1Department of pharmacy, University of Chenab, Gujrat, Pakistan
2Department of Pharmacy, University of Lahore, Lahore, Pakistan
Received Date: 17/09/2024; Published Date: 05/11/2024
*Corresponding author: Prof. Dr. Aqna Malik, Assistant Professor, PharmD, MPhil, PhD (Pharmacology), Department of pharmacy, University of Chenab, Gujrat, Pakistan
Vitamin A, a crucial micronutrient for maintaining vision, promoting healthy skin, and supporting the immune system, significantly impacts public health across the globe. Despite its vital role, disparities exist in the availability and standards of vitamin A products, particularly when comparing developed and developing countries. A comparative review of the medicines' standards for vitamin A in the British pharmacopoeia versus those in Pakistan not only unveils these differences but also highlights the importance of harmonising health standards worldwide. This analysis is imperative for understanding how variations in pharmacopoeial standards and product availability can influence the treatment and prevention of vitamin A-related diseases.
The article will delve into an overview of vitamin A and the associated British pharmacopoeia standards, then explore the available vitamin A products in Pakistan, providing a detailed comparison. Moreover, it will engage in a comparative analysis of products having vitamin A in both pharmacopoeias, spotlighting the medicines which use vitamin A in its pure form without additional compounds for specific disease treatments. Furthermore, the review will cover the dosage and treatment protocols for vitamin A deficiency, concluding with the critical assessment of how these standards and availability directly impact the effective management of vitamin A deficiency. Through a clear layout of these topics, the article aims to offer a comprehensive understanding of the current landscape surrounding vitamin A treatment protocols and product accessibility in both the UK and Pakistan.
British Pharmacopoeia: An Overview
The British Pharmacopoeia (BP) is a critical document that provides official standards for pharmaceutical substances and medicinal products in the UK. Established in 1864, the BP includes comprehensive collections of authoritative standards, incorporating all texts and monographs of the European Pharmacopoeia, marked with a chaplet of stars, as well as national standards developed specifically for the UK [9]. It is developed by the BP team, a group of experts who ensure the pharmacopoeia meets the highest quality standards for medicine safety and efficacy. The BP is updated annually and becomes legally effective at the start of each year, ensuring that it remains a current and vital tool in the regulation of medicines [9].
Vitamin A Products Available in Great Britain
The standards for Vitamin A and other pharmaceutical substances in the British Pharmacopoeia are defined through rigorous testing and quality control measures. British Pharmacopoeia Chemical Reference Substances (BPCRS) are primary standards used to perform these tests. These standards are established using absolute methods, and their declared content figures are determined without comparison to another substance [2,4]. The BPCRS are critical for ensuring the consistency and accuracy of pharmaceutical testing in the UK, making them an essential component of the BP's regulatory framework.
Moreover, the BP includes specific monographs for active pharmaceutical ingredients and excipients, which provide mandatory standards for substances like Vitamin A. These monographs detail the required purity, composition, and other critical parameters that must be adhered to, ensuring that all pharmaceutical products manufactured and sold in the UK meet stringent safety and efficacy guidelines [8]. The BP also contains appendices and supplementary chapters that support the monographs by providing additional guidance on methods of analysis and calibration requirements for analytical techniques [8].
These standards are not only a testament to the BP's commitment to public health but also reflect its role as a cornerstone of the Medicines and Healthcare products Regulatory Agency's strategy to safeguard public health in the UK [9].
Forms of Vitamin A
In Pakistan, Vitamin A is available in various forms to cater to different health needs and preferences. These include syrups, tablets, and capsules, each designed to provide specific dosages of Vitamin A. For instance, syrups are available in concentrations like 0.9 mg/5ml, 1.5 mg/5ml, and dosages extending up to 2800 IU/4ml [12]. Tablets offer a broader range of dosages, from as low as 300 IU to as high as 30,000 IU, allowing for tailored intake based on individual health requirements [12]. Capsules are also available, with dosages ranging from 500 IU to 25,000 IU, providing options for both maintenance and therapeutic uses [12].
Popular Vitamin A Products in Pakistan
Several brands in Pakistan offer Vitamin A products, ensuring accessibility and variety for consumers. Notable among these is the Nutrifactor brand, which offers supplements like Visionex and Icelandic Cod Liver Oil. Visionex is an advanced liquid formulation that not only contains Vitamin A but also includes vitamins C and E to enhance antioxidant support and protect against free radicals. It is designed to support healthy vision and long-term eye health [15]. Icelandic Cod Liver Oil, another product from Nutrifactor, is rich in Vitamin A and D and includes omega-3 fatty acids, which support heart and brain health [15].
Moreover, products such as VI-DAYLIN are available in various formulations at different price points, making Vitamin A supplements accessible to a broader segment of the population. For example, VI-DAYLIN syrup is offered at a retail price ranging from PKR 25.00 to PKR 107.00, depending on the concentration and volume [12].
These products play a crucial role in addressing Vitamin A deficiency, which can lead to severe health issues such as night blindness and immune system impairments. By providing a range of Vitamin A supplements, Pakistan's healthcare market caters to the needs of its population, aiming to reduce the prevalence of Vitamin A deficiency and its associated health complications [15].
Comparative Analysis: British Pharmacopoeia Standards vs. Pakistan Availability
Assessment Criteria: Purity, Potency, and Safety:
Vitamin A's role as an "anti-infective" agent, underscored by studies highlighting its significance in immune responses to infection, forms the basis for its widespread therapeutic use. However, the potential adverse effects associated with synthetic vitamin A supplementation, particularly the risk of bulging fontanelle in infants, necessitate a careful evaluation of purity, potency, and safety standards. This is further complicated by the dose-dependent inhibition of Mycobacterium tuberculosis growth by vitamin A and its metabolites, indicating a narrow therapeutic window where efficacy must be balanced against safety.
Quality and Purity Standards
The British Pharmacopoeia (BP) establishes rigorous standards for Vitamin A, utilizing British Pharmacopoeia Chemical Reference Substances (BPCRS) to ensure high-quality testing and consistency. These primary standards are absolute, meaning their content figures are determined without comparison to another substance [20]. In contrast, Pakistan follows Codex guidelines for maximum residue limits of pesticides and other contaminants in foodstuffs, but does not have a system to enforce these limits in domestically produced foods [24]. This discrepancy highlights a significant difference in the enforcement and application of quality and purity standards between the two regions.
Packaging and Labeling
The BP mandates specific packaging and labeling requirements to maintain the integrity and information transparency of pharmaceutical products. Every package must clearly display critical information such as the name of the product, manufacturer, net contents, and expiration dates [19]. Meanwhile, in Pakistan, packaging requirements are less stringent, generally following Codex rules with no special requirements for environmental concerns such as waste disposal or recycling [24]. Additionally, while British standards require detailed labeling including potential allergens and storage conditions, Pakistani regulations focus more on basic labeling in Urdu and English and mandatory Halal certification without stringent requirements on environmental or health warnings [23].
Regulatory Compliance
The UK's regulatory framework is tightly controlled, with annual updates to the BP to reflect the latest scientific and health standards [9]. Conversely, Pakistan's approach to regulatory compliance in food safety and consumer education was only recently updated with the implementation of Statutory Regulatory Order (SRO) 237 on July 1, 2019 [23]. This order aims to improve food safety but still lacks the comprehensive and detailed approach seen in the BP. Furthermore, the UK's involvement in international development programs like the Food Fortification Programme indicates a proactive approach to addressing micronutrient deficiencies abroad, specifically in Pakistan, by providing technical and financial support to fortify foods like edible oils with Vitamin A [26].
The comparative analysis of the British and Pakistani standards reveals a broader commitment and rigorous approach in the UK towards quality control, packaging, and regulatory compliance, which contrasts with the more flexible and evolving standards in Pakistan.
Dosage and Treatments for Vitamin A Deficiency
Vitamin A plays a pivotal role in maintaining vision, skin health, and immune function. When levels fall too low, supplementation becomes necessary to avoid serious health issues, including night blindness and immune deficiencies. The treatment for Vitamin A deficiency varies based on the severity of the deficiency, patient age, and the presence of any complicating health conditions.
Recommended Dosages
The recommended daily amount of vitamin A is 900 micrograms (mcg) for adult men and 700 mcg for adult women, with variations for pregnant and breastfeeding women, and children depending on their age [32][33]. For treating deficiency, healthcare providers might prescribe high doses of vitamin A supplements for several days, followed by lower doses until symptoms resolve [31][34]. In areas with high prevalence of Vitamin A deficiency, the World Health Organization recommends large oral doses for children to prevent morbidity and mortality, with specific doses outlined for different age groups [28]. It's crucial that dosing is based on the severity of deficiency and under healthcare provider discretion [35].
Common Treatments
Treatment begins with high doses of vitamin A supplements for a few days, transitioning to lower doses to allow for recovery from symptoms such as night blindness and dry eyes [31]. For infants and young children, where high doses can be toxic, the correct dosage must be carefully determined by a healthcare provider [31]. In specific cases, such as cystic fibrosis, lifelong treatment with vitamin A and other fat-soluble vitamins is standard care [28]. Intramuscular administration of vitamin A is recommended when oral administration is not feasible [30]. In regions with high prevalence of Vitamin A deficiency, universal supplementation of select populations is advocated by th e World Health Organization [35].
Personalized treatments utilizing vitamin A Xerophthalmia:
It signifies a severity of VAD that can cause mortality from malnutrition and increased susceptible to infections it is mainly characterized by dry eyes, vision difficulty if left untreated results into night blindness and the lesions on the eye ball mucous membrane it is due to deficiency of vitamin A. Its treatment involves
Vitamin A Therapy: It can be through oral vitamin A supplements ( Retinol, Vitamin A palmitate and Vitamin A propionate) Artificial Tears: It can be through eye drops( Systane Ultra, Restasis and Thera tears)
Psoriasis:
It is a chronic skin disease that causes itchy, scaly patches on various parts of body its treatment depends on severity of condition and individual patient response its treatment involves:
Topical Retiniods: These are creams or gels applied to skin like Tazarotene, Tretionin and Adapalene. Oral Retinoids: It include Acitretin, Isotretinoin and Bexarotene.
Future Treatment:
Retinoic Acid: Derivatives of vitamin A play a crucial role in rregulating cell cell differentiation proliferation and apoptosis which are essential for cancer treatment.
Retinol binding proteins: Proteins like CRBP regulate the uptake and bioavalibility of retinol signalling during cancer progression.
Intracellular retinoid: The presence of specific cytoplasmic retinol and binding proteins (CRBP and CRABPs) regulate intracellular retinoid availability which is crucial for cancer treatment.
Risk and Side Effects:
Supplementation is essential in treating deficiency, it's important to be aware of the risks associated with excessive intake. Acute toxicity can occur from ingesting very high doses in a short period, leading to symptoms like severe headache, blurred vision, and nausea [28]. Chronic intake of high doses can result in dry skin, joint pain, and liver abnormalities [28]. The Food and Nutrition Board has established upper limits (ULs) for preformed vitamin A to mitigate risks associated with excessive intake [28]. Pregnant women need to exercise caution with vitamin A supplements due to the risk of birth defects from excessive use [33]. Possible interactions with medications such as anticoagulants, cancer drugs, and weight-loss drugs highlight the importance of consulting healthcare providers before taking vitamin A supplements [33].
In conclusion, the treatment of Vitamin A deficiency requires a nuanced approach, balancing the need for supplementation to address the deficiency with the potential risks of excessive intake. Healthcare providers play a crucial role in determining the appropriate dosage and form of vitamin A, considering individual health needs and potential interactions with other medications.
Through this comprehensive review, it has been established that Vitamin A is not only essential for maintaining vision, immune function, and skin health but also that disparities in availability and pharmacopoeial standards pose significant challenges to global health. In comparing the British and Pakistani contexts, it is clear that while the UK's rigorous pharmacopoeial standards and regulated market ensure high-quality Vitamin A products, Pakistan faces unique challenges in quality control and product availability. The discussion on specific Vitamin A treatments, including dosage and brands available in Pakistan versus abroad, illustrates the critical need for improved accessibility and quality standards in developing countries to combat Vitamin A deficiency effectively.
Furthermore, these comparisons underscore the broader implications of pharmacopoeial standards on public health. While the UK serves as an example of strict regulatory enforcement ensuring product efficacy and safety, Pakistan's evolving standards represent a significant opportunity for international collaboration and support to enhance medicine quality and accessibility. As this article concludes, it reinforces the call for harmonizing health standards and suggests further research into innovative solutions for Vitamin A supplementation and deficiency prevention. Ensuring that individuals worldwide have access to safe, effective, and high-quality Vitamin A treatments is not only vital for addressing a global health issue but also for advancing towards more equitable health outcomes across countries.
What is the safe limit for vitamin A intake?
Regularly consuming more than 25,000 IU of vitamin A daily can lead to chronic poisoning in adults, while acute poisoning can occur from taking several hundred thousand IUs at once. Babies and children are particularly vulnerable to the effects of vitamin A.
What causes a deficiency in vitamin A?
A deficiency in vitamin A typically arises from not consuming enough foods that are rich in vitamin A to meet the body's physiological needs. This situation can be worsened by frequent infections such as diarrhea and measles. While common in developing countries, vitamin A deficiency is rare in developed nations.
Is it safe to consume 3000 mcg of vitamin A daily?
An upper intake level of 3,000 mcg of preformed vitamin A is considered safe, which is more than three times the recommended daily amount. However, intake at this level may be associated with an increased risk of bone loss, hip fractures, or certain birth defects according to some studies.
Do Americans get enough vitamin A in their diet?
In the United States, vitamin A deficiency is uncommon as most Americans consume sufficient amounts of vitamin A through their diet. Conversely, vitamin A deficiency remains a significant issue in many developing countries, particularly among young children.