Wednesday, January 24, 2007

GOOD PHARMACY PRACTICE IN SRI LANKA

In a flourishing market economy, private providers have started to play a dominant role in Provision of pharmaceutical care. In such a scenario, the state’s objective of providing safe and Efficacious drugs to the consumer may loose to maximisation of profits by the private provider.The role of profit maximisation is more often associated with the risk of low quality of the practice at private pharmacies.

Policy analysts have identified mechanisms such as regulation, advocacy and monitoring as mechanisms to liaise with private providers. The state lays down rules, regulations and enforces such legislations through a legitimate body. In Sri Lanka, the relevant legislation is the Cosmetic Devices and Drugs (CDD) Act No27 of 1980, amendments No 38 of 1984, Act No27 of 1987 and Act No 12 of 1993. Cosmetic Drugs Devices Regulatory Authority (CDDA) exercises the enforcement of the act for the state. It is the duty of the authorised officers to ensure the provision of safe efficacious drugs to the consumers. In addition to the Food and Drug Inspectors (FDI), Deputy Provincial Director of Health Services (DPDHS) and divisional public health authorities such as the Medical officer of Health (MOH) have been specified by the CDD Act as authorised officers.

In order to provide safe and efficacious drugs to the consumers at the pharmacy level, it is imperative that these officers ensure the compliance with Good Pharmacy practices (GPP) by the pharmacy staff. GPP is defined as “the practice of pharmacy aimed at providing the best use of drugs and other health care services and products by patients and the members of the public”. It emphasises that the welfare of the consumer is the prime concern at all times.

The elements of GPP can be categorised in to seven broad groups: licensing, physical environment of the pharmacy, order in pharmacy, storage of drugs, and maintenance of cold chain, dispensing and documentation. A recent study carried out in urban areas of Gampha district and rural Polonnaruwa district has focussed on the status of compliance with the GPP at retail pharmacies.

A substantial floor area is a pre requisite for issuing recommendation for licensing of a pharmacy. Though a floor area of more than 120square feet is a pre requisite for recommendation for licensing, It has been highlighted that this has not been adhered in certain occasions. Inadequate floor area of pharmacies presents problems such as difficulty in movement, lack of space to fix a wash basin and for proper placement of refrigerators. Improper placement of a refrigerator may adversely affect the maintenance of the cold chain thereby perishing lifesaving drugs while inadequate space to move about may influence the efficiency of dispensing medicines.

Another pre requisite for issuing a licence for a retail pharmacy is the availability of a water supply with the requirement of a wash basin with its location in an easily accessible place. According to the study, this has been poorly adhered to in majority of pharmacies in the study areas. Some pharmacies did not have spacious premises to locate a wash basin while the reason for non availability of a wash basin in certain pharmacies which had adequate space was mere ignorance of this requirement. It was elicited that the reason for recommending license without fulfilling these pre conditional requirements was to improve the access to drugs. However, it is clear that such a move drastically reduces the quality of pharmaceutical services offered by the pharmacies.

Drug regulation 43(b) specifies that the premises shall have proper storage conditions for preserving the properties of drugs. In Sri Lanka, the average room temperature exceeded300C and this had been observed in majority of inspected pharmacies. Installing air conditioners was affordable only to a handful of owners of large-scale pharmacies. The High ambient temperatures of the pharmacy interior pose a problem for drugs that should be kept within 15-25 0C. The question of the efficacy of these medicines arises as a result of prolonged exposure to these temperatures exceeding 250C.Testing of these samples is thus essential to ascertain the quality failure.

Another issue that was highlighted in the pharmacy study was the inadequate coverage of an alternative power supply to be used in an event of prolonged power failure. Of the pharmacies which did not have an alternative power supply, almost all did not have an alternative arrangement to move vaccines and other drugs that needed a storage temperature between 2-8 C in an event of a prolonged power failure. This presents an inherent danger in terms of providing efficacious drugs to the consumers as Pharmaceuticals that need a storage temperature between 2-8 C are found in majority of pharmacies. Vaccines for human consumption were also available in more than two third of inspected urban and rural pharmacies while veterinary vaccines were available only in 1/3 of the pharmacies.

The commonest vaccine that was found in private pharmacies in both urban and rural district was the Tetanus Toxoid. Two thirds of the pharmacies had this vaccine. In rural pharmacies, other types of vaccines were not available. This reflects the low demand of vaccines in the private sector due to the better access to vaccination in the public sector. This was almost similar in the urban sector. However in a handful of pharmacies in the urban sector, Oral Polio, Measles Mumps & Rubella(MMR), Hepatitis A, Hepatitis B, and Haemophilus influenza
B (Hib) vaccines were available.

Though the maintenance of the temperature was an important aspect of ensuring the potency of vaccines and drugs, the temperatures inside the refrigerator exceed 2-8C in majority of pharmacies. Thermometers were not available. Recording of the temperature had been carried out only in exceptional cases. Since pharmacies are business premises, drugs, food and beverages are stored together in the refrigerator. As a result, the space of the drugs food and beverages took up more than50% of the total space in refrigerators in many pharmacies. Frequent opening of the refrigerator and the warmth of food and beverages cause the temperature to rise within the refrigerators affecting the potency of the drugs. Non availability of water bottles and icepacks also increase the temperature within the refrigerator. Additionally, practice of compact storage of vaccines, drugs, foods and beverages cause poor circulation of air between drugs and vaccines.

In majority of bigger pharmacies, the drugs had been stored even in doors of the refrigerator exposing them to the room temperature whenever the refrigerator was opened. However, smaller pharmacies do not stick to this due to the small numbers of vaccines and refrigerated drugs in their refrigerators.
All these observations suggest the questionable potency of drugs and vaccines available in pharmacies. In Contrast to this, in the public sector, there is a well established system of monitoring of Cold Chain. Cold Chain monitors indicate the need for quick use or discarding vaccines. There are hierarchical officers who monitor the cold chain ensuring the efficacy of the vaccine.

In Sri Lanka, as the majority of pharmacies are situated facing to motorable roads, dust is very common. However, the contamination with dust can be minimised by adhering to the practice of shutting down doors of shelves after transactions. In certain pharmacies, there were expired drugs contrary to the regulation 46 (b) of the CDD Act. The finding is suggestive of some deficiencies: inadequate or infrequent inspection by authorised officers, owners/staff not willing to have regular inspection of shelves and removal of expired drugs and non availability of a system to identify slow moving drugs when the expiry dates are close. The other danger is that the slow moving expired drugs especially when not dispensed in original pack can be sold to the clients.

The other biggest concern was the non availability of a proper mechanism to destroy expired drugs. The expired items are discarded to the rubbish collection in many pharmacies and subsequently removed by garbage disposal units of the local bodies as only a handful of drugcompanies collect expired items. This contravenes the Regulation No.72 of the CDD Act which specifies that any drug which fails to confirm to the specified standards or the storage life of which has expired shall be destroyed under the supervision of an officer authorised by the authority.

The CDD Act has clearly specified its objective of providing safe and `efficacious drug supply to consumers. The Sri Lankan experience demonstrates that there is a divergence of the service provider’s objective of profit maximisation from the objective of the CDD Act. As pointed out by health policy analysts, regulation and monitoring remain the core mechanisms to approximate these two objectives. Many of these deficiencies can be corrected within the current system. In order to effectively implement these regulatory mechanisms, routine monitory mechanism should be strengthened with introduction of targets for the officers involved.

It is imperative that more focus should be on the storage of drugs including cold chain items. At the district level, the services of the Regional Epidemiologists can be used by the Deputy Provincial Directors to improve maintenance of cold chain at private pharmacies. Regional Epidemiologists are specially trained by the Epidemiology Unit to supervise maintenance of cold chain in curative and preventive institutions in the public sector. As the CDD Act specifies the Medical Officer of Health as an authorised officer, he can also be utilised for this purpose. Independent monitoring of the elements of GPP by MOH in addition to the FDII will be an additional measure to improve the provision of efficacious drugs to consumers. As the disposal of bio waste remains a problem in relation to drugs, it is timely to consider a central low-cost model bio-waste plants at district levels. Mechanisms need to be worked out to collect and safely dispose of expired drugs under the supervision of authorised officers at the district level.
( AN ARTICLE PUBLISHED IN THE WEEKLY EPIDEMIOLOGICAL REPORT-WER OF THE EPIDEMIOLOGICAL UNIT OF THE MINISTRY OF HEALTH CARE, SRI LANKA)

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