16 2011-16-AJPP-Avoidable Childhood - Nazir and Zaidi 2011 F
16 2011-16-AJPP-Avoidable Childhood - Nazir and Zaidi 2011 F
16 2011-16-AJPP-Avoidable Childhood - Nazir and Zaidi 2011 F
Case Report
Rational drug usage, clinical regulations and pharmaceutical care are important features of health
practice. Thus; we have aimed case report to elaborate the clinical pharmaceutical services. A 3 year
old girl, was presented in a hospital with minor burn that happened by spilt hot water on her wrist. She
was in severe pain. The emergency ward staff applied an ointment. The doctor instructed injection
Dormicum two times with short gape and then 3rd injection of Pavulon (Pancuronium). Patient went
silent and started losing consciousness and eventually passed away. In view of the above facts and
circumstances the inquiry board and judiciary took action against the negligence, mishandling. While;
going through the investigation the inquiry board did not bothered the channel through which this
injection came without proper check that is therapeutical drug monitoring, prescription reviewing, bio-
safety and pharmaceutical evaluation. Furthermore, it is not a single death but representation of so
many casualties because of the wrong medications. The medial practice needs some more legal,
professional and principled restrictions to make sure the safe and correct therapy plans. The clinical
legislation, drug rules and medical practice seriously need the attention of judiciary, society and
leadership to assure the safety of precious live.
Key words: Wrong medication, medical malpractice, professional negligence, pharmaceutical services, Suo-
moto notice of chief justice of high court.
INTRODUCTION
Health care providers are said to be negligent if they fail advance counties owes a duty to conduct his practice like
to provide the standard care that an expert would give in a prudent and diligent physician (Medical Malpractice,
similar circumstances. If the negligence resulted in 2010). Standards and regulations for medical malpractice
injuries or illnesses the health care provider may be may differ from one country to other and with the
liable. If the doctor was clearly wrong, patient can sue jurisdiction within the countries. Medical professionals of
him/ her for malpractice (CBA, 2010). Healthcare developed nations are especially required to maintain
professionals are expected to be current in their professional liability insurance to offset the risk and costs
knowledge of disease diagnoses and treatment to meet a of lawsuits based on local medical malpractice (BBC
reasonable standard of treatment; depending upon the News, 2010).
available facilities for optimum patient’s care. The health This report therefore aimed to look at the reasons of
care professional of the developing part of the worlds clinical errors in developing part of the world. It is not
may be partially exempted because of the compulsion of professional revenge, unenthusiastic critics or
adopting the crude methods of care to save the patient’s commercially biased outlook but an optimistic report to
life. According to medical malpractice law, a doctor of encourage the accomplishment of health standards and
rational drug usage. Therapeutical drug monitoring, bio-
safety, pharmaceutical care, prescription review and
clinical services carry their meanings in health science.
*Corresponding author. E-mail: tahanazir@yahoo.com, We have to assign the responsibilities to other health
taha.nazir@uos.edu.pk. Tel: +92 51 282 9162-64, 282 9697-8. caring professionals especially the pharmacists to avoid
Fax: +92 51 282 9238. irrational drug usage.
Nazir et al. 293
pediatric consultation who prescribes this injection stated Xylocaine is an anesthetic used on the skin to relieve
that he has advised it as a sedative drug just to relax the itching and pain associated with various skin disorders
patient from unbearable pain as well as to lessen the such as insect bites, burns, scrapes, plant poisonings,
anxiety of her family members. Thus; the board members hemorrhoids, urinary tract procedures or the placement of
were afraid that the concept of pediatric consultation in endotracheal tubes. Some forms of Xylocaine are used
respect of Pavulon injection is not correct. His action and during certain procedures to reduce pain (77
suggestion in the above mentioned case is apparently an Canadapharmacy.com, 2010). It works by preventing
error and misconception. Therefore; the committee held nerves from transmitting painful impulses to the brain
pediatric consultation responsible for negligence, (Drug Information Online, 2010). Dermazine ointment
mishandling of the patient and failure to provide standard (Silver Sulphadiazine) is a topical anti-infective agent with
treatment. He did not have sufficient professional exposure and the antibacterial properties of both silver ion and
therapeutical skills regarding the drugs and medications. sulfadiazine. Both free silver and the sulfonamide moiety
Postmortem examination of the deceased was performed, may exert activity, Silver Sulphadiazine is used to prevent
opinion of which is as under: “1% antemortem burns and treat infections of wounds caused by second- and
stated above, are not sufficient to cause death in the third-degree burns. Brufen or Ibuprofen (iso-butyl-
ordinary course of nature. History, police record, injection propanoic-phenolic acid) is a non-steroidal anti-
marks and autopsy findings are suggestive of asphyxia inflammatory drug (NSAID) available under various other
death as a result of medication. Viscera / specimens / trademarks; Nurofen, Advil, and Motrin. It is a ‘core’
fluid are sent to the chemical examiner and bacteriologist medicine in the World Health Organization's "essential
to the Government authorities for Laboratory evaluation”. drugs list", which is a list of minimum medical needs for a
The management of hospital was contacted before basic health care system (WHO Model List of Essential
proceeding. The Chief Executive of hospital explained that, Medicines, 2010). Phenergon (Promethazine) belong to
General Manager has been arrested by the police and the class of chlorpromazine (Thorazine) and
Pharmacy of the hospital has also been sealed. Moreover, trifluoperazine (Stelazine). However, unlike the other
doctors who handled the said minor girl have been terminated drugs in this class, promethazine is not used as an anti-
and as such no doctors were available for enquiry. psychotic. It used as an anti-histamine, sedative, and
Afterwards, the Board went to visit the hospital with a view to antiemetic (anti-nausea). It is used as a sedative because
physically inspect the facilities provided in the Emergency it causes drowsiness as a side effect. The FDA approved
Department for the patients. The Board on its visit to hospital promethazine in 1951 (William and Melissa, 2010).
confirmed availability of enough number of ventilators, Dormicum (Midazolam) is a short-acting benzodiazepine
but none was provided to this patient to save her life. with an elimination half-life of one to four hours (Barash
Moreover, ambulance was also available in the hospital at el., 2009)); however, in the elderly, as well as young
which too was not provided, the hospital has good children and adolescents, the elimination half life is
resources available in enough quantity for rendering longer (Rosenbaum et al., 2009). Midazolam is
services, probably because; (1) Doctors performing CPR metabolized into an active metabolite alpha1-
had confirmed death of patient but did not disclose it to hydroxymidazolam. Age related deficits and renal or liver
her parents, (2) No body accompanied the patient to the status affect the pharmacokinetic factors of midazolam
other hospital and the parents were asked to take their and its active metabolite (Spina and Ensom, 2007). It is
critically unwell child to another hospital without a referral poorly absorbed orally and metabolised by cytochrome
and without help, (3) Treatment file was not handed over P450 (CYP) enzymes and by glucuronide conjugation.
to the father on the same day and perhaps notes were Pharmacological properties include; sedation, hypnotic,
added later on, (4) Apparently a discharge ticket was anxiety, anterograde amnesia, muscle relaxation and
subsequently prepared not showing any complications or anti-convulsion (Riss, et al., 2008).
death. The board agrees with the cause of death declared The most important drug of this case report is
by postmortem examination report. The board concluded pancuronium (Pavulon) is a muscle relaxant with various
from the above, it is evident that the patient died due to purposes. It is the second of the three drugs administered
criminal professional negligence / wrong treatment. The during a lethal injection in the United States (BBC article
patient came to hospital and the responsibility of any on lethal injection, 2004). Pancuronium is used with
negligence of any of the employees has to be shared general anesthesia in surgery for muscle relaxation and
equally by the management of hospital. as an aid to intubation or ventilation. It does not have
The main medication prescribed and administered sedative or analgesic effects. In Belgium and the
during the treatment of patient were the Xylocain Gel Netherlands, pancuronium is recommended in the
(Local anesthetic), Deramzin ointment (Silver protocol for euthanasia after administration of sodium
Sulphadiazine), Brufen Syrup (Ibuprofen), Phenergon thiopental to induce coma, pancuronium in order to stop
Syrup (Promethazine), injection Dormicum (Midazolam) breathing (Royal Dutch Society for the Advancement of
given 2.5 mg and then amended to 2.0 mg and injection Pharmacy, 1994). It was also used in Efren Saldivar's (an
Pavulon (Pancuronium bromide). American serial killer who murdered patients while
Nazir et al. 295
working as a respiratory therapist) killing spree without proper procedure of pharmaceutical practiced.
(Katherine, 2010). The physician had to provide his formal informations
Pancuronium is a typical non-depolarizing curare- (name, license number, prescription detail etc) along with
mimetic muscle relaxant. It acts as a competitive the patient’s data (medical history, social background,
acetylcholine antagonist on neuromuscular junctions, personal profile etc). Moreover; scientifically the
displacing acetylcholine from its post-synaptic nicotinic prescription is considered as health-care program to
acetylcholine receptors. The initial dose of Pavulon for implement and governs the plan of care for an individual
neuromuscular blockade is 0.06-0.1 mg/kg or 0.05 mg/kg patient (Belknap et al., 2008). The procedure of
after initial dose of succinylcholine for intubation. The prescription and dispensing is applied to avoid
maintenance dose is 0.01 mg/kg 60-100 min after initial ambiguities or misinterpretation in clinical practice
dose and then 0.01 mg/kg every 25-60 min. (Teichman and Caffee, 2002). In this case report the
Neuromuscular blockade in the ICU is 0.05-0.1 mg/kg standard procedures have been violated. The chance of
bolus followed by 0.8-1.7 mcg/kg/min once initial this wrong medication was possible to control if the
recovery from bolus observed or 0.1-0.2 mg/kg every 1 to prescription be reviewed properly, the clinical plan
3 h (GlobalRPh.com, 2010). The ED95 (dose causing a evaluated correctly and pharmaceutical services provided
95% reduction in muscle activity) is only 60 µg/kg body with all of their formalities.
weight administered intravenously. Muscle relaxation Therapeutic drug monitoring and pharmacovigilance
suitable for intubation sets in about 90 to 120 s after are safety valves in clinical practice. The blood levels of
administration of the drug. Full muscle paralysis for major potent drugs with a narrow therapeutic index are
surgery is achieved about 2 to 4 min after application. measured periodically to assure the safety of life
Clinical effects last for about 100 min. The time needed (Marshall and Bangert, 2008). These are useful
for full (over 90% muscle activity) recovery after single constraints employed to minimize the therapeutical
administration is about 120 to 180 min in healthy adults, complications; detection, assessment, understanding and
but can be protracted to more hours in poor health prevention of adverse effects of medicines (WHO, 2002).
subjects and when concomitantly administered with other FIP (2010) has emphasized the six major elements to
long-acting anesthetics BBC News (2010). The patient contribute to an overall strategic thrust of the board of
under discussion attained the toxicity and her heart beat pharmacy practice in hospital pharmacy section
and respiration gradually diminished. (http://www.fip.org/hospital_pharmacy). The six major
Therapeutical findings of the report under discussion elements are including the partnership with patients,
are in line with Wysowski (2007), who reported that the enhancing pharmacy practice, better financial models,
deaths due to overdoses are the most prominent cause evidence-based practices, assuring competency and
of drug-related mortality in death certificate data. He sufficient workforce. These factors designed with the
concluded that the certain drugs classes, especially the collaboration of World Health Organization, UNESCO,
opioids, psychoactive, anticoagulants and antibacterials World Health Professions Alliance, Regional
are associated with large and increasing numbers of Pharmaceutical Forums and all other partners (FIP,
deaths. The preventive strategies should be considered 2010). The patient’s critics, complaint, views or
while administering this drug. resentment are another important feature of therapeutical
Madea et al. (2009) reported a retrospective practice. Which are the expressions of displeasure or
multicentre study on medical malpractice cases with grievance (Lee, 2010).
lethal outcome, drug related cases. In 232 cases a causal In view of the aforementioned facts and circumstances,
connection between drug therapy and death could be the inquiry board suggested to the honorable Chief
approved. However, within the legal context only in 70 Justice of the High Court, to take serious action on
cases a medication error was approved which was in 42 account of this negligence. But they have totally ignored
cases causal for death and 28 are not. Concerning the the poor channel through which this injection was
frequency of adverse drug events (ADE) the medication provided without proper procedure. The government
errors are underreported in all data sources on medical authorities and judiciary should have to consider the
malpractice; this seems to be due to the fact that, even pharmaceutical services, drug rules, therapeutical drug
doctors and attending physicians rarely recognize an monitoring, phramcovigilance, prescription review and
ADE. clinical evaluation. The clinical setup of hospital
In another way, clinical report under discussion also pharmacy of third world countries need the bio-safety,
demands the elaboration of certain clinical and drug informations, aseptic dispensary as accomplished in
pharmaceutical issues to figure out the scientific reasons, the developed part of the world. We must have to build
permissible matters and professional concerns. As; the up awareness about the pharmaceutical services. The
pharmaco-therapeutical requirements are not been inquiry board have not written even a single word to place
fulfilled. The pharmaceutical services did not meet the a check between the physician and patient to make sure
standard of hospital pharmacy practice. The physician of the correct medication, right dose, proper route in
got the injection directly, the pharmacy staff issued it exact time. It is not single death but a representation of
296 Afr. J. Pharm. Pharmacol.
so many casualties occurring every day because of the 10. The patient should be addressed directly in case of
wrong medications. It needs a collective effort of society, clinical grievance. The physician has to involve him more
judiciary and leadership to change the rules, system, seriously to assure the quality of care concerns. The bad
policies and strategies to assure the safety of precious result is not necessarily the result of any human failures/
live of innocent people. error.
11. The problems related to the irregular visit,
nonprofessional behavior, inadequate diagnostic facilities
RECOMMENDATIONS and non healthy condition in the hospital setting can only
be resolved by designing certain rules and regulations.
1. Enforcement of drugs rules to assure the standard
drug monitoring system including prescription review,
dose calculation and therapeutical evaluation. ACKNOWLEDGEMENT
2. Examination and update of the physicians for their
executed procedures, scientific techniques, The author wishes to acknowledge Mr. Wajahat Latif,
chemotherapy protocols, professional skills and clinical Director, University of Lahore (Islamabad Campus),
expertise. Islamabad, Pakistan.
3. Maintenance of the threat of lawsuit is an excellent
reason of quality services. If may become more effective
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