A study on adverse drug reactions in a tertiary care hospital of Northeast India

Peer review under responsibility of Alexandria University Faculty of Medicine.

Available online 27 June 2016

Figures & data

Table

		Yes	No	Do not know
1	Are there previous conclusive reports on this reaction?	+1	0	0
2	Did adverse event appear after the suspected drug was administered?	+2	−1	0
3	Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered?	+1	0	0
4	Did the adverse reaction appear when the drug was readministered?	+2	−1	0
5	Are there any alternative causes (other than the drug) that could on their own have caused the reaction?	−1	+2	0
6	Did the reaction reappear when placebo was given?	−1	+1	0
7	Was the drug detected in the blood (or other fluids) in concentration known to be toxic?	+1	0	0
8	Was the reaction more severe when the dose was increased or less severe when the dose is decreased?	+1	0	0
9	Did the patient have a similar reaction to the same drug or similar drugs in any previous exposure?	+1	0	0
10	Was the adverse event confirmed by any objective evidence?	+1	0	0

Table

ADR probability classification	Score
Causality assessment score
Definite	9
Probable	5–8
Possible	1–4
Doubtful	0

Table

As per this scale ADRs were classified as follows:
1	Mild reactions which were self limiting and able to resolve over time without treatment and did not contribute to prolongation of length of stay.
2	Moderate ADRs were defined as those that required therapeutic intervention and hospitalization prolonged by 1 day but resolved in <24 h or change in drug therapy or specific treatment to prevent a further outcome.
3	Severe ADRs were those that were life threatening, producing disability and those that prolonged hospital stay or led to hospitalization, required intensive medical care, or led to the death of the patient.

Table 1 Age and gender wise distribution of patients with ADRs.

Age range	Male	Female	Total patients (%)
⩽1–10	7	4	11(5.0)
11–20	19	15	34(15.5)
21–30	31	51	82(37.4)
31–40	18	27	45(20.5)
41–50	13	17	30(13.6)
51–60	9	3	12(5.4)
⩾61	4	1	5(2.2)
Total patients	101	118	219

Table 2 Department wise distribution of patients with ADRs.

SI. no.	Departments	Number of patients with ADR (%), N = 219
1	Dermatology	138(63.01)
2	Haematology	40(18.26)
3	Psychiatry	26(11.87)
4	Medicine	3(1.36)
5	TB & Chest	3(1.36)
6	Cardiology	2(0.91)
7	Gynaecology	2(0.91)
8	Paediatric	2(0.91)
9	Neurology	2(0.91)
10	Ophthalmology	1(0.45)

Table 3 Suspected drugs and their reported ADRs.

Sl. no.	Suspected drugs	Number of ADRs, N = 255	ADRs (frequency of occurrence)
1	Betamethasone sodium phosphate (topical)	58	Acne(23), Itching(3), Erythematous Skin rash(2), Aggravated tinea, Melasma(10), Hypertrichosis(3), Telangiectasis(4), Freckles, Rosacea, Skin Atrophy(2), Hyperpigmentation, Acneiform lesions, Skin erosion, Skin Striae(2), Dandruff, Truncal Acne, Acneform eruption
2	Clobetasol propionate (topical)	24	Acne(11), Eczema over hand, Erythema, Dry skin (2), Skin rash (purpurea), Skin fissures with erythema, Rosacea, Allergic reaction, Melasma, Aggravated Acne (4)
3	Imatinib	15	Skin discolouration, Blackness of skin (4), Scrotal edema, Abdominal swelling, Erythematous skin rash (2), Diarrhoea, Pain in leg, Bone marrow suppression, Itching over head, Mucositis, Headache
4	Derobin ointment (Salicylic acid-1.15%, Dithranol-1.15%, Coal tar-5.3%)	10	Dermatitis, Itching, Irritant Contact dermatitis (7), Tinea Incognito
5	Paracetamol	8	Fixed drug eruption(5), Erythema, Itching over hands & palms, Skin rashes
6	Bortezomib	7	Pneumonia with respiratory distress, Vision problem, Knee pain, Burning sensation in chest, Constipation, Tastelessness, Oral ulcers
7	Cytarabine	6	Pancytopenia, Hypersensitivity, Mucositis, Neutropenia, Knee pain, Reddening of legs
8	Mometasone furoate	6	Dermatitis, Itching(2), Erythema, Papular eruption, Photosensitivity
9	Cefixime trihydrate	6	Toxic Epidermal Necrolysis (TEN), Burning sensation, Hyperpigmentation, Skin rash, Urticaria, Fever
10	Phenytoin sodium	6	Lichenoid Drug Eruption, Erythema, Papular lesions, Maculopapular Skin rash, Exfoliative dermatitis, Gum hypertrophy
11	Clobetasol butyrate (topical)	6	Acne (5), Facial dermatitis
12	Methotrexate	5	Diarrhoea, Hair loss, Weight loss, Bullous Skin rashes, Mucositis
13	Prednisolone acetate	5	Acne (3), Comedones, Rosacea
14	Ketoconazole	4	Erythema, Papular lesions, Itching, Burning sensation
15	Triderm ointment (Gentamycin sulphate-0.5 mg, Betamethasone dipropionate-0.64 mg, Clotrimazole-10 mg) (topical)	4	Atrophy, Erythematous skin rashes(2), Hyperpigmentation
16	Fluconazole	4	Erythematous skin rashes (2), swelling on scrotal skin, Skin rash
17	Diprovate-N ointment (Betamethasone 0.05% + Neomycin sul. 0.5%)	4	Erythematous maculopapular lesions(2), Itching(2)
18	Olanzapine	4	Extrapyramidal Symptoms (2), excessive sedation, Urinary retention
19	Clonazepam	3	Palpitation, Decreased sleep, Dryness of mouth
20	Diclofenac gel	3	Irritant Contact dermatitis (2), herpes zoster
21	Betamethasone dipropionate (topical)	3	Acne (2), Freckles
22	Risperidone	3	Extrapyramidal symptoms (2), Vomiting
23	6 Mercaptopurine	3	Diarrhoea, Erythrocytopenia, Jaundice
24	Iron-Sucrose Inj. (Saccharated iron oxide)	3	Rigor, Vomiting, Pain at infusion site
25	Cycloserine	3	Restlessness, Suicidal tendency, Vomiting
26	Haloperidol	3	Akathisia, Extrapyramidal Symptoms (2)
27	Naltrexone	2	Decreased appetite, Episodic Irritability
28	Dexamethasone	2	Abnormal hair growth on face, Adrenal suppression
29	Herbal Medication (topical)	2	Skin Rash, Aggravated Plaque over scalp
30	Hydrocortisone	2	Melasma, Acne
31	Clobetamil-G ointment (Clobetasol propionate-0.05%, Gentamycin sulphate-0.1%)	2	Melasma, Hyperpigmentation
32	Aculip-H	2	Disturbed sleep, Crawling sensation
33	Temovate ointment (Clobetasol Propionate)	2	Papular Rash, Erythema
34	Homeopathic & Ayurvedic Medicine (topical)	2	Skin Rash, Itching
35	Valproin Syrup (Valproate sodium)	2	Steven Johnson’s Syndrome, Skin rash
36	Doxycycline	2	Itching, Photosensitive allergic reaction
37	Vaccine DPT (Tetanus/Diphtheria/Pertussis)	2	Fever, Seizures
38	Diclofenac Sodium	2	Fixed Drug eruption, Urticaria
39	Zincofer (Ascorbic acid/Pyridoxin HCl/Folic Acid/Ferrous fumarate, etc.)	2	Giddiness, Headache
40	Triglow Cream (hydroquinol with tretinoin fluocinolone acetonide)	2	Telangiectasis, Acneform rash
41	Blood transfusion	2	Fever, Rigor
42	Mustard Oil (Brassica Nigra seed oil)	2	Oedema, Exfoliative dermatitis
43	Rituximab	1	Respiratory paralysis
44	Lenalidomide	1	Diarrhoea
45	Cyclosporine	1	Kidney dysfunction
46	Candid B ointment (Beclomethasone dipropionate 0.025% + Clotrimazole 1%)	1	Irritant contact dermatitis
47	Ayurvedic Medication (topical)	1	Itching
48	Olay Complete defence moisturizing lotion (Zinc oxide/Octinoxate)	1	Itching
49	Cortisone acetate	1	Acneform eruption
50	Karpin lotion (Tartaric acid-2%, Phenol-0.2% in aq.soln.)	1	Contact dermatitis
51	Betamil-GM ointment (Betamethasone dipro.-0.05%, Gentamycin sulph. 0.1%, Miconazole nitra.2%)	1	Eczematoid dermatitis
52	l-asparaginase	1	Abdominal pain
53	Minoxidil lotion	1	Dizziness
54	Sodium valproate	1	Mucositis
55	Methyl prednisolone	1	Hyperglycaemia
56	B-tex lotion(salicylic acid-10%, camphor, boric acid)	1	Contact dermatitis
57	Gatifloxacin eye drops	1	Allergic contact dermatitis
58	Clobetasol propionate (topical)	1	Acne
59	Targocid	1	Anaphylactic reaction

Table 4 Organ system affected by ADRs.

Organ system	Number of ADRs (%), N = 255
Skin	162(63.52)
Nervous	39(15.29)
Digestive	22(8.62)
Cardiovascular	6(2.35)
Genitourinary	2(0.78)
Respiratory	2(0.78)
Endocrine	1(0.39)
Musculoskeletal	1(0.39)
Other	20(7.84)

Table 5 Causality and severity assessment of ADRs and their outcomes.

Parameters	Number of ADRs (%), N = 255
Causality
Doubtful; ⩽0	3(1.1)
Possible; 1–4	240(94.1)
Probable; 5–8	10(3.9)
Definite; ⩾9	2(0.7)
Severity
Mild	222(87.0)
Moderate	32(12.5)
Severe	1(0.3)
Outcomes
Recovered	239(93.7)
Continuing	5(1.9)
Recovering	0(0)
Unknown	10(3.9)
Fatal	1(0.3)