8) Pharmacy Procedures and Exemption to Retail Rules Flashcards
Jan 2005?
Every pharmacy must have in place and be operating in accordance with written standard operating procedure
- Applies to both hospital and community pharmacy and covers all activities from receipt of a prescription through to the transfer of the completed prescription and the medication of the patient
Operation procedures do not apply to pharmacies that don’t employ staff
exactly
What did the RPS require to put in place to minimise harms?
SOPs = an SOP is a document which you and the staff will work to
- will specify in writing what should be done, when, where and by whom it should be done, so it’s very specific and it outlines everything within a process.
Benefits of a SOP?
- anyone coming into a pharmacy, if they’re able to read the SOP and it adhere to those steps of a process that every process would be the same. no matter who is carrying it out
also those steps that have been articulated in such a way and put in such a way to ensure reduction of risk and also to achieve harm minimisation - sticking to the concept of clinical governance, all NHS organisations either centrally eg hospital pharmacies or via contract like community pharmacies, are under statutory requirement to haver clinical governance procedures in place.
- so it has a duty to put and keep in place arrangements for the purpose of monitoring and improving the quality of healthcare it provides to individuals
- quality
- consistency
- safe practice
- fully utilise skill mix
- free up pharmacist
- avoid confusion
- advice and guidance for locums
- training new staff
- contribute to audit
What mistakes can go wrong in the dispensing process?
- illegal or unsafe prescriptions
- wrong prods or wrong strengths
- wrong info being transcribed into the label of the product
- ## insufficient warning info
What mistakes can go wrong in the dispensing process?
- illegal or unsafe prescriptions
- wrong prods or wrong strengths
- wrong info being transcribed into the label of the product
- insufficient warning info
How many dispensing errors can occur?
So, on average, for every 10,000 items
dispensed, there are 22 near misses and four dispensing errors.
What is a near miss?
When an error is identified and corrected before it actually reaches the patient.
Dispensing error?
Dispensing error is when
the error actually reaches the patient. So, a dispensing error could occur at least once or twice a month in every pharmacy in the U.K
What can the pharmacist be punished with?
hey could be subject to criminal prosecution. They could be
subject to “fitness to practice” action. They could also be subject to disciplinary action by the NHS
and they can be sued by the patient.
How can these errors come about?
- We could have misreading of the prescription.
- We can have incorrect medicine selection.
- Dispensing from the label and not from the prescription. Now, that’s just sometimes bad
habit. You should always use the prescription as the reference. - Transposing the label or labelling the medicine incorrectly.
- Giving the wrong prescription to the wrong patient or supplying contaminated or outof-
date stock.
You’re a pharmacist manager of a local
pharmacy. Now, the superintendent is concerned about the level of dispensing errors that’s
increasing in your pharmacy and they ask you to identify actions to reduce this. So what can you do in answer to his query?
- So, you could ensure that standard operating procedures for the supply of medicine are in
place. They’re regularly used, evaluated, and reviewed. So you really want to make sure the
paperwork is up to date.- - You want to ensure that there isn’t just one person as a sole dispenser and checker of the
medicine. You want to make sure that someone else’s eyes are looking at this process. - You want to ensure that medicines of similar sounding names or with similar packaging are
not placed next to each other on the self. So you might have strategies of highlighting where
those medicines that sound the same, look the same, might be put in different places or
they may be highlighted differently on shelves or drawers or wherever they are stored. - Another way to reduce risk of errors – by maintaining a medication error log. And what
you would do is you monitor near misses. So if you can see that there are frequent near
misses with a particular drug or drugs, then that would allow you to identify any specific
issues and you can start to look at addressing those issues. - You might look at the work environment. So you might want to look at dispensary layout
to see if you can reduce risk. - It may be an issue around ability to concentrate. So that might be something that needs to
be addressed. A workflow pattern. So, in some pharmacies, they may actually stipulate
where certain aspects of the dispensing can take place within the pharmacy. So on one
bench, that’s where the actual check is done. On another bench, that’s where the labelling is
done, et cetera. - Dynamics of the team. So taking on board all the skills within the team that may need to be
considered in understanding where risk of error can lie. And if there are any personalities
that are also contributing to errors –so, maybe a conflict within the team may be
contributing to a stressful environment, therefore increasing the possibility of error.
What is the Professional Duty of Candour?
Now, if a dispensing error does actually happen, there is something called the Professional Duty of
Candour. Now, this is where health professionals must be open and honest with patients when
things go wrong. This means that you need to tell the patient when something has gone wrong. You
should apologise to the patient and offer an appropriate remedy or support to put matters right.
And you really need to explain to the patient the short and the long term effects of what has
happened. So you need to be really open with the patient.
If a mistake was made, patients may like to take the matter further. Okay? Why might they like to do so?
Well, the fact that the error has been made at a
pharmacy, which many members of the public believe should work 100% accurately, may be a
reason why they think they need to take the matter further. Because it proves that there isn’t 100% accurate. Also, a patient may have been harmed by that error and therefore may want a further investigation. Or a patient is dissatisfied with the way in which the error was dealt with in the
pharmacy. So, maybe there wasn’t a clear, transparent owning up of the error and explanation of how it happened or any kind of effort to resolve anything, really, that happened.
Now, if the patient
takes a complaint further, does it mean that the pharmacist will be struck off?
Not necessarily. The
GPhC will determine if the error is of sufficiently serious nature to require a referral to fitness to
practice hearing.
What occurs within the GPhC process?
They’ll have an initial investigation and that’s
carried out by the GPhC inspector. They will deem if a threshold criteria are met. And if it is, the
cases are referred to an investigating committee. Now, the investigating committee can then refer
to Fitness to practice committee, and the fitness to practice committee can remove the pharmacist
from the register. So it’s quite a lot of investigations that need to be undertaken before a pharmacist
will be struck off. Now, the criteria for referral of dispensing errors.
Cases are not referred to the investigating committee unless they meet certain thresholds, and those are stipulated by the GPhC
and are available on the GPhC website. Now, they really include that:
- there is either moderate to severe harm, which was avoidable;
- there was a deliberate attempt to cause harm;
- there was failure to act when necessary to protect the safety of the patient;
- there are unsafe working practices;
- and also, the pharmacist is unfit to practice safely.
So if those aspects are met, then there is a referral of the error to the investigating committee. It’s
important to remember that, until now, pharmacists are committing a criminal offence each time
they make a dispensing error. And that’s because there have been breaches of law – so Section 64 of
the Medicine’s Act 1968 – and then, specifically, Regulations 268, 269, and 270 of the Human
Medicine’s Regulations 2012. Currently, all dispensing errors are considered as strict liable offences
and a criminal offence is committed even if the error itself is unintentional and regardless of the
level of patient impact. Now, the majority of cases are brought under Section 64, and that stipulates
that a person commits an offence under Section 64 if he or she, prejudice to the purchaser, sells any
medicinal products and that product is not of the nature or quality demanded by the purchaser or
specified in the prescription. So, basically, anything outside of what was written on a prescription is
breaking the law. Prosecutions are rare. Cases will be referred to the criminal justice system if there
have been – there has been a death following an error and gross negligence or manslaughter
charges are being considered. I THINK THERES UPDATES TO THIS
just read thatalso watch/ read this
Since this video cast legislation has been passed on inadvertent dispensing errors: UPDATED INFO ON GPHC PROCEDURES IN LINK
https://www.pharmacymagazine.co.uk/dispensing-error-protection-comes-into-force