Pharmacy Law, Regulations and Ethics Report

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Introduction

Pharmacy is the field that is mainly involved in ensuring that safety and effectiveness is adhered to during the usage of pharmaceutical drugs. More importantly, the scope of pharmacy has widened thus incorporating the provision of drug information and pharmacology. The United Arab Emirates had about 1000 pharmacies in 2003. The minimum standards are upheld and regulated through the enforcement of the guidelines set by the world health organisation (WHO). The UAE has set guidelines for pharmacists and assistants. The pharmacy law and code of practice has asserted that all pharmaceutical practitioners must adhere to the laid down guidelines in the UAE Pharmacy Law and the MOH code of conduct. The two legal frameworks are the main pillars of the regulatory functions in the UAE (MOH, UAE, 2003, para. 1).

Pharmacy is basically divided into several distinct and intertwined categories. Pharmaceutics relates to the facets that are part of the production process of medications that can be effectively and safely utilised by patients in the society. The pharmaceutics is therefore important in the understanding of the dosage requirements of the final product. Pharmacokinetics and pharmacodynamics fall under this category. Medical chemistry is typically the field that is involved with the design and overall synthesis of the pharmaceutical drugs. It provides the basis for therapeutic usage of all drugs.

Structure and function of health services and legislation

Pharmacy practice is mainly concerned with the development of the professionals by instilling new and evolving knowledge. In this area, continued professional development is emphasized. Integration with disease management and patient care are also taken in considerations. The functional services transcend the private and the public components of health care in the UAE (Al Nahyan, 1983).

Health care legislations in the UAE are coordinated from the regional and the federal authorities. The federal government is reliant on the Ministry of Health to enforce and set policy guidelines on the provision of health care in the UAE. The health care legislations cover the implementation of the various guidelines, the setting up of pharmacies and the eventual registrations of the practitioners and their businesses. The MOH inspectors and the pharmacy licensing committee work in synergy in ensuring the process is smooth. The applicant must pass a mandatory examination before the inspectors can engage in the inspection process in the premises (MOH, UAE, 2003, para. 10-15).

Professional regulation and governance

The pharmacy licence is granted when the applicants satisfactorily fulfils the requirements of the pharmacy license committee. Applicants must pass the compulsory UAE pharmacy regulatory exam before the relevant accreditation documents are forwarded to the MOH for the processing of the licence. The applicant is therefore required to submit a copy of Arabic and the mandatory pharmacy exams. An authenticated copy of the qualification received is then processed through the relevant authorities in the country of origin in conjunction with the ministry of foreign affairs in Dubai. Other requirements include testimonials from previous employers and a mark sheet.

On the other hand, continued professional development must be ensured at all levels. In this regard, all the students in UAE can only commence training after the MOH has approved. The legal framework asserts that all practitioners must undertake refresher and additional training in order to keep with pace with the current occurrences in the field. In this regard, all staff are supposed to maintain a record of all activities where they are involved in professional development. According to Shamma (2008, para. 1-4), more than 565 pharmacists were compelled to undertake a continuing education program in order for the MOH to renew their licences. The continuing pharmacy education taking duration of 20 hours was mandatory for all staff in the public and private sectors.

In the late 90’s, the UAE MOH initiated a code of ethics that were to be observed by all professionals in their undertakings. The pharmacists should observe high levels of competence while showing a lot of respect to the patients and fellow workers. Moreover, personal integrity is required of them in their daily activities. Competence must be maintained through regular and continuous professional development and communication directed on the patient particularly on the usage of the drugs (Ministry of Health, UAE, 1999, para. 5-9). A competent pharmacist must also be affiliated to a recognised pharmaceutical organisation and advise the juniors on matters concerning competence. The pharmacist should embrace the patient demographics, culture and appreciate their right to have access to safe medicine. Respect must also be observed towards the environment and the pharmacy fraternity. Upholding the confidentiality of all patients’ medical records and strict observance of the official policy is part of the professional integrity.

Disciplinary procedures are contained in the UAE federal law No. 4 of 1983 which is mandated to govern the pharmaceutical professions and the operating institutions. The license committee is charged with the responsibility of identifying violations, determination of the cases and then making their judgements based on the rules and regulations (Al Nahyan, 1983).

The federal law has set out some requirements for the applicants wishing to start a pharmacy. The applicants must avail their particulars and those of the professional practice licence. Approval of the license is bestowed in the administrative authority department in the MOH. The department ascertains that all the conditions are met before forwarding their recommendations to the licence committee for approval.

The MOH released the guidelines to be observed in good pharmacy practice in UAE. The document sets out the legal framework and ethics to be followed. Supervision of all unlicensed personnel including students is also stressed. All structural changes to the equipment and the environment must be approved before they are effected. The environment must be properly maintained through proper disposal of drug wastes. Documentation such as licences must always be displayed in the premises while registers on drugs and MOH circulars must be kept. The MOH must have authorised all the drugs on offer in the UAE pharmacies while specifications on distribution and sale of medicines must be adhered to safeguard the safety of clients (Al Nahyan, 1983).

The GPP guidelines are utilised as the main basis for routine inspections of pharmacies before registration or extension of license by the MOH inspectors. Inspectors are chosen by the relevant ministries and are supposed to work together with the pharmaceutical practitioners.

Drug registration in the UAE is approved by the minister in accordance to the guidelines in the federal law that dictate procedures to be followed in preparation of the products. The MOH requires information provided in the insert to have similar message as that in the country of origin. Leaflets must be in both English and Arabic languages. All imported medicines must undergo registration before they are circulated.

Laws and regulations pertaining to the sale and supply of medicines

All marketers should register their medical company before they can commence the marketing operations. The federal law also brings out the guidelines in the establishment of medical factories and the storage of the medicines. Imported products must have labelling indicating their shelf life, correct amounts to be dispensed and their level of toxicity (Ministry of Health, UAE).

Permission to sell or dispense dangerous substances such as poisons is denied by the federal law. The article further directs that only competent doctors can utilise the poisonous material. Article 52 asserts that the manager is charged with the responsibility of ensuring the safety of the dangerous drugs.

There are elaborate programs in the federal law of 1983 aimed at protecting he patients from harm and exploitation by the manufacturers and pharmacies. Prescriptions concerning dangerous drugs are regulated and updated by the minister in charge as set in article 72. The overall chain in the management of drugs has programs set to protect the patient from harm (Department of Health, 2008).

Evaluation of the UAE and UK pharmacy practice

Pharmacy practice is far much developed and advanced in UK when compared to UAE. The UK and UAE pharmacy practices are similar in many ways as dictated by the regulations set by the World Health Organisation. However, some differences exist in their implementation in the two countries.

The healthcare legislation is governed by the Department of Health which is supported by several legislations and orders. The Royal Pharmaceutical Society of Great Britain (RPSGB) is mandated to regulate the pharmacists and pharmacist technicians particularly in England, Wales and Scotland. Like in the UAE, continuing professional development is emphasized and regulated. The RPSGB leads the call for advancement in pharmacy practice and education in a bid to improve and broaden the knowledge and education in pharmacy. Licensing in the UK is governed by the Pharmacists and Pharmacy Technicians Order of 2007.

The code of ethics in UK is patient centred unlike in the UAE where equal weight is given to the patients and practitioners. The patient is considered as the first concern and judgements are based on their preferences. In UAE, the practitioners are also supposed to observe personal integrity and respect when dealing with the customers (Royal Pharmaceutical Society of Great Britain, 2007, p.1-10). However, UAE lacks an official ethical document compared to the much developed UK (Dajani, 2004, para. 10).

The UAE lacks clear legal framework that govern the operations of the pharmacy institution operations. The UK has developed over time and has therefore entrenched a solid framework that ensures effective legislation of the public and private institutions. The Medicines Act of 1968 has set the guidelines that have divided the categories of drugs and the enforcement measures. This is almost similar to federal law of 1983 in UAE that set to regulate the selling manufacture, distribution and prescription of the drugs. UAE lacks the pharmacist prescribing and electronic patients’ records that are generally common in the UK (Dajani, 2004, para. 12-18).

Patient safety program are advanced in UK and are backed up by stringent regulations to ensure that misuse of drugs is minimised. The misuse of drugs act of 1971 controls the utilisation of the medicinal drugs and prohibits reckless dispensing of harmful drugs to patients. Similarly, UAE has enacted regulations that bars and sets penalties for violators of the set regulations.

Conclusion

Pharmacy practice has improved over the years in UAE due to the embracement of reforms and the growth in the economy. The federal law of 1983 is the foundation of the regulatory framework. Several regulations on code of ethics, continued professional development and licensing of institutions and pharmacists are in place. The UAE and UK share several similarities in their pharmacy practice despite the fact the UK system is far too much advanced. Ethics must be upheld to ensure that the practitioners and patients rights are maintained.

Reference list

Al Nahyan, S. (1983). UAE Federal Law No: 4, 1983: The Pharmaceutical Professions and Institutions. Web.

Dajani, S. (2004). Gold, golf and pharmacy in the Gulf. The Pharmaceutical Journal, 273(733), 930-931.

Department of Health. (2008).The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008: guidance. Web.

El Shammaa, D. (2008). Abu Dhabi pharmacists to undergo training programme. Web.

Ministry of Health, UAE. Guidelines and minimum standards for Good Pharmacy Practice (GPP) in UAE Pharmacies. Web.

Ministry of Health, UAE. (1999). Code of ethics. Web.

Ministry of Health, UAE. Human drugs. 2010. Web.

Royal Pharmaceutical Society of Great Britain (RPSGB). (2007). Code of Ethics for Pharmacists and Pharmacy Technicians1. Web.

Royal Pharmaceutical Society of Great Britain (RPSGB). (2000). Code of Ethics and Professional Standards in Medicines, Ethics and Practice: A Guide for Pharmacists. Web.

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