D. Pharm - II Examination - 2010 (I) | HOSPITAL & CLINICAL PHARMACY (THEORY)

 

ODISHA STATE BOARD OF PHARMACY

D. Pharm - II Examination - 2010 (I) 

HOSPITAL & CLINICAL PHARMACY  (THEORY) 

Time - 3 Hours                              Full Marks - 80

__________________

(Answer any five questions including question no-1)

1. (A)Give the full forms of the following:

(1) F.B.S. 

(ii) EOQ 

(iii) DIS

(iv) TLC

(v) MRI

(vi) HEPA

(vii) NPD

(viii) DIB

(ix) EEG

(x) CUDD

(B)Give the normal values of the following physiological parameters along with its significance.

(I) Sperm count 

(ii) Blood Sugar Level

(iii) B.T.C.T 

(iv) Cholesterol

(v) E.S.R.

2. What are the objectives of PTC and narrate how it functions.

3. What is bioavailability ? Write the factors affecting bio availability. 

4. What are the pathophysiology and manifestations of

(i) Jaundice

(ii) Epilepsy

(ii) Rheumatoid Arthritis.

5. Write brief notes on the following.

(i) Drug induced disease.

6. What is Drug information Bulletin ? Discuss the function of Drug Informations Services in a Hospital Pharmacy and the qualification of the Pharmacist to run DIS.

7. What are the various drug distribution systems for in-patients ? Write in detail about unit dose dispensing

ANSWER TO 2010

1. (A) Give the full forms of the following:

Ans. 

(i) F.B.S.: Fasting Blood Sugar

(ii) EOQ:Economic Order Quantity 

(iii) DIS : Drug Information System

(iv) TLC: Total Leukocyte Count

(v) MRI: Magnetic Resonance Imaging

(vi) HEPA: High Efficiency Particulate Absorption

(vii) NPD: Number of Prescribed Doses

(viii) DIB: Drug Information Bulletin

(ix) EEG: Electro Encephalo Gram

(x) CUDD: Centralised Unit Dose Dispensing / Distribution system.

(B)Give the normal values of the following hophysiological parameters along with its significance.

Ans. 

(i) Sperm count: 20-40 million sperm per mililitre

(ii) Blood Sugar Level: 70-100 mg/dl - fasting, <140 mg/dl 2 hours pp

(iii) B.T.C.T: See Q. 1 B (v) in 2011

(iv) Cholesterol: <200 mg/dl - Total cholesterol LDL cholesterol - <100 mg/dl

(v) E.S.R.: 0-20 mm/hr

2. What are the objectives of PTC and narrate how it functions.

Ans. 

Objectives of PTC :

The two main objectives of the PTC are advisory and educational. The PTC has an advisory role on all matters relating to safe and effective use of drugs in the hospital. It recommends policies for the evaluation, selection, and therapeutic use of drugs in the hospital. All actions and decisions of the PTC are subject to review by the Executive Committee of medical staff. PTC also assists in the development of programmes to cater to the needs of the professionals involved in patient care.

Functions of the PTC :

(i) PTC has an advisory role in all matters relating to rational and safe use of drug in a hospital.

(ii) It develops a formulary of drugs for use in the hospital. The drugs included in the formulary are, of course, a subject to constant revision. Drugs for the inclusion in the formulary are selected on the basis of their proven therapeutic value, safety and the cost. The PTC evaluates, approves or rejects drugs proposed for inclusion in the hospital formulary. Many authorities consider that developing and operating the hospital formulary constitutes the sole purpose of the PTC. This is not so as there are many hospitals with a PTC but without a formulary system and vice versa.

(iii) PTC participates in quality assurance activities related related to distribution, administration and use of medications.

(iv) PTC reviews and monitors adverse drug reactions and medication errors. 3

(v) It reviews the safety/efficacy profile of drugs.

(vi) Prepares a list of drugs required to be available in the wards and emergency as also a list of charge and non-charge drugs.

(vii) Advises the pharmacy on cost effective drug distribution and control procedures. (viii) Establishes procedures for cost effective drug therapy.

(ix) Develops training programmes for the staff on drug use.

(x) Participate in the developing of Standard Treatment Guidelines.

3. What is bioavailability ? Write the factors affecting bio availability.

Ans.

Bioavailability is defined as rate at which and the extent to which the active concentration of the drug is available at the desired site of action.

Bioavailability= Rate & Extent of absorption = Area under the plasma conc Vs. time curve. (AUC)

Factors Affecting Bioavailability: Factors affecting bioavailability can broadly be classified as:

1. Pharmaceutical factors

2. Pharmacological factors

1. Pharmaceutical factors: When a drug is administered by a route other than iv, the drug must dissolve before it becomes available for absorption. An important influence on bioavailability is, therefore, the formulation of the drug in the form of tablet, capsule, suspension, solution etc.Generally, bioavailability would be expected to decrease in the following order solution > suspension> capsule > tablet> coated tablet. Various pharmaceutical of formulation factors affect disintegration and dissolution. Some of these are :

(a) particle size: The smaller the particle size the greater would be the surface area which would result in greater rate of dissolution.

(b) Salt form: The dissolution rate of a particular salt is usually different from that of the parent compound. Salts of weakly acidic drugs, as a rule, are water soluble. Free acidic drug is precipotated from these salts in a micro crystalline form which has dissolution rate and hence enhanced bioavailability e.g. sodium tolbutamide and sodium secobarbital have better bioavailability than tolbutamide and secobarbital.

(c) Crystal form: The absorption rate and bioavailability of a drug depends upon its crystalline form also e.g. amoprphous chloramphenicol palmitate and amorphous novobiocin have faster dissolution rate and better bioavailability as compared to their crystalline forms.

(d) Water of hydration : Many drugs can associate with water to produce crystalline forms called the hydrates. The anhydrous forms of caffeine. theophylline and ampicillin have faster dissolution rate and better bioavailability than the hydrous forms of these drugs.

(e) nature of excipients and adjuvants : These are the pharmacologically inert substances (e.g. starch, lactose, calcium sulphate, gums, polysorbate-80) which are added to the formulation as a filling material (when drug contents are too small) or as binding agents or to obtain a proper granular size. These too, have tremendous effect on the bioavailability of drugs like phenytoin, digoxin, levodopa, and warfarin etc.

(f) Degree of ionization: Nonionized lipid soluble drugs are better absorbed while strongly acidic or basic drugs or highly ionised drugs show reduced bioavailability e.g. streptomycin, sulphaguanidin, neostigmine, and d-tubocurarine.

2. Pharmacological factors: In addition to the pharmaceutical factors other pharmacological and physiological factors also affect the absorption and bioavailability. These are

(a) Gastric emptying and gastrointestinal motility: Gastric emptying is promoted by fasting, anxiety, lying on right side, hyperthyroidism and with drugs like metoclopramide. Gastric emptying is retarded by fatty diet, endogenous depression, lying on left side, pyloric stenosis, hypothyroidism and with drugs like atropine, propantheline, imipramine and chlorpromazine.

The extent of absorption of drugs that are incompletely absorbed (e.g. digoxin), may be dependent on intestinal motility. For example, propantheline increases while metoclopramide decreases the bioavailability of digoxin by increasing or reducing the transit time of the unabsorbed drug respectively, through the small intestine.

(b) Gastrointestinal disease: There are several pathophysiological factors that affect drug absorption. For example in achlorhydria, gastric acid secretion is decreased with a concomitant increase in gastric pH. This increases the absorption of weakly acidic drugs like aspirin because at higher pH its dissolution is faster.

(e) Food and other substances : In general, gastrointestinal absorption is favoured by an empty stomach while the absorption rate (not the extent) is reduced after the ingestion of food. However, both the rate and extent of absorption of certain antibiotics (e.g. rifampicin) is reduced after meals. Absorption of tetracyclines is also markedly reduced if taken with milk or milk products (forms poorly absorbed complex with calcium ions). Absorption of certain antifungal drugs (e.g. griseofulvin) is enhanced by administering the drug with a fatty diet.

(d) First pass effect: First pass effect meansbthe drug degradation occurring before the drug reaches the systemic circulation. The net result is the decreased bioavailability and diminished therapeutic response.

(e) Drug-drug interactions : Differences in bioavailability can also be observed due to drug-drug interactions. For example, liquid paraffin decreases the bioavailability of vitamin A as it emulsifies fats and, therefore, causes deficiency of fat soluble vitamins like A, D and E. Antacid containing aluminium, calcium and magnesium and hematinics containing iron cause reduced bioavailability of tetracyclines.

(f) Pharmacogenetic factors : Large differences in bioavailability often exist among humans due to pharmacogenetic reasons. Obviously, slow acetylators of isoniazid and PAS show increased bioavailability and, therefore, are more subject to isoniazid and PAS toxicity (e.g. Eskimos, japanese and Chinese). Contrarily, fast acetylators, like Egyptians, Israelis and Scandinavians show reduced bioavailability.

(g) Miscellaneous factors: Besides these factors, multiple other factors like (i) route of administration (ii) area of absorbing surface and (iii) state of circulation at the site of absorption also affect the bioavailability.

4. What are the pathophysiology and manifestations of 

(i) Jaundice 

(ii) Epilepsy

(iii) Rheumatoid Arthritis.

Ans. 

(i) Jaundice :

 Signs and symptoms: Yellowish pigmentation of the skin, conjuctival membranes and other mucous membrane.

Hypebilirubinemia: It is often seen in liver disease such as hepatitis or liver cancer. It may also indicate obstruction of the biliary tract for example by gallstones or pancreatic cancer or less commonly be congenital in origin.

Category:

(i) Pre-hepatic/hemolytic - Pathology is occuring prior to the liver.

(ii) Hepatic/ Hepatocellular - The pathology is located within the liver.

(iii) Post hepatic / cholestatic- The pathology is located after the conjugation of bilirubin in the liver. 

Pathophysiology: Jaundice itself is not a disease but rather a sign of one of many possible underlying pathological processes that occur at some point along the normal physiological pathway of the metabolism of bilirubin in blood. When the RBCs have completed their life span of approximately 120 days, cellular contents including hemoglobin are subsequently released released into the blood. The hemoglobin is phagocytosed by macrophages & split into heme and globin. The name is first oxidised to biliverdin & then reduced to bilirubin. Approximately 4 mg of bilirubin per kg of blood is produced each day.

(ii) Epilepsy:

Ans. 

Epilepsy are a group of disorders characterized by chronic, recurrent, paroxysmal changes in neurologic function caused by abnormalities in the electrical function of the brain. Seizures are referred to as a transient alteration of behaviour due to an abnormal, synchronized and repetitive burst of firing of neuronal population in the central nervous system. The term ictal refers to the seizure itself and interictal means between seizures. Convulsions imply ictal behaviour associated with aggressive motor activities. Status epilepticus refers to a prolonged seizures occuring so frequently that full recovery of brain function does not occur interictally. Seizures may also be manifested by other changes in neurologic function such as sensory, cognitive or emotional.

Partial seizure begins in a local area whereas generalized seizure shows widespread involvements of both hemispheres from the outset. Complex partial are usually associated with impairment of the level of consciousness. Most of the complex partial seizures originate in the temporal lobe and are, therefore, also called temporal lobe seizures. When a simple partial seizure precedes a complex partial seizure it is called 'aura".

Pathophysiology: The altered, physiological state of epilepsy is a rhythmic repetitive firing of many neurons localized to a particular area of the brain as reflected in the electroencephalogram (EEG). In the epileptic focus, neurons in a small area of the cortex are activated in an unusually synchronized manner. This produces a larger, sharper wave form in the EEG which is called spike discharge. If the neuronal hypersynchrony is large a simple focal seizure results. If it spreads through the brain and lasts for a few seconds a complex partial seizure or generalized seizure results. The EEG in generalized seizure will have a variety of appearances depending upon the area of discharge and the spread of the seizure, Metabolic events in the brain may contribute to the development of an epileptic focus, the transition of seizures and the postictal dysfunction. For example, there is an observed increase in extracellular K and decrease in extracellular Ca concentration. These ionic changes mainly affect neuronal excitability. neurotransmitter release and the neurotransmitter metabolism. Certain neurotransmitters and neuropeptides are released in large quantities during epilepsy and some of these can prolong the actions of certain neurons and postictal phenomenon. Furthermore, there is an increased blood flow to the primary area involved, increased utilization of glucose, an alteration in oxidative metabolism and a change in the local pH. All these factors may be contributory to the development of seizures.

Drugs which facilitate the actions of the inhibitory neurotransmitter gamma amino butyric acid (GABA) are potential anticonvulsants. Thus, a decrease in the level of inhibition of GABA may be involved in some forms of epilepsy. Some forms of generalized epilepsy could also be due to an abnormality in the GABA inhibitory system. Electrical stimulation can also result in the development of seizures. Epilepsy may also be a result of neurologic injury or a structural brain lesion or may occur as a manifestation of other systemic diseases. 

(iii) Rheumatoid Arthritis:

Rheumatoid Arthritis (RA) is s chronic diseases manifested primarily by inflammatory arthritis of the peripheral joints.

Actiology: Susceptibility of an individual for developing RA is influenced by the nature of the immune response, which is genetically determined. The factors which initiate or precipitate RA are unknown. The serum and joint fluid of majority of patients with RA contains antibodies specific to Fe fragment of IgG (rheumatoid factors). These are a heterogeneous set of antobodies of IgM, IgA, and IgG called IgM rheumatoid factor, IgA rheumatoid factor and IgG rheumatoid factor respectively. How the rheumatoid factors lead to the initiation and development of RA is unknown. However, there is generation of chemotactic factors and other vasoactive factors in the joint. Phagocytosis of immune complexes by polymorphonuclear cells result in liberation of lysosomal enzymes.

Manifestation: The onset of RA may be insidious. A feeling of fatigue, weakness, arthralgia, myalgia may appear several weeks before joint swelling. Joints are affected in a symmetrical fashion. Initially those. of hand, wrist or feet are affected and subsequently the other joints. Some individuals may have an acute onset with fever, with multiple swollen and painful joints.

Pathology: There is inflammation of the synovium. Infiltration by mono-nuclear leucocytes occurs together with oedema, vascular congestion and fibrin deposit. As a result, there is thickening of the synovium which forms large villi which is referred to as a pannus. The pannus erodes the underlying cartilage and bone leading to weakness of the tendons, ligaments and supporting structures.

Pathophysiology: Rheumatoid factors. (antibodies of the IgM, IgG, IgA classes) are found in the serum and the synovial fluid of most patients. The role of rheumatoid factors in the development of rheumatoid arthritis is not known. However, the immunogenic mechanism do appear to have a role. Complexes of immunoglobulins, rheumatoid factor and complement generate vasoactive and chemotactic substances. There is also a release of lysosomal substances from phagocytic cells which cause injury to the tissues.

5. Write brief notes on the following.

(i) Drug induced disease.

Ans.

 Drug-induced diseases are also called iatrogenic (physician-induced) diseases. Many of these persist even after the drug has been withdrawn and mostly eliminated. The most common are:

i. Parkinsonism by phenothiazines and butyrophenones.

ii. Peptic ulcer by salicylates and corticoids. 

iii. Hepatitis by isoniazid.

iv. Lupus syndrome by hydralazine.

(ii) Computer application in hospital pharmacy. 

Ans. 

Computer Applications in Pharmacy :

(i) Drug information service: Computers have become an important tool for pharmacists involved in drug information service. It provides for storage and retrieval of bibliographic and other specialised databases, CD-ROM technology has helped in the evolution of compact electronic libraries. Micromedex, a pioneer in this effort, provides for a large number of information on drugs, their identification, poisons, emergency medicine etc, on a single compact disk.

(ii) Drug use review: Drug use review is a necessary activity to meet the goal of optimum drug therapy besides controlling instances of fraud and patient information misuse. Prescriptions of a particular patient received over a period of time are stored which serves as a chronological patient drug profile.

(iii) In the pharmaceutical industry: The pharmaceutical industry has to rely heavily on the market evaluation and reports in order to decide upon the thrust areas in drug research and production. For this reason the available data on the disease state, current medications and population demographics is processed to yield information on desirable new products. A computer is of immense help in the collection, storage and evaluation of the required information.

(iv) Drug development: Computer aided drug design helps the medicinal chemist to design a drug molecule that is likely to possess the desired pharmacological properties. Molecular models can be generated through graphics and precise study of molecular configuration, chemical bond angles and energies deduced. The interaction of the proposed drug molecule with the active site on an enzyme or receptor can also be evaluated.

(v) Drug evaluation: Computers are also useful for storage of relevant results of the pharmacological, toxicological and other studies for reporting to the Drug Authorities for the approval of a new product.

(vi) Project management: Computers a for project management wherein, information on analysis, scheduling of resources, product formation and are used planning. design are screened and adopted by the pharmaceutical industry.

(vii) Instrumentation : Most of the sophisticated instruments are connected to computers. This helps in sampling, adjustment and calibration of the instruments.

(viii)Drug manufacture and quality control: Software covering the entire process beginning from the procurement and approval of the raw product with complete information on every step till the finished product is obtained are now available. Computer programmes are also available on quality control and quality assurance, The software generates worksheets for the analysis of a preparation in accordance with the official requirement and in-house standards. The quality control chemist has simply to insert the observations and values of the test performed. The computer will then calculate the result and compare it with official and in-house standards. On this basis, the sample may be approved or rejected by the quality control department.

(ix) Marketing and distribution: Computers are also of immense help in marketing and distribution of pharmaceuticals. This involves processing of orders, dispatch of the material, invoicing, record keeping, billing and post market surveillance.

(x) Hospital pharmacy: Computers have greatly reduced the work load of a hospital pharmacist and have improved his efficiency in record keeping and the overall patient care. Some of the areas of application of computers in the hospital are in-patient record database management, entry of medication orders, drug labels, list of preparations manufactured in the pharmacy, drug use reviews, drug consumption, drug cost, drug information service, monitoring of problem associated with drug therapy, drug formulary preparation, update and search, purchase and inventory control, vendor list, medication billing, staff requirements with utilization and salaries. Computers in the hospital pharmacy should be linked to the accounts and purchase section, billing section, central admissions, nursing floors, dietician and the laboratory for effective sharing of data, for tracking new admissions, discharge information or transfer, for new or drug orders and other necessary information meant for streamlining of the working of the hospital.

(xi) Community pharmacy: For the community pharmacist, the computer has been of valuable assistance in the prescription processing. The prescription processing system performs a variety of functions like displaying the complete patient information with his complete drug information and patient drug profile to check for drug duplication or to gather information on adverse reactions to certain drugs for the safe and rational use of drugs. Computers are also used for printing out prescription labels with special warnings and cautions.

6. What is Drug information Bulletin ? Discuss the function of Drug Informations Services in a Hospital Pharmacy and the qualification of the Pharmacist to run DIS. 

Ans. 

Drug Information Bulletin : 

It is the responsibility of the Clinical Pharmacist to provide information about drugs relevant to patient care to all members of the patient care team. This may conveniently be done through Drug Information Service or through a bulletin which publishes the latest development in medical sciences, new drugs introduced, new indications for drugs, newer drug delivery system, update of drug interactions and adverse drug reactions etc. A regular publication of the bulletin will update the knowledge of the patient care staff on the latest development in their area of specialization.

Functions: The hospital pharmacist today faces a stupendous task of providing drug related information to medical, nursing and paramedical staff of the hospital. He is also required to respond to the queries of the patient in the out-patient pharmacy. With considerable advancements in information technology, and the growing awareness of the patient both with respect to the nature of illness and its current therapy, the pharmacist needs to keep his knowledge updated. The source of available information may be classified as primary, that is directly obtained from the author without any evaluation or comments; secondary, in which the original information has been reviewed, modified or commented upon by some other person or tertiary, where the information available from the primary or secondary source is presented in composite form. The hospital pharmacist is also responsible to provide relevant information about drugs to all members of the patient care team and respond to drug related queries. For this the pharmacist has to classify the question, obtain background information and make a systematic search of literature. The usual sequence is tertiary, secondary and primary. The pharmacist answers such queries through Drug Information Centre of Drug Information Services of the hospital. The scope of these services can be extended to answer poison related queries and making available useful information regarding the treatment and availability of antidotes and monitoring and treating adverse reactions to drugs. The Centre also publishes a Drug Information Bulletin for transmission of information to members of the health care team.

7. What are the various drug distribution systems for in-patients ? Write in detail about. unit dose dispensing.

Ans.

After obtaining the medication order for at patient, it is the responsibility of the pharmacy to make all the medicines that have been prescribed available to the patient. Various systems are available by which this is accomplished. There are four general methods by which the medicines are dispensed to the patients namely: 

(a) Individual in-patient prescription order system

(b) Complete floor system 

(c) Combination of (a) and (b); and

(d) UDDDS

Unit Dose Drug Distribution System (UDDDS) ;

Unit dose drug distribution system has been found to be the safest and the most efficient means of delivering drugs from the pharmacy to the patients. Once a prescription is written, the nurse forwards it to the pharmacy. The pharmacist enters the drug on the patient's profile card, places the drug in a ready-to-administer form in sufficient quantities so as to last until the next time the unit dose cassettes are exchanged and sends it to the nursing station. The nurse then removes the initial dose of the medication and shifts it to the patient's room. The dose is then administered to the patient and the event recorded. A physician's order notifies the pharmacy about the discharge of the patient or discontinuation of the drug. The pharmacy will then not dispense any further drug. Billing is at the time of discharge or at specific intervals.

Features:

(i) Safe and efficient.

(ii) Package mentions relevant details

(iii) Drugs dispensed in a ready to use form 

(iv) chances of medication error minimized

(v) Wastage reduced as amount dispensed at one time is less

(vi) Reduction is nursing time, no recordering of drug

(vii) Record keeping is simple unit

(viii) Dose package can be returned to the pharmacy. in case drug is discontinued

(ix) Reduction in cost of medication

The advantages of UDDDS are :

1. The package identifies the drug name, strength, expiry date and, therefore, minimizes wrong administration.

2. Accurate delivery of medication due to stringent repackaging requirements. 3. Minimum wastage of drug.

4. Reduction in nursing time.

5. Maintenance of records is simple. 

The advantages of UDDDS over the traditional method are many while in the traditional system the nurse must prepare the drug for each administration, in UDDDS, the pharmacy dispenses the drug in unit dose package which is ready for administration. The unit dose package is one which contains the particular dose of the drug ordered for the patient. The package mention the name of the drug, its strength, expiry date etc. Preparation of unit dose packages are subject to stringent repackaging controls which ensures accurate medication. UDDDS also minimizes wastage of drugs. If the drug is discontinued, unit packed drugs can be placed back in the pharmacy inventory and reused provided the package is not opened. In the traditional system, unused drug has to be discarded for safety reasons. Reduction in nursing time is also effected as the nurse has no longer to transcribe orders of the patient's treatment to medication profile and the medication record. Maintenance of record is also simplified as this can be done immediately after administration of the drug. Besides the need to reorder medication is eliminated since the pharmacy will automatically send the next dose for further administration. Therefore in the UDDDS, there is a decreased possibility of mistakes and medication errors due to crosschecks. It also saves nursing time and brings about a reduction in costs. Reduction in cost is brought about by 

(i) storage of drug gets limited to those currently in use and the emergency drugs; 

(ii) re-inventory of unused unit packed drugs not used by the patient; and 

(iii) dispensing off with medication cups, prescription labels, vial forms etc. which were necessary under the traditional drug distribution system.