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Pharmaco Legal Risks
Alan FrameRisk Adviser
The role of MDDUS Advice
Complaints
Indemnity
Regulatory Support
Risk Management
Consultancy
Common Pitfalls
Complaint Handling Confidentiality Consent
1. Complaints
“ An expression of dissatisfaction requiring a
response”
General Pharmaceutical Council
Standards of conduct, ethics and performancePrinciple 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’
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
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
Organisational Defences - The ‘Swiss Cheese’ Model
Adapted from the work by James Reason
Other holes due to latent conditions (e.g. faulty equipment, lack of training)
Successive layers of defences, barriers and safeguardsSome holes due to active failures (e.g. mistakes, procedural
violations)
latent Failures x local triggers x active failures
‘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
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
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.
2.Confidentiality
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
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.
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.
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.
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.
•Look after patient information
Protect
•Ensure the patient is aware of how their information is used
Inform
•Allow patients to decide if and what information can be disclosed, and in what ways
Provide Choice
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.
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?
3. Consent
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.
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.
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
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
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
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.
What are the patients main concerns ? What will be the effect of my medication on:
Sleep pattern Activity levels Alertness Weight gain Libido
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?
Pharmaco Legal Risks
Alan FrameRisk Adviser