6.3.4 Personal Medicines Control
Hi All,
Can anyone give me tips on how you implement this requirement of BRC Standard for Packaging? When I present my Gap Analysis result to the management, they think it is not needed and I have to explain to them again and again that it needs to be done.
6.3.4 Procedures shall be in place to control the use of personal medicines to minimize the risk of contamination of the product.
Best Regards,
Lorena
Hi Lorena,
The easiest way to take care of this is to make it part of your GMP policy. Ours is that all medication are to be stored in your personal locker (unless otherwise directed by your doctor) and used only in designated areas (break room, bathroom).
Kevin
Hi Lorena,
When applying procedures in a plant, you have to look not only at the safety of your product but as well of the employees. All auditors will always look at how safe is the workplace.
Is the management aware of what type of medicine the employees are taking (the medicine can cause diziness, impaired vision etc.)?
As a general practice all medicine as well as personal items should be stored in lockers (away from the production and storage areas).
Hi Lorena,
When applying procedures in a plant, you have to look not only at the safety of your product but as well of the employees. All auditors will always look at how safe is the workplace.
Is the management aware of what type of medicine the employees are taking (the medicine can cause diziness, impaired vision etc.)?
As a general practice all medicine as well as personal items should be stored in lockers (away from the production and storage areas).
Thank you! For now no, the management is not aware of what medicines employees are taking. They think that it might violate the privacy act, same thing with the medical questionnaire for visitors.
Hi Lorena,
The easiest way to take care of this is to make it part of your GMP policy. Ours is that all medication are to be stored in your personal locker (unless otherwise directed by your doctor) and used only in designated areas (break room, bathroom).
Kevin
Thank you Kevin, do you have cases wherein employees are advised by their doctor to have their medicine with them always? How did you handle them?
Thank you! For now no, the management is not aware of what medicines employees are taking. They think that it might violate the privacy act, same thing with the medical questionnaire for visitors.
They would be right. Employees have the right to privacy when it comes to medical history and what medicines they are taking.
Thank you! For now no, the management is not aware of what medicines employees are taking. They think that it might violate the privacy act, same thing with the medical questionnaire for visitors.
It is about the company's product safety as well as its employees. You are just ensuring that, in case, the employees/visitors/contractors are carriers of transmissible diseases, cuts, lesions, your product is safe to be shipped to your customers. You will need to adapt your medical questionnaire for visitors/contractors based on your risk assessment, and also enumerate the basic GMP guidelines to ensure product safety and quality.
Thank you Kevin, do you have cases wherein employees are advised by their doctor to have their medicine with them always? How did you handle them?
Examples of medication that may need to be on a person would be a rescue inhaler for asthmatics, a sugar tablet for brittle diabetics, nitroglycerin for heart patients. But think the last two would be rare in a production environment.
Thank you Kevin, do you have cases wherein employees are advised by their doctor to have their medicine with them always? How did you handle them?
No we have not had to deal with this even though i am asthmatic. I never felt the need to have my inhaler in the production room with me, but if i did it would have been in a pocket that was below the waist line to minimize the chance that it would get into the product line.
Great points about balancing the safety of your consumers and the safety and privacy of your employees. in developing your personal medicine policies, you need to consider the following aspects:
- what medicines fall into this group, how are they defined (in North America, you can't really ask your employees what medicines they take), so it becomes more of a telling them - recommended by your health care professional is one good way. I would be very cautious about any restrictions like keeping it in their locker, or a supervisors office - talk to your HR folks before you go that route.
Assuming you are going to allow certain medicines into the production areas, you need to define what the risks are, and how you control them. The main risks would likely be accidental (do you need to consider deliberate as well? this would be part of your food defence protocol) contamination of the product, what are the routes? Time to pull out a risk assessment...
- what are they stored in? the container should not in itself introduce new risks, and should minimize the risk of losing the container
- how many doses are allowed to be in the product zone (would you allow 2 months' worth of warfarin on the floor, or should it be a single dose?)
- how is the container to be labelled?
- if needed, where is the medicine to be taken (do they need to step away from open product?)
- what happens if they lose their medicines in the facility?
I would think a nice concise policy would be able to cover a lot of this, and educating all your employees on the "why" part of the whole issue re-enforces your culture about protecting your consumers, and your employees.
John
A nice concise policy is to ban all medicines from the production area and this is what should be implemented.
Being practical people are not going to have time to carry out a risk assessment for every medicine each employee wishes to take into a production area.
If employees aren't fit to go into a production area for a few hours without their medicines then they really shouldn't be working in that area.
For employees such as Asthmatics who do get sporadic attacks and are likely to require medicines or specific treatment it is in their interest that supervisory staff and first aiders are made aware of this situation and I don't see that as an invasion of privacy.
I have seen medical alert bracelets/necklaces permitted in these situations but certainly not permission to take medicines into the production area.
Regards,
Tony
Assess if there is really a need to bring personal medicines to the production area. Gather data, set a meeting on other departments assigned on the production area and discuss. If agreed that there is really a need, establish a control (you can implement a loose material monitoring) and a policy regarding this. Be sure to cascade and explain the reason for the implementation to employees prior implementation.
Assess if there is really a need to bring personal medicines to the production area. Gather data, set a meeting on other departments assigned on the production area and discuss. If agreed that there is really a need, establish a control (you can implement a loose material monitoring) and a policy regarding this. Be sure to cascade and explain the reason for the implementation to employees prior implementation.
Do or do not. There is no try.
two people with AF and take Warfarin (outside of working hours), then the first aiders are notified for obvious reasons in
case they cut themselves. If required I can then inform any medical intervention of the medication in case the employee is
unable to.
No-one has raised any objections to this. Our procedure states this policy.
The medication is stored in the employee's personal locker
The medication is stored in the employee's personal locker
Would your policy ever allow medications on the factory floor? (eg epipen)
Kind Regards
Mike
would have to do a risk assessment.
I maintain a register of all medication brought on site and the reason for it. If people have particular issues eg we have
two people with AF and take Warfarin (outside of working hours), then the first aiders are notified for obvious reasons in
case they cut themselves. If required I can then inform any medical intervention of the medication in case the employee is
unable to.
No-one has raised any objections to this. Our procedure states this policy.
The medication is stored in the employee's personal locker
That is a good idea, as long as the employees are honest and tell you all the medication that they are bringing in and also if you have for each type of medicine all side effects (or even more what would be the risk of cross-contamination with final product).
This is just my thought/thinking of situation.
I am going to be the fly in this ointment. Production floor is one thing and things like rescue inhalers need to be looked at it but primary should not only be the safety of the food supply but the employee. In the locker or in the car is another issue. First 99% of people won't bring that stuff into the production area as long as they have reasonable access to take it at the needed time. If you have a condition that might require emergency care then wear a medi-alert tag or someone should know, not necessarily the company management. But otherwise, we need to stay out of people's medical care. There is a reason the law allows privacy on these issues. Common sense a bit a of curtsey can go a long way.
Medicines have to be kept in personal lockers etc - but you can take my epi-pen from my cold, dead hands.
:cm:
By the time someone has located my medi alert tag, opened it and read what it says, I may already be dead!
Common sense should prevail; its got nothing to do with a persons privacy; you're not going to be sacked because you have a medical condition, but it is courtesy to let your employer know that you have a condition and that it may need medical intervention.
I once worked in a factory where a member of staff wanted management to buy her a personal fridge to store her medication as she had developed an illness that needed to be controlled by a cocktail of drugs. As one of the first aiders on site I exercised my right not to treat her if there were any episodes as I had no idea if I were dong wrong! Its not being nosy, its being sensible and if you valued your health, you'd let your employer know!
Caz
Its not being nosy, its being sensible and if you valued your health, you'd let your employer know!
Caz
This may be a US issue. Although we are supposed to be afforded protections under the law, most states are "right to work" states which means that you can be let go for any reason or no reason. All too often discrimination is too prevalent, but difficult to prove. Whether it is reproductive issues, issues that gross people out or make moral judgments about or simply viewed as a potential liability issue, too often "letting your employer know" what your being treated for can get you fired. With as few jobs as their are, and as poorly as many of them pay, treating your medical condition gets a lot harder with no or little money and no insurance.
Common sense should prevail; its got nothing to do with a persons privacy; you're not going to be sacked because you have a medical condition, but it is courtesy to let your employer know that you have a condition and that it may need medical intervention...
Caz
Sadly while you may not be told that is the reason....it happens way too much as your condition may raise the cost of insurance to the company.
We're lucky here in that we have something called the Equality Act 2010 which offers some protection to disabled employees.
We're lucky here in that we have something called the Equality Act 2010 which offers some protection to disabled employees.
We are supposed to have protections....but the reality is that they often don't protect workers. While there are many things the US does well this is area with great opportunity for improvement.
Hi Guys,
I am amazed with the discussion! Thank you so much for giving attention. I realized I am not alone :). Anyway, I discussed with my boss and have agreed to put an emergency cabinet on the supervisor's area because it is in the middle of the production floor. Although this is not implemented yet though. The details of how we are going to protect the privacy and at the same time protecting the employees medical condition is not discussed yet but I know now with everybody's suggestion here that this is possible.
Thanks much guys!
If you have an emergency medicine cabinet accessible to anyone it may be good to have that under control by means of inventory and someone initialing what they've taken out from there.