List of questions with respective answers – Malta Chamber of Pharmacists

Hereunder is a list of questions with respective answers pertinent to our profession.

Question: Re Professional Indemnity Insurance Cover

I am a locum pharmacist working only 3.5 hours every two weeks. Do I still have to get PII cover? It’s a cost that is uncalled for!

Answer

Yes, the requirement for PII cover is irrespective of the number of hours because the possibility of committing an error or omission and subsequent indemnity claims is there. With the inception of the EU Cross Border Health Care Directive and its transposition into the national legislation (LN 388 of 2013), Professional Indemnity Insurance cover is no longer a choice but an obligation. It safeguards patients’ rights for redress as well as allowing for solid defence and financial indemnification for the individual pharmacist facing the claim. It also safeguards patients that pharmacists serve.

Starting at just 2.42 euros per week you can have peace of mind. You should consider talking it over and negotiating with your employer and increase your hourly rate to include this obligatory cover. In a survey conducted in October 2013 we found that the going hourly rate for locums is 12 euro/hour. However, there are locums receiving up to 15 euros/hour and even more. Thus if you fall in the 12 euro bracket your request to raise your hourly rate is fair and just.

We strongly advise you to purchase your own PII cover rather than opt to be covered by your employer’s insurer. Many employee pharmacists and locums are led to believe that they do not need their own insurance because they are covered by their employer’s insurer.

This is an over simplification, because if the employer takes on pharmacy cover the indemnity cover is shared among the other pharmacist staff; so unless the employer takes on extra cover, you may be left out in the cold should more than one claim per employee arise in a given year. With the pharmacy cover , in the event of a claim , the employer and pharmacist may have opposing postions on the matter. This potentially puts the employee and locum pharmacists at a disadvantage should they wish to defend their own reputation. Furthermore, the pharmacy cover is not transferable while the individual cover addresses the individual’s claim wherever it arises (within the scope of the policy).

Thus our recommendation is to have your own individual cover so that you are always in control. The Directive also requires the individual to have his or her own cover.

This query was received by telephone in February 2014

Question: Re Professional Indemnity Insurance Cover

If a pharmacist is only working on a part-time basis as a locum POYC pharmacist (i.e. he/she does not practice in a community pharmacy), does that job still require the insurance cover? This point is being raised since the Government stated that his employees need not get a separate cover. After all POYC is purely dispensing Government stocks of medicinal products to those patients which are entitled to get them!

Answer

It is incorrect to state that by working on a part-time basis as a locum POYC pharmacist, a pharmacist does not practice in a community pharmacy. There is no distinction between working as a POYC pharmacist and a community pharmacist. Both are one and the same thing: dispensing and providing a patient healthcare service. And Pharmacists in this context are all employed by the private sector by virtue of a private-public partnership contract.Pharmacists employed by the Government are those who are on the Government payroll. Only these will be covered by Government. All those pharmacists dispensing POYC medicines from private community pharmacies need to have their own individual professional indemnity insurance cover. We also advise that 5 yr retro cover is also purchased.We strongly advise that this is purchased by the individual employed pharmacist rather than he/she relying on the fact that the pharmacy owner purchases cover for the whole staff complement.

Question: Re Professional Indemnity Insurance Cover

Is the managing pharmacist responsible for ensuring a last minute Locum is covered by an insurance?

Answer

While the law does not state that the managing pharmacist is responsible for ensuring a last minute locum is covered by a PI insurance, nor with a valid registration with the Pharmacy Council, it does state that the licensee is because it is a licence requirement to have a registered pharmacist present whenever a pharmacy is open to the public. Valid registration of a pharmacist with the Pharmacy Council is a major prerequisite to practice the profession. It is up to the individual pharmacist to ensure that valid licence registration and individual PII cover are in place in the eventuality that a claim is brought against him/her. However, from a litigation aspect it might be the case that the patient might sue the pharmacy owner/licensee for his redress. It is then that you as a licensee if you are also a managing pharmacist might face an issue… This will however depend on the ruling given and more especially on the judge discretion in giving that ruling.

This query was received by email in February 2014

Question: Re Pharmacy Technicians Obligations at Law

Is there a link that you could forward with respect to the duties and
obligations of pharmacy technicians in a community pharmacy setting
according to law? Thanking you in advance.

Answer:

The roles of Pharmacy Technicians as not listed specifically in the legislation.
The Medicines Act refers to the activities of Pharmacists and Pharmacy Technicians in Part III, Title IV, Articles 66-89. (http://justiceservices.gov.mt/DownloadDocument.aspx?app=lom&itemid=8924).

The only specific mention of Pharmacy Technicians in the law is in article 76 which states: ”(1) Unless otherwise provided by or under this Act, a
medicinal product shall only be prepared or dispensed from a pharmacy and by a pharmasist:
Provided that a pharmacist may permit medicinal products to be prepared or dispensed by a pharmacy technician under his personal supervision as regulated by or under this Act.” (my bold characters and underlining of the text)

Thus the pharmacist is responsible and must be in a position to supervise. It is up to the Pharmacist to decide which tasks to delegate to the Pharmacy technician. This does not

however

exonerate the Pharmacy technician for his or her responsibilities, being registered and certified by the Pharmacy Council. Also please note that the code of ethics of the Pharmacy Council

call

on the Pharmacy technicians too.

As far as we are aware, the Pharmacy Council is working on the establishment of the roles of Pharmacy technicians and this would be welcomed by this Chamber which expects to be consulted on this matter. We would inform our members accordingly.
This query was received by email in December 2013

(Published 24/01/2014)

Question: Re Professional Indemnity Insurance (PII) Requirement for Pharmacists working in the Industry

It is to my understanding that professional indemnity insurance will become obligatory to all pharmacists and might even be linked with our warrant.

As the Chamber is a union also representing pharmacists working in the industry, can I respectfully ask the Chamber to address my following concern.

Legal notice 388 of 2013 clearly specifies that: “All health care professionals providing a health care service in Malta must be in possession of an appropriate professional indemnity insurance cover or equivalent.” I work as a QA in a pharmaceutical company and never work in the community or hospital. I thus do not offer any health care service. On the other hand I do not wish to lose my warrant since this is required to handle dangerous drugs in the pharmaceutical industry.

I do not think that it is fair to link the professional indemnity with one’s warrant, since as I showed you above one can have the need for a warrant without providing direct clinical service to the patient.

Answer:

Your query is legitimate.

As you rightly say, the LN 388 of 2013 clearly states that the legislator is requiring ”health care professionals delivering a healthcare service” to have a PI or similar cover. As you are aware this is a requirement by the EU

cross border

healthcare and patients’ right directive.Thus it is clear that the health care professional must be delivering a healthcare service.

After representations by the Chamber and other stakeholders with the Minister for Health, the latter convened a Ministerial ‘Medicinal’ Indemnity Committee which has informed us that it has looked at the LN and shall amend it to define with more detail and specificity ”healthcare professional” and ” healthcare service”.

In your present area of practice, as you have described it to us, you do not fall under the directive or the LN, and thus you do not require PI cover as required by the LN.

However, in a more general sense, we do advise you to check with your company if it does provide cover for its employees. In future, on the basis of the directive of free movement of professionals, the requirement for PI cover for all professionals will become a legislative obligation.

I now refer to your query re your desire to retain your registration as a pharmacist. Yes, the authorities have indicated that there will be a requirement for PI cover linked to registration with the Pharmacy Council. But we do not have any information to date on how and when this will become a legal obligation. We are aware that there are pharmacists who do not provide direct healthcare services but would wish to remain on the register and we are addressing this with the Pharmacy Council and the Ministry. We will keep our members posted as things develop.

This query was received by email in November 2013

(Published 24/01/2014)

Question: I would appreciate the Chamber’s advice re a concern on a specific POYC directive.

There are residents from Zejtun* who have been collecting their medicines from other localities eg Ghaxaq* or B’Bugia* but now wish to start collecting their medicines through my pharmacy however POYC staff have informed them and us that they would need to re-apply through us and would have to fill in the form again including the doctor’s section. The patients are complaining that they would have to re-pay the doctor to refill the form when POYC department already have their details. Rightly so!I don’t know whether there is an alternative to this system because the patients are chosing their pharmacy of their choice at an extra expense…..Answer: The directive by POYC dept that patients need to reapply by filling the registration form again is correct. You should help your patients understand that in the first instance, they are applying to register with a new pharmacy and that, since some time would have passed since their original registration, their treatment may have changed, so it is in the interest of their health and safety.We understand that there is the question of paying their GP but they could be advised to go to the health centre doctor.We trust that this clarifies the matter.

This question was received via e-mail on the 6th February 2013 and asnwered on the 26th February 2013 via e-mail to the pharmacist asking the question. *Locality names have been changed.

(Published 27/02/2013)

Question: As pharmacists working in the community sector, we are constantly being approached by patients requesting medical certificates for sick leave, leaving details with us to be passed on to their respective general practitioner thus by-passing the GP visit. Please advise whether this practice is legally correct and how we should proceed when faced with these circustances?Answer: The doctor Issuing the certificate is legally responsible and liable at law. Although prima facie there seems to be nothing wrong such practices are discouraged as the pharmacist is conniving with the patient and doctor. Furthermore, we believe that a pharmacist’s time could be better spent with a focus on patient care rather than being burdened with such an onus.. In this case we recommend that you advise the patient to visit his or her doctor to obtain the certificate. After all it is the doctor’s repsonsibility to ascertain whether the patient is really fit or unfit to go to work. A healthy discussion with the attending doctor in question would be encouraged. Maybe even the doctor does not like the patients’ attitude after all! (Published: August 2012)

When a Pharmacist administers an IM or SC injection what are his/her responsibilities and liabilities (if any)?(Published: Jul 2010)

Is Medical Representation a regulated practice? (Publsihed: Oct2010)

Question: Who is Regulating the Profession and Pharmaceutical Practices Locally?

The Medicines Authority regulates pharmaceutical activities and is responsible for enforcement and inspections at a community pharmacy level as well as at a wholesaler level and beyond in that it oversees and ensures a regular supply chain of medicines and that the right medicines with the correct MAH are on the market. On the other

hand

the Pharmacy Council is responsible for ensuring adequate and ethical practices by pharmacists

practicing

in Malta.

Whenever,

a pharmacist is deemed to be in breech it is the Pharmacy Council who is responsible for conducting the disciplinary function. If upon inspection in a community pharmacy the Medicines Authority notices there is a breech the Licensing Authority is notified and it is the latter who will then levy the fine. A list of fines may be found in the Medicines Act Reference… If then the MA thinks that the breech was due to the pharmacist’s negligence then they shall notify the Pharmacy Council so that the necessary proceeding/case may be put forward and processed accordingly by the Pharmacy Council. (Published: May 2011)

Advertising of pharmaceuticals and marketing activities

Medical representation is a self-regulated area of practice. Furthermore, the advertising regulations are to be abided by and whereas in the past if one wished to advertise a medicine there

was need

to apply for prior approval and get a DH number now this has changed. If there is a breech according to the advertising regulations the medicines authority will step in and take the necessary action.

Who is Regulating the Profession and Pharmaceutical Practices Locally

hand

the Pharmacy Council is responsible for ensuring adequate and ethical practices by pharmacists

practicing

in Malta.

Whenever,

Advertising of pharmaceuticals and marketing activities

Medical representation is a self-regulated area of practice. Furthermore, the advertising regulations are to be abided by and whereas in the past if one wished to advertise a medicine there

was need

to apply for prior approval and get a DH number now this has changed. If there is a breech according to the advertising regulations the medicines authority will step in and take the necessary action.

Pharmacy advertising

a pharmacy

services as being the “best in the island or locality” which poses an issue and goes against the code of ethics. For further guidance please refer to the Code of Ethics hereunder.

Telephone and/or SMS prescribing

cases

it is advisable that the pharmacist keeps

tab

in the daily register. Furthermore, the Medical & Kindred Professions Register may be downloaded from (insert link)

E-mail prescriptions

These per se are not acceptable because the legal framework does not provide for such instances. However, a scanned prescription or an electronic prescription which is then signed and sent via e-mail would be acceptable (such as in a pdf file format).

Prescription validity

Prescriptions are valid for 6 months except those for antibiotics which are valid for 10 days from the date of prescription. If a patient presents a prescription which has been issued more than 6 months ago then it is advisable that the pharmacist asks the patient to go to the doctor for

prescription

renewal. Furthermore, pharmacists should ideally stamp and sign every prescription they dispense. This is so as to ensure that patients do not abuse

their medications.

Over-the-Counter medicines

At the point of Marketing

Authorisation

the product is classified as OTC, Pharmacy Only (P), or Prescription-Only-Medicine (POM). Sometimes this will depend on pack size as to whether it will be classified as OTC, P, or POM. It is the MAH who decides on classification and not the Regulatory Authority of the country. The classification of the same product may be different across EU member states. This is because in certain countries it would be more viable for the MAH to classify as POM vs OTC or vice-versa depending on what reimbursement model is in place in that particular EU member state.

OTC medicines are the full responsibility of the pharmacist. Thus if the pharmacist is suspecting abuse by a patient then he/she can refuse

dispensing

the item. It is not advisable that pharmacists recommend OTC products for

off-label

indication as then the responsibility and liability of the pharmacist escalates in the eventuality that the patient experiences an adverse event at worst resulting in overdose and death. In such

instances

this would be considered a criminal offence. LN292 of 2006 Prescriptions and Dispensing Requirements Rules.

Temporary Closure of a Pharmacy & Locum Pharmacists

If a pharmacist proprietor would like to take a period of rest he/she is obliged by law to appoint a temporary managing if the rest period is 5 days or more and in addition ensure that the pharmacy is open at all times during his absence. The Medicines Authority is not in a position to grant permission for pharmacy shutdown at any point in time according to the present legislation. Temporary Closure due to refurbishment or sickness is acceptable on condition that the Medicines Authority is advised.

It is advisable for the Managing Pharmacist to keep a “Locum Pharmacists Register”. In this

the locum pharmacist replacing the managing pharmacist should record his name, pharmacy council registration number and signature with specific date and time.

Discounts and Incentives

Medicines are priced at the recommended retail price as per wholesaler/importer invoice. Although there is no provision in the law that prohibits discounts and incentives it is ethically and professionally discourage to give discounts and incentives at

point

of sale even in a verbal manner as this goes against the code of ethics issued by the Pharmacy Council (insert link).

Purchasing Responsibly

The Managing Pharmacist is responsible for buying medicines from a Licensed Wholesale Dealer so as such will not be liable in the eventuality that upon inspection by the Medicines Authority a medicine is found without the correct Marketing Authorisation Holder (MAH) on condition that the Managing Pharmacist can prove that that medicine was bought from a Licensed Wholesale Dealer. A full list of Licenced Wholesale Dealers may be downloaded from the Medicines Authority website.

Off-Label Prescribing

In certain

cases

a doctor may decide to prescribe a medicine for its side-effect rather than for its therapeutic indication as per Summary of Product Characteristics or even higher doses than

indicted

on the label. In both

cases

the doctor is fully responsible. Although it is advisable that when a pharmacist notices a higher than

normal

dose that the doctor is informed as it could be an error on the side of the doctor. If the doctor is then sure and does not want to change then that means it is an off-label prescription. In that

case

the pharmacist should record it in the daily register.

Can Pharmacists and Other Allied HCPs Prescribe?

As mentioned earlier when a pharmacist is dispensing a medicine that is used on a long-term basis against a prescription which was issued more than 6 months ago then that is a form of pharmacist prescribing. One has to keep in mind that according to the present legislation ONLY medical doctors, veterinary surgeons and dentists may prescribe. Thus even other allied healthcare professionals such as Podologists do not have the right to prescribe. Their ‘prescriptions’ are not valid because they are not considered as ‘prescriptions’ in the first place as it is unlawful for them to prescribe. Thus if a pharmacist dispenses an antifungal preparation or antibiotic cream or a callous preparation for a diabetic patient against a podologist’s ‘prescription’ then it is as if the pharmacist dispensed a POM without a prescription and in that

case

the pharmacist breached the law and is fully responsible for whatever happens to the patient.

Controlled Drugs Dispensing in an Emergency

In the case when patients bring a green prescription without the white control card then the pharmacist may consider as an urgent case and dispense 15 days supply BUT not the full amount as per prescription. It is imperative that the prescriber fills in the white control card also if all the quantity is to be dispensed by the pharmacist. It is recommended that the pharmacist records the prescription and details as to why the full amount could not be dispensed.

References & supporting materials:

Medcines

Act 2003; Pharmacies and related pharmaceutical activity:

Part III Title IV Articles 66-89; pp. A236-A247

LN 292 of 2006 Prescribing & Dispensing Regulations

Legislation. Mark Cilia presentation

Pharmacists Responsibility & Accountability Part I presentation

Pharmacists Responsibility & Accountability Part II presentation

Code of Ethics for the Pharmacy Profession. Pharmacy Council

Pharmacy advertising

Advertising of a pharmacy falls within the remit of the Pharmacy Council and not the Medicines Authority. While advertising a pharmacy is not prohibited as for example in a local magazine so as to support the local community it is the explicit advertising of a pharmacy services as being the “best in the island or locality” which poses an issue and goes against the code of ethics. For further guidance please refer to the Code of Ethics hereunder.

Telephone and/or SMS prescribing

This is not illegal however the pharmacist should only except it in cases of emergency (e.g. Sunday’s and/or Public holidays). Furthermore, the prescribing doctor should furnish the pharmacist with a handwritten prescription within 24 hours. In such cases it is advisable that the pharmacist keeps tab in the daily register. Furthermore, the Medical & Kindred Professions Register may be downloaded from (insert link)

E-mail prescriptions

Prescription validity

prescription

renewal. Furthermore, pharmacists should ideally stamp and sign every prescription they dispense. This is so as to ensure that patients do not abuse

their medications.

Over-the-Counter medicines

At the point of Marketing

Authorisation

OTC medicines are the full responsibility of the pharmacist. Thus if the pharmacist is suspecting abuse by a patient then he/she can refuse

dispensing

the item. It is not advisable that pharmacists recommend OTC products for

off-label

indication as then the responsibility and liability of the pharmacist escalates in the eventuality that the patient experiences an adverse event at worst resulting in overdose and death. In such

instances

this would be considered a criminal offence. LN292 of 2006 Prescriptions and Dispensing Requirements Rules.

Temporary Closure of a Pharmacy & Locum Pharmacists

It is advisable for the Managing Pharmacist to keep a “Locum Pharmacists Register”. In this

the locum pharmacist replacing the managing pharmacist should record his name, pharmacy council registration number and signature with specific date and time.

Discounts and Incentives

point

of sale even in a verbal manner as this goes against the code of ethics issued by the Pharmacy Council (insert link).

Purchasing Responsibly

Off-Label Prescribing

In certain

cases

a doctor may decide to prescribe a medicine for its side-effect rather than for its therapeutic indication as per Summary of Product Characteristics or even higher doses than

indicted

on the label. In both

cases

the doctor is fully responsible. Although it is advisable that when a pharmacist notices a higher than

normal

dose that the doctor is informed as it could be an error on the side of the doctor. If the doctor is then sure and does not want to change then that means it is an off-label prescription. In that

case

the pharmacist should record it in the daily register.

Can Pharmacists and Other Allied HCPs Prescribe?

case

the pharmacist breached the law and is fully responsible for whatever happens to the patient.

Controlled Drugs Dispensing in an Emergency

References & supporting materials:

Medcines

Act 2003; Pharmacies and related pharmaceutical activity:

Part III Title IV Articles 66-89; pp. A236-A247

LN 292 of 2006 Prescribing & Dispensing Regulations

Legislation. Mark Cilia presentation

Pharmacists Responsibility & Accountability Part I presentation

Pharmacists Responsibility & Accountability Part II presentation

Code of Ethics for the Pharmacy Profession. Pharmacy Council

Question: Is Medical Representation a regulated area of practice?

Answer:
Medical representation is not yet a regulated practice and thus it is self-regulated.

In the past, especially in the run-up of pre-EU accession negotiations with the Government, the Chamber independently and in collaboration with the AMR Council had made thrusts so that medical representation would be recognised as another area of practice for pharmacists and had called on the Pharmacy Council to maintain registers for separate areas of practice. More recently, this was again actively discussed with the present AMR council.

As pharmacists by profession, medical representatives are duty bound to follow the Code of Ethics of the Pharmaceutical Profession which was recently updated by the Pharmacy Council after

intense

debate with stakeholders to which the Kamra and its members contributed substantially.

Pharmaceutical Section of the Code, Section: 2.3, Personal Professional Responsibility – states :

“Members of the pharmaceutical profession must ensure that they have the requisite skills and knowledge to undertake, perform or provide services in their area of practice.”
You may download the Code of Ethics of the Pharmaceutical profession from the following link:

http://www.sahha.gov.mt/showdoc.aspx?id=89&filesource=4&file=Ethics%20for%20the%20Pharmaceutical%20Profession.pdf (code of ethics)

Moreover

medical representatives should abide by other local laws and regulations which regulate the promotion and advertising of medicinal products. The advertising regulations may be found in the Medicines Act, 2003 (Act No III of 2003) and the Medicinal Products (Advertising) Regulations, 2005, L.N. 380. The regulations explain the different requirements for advertising to the general public and healthcare professionals. You may wish to download them from the links below:

Guidelines for the advertising of medicinal products for human use (version 1.02)

Medicinal Products (Advertising) Regulations, 2005, L.N. 380

The control of medicines advertising in Malta, from 1 May 2004, is based on the system of self-regulation. The Advertising Committee within the Medicines Authority is responsible for enforcing these regulations and that the industry abides by them. The committee as such does not review or approve any advertisements prior to their publication. BUT the committee will investigate any complaints received and routinely monitors advertisements and provides advice to industry and healthcare professionals and other regulatory bodies.

The Medicines Authority issues warnings, sanctions and penalties whenever there is a breach

these regulations. Below is a form which one may use to make a complaint to the Medicines Authority:

Complaints Form for Advertised Medicinal Products

Further information may be obtained from:

Advertising.mru@gov.mt

In conclusion, it may be noted that it is not mandatory that pharmacists medical representatives pay the annual retention fee to the Pharmacy Council because medical representation is not a regulated area of practice. However, the Chamber strongly advises medical representatives to pay the retention fee to the Pharmacy Council to ensure and maintain registration as a pharmacist.

Furthermore, we also advise pharmacist medical representatives to obtain e-ID registration. This is mandatory for the POYC implementation thus ensuring

that pharmacist medical representatives who

engage in part-time / locum practice in community pharmacy where the POYC service is offered.

References:

Malta Medicines Authority Website

Pharmacy Council Website

http://www.mcppnet.org/publications/ISSUE04-5.pdf pg 10 &13.

Prepared by: Claire Calleja

Reviewed by: Executive Committee of the Kamra ta’ l-Ispizjara ta’ Malta