Pharmacovigilance Studies of Breast Cancer Chemotherapy in BINO Hospital, Bahawalpur- Pakistan Essay

Pharmacovigilance Studies of Breast Cancer Chemotherapy in BINO Hospital, Bahawalpur- Pakistan



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The intent of the survey was to mensurate the figure of ADRs and their direction by the rating and monitoring of the therapy


It was the randomized, coincident drug use rating and pharmacovigilence survey of chest malignant neoplastic disease chemotherapy. The sample includes 130 prescriptions taken from twenty-four hours attention Centre and wards of Bahawalpur Institute of Nuclear Medicines and Oncology ( BINO ) infirmary. All the facets of upcoming ADRs of chemotherapy were considered and their direction were compared with the standard direction harmonizing to the American malignant neoplastic disease society. ( ACS ) .


All the 130 prescriptions were harmonizing to the criterion regimens. FAC regimen was largely prescribed.76 % instances were of carcinoma of right chest and 24 % instances were of carcinoma of left chest. Merely 2 % of the patients had differentiated symptoms among all the chest malignant neoplastic disease instances. Most normally occurred ADRs included alopecia ( 100 % ) , failing and weariness ( 33.3 % ) , sickness, purging, organic structure hurting, febrility ( 26.67 % ) . 49.6 % of terrible ADRs and 28.36 % of moderate ADRs were produced. Most outstanding ADRs occur after the 1strhythm of chemotherapy.50 % of the instances got the direction by the doctor as the supportive therapy. As the symptoms of the chest malignant neoplastic disease were non prominent so most of the instances come at phase III or IV of the chest cancer.56.3 % of the instances of phase IV. 18.7 % of phase III, 25 % of instances of phase II.


The given direction of the ADRs of chest malignant neoplastic disease chemotherapy was harmonizing to the standard guidelines as the full obliteration of the side effects was non possible they can be minimized by interacting with the wellness attention squad on patient unit of ammunition, questioning patients, prescription rating and monitoring ADRs.


Pharmacovigilance, Breast Cancer, Adverse Drugs Reactions, Chemotherapy


Pharmacovigilance( abbreviatedPVorPhV) is the pharmacological scientific discipline concerns with long term and short term inauspicious effects of medical specialties, besides covering with sensing, rating, bar, consideration of inauspicious effects. PhV officially described as: “ A response to a drug which is noxious and unintended, and which occurs at doses usually used for the prophylaxis, diagnosing or therapy of disease, or for the alteration of physiological function” . PhV deriving importance in both physicians and scientists, because it helpful tool to observe the inauspicious drug reactions or ADRs, during the clinical tests little population is considered for the drug trial as consequence some serious ADRs such as liver harm remain undetected. But during the station selling of the drug, PhV is use as helpful tool to keep informations excavation and probe of instance studies to place the relationships between drugs and ADRs. [ 1-3 ]

Now-a-days, Breast malignant neoplastic disease is more raising job in the medical field. For the intervention of Breast Cancer, chemotherapy agents are widely used. The basic intend of Chemotherapy uses to killing unnatural cells ( quickly spliting cells ) in the organic structure. In many instances, for the intervention of chest malignant neoplastic disease, a combination oftwo or more agents will be used. The major intents of chemotherapy agents to use against chest malignant neoplastic disease underlined in three classs ;

  1. Accessory therapy:This therapy is employ to prorogue or forestall cancerous onslaught after the initial radiation or surgery intervention. When cancerous onslaught seems in chest and lymph secretory organs under the arm, there are a opportunities the cancerous cells may metastasise [ 4 ] .
  2. Neo-adjuvant therapy:In some instances, cancerous cells in the chest are large in size that shriveling with radiation or surgery is hard. So, this therapy employ to shrivel the cell foremost so it may be easier to make surgery [ 5, 6 ] .
  3. To handle metastatic Cancer:If the cancerous cell spread to other variety meats or organic structure parts, or opportunities of metastasize is present so this therapy is used to forestall metastatic malignant neoplastic disease [ 7 ] .

Choice of Chemotherapy for Breast Cancer

Fortunately, there are many differentoptions with good response rates against for cancerous cells, may be used in individual therapy agent or in combination signifier. The ground to take one of combination is that if a patient did n’t react to one chemotherapy program, it does n’t intend, patient can non bring around, so patient can be switch to another combination options to acquire better consequences. Sometimes, Doctors suggest to take merely individual drug before seeking a combination program because individual agent has fewer ADRs while combination therapy have risk to exposed more ADRs [ 8 ] .

The ideal or standard combination therapy regimen may hold following features:

  1. It has belongings to assail all types of cancerous cells in the chest malignant neoplastic disease.
  2. It may utilize in combination without crossing benefits or side effects of other drugs.
  3. Some malignant neoplastic diseases cells has opportunities to defy against the agent. So these agents have characteristic protect themselves from developing opposition.
  4. It has minimal degree of side effects

Table no 1. Individual Drug Therapy and Combination Drug Therapy

Single-drug therapy

Combination Drug Therapy

  1. Taxane: docetaxel, paclitaxel
  2. Doxorubicin
  3. Capecitabine
  4. Vinorelbine
  5. Gemcitabine
  1. Astatine
  2. AC ± T
  3. CMF
  4. CEF
  5. FAC
  6. TAC
  7. CAF
  8. Get

A: Adriamycin ( chemical name: doxorubicin )

C: Cyclophosphamide

Tocopherol:Epirubicin ( holding similar belongingss to Adriamycin )

F: Fluorouracil ( 5-fluorouracil )



Thymine: Taxotere ( chemical name: docetaxel )

Possible Adverse Drugs Reaction of Chemotherapy

Chemotherapy agents kills cells that are quickly spliting, due to that ground they doesn’t recognize between normal cell and cancerous cells. As consequence non-recognition between normal and unnatural cells, chemotherapy agents attack on the other cells in the organic structure which are quickly spliting, like cells in the liner of the bowels and oral cavity, bone marrow cells, and the hair follicles, which can take to side effects.

The side effects of chemotherapy depend on the type of drugs, the sum taken, and the length of intervention. Some of the most common possible side effects include:

  1. Hair loss
  2. Loss of appetency
  3. Nausea and emesis
  4. Increased opportunity of infections ( due to low white blood cell counts )
  5. Easy bruising or hemorrhage ( due to low blood thrombocyte counts )
  6. Fatigue ( due to low ruddy blood cell counts and other grounds )
  7. Menstrual alterations: The chemotherapy agent’s consequence on catamenial periods, the opportunities of occur depend upon age. For younger adult females, premature climacteric and sterility may happen and may be lasting. While in older adult females at that place more opportunities to acquire sterility or menopausal as a consequence of chemotherapy. Due to these alterations, adult females lead to rapid bone loss from osteoporosis.
  8. Birth defects: During having chemotherapy acquiring pregnant can take to birth-defects and besides interfere with intervention.
  9. Neuropathy: Some agents such as taxanes, Pt agents and ixabepilone, can take to damage nervousnesss present outside the encephalon and spinal cord. As a consequence this detrimental lead to symptoms like combustion, numbness, hurting or prickling esthesiss, sensitiveness to cold or heat, or failing. These symptoms normally appear on thenars of manus and pes and called hand-foot syndrome.
  10. Heart harm: Heart harm is reported when Doxorubicin, epirubicin, and some other drugs may used for a long clip or in high doses. It is commonly permanent. When bosom damaging marks appears and its map begins to worsen, chemotherapy agents must be stopped to avoid farther diminution of bosom map.
  11. Chemo encephalon: Chemo encephalon is another possible ADR of Chemotherapy agents in which adult females having chemotherapy study slight lessening in mental map such jobs in concentration and encephalon. The chemo encephalon may be long clip job in some adult females.
  12. Increased hazard of leukaemia: Very seldom, certain chemotherapy agents for good damage the bone marrow cells due to quickly spliting nature of bone morrow cells, taking to acute another malignant neoplastic disease know as myeloid leukaemia, a dangerous malignant neoplastic disease of white blood cells. This may besides take to exposed to more infections.

Table.2: List of Primary Breast Chemotherapy agents in Pakistan

Sr #

Chemical Name

Aclarubicin ( HCl )






Doxorubicin ( HCl )










Leuprolide ( Acetate )

Medroxyprogesterone ( Acetate )

Megestrol ( Acetate )



Mitomycin C

Mitozantrone ( HCl )



Tamoxifen ( Citrate )

Testosterone ( Esters )

Vincristine ( Sulphate )

Aclarubicin ( HCl )

Table.3: List of Secondary Breast Chemotherapy agents in Pakistan

Sr. #

Chemical Name


Idarubicin ( HCl )





Idarubicin ( HCl )




Research Methodology:

Sample frame:

Breast malignant neoplastic disease samples of the patient were taken from twenty-four hours attention centre every bit good from wards of

BINO infirmary.

Study design:

Day care centre every bit good wards of the Bahawalpur Institute of Nuclear Medicines and Oncology ( BINO ) infirmary were visited. Prescriptions on chest malignant neoplastic disease were taken. This pattern was continued for 3months. Adverse drug reactions ( ADRs ) of the given protocols were monitored and evaluated by questioning the patients as good by analyzing the standard guidelines of the several drugs direction of ADRs were evaluated against standard guidelines.

Inclusion and exclusion standards:

The patients taking chemotherapy for chest malignant neoplastic disease of class II to IV are included. The patients taking their last rhythm of chemotherapy against chest malignant neoplastic disease are excluded.

Methods used to roll up selected grounds:

The Pharmacovigilance information of the chest malignant neoplastic disease chemotherapy were taken on the Data Collection Forms and given intervention regimen were taken on the Medication Form

Aspects to be included:

  1. How much per centum of differentiated symptoms of chest malignant neoplastic disease.
  2. What is the % age of moderate and terrible side efects of chest malignant neoplastic disease chemotherapy?
  3. In which rhythm of chemotherapy most outstanding side effects are produced?
  4. What is the % age of chest malignant neoplastic disease in married and single adult females?
  5. What are the most dominant phases of the chest malignant neoplastic disease?
  6. Which intervention protocols are sooner prescribed?

Consequences and Discussions:

130 prescriptions were collected from twenty-four hours attention centre and wards of BINO infirmary. These prescriptions were evaluated consequently. Following parametric quantities were considered.

  1. Evaluation of intervention protocols
  2. Adverse drug reactions ( ADRs ) observed
  3. Comparison of direction of observed ADRs by the doctor with the criterion guidelines

Evaluation of intervention protocols

It was evaluated from the prescriptions that ;

  1. 66.7 % of prescriptions contained FAC regimen.According to the doctor, in most instances of chest malignant neoplastic disease chemotherapy started with this regimen.
  2. 13.3 % of prescriptions contained AC regimen
  3. 10 % of prescriptions contained AC regimen
  4. 10 % of prescriptions contained AC ±T regimen

Harmonizing to the AMERICAN CANCER SOCIETY and WHO guidelines the Most preferable prescribed regimen were

  1. FAC: Flourouracil, Adriamicin, cyclophosphamide
  2. TAC: Taxotere, Adriamycin, and cyclophosphamide
  3. Astatine: Adriamycin and Taxotere
  4. AC ± T: Adriamycin and cyclophosphamide, with or without Taxol or Taxotere

It was evaluated that all the prescriptions were harmonizing to the standard guidelines and the largely prescribed combination was FAC.

  1. In phase II invasive ductal carcinoma the largely prescribed regimen were FAC & A ; AC±T
  2. In phase III invasive ductal carcinoma the prescribed regimen were AC & A ; FAC
  3. In phase IV invasive ductal carcinoma the prescribed regimen were TAC & A ; FAC

After completion of 1stregimen rhythms herceptin was given as targeted therapy.

Table.4: Ascertained phases of chest malignant neoplastic disease

Sr. #

Classs of malignant neoplastic disease phase

% age










Adverse drug reactions ( ADRs ) observed

It was evaluated that a big figure of ADRs occur during chest malignant neoplastic disease chemotherapy.The most common ADRs which occur in about all patients taking chemotherapy were alopecia, sickness, purging, weariness, anxiety.Mostly ADRs occurred during and after the 1strhythm of chemotherapy ( e.g. FAC regimen ) .With the transition of clip when patient’s chemotherapy proceeded to the following rhythms of the same regimen the prevalence of ADRs go less terrible.

Table.5: Ascertained Adverse Drug reactions:

Sr. #


% age of happening of ADRs

















Body hurting





















Nail alterations



Dry oral cavity






Weight loss



Weight addition



Blood force per unit area alterations








Table.6: Happening of ADRs in different rhythms of chest malignant neoplastic disease chemotherapy:


Adverse Drugs Reactions


Nausea, Vomiting, Loss of apetite, Body hurting, Fatigue, Weakness, Anxiety,


Alopecia, Nausea, Vomiting, Weight alterations, Opportunities of infection, Nail alterations


Alopecia, Nail alterations, anorexia


Pruritis, Dry oral cavity

Table.7: Percentage of ADRs in different rhythms:

Sr. #

Chemotherapy Cycle

% age of ADRs













Comparison of direction of observed ADRs by the doctor with the standard guidelines:

The direction of ADRs by the doctor to the patients were harmonizing to standard guidelines such as,

  1. Alopecia:there is no specific guidelines to forestall the falling of hairs.But safeguards were provided to the patient to avoid any scalp hurt or any environmental effects.
  2. Nausea and emesis:these were prevented by Ondansetron, Domperidone, gravinate. Ondansetron in injection signifier was already added to extract at the start of chemotherapy.
  3. Diarrhea:largely patients face the job of diarrhoea as comparison to irregularity.

And diarrhoea is treated with Flagyl, Imodium, Lomotil. But preferable pick was Flagyl.

  1. Anxiety and giddiness:these were observed at the 1sttwenty-four hours of chemotherapy. These are non so serious ADRs that should be treated at once.But if patient have this job at terrible degree so the doctor prescribed Bromazepam.
  2. Body hurting:Largely organic structure hurting occur with febrility and they are merely relieved by Piroxicam, Diclofenac Na, paracetamol.
  3. Weight loss:It was observed that largely patients face the job of weight alterations and it was evaluated that it can be minimized by toller solutions, TPNs, high protein diet, multi vitamins & A ; Fe incorporating diet
  4. Constipation: it was relieved by Lactulose
  5. Dry oral cavity:it is non so much serious job it was advised that it can be recovered by taking big volume of H2O. If this job become worse than unreal spit was recommended.
  6. Anorexia: it is prevented by ordering Trimetiron,
  7. Neutropenic febrility:it was relieved by ordering the antibiotics e.g. levofloxacin, Cephradine.


Our consequences indicate that the direction of side effects of chest malignant neoplastic disease chemotherapy, after measuring the prescriptions in twenty-four hours attention Centre & A ; wards in BINO infirmary, were following the guidelines of American malignant neoplastic disease society. Although many ADRs were present but they were managed consequently. As the side effects of chemotherapy can’t be to the full eradicated but can be minimized by proper direction of ADRs.

The results of pull offing the ADRs can be improved in a better manner by interacting with wellness attention squad on patient unit of ammunitions, questioning patients, prescription rating and by supervising ADRs.


We merrily thank toMr. Fahad Perviz,Lecture Islamia University Bahawalpur, Pakistan who encouragement and supervising made us to finish this undertaking in BINO Hospital Bahawalpur. We thanks Director of BINO Hospital, BahawalpurDr.Shabab Fatimigave us permission and facilitate to roll up informations from patients. Last we pay thanks toDr. KokabBINO Hospital, whose kindness counsel and moral and proficient support in accomplishing end consequences of undertaking.


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