ODISHA STATE BOARD OF PHARMACY
D. Pharm - II Examination - 2009 (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:
[1x8
(i) B.P.
(ii) ECG
(iii) EDTA
(iv) DLC
(V) DDT
(vi) PH
(vii) ESR
(viii) FBS
(b) Define the following terms:
[1x6
(1) Anaphylaxis
(ii) Satellite Pharmacy
(iii) Hospital
(iv) Drug interaction
(v) Teratogenicity
(vi) Detoxification
(c) What is the range of Cholesterol in the case of a Jaundice patient and a normal person ?
[1
(d) How many pharmacists are required for a hospital of bed strength upto 50 ,100, 300 and 500.
[1
2. What do you mean by term Clinical Pharmacy? Write down the various drawbacks on to development. Enumerate in detail its scope in a hospital.
[1+3+12
3. Define Hospital and its Pharmacy. What are its objectives ? Discuss briefly about ocation and lay out of a Hospital Pharmacy Service.
[2+4+10
4. What is Bio availability ? Write the factors affecting the Bio availability.
[2+14
5. Write brief notes on any two:
[2x8
(a) Drug dependence :
ANSWER TO 2009
1. (a) Give the full forms of the following:
Ans.
(i) B.P: British Pharmacopoeia
(ii) ECG :Electrocardiogram/ Electrocardiography
(iii) E.D.T.A: Ethylene Diamine Tetraacetic Acid
(iv) D.L.C.: Differential Leukocyte Count
(v) D.D.T: Dichloro Diphenyl Trichloroethane
(vi) PH: Primary Hospital
(vii) E.S.R.: Erythrocyte Sedimentation Rate
(viii) F.B.S.: Fasting Blood Sugar
(b) Define the following terms:
Ans.
(i) Anaphylaxis: It is the immediate hypersensitivity reaction. It is a serious allergic reaction that is rapid in onset and may cause death.
(ii) Satellite pharmacy : It is a smaller pharmacy that is located elsewhere from the main pharmacy in a hospital.
(iii) Hospital: It is an integral part of the social organisation meant to take care of the acutely ill and to promote health of the community. It also imparts training and education to its medical and pharmaceutical staff with a view to update their knowledge for better patient care.
(iv) Drug Interaction: When a drug is simultaneously used with another drug or food or drink or disease condition and there is change in duration or the magnitude of the pharmacological response of one or both the drugs then there occurs drug-drug interaction or drug-food interaction or drug-drinks interaction or drug-disease interactions.
(v) Teratogenicity: This is the process by which a drug taken by the pregnant mother can interfere with normal embryonic development of her fetus and prevent organogenesis.
(vi) Detoxification: Biotransformation is also known as detoxification as it helps in elimination of the drug from the body and reduces toxicity of a drug.
(c) What is the range of Cholesterol in the case of a Jaundice patient and a normal person?
Ans.
<200 mg/dl - Normal
> 200 mg/dl - Jaundice
(d) How many pharmacists are required for a hospital of bed strength upto 50 100 300 and 500.
Ans.
50 bed - 3 Pharmacists
100 bed - 5 Pharmacists
200 bed - 8 Pharmacists
300 bed - 10 Pharmacists
500 bed - 15 Pharmacists
2. What do you mean by term Clinical Pharmacy? Write down the various drawbacks on to development. Enumerate in detail its scope in a hospital.
Ans.
Clinical Pharmacy:
Clinical pharmacy is that branch of pharmacy which is concerned with various aspects of patient care and deals not only with dispensing of drugs but also on advising the patient on the safe and rational use of drugs. The clinical pharmacist serves as a source of information on drugs and dosage forms to the members of the medical faculty, the nursing staff and other health care professionals.
The emergence of clinical pharmacy as a branch has been largelybecause of an explosive increase in the availability of a large number of drugs and the excessive patient load on the physician. The physician has to depend upon the pharmacist for imparting drug related information to the patient especially in a hospital setting. The clinical pharmacist has, therefore, partially taken over the duties of the physician for providing information on drugs and their administration to the patient. The clinical pharmacist thus, bridges the gap between the professional and lay understanding of drug action.
Scope of Clinical Pharmacy:
A clinical pharmacist has a role from the time the patient reports to a hospital for treatment of an ailment till the time he recovers, which includes follow up period after hist discharge. The scope of the services of a clinical pharmacist is so wide that he helps not only the physician and the patient but also the nurse and other members of the health care team. He records the medication history of the patient upon his entry to the hospital which includes drug exposures in the past, known adverse or hypersensitivity reactions, use of OTC drugs, herbal drugs, drugs of alternate systems of medicine and habits for example smoking, drinking etc. because all the above have been known, in many cases, to affect the outcome of therapy. The check up of the patient, diagnosis and treatment are the prerogative of the physician but a clinical pharmacist by virtue of this training and handling of drug information may serve as a helpful guide. The scope of clinical pharmacy may also be involved in suggesting or recommending certain clinical laboratoty testing or special diagnostic procedures for monitoring succes of therapy. Clinical pharmacy is also involved with patient education with regards to safe and proper use of drugs, knowledge of side effects and the steps that need to be taken if an adverse reaction does occur. Patient education will also improve patient compliance. In chronically ill patient, once therapy has been initiated by the physician, the clinical pharmacist may be involved in the long term management of the patient. In emergency situations, the scope of clinical pharmacy services include providing consultation on drug selection, making available pharmacokinetic data on the basis of which therapy can be monitored, parenteral nutrition and intravenous therapy. Clinical pharmacist is also involved in clinical trials, drug utilization studies, participation and organizing training programmes with the view to update knowledge and introduce newer concepts about drug therapy, instruments, methodology and other aspects of patient care.
Scope of clinical pharmacy
1. Medication history
2. Monitoring of drug therapy
3. Patient education and counselling
4. Clinical trials
5. Educational programmes for members of health care team
Clinical pharmacy is still in its infancy in India and it may take many more years for it to attain a status of importance in the hospital setting or as a private consultancy on various aspects of drug use. How ever, the scope of this discipline is immense. With the development of clinical pharmacology, limited instructions in pharmacology to medical students, innovative teaching methods, increasing patient load in hospitals and an explosion of drugs, there can be no doubt that the clinical pharmacy as a discipline will assume considerable importance in the near future.
Drawbacks on its development :
(i) Clinical pharmacy set up is not developed in the country.
(ii) Current education system does not provide enough scope for the to be pharmacists.
(iii) There is no policy by the Govt.
(iv) Noncoaperation of physicians.
3. Define Hospital and its Pharmacy. What are its objectives? Discuss briefly about ocation and lay out of a Hospital Pharmacy Service.
Ans.
Objectives of a Hospital Pharmacy :
The objectives of hospital pharmacy are:
1. To professionalize the working of the hospital pharmacy so as to effectively meet the objectives of the hospital.
2. To ensure availability of the required medication at an affordable cost at the time it is required and without compromising with the quality and/or the efficacy of the medicament.
3. To plan, organize and implement the policies of the pharmacy which are in accordance with those of the hospital.
4. To perform functions of management of material purchase, storage of essential items and medicaments and to maintain a strict inventory of all items received and issued.
5. To counsel the patient, medical staff, nurses and others involved in patient care on the use of drugs, possible side effects, toxicity, adverse effects, drug interactions etc.
6. To serve as a source of information on drug utilization.
7. To manufacture drugs, large/small volume parenterals which are critical for use in patients and especially those which are not readily available from the drug manufacturing companies. 8. To participate in and implement the decisions of the Pharmacy and Therapeutics Committee.
9. To organize and participate in research programmes, educational programmes and to provide training to various members of the patient care team on various aspects of drug action, administration and usage.
10. To engage in public health activities to improve the well-being of the population.
11. To interact, cooperate and coordinate with various other departments of the hospital.
Location and Layout :
The Pharmacy should be located, if possible on the ground floor or the first floor for easy accessibility and to ensure sufficient and effective service to the various departments and nursing stations. However, if there be an out-patient department in the hospital, the pharmacy or a branch thereofmay be located near it. In a multistorey hospital, pharmacies may be provided on each floor for convenience. The floor pharmacies are laid out in a manner that there is s continuous flow of men and materials.
A complete unit of the hospital pharmacy usually comprises of the following areas:
(i) office of the Chief,
(ii) dispensing unit,
(iii) bulk compounding area,
(iv) manufacturing unit for
(a) sterile preparations and
(b) non-sterile preparations,
(v) packaging and labelling area,
(vi) alcohol and volatile liquid area,
(vii) narcotic vaults,
(viii) radio isotope storage and dispensing area,
(ix) central sterile supply area,
(x) cold storage area,
(xi) research wing,
(xii) pharmacy store room,
(xiii) library and
(xiv) waiting room.
The out patient pharmacy, which ought to have a pleasant look, should provide sufficient space for seating of patients who are waiting for the medicine so that there is no congestion of the interior. The waiting room of the out-patient pharmacy should not only bear a professional look but should display educative posters on health and hygiene and offer light literature for reading to keep the visitors engaged. This leaves a positive image of the pharmacy on the patients.
For the routine manufacturing of bulk preparations such as stock solutions, bulk powders and ointments etc., suitable space may be provided adjacent to the pharmacy or in the basement directly below the pharmacy. The medical stores of a pharmacy should be adjacent to the pharmacy itself or should be directly beneath the pharmacy with a stairway connection.
4. What is Bio availability ? Write the factors affecting the 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, ble 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 faster 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.
(1) 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.
(c) 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 means the 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.
(g) 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.
5. Write brief notes on any two:
(a) Drug dependence: Drug dependence can be defined as a state of an individual whereby he takes a drug repeatedly, periodically or continuously so must so that its use results in harm to the individual and sometimes to the society at large. There is a desire, need or compulsion to use the drug and if he is not allowed the drug he feels ill.
Drug dependence is not always a problem in itself, for example, use of caffeine or nicotine. Drug dependence is frequently, but not always, associated with the development of tolerance.
Drug dependence is a biological phenomenon. Psychic dependence is signified as a compulsive drug seeking behaviour for personal satisfactionbeing fully aware of the harmful effects of the drug e.g. cigarette smoking. Physical dependence refers to an altered physiological state produced by repetitively taking a drug so much so that continued intake of the drug becomes necessary to avoid development of withdrawal or abstinence syndrome thatis characteristic of the drug. The use of terms like drug dependence and physical dependence to denote behavioural patterns and biological alterations that underlie withdrawal syndromes causes much confusion. The term 'neuro adaption', has, therefore, been proposed as a substitute for physical dependence.
Cross Dependence :
Cross dependence refers to the ability of one drug to supress the manifestations of physical dependence and to maintain the physically dependent state produced by another drug.
Most sedative-hypnotics exhibit cross dependence amongst each other and with other CNS depressants like alcohol, barbiturates, anaesthetics, benzodiazepines etc. Amongst the opioids, cross dependence or cross tolerance develops only between those agents that act on the same receptor type. There are four major categories of opioid receptors in the CNS i.e. u (mu), k (kappa), o (sigma) and 8 (delta). Physical dependence induced by a pure u agonist will be adequately suppressed by a less specific agonist (e.g. morphine) but that induced by morphine will only be partially supressed by the pure μ, k, o or 8 agonist. The above represents an example of asymmetrical cross-dependence.
Abrupt withdrawal of drugs which have longer half-lives (methadone, phenobarbitone, diazepam) generally produced withdrawal symptoms that are less severe but more protracted. This is the basis of substitutiontherapy for physical dependence with both opioids and CNS depressants. Thus, if methadone is substituted for morphine over several days abrupt discontinuation will produce withdrawal symptoms characteristic of methadone rather than of morphine.
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