PHARMACY BULLETIN - Hospital Putrajaya Farmasi... · Issue 1/2013 HPJ Pharmacy Bulletin Allergic...

HPJ Pharmacy Bulletin Issue 1/2013

Allergic

conjunctivitis

2

Osteoarthritis (OA) is a painful

condition in which joints

become swollen and stiffs. In

patient with osteoarthritis, the

tissue called cartilage start to

break down. page 2

PHARMACY BULLETIN (Issue 1/2013)

April 2013 Edition

1

Osteoarthritis

Primary open angle glaucoma

(POAG) is a progressive,

chronic optic neuropathy that

commonly involves decrease in

aqueous humor outflow from

anterior chamber of eye. page 6

3

Management

of Glaucoma

Allergic conjunctivitis is a

common ocular disorder. There

are few types of conjunctival

allergic reactions. page 5

Editorial Board:

Cik Salmi Abdul Razak

Pn Aina Yazrin Ali Nasaruddin

Pn Nadiah Mohamed Khazin

Hemananthini Suppiah

Muhammad Farid Ismail

Eddil Farhan Zawawi

Koon Ee Reen

Zahirah Zaharuddin

Yellow Fever

4

Yellow fever is a severe arthropod-borne hemorrhagic fever transmitted by infected

mosquitoes. page 9

Editorial Members:

Pn Kamarunnesa Mokhtar Ahmad

Advisor:

Look Alike Medication

page 12

High Alert Medication

page 15

Adverse Drug Reaction

Report

page 18

Other Issues

5

2

Issue 1/2013 HPJ Pharmacy Bulletin

Osteoarthritis & Buprenorphine

Osteoarthritis (OA) is a painful condition in which joints become swollen and stiffs. In patient with osteoarthritis, the tissue called cartilage starts to break down. Cartilage is a

soft tissue acts as a cushion between the bones that meet at a joint. It allows the connecting bones to move smoothly

without rubbing against each other. Diminished of this

cartilage causes pain, joint swelling and damage and may get

worse over time.6 Factors that can accelerate osteoarthritis are age, obesity, physical activity, work activity, history of injury, bone mineral density, genetic, systemic disease.6, 7

Osteoarthritis pain classified as nociceptive pain which the pain is arising from disease injury or dysfunction of muscles,

joint, skin, bone etc (somatic) or internal organ (visceral). 8

Osteoarthritis pain as well as improve function can be managed by exercise, weight control, rest, pain relief, alternative therapies and surgery. Usually people with

osteoarthritis have joint pain and stiffness. Osteoarthritis affects only joint function compared to some other forms of

arthritis, such as rheumatoid arthritis. It does not affect skin tissue, the lungs, the eyes, or the blood vessels.11,12

Parts of body usually affected in OA

Figure shows the parts of body where as osteoarthritis

most often occurs in the hands (at the ends of the

fingers and thumbs), spine (neck and lower back),

knees, and hips. 11,12

A Healthy Joint (Representation) A Joint with Severe Osteoarthritis (Representation)

Figure shows differences between a healthy joint and a joint with severe osteoarthritis. In the healthy joints of the ends of bones are encased in smooth cartilage. Together, they are protected by a joint capsule lined with a synovial membrane that produces synovial fluid. The capsule and fluid protect the cartilage, muscles, and connective tissues. With osteoarthritis, the cartilage is worn away. Bone spurs grow out from the edge of the bone, and synovial fluid increases. This contributes to joint stiffness and sore.

3


Buprenorphine is a partial mu (µ) agonist, which has a ceiling effect on its agonist activity. Buprenorphine is classified as strong opioid and can be used for managing osteoarthritis in patient

whom non-opioid analgesic is insufficient to provide analgesic effect. Buprenorphine is formulated as sublingual tablets and trandermal patch. Other opioids that can also be used to give an analgecis

effect in osteoarthritis patient are fentanyl, morphine, pethidine, methadone, tramadol, dihyrocodeine etc. However, Ministry of Health (MOH) only approved tramadol and dihydrocodeine as analgesic for non-malignant moderate to severe chronic pain.

World Health Organization (WHO) analgesic ladder for chronic nociceptive pain suggests that opioid should be used if non-opioid + adjuvant are not adequate to provide analgesic as stated beside.

Classification of opioids

4


There are clinical trials and studies that show the effectiveness of buprenorphine compared other opiods analgesic. In patients with chronic, moderate to severe OA pain of the hip and/or knee, 7-day low-dose buprenorphine patches were an effective and well-tolerated analgesic. The buprenorphine

patches were non inferior to prolonged-release tramadol tablets 13. In a randomized, double-blind, placebo controlled, maintenance-of-analgesia study which conducted in adult subjects with persistent

non cancer-related pain who required opioid therapy, 7-day buprenorphine transdermal patch system (BTDS) treatment was associated with analgesic efficacy and was generally well tolerated14.

In a study involving 315 patients with osteoarthritis of the knee or hip, buprenorphine transdermal patch is compared with placebo over a seven-day assessment phase. Significantly more

patients in the buprenorphine group achieved the primary outcome of successful pain management.

Failure is defined as early discontinuation from the study due to ineffective treatment or a final score of

poor or fair on a patient satisfaction with study medication scale (44% vs. 32%, p=0.036; adjusted odds ratio 1.66 (95% CI, 1.04 to 2.69)).

In different clinical study shows the most adverse events were mild to moderate in

intensity in patient who receiving buprenorphine. This study involves

buprenorphine patches and sublingual tablets in patients with OA. The result significantly

shows fewer patients in the buprenorphine patch group reported an adverse event during treatment compared with those using the

tablets (81% vs. 92%) 15

Buprenorphine is categorized as C for

pregnant ladies. There is limited human data to suggest the safety in pregnant women.

However, animal studies have demonstrated dose-related maternal, embryo, and fetal

toxicity and dose-related behavioral changes in offspring but no congenital malformations.16

5


Treatment for allergic

conjunctivitis

Allergic conjunctivitis is a common ocular disorder. There are few types of conjunctival allergic reactions. The

pathophysiology of allergic conjunctivitis involves primarily a type I hypersensitivity mechanism, with release of histamine and other chemical mediators from mast cells. However, a type IV

hypersensitivity with participation of secondary inflammatory cells, such as T-helper cells, eosinophils, and their chemical

mediators, also plays a role. Current therapy of allergic conjunctivitis is based on general measures that aim at

eliminating exposure to the allergen, and medical treatment. The main classes of drugs involved in medical therapy are antihistamines (used with or without vasoconstrictors), mast-cell

stabilizers, nonsteroidal antiinilammatory drugs, and corticosteroids.

The most common symptom of ocular allergy is itching. Without itching, a condition should not be considered ocular

allergy. The accompanying vasodilation appears superficial and pink rather than a deep red. Swelling of the conjunctiva, also

known as chemosis can be present, although it is usually subtle and thus only visible on slit lamp examination. More readily

observable is the glassy appearance of the eye. Swelling can also become apparent in the lids. Although lid swelling peaks within 15 to 30minutes after exposure, it tends to dissipate slowly and is

often more visible on examination. Although transient, the initial intensity of this swelling can induce structural changes in the

delicate collagen fibers of the skin surrounding the eye.

In relieving the acute symptom

of allergic conjunctivitis,

topical application of lowest

potency steroid is usually

effective. Potential adverse

effect associated with steroid

such as risk of increased

intraocular pressure and

cataract formation limits its use

in acute symptom suppression.

Ketorolac as a topical NSAIDS

is also effective in reducing

signs and symptoms of allergic

conjunctivitis. Topical anti-

histamine such as levocabastine

hydrochloride 0.05% and

azelastine hydrochloride 0.05%

is effective in relieving

symptoms of allergic

conjunctivitis. Mast cell

stabiliser such as sodium

cromoglycate is more effective

when used in combination with

steroids or anti-histamine and

also reduces the dose. Apart

from that, olopatadine may be

more effective in targeting

subtype of mast cell of

conjunctiva than other mast cell

stabilising agent like sodium

cromoglycate.

Allergic Conjunctivitis

6


Management of Glaucoma

PHARMACY BULLETIN

2012 Edition (Volume 2/2012)

Primary open angle glaucoma (POAG) is a progressive, chronic optic neuropathy that commonly involves decrease in aqueous humor outflow from anterior chamber of eye. Glaucoma can result in irreversible blindness. Ocular hypertension refers to any eye condition with intraocular pressure > 21 mm Hg. In ocular hypertension, visual field and optic nerves can be normal and with absence of any other ocular

diseases.

Elevated intraocular pressure (IOP) is the primary risk factor for glaucoma and ocular hypertension. It can result in progression of optic nerve deterioration and visual field loss.

Effectiveness of IOP lowering is shown in recent randomized, controlled clinical trials in which it can delay or prevent the development of glaucoma in patients with ocular hypertension and to delay or inhibit progression of established glaucoma. Lowering of IOP to target individualized IOP is by either increasing aqueous outflow or reducing aqueous production or both. In general, IOP lowering agents in which topical agents are the mainstay of treatment in glaucoma and ocular

hypertension.

Major classes of topical IOP lowering agents include beta blockers, prostaglandin analogues, carbonic anhydrase inhibitors, alpha-2 selective adrenergic agonists, miotics and mydriatics. Ocular beta blockers include timolol, betaxolol, and levonubolol have beta-adrenergic receptor blocking effect that results in reduced aqueous humor production and IOP loweing. Beta blockers are the most commonly prescribed first line

IOP lowering agent if no contraindication.

Prostaglandin analogues such as latanoprost

and travoprost act as selective prostaglandin receptor agonist that increase uveoscleral aqueous

outflow that reduce IOP.

Prostaglandin analogues should be used once daily at bedtime only as administration more than once daily is associated with decreased IOP lowering effect or causing paradoxical elevations in IOP. Prostaglandin analogues are often used as first line agent due to its convenient once daily dosing, effectiveness that are comparable to ocular beta

blockers and with minimal adverse effects.

Topical carbonic anhydrase inhibitors (CAI) such as dorzolamide and brinzolamide are alternative to oral CAI (e.g acetazolamide) in treatment of elevated IOP as they have a favorable safety profile, and are better tolerated with less systemic side effects. Mechanism of action is inhibiting CA isoenzyme in ciliary processes of eye, reducing bicarbonate and aqueous humor production and thus loweing IOP. Caution in use in patient allergic to sulfonamides drugs as both dorzolamide and brinzolamide are

sulfonamides.

Alpha-adrenergic agonists such as bromonidine and apraclonidine decrease production of aqueous humor, increasing uveoscleral outflow that leads to IOP lowering. In a large, open label study involving 2335 patients, brimonidine as the selective alpha-2 adrenergic agonist effectively lowered IOP whether used as monotherapy, replacement therapy or adjunctive therapy. A significant mean additional IOP lowering is achieved when brimonidine is used as adjunctive therapy concurrent with other ocular hypotensive agents such as beta-blockers, carbonic anhydrase inhibitors and the prostaglandin analogue

latanoprost. Apart from IOP lowering, a study found that brimonidine has potential neuroprotection that is beneficial in preventing the progression of functional changes and visual field loss in glaucoma and ocular hypertension.

7


Comparison table of topical IOP lowering agents

Generic

Name

Brimonidine

Tartrate 0.15%

Ophthalmic

Latanoprost

0.005% Eye

Drops

Dorzolamide

HCl 2%

Ophthalmic

Solution

Betaxolol

0.25% Eye

Suspension

Timolol

Maleate

0.5% Eye

Drops

Trade Names Alphagan P Xalatan Trusopt Betoptic Timolol-POS®

Drug Class Selective alpha-2 adrenergic agonist

Prostaglandin derivative/prostamide (Analogs of prostaglandin Fα - Selective prostaglandin Fα receptor agonist )

Carbonic anhydrase inhibitor (CAI)

Selective beta-blockers (beta-1 adrenergic antagonist)

Non –selective beta-blockers (beta adrenergic antagonist)

Mechanism of Action Decrease production of aqueous humor & increase in uveoscleral outflow

Increase in uveoscleral outflow

Reduction of aqueous production



Treatment option 1st or 2nd choice 1st or 2nd choice 2nd choice 1st or 2nd choice 1st or 2nd choice

Dosage 1 drop in the affected eye(s) 3 times daily

The recommended dosage is one drop (1.5 ug) in the affected eye(s) once daily in the evening. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart

Monotherapy : 1 drop 3 times daily. Adjunctive therapy with an ophthalmic beta-blocker : 1 drop 2 times daily. When substituting for another ophthalmic antiglaucoma agent with this product, discontinue the other agent after proper dosing on one day and start Trusopt on the next day. If more than 1 topical ophthalmic drug is used, the drugs should be administered at least 10 mins apart

One to two drops in the affected eye(s) twice daily

Initially, 1 drop of 0.25% 2 times daily, if clinical response is not adequate, 1 drop of 0.5% 2 times daily

IOP reduction efficacy

20-25%

Brimonidine lowers IOP by mean values of approximately 4-6 mmHg.

25-30 %

Latanoprost lowers IOP by mean values of approximately 4-6 mmHg.

15-20%

Dorzolamide lowers IOP by mean values of approximately 3-5 mmHg.

20-25%

Clinical studies show

that topical Betaxolol

Hydrochloride

Ophthalmic Solution

reduces mean

intraocular pressure

25% from baseline.

20-25%

Timolol lowers IOP by mean values of approximately 6 mmHg.

8


Generic

Name

Brimonidine

Tartrate 0.15%

Ophthalmic

Latanoprost

0.005% Eye

Drops

Dorzolamide

HCl 2%

Ophthalmic

Solution

Betaxolol

0.25% Eye

Suspension

Timolol

Maleate

0.5% Eye

Drops

Pharmacokinetics

Mean apparent half-life in the systemic circulation ~ 3 hours.

Rapid onset of action, with peak ocular hypotensive effect seen at 2-3 hours post-dosing

Brimonidine is extensively metabolized in liver.

75% of the bromonidine was excreted as metabolites in urine within five days in which no unchanged drug was detected in urine.

Half life ~ 17 minutes.

Reduction in intraocular pressure starts about three to four hours after administration and maximum effect is reached after eight to twelve hours.

Pressure reduction is maintained for at least 24 hours.

The main liver metabolites, the 1,2-dinor and 1,2,3,4-tetranor metabolites are excreted primarily in the urine.

Half-life ~four months.

Dorzolamide and its metabolites accumulate in red blood cells during chronic dosing as a result of selective binding to CA-II while extremely low concentrations of free drug in plasma are maintained.

Reduction in intraocular pressure persists for 8 hours or longer.

Dorzolamide binds moderately to plasma proteins (approximately 33%).

Dorzolamide is primarily excreted unchanged in the urine with its liver metabolites also excreted in urine.

Half-life ~16-22 hours.

Onset of action is within 30 minutes and the maximal effect can usually be detected 2 hours after topical administration.

A single dose provides a 12-hour reduction in intraocular pressure

Major liver metabolites include two carboxylic acid forms plus unchanged betaxolol in the urine (approximately 16% of the administered dose).

The elimination of betaxolol is primarily by the renal rather than faecal route.

Half life ~ 7 hours.

Timolol is not extensively bound to plasma protein.

Part of the dose is absorbed systemically where it is extensively metabolised in the liver.

Timolol is partially metabolised by the liver with timolol metabolites excreted by the kidney.

Side effects Very common: Oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue, drowsiness, conjunctival follicles, ocular pruritus.

Common: Dizziness, abnormal taste

Very common: Slight discomfort, mild to moderate conjunctival hyperaemia(burning grittiness, itching, stinging and foreign body sensation), transient punctate ephitelial erosions, increased pigmentation of iris, rash.

Common:Transient punctate epithelial erosions, mostly without symptoms; blepharitis.

Very common: Burning and stinging.

Common: Slight discomfort, mild to moderate conjunctival hyperaemia, transient punctate ephitelial erosions, increased pigmentation of iris, rash

Common: Ocular

stinging, pain, itching,

erythema, dry eyes

and allergic

blepharoconjunctivitis,

corneal disorders

Very common: Burning and stinging upon instillation (approximately one in eight patients).

Less frequently: Bradycardia, hypotension, confusion, depression, dizziness, fatigue, abdominal pain, diarrhoea, dyspepsia, dry eye, corneal anaesthesia.

9


WHAT IS YELLOW FEVER?

Yellow fever is a severe arthropod-borne hemorrhagic fever transmitted by infected

mosquitoes. The "yellow" in the name refers to the jaundice that affects some patients. Up to

50% of severely affected persons without treatment will die from yellow fever. There are an

estimated 200 000 cases of yellow fever, and the

fatality rate is about 20%-50%. The virus is endemic in tropical areas of Africa and Latin

America, with a combined population of over 900 million people. Yellow fever cases have been

uprising for the past two decades due to declining population immunity to infection, deforestation,

urbanization, population movements and climate change. Unfortunately there is no cure for yellow fever and treatment is symptomatic which aimed

at reducing the symptoms only. Vaccination is the most important preventive measure against

yellow fever. The vaccine is safe, affordable and highly effective, and appears to provide

protection for 30–35 years or more. The vaccine provides effective immunity within one week for 95% of persons vaccinated.

SYMPTOMS

TRANSMISSION

There are several different species of the Aedes

and Haemogogus mosquitoes that transmit the

virus. These mosquitoes either breed around houses (domestic), in the jungle (wild) or in both habitats (semi-domestic). There are three types of

transmission cycles.

Sylvatic (or jungle) yellow fever: In tropical

rainforests, yellow fever occurs in monkeys that are infected by wild mosquitoes. The infected mosquitoes bite humans entering the forest,

resulting in occasional cases of yellow fever.

Intermediate yellow fever: In humid or semi-

humid parts of Africa, small-scale epidemics occur. Semi-domestic mosquitoes (that breed in

the wild and around households) infect both monkeys and humans. Increased contact between people and infected mosquitoes leads to

transmission. This is the most common type of outbreak in Africa. An outbreak can become a

more severe epidemic if the infection is carried into an area populated with both domestic

mosquitoes and unvaccinated people.

Urban yellow fever: Large epidemics occur

when infected people introduce the virus into

densely populated areas with a high number of non-immune people and Aedes mosquitoes.

YELLOW FEVER

The yellow fever virus is an arbovirus of the

flavivirus genus, and the mosquito is the

primary vector. It carries the virus from one

host to another and it normally spread to humans from bites by infected mosquitoes.

People cannot spread yellow fever among

themselves through casual contact, although the infection can be transmitted directly into the blood through needles.

http://www.webmd.com/heart/anatomy-picture-of-blood

10


TREATMENT

Since it has no cure, the medical treatment is mostly focusing on resolving the symptoms of

yellow fever such as fever, muscle pain, and dehydration. Due to the risk of internal bleeding, it is advisable to avoid aspirin and other non-

steroidal anti-inflammatory drugs such as ibuprofen or naproxen. Hospitalization is often

needed.

PREVENTION OF YELLOW FEVER

THROUGH VACCINATION

The yellow fever vaccine is recommended for:

those ≥9 months of age travelling or living

in any country in West Africa regardless

of where they will be in that country, those ≥9 months of age travelling or living

outside urban areas of all other yellow

fever endemic countries , and laboratory personnel who routinely work with yellow

fever virus

Nowadays countries like Africa and South America which has the highest risk exposure to

yellow fever require proof of yellow fever vaccination before you are allowed to travel there.

People who should not be vaccinated include:

children aged less than 9 months for

routine immunization (or less than 6 months during an epidemic);

pregnant women – except during a yellow fever outbreak when the risk of infection is high;

people with severe allergies to egg protein; and

people with severe immunodeficiency due to symptomatic HIV/AIDS or other

causes, or in the presence of a thymus disorder.

Dosage and administration

Administration : IM or SC Dose : 0.5 mL of reconstituted vaccine regardless of age.

VACCINE

Yellow fever vaccine contains neither antibiotics

nor preservatives, and does not contain gelatin.The vaccine is a live, freeze-dried preparation of the 17D attenuated strain of

yellow fever virus cultured in, and harvested from, embryonated chicken eggs.

Vaccination elicits protective levels of neutralising

antibodies in approximately 90% of adult vaccinees by day 14, and in virtually all by day

28.The Immunity is long lasting and sometimes it is life-long, however revaccination is required

after 10 years under the International Health Regulations for a valid International Certificate of Vaccination. This is due to the fact that vaccine

produces a transient very low level viraemia in healthy adult recipients; they cannot serve as a

source of infection for mosquitoes.

The effectiveness of the yellow fever vaccine has never been determined in prospective clinical

trials however there is considerable observational evidence that it is very effective in preventing the disease.

http://www.webmd.com/pain-management/guide/pain-management-myofascial-pain-syndrome-muscle-pain

http://www.webmd.com/a-to-z-guides/dehydration-adults

http://www.webmd.com/drugs/mono-3-ASPIRIN+-+ORAL.aspx?drugid=1082&drugname=Aspirin+Oral

http://www.webmd.com/drugs/index-drugs.aspx

11


Transport, storage and handling Transport according to National Vaccine Storage

Guidelines: Strive for 5.

vaccine and diluent should be stored at +2oC to +8oC.

Do not freeze.

Protect from light.

should be used within 1 hour of reconstitution.

Contraindications

1) Known anaphylactic sensitivity

anaphylaxis following a previous dose, or anaphylaxis following any of the vaccine

components. known anaphylaxis to eggs.

2) Infants <9 months of age.

3) Altered immune status due to either disease or medical treatment

4) People with history of any thymus disorder (myasthenia gravis, thymoma, thymectomy and

DiGeorge syndrome).

Precautions! 1)Adults ≥60 years of age Due to the greater risk of severe adverse effects than younger adult. Recommended only if they

are traveling to endemic countries and have been informed about the risk of developing severe

complication.

2) Pregnancy

Recommended only if they insisted on going to endemic places. The yellow fever vaccine has been given to a number of pregnant women and

showed no evidence of any adverse effect.

3) Administration of other vaccines on the same

day The administration of other live virus vaccines (MMR, varicella vaccine) should be on the same

day as yellow fever vaccine, or separated by a 4-week interval. Other vaccines relevant to travel

can be given with, or at any time before or after, yellow fever vaccine.

12


From left-right: Maxitrol sterile opthtalmic

ointment 3.5 g & Gutt. Maxitrol sterile ophthalmic preparation 5 ml.

From left-right: Clomatrimazole vaginal inserts USP 500 mg & Clomatrimazole vaginal inserts USP 200 mg.

From left-right: Ampicillin 0.5 g injection & Penicillin G sod. 1,00000IU/IU(0.6 g) injection.

From left-right: Clexane 20 mg injection, Clexane 60 mg injection & Clexane 40 mg

injection.

LOOK ALIKE MEDICATIONS

13


From left-right: Mirtazapine 30 mg orodispersible tablet & Mirtazapine 15 mg orodispersible tablet.

From left-right: Cefuroxime axetil 250 mg tablet

& Sodium fusidate 250 mg tablet.

From left-right: Vitamin B complex tablet & Folic acid 5mg tablet.

From left-right: Enalapril 5 mg tablet &

Enalapril 10 mg tablet.

14


From left-right: Medroxyprogesterone Acetate 5

mg tablet & Trimetazidine dihydrochloride 20 mg tablet

From left-right: Mist expectorant stimulant, &

Ferric ammonium citrate 400mg/5ml.

From left-right: Gutt. Phenylephrine HCl 2.5%, Gutt. Isopto-Atropine 1%,

Gutt. Tropicamide 1%, Gutt. Cyclopentolate HCl 1%

From left-right: Ticlopidine HCL 250 mg tablet, Clopidogrel 75 mg tablet & Eterocoxib 90 mg tablet.

15


High alert medications are defined as those medications which could cause an immediate life

threatening condition for the patient if an error in administration occurs.

How to avoid HAM errors:

Risk awareness – Be aware of high alert

medications arrangement in pharmacy.

Review Floor Stocks in ward to reduce

availability of HAM items, as well as,

quantities.

Physicians should be alert with the

medications that they administer e.g.

dose, route, common adverse effect &

monitoring

Read the label repetitively during

prescription filling and counter checking.

Additional product labels for high alert

medication during dispensing medication

from pharmacy to the nurse unit.

Storage of high alert medication in cabinet

with HAM labels.

Common Risk Factors Associated with HAM:-

Incorrect dilution procedures

Confusion between IM, IV, Intrathecal,

Epidural preparations

Confusion between different strength of

the same medications

Ambiguous labeling on concentration and

total volume of medications

Wrong infusion rate

Significantly risky HAM in acute care setting:-

Drugs Serious Adverse

Events

Heparin Severe bleeding & heparin induced

thrombocytopenia

IV Potassium Chloride

Cardiac arrest, potassium intoxication,

life threatening hyperkalemia

Neuromuscular

agents (Atracurium)

Prolonged skeletal

muscle paralysis, respiratory insufficiency

Opioids Oversedation,

respiratory depression

Chemotherapy drugs

Myelosuppression, Immunosupression

High Alert Medication (HAM)


*List of High Alert Medication

Class / Category Medication

Adrenergic Agonists, IV

Adrenaline 1mg/ml Inj

Noradrenaline 4mg/4ml Inj

Ephedrine 30mg/ml Inj

Isoprenaline 0.2mg/ml Inj

Phenylephrine HCl 10mg/ml Inj

Salbutamol 0.5mg/ml Inj

Salbutamol 5mg/5ml Inj

Terbutaline 0.5mg/ml Inj

Adrenergic Antagonists, IV

Labetalol 25mg/5ml Inj

Propranolol 1mg/ml Inj

Anaesthetic Agents, general, inhaled, and IV

Dexmedetomidine 200mcg/2ml

Inj

Ketamine Inj

Propofol 1% Inj

Bupivicaine 0.5% Adrenaline

1:200,000 Inj

Bupivicaine 0.5% Heavy Inj

Bupivicaine 0.5% Inj

Ropivacaine 7.5mg Inj

Ropivacine 2mg/ml (0.2%) Inj

Desflurane (Suprane) 240ml

Ethyl Chloride Spray

Isoflurane 250ml Liquid

Sevorane Liquid 250ml (Sevoflurane)


Antiarrhythmias IV Amiodarone 150mg/3ml Inj

Lignocaine 2% Inj

Lignocaine 100mg/5ml Inj

Lignocaine 500mg/5ml Inj

Antifibrinolytics, haemostatics

Vitamin K Inj (10mg; 1mg)

Tranexamic Acid 500mg/5ml Inj

Antithrombotic Agents

Heparin Inj

Streptokinase 1.5 miu Inj

Tenecteplase 50mg Inj

Warfarin

Antivenom Sea Snake Antivenom

Cobra Antivenom

Pit Viper Antivenom

Polyvalent Antivenom

Chemotherapeutic Agents, Parenteral & Oral

Methotrexate Inj & Tab

Fluorouracil Inj

Epirubicin Inj

Cyclophosphamide Inj

Docetaxel Inj

Bleomycin Inj

Dextrose, hypertonic, 20% or greater<

Dextrose 50% Inj

Epidural & Intrathecal Medications

PCA Morphine

Epidural Cocktail 0.05%

Epidural Cocktail 0.1%

Epidural Pethidine 2%

Glyceryl Trinitrate Injection

GTN Inj 50mg/10ml Inj



Inotropic Medications, IV

Digoxin 0.5mg/2ml Inj

Dobutamine 250mg/20ml Inj

Dopamine 200mg/5ml Inj

Insulin, s/c & iv Actrapid

Magnesium Sulphate Injections

Mg Sulphate 2.47mg/5ml (10mmol) Inj

Moderate Sedation Agents, IV

Midazolam 5mg/ml; 15mg/3ml Inj

Diazepam 10mg/2ml Inj

Neuromusular Blocking Agents

Atracurium 25mg/2.5ml Inj

Pancuronium 4mg/2ml Inj

Rocuronium 50mg/5ml Inj

Vecuronium 4mg/ml Inj

Opiates & Narcotics Naloxone 0.4mg/ml Inj

Cocaine Powder

Morphine 10mg/ml Inj

Fentanyl Inj

Remifentanyl Inj

Nalbuphine 10mg/ml inj

Sodium Chloride 20%

*List adapted from ISMP’s List of Hight-Alert Medications & Guideline On Safe Use Of High Alert Medications Ministry of Health

Malaysia Pharmaceutical Services Division 2012


Parenteral Nutrition Preparations

Nutriflex Lipid Peri 955kcal

(Regimen 1)

Kabiven Peripheral 1000kcal

(Regimen 2)

Nutriflex Lipid Peri 1435kcal (Regimen 3)

Kabiven Peripheral 1400kcal (Regimen 4)

Kabiven Central 1900kcal (Regimen 5)

Nutriflex Lipid Special

1475kcal(Regimen 6)

Amino Acids 11.4% (Vamin

18EF) 500ml

Lipid LCT 20% (Intralipid)

Lipid MCT/LCT 10% (Lipofundin)

Amino acid 6.5% (Vaminolact)

100ml

Amino acid 6.5% (Vaminolact)

500ml

Amino acid 13.4% (Dipeptiven) 100ml

Potassium Salts Injection

Potassium Chloride 1g/10ml (13.41mEq) Inj

Potassium Dihydrogen Phosphate 10mmol/10ml Inj

Sodium Chloride Solutions (greater than 0.9%)

Sodium Chloride 3%

Sodium Chloride 20%


In the year 2012, total number of adverse drug

reactions reported was 62 cases, which consist of

various pharmacological categories with highest

number in anti-infective group (18 cases). Anti-

infective that causes the most adverse reaction

fall into beta-lactam antibiotics with most

common in Amoxycillin-Clavulanic Acid drug.

The next leading ADR group was cardiovascular

group with total number of 9 cases. Tailing very

close to cardiovascular gro up was analgesics and

endocrine with 7 cases respectively. For the least

number of cases were among nutrition & blood

disorder drug and neuromuscular drug with only

1 case.

According to the statistics of ADR as of March

2013, the leading is still anti-infective group with

7 cases among total of 11 cases reported. Beta-

lactam antibiotics hold the most number with 4

cases consists of Amoxycillin-Clavulanic Acid,

Cloxacillin and Bacampicillin. The remaining

groups- rheumatology, respiratory, analgesics

and cardiovascular reported each a case.

Majority of cases reported about anti-infectives is

related to dermatogical problem such as

angioedema, pruritis, macular papular rash and

rashes. Other severe cases reported include severe

bronchospam, hypoglycemia, leukopenia and

liver transaminitis.

To conclude, these statistics showed that

antiinfectives are the main ADR causing group,

with this in mind proper care and caution should

be applied during usage of anti-infectives in

future. Vast exposure in usage of antibiotics is

needed among medical personnel in order to

reduce the occurrence of adverse drug reactions

which could be life threatening. So all watch

out!!!!!!

Adverse Drug Reaction Report

19


Adverse Drug Reaction (ADR) Cases Reported Year 2012

Adverse Drug Reaction (ADR) Cases Reported Year 2013 (As of March 2013)

20


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