer drugs and newer research products, while at the same time maintaining a healthy competitiveness in respect of the most essential drugs. [AKM Shamsuddin and KMA Humayun Hye]

There are several sectors on which Bangladesh can be proud of and undoubtedly the pharmaceutical sector is one of these sectors, rather it is the sector, which is the second-largest contributor to the government exchequer. There are about 231 companies in this sector and the approximate total market size is about Taka 76,500 million per year of which about 97% of the total requirement of medicines is created by the local companies and the rest 3% is imported. The imported drugs mainly comprise of the cancer drugs, vaccines for viral diseases, hormones etc.

Bangladesh Pharmaceutical Industry is now heading towards self-sufficiency in meeting the local demand. The industry is the second highest contributor to the national exchequer after garments, and it is the largest white-collar intensive employment sector of the country. There are about 450 generics registered in Bangladesh. Out of these 450 generics, 117 are in the controlled category i.e. in the essential drug list. The remaining 333 generics are in the decontrolled category, The total number of brands /items that are registered in Bangladesh is currently estimated to be 5,300, while the total number of dosage forms and strengths are 8,300. Bangladesh pharmaceutical industry is mainly dominated by domestic manufacturers. Of the total pharmaceutical market of Bangladesh, the local companies are enjoying a market share reaching around 80%, while the MNCs are having a market share of 20%.

During the the last two decades the pharmaceutical industry of Bangladesh has been taken a newer height. Besides meeting the 97% need of local demand we are exporting the medicines into 72 countries. This sector contributes a lot into the national economy by exporting raw materials and finished goods. Bangladesh is ready to enter the Highly Regulated Market. For this reason different pharmaceutical companies are investing to build high tech pharmaceutical industries. Some renowned companies have already entered the Highly Regulated Market and got the UK MHRA, EU, TGA Australia and GCC approval and some are in the process to get the USFDA & UK MHRA approval. Through this accreditation these companies will be able to export medicine and through contract manufacturing agreement.

ADVERSE DRUG REACTION IN HOSPITAL

The World Health Organization (WHO) defines an ADR as “a response to a drug that is noxious and unintended and occurs at doses normally used in man;” this definition was refined about a decade ago to include the concept of error, highlighting that preventative action may help avoid adverse effects. The American Society of Health-Systems Pharmacists (ASHP) guidelines on ADR are monitoring and reporting focuses on comprehensive ADR monitoring and reporting and suggests that methods for ranking ADRs be established.
The ASHP defines significant ADRs as any unexpected, unintended, undesired, or excessive response to a drug that:

1.      Requires discontinuing the drug

2.      Requires changing drug therapy

3.      Requires modifying the drug dose

4.      Requires admission to a hospital

5.      Prolongs stay in a health care facility

6.      Requires supportive treatment

7.      Significantly complicates diagnosis

8.      Negatively effects prognosis, or

9.      Results in temporary or permanent harm, disability, or death

Why adverse drug reactions?

Large proportions of negative reactions to medicines are due to irrational use or human error and are therefore preventable. The main ones are:

• Wrong diagnosis of the patient condition
• Prescription of the wrong drug or wrong dosage of the right drug
• Undetected medical, genetic or allergic condition in the patient which might cause a bad reaction to the drug
• Self-medication
• Lack of adherence to the prescribed course of the drug
• A large number of different drugs being taken by the patient (polypharmacy), which may interact.

However, it is important to remember that even when the above situations are carefully avoided, all medicines have side effects and some of those can be damaging. The effects of any medical intervention cannot be predicted with absolute certainty. No drug is totally devoid of risk. For all medicines there is a trade-off between the benefits and the potential for harm.

Classification

ADRs may be classified by e.g. cause and severity

Cause:

Ø  Type A: Augmented pharmacologic effects - dose dependent and predictable

v  Intolerance

v  Side Effects

Ø  Type B: Bizarre effects (or idiosyncratic) - dose independent and unpredictable

Ø  Type C: Chronic effects

Ø  Type D: Delayed effects

Ø  Type E: End-of-treatment effects

Ø  Type F: Failure of therapy

Types A and B were proposed in the 1970 and the other types were proposed subsequently when the first two proved insufficient to classify ADRs

Seriousness and Severity:

The American Food and Drug Administration defines a serious adverse event as one when the patient outcome is one of the following:

• Death
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability - significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
• Congenital anomaly
• Requires intervention to prevent permanent impairment or damage

Severity is a point on an arbitrary scale of intensity of the adverse event in question. The terms "severe" and "serious" when applied to adverse events are technically very different. They are easily confused but cannot be used interchangeably, require care in usage.

A headache is severe, if it causes intense pain. There are scales like "visual analog scale" that helps us assess the severity. On the other hand, a headache can hardly ever be serious, unless it also satisfies the criteria for seriousness listed above.

 

PREDISPOSING FACTORS FOR ADVERSE DRUG REACTIONS (ADRs)

Multiple drug therapy

Incidence of ADRs from drug interactions increase sharply with the number of drugs taken.

Age

The very young and very old are more susceptible to having adverse reactions. This reflects age related differences in body composition and in activity of metabolic pathways.

Gender

Women appear to be at greater at risk of ADRs than men.

Current disease

Drug handling may be altered in patients with impaired metabolism such as renal or liver impairment. Diseases in which multiple drug treatment occurs are also associated with greater likelihood of ADRs.

Pharmacokinetic Differences

There may be increased toxicity from a drug because of genetic factors (e.g. difference in enzyme activity) or environmental influences (e.g. high alcohol intake).

Ethnic Differences

Ethnic genetic or dietary differences may increase the risk of ADRs. Examples include interaction of diet with glucose 6-phosphate dehydrogenase deficiency; and iron overload resulting from giving iron supplements to sickle cell patients when they do not need it.

Incomplete Medicines Reconciliation

Medicines reconciliation refers to the checking of medicines patients are taking, either prescribed, over the counter, folk medicines, or from other sources.  High risk settings where medicines reconciliation is a problem include acute presentation to the Accident and Emergency Department and new interactions within parts of the NHS which may currently hold separate clinic records e.g. HIV services.

Location

Adverse effects may be local, i.e. limited to a certain location, or systemic, where a medication has caused adverse effects throughout the systemic circulation.

For instance, some ocular antihypertensives cause systemic effects although they are administered locally as eye drops, since a fraction escapes to the systemic circulation.

Mechanisms

As research better explains the biochemistry of drug use, fewer ADRs are Type B and more are Type A. Common mechanisms are:

• Abnormal pharmacokinetics due to

v  genetic factors

v  comorbid disease states

• Synergistic effects between either

v  a drug and a disease

v  two drugs

Abnormal pharmacokinetics

Comorbid disease states

Various diseases, especially those that cause renal or hepatic insufficiency, may alter drug metabolism. Resources are available that report changes in a drug's metabolism due to disease states.

Genetic factors

Abnormal drug metabolism may be due to inherited factors of either Phase I oxidation or Phase II conjugation. Pharmacogenomics is the study of the inherited basis for abnormal drug reactions.

Phase I reactions

Inheriting abnormal alleles of cytochrome P450 can alter drug metabolism. Tables are available to check for drug interactions due to P450 interactions.

Inheriting abnormal butyrylcholinesterase (pseudocholinesterase) may affect metabolism of drugs such as succinylcholine.

Phase II reactions

Inheriting abnormal N-acetyltransferase which conjugated some drugs to facilitate excretion may affect the metabolism of drugs such as isoniazid, hydralazine, and procainamide.

Inheriting abnormal thiopurine S-methyltransferase may affect the metabolism of the thiopurine drugs mercaptopurine and azathioprine.

Protein binding

These interactions are usually transient and mild until a new steady state is achieved. These are mainly for drugs without much first-pass liver metabolism. The principal plasma proteins for drug binding are:

1. albumin
2. α1-acid glycoprotein
3. lipoproteins

Some drug interactions with warfarin are due to changes in protein binding.

Cytochrome P450

Patients have abnormal metabolism by cytochrome P450 due to either inheriting abnormal alleles or due to drug interactions. Tables are available to check for drug interactions due to P450 interactions.

Interactions with other drugs

The risk of drug interactions is increased with polypharmacy.

Synergistic effects

An example of synergism is two drugs that both prolong the QT interval.

Limitations of adverse effects reporting

In principle, medical professionals are required to report all adverse effects related to a specific form of therapy. In practice, it is at the discretion of the professional to determine whether a medical event is at all related to the therapy. For example, a leg fracture in a skiing accident in a patient who years before took antibiotics for pneumonia is not likely to get reported.
As a result, routine adverse effects reporting often may not include long-term and subtle effects that may ultimately be attributed to a therapy.

Part of the difficulty is identifying the source of a complaint. A headache in a patient taking medication for influenza may be caused by the underlying disease or may be an adverse effect of the treatment. In patients with end-stage cancer, death is a very likely outcome and whether the drug is the cause or a bystander is often difficult to discern.

Examples of adverse effects associated with specific medications

Condition	Substance
Abortion, uterine hemorrhage	misoprostol (Cytotec), a labor-inducing drug
Addiction	many sedatives and analgesics such as diazepam, morphine, etc
Birth defects	Thalidomide and Accutane
Bleeding of the intestine	aspirin therapy
Cardiovascular disease	COX-2 inhibitors (i.e. Vioxx)
Deafness and kidney failure	gentamicin (an antibiotic)
Death, following sedation	propofol (Diprivan)
Dementia	heart bypass surgery
Depression or hepatic injury	interferon
Diabetes	atypical antipsychotic medications (neuroleptic psychiatric drugs)
Diarrhea	orlistat (Xenical)
Erectile dysfunction	many drugs, such as antidepressants
Fever	Vaccination (in the past, imperfectly manufactured vaccines, such as BCG and poliomyelitis, have caused the very disease they intended to fight).
Glaucoma	corticosteroid-based eye drops
Hair loss and anemia	chemotherapy against cancer, leukemia, etc.
Headache	spinal anesthesia
Hypertension	ephedrine users, which prompted FDA to remove the status of dietary supplement of ephedra extracts
Insomnia	stimulants, Ritalin, Adderall, etc.
Lactic acidosis	stavudine (Zerit, for anti-HIV therapy) or metformin (for diabetes)
Liver	paracetamol
Melasma and thrombosis	estrogen-containing hormonal contraception such as the combined oral contraceptive pill
Rhabdomyolysis	statins (anti-cholesterol drugs)

Monitoring bodies

Many countries have official bodies that monitor drug safety and reactions. On an international level, the WHO runs the Uppsala Monitoring Centre, and the European Union runs the European Medicines Agency (EMEA). In the United States, the Food and Drug Administration (FDA) is responsible for monitoring post-marketing studies.

PREVENTION:

ü  Be aware that you are at an increased risk of ADR if you are taking two or more medications (and an extremely increased risk if taking four or more).

ü   Make sure your doctor is aware of your medication history and drugs you are currently taking -- including vitamins, herbs and over-the-counter meds. If he or she doesn't ask (though they should), bring it up and tell them yourself!

ü   If you are taking multiple drugs, ask your doctors specifically: "Will this new medication interact with X, Y or Z?" (the medications you're already taking)

ü   Be aware that certain drug categories are especially risky in terms of interactions. These include:

a. Anticonvulsants

b. Antibiotics

c. Certain cardiac drugs such as digoxin, warfarin, and amiodarone

ü  When picking up the prescription, check again with the pharmacist by asking if this drug interacts with any drug you are already taking, possible side effects, risks, etc.

ü   If you experience any unusual symptoms upon taking the medication, call your doctor immediately and explain the problem.

THE ROLE OF PHARMACIST:

Medication therapy management (MTM) is a partnership of the pharmacist, the patient or their caregiver, and other health professionals that promotes the safe and effective use of medications and helps patients achieve the targeted outcomes from medication therapy. MTM was first proposed by Ronald Jordan, former APhA president. MTM includes the analytical, consultative, educational and monitoring services provided by pharmacists to help consumers get the best results from medications through enhancing consumer understanding of medication therapy, increasing consumer adherence to medications, controlling costs, and preventing drug complications, conflicts, and interactions. This is the side of pharmacy giving value to cognitive services and removing the pharmacist from a solely distributive function. There are many topics/disease states that can be improved by MTM, including, but not limited to Diabetes, Asthma, and Elderly Care.
A clinical pharmacist will typically provide medication therapy management services through review of a list of medications the patient provides. The things the pharmacist will be looking at include drug interactions, duplications of drugs from the same family, doses, routes of administration, and the formulation the patient is using. This review will also include evaluating medication habits to see where we may be able to optimize the benefit a patient receives.

Medication Therapy Management was coined by Congress in the Medicare Modernization Act of 2003 (MMA 2003). The MMA 2003 established the requirement that each Medicare Part D plan sponsor offer a Medication Therapy Management program to targeted beneficiaries beginning in 2006. At a minimum, targeted beneficiaries include those members with multiple chronic conditions, taking multiple Part D drugs, and likely to incur annual costs for covered Part D drugs that exceed a predetermined level. While plan sponsors are required to offer MTM to these targeted beneficiaries, other patients can also benefit from MTM and many plans have employed MTM programs as a proactive strategy to prevent medication-related complications and associated health care costs by extending the MTM benefit to their full population of members. It is important to also note that MTM may apply to populations outside of Medicare, including patients less than 65 years of age.
The provision of MTM services requires pharmacists to collaborate with both patients and prescribers to resolve medication-related complications. According to guidance set forth by the Centers for Medicare and Medicaid Services (CMS), each MTM-eligible patient should be covered for an annual Comprehensive Medication Review (CMR), inclusive of an interactive, person-to-person consultation. In addition to the annual Comprehensive Medication Review, quarterly targeted medication reviews are also required. Appropriate MTM services should also be provided on an ad hoc basis as medication-related complications are identified.

Improving Reporting in the Hospital Setting

One of the most important methods to improve reporting is to change the reporting culture of an institution. This requires a commitment from hospital administration, management, and individual employees to value and support an environment that recognizes and rewards AE and ADR reporting. From previous successful campaigns for hand-washing and other quality measures a good first step to changing the culture may involve an educational campaign that focuses on the importance of ADR reporting and specifically addresses complacency, insecurity, diffidence, indifference, and misunderstanding. All health care professionals, including physicians, nurses, and pharmacists, should be included and encouraged to report. Institution-wide presentations (eg, grand rounds, continuing education courses, and inservices), media campaigns, advertisements, and personal communications should all be considered.
Goal-setting may be used to encourage ADR reporting within a health system. Depending on the institution, reporting goals can be broad or specific, identifying successful reporting by select departments, units, or personnel. Recognition of successful ADR reporting is an important feedback step and its extent and implementation should be determined by the institution.
According to a nationwide survey of hospitals, the most frequently used methods in support of a safety culture included taking a nonpunitive approach to ADEs (84.6%), using errors as an opportunity to learn (75.7%), communicating improvements resulting from reported events (67.6%), sharing reporting rates with staff (53.5%), and making ADEs nondiscoverable by plaintiffs in the course of litigation (48.3%). Other less frequently used methods included modifying performance appraisal instruments to reward reporting (19.1%) and providing incentives to staff for reporting (14.4%). Approximately 2% of hospitals surveyed had none of these measures in place.
Organizations such as the Agency for Healthcare Research and Quality and the Institute for Healthcare Improvement have developed systematic procedures for analyzing ADEs and ADE reporting that can be implemented by institutions. One such tool is Root Cause Analysis (RCA), which is a retrospective error analysis widely applied to the investigation of major industrial accidents.⁶³ The application of RCA allows investigators to potentially uncover common root causes that link a seemingly disparate collection of AEs. RCA is a process-focused framework for identifying and addressing errors without attempting to assign individual blame. Another useful tool is the Failure Mode Effects Analysis (FMEA), which identifies where and how a process might fail and assesses the relative impact of different failures to focus attention on the parts most in need of change. Although FMEA was initially developed outside of health care, it is now being used by hundreds of hospitals.
A “trigger tool” analysis can be performed using an interactive automated program for detecting ADEs using a list of known signal words or “triggers” identified in patient medical records by customized software linked to hospital pharmacy records. This allows for a retrospective, focused assessment of ADEs, tracked over time within an institution, and may be modified to assess ADEs related to specific drugs, including high-risk drugs. The trigger tool analysis can also be performed by reviewing records manually without an automated program. Tracking ADEs over time allows for an assessment of whether implemented changes within an institution are resulting in improved medication safety. In addition, the results of a trigger tool analysis can be compared to an institution’s actual rate of AE reporting, which may provide insight into the degree of underreporting of AEs. Institutions may have dedicated medication safety officers (who could be physicians, pharmacists, or nursing administrators) in charge of developing process changes to improve medication safety and conducting and implementing the findings from RCAs, FMEAs, and trigger tool analyses. The medication safety officer also serves as the champion for an institution’s drug safety program, including medication error data management, trending, and benchmarking.

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