Overprescription Of Antibiotics In Pakistan- A Legal Context

Overprescription Of Antibiotics In Pakistan- A Legal Context

Antibiotics are kind of powerful anti-microbial[1] drugs which fight against bacterial infections. In Pakistan, the trend of prescribing antibiotics is rising day by day and has resulted in antibiotic resistance. “Increasing incidence of antibiotic resistance poses a serious threat to public health and there is an urgent need that people, particularly health professionals, exercise caution and do not use or prescribe the drugs unless their need is indicated by relevant laboratory tests”[2]

There are Antibiotic Susceptibility Tests and Minimal Inhibitory Concentration (MIC) Tests to be carried out before prescribing antibiotics but these steps are hardly followed by medical practitioners in Pakistan. Irrational drug prescription and drug resistance have become major problems not only in Pakistan but worldwide as well. It is primarily due to the high level of prescription by non-qualified practitioners, self-medication, overuse of medicines and inappropriate prescription particularly by qualified providers.[3]

The huge antibiotic prescription rate has led to an increase in antibiotic resistant bacteria and reduction of natural immunity level in both human beings and livestock. The gravity of the situation can be estimated from the fact that World Health Organization (WHO) published its first ever list of antibiotic-resistant “priority pathogens” – a catalogue of 12 families of bacteria that pose the greatest threat to human life.[4]

Therefore, it is of utmost importance to curb this problem and deal with it strategically and in legal terms.

Medical practitioners are duty-bound to administer antibiotics with extreme care and due diligence. Critical analysis of the overall legal framework depicts that there is no concrete law regarding the use of antibiotics in the world, particularly in developing countries. “Suggesting antibiotics to the patients and animals, etc. without applying antibiotic sensitivity test causes serious damage to the health of animals and particularly humans beings, which is a violation of human rights in a civic society and it is the responsibility of state that stringent and concrete steps must be taken in this context.”[5] In Pakistan, most general practitioners prescribe antibiotics without Microbial Diagnostic tests (Minimal Inhibitory Concentration of Antibiotics and Antibiotics Sensitivity tests).

The following is some relevant legislation that exists in the field over the same subject matter:

Punjab Health Care Commission Act, 2010:

Any practitioner who prescribes unnecessary antibiotics is guilty of medical negligence covered by Section 19 of Punjab Health care Commission Act, 2010 which states the following:

(19) Medical negligence – (1) Subject to sub-section (2), a healthcare service provider may be held guilty of medical negligent on one of the following two findings:

(a)  the healthcare establishment does not have the requisite human resource and equipment which it professes to have possessed; or

(b)  he or any of his employee did not , in the given case, exercise with reasonable competence the skill which he or his employee did possess.

(2)  The recognized and known complications of a medical or surgical treatment are not considered as medical negligence.

Allopathic System (Prevention of Misuse) (West Pakistan) Rules, 1968:

Rule 4 of Allopathic System (Prevention of Misuse) (West Pakistan) Rules, 1968 Rules enunciates stringent criteria for licensing such practitioners who want to prescribe antibiotics. This clearly indicates that prescription of antibiotics is a serious matter and therefore should be done by the practitioners duly authorized under the law.

Pakistan Medical and Dental Council – Code of Ethics of Practice for Medical and Dental Practitioners:

The Code of Ethics of Practice for Medical and Dental Practitioners lays down the code of conduct to be observed by medical practitioners during their practice. Section 9 of the same Code mandates the rational use of drugs and requires medical practitioners to never forget that the lives and health of patients are dependent on their attention and skills which they should exercise mindfully and reasonably. Section 9 is reproduced below:

Section 9:

Rational use of drugs.- (1) Every Medical or dental practitioner shall adopt practice with good and rational practices to prescribe drugs.

(2) A medical or dental practitioner shall

(a) be free to choose whom to serve, with whom to associate and lay down the timings and place of professional service for the patients;

(b) not be bound to treat each and every person asking his services, but he shall not only be ever ready to respond to the calls of the sick and the injured, if in his opinion the situation Warrants it as such, but shall be mindful of the high character of his mission and the responsibility he discharges in the course of his professional duties;

(c) in his treatment, never forget that the health and the lives of those entrusted to his care depend on his skill and attention; and

(d) if not available due to any reason and the patient requires continuous monitoring or care, then the Medical or dental practitioner shall arrange for another Medical or dental practitioner of sufficient proficiency as an alternative and inform the patient.

(3) For. a medical or dental practitioner to advise a patient to seek service of another medical or dental practitioner is acceptable, however, in case of emergency, the medical or dental practitioner must treat the patient first.

(4) No medical or dental practitioner shall normally refuse treatment to a patient, however for good reason if the medical or dental practitioner thinks it would not be appropriate to provide his professional services to a particular patient or when a patient is suffering from an ailment which is not within the range of experience of the treating medical or dental practitioner, the medical or dental practitioner may refuse treatment and refer the patient to another medical or dental practitioner.

 World Health Organization Guidelines:

There are strict guidelines and policies by the World Health Organization as to the licensing of antibiotics and practitioners who prescribe them.

Drug Regulatory Authority of Pakistan (DRAP):

The Drug Regulatory Authority functions via DRAP Act 2012 (as amended in 2017). It is working under the Ministry of National Health Services, Regulation and Coordination. It aims and functions to regulate production and distribution of drugs at the national level. Though it is less of a practical check upon practitioners regarding prescription of antibiotics, this body exists at the national level and is functioning to improve health facilities in Pakistan.

Courts in Pakistan have also taken a clear stance on the issue of unnecessary antibiotic prescription. The honourable Lahore High Court has held in a case cited as 2016 CLC 95:

“Considering different side effects of antibiotics, dispensation and prescribing antibiotic and other allopathic medicines was not child’s play. Anyone who would dispense allopathic medicines, particularly antibiotics, without knowledge of its side effects, which were likely to occur, would be at risk of actionable wrong or negligence.”

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References:

[1] Lyndal Rowland, “Utilizing antibiotics agents effectively will preserve present day medication”, 21 November 2015.
[2] Faiza Ilyas, “Antibiotic resistance: A Threat to Public Health”, published on March 24, 2015
[3] S. Zaidi, N. Nishtar, “Access to Essential Medicines in Pakistan: Identifying Policy Research and Concerns”, p. 10
[4] WHO Media Center, News Release, February 27, 2017
[5] Khan. NaeemUllah, Nawaz.S.Kashif, Hassnian. Dr.Shahida, “Combating Antibiotic Resistance at National Level in Pakistan: Reasons and Recommendations”, 2008, PLJ Lawsite

Ahmed Z, Tahir A, Sohail A. (2005) High rate of prescription of antibiotics in treatment of upper respiratory infections. Pakistan Armed Forces Medical Journal Issue Number 1

Access to Essential Medicines in Pakistan: Policy and Health Systems Research Concerns; Shehla Zaidi, Maryam Bigdeli, Noureen Aleem, and Arash Rashidian

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