Nice piece on anti-depressants from The Journal

http://www.thejournal.ie/readme/antidepressants-and-mental-health-1507283-Jun2014/

 

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Have you got your submission in yet?

Friday the 13th is the closing date for submissions to the PSI in the delivery guidelines.  Have you got yours in yet?

Here are my submissions that you can use as a basis for yours if you haven’t sent one in yet.  This is too important to just leave to somebody else.  Remember anybody can do it, everybody thought that somebody would do it but in the end nobody did it.

These might be a little dis-jointed as they were sent as three separate submissions.

First

The opening paragraph states that “The delivery of medcines has always been permitted”. I would hold that this statement is inaccurate in so far as that the delivery of prescription only medicines has never been expressly permitted nor has it never been expressly forbidden. This changed with Regulation 19 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003.

From the draft guidance there are three elements that define a supply by mail order.

Firstly there must be “after solicitation of custom by the supplier.” According to Merriman Webster to solicit is to ask for. In this instance it would be to ask for custom. This covers all forms of advertising. So that once a pharmacy has used any form of advertising then it would meet this requirement. The definition in the regulation does not require the addition of a delivery service to the solicition of custom to meet this definition.

Secondly the requiement that “any supply made,…..without the supplier and the customer being simultaneously present” can only be met by the customer (the patient) or their carer being physically present in the pharmacy. The supplier in every instance is the Retail Pharmacy Business (RPB). This is the entity in law that recieves payment for the prescription. The Pharmaceutical Society of Ireland (Retail Pharmacy Businesses) (Registration) Rules 2008 states that

“premises”, in relation to a retail pharmacy business means a fixed premises,

That is to say that by the supplier the regulations imply a fixed premises.

I would take this to mean that a RPB may only operate and dispense prescription only medicines (POM) from a fixed premises. Best practice dictates that transfer of a POM from the Pharmacy to the patient if not carried out personally by the pharmacist should be carried out under their direct supervision. This cannot be done at a distance. If there was to be a transfer to the patient outside of the RPB then it would have to be carried out with a pharmacist employeed by the RPB physically present so that he/she can perform this duty personally or directly supervise this operation.

The physical presence is required because of the third element “any supply made,…..using a means of communication at a distance,..”

If the pharmacist is physically present then communication is not at a distance and the third element is not met. My interpeption of this is that if a pharmacist is physically present when transfer takes place outside of the fixed premises then this transfer does not meet the definition of “Supply by mail order” in the regulations. If transfer of POM occurs without a pharmacist being present then any transfer of POM outside of the fixed premises of the RPB meets the definition of mail order pharmacy.

There will always be instances where it is in the patients best interests to have the medicine delivered to their home. But in these instances to ensure best practice and to meet the requirements of Clause 9 this should be carried out by the pharmacist or a pharmacist employee of the RPB. And because of this these situations should be the exception rather than the standard practice.

The regulations are silent in respect of Nursing Homes and other institutions. I would see these as a different case as here transfer is made to another healthcare professional. However as outlined above if these transfers are carried out by a pharmacist employed by the RPB then there should not be any issue.

Second

Traditionally delivery of prescription only medicines (POM) would have been understood to mean delivery within a local area. This has changed recently with the advent of the growth in nursing homes and other institutions with a large number of inmates who require POM. Many of these are being serviced from locations which are some distance from the institution. Also we have recently seen the development of a discount model of pharmacy offering delivery services nationwide. On as an aside I note that this pharmacy has advertised that their delivery service has the PSI’s imprimatur. Despite requests for clarification on this matter the PSI has remained silent.

As outlined in my first submission it is my opinion that any delivery service which is not carried out by a pharmacist in person meets the definition of “Mail Order Pharmacy” as laid down in the 2008 regulations. Not with standing this I wish to outline the reasons why I feel that delivery by anybody but a pharmacist or at a great distance can result in a poor outcome for patients.

It would very difficult to ensure that the patient received proper advice about their medication. Presuming that some counselling was offered via telephone for instance it would be impossible to give proper directions on inhaler technique for instance. All the more so with the multiple types of inhalers now available. Also it would be important to indicate the correct amount of a topical preparation to be applied and where it should be applied. This is of particular importance when dealing with steroid creams.

It would be unlikely that there could be timely delivery of medications which would require immediate commencement. Short course antibiotics are the first that spring to mind. Similarly additional or inhalers of a higher strength for exacerbation of various pulmonary conditions. Also anxiolytics for patients who are undergoing a crisis. Presuming that it may be permissible to dispense against a faxed copy pending receipt of the original prescription there would be a significant time delay in delivery to anywhere but local addresses. This presumes that the patient would have access to a fax machine and that confidentiality could be guaranteed at both ends. In all but exceptional cases dispatch of the POM would need to be withheld until receipt of the original prescription form. This is in cases where the patient may send an electronic copy to the pharmacy offering the delivery service and then have the prescription dispensed in another pharmacy. One would immediately think of possible abuse of psycho-active medicines.

In cases where a POM is needed urgently the patient may well choose to have the prescription dispensed locally. In this instance the dispensing pharmacist would have no knowledge of any other POMs that the patient may be taking. The patient may volunteer the information but might only be able to give an incomplete picture. This can also occur in reverse where the remote pharmacy is unaware of any POMs that the patient obtains locally. While this can happen at present it is the general practice that most patients on long term medications attend just one pharmacy. The chances of this occurring if delivery services become widespread is much higher.

Next I wish to touch upon who would actually receives the medication from the delivery person. There is no way of ensuring that the POM will be handed to the patient or their carer. Several scenarios can arise. A child, another family member or a house mate may answer the door. In my own pharmacy I would be reluctant to hand a POM to a minor without being aware of the back ground. Handing the POM over to another family member or a house mate can lead to a breach of patient confidentiality. All of these scenarios may follow when there is somebody to answer the door. But what if there is nobody home? Is it left with a neighbour? Or is it to be left in the delivery van over night to attempt delivery the following day or returned to the pharmacy to await further instructions. If medications are to be left in the van over night what of the storage conditions. Excessive heat in summer and cold in winter can affect the stability of medicines. And what of the security of controlled drugs. In a pharmacy setting we must store the completed CD POMs in the safe until it is handed over to the patient. Could this be replicated in a couriers van? What would be the status of thermolabile POMs? Would delivery vans be required to maintain a proper cold chain?

Delivery services would introduce a new element to out two tier health service. Patients with medical cards would not be attractive to these pharmacies. The reimbursement rate for ingredients at below cost and a fixed fee of €3.50 per item means that the costs of a delivery service would most likely exceed any possible return.

The costs of delivery would lead to a situation similar to other jurisdictions where several months supply are delivered at one time to reduce costs. This is already discouraged in the PSI’s guidelines. It is not in the patients interests to have large quantities of any medication present in the home. The risk of poisonings or over-dosage, either accidental or otherwise is much higher when several months supply are present. This is all the more so in the case of psycho-active medications which may be prone to abuse by the patient and other members of the household. The delivery of several months supply does not encourage the rational and proper use of medicines. There is also an economic cost as frequently medication regimes are subject to change. Unused medicines would have to be disposed of properly giving rise to further costs. It would not be wise (or possibly ethical) to send out further supplies of new POMs when large quantities of discontinued medications are still present in the patient’s home. There may also be pressure from patients to have unused medications returned for credit. When they are told that pharmacies are unable to credit them as they cannot re-use them the temptation for the patient to keep them becomes greater. This would further increase the risk of over-dosage or poisoning leading to further costs to the health services.

It is for these reasons amongst others that there is a prohibition on dispensing more than one months supply in the PSI’s guidelines. However there does not seem to be any effective way of enforcing this.

The PSI’s Code of Conduct for pharmacists states

The practice by a pharmacist of her/his profession must be directed to maintaining and improving the health,wellbeing, care and safety of the patient. A pharmacist must employ her/his professional competence, skills and standing in a manner that brings health gain and value to the community and the society in which she/he lives and works. A patient is a person who stands in such a degree of relationship to a pharmacist that the pharmacist ought to reasonably apprehend that such a person’s health, well being and care are likely to be affected by the acts or omissions of that pharmacist.”

I find it hard for any pharmacist to meet this requirement without actually meeting the patient. The very concept of a remote delivery service falls very short of the ideal of trying to provide the best professional care to patients.

Again, from the Code of Conduct;

” a pharmacist must ensure that their professional judgement is not impaired by personal or commercial interests including incentives, targets or similar measures”

A delivery service for POMs from a remote location can only be driven from a commercial considerations. In such a service the commercial consideration would take precedence over the patient’s welfare.

The various pharmacy wholesalers already operate a delivery system for POMs to pharmacies. Even with their experience and professionalism there are still mistakes. Orders go astray, items go missing or arrived damaged and unusable. At least in these situations there is the pharmacist present to intervene before any of this reaches the patient. It goes without saying that any delivery service from the community pharmacy to the patient also runs the same risks as this. The absence of a pharmacist as the final link to protect the patient gives rise to great risks for the patient.

Any sort of large scale delivery service of POM’s from remote locations would undermine the economic viability of many pharmacies especially the smaller ones. Declaration of interest here. I own and operate as my main source of income a small independent pharmacy. Many of the state schemes are now operating at break even at best. The state pharmacy service is effectively being subsidised by the private patients. If the bulk of private prescriptions are cornered by a pharmacies offering a delivery service then the economic base of all pharmacies will be affected. Depending on which figures that you look at this could lead to the closure of up to 700 smaller pharmacies. Earlier I mentioned that patients may need some POMs urgently. If the local pharmacies are closed then this may not be possible. One of the biggest advantages to the state and the public is access to free advice from a healthcare professional from a pharmacy service in practically every town and village in the country. If the economic basis for many of these pharmacies goes than patients will suffer hardship through having to travel further distances and the subsequent delay. The state will face higher costs in poorer patient outcomes and increased social welfare payments for staff of the closed pharmacies. The importance of a rural pharmacy service is recognized in Northern Ireland where the state pays an allowance for pharmacies in remote and disadvantaged areas.

In brief it is in the patient’s best interests to have regular contact with their pharmacist. It is also in the state’s best interests for the pharmacist to keep regular contact particularly with vulnerable patients. The pharmacist cannot meet their ethical and professional obligations as outlined in the Code of Conduct without meeting the patient face to face. While a certain cohort of patients may see a financial benefit in a remote mail order/delivery service in the long run it will lead to poorer patient outcomes and increased costs to the state.

Third

Some additional points
The draft guidance make no mention of distance for deliveries.  Is it to be acceptable for a pharmacy in Dublin to deliver to a patient in Cork?  Or what distance would be acceptable?
Neither does the guidance make any mention of quantities that may be delivered.  I presume from other guidances issued by the PSI that one months supply would be the maximum amount which should be supplied.