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Medicine disaster in Pakistan points to enhanced safety role for pharmacists

Recently many patients with heart problems have suffered severe reactions to a number of substandard drugs. Syed Shahzad Hasan and Syed Imran Ahmed discuss the implications

By Syed Shahzad Hasan and Syed Imran Ahmed

Recently many patients with heart problems have suffered severe reactions to a number of substandard drugs. Syed Shahzad Hasan and Syed Imran Ahmed discuss the implications

Being one of the most responsible and challenging health professions globally, pharmacists have been often labelled as drug experts due to their roles in drug discovery and development, drug distribution and storage, and the appropriate use of medicines. Pharmacists have always been under-used in Pakistan, particularly on public healthcare premises. This may come as a consequence of the uncertainty and absence of proper legislation and policies, as well as infrastructure of pharmacy practice in the country.

The problem in Pakistan

Long neglected and rarely discussed, the clinical role of pharmacists has recently become a topic of discussion in social networking sites after a dreadful incident where a number of patients are believed to have died as a result of taking suspected substandard medicines in the province of Punjab. According to government officials, about 40,000 patients with heart problems might have received poor quality drugs since 15 December 2011. More than 150 patients have been admitted at different hospitals in Lahore following adverse drug reactions (ADRs) associated with the prescribed medicines supplied free of charge.

The officials added that most of the patients affected by the substandard drugs experienced a rapid depletion of white cells and blood platelets, leading to an impression that they were suffering a form of dengue fever. Other reported symptoms include marks on the body and bleeding from various parts of the body. Whatever the reasons behind this miserable event, it indicates the inability of healthcare professionals, physicians in particular, to recognise these ADRs early in the course of treatment. Otherwise many lives could have been saved. This emphasises the need of a proper practice of clinical pharmacy and an organised adverse drug reporting programme in Parkistan’s healthcare institutions.

Substandard drugs

After the initial probe by the authorities six drugs are suspected to have caused these symptoms. The suspected tablets include simvastatin 20mg, clopidogrel 75mg, amlodipine besylate 5mg, soluble asprin 300mg, atenolol 100mg, isosorbide-5-mononitrate 20mg. Unfortunately, there are no facilities for detailed drug analysis at our drug regulatory authorities (DRA) laboratories in Lahore and Karachi. With no options in hand, the government has sent the drug samples to France, Belgium and Singapore for detailed drug analysis. Now, if the DRAs do not have the capacity to analyse the drug samples thoroughly, how do they or the federal government examine the drug before issuing a licence to produce or market the drug? Under such circumstances, is it not possible that Pakistan may see such events again in future?

Pharmacists’ role

This tragic incident should be an eye-opener for our legislators. They tend to focus on issues that benefit them politically. Many other important issues, especially if potentially controversial, are often quickly and quietly set aside by them, and they would rather choose not to become part of the public discussion. This incident in Punjab highlights the scarcity of pharmacists who can implement proper drug safety surveillance programmes in healthcare institutes in Pakistan. Most developing countries, such as Malaysia, Thailand and Turkey, have made advancements in detection and reporting of ADRs by actively involving pharmacists.

The current role of the pharmacist in Pakistan is mainly confined to the pharmaceutical industry, sales and marketing, and, to a lesser extent, in private hospitals. The role of pharmacists should be extended to reporting drug-related problems, introduction of generic or therapeutically equivalent medicines, reviews of older medicines, as well as traditional, complementary and alternative medicines, non-prescription medicines, blood products, biological drugs, medical devices and vaccines.

Pharmacists have a clinical responsibility to detect ADRs and other drug-related problems early, as well as to monitor the effectiveness of medicines. Pharmacists, as a part of the healthcare team, are a source of information. They can also critically evaluate drugs used in clinical practice. Clinicians in Pakistan should respect and understand the pivotal role of pharmacists in the surveillance of the safe use of medicines. The government and healthcare institutes in Pakistan should also acknowledge and promote the role of pharmacists in the detection and reporting of suspected ADRs and other drug-related problems.

Greater participation by pharmacists in all practice settings would be an important step to improve the surveillance of ADRs and other drug-related problems in Pakistan. The pharmacist’s role in surveillance of drug safety varies from country to country, but the professional responsibility is the same, regardless of jurisdiction.

Improving drug safety

Certainly, there are ways for the government and policy makers in Pakistan to improve the surveillance of drug safety. There are at least two levels of improving medicines use. At the government level, decision-makers should take a clear stance to stop or reduce political interference in issuing licences to pharmaceutical companies, to ensure regular inspection of pharmaceutical companies’ production and storage facilitates, to make drug inspectors and controllers accountable for their unlawful activities, to establish transparent and efficient governmental production and marketing approval process, to have legislation on third party payer and regulation of pharmacist practitioners, and to ensure regular testing of sensitive or thermolabile drugs, both from the factory and the market.

On the other hand, at an institution level, management should form a committee to monitor drug safety and it should be made an integral part of clinical practice, to educate and train health professionals in drug safety, to ensure the representation of all the relevant healthcare professionals in drug safety committees, and to ensure that the committee members regularly meet to discuss issues related to ADRs.

Conclusion

It is the duty of policy-makers to take steps to assure the provision of an optimal role for pharmacists, who will implement the best and most realistic healthcare plans for meeting the needs of society in Pakistan.

 

Syed Shahzad Hasan and Syed Imran Ahmed are lecturers and clinical pharmacists at the School of Pharmacy and Health Sciences, International Medical University, Kuala Lumpur, Malaysia.

Citation: The Pharmaceutical Journal URI: 11096691

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