Legal and Ethical Responsibilities

1. Martin Knowles Director Pharmaceutical Quality Assurance Legal and Ethical Responsibilities

2. Learning Outcomes • Describe the legal requirements for dispensing of medicines and medicinal products • State the laws and guidance relating to the dispensing of medicines and medicinal products • Discuss the legal and ethical implications of technician checking • Describe the consequences of dispensing/checking errors

3. CIVIL = People Deals with disputes where one person brings legal action against another person they believe caused them harm Tort or civil wrong If proven usually claim financial damages Judges decision CRIMINAL = State Offences against the state Or the “Law of the Land” Crown brings action against the defendant In front of Judge and Jury Jury decision UK Legal System

4. Civil or Criminal?

5. Who enforces which laws ? • Criminal – generally Police • Administrative – nominated representatives of the body concerned • Professional – the professional body concerned • Civil – action taken by whoever was ‘wronged’ (called the plaintiff)

6. What are the sanctions ? • Criminal – fines, imprisonment • Administrative – ‘loss’, generally financial through loss of contract • Professional – reprimand or removal from register • Civil – ‘loss’, generally through payment of compensation

7. What law is relevant to pharmacy? • Pre Medicines Act 1968 - voluntary codes of practice within industry Medicines Act 1968 • Misuse of Drugs Act 1971 • Poisons Act 1972 • Evans Medical Disaster/Devonport Hospital/ Clothier Report 1972 • Breckenridge Report 1976 • Loss of Crown Immunity for NHS 1991 - NHS and Community Care Act 1990 • Manchester Incident 1994 • 1994 - Farwell Report • EL 96 (95) - Internal audit of all unlicensed units in UK • EL 97 (52) - Reported results of above and external audit now a requirement • Human Rights Act 1998 • Health Act, 1999 and 2006 • Employment law, such as Health & Safety at Work Act • The Bribery Act 2010 • Pharmacovigilance Directive 2010/84/EU • Falsified Medicines Directive 2011/62/EC • Human Medicines Regulations 2012 (SI 2012/1916) • Health and Social Care Act 2012

8. Law relevant to Pharmacy… • Laws that protect the public • Laws that protect the profession • Laws that maintain the quality of pharmaceutical products and materials.

9. History of Pharmacy, Medicines and Poison Laws • Pharmacy Act 1852 • established framework of RPSGB • Pharmacy and Poisons Act 1933 • established Poisons Board to advise Secretary of State register of premises set up by act • pharmacists were required to be members of PSGB • establishment of disciplinary body • appointed society inspectors to enforce law • Pharmacy Act 1954 repealed and replaced with “The Pharmacists and Pharmacy Technicians Order 2007”

10. History of Pharmacy, Medicines and Poison Laws • Medicines Act 1968 • replaced all earlier legislation- objective safety and quality of drugs (1961 Thalidomide) • Poisons Act 1972: non-medicinal poisons • Dangerous Drugs Act 1920/1965 • Prevention of Misuse Act 1964/ Misuse of Drugs Act 1971 • Misuse of Drugs Regulations 2001

11. History of Pharmacy, Medicines and Poison Laws • Health Act 2006 • makes provision in relation to the prevention and control of health care infections • makes provision in relation to the management and use of controlled drugs • makes provision in relation to the supervision of certain dealings with medicinal products and the running of pharmacy premises

12. History of Pharmacy, Medicines and Poison Laws • Its amendments to the Medicines Act will establish the overarching requirements for the preparation, sale and supply of medicines from registered pharmacy premises • Responsible Pharmacist • Supervision: delegation of supervision activities for certain tasks e.g. Section 10 Preparation to Registered Technicians under competency framework.

13. Why have Medicines Legislation? • To ensure there is a constant process of checks and counter checks which enforce quality, safety and efficacy - so that medicines we take are of the appropriate quality • It contains the correct amount of drug substance • It’s the right drug • It’s stable to the declared label shelf-life • The manufacturing factory has been inspected and not found wanting • It’s been made and tested by trained professionals

15. How did the Medicines Act come about? • Following the Thalidomide tragedy • Drug for morning sickness • Early ’60s: up to 10,000 babies worldwide deformed • Highlighted gaps in controls relating to the manufacture, marketing and supply of medicines • About Consumer Protection – seeks to ensure the safety, quality and efficacy of medicinal products • All medicinal products to have full PL and be manufactured only under full ML’

16. Legal maintenance of the quality of pharmaceutical products and materials • The Medicines Act 1968 • The primary medicines legislation in the UK • A number of committees of experts were established under the Act including: • Medicines and Healthcare Regulatory Agency • Committee on Safety of Medicines

17. How does the Medicines Act ensure consumer protection? • By a system of licences, registrations and exemptions thereof • Licences: • Product Licence (PL) or Marketing Authorisation (MA) • Manufacturer’s Licence (ML) & ML Specials • Wholesale Dealer’s Licence • Investigational Medicinal Products Licence (IMP) • Registration – of retail pharmacy premises • Exemptions – most importantly Section 10

18. Licensing • Licences (marketing authorisations) are granted by the Licensing Authority • Licences are continuous • Licensed facilities are inspected to ensure continued compliance • Licences can be reviewed, suspended, revoked etc. at any time

19. Good Manufacturing Practice (GMP) • 1968 - Medicines Act • 1971 - First ‘Orange’ Guide • 1983 – ‘Orange’ Guide • 1992 - 1st EC ‘Pale Orange’ Guide • 1994 - Isolators for Pharmaceutical Applications • 1995 - QA of Preparative Services • EL(96) 95 and EL97 (52) • 2002 – New issue ‘Orange’ Guide incorporating EC Guidelines • 1997 – ‘Orange’ Guide • 2014 – Orange Guide – the latest but intention is to publish ever year!

20. Professional Law • Law underpinning the powers to discipline healthcare professionals • currently authority to discipline pharmacists lies in Pharmacy Act 1954 and its new regulations made in 1978 • Standards of care expected- professional ‘Code of Ethics’ + standards, guidelines, protocols set down in NHS care • Professional tribunals judge cases of professional misconduct

21. Law and EthicsThe Purpose and Main functions of the Five Main Pharmaceutical Organisations • Royal Pharmaceutical Society • The Guild of Health Care Pharmacists • The National Pharmaceutical Association • The Association of Pharmacy Technicians But the teeth are here: • The General Pharmaceutical Council (Established by the Pharmacy Order 2010)

22. RPSGB / GPhC • RPSGB de-regulation • Formation of Royal Pharmaceutical Society • Formation of General Pharmaceutical Council

23. GPhC (1) • The General Pharmaceutical Council (GPhC) is the regulator for pharmacists, pharmacy technicians and pharmacy premises in Great Britain. It is our job to protect, promote and maintain the health, safety and wellbeing of patients and the public who use pharmaceutical services in England, Scotland and Wales.

24. GPhC (2) • Continuing Professional Development – legal requirement • Standards are set according to the level of risk that activities pose to the health and wellbeing of the public, and to the level of risk posed by pharmacists, pharmacy technicians and pharmacy owners/employers. • Register only those appropriately qualified and fit to practise (Registration technicians 30 June 2011) • Standards published (‘output’ standards no details as yet how to achieve)

25. Royal Pharmaceutical Society (1) • Our Mission: • We are member driven and will offer the leadership, support and development that our members need to fulfil their potential • We will address the issues that are important to our members to enhance their job satisfaction and professional rewards • We will ensure that the voice of the pharmacy profession is heard and actively promoted in the development and delivery of healthcare policy, and that the vital contribution of pharmacy to patient and public health is widely recognised and acknowledged • We will increase the recognition that pharmacists enjoy as valued partners with the NHS and wider society and ensure that they are positioned and trusted as the experts in medicines • We will lead and promote the advancement of science, practice and education in pharmacy in order to shape and influence the future delivery of pharmacy driven services

26. RPS Benefits (2) • Support • Recognise • Network • Lead • Develop

27. Royal Pharmaceutical Society (3) • Membership category  • Member Applicable to anyone who is currently or has ever been registered as a pharmacist with the GPhC or the previous regulator (i.e. the Society). • Fellow Fellowships can be awarded to a Member of not less than 12 years' standing who has made an outstanding contribution to the advancement of pharmaceutical knowledge or attained distinction in the science, practice, profession or history of pharmacy. • Associate(available from 1 March 2011) Applicable to anyone who holds a degree in pharmacy from an institution recognised by the Society but who is not (yet) eligible to become a Member. • Student(available from 1 March 2011) Applicable to anyone studying for a degree in pharmacy at an institute recognised by the Society. Student members will also receive joint membership of the British Pharmaceutical Students Association. • No registered technicians

28. The Pharmacists and Pharmacy Technicians Order 2007 • Replaces the Pharmacy Act 1954, which is repealed • Professional regulation of pharmacists and pharmacy technicians (E&W), extending to Scotland • Under Section 60 of Health Act 1999 to modernise the regulation of health care professions • Statutory regulation of Pharmacy Technicians for the first time • Requirement to demonstrate maintenance of CPD and unimpaired fitness to practice • All practising registrants to be covered by indemnity/insurance with regard to professional liability

29. Section 60: Health Act 1999 The Pharmacists and Pharmacy Technicians Order 2007 • Statutory committeesThe Society shall have the following committees (in addition to any other committees established under the Charter • (a) Continuing Professional Development Committee;(b) Disciplinary Committee (Fitness to Practise);(c) Education Committee;(d) Health Committee (Fitness to Practise);(e) Investigating Committee (Fitness to Practise);(f) Registration Appeals Committee

30. Pharmacy Technician Regulation and Registration • RPSGB voluntary registration of pharmacy technicians commenced in January 2005 • Statutory powers via an Order under Section 60 of the 1999 Health Act • Statutory registration will commence as soon as is practicable after the necessary legislation is in place expected Spring 2009 • From this date there will be a two-year transitional registration period during which grandparenting arrangements will continue to apply • Long term entry criteria • “Registered Pharmacy Technician” and “Pharmacy Technician” are expected to become protected titles

31. Proposed Mandatory Registration requirements • S/NVQ Pharmacy Services Level 3 • Accredited underpinning knowledge meeting the requirements of the Pharmacy L3 Technical Certificate • Minimum work experience: 14hours per week/2years undertaking duties as a student pharmacy technician • Health declaration • Signature of supervising pharmacist

32. Registered Pharmacy Technicians “RegPharmTech” • Continuing Professional Development [CPD] will be mandatory from first registration • Code of Ethics - key responsibilities • standards of practice • confidentiality

33. White Paper • Trust, Assurance and Safety - The Regulation of Health Professionals in the 21st Century • published on 21 February 2007 • sets out the Government's intention to remove regulation from the RPSGB • give it to a newly-created General Pharmaceutical Council (GPhC) • Government also wishes to see what it describes as a "body akin to a Royal College" to provide leadership for the profession. • Draft Pharmacy Order 2009 (consultation closes Mar 09) takes this forward.

34. Pharmacy Support Staff • Medicines Counter Assistants • Since 1996: professional requirement /RPSGB- any assistant who is given delegated authority to sell medicines under a protocol should have undertaken, or be undertaking, an accredited course relevant to their duties • Dispensing Assistants / Pharmacy Assistants • 2nd consultation/ regulation of pharmacy support staff, from December 2002 to January 2003, the Society's Council agreed to put in place a minimum competence requirement for dispensing/pharmacy assistants from 1 January 2005. • Successful achievement of Pharmacy Services NVQ level 2

35. Break!

36. Ethics • DEFINITIONS • Values: concepts or ideals • Morals: the standards of right and wrong • Ethics: can be defined as declarations of what is right or wrong and what ought to be • Ethical dilemma • An ethical dilemma occurs when an individual must choose between two unfavourable alternatives and requires the application of critical thinking. • THE CONCEPT OF ETHICS • ‘ethics’ is derived from the Greek term ethos, which means customs, habitual usage, conduct, and character

37. Decision Making • Requires understanding of • Criminal law • Civil law • NHS Regulations • Professional Standards / Code of Ethics • Professional Knowledge

38. Decision Making • Mapped on to these is an assessment of values and duties to: • Patient • Carer / guardian / parent • Other professionals • Employer • Oneself

39. Decision Making • Using all of the above together: • What could I do? – the options • What should I do? – the choice • Documentation • Your decision and reasoning, especially where you have ‘doubt’ or intend to go outside of approved local practice (such as SOPs)

40. Ethical decision-making within healthcare • Principles for ethical decision-making: • respect the autonomy of the individual • Individuals action ought to be the result of his/her own choices • avoid harm = non-maleficence • where possible achieve benefit = beneficence • justice • treat similar cases in similar ways • distribute goods and services based on need • consider, fairly, the interests of all those affected • Fidelity: maintain truthfulness and confidentiality • Veracity: honesty

41. Code of Ethics • Codes of Ethics (Now GPhC) • Professional responsibilities • duties and obligations • Professional relationships • professional behaviour • good communication • Accountability

42. The principles of the Code of Ethics are mandatory. As a registered pharmacistor pharmacy technician our professional and personal conduct will be judged against the Code.

43. RPSGB Code of Ethics for Pharmacy Technicians • Pharmacists have overall responsibility for pharmaceutical services. • Pharmacy technicians are personally responsible for their own professional actions and for complying with the principles of the Code of Ethics. • At all times act in the interests of patients and other members of the public. • Seek to provide the best possible healthcare. • Treat all those who seek professional services with courtesy, respect and confidentiality. • Ensure knowledge, skills and performance are of a high quality, up-to-date, evidence based and relevant to field of practice. • Must ensure own work procedures are safe and effective. • Professional activities are covered by indemnity arrangements • They work within standard operating procedures • Maintain records of CPD and make these records available for review by the RPSGB

44. Revised Code of Ethics for both Pharmacist & Pharmacy Technicians Sale and supply of Medicines: Extemporaneous Preparation/Compounding • Public is entitled to expect that products extemporaneously prepared are prepared accurately and are suitable for use. • You must ensure that: • a product is extemp prepared only when there is no licensed product available • you / other staff involved are competent to undertake the task. • The requisite facilities and equipment are available, in good order and fit for the intended purpose. • you are satisfied of the safety and appropriateness of the formula of the product. • All calculations/measurements should be checked. • ingredients are sourced from recognised pharmaceutical manufacturers and are of a quality accepted for use. • the product is labelled correctly, including safe handling/ storage requirements and an expiry date. • records are kept for a minimum of two years and where possible for five years. The records must include: • The personnel involved, including the identity of the pharmacist taking overall responsibility. • If you are undertaking large scale preparation of medicinal products, all relevant standards/guidance are adhered too.

45. Responsible for (a thing) or to (a person) What is Accountability?

46. What is accountability? • Once qualified we have discretion within the law as to how we practice. • However we will be accountable to: • Society as a whole (criminal, civil courts and RPSGB) • Individuals (our patients) • Employer • Awareness of RPSGB Code of Ethics and Standards of Practice • Accountability and responsibility within NHS organisation • CPD to maintain to maintain professional knowledge and accountability

47. Professional Accountability and Responsibility • RPSGB – Accountability, thus professional responsibility, depends on competence for the role • For Technicians = NVQ3 • Technician has accountability for other staff and can themselves be held responsible under SOPs and in professional discipline. • Pharmacists still have overall responsibility even if roles are delegated to Technicians using SOPs • If Technician • complies with SOP then pharmacist still holds responsibility. • is in breach of SOP then professional responsibility is at least shared • If a dispensing error occurs the person making the error is primarily responsible.

48. Criminal courts • The law will consider health professionals in the same way as lay people. • Medicines Act 1968 - sanctions come under criminal law. • Under Section 64

49. Civil Courts • Negligence claims • Balance of probabilities and Bolam Test • Responsibility of pharmacy technician to act within expertise

50. Civil Law - Negligence • Failure in duty of care • Careless acts • Omissions • Careless statements • Contested in civil court • Breach of professional responsibility also an issue for professional regulator