Dear Colleagues! This is Asrar Qureshi’s Blog Post #986 for Pharma Veterans. Pharma Veterans Blogs are published by Asrar Qureshi on its dedicated site https://pharmaveterans.com. Please email to aq.pharmaveterans@gmail.com for publishing your contributions here.
Medicines and medical devices are the most needed component of healthcare, after medical consultation. Availability, price, authenticity, and quality are the main topics which are discussed as concerns from various quarters. In this post, we dig a little deeper to see this important component.
The variety of medicines used in healthcare includes pharmaceutical products, biological drugs, medical devices, health & OTC or non-drugs such as nutritional products, supplements, homeopathy, Unani (tibb e Islami), and Ayurvedic etc. Out of these, Pharmaceuticals and biologicals are controlled quite closely, medical devices are controlled but there is a portion of smuggled items which also gets used. Health & OTC category is very loosely controlled only to the extent of enlisting them, otherwise, the quality and prices are not regulated.
Locally produced, generic drugs dominate the market. These are generally low-cost and affordable. Local production and supplies also make these drugs accessible to everyone in the country.
Pharmaceutical licensing and manufacturing are regulated by the federal government while the distribution and market sales are regulated by the provincial governments. This dichotomy creates certain issues.
Quality of Drugs
Let us look at the biggest concern and question often raised by public, and even from highly placed people; it is about quality of drugs.
Although various percentage figures are thrown around, 40% to 80% drugs being substandard or spurious or counterfeit, no one knows precisely the extent of quality issues.
The biggest argument against this is that 90% retail market is captured by the top 50 companies. They are all developed and reputed organizations who have good controls in place. It means that 90% products have reliable quality.
The second argument is that if 40-70% drugs were of poor quality, then the patients would not be getting relieved of their ailments. The success rate of medical treatment in Pakistan is comparable to other countries.
The third argument is that the government has strengthened and reinforced its testing labs structure, including stringent checks on their processes. The number of failed samples has not grown considerably.
The fourth argument is that retail pharmacy business has evolved and developed greatly. No good retail pharmacy is involved in such practices.
Having said all this, counterfeit drugs business is a worldwide problem. Counterfeit drugs are defined as products deliberately and fraudulently produced and /or mislabeled with respect to identity and/or source to make it appear to be genuine product. These may include drugs that contain no active pharmaceutical ingredient, an incorrect amount, of inferior quality, or wrong formulation, and may be produced in substandard conditions. WHO states that almost 10.5% of the medications worldwide are either substandard or fake. In low-and-middle-income countries, this figure rises to 13.6%.
Incentive-linked Prescribing – ILP
The bigger problem in Pakistan is ‘incentive-linked’ prescribing which is aimed at benefitting the prescriber.
A 2024 research article states, “Three interlinked factors perpetuating incentive-linked prescribing we identified were:
- gaps in understanding of conflicts of interest and loss of values among doctors
- financial pressures on doctors operating in a (largely) privately financed health-system, exacerbated by competition with unqualified healthcare providers
- and aggressive incentivization by pharmaceutical companies, linked to low political will to regulate and an over-saturated pharmaceutical market.”
Another article published in October 2023 focuses on Conflict of Interest – COI – in medical practice, and its impact on healthcare delivery and quality. COI can be broadly defined as a situation that arises when the opportunity for personal gain takes priority over professional responsibility.
Trust is the cornerstone of the doctor-patient relationship. Doctors hold an authoritative position based on their knowledge and expertise and are trusted by the healthcare system and patients both. The doctors are required and entrusted to diagnose, treat and/or manage patients’ illnesses, while considering their social and financial circumstances.
COI occurs as a result of interactions between doctors and medical representatives – MRs. While MRs are a source of drugs and drug-related information, this interaction may turn into a ground for financial corruption. Incentivizing of doctors by pharma companies is a win-win situation apparently for both parties. The company gets business and profit, and the doctor gets paid additionally on top of the money he charges from the patients. In 2021, DRAP published rules prohibiting pharma companies to offer incentives to doctors in any form, but rules are never enforced or followed.
Incentive-linked prescribing – ILP has become normalized among the doctors community, in fact, they also devise ways to maximize their incentives. Doctors may prescribe costly or unnecessary drugs to patients thereby burdening them without justification. The patients suffer financially and may also have adverse effects on their health. For example, ILP is the largest contributor to the consumption of antibiotics and antiulcer drugs in Pakistan. Misuse/abuse of antibiotics is causing antimicrobial resistance which has taken the proportion of a worldwide threat, even more so in Pakistan. ILP is also playing a key part in the prescriptions of supplements/ vitamins/ herbal drugs, and it has opened a huge window for making money. These products, being without control, are priced very high and the incentive money is also proportionately quite high. DRAP also notified and asked doctors to stop prescribing these non-drugs, but DRAP has no means to follow it through; nothing changed.
Few words about medical devices, which include the very basic disposable syringes and go up to cardiac stents, intraocular lenses, and other sophisticated items. These items are registered by DRAP, but the price is not fixed. In most clinics, the cheapest products are used but patients are charged for the most expensive brand. Cardiac stents are a huge scam because the need is prescribed by the cardiologist and his word is final. He would do the intervention and put one or more stents and charge for these in hundreds of thousands of rupees. Because stents are not sold in pharmacies, the patient will not know which brand he got and what was its actual price. India-made stents are very low cost while US-made ones are quite costly. Same practices are going on in other such procedures. There is no ILP involved here, but the doctor has the possibility to maximize his profit, and he does.
Sum Up
Pharmaceutical and medical devices companies are an integral part of healthcare everywhere. Their importance and contribution cannot be overstated. However, malpractices in this relationship are occurring everywhere. The problem is the implementation of rules, not their absence. In Pakistan, the writ of doctors is much stronger than that of the government, in fact, they are not the only pressure group, there are others also, for example, lawyers.
Concluded.
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For most blogs, I research from several sources which are open to public. Their links are mentioned under references. There is no intent to infringe upon anyone’s copyrights. If, however, it happens unintentionally, I offer my sincere regrets.
References:
https://www.uspharmacist.com/article/counterfeit-meds
