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Pharmacy Legal Risks


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  • The Medical and Dental Defence Union of Scotland is an independent mutual organisation offering expert medico and dento-legal advice, and professional indemnity for doctors, dentists and other healthcare professionals throughout the UK. A similar role is provided by the Pharmacists Defence Association. (PDA)- We provide Indemnity against claims of negligence and legal representation from in-house lawyers who are recognised as among the UK's leading experts.-We also provide representation and legal support at Regulatory body hearings-Help in dealing with complaints and assistance with disciplinary matters -Legal representation and support at fatal accident inquiries and coroner's inquests.For all of these reasons we would consider it prudent for pharmacists to also be fully indemnified and protected for matters arising from their professional work. Our own advice calls analysis show that ‘complaints’ feature at number 1However, we also know that prescribing and drug errors are a common cause of medico-legal negligence claims, sometimes with tragic consequences.
  • The range and extent of pitfalls in a modern pharmacy service are huge, and to illustrate this and for the purposes of this learning module we shall be concentrating on three recurring areas of risk, namely complaints handling, confidentiality and consent.
  • It is both a legal and professional responsibility to listen, respond and learn from comments and complaints from patients. This is part of the delivery of modern high quality care delivery. This NHS adopted definition comes from the Citizen’s Charter Complaints task Force, which says that patients have the right to raise concerns about the service they receive, and to expect an adequate explanation at the minimum.Receiving a complaint can be both stressful and upsetting and staff often feel unsupported and fearful of consequences, including litigation. But making a complaint can be equally as difficult, and it is often not easy to ‘stick your head above the parapet’. Patients often worry about how a complaint may adversely impact on their future care, and if the organisation being complained about has an obstructive complaints procedure it can lead to a complaint being dropped or not pursued.While this may sound appealing to less enlightened organisations and services, it does little to promote the positive aspects of what you do well, and removes a potentially rich area of learning and development.This is not to say that all complaints are reasonable. Dealing with frivolous concerns and overly vexatious complainants can be both frustrating and time consuming for everyone involved. While it is important to be able to identify and deal appropriately with these types of complaints, services should guard against tarring everything with the same brush.
  • Prior to Sept 2010 the Royal Pharmaceutical Society acted as the professional pharmacy regulator. This is now under the jurisdiction of the General Pharmaceutical Council and the Royal Pharmaceutical Society has now reverted to the role professional leadership body.The General Pharmaceutical Council has Seven Principles which govern the standards of conduct, ethics and performance expected of registered pharmacists.Principle 7 relates to the pharmacist taking responsibility for your own working practices.Specifically, paragraph 7.10 states – “Make sure that there is an effective complaints procedure where you work, and follow it at all times”.Whether you are employed by a private pharmacist or by a Health Board, your regulatory body places the onus on you as the pharmacist to make yourself familiar with any complaints policy or processes, and by implication, to raise your concerns if there isn’t one.In the event of receiving a complaint from a patient or their representative, you should also make a record of the complaint, concern or incident and the actions taken. You should review your records and findings and audit them regularly. (GPC advice - Responding to complaints and concerns guidance note 2010)Please note, that for pharmacists working for the National health service, there is a nationally agreed complaints procedure, including set time scales for responses which must be adhered to. At MDDUS we recommend to members working in the private sector that where applicable, good practice is also to follow any agreed NHS protocols in relation to the management of complaints.
  • Looking at the exact requirements for NHS complaints procedures, they vary between the home countries, but in general all require to have - 1. Ownership – of, and familiarity with the processes involved, by all staff2. A named individual / officer with responsibility for ensuring that complaints are handled in compliance with the regulations.3. Leaflets, posters and web pages available, which publicise the complaints procedures, how to go about making a complaint, and expected timescales for response.4. A full Investigation of the complaint including an interview with the complainant, the practitioner and any other staff involved.5. A full response provided in writing, within the agreed timescales set out in NHS procedures.6. Information about the role of, and how to contact independent advice and support agencies such as a solicitor, Citizens Advice or Public Service Ombudsman
  • There are numerous reasons why a pharmacy related complaint may arise, but I would like to impress upon you, three common themes:Human Error, for example, mistakes in dispensing medicines.While it is usually someone’s mistake or error that brings an adverse incident to light, these are often caused or influenced by underlying systems failures, which practitioners may be well aware about but choose to ignore, or perhaps find innovative ways of working around.Also, the way in which a complaint is subsequently handled by a pharmacy, can determine whether or not it is resolved locally to the satisfaction of the person making the complaint, or is then referred to an independent body such as the Ombudsman or General Pharmaceutical Council.As a matter of interest and possible concern for pharmacists, under the Medicine’s Act, it is presently ‘illegal’ for a pharmacist to make a dispensing error. The good news is that there are currently steps being taken at a national level to de-criminalise dispensing errors.
  • The ‘Swiss – Cheese’ model hypothesised by Professor James reason in the 1980’s, first identified how human error and systems failures interact in safety critical organisations and services, using the Organisational defences – Why things go wrong model.
  • The sinking of the Herald of Free Enterprise, outsideZeebruge harbour is a tragic example of how the model works in practice: You may recall that the car ferry set sail with it’s bow doors still in the open position, quickly allowing the lower car decks to flood which resulted in the ship capsizing with the resulting loss of hundreds of lives. Following an extensive investigation and enquiry into the disaster the following words of Mr Justice Sheen are telling:“At first sight the faults which led to this disaster were errors of omission on the part of the Master, the Chief officer and the assistant Bosun… But a full investigation into the circumstances of the disaster leads inexorably to the conclusion that the underlying or cardinal faults, lay higher up in the company.. From top to bottom the body corporate was infected with the disease of sloppiness”The real cause of the disaster lay in a combination of latent organisational failures (in the shape of poor policies, training and a toxic organisational culture,) x Local triggers (a high spring tide and a faulty set of bow doors ) x Active Failures (Significant communication failures and procedural violations ).If we view these three factors as a chain of events, the removal of any one of them from the equation would probably have prevented the disaster taking place. This is an example however, of how a series of circumstances come together in the wrong place and at the wrong time, leading to an adverse event or disaster.
  • There seems to be a fairly widely held belief, that Defence Organisations advise members not to apologise in the event of a complaint being received. The wisdom behind this seems to be that an apology amounts to an admission of liability. This is completely erroneous.Say sorry, and mean it…. There is no harm in a sincere expression of regret!Once you have listened carefully to what the complainer has to say, you may express regret that the patient is dissatisfied/unhappy/ upset. This is not an admission of liability and is often all that the patient is looking for. Saying “I’m sorry this has happened”, or “Thank you for bringing this to our attention”, can be very powerful and de-fusing if done appropriately and with sincerity.Beware however, that an admission of responsibility is something quite different and can equate to an indication of ‘liability’.
  • Claims against all healthcare professionals continue to rise. A slight levelling off in numbers over the past three to four years, has now seen a sharp increase again in 2010 / 2011. The reasons for this are unclear but a contributory factor may be the current economic climate, as people are know to ‘sue’ more readily, when times and personal circumstances are hard. What continues to rise steadily is the associated legal costs in managing and defending negligence claims.If harm can be attributed to incompetence or poor judgement on the part of the pharmacist, it can then provide legal grounds for a compensation claim.The majority of current health care related negligence claims relate to medical and surgical errors, and to date pharmacists have been involved in relatively few civil cases in the UK.However, a proportion of all clinical negligence claims do relate to medicines management issues, and many reflect on the prescribing - dispensing chain, leading to error and harm.It is also common for more than one person to be involved in the supply of medicine chain, both the prescriber & supplier can be apportioned blame, and subsequently the level of any damages awarded can be shared.
  • The concept of ‘duty of care’ is well established in health care provision. It is the first test that a claimant has to establish in a clinical negligence claim, and in reality this relationship almost always exists between the health care provider and patient.Importantly however, the second matter that any claimant has to address is that this duty was breached by the defendant.So how does the court test if any breach of duty has taken place? One of the first and most important pieces of case law in this respect, arose in the case of Bolam v Friern Hospital Management Committee in 1957.The test applied by the court was – ‘The test of negligence is the standard of the ordinary skilled man exercising and professing to have that specific skill.’ A pharmacist is therefore not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of similar professionalmen skilled in that particular art’In this case, Electro Convulsive Therapy (ECT) was administered to the patient without use of an intra-venous muscle relaxant, whichcompliedwith hospital policy at the time. The treatment which causes convulsions in the patient, resulted in bilateral hip fractures. Significantly, and different to nowadays, Mr Bolam had not been warned about the risk of fractures before consenting to the treatment.Mr Bolam alleged negligence on the part of the hospital and sued.Expert witnesses from both sides agreed that large bodies of competent medical opinion were bothopposed to and for the use of muscle relaxant in ECT at the time, but disagreed about whether it was desirable or not to warn the patient of risk of fracture.In Bolam, the court ruled that giving ECT without sedation was an accepted and recognised method of treating depression. The hospitals actions were therefore thought to be ‘reasonable’ by a “group of peers”- and therefore could not be negligent.The Court held that the action was not negligent simply because a contrary opinion existed.The ‘Bolam Test’, became the standard test for all medical and thereafter clinical negligence claims, for many years afterwards. Subsequent court rulings later developed the Bolam argument further. Nowadays it is usually insufficient to mount a defence simply on the basis that because an accepted body of clinical opinion exists, it must be okay to act in this way. If the defendants position does not stand up to logical analysis, then the court reserves the right to reject the argument.
  • Confidentiality is a patients right and must be respected by Pharmacists. It is central to a therapeutic relationship based on trust and breaches of confidence can have serious consequences for the pharmacist.In general terms,explicit consent is needed to disclose information about an identifiable patient, unless the pharmacist is acting under a valid reason allowed by law.In orderto give valid and informed consent the patient must know:-To whom the information will be disclosed-What information will be disclosed-For what purpose it will be disclosed-Any foreseeable consequences which may be significant
  • In the General Pharmaceutical Council – Standards of Conduct, ethics and performance. The relevant entriesrelating to patient confidentiality are contained in Principle 3 – ‘Showing respect for others’.Paragraph 3.5 highlights the need to protect and respect people’s dignity and privacy. The pharmacist must take all reasonable steps to prevent accidental disclosure or access to personal information. The issue of first obtaining informed consent is also highlighted.Paragraph 3.7 is concerned with how the pharmacist uses personal information which, has come into their possession in the course of their professional practice. The over riding principle here is that the information should only be used for the purpose it was intended for, or where the law permits.Paragraph 3.8 requires pharmacists to provide appropriate levels of privacy for patient consultations, and this applies equally to a private pharmacy or a hospital setting.
  • In this case study we shall look at any identified risks and pitfalls, where patient confidentiality is or could be breached, and what could have been done differently.Please read the slide before progressing.The initial encounter shows that the pharmacist was actually observant and empathetic, recognising that the patient was experiencing some embarrassment, due to the nature of the medication. This situation may be very important to a male patient, especially where the counter staff are predominately or entirely female. The first problem encountered however, is the lack of stock held at the pharmacy. Are four tablets sufficient stock? Are the pharmacists stock control systems fit for purpose? In essence, could this particular scenario have been foreseeable, and if so preventable?However, the resilient pharmacist has come up with a plan, which is put to the patient and is agreeable to him. Again, thinking about the patients confidentiality and prevention of any embarrassment, the Pharmacist’s plan is to leave the balance of the medication in a sealed box, with only his name on it, for collection the next day.Can you think of how or where this particular arrangement could come unstuck? Let’s say that the normal arrangements are for dispensed drugs to be securely attached to the relevant prescription, and left on a shelving system, laid out in alphabetical surname order. Are sufficient checks able to be carried out by a counter assistant in the absence of any documented information apart from the patients name? The dispensing pharmacist knows all about the situation but what if he or she is called away, absent or otherwise engaged. Could you be sure that the counter assistant will not hand over the medication until further checks have been undertaken?Does the fact that the patient has agreed to the arrangement offer any mitigation to the pharmacist if anything goes wrong. Well, morally perhaps a case could be made, but legally and professionally it would be extremely unlikely.
  • There can be many advantages to a local pharmacy in knowing who your regular local customers are, especially if you also have close links with local GP practices. For example, remembering who regularly get’s prescribed what by the doctor, often means that it is the pharmacist who will detect a potential prescribing error before anything is dispensed, and a potential patient safety incident can be avoided.However, this local familiarity can pose substantial risks as well, and local talk and gossip can and do lead to serious breaches of confidentiality. Again, everyone is trying to be helpful here, but without giving proper consideration to local protocols and practices which are in place to prevent such breaches arising.The fact that the patients script has been left right next to his brothers on the shelve, makes it very easy for the counter assistant to see both items at a glance. This may not have been an issue however, had the assistant stuck to local Standard Operating Procedures.What do you think about the general principle of handing out medication to others than the person it has been prescribed for? The principle consideration for the pharmacist here is one of ‘consent’. Particular patients may be happy give their permission for medication to be uplifted by members of family or friends, and this is fine as long as the arrangements have been documented and everyone knows what they are. In all cases, the general warning is ‘beware’. In the absence of documented and current consent, no prescriptions should be handed over to any third party by the pharmacist.Also be mindful that personal circumstances can change over time, and previously agreed and documented permissions and consents may no longer be valid.Where this first breach of confidentiality took place is perhaps a moot point. Was it when the Viagra was handed over to the patient’s brother by the assistant, or was it when his curiosity got the better of him and he opened the sealed box for a look? Clearly, the crucial issue is that the prescription is now out of the pharmacists control and in the hands of a third party. Does this constitute a breach of duty of care?Does the nature of the drug in question make any difference here. Well, in theory no. The breach of confidence occurred when the medication was handed over to the third party, regardless of what it was. In practice however, a script for prednisolonewould have been unlikely to generate any adverse outcome!
  • This development perhaps illustrates the importance of having a local complaints handling policy or procedure which staff can follow. However, even if such a procedure was in place it would probably still not have prevented the shop assistant acting in the way she did, having now realised the ‘enormity’ of what she has done.Would the situation have been less serious if she had owned up to the mistake at this point?Undoubtedly so, as what we now have is second serious and on this occasion pre-meditated breach of confidentiality. We can perhaps sympathise with her position and what must be going through her mind, but her subsequent actions in contacting the patient’s mother, is a deliberate violation of confidence, rather than the initial human error which had been caused by an underlying ‘system failure’ – Remember the ‘Swiss-Cheese’ model!What we have now is a perhaps valuable employee, who is going to lose her job over something that could or should have been preventable!
  • As this scenario draws to a close it is perhaps clearwhere this is all heading.At the every least the pharmacist now has a serious complaint to manage. Do you think that the patient is likely to be content with an apology, and a re-assurance that lessons have been learned and procedures changed to ensure a similar situation cannot arise again?Perhaps, if you are lucky, and the previous relationship between the pharmacist and the family was a good one!Otherwise, there is clear indication that the patient wants and expects more than an apology and an explanation, and that monetary compensation is indicated.Before considering ‘labelling’ the patient as some ‘money grabbing, ambulance chasing, opportunist’, please remember that in UK civil law, the only recognised method of compensating an individual against a civil wrong done to them by another, is though monetary compensation.It is now up to the claimant to establish that they were owed a duty of care, that it was breached, and that the pharmacist is therefore liable under law for their actions. Once these grounds have been established it only remains to demonstrate ‘on the balance of probability’, that it was the breach of confidentiality that caused the claimant such emotional distress, and on this basis he has a right to claim compensation.The key question in this scenario would now be whether the two parties can agree on liability and a settlement between them, or whether it is going to be a court that decides and sets the level of compensation.
  • To summarise: Duty of Confidence is as important for the pharmacist as any other health care professional, and the broad obligations can perhaps be set out in this slide: Protect, Inform and Provide Choice
  • There are several circumstances and reasons why a pharmacist may have lawful reason to disclose personal information without the patients consent. One of the common reasons is the ‘public interest’ argument.For example this could involve the pharmacist being told something which indicates that a serious crime or offence has been committed, or even a direct approach from the police who are looking for information relating to an investigation into a crime or offence. Section 29 of the Data Protection Act authorises the police to require the disclosure of information in these circumstances, but the pharmacist should also check current guidance from the General Pharmaceutical Council who may require the pharmacist to take other matters into consideration before any personal information is disclosed.A good ‘rule of thumb’ to abide by, where a pharmacist is disclosing personal information with or without the consent of the patient is, that it should always be the minimum amount of information necessary to achieve the purpose it is being requested for.There are several other circumstances under which the pharmacist can be compelled to provide information or to give evidence at. These include; Any Criminal Court ProceedingsCivil Court ProceedingsIndustrial and Employment TribunalsHealth & Public Service Ombudsmen EnquiriesFatal Accident Enquiries and Coroner’s InquestsRegulatory body committees – GPHC, GMC, GDC, NMC,
  • Finally, in relation to confidentiality, please think about any environmental factors and constraints which could provide fertile grounds for breaches of confidence to take place. Consider the dispensing counter of your own pharmacy-Do you contact patients by telephone from the reception area?, and if so can it be heard by members of the public?Are prescriptions waiting collection ever left visible to the public?Can members of the public hear the team from waiting areas / counter?We are often constrained the physical lay-out of the environment we work in, and in such cases greater awareness and vigilance is indicated to prevent any unintentional breaches of patient confidentiality.
  • The third risk area we would like you to consider as part of this module concerns the area of obtaining valid and informed consent from a patient, and how this may impact on the work of the pharmacist.
  • The relevant sections of GPHC Standards of conduct, ethics and performance relating to consent can be found in principles 3 – Show respect for others, and 4 – Encourage patients and the public to participate in decisions about their care.These principles address the issues of first obtaining valid consent where indicated, for the professional services you provide and how you use patient information which you hold.It also stresses the importance of explaining for example the risks and benefits of any drug therapy, including relevant side effects and contra-indications. In the chain of care, this is not only the responsibility of the prescribing doctor, and the pharmacist has an important role to play here. It also places a duty on you to keep up to date and accurate regarding the pharmaceutical information and knowledge you possess.
  • Does any uneasiness and discomfort in this scenario arise from your own uncertainty as to whether the patient truly understands the full implications of his treatment?What are your professional obligations here, and where do they end?Has the patient’s health care team done it’s job properly? You may presume that the prescriber has already had a full discussion with the patient about the potential side-effects, and that he or she fully understands the implications of this.However, as the dispensing pharmacist you are unable to confirm that the patient does understand the risks involved. The decision to go ahead and dispense rests entirely with you.Your professional regulator’s guidance here is quite specific, in the the pharmacist has a professional obligation to counsel so that their patients are informed and empowered.There is no right or wrong answer here, but suffice to say if the pharmacist goes ahead and dispenses, and it transpires that no one has satisfied themselves that the patient has received and understood the advice about alcohol abstention, then the potential for liability arises in the event of an adverse reaction.There may seem to be an element of inherent unfairness about all of this, but the fact remains that this type of scenario often forms the bases of a clinical negligence claim. The patient will go on to allege that no one had fully explained the risks associated with the prescribed treatment, and if they had then they would never have agreed to take the medication or consumed alcohol for the duration of the treatment.As the pharmacist, you can probably demonstrate that you had the conversation with the patient, but can you demonstrate that you were confident that the patient understood any of what you were attempting to tell him or her?
  • This research perhaps identifies that pharmacists have a key role and opportunity to play here,as well as an opportunity to develop their own communication and clinical skills, while building relationships with their patients.
  • The concept of patient consent in the context of medical research first seized the public’s attention half a century ago during the Nuremberg war crimes trials. This led to the Nuremberg code of ethics which articulated 10 principles safeguarding subjects in research including voluntary consent and the disclosure of the risks and benefits of participation.In 1964 the World Medical Association adopted the Declaration of Helsinki, as it’s official set of guidelines for research involving human subjects. These also re-enforced the risks and benefits of proposed participation and emphasized the human rights protection elements.
  • All health care professionals must understand the principles of informed consent, but to be considered legally valid it must also be demonstrated that the consent has been obtained voluntarily, without coercion or undue pressure.Central to the concept of informed consent is the patient’s fundamental right to choose the best treatment in light of the information he or she has received – this is what is meant by the ethical principle of‘autonomy’. Essentially, for autonomy to exist the patient must have the capacity to fully understand what is being proposed as a treatment, and if they have capacity, retain the right to with hold or withdraw their consent at any time.Regardless of whether informed consent is written or given verbally, the key is that it is an interactive process. It’s success is measured by the patients ability to verbally recapitulate the information. If the patient cannot reiterate the information then by definition, ‘informed consent’ has not taken placeImplicit v explicit consent. Implicit consent may be sufficient and appropriate as long as the patient is given information that meets the standard of reasonable care, and still has the opportunity to ask questions. However it can rarely be relied on with any certainty. As a rule of thumb, the more complex or hazardous the treatment, the greater the requirement becomes to obtain explicit consent.
  • Studies indicate that of almost universal concern is the effect of medication on sleep and activity and Pharmacists have a key role here by using a standard counselling session to determine what the patient needs and wants to know.This may be particularly relevant if the patient has not had the opportunity, or felt unable to discuss these issues with their own doctor, which may indeed be the case.
  • The pharmacists role in the informed consent process is being rightly promoted, and perhaps the public now see pharmacists as being easily accessible for advice on a whole range of treatment issues. This is without the hassle of receptionists screening their calls, and making appointments associated with going to see their GP or hospital consultant.However these potential benefits are often countered by gaps in the information flow, for example where the pharmacist may not have the benefit of knowing what the doctor intends the medication to do, or have access top the patients full medical notes. In the circumstance of relatives requests that information be withheld from a patient-If the patient has capacity and is deemed competent, then pharmacist should take the lead from the patient in these circumstances.Doctors should not withhold information from patients unless it would be likely cause serious physical or psychological harm.Although ‘distress’ may constitute harm in some circumstances, it is not generally accepted as sufficient reason to withhold relevant information.
  • Transcript

    • 1. Pharmaco Legal Risks
      Alan Frame
      Risk Adviser
    • 2. The role of MDDUS
      Regulatory Support
      Risk Management
    • 3. Common Pitfalls
      Complaint Handling
    • 4. 1. Complaints
      “ An expression of dissatisfaction requiring a response”
    • 5. General Pharmaceutical Council
      Standards of conduct, ethics and performance
      Principle 7:
      You must ‘Take responsibility for your working practices’
      7.10 ‘Make sure that there is an effective complaints procedure where you work, and follow it at all times’
    • 6. Complaints Procedures - Requirements
      Ownership and familiarity of processes
      A named individual with responsibility
      Publications detailing the complaints procedure
      A proper investigation
      A full response
      Access to independent advice
    • 7. Common causes of complaints
      Human Error (mistakes, lapses, violations)
      System Failure (e.g. pharmacy doesn’t have adequate SOPs in place)
      How a complaint is managed by the pharmacy
    • 8. Organisational Defences - The ‘Swiss Cheese’ Model
      Adapted from the work by James Reason
    • 9. Successive layers of defences, barriers and safeguards
      Some holes due to active failures (e.g. mistakes, procedural violations)
      Other holes due to latent conditions (e.g. faulty equipment, lack of training)
    • 10. latent Failures x local triggers x active failures
    • 11. ‘Sorry seems to be the hardest word’
      An expression of regret is not an admission of liability
      Be sincere – the complainer will detect a forced or automatic response.
      Try to avoid apologising on someone else’s behalf, or have someone else apologise for you – The complainer may feel fobbed off and end up unhappier than before
    • 12. Clinical Negligence Claims – key facts
      Claims against healthcare professionals continue to rise
      If harm can be attributed to incompetence or poor judgement, it can provide grounds for a compensation claim
      The majority of negligence claims relate to medical and surgical errors, and to date pharmacists have been involved in relatively few civil cases in the UK
      A proportion of all clinical negligence claims do relate to medicines management issues, and many reflect dispensing errors.
      Common for more than one person to be involved in the supply of medicine chain i.e. prescriber & supplier, apportion of blame, and level of damages can be shared
    • 13. Duty of Care
      The law places a duty of care on all health professionals (Kent v Griffiths 2001). Pharmacists are required to prescribe and administer medicine to others to a standard consistent with a responsible body of professional opinion (Bolam v Friern HMC, 1957)
      The Court of Appeal has also held that ‘duty of care’ includes giving advice to patients, carers and nurses about inherent risks in treatment and safe methods of drug administration.
      Royal Pharmaceutical Society guidance states that the supplying pharmacist remains accountable for it’s quality.
    • 14. 2.Confidentiality
    • 15. GPHC – Standards of conduct, ethics & performance
      Principle 3: Show respect for others
      3.5 Respect & protect people’s dignity and privacy. Take all reasonable steps to prevent accidental disclosure or unauthorised access to confidential information. Never disclose confidential information without consent, unless required to do so by the law or in exceptional circumstances
      3.7 Use information you obtain in the course of your professional practice only for the purposes you were given it, or where the law says you can
      3.8 Make sure you provide appropriate levels of privacy for patient consultations
    • 16. Case Study – Confidentiality (part 1)
      A male patient arrives at the pharmacy with a private prescription for Viagra 50mg – eight tablets. The principle pharmacist can see that the patient appears rather embarrassed, and decides to deal with the dispensing himself.
      However, due to a lack of stock, he explains to the patient that he will only be able to supply four tablets today, and asks if he can come back tomorrow for the remainder.
      The patient agrees to this and the Pharmacist explains that he will leave the remaining tablets in a sealed box ready for collection, so that no one else will be aware of the contents.
    • 17. Case Study – Part 2
      The patients family are in fact well known to the shop assistants, and the next day the patients brother comes into the shop to collect a prescription of his own. One of the assistants ‘helpfully’ suggests that he takes the balance of his brother’s prescription for him, as she can see it lying on the shelf next to his.
      The brother happily agrees, but on leaving the shop his curiosity get’s the better of him and he decides to open the pack for a look. On making his discovery he then goes round to his brothers house and proceeds to laugh and make jokes at his expense.
    • 18. Case Study – Part 3
      The patient is understandably furious, and immediately telephones the shop to complain. As chance would have it, his call is answered by the same shop assistant who listens in horror and tells him that she will look into what has happened and get back to him.
      Realising what has happened and rather than report the occurrence to the principle pharmacist, she then decides to telephone the patient’s mother, to see if she can help by talking to her son, and try to ‘sort things out’ with him.
    • 19. Case Study – Part 4
      Perhaps unsurprisingly, it turns out that the patient’s mother is also completely unaware that her son has been prescribed Viagra.
      This further disclosure only adds to the fact that the patient, and his wife were caused acute embarrassment by the whole episode.
      A furious letter of complaint is then received by the pharmacist including a demand for compensation.
    • 20.
    • 21. Public Interest Disclosures
      General Principle is that confidentiality is maintained except where wider public interest may override pharmacist/patient relationship. If consent is withheld – where the benefits to an individual or society outweigh the patient’s interests in maintaining confidentiality.
      Where failure to disclose could place the patient or others at risk of serious harm or death.
      Where disclosure could assist in the prevention, detection or prosecution of a serious crime.
    • 22. Reception Areas / Dispensing Counters
      Can you identify situations and circumstances in which a patients confidentiality could be compromised?
      What could be done to make improvements?
    • 23. 3. Consent
    • 24. GPHC – Standards of conduct, ethics & performance
      Principle 3: Show respect for others
      3.6 Get consent for the professional services you provide and the patient information you use
      Principle 4: Encourage patients and the public to participate in decisions about their care
      4.3 Explain the options available to patients and the public, including the risks and benefits, to help them make informed decisions. Make sure that the information you give is impartial, relevant and up to date.
    • 25. How would you handle this situation?
      An inscrutable recipient of metronidazole stands mute and trance like, as you attempt to impress on him the importance of not consuming alcohol for the duration of his prescribed therapy
      Pharmacists have a professional obligation to counsel so that their patients are informed and empowered.
    • 26. Food for thought!
      “It is becoming common knowledge that between 30% to 50% of patients do not use their medication as prescribed because they lack information.”
      Farley D. FDA’s Rx for better medication information 2001
    • 27. Historical context – Informed Consent
      1947 – Nazi war crimes trials – unethical use of subjects in cruel, tortuous and life-threatening experiments
      Nuremberg Code of Ethics in Medical Research – codified informed consent
      1964 – Declaration of Helsinki guidelines for research involving human subjects
      Global Thalidomide tragedy – global public outcry
    • 28. Valid Consent
      Has been obtained voluntarily, without any coercion e.g. undue pressure from clinician, family, parents etc.
      Patient may also withdraw consent at any time!
      Sufficient information to allow the patient to make a decision weighing up the balance of risks v benefits. A patient must first understand the nature of their condition and the options for intervention before consent can be considered valid.
      Informed Consent
    • 29. How much information should be given?
      You must warn of all risks that are material to that patient
      A careful balance needs to be struck between listening to what the patient wants, and providing enough information in order that their decisions and choices are informed.
      Leaflets and written information can be a useful way of improving information provision but should not be used as an alternative to full discussion.
    • 30. What are the patients main concerns ?
      What will be the effect of my medication on:
      Sleep pattern
      Activity levels
      Weight gain
    • 31. Can you withhold information?
      Not if directly asked!
      Harm issues - Doctors may withhold details of treatment and attendant risks only if disclosure would be likely to cause serious harm to the mental or physical health of a patient.
      What about relative’s asking a pharmacist to withhold information from a patient?
    • 32. Pharmaco Legal Risks
      Alan Frame
      Risk Adviser